 We are on the record at 9.12 a.m. August 28, 2015 in the matter of Commonwealth of Kentucky Pike Circuit Court Division 2, Civil Action Number 07-CI-01303, Commonwealth of Kentucky versus Purdue Pharma. This is the deposition of Dr. Richard S. Sackler, if I could have the attorney state the name into the records. Do you want to just go ahead and read the list of names? I'll tell you what, just go ahead. Let's just say our name. We'll pick it up. Jason Sayers on behalf of Abbott. Dan Danford on behalf of the Purdue Defendants. Donald Straber on behalf of the various Purdue Defendants. Oh, sorry. Richard Silver in-house at Purdue. Jay Henneberry on behalf of the Purdue Defendants. Tyler Thompson on behalf of the State of Kentucky. Anthony Ross on behalf of the State of Kentucky. Ed Mitchell Denham from the Attorney General's Office, behalf of Kentucky. Did you state your name please? Richard Sackler. And you are here today to give testimony in a case pending against Purdue various entities by the State of Kentucky. You're aware of that? That's my understanding. Mr. Thompson, before you get started, I'd just like to note that I expect we will be designating portions of this transcript as confidential pursuant to the order. Is that correct, Mitchell? Yeah, it is. Sure. Okay. We want to disseminate it until you all designate and we respond. There's a certain period in the rule when you get shot. Right. And just so you know, I know you're not from Kentucky. Is that correct? That's correct. All objections other than to the form of the question are preserved in Kentucky. I'm going to start with a quick question from the bottom of the video. What is your current role at Purdue? Excuse me, there are a number of defendants with some portion of Purdue name and the distinction can be significant. So I'd ask when you phrase your questions, specify which Purdue entity you are talking about. Well, let's talk about the number of Purdue entities there are. How many Purdue entities are there? I don't know. There are upwards of 69 different corporations perhaps that the Sakura family owns. Is that correct? If you've counted them, I can't differ with you. I don't know the answer. There are a number of Purdue entities. The Purdue Frederick Company Inc. Does it still exist? I don't know. Tell me what companies that you currently have a role with that involve Purdue? Purdue Pharma. Do you sit on the board of any other Purdue companies? Not to my knowledge. What about Mundy Pharma? I sit on the board of a consulting firm which consults to Mundy Pharma. Does the Sakura family own Mundy Pharma? Yes. What about what is Mundy Pharma? Mundy Pharma is a name that is attached to many different companies such as just similar to Purdue. Is that company over in Germany? There is a Mundy Pharma company in Germany. What about Roxanne? Does Purdue own Roxanne? No. Did they own Roxanne in the past? Never. Do you know how many current companies are owned by the Sakura family? No. In discussing Oxycontin, how many companies were involved in the production, manufacturing or distribution of Oxycontin? Could you specify the geography? In the world. Many. I've never counted them. Does Purdue do licensing agreements with other companies to sell Oxycontin? It does. Do they own parts of those companies? No. How many companies does Purdue own that distributes or dispenses Oxycontin? Many. Can you tell me the names of them? A few of them, but not all of them. Are you still the director of Purdue Pharma, Inc.? I'm not sure. Are you still a general partner of Purdue Pharma LP? I am not. It is owned by two trusts. In July 30th of 2014, were you a director of Purdue Pharma, Inc.? Not that I'm aware. This is a affidavit filed in the southern district of West Virginia. And does that appear to be your name? That does. Once dated July 30th, 2014, it says declaration of Dr. Richard S. Sackler. I am a director of Purdue Pharma, Inc., the general partner of Purdue Pharma LP. I've held this position since 1990. That's what it says? And that's what it says? How involved were you in the production and marketing and promotion and the training and management of Purdue sales representatives for Oxycontin? I object to the form of the question. Should I answer? Go ahead. You can answer. It depends on the time. And when you say it depends on the time, why do you say that? Because I was involved in the areas at a supervisory level, not as an active level, for a period of time that began with the launching of Oxycontin and ended in early 2003. When you were involved on the supervisory level, but not the active level, how much of your day-to-day activity was devoted to Oxycontin? It varied enormously. In this declaration, it says, during the time period set forth in the amended complaint, 1996 to 2009, I was not directly involved with the day-to-day marketing or promotion of Oxycontin, the training or management of Purdue sales representative, scientific research into the conversion ratio from MS-contin to Oxycontin. Those responsibilities principally fell to Purdue senior management in research and development, regulatory affairs, sales training and marketing, among others. Is that accurate? Yes. I want to show you an email Dr. Sackler dated Monday, May 31st, 1999. Do you know who Dr. Cornelia Hinch is? I do. And who is that? She was general manager of Munda Farma, Australia. Okay. And to give us a little bit of context, you all had a drug called MS-contin, a morphine sulfate that was an immediate release narcotic opioid or narcotic. Is that correct? It was controlled release. Controlled release, I'm sorry. And that was used primarily for cancer patients or malignant end patients. Is that correct? Majority of use, yes, but not... I don't think primarily conveys an accurate picture. Majority of use was for... Over 50%. It was sort of felt by Purdue Farma that morphine had a stigma attached to it that kept doctors from prescribing it across the board. Is that accurate? Yes. And you all had a... May I amend that? Yes. It didn't prevent doctors from prescribing it across the board. It was an inhibition to the use of the product in every application. Okay. Have you ever gone back and studied the history of addiction and how it has played out in the 19th and 20th century? I'm not a student of that literature. All right. What was your understanding of why doctors did not want to prescribe morphine for anything or had a stigma about prescribing it for anything other than cancer and malignant pain? As I said before, the stigma prevented many physicians from prescribing it for any pain. Why do you think that stigma existed? I'm not a student of the issue, but I believe the stigma existed because of a popular understanding shared by both professionals and by laymen that morphine was an end-of-life drug if it was to be used at all. Okay. Were there concerns about addiction and dependence with respect to morphine? Some people had those concerns. Going back to building our context here, you all had a drug called MS-Contin that you had the exclusive right to sell. Is that correct? That's correct. Do you know when that exclusivity was set to expire? I'm not certain that I know the date. Do you recall that one of the concerns that Purdue's senior management had, I'm using Purdue in relation to Purdue companies that are involved with OxyContin, and rather than just sit here and name them all out, can we agree that when I say Purdue, I'm referring to Purdue companies involved with OxyContin? That's correct, because I said at the outset there are different Purdue entities that are defendants in the case, and the distinction between them may at times be significant. And so if you lump them all together under Purdue, we're going to get a record that will not be easily decipherable at the end. Let's talk about it then. Which Purdue companies were involved in the cell and distribution of OxyContin? Both Purdue Frederick and Purdue Pharma were involved in the early years of selling the product. Were there any other Purdue companies involved in the selling of the product? Not in the U.S. Who had the exclusive right to sell MS-Contin? At first, it was Purdue Frederick. I don't know at what point Purdue Pharma acquired rights to sell it, or if it did at all. What is the distinction between Purdue Frederick and Purdue Pharma? Purdue Frederick was the original company that my father and uncle acquired in 1952. It was a shell company, and it was the first pharmaceutical company that they owned. Purdue Pharma was established in the early 1990s to take on new products and to also take on the risk of new products and also a few established products. But not all. Were there any actions taken with respect to Purdue or with respect to OxyContin that would not fall under the Purdue Pharma umbrella? I'm sorry, could you repeat the question? Are you maintaining that there are any actions done with respect to OxyContin? It's creation, production, marketing, sales that do not fall under the Purdue Pharma umbrella. Its creation was done in Purdue Frederick until the early 90s when that responsibility was transferred to Purdue Pharma. And then Purdue Frederick continued to exist though, correct? It did. And was Purdue Frederick also a company involved with marketing, promoting, sales and production of OxyContin? I'm trying to give you an accurate answer because this is confusing and complex. There was a period of time in which once Purdue Pharma became involved, that Purdue Frederick was involved. But Purdue Frederick was never involved nor Purdue Pharma in manufacturing the drug, which was, when it was developed, was manufactured by a company named PF Laboratories. Okay. Other than the manufacture, did Purdue Frederick and Purdue Pharma both play a role in the... I can't recall in detail whether they both played a role or whether when Purdue Pharma took on the project it carried most of the weight. Is there any difference between the employees of Purdue Frederick and Purdue Pharma? There were differences. Any difference in the board of directors? That would test my memory and I'm not sure. All right. Well, let me go back to... Let's talk about OxyContin. And I'm going to use the term Purdue for both Purdue Frederick and Purdue Pharma. If at some point you feel like there's a distinction to be made, you let me know, okay? But at a time when... Mr. Thompson, I object to your combining the two under the name Purdue. If you're going to do it, then I'd like to have a standing objection to that combination. What is your reason for the objection? My reason is, as Dr. Sackler has explained briefly, there were two entities that did different things at different times. And if you lump the two together, inevitably there's going to be confusion in terms of the witness's answer. Okay. Let's do this. I'm going to refer to Purdue as Purdue Pharma LP and also Purdue Frederick LP. If at some point you feel like it's only Purdue Frederick or only Purdue Pharma, you let me know, okay? It's kind of a burden, but with the help of my attorney. Sure. Because there may be issues. It's going to be, it tests my memory to separate the two. So I'm sorry for the confusion, but it is important. For instance, let me ask you this, sales reps. Were sales reps employed by Purdue Frederick or Purdue Pharma? For a period of time they were, each sales rep was employed by one, but not necessarily the other. Do you know which sales reps were employed by Purdue Frederick or Purdue Pharma? I don't know. Do you know if they received different training? I believe the training was the same. I'll tell you what, I'm going to refer to, when I say Purdue as Purdue Frederick, if you feel like it's Purdue Pharma, you let me know, okay? Okay. All right, so back in the 1990s, when you were developing MS-Contin, this exclusive license that you had to sell MS-Contin was going to expire, and there was going to be competition from generic companies, correct? Well, the product MS-Contin was developed in the late 70s and early 80s. And so are you discussing development or are you discussing a later time? The later time when its license is about to expire. Eventually, we knew that there would be competition for MS-Contin. And one of the things that, in developing Oxycodone controlled release, one of the concerns was how to position it for market and whether you were going to position it and obsolete MS-Contin or try to position it alongside MS-Contin. Do you recall that issue? I object to the form of the question. Could you repeat it? I'm not sure I understood. Yes. One of the concerns when you were developing Oxycodone or, I'm sorry, Oxycontin controlled release was how you were going to position it for market share and whether you were going to position it and make MS-Contin obsolete and take that market share that MS-Contin had or whether you were going to position it alongside MS-Contin and sell them both together. Do you recall that concern? I recall discussions, but that wasn't the principal driver. The principal goal was to produce the best product we could, and we believed when we started it and subsequently, should I stop? No. We believed it was and is a better product than MS-Contin. Thank you. Here's a memo dated to Richard S. Sackler from Robert Kaiko. Do you know Dr. Kaiko? I do. He's a PhD. He is. What was his role? He was the person who undertook or ran the project and was involved in the project of developing Oxycontin and was, as a clinical pharmacologist, was deeply involved in selecting formulations that would be most likely to achieve the desired effect. And under here it says rationale for another controlled release opioid analgesic. This is Bates number. It's actually got two Bates stamps, so it's PDD 9520805292. But it says rationale for another controlled release opioid analgesic. MS-Contin may eventually face such serious generic competition that other controlled release opioids must be considered. Other pharmaceutical firms are thought to also be developing other controlled release opioid analgesics. Mr. Thompson, if you're reading from a document, could you show it to the witness? Sure. That's why I was holding it over here in the front. It's hard to read from that distance. One extra copy? Yeah. Great. Great. Just always handy. Do you have a copy for me? We'll see. Thank you. So do you see down there the second highlighted portion that says rationale? Mine is not highlighted. So. Yeah. I'll tell you where I go. Okay. Okay. So the second highlighted portion, rationale for another controlled release opioid analgesic. And do you see the first sentence below that? I see. That's a cross title. Yes. I was looking at the text. And the text below that says MS. Cotton may eventually face such serious generic competition that other controlled release opioids must be considered. Other pharmaceutical firms are thought to be, to also be developing other controlled release opioid analgesics. Did I read that correctly? You did. And was that a concern at that time? It was a secondary or tertiary driver. And then if you'll turn to the next page and look at the second paragraph and I'll read that, it says, while we have reason to believe that other pharmaceutical firms are formulating controlled release morphine and controlled release hydromorphone, there is no evidence to date that this is being done with oxycodone. A controlled release oxycodone is thus less likely to initially have generic competition. And was that a consideration when deciding to come out with oxycodone or oxycontin? Not for me. All right. Now, we read your paragraph 11 where you discussed that you had limited role in the tone. Do you have a copy of that? Yes, paragraph 11. Let's make this exhibit one to the deposition. Need to see that backwards. Is this the same as this? Thank you for underlying. Yeah. And this declaration said that you were not directly involved with the day-to-day marketing or promotion of oxycontin, the training or management of the produced sales representatives, or the scientific research into the conversion ratio of MS-contin to oxycontin. Is that correct? That is correct. I want to show you an email. Let's mark this exhibit two to the deposition. Which one is it? Allow me to just clarify. I'm emphasizing directly involved. I didn't do any of the work. I didn't do any of the training. I was not a salesperson. But as a senior executive, I certainly was aware of what was going on. And I consulted with other senior executives about what was going on and what should be going on and so on. And then this email that was just handed to you a few moments ago says, again, it's Cornelia Hinch. It's dated May 29, 1999. It says, if you'll read the highlighted portion, it says, this is an email from you to her, correct? Yes. It says, you won't believe how committed I am to make oxycontin a huge success. It is almost that I dedicated my life to it. After the initial launch phase, I will have to catch up with my private life again. Did I read that correctly? You did. When you say you dedicated your life to it and that you have no time for your private life, what were your day-to-day activities with respect to oxycontin? May I read the whole document? I haven't seen this for 16 years. Have you read your deposition in the endo litigation? In preparation for this? Yes. No. The context of this was to encourage Dr. Hinch, who was the head of the Australian business and was meeting with great success with MS Com to pay perhaps more attention than I thought she was paying to the prospects of potential for oxycontin. And so this was in the spirit of motivating her. It was true that I was very gladdened to see that oxycontin was meeting with such a strong, positive reception by both physicians and patients. And I was working hard at the business, but you would misinterpret this if you thought that I was working only on oxycontin. That was not the case. Thank you. When you say you were encouraged by the number of physicians that were selling it? Prescribing it. Prescribing it. You were not aware at this time were you, or were you aware that your company was committing a felony in how they were marketing and branding the drug? I objected to the form of the question. I was not aware at all of what you're saying. And when I say I was heartened by physicians' reception, when I did speak to physicians at meetings, I didn't go on sales calls, but at some meetings and conferences, they were extremely enthusiastic about the effectiveness and the safety and the reception their patients had, response they had to the product. That was what I was referring to. Because, as I had told you before, our goal was to make a better product than MS-contin. And I believe this was one of the ratifications of that. Let's mark this exhibit. Three. You already had it. No, the witness has it. I think you're having it in front of you and your hand is physically on it. Can you tell me? I don't see it. You're holding it. One and two. That email that you have your hand on. There's three. I've marked it twice. That may be the problem. Yeah, it just got marked twice. If you've marked it twice, it's a three and two of the same. Okay, then I have it because I have two. And we'll get into this a little more later on, but you're aware that Purdue pled guilty to a felony charge of misbranding a drug, which was Oxycontin, with the intent to defraud or mislead. You are aware of that, correct? That is Purdue. That is Purdue to your earlier statement. That is Purdue Frederick, is that right? Okay, so when you said Purdue, you meant Purdue Frederick. Purdue Frederick Company each. Yes, I am aware. Is it your understanding that the fraud only occurred with respect to the Purdue Frederick Company and not with respect to Purdue Pharma LLP? That's my understanding. But I'm not an attorney in them. That's a very deep legal question. Did you do any investigation to find out whether sales reps employed by Purdue Pharma were exceeding what they were allowed to do when they were marketing, that they were making claims that were untrue? You have objection to form, you can answer. When you say you, are you referring to me personally or are you referring to the company? I'm referring to you personally. I did not conduct or manage any investigation, but from the time we learned at top management levels that there was an abuse and diversion problem, which was years before the settlement with the government, we launched multiple investigations, both with inside resources and people and with external attorneys and others to identify, and this was before any charges were made, to identify if we had, in any sense, misled or caused this to happen. More important, we spent enormous resources to try to mitigate the problem, whatever the cause was. And that effort, which was launched sometime in 2000 or 2001, continued right through the period that you're referring to of the plea with the U.S. government. And did you all launch this investigation as soon as you learned there was a problem? Yes, within months or weeks, I can't recall. 16, 15, 16 years ago. Who's Michael Friedman? Michael Friedman was at that time the head of sales and marketing. Have you seen his presentation at Purdue that he... You know what at Purdue is? The Bureau's internal newsletter that goes out to all the employees. I don't believe I saw a presentation at Purdue from him. We'll get to that later. This is a memorandum dated July 15, 1992, meeting with Shia Nugi held Wednesday, July 24, 1992 from Dr. J. W. Watkins. And there's a distribution list. And I assume you are Dr. R. S. Sackler. Is that correct? That would be me. And if you would turn to page six of this document, that is PDD 1701546226. And to give it a little context, Shia Nugi, is that a Japanese company? It is. At one time were you all talking about doing some sort of business with them involving potentially OxyContin controlled releases? Yes. And did you do business with them involving OxyContin controlled release? Yes. Let's look at page six if you would. The... Looks like maybe the third paragraph down that begins with Dr. Kaiko. Yes. You see that? Dr. Kaiko presented two options identified for positioning of OxyCodone acrocontin. Now, is that the controlled release? That was our working title of the controlled release system. Versus MST-contin tablets in the U.S. The first was relevant if PF, who's PF? Purdue, Frederick. Did not suffer substantial erosion of its MS-contin market by generic competition. This envisioned using OxyCodone acrocontin tablets over the entire spectrum of pain in patients whose treatment had been initiated with this product whilst MS-contin tablets would be used as therapy for chronic, severe pain in patients who were changed from other medication including OxyCodone acrocontin tablets. An alternative scenario would apply if MS-contin tablets were subject to erosion by generic competitors. In this case, OxyCodone acrocontin tablets would be promoted for the use across the entire pain spectrum including those patients who might otherwise receive controlled release morphine. Did I read that correctly? You did. And was it your intent to promote OxyContin controlled release across the entire pain spectrum? Where you're referring to Japan, which is where Shianogi either had or was negotiating a license for OxyContin. Was it also your intent in the U.S. to promote it across the entire pain spectrum? It was our hope that it would be well received from pain moderate to severe pain requiring opioids. Let's mark this as exhibit. And here is PDD 9524706426. OxyContin launch team memo dated 33195. And OxyContin was actually launched in January of 1996. Is that correct? That sounds correct. And what this says, if you will turn to page three. First of all, let me ask you this. Do you recall having any significant problem with MS-contin with respect to addiction, abuse, diversion or any of the problems that you experienced with OxyContin CR? I recall never hearing about that. So let's look at page two, the last paragraph. It says, our meeting ended with a question and comment period. Michael Friedman emphasized the threat that AB rated generics posed to MS-contin. We're not sure when AB rated generics will be launched, but we don't think it will be until 1996. Inevitably, AB rated generics will arrive and this is why it is of extreme, timely importance that we must establish OxyContin. OxyContin can cure the vulnerability of the AB rated generic threat and that is why it is so crucial that we devote our fullest efforts now to a successful launch of OxyContin. Did I read that correctly? You did. And who is Lydia Johnson? I don't know. This department, it looks like it's the marketing department. Is that right? I just see a distribution list. I don't see a source. I don't know. It says that the department is marketing, but I don't know Lydia Johnson. Was it your belief that it was of extreme, timely importance that OxyContin be established because AB generics were going to arrive and compete with MS-contin? No. Let's mark this as exhibit four. No, we already have four. I'm sorry. Then this would be five. Is this what he's reading? That would be a question for these gentlemen. I think you already marked this, Tom, as four. Pat, don't worry about marking it. We'll make sure it gets marked. It has been ordered. Yeah, okay. Okay, I'm sorry. Where are we on the numbers? I don't think this has been marked as an exhibit. I thought the launch team memo was included. No, four is something at a research center. The Japanese government. No, this has not been marked as an exhibit. So that's five, right? It'll be five? I'll keep track. Yeah, this should be five. Okay. Dr. Sackler, do you know how much money to date has been generated by the sale of OxyContin? I don't understand the question, money generated. How much money has Purdue Frederick or Purdue Pharma made off the sale of OxyContin? I don't know. Okay. There was an article last month in Forbes. The OxyContin Clan, the 14 billion newcomer to Ford's 2015 list of the richest U.S. families. Have you seen that? I have seen it once. Do you know what percentage of Purdue Pharma's sales is made up of OxyContin? Presently? Yes. Approximately two-thirds. I've looked at the... That's Purdue Pharma's sales. Purdue Frederick does not sell anymore, correct? You've got another number of other entities that generate income from the sale of OxyContin, correct? Overseas. Yes. And approximately 90% of the profits of the company come from OxyContin. Question. The company you're referring to now, Purdue Pharma? Purdue Pharma. I don't believe it would be 90%, but it is certainly a majority. Do you currently make over a billion dollars a year selling OxyContin? Objection is the form I do. By you now you're talking about Dr. Sackler. Yes. No, I don't. All right. Does Purdue Pharma make over a billion dollars a year? I'm not sure. I don't think it would be that much. Let's talk about gross sales. Are gross sales over three billion dollars a year? No, they're not. What are the gross sales? Well, I think what you're looking for is net sales because in the industry, a lot of money is inherently rebated back to purchasers, insurance companies, hospitals, et cetera, through wholesalers in rebate agreements which are negotiated. And so I believe the net sales are in the range of this year a billion dollars. Your question was directed to Purdue Pharma. Right. Purdue Pharma. Right. Are there any other Purdue entities that make money that would not be included in that $1 billion sales? Not in the... The connection to the form of the question. You can answer it. Not in the United States. Do you know how much the Sackler family has made off the sale of OxyContin? I don't know. But fair to say it's over a billion dollars. It would be fair to say that, yes. Do you know if it's over $10 billion? I don't think so. You know if it's over $5 billion? I don't know. All right. This appears to me... It's been marked as exhibit five. It's PKY6. exhibit six. PKY173810206. Appears to be a profit calculation for a Purdue entity. Can you tell me which entity that is? If it's not on the document, I couldn't possibly tell you. Did Purdue Frederick still exist in 2006? I'm not clear. I think it did. This appears to be a profit calculation for OxyContin tablets only. Do you see that? I do. And it appears that at least by 2006 profit contribution was $4,718,767,000. Correct. You've read the number correctly, but profit contribution is not profit. And what would you subtract from that? All of the money that was invested in the business to develop new products would be a major deduction from that. Let's mark this... Well, let's... You're right. I think it is. Look up at the top where it says gross profit. $7,502,367,000. That's a second. Small type. That's a second. Gross profit. See, gross sales. I say rebates and net sales. Okay. I'm with you on gross profit. Thank you. So deducted from that is shipping warehousing. You have $536,000,000 paid to Abbott for co-promotion commission. That's correct. You have an S&P expense. What's that? Sales and promotion. All right. That was $141,000,000 on sales and promotion. Is that correct? That's correct. R&D expense, $308,000,000. Right. And I'm looking for the number. I'm sorry. Sales force? Yes. I see that. But can I explain? That's the R&D associated with the product. Right. Not the R&D for other products. Right. And then sales force is 960 or 87,222,000 that they've been paid. That's what it says. And then it's got a G&A expense. What is that? General and administrative. All right. $492,000,000. Yes. Over how many years? 96 to 2005. So it's nine years. Am I counting correctly? You are. Then there is product liability and patent litigation expense. You had oxycontin litigation expenses. Then you have profit after all those are subtracted on oxycontin of $4,718,000,000. Is that correct? That's what it says. I can't testify that it's correct, but that's what it says. Let's mark this as plan 6. It is marked. Do you want the original? I'm trying to go a little bit longer. If you all need a break, we can take a break. Do you want to shut down? Do I have to wait? We are off the record at 10.06 a.m. We are back on the record at 10.18 a.m. All right. That's about this. Do you have a copy of that? Somebody already didn't have an exhibit list here. Dr. Sackler, I want to ask you about one more thing in exhibit 4. If you look at the second paragraph, there's a comment that says, when discussing oxycodone acrocontin, which is controlled release oxycodone. I'm sorry. Just taught me on a little bit. Page what? The first page. Page second paragraph. Okay. It says, the molecule lacks the stigma of morphine and may be a particular advantage in the 5% approximately of patients who cannot be adequately treated with morphine. Was it your understanding that approximately 95% of the patients out there could be treated with MS-contin? No. Do you disagree with that statement? I do. I disagree. What percentage do you think of patients could be adequately treated with MS-contin? Between 50 and 75%. And what studies are you basing that on? I'm basing it on general experience of being involved with MS-contin and oxycontin since 1980. Did you ever do any studies to determine what percentage of patients could be adequately treated with MS-contin? I don't remember any. Did you ever do any studies on abuse liability for oxycontin before you all put it on the market? I'm not aware of any. Let me show you what's been identified by Bates Stamp PDD 880-112-3847. I'll ask you if you can identify this. May I have a copy? Thank you. Does this appear to be a memo to you from Paul Goldenheim? It is. Who is Paul Goldenheim? At the time he was head of research and development. And just to kind of walk through this memo from the bottom down there, it looks like you had sent a memo on March 14th of 97 to a number of individuals at... I'm looking for that. I'm looking for my... Oh, from me. Okay, I see that. Okay. I'm sorry, I see now it's two emails. Okay, thank you. And the paragraph at the bottom says the B-F-A-R-M. What is that? That was the German regulatory agency at that time. It says we're asked whether oxycontin could be classified as a controlled drug or whether it would be possible to obtain a relaxed status because of the difficulty in extracting oxycodone from the matrix. And the fact it was less liable to abuse because it was unknown. So just dialing down on that first sentence, you were wondering whether oxycodone could be less regulated in Germany. Is that correct? I believe that I was reporting something to Paul that I must have heard, but I was not involved in making any discussions or meetings with B-Fram. Okay. May I just read the rest of it if we're going to continue on this? Sure. I'll tell you, I'll read it to you. It's okay. The next sentence says the B-F-R-M, which understands the German regulatory authority. That's correct. Answered that unfortunately oxycontin would definitely be classified as a controlled drug for all strengths as is morphine. There could be no exception because of the controlled release protection because there had been a few reports of abuse and there were limited data on long-term use. Did I read that correctly? You did. Okay. And then you have here in CAPS, we have a lot of use data in the U.S. with very, very, very few ADEs. What are ADEs? Those are reports to the agency, to the FDA, and ADE stands for Adverse Drug Experience. All adverse drug experiences are reportable to the agency. Anything we are aware of, we must report periodically. Anybody else, however, can also report ADEs to the agency. And so the agency maintains a catalog for every drug of ADEs. Okay. And then you have in CAPS continuing, we can run another long-term trial to get more data. And if the abuse potential is equal or lower than with other non-scheduled drugs, would B-fram unschedule it? That's your question, correct? That was a question. And then Dr. Goldenham writes back on the subject of, is this an opening to descheduling the agent? And descheduling means make it less restrictive, correct? That's how I would understand it. And if it's less restricted, would you think that you could sell it to more people? It would be easier for physicians to prescribe it. It's going to increase sales. That is reasonable because they could prescribe it. If it were schedule three instead of schedule two, as are some drugs, physicians could prescribe by telephone. And his response is, we do not have any abuse liability studies. And this is as of 1997, correct? That's correct. To date, have you done abuse liability studies? Yes, many. When were they done? I don't know when the first ones were done, but they were done repeatedly for many formulations, subsequently, of both oxycodone and of other abusable opioids, both in controlled release form and in immediate release form. Have you done abuse liability studies for oxycodone and controlled release? Yes, the new formulations definitely. And when were those done? I don't know exactly, but before the products were submitted to the agency. You're saying the new formulations? The new formulations. When were the new formulations submitted? I'm doing this from memory now, about 2008, but I could be in error by a year or two. So by 1997, two years after this product was on the market, he says, we do not have any abuse liability studies. I think this is a dead end. Adding naloxone, I think, is the only possibility, but this is a difficult project from the clinical perspective. We are investigating for hydrocodone. Was that his response? That is what he wrote? He's basically saying they're not going to schedule this. Unless perhaps they might if it incorporated naloxone. And naloxone is an additive? It is a reversal agent. It blocks the effect of opioids. And you all did not incorporate naloxone, correct? We subsequently did in some markets, in Europe in particular, and to some extent elsewhere. Did they require you to do that? No, we did it for another reason. What was the reason? We discovered that it did not block the effect of the opioid, apparently at all, but it did reduce the gastrointestinal side effects dramatically, including constipation, which is the most common side effect for any opioid. I could add that by the time we had a full press to develop abuse-resistant form of Oxycontin, we did do extensive work with another antagonist called naltrexone. And naltrexone did, when it got released, block the effect of the opioid. But unfortunately, after a huge investment, we could never be certain that it wouldn't be released when it was taken orally. It was almost perfect, but it had to be perfect because the agency said that if it released and blocked the effect of the opioid in patients, they would not approve it. And we could not reach perfection. Let me show you an email chain that's been produced. Mark this. And it's PDD 29520806-439. And if you start at the back, I believe, this email chain begins at the back. And this is an email from you dated, the last email is the first email, and it's dated 3297. Wait, I'm seeing 31197. Oh, 3297. It's sort of a little out of order, isn't it? I'm sorry, yeah, there is my tour off. Okay. Oh, no, 31297. 22797 is the first. Okay. Pardon? I highlighted the, you know, the last page. 227, it's not, oh, it's the middle page for me. Not the last. Okay. Yep. Yeah, I'm not sure the pages have been assembled properly. Yeah. These are the, this is the way this document was produced to us. And the reason that there's a skip in the Bates range from the last two pages is because Purdue produced a totally random document in between it. But if you look at the Bates numbers of the original Bates stamp on this document, they're consecutive among those pages in a consecutive email chain. So I have taken the liberty of removing the completely erroneous page that has nothing to do with this email chain and produced it to us. I have a question about that. The question is, he has a different formulation that he's talking about. No, he's got the same document. Exactly. We're just trying to make sure that we're all working from the same document here. So if you'll go to the 22797 email. That's it. Yeah. No, I had to look for it. I expected it at the end, but it wasn't. Okay. Yes. It says, this is from Walter Wimmer at Mundy Pharma, Germany. And that's a company that's owned by the Sackler family, correct? It is. And who's Walter Wimmer? He was the general manager at that time. And he says, dear Bob, first paragraph, in the course of this conversation, he explained to you that due to his discussions with BFARM, he does see a 50% chance to get OxyContin off the narcotic drug status provided you could give some information on the very low abuse potential of our CR formulation. Did I read that correctly? You did. And then in response to that, if you go up to the top, Dr. Robert Keiko has an email dated 22797. He does. And he says, while my thinking is still developing, frankly, I'm very concerned. And I would have to recommend against the uncontrolled but monitored proposal at this time, parentheses, perhaps, if only to make sure the risks are appreciated and accepted before we proceed as proposed. Do you know what risk he was discussing? I have no idea. Did you ever discuss with him why he was recommending against going uncontrolled but monitored with respect to OxyContin? I don't even know what it means. Sorry. If I read the rest of it, do you think it would give me a clue? Or I infer that because you didn't highlight it, you don't think it would shed any light on what was meant above? Well, let's read the rest of it. It might help. He says under paragraph B, I don't believe we have a sufficiently strong case to argue that OxyContin has minimal or no abuse liability. And this is dated 1997, correct? Yes. He says in the U.S., OxyCodone containing products were once less controlled than now. Abuse resulted in greater controls. Is that accurate? I believe it is. And what he's saying there is these weren't as controlled at one time and they got abused and that's why we have controls now, correct? I believe that is the case. He says OxyCodone containing products are still among the most abused opioids in the U.S. This information is available to BFARM, the German regulators. That's certainly true that the information would be available to them. And he says the local tissue necrosis that can result from injection of OxyContin fixed in quotations for such abuse is not likely to be a deterrent to abuse. Let us not forget that in New Zealand, MST is the most common sources of parentarily abused morphine slash heroin. And were you aware at that time that OxyContin, there was a concern that OxyCodone opioids could be injected or abused? I don't remember this memo and I don't remember whether I had read the whole chain carefully or not. And then he says our dossier acknowledges, by dossier I assume he means the documents Purdue has, our dossier acknowledges a small handful of patients in our research program. And that means studies you all were doing, is that correct? That's what I would understand. Who were suspect in terms of their drug accountability. Do you know if that was reported to anyone that if you're all dossier had a handful of patients who were suspect in terms of their drug accountability. I don't know if it was reported but I'm confident it was. If it was an FDA submitted trial, it would have been in either the safety summary or the efficacy summary. Do you remember the issues with the Roth reprint where there were patients who they determined had withdrawal symptoms and that was not reported? No, I'm sorry. Are you familiar with the Roth reprint? No. You know whether that was part of the plea agreement that Purdue Frederick had when they played guilty to a felony? I don't recall. And it says under paragraph C, we do not have a post-marketing abuse monitoring system and database from which we could conclude that diversion abuse is not occurring. Were you aware that you all put this on the market in OxyContin CR and did not have a post-marketing abuse monitoring system or database from which you could tell whether abuse or diversion was occurring? I was not aware of that. I don't believe it was a requirement. At the time, I'm sure we would have fulfilled all the FDA requirements that they asked us. Do you think it would have been a good idea before putting OxyContin controlled release on the market to have an abuse monitoring system and database from which to tell if it was being diverted or abused? Absolutely, yes. And then under paragraph C, it says if OxyContin is uncontrolled in Germany, it is highly likely that it will eventually be abused there and then controlled. This may be more damaging to OxyContin internationally than any temporarily higher sales that could be cleaned from an uncontrolled status. Let us not forget the experience with buprenorphine, which was initially uncontrolled, reports of abuse in Germany in part eventually led to lots of bad press and controlled status. Worldwide sales suffered even where buprenorphine had already been controlled. So given the above, what do others have to offer that should prompt us to pursue the proposal for uncontrolled status for OxyContin anywhere? Question mark. And was that the response of Robert Keiko? It appears to be so. And who was Robert Keiko? He was in charge of the development program of OxyContin. Was he the chief medical officer? But he was respected, his opinions were respected and were heeded. And then the next email which comes from you is Dr. Richard Sackler at Norwalk. Give me just a little time to find it since they're not in order. But okay, Norwalk, could you read the date please? It looks like it's 3-2-1997. 3-12. 3-12-1997? I'm looking at 3-2. It says 020397, but I think the way it's computed is really March 3rd. Okay. I see something from 3-12. I see something from 11-3-97. It's page 5. Oh, I don't think I have page 5. Okay, thank you. This is your response to Robert Keiko saying this is a bad idea for all these reasons. And you say, this is the first time I've heard of this idea. What makes us believe that we can accomplish it? Walter, how substantially would it improve your sales? What you're talking about there is if we can get it uncontrolled in Germany, how substantially will it improve sales, correct? Yes, it would appear that that's what my question was. Please give a five-year projection with control and without. Does each member of the EU, is that the European Union? Yes. Decide this for themselves or would one lead? If one would lead, then is Denmark or Germany more likely to agree? And then Harry Klutsko of Mundy Pharma writes you back on March 7th and says, Dear Dr. Richards. Just a second. So we're now on page one or two. That's the same page, the one right above. Okay, I'm sorry. Please find, stated below, our five-year projection of OxyContin without and with controls as requested. And it was projected that with first-year non-narcotic drug with control would be 3.0000 TDM. Do you know what that is? I assume total or something, Deutschmarks, something, Deutschmarks. And that would be 3 million? That would be my understanding. And then turn over non-narcotic drug without control is 10 million? The first year. Yes. And on the fifth year, it was projected to be 18 million with control but 30 million without control. That's what it says. And then you wrote back on 3897 right above that one and it says, BK advised that the regulatory authorities did say- Okay, BK, sorry. I heard DK. And advised the regulatory authorities said that Oxy would be scheduled and so would be under narcotic control. Does this correspond to your info? If so, is this matter now closed or is there some appeal or other procedure you would want to consider? So, you still saw the advantage of getting Oxy-contin-CER uncontrolled and were wondering if there was some way you might appeal the German decision. Objection of the form, that's not what the statement says that you just read. Well, correct me if I'm wrong there. Why did you say is there some appeal or other procedure you want to consider? Okay. This whole experience is actually like reliving a third of my life and I had completely forgotten until I saw this document that Walter had been very hesitant to pursue the development or the marketing of Oxy-contin because he didn't believe it would sell very well. He turned out to be completely wrong and when it was introduced it did extremely well. We were of the contrary opinion but he said he came back and he did quite a bit of work without any reference to anybody else on determining or trying to get the B-farm to consider and not scheduling it. And this whole stream was occasioned by that. Many of us in the U.S. were not enthusiastic about not scheduling it. In Germany there is no equivalent at least at that time that I recall of anything like Schedule III. You are either an abusable drug and thus you had all the abusable drug controls or you were not. And we were not in favor of this but we were trying to be polite and solicitous rather than saying this is a terrible idea forget it, don't do it because we still felt that with the controls which we thought would be appropriate and were appropriate obviously it would still be very welcome, very useful to patients in the German market. So this whole stream this whole trail really was occasioned by that but I don't remember anymore so if we go on and we are going to relive another few days of my life. Sure, let me ask you if you thought controls were appropriate why were you asking here raising the issue if there was some appeal that could be taken just to be polite not to just shut him down. Okay, well let me ask you this let's go to the next one which is page 4 he writes back yes Richard this does correspond to the information given by Mr. Gerich our registration office we also attended the meeting with the BGA this matter is now closed there is no way of appeal is that what he told you? It seems to be what he told me and then you wrote back and said when we are next together we should talk about how this idea was raised and why it failed to be realized I thought that it was a good idea if it could be done was that your response to? That's what it said but I didn't mean it I just wanted to be encouraging I was very glad it was closed up at the top there's a note there's another response from Walter Wimmer who says to get the product off narcotic drug status it would be possible to combine oxycodone with naloxone provided the development cost weren't too high that was sent on 312 and then the top one is cut off but it says Paul Michael would this be a feasible approach here in the US? I don't know of any C2 narcotic that is descheduled when naloxone is added to you is that a question you were raising? It looks like I raised it just as a matter of information as I said they eventually did develop that product and it was extremely successful but at the time they researched it they quickly discovered that naloxone didn't achieve the desired blocking effect but they made another discovery that was even more valuable you got this one? would I be correct that Purdue Pharma never conducted or retained anyone to conduct studies regarding addiction and physical dependency rates of oxycodone products at least as of March 4, 2002 I don't know the answer are you aware that counsel for Purdue Pharma's answered interrogatories that requested the names of all individuals retained by Purdue Pharma to do studies regarding addiction and physical dependency rates of oxycodone products and copies of all studies and he answered we never conducted or retained anyone to conduct studies regarding addiction and physical dependency rates of oxycodone products Mr. Thompson if you're reading from a document could you show it to the witness? I'm just asking if he's aware of it because I'm trying to move the deposition along so are you aware of that? no I'm not aware of his statement are you aware of any studies conducted or retained or anyone being retained to conduct studies regarding addiction and physical dependency rates of oxycodone products probably 2002 I'm not aware of any or I don't remember any you got these in 2002 I was the president of Purdue Pharma and this would not have necessarily this wouldn't have required my approval or knowledge unless it was it led to something that was surprising important and unexpected I still want to ask about this Mr. Thompson did you put in a different number to the last document that we were discussing which was a series of emails? it was eight it's the oxycodone product team alright I'm going to switch and ask you a little bit about the oxycodone project team and this is a memo dated December 14, 1993 PDD 9520 509 356 and a few paragraphs I want to try to cover here if you will look at the bulletin points on the front page the second one from the bottom says marketing oxycontin tablets will be marketed against Percocet and Duragesic the oxycontin line may replace our MS-contin line if MSC generics are competing that's correct and that's not the is that the malignant cancer group of patients or is that a non malignant cancer group of patients? I don't understand the question you may answer MS-contin as I said before was used in treating both cancer patients and non cancer patients and there was no focus I don't believe or consideration in this statement whether it would be both I think do you have a knowledge of what Percocet and Duragesic was used mostly to treat? Percocet was an extremely widely used product used to treat both short and long-term pain conditions both non malignant and malignant and then if you'll turn over to paragraph 2.3 and this is 1993 it says abuse toxicity bench top study the results of a spoon okay I see 2.3 you said yes thank you the results of a spoon and shoot study have been sent to the FDA what was the spoon and shoot study? I don't know I could guess but I don't know was that a study done to determine if the drug could be abused by extracting oxycodone from the tablet? it's a reasonable guess but I don't know the details of what that study was under 3.2 the last sentence says a crushed tablet study may be conducted if we decide such a study is needed you know if you ever decided such a study was needed well what's the number on that I'd just like to read it 3.2 last time I'm sorry thank you 3.2 yes okay I read that I don't know if such a study was done okay and then on 5.4 the last sentence says Mike in Orato was he a guy in charge of marketing? no he worked in the marketing department but at this time he was not in charge he was a middle manager in marketing Mike in Orato asked if we had any quality of life questions in our ongoing studies Robert Reader stated that we did not but that we could include quality of life questions in future studies do you know if quality of life questions were included? I believe there were studies later that included quality of life measures but I am not certain of that I'm certain it would have been favorable but I'm not certain just what studies were or were not done let's mark that as exhibit market exhibit 9 oops yep with respect to oxycodone and morphine do you know whether oxycontin is more powerful or less powerful a drug than morphine? it depends what you mean by powerful I think Dr. Goldenheim was he an employee of I think he testified that oxycontin was twice as strong as morphine is that your understanding? if the question if powerful means potency absolutely it is twice as potent as morphine and we were very proud that we discovered this first in animal studies and then in human studies and we made it widely known perhaps even before the drug was introduced but certainly in the package insert in all the promotional material do you know how many doctors or what percentage of doctors thought that it was equal to or less strong than morphine? I would assume very few if they were promoted to I can't believe that they wouldn't have understood that that formed the basis of our recommendations of dosing of the strength of the tablets that were developed and in fact it was consistent with physician's own experience with Percocet where they would administer a 5 milligram dose and if they used morphine they knew that 5 milligrams of morphine would achieve very little pain relief if given orally perhaps somewhat more if given by injection let's mark this as plaintiffs exhibit 10 this is the a memo dated 1992 august 10th oxycodone project team meeting minutes I'm sorry, August 10th and it is PDD 952 1410329 39 I had 30 the first page is 39 correct and if you'll look at this it says a literature search the second paragraph a literature search on oxycodone and oxymorphone is being conducted I'm sorry this is just not very clear give me a second the issue a literature search are we looking at the same page? you're on page 2, I'm on page 1 I thought you said August 10th okay this one is August 4th second paragraph a literature search on oxycodone and oxymorphone is being conducted by one of the summer employees do you know who was doing the literature search? no a son or daughter of one of the people who work for Purdue Frederick or Purdue Pharma fifth paragraph down second sentence says the current consideration is to develop 20, 40, 80 and 160 milligram tablet in addition to the 10 milligram tablet now in the clinic and whose idea was it to develop 20, 40, 80 and 160 milligram tablets which page are you reading from? first page just what I called out fourth paragraph, second sentence okay thank you this was a team decision it was discussed extensively if you'll go to the second page um first paragraph it says with regard to the package insert and the first year advertising claims it was discussed that Mr. Segar should meet with others and rework the quote draft package insert the purpose would be to idealize the insert and coordinate the contents with the advertising claims and clinical trials program the package insert should include comparative claims it must be kept in mind this is a working document why did you want to coordinate the package insert with your advertising claims? the package insert is the bible for the product it is the core document from which all promotion or communication with physicians is to be based it is typical in the industry that a lot of work is expended to make the package insert as comprehensive and complete as possible and this is a you talked about physicians being aware of oxy cotton being twice as strong as morphine a second ago let me hand you let's mark this as exhibit 11 this is an email it says the author is may I have a comment oh I'm sorry it says the author is Dr. Richard Sackler at Norwalk dated 528-97 are you familiar with this email to Michael Friedman? yes who's Michael Friedman? he was head of marketing and sales ok and let's drop down and see what Michael Friedman has written first paragraph he says my purpose in writing this memorandum is to clarify our position on the very complex issues raised by Mike Cullen during the phase 4 team meeting in which were the subject of Dr. Richard's inquiry when they say Dr. Richard's who's that? that was me first paragraph we are well aware of the view held by many physicians that oxycodone is weaker than morphine we all know that this is the result of their association of oxycodone with less serious pain syndromes this association arises from their extensive experience with and use of oxycodone combinations to treat pain arising from a diverse set of causes some serious but most less serious this quote personality of oxycodone is an integral part of the quote personality this personality of oxycodone is an integral part of the personality of oxycodone when we launched oxycodone we initially intentionally avoided a promotional theme that would link oxycodone to cancer pain we specifically linked oxycodone to the oxycodone combinations with our old way, new way campaign we made sure our initial detail piece provided reps with the opportunity to sell the product for a number of different pain states with all of this we were still concerned that the drug would be slotted for cancer pain and we would encounter resistance in the nonmalignant pain market and says our pricing of the product was geared toward the nonmalignant market we knew if we priced low per milligram for the higher dose cancer patient we would be priced way too low per milligram for the standard nonmalignant pain patient where we really wanted to make a market we feared that the quote cancer pain experts in quote would object to the 2 to 1 ratio and that 2 to 1 ratio is the ratio of oxycodone, oxycontin to morphine is that correct actually if you want to strictly understand the ratio the 2 to 1 would refer to the ratio of morphine to oxycodone okay that's not the other way around I know that's what you meant to say yes and resulting cost of therapy for high dose patients however we had no choice given our position for oxycontin in any case we're developing hydromorphone code I've lost you here okay in any case we're developing hydromorphone code for the high dose patient right okay I'm at the end of paragraph 4 and then it says despite our initial uncertainty we've been successful beyond our expectations in the non malignant pain market yes and non malignant pain market is sort of the chronic arthritis back pain those types of patients well those are most typically moderate pain patients some of them may be severe but there are many less common conditions that produce severe crippling life destroying pain and we had an indication and still have for all pain states that are appropriately treatable with opioids for an extended period of time we want it so non malignant really is a distinction all pain other than the pain directly caused by the encroachment and destruction of tumors tissue in the patient and then he says here doctors use the drug in non malignant pain because it is effective and the personality of oxycontin is less threatening to them and their patients than that of the morphine alternatives I apologize for this unspecific term but I feel it captures the notion that there are image related attributes that influence drug acceptance while we might wish to see more of this product sold for cancer pain it would be extremely dangerous at this early stage in the life of the product to tamper with this quote personality to make physicians think the drug is stronger or equal to morphine we are better off expanding use of oxycontin in the non malignant pain states and waiting for hydromorphone in 1999 to relaunch cancer pain why was it felt that there would be a danger it would be extremely dangerous at the early stage in the life of this product to tamper with this quote personality to make physicians think the drug is stronger or equal to morphine the context of this was as you know a threat of emails that actually he alludes to I started the whole context and the whole discussion of Mr. Friedman here and in other I'll pause here because I think it's really important for you to understand this the whole context was not to the context was not stigmatize oxycodone in a way that morphine was stigmatized morphine was seen as an end of life extreme duress patient extreme duress often dying of cancer but not only cancer it was reserved by most physicians if it was used at all even when patients were in serious severe even crippling pain because telling a patient I'm going to put you on morphine I'm going to prescribe morphine for you now we got to use morphine however the physician told the patient was associated with a death sentence oh thinks the patient he's telling me I'm going to die even worse my doctor is putting me on morphine he's giving up on me we didn't want oxycodone to change the personality of oxycodone but you could say all the associated feelings of oxycodone which were generally appropriate to a narcotic we didn't want that to be polluted by all of the bad associations that patients and healthcare givers had with morphine did you think that if physicians thought it was stronger or equal to morphine much less twice as strong as morphine that they would be less likely to write prescriptions and sales of oxycodone would go down no if it's personality was changed if it was stigmatized as an end of life drug it could limit its usefulness the term stronger here meant threatening nor frightening there is no way that this intended or had the effect of causing physicians to overlook the fact that it was twice as potent it was called out in virtually every promotional piece of literature it was reflected in a conversion chart which we had developed for a few patients who were being treated with morphine where we made it very clear if they're on any daily dose of morphine you cut that dose in half for oxycodone every action we took before the product was launched with the FDA in the package insert in promotion all detailing emphasized that it was twice as strong some physicians had formed their own impression that it wasn't twice as strong it was less strong and we insisted that they observe we said with this drug doctor it is twice as strong even when they said no I think it's one and a half times as strong and some physicians even said I think it's about the same potency as morphine we would insist no please use it the way we have researched it and the way the FDA has approved it now and I think we were effective in getting that message across in time to most and eventually almost all physicians this is 1997 two years after the launch of oxycodone control release correct so it's been on the market now over well January 96 we're now in May of 97 and it says we are well aware of the view held by many physicians that oxycodone is weaker than morphine and the conclusion of this was I do not plan to do anything about that and you wrote back and said I agree with you general agreement or are there some holdouts is that what you wrote up at the top of the I did and I agreed with them then and I agreed with them now because I knew what he meant and so did everybody else know you what he meant and more important our actions in promoting that twice as potent as morphine never wavered we never disguised it or hid it we emphasized it so you weren't doing this because the pain market for non-malignant pain was a much greater market share is that your testimony no no that isn't we wanted to address both markets the email which perhaps you want to explore or not that started this was as he says in the first paragraph something that I had inquired about and what I had inquired about was an error on my part when we before we launched oxycontin we thought that our sales would be about equally divided between cancer pain and non-malignant pain we knew that the market for non-malignant pain was much larger of course fortunately for all of us cancer is not as much less common than other pain states but we had expected it would be about 50-50 I had seen some reporter attended a meeting where I learned it was about 20% of our sales and thus I wrote to Michael and said why what's going on here why aren't we getting more cancer sales let's look at the email you wrote to Michael Cullen at Norwalk let's mark this as plaintiffs exhibit 12 and Michael Cullen writes on June 2 of 97 and that was after the email we were just looking at and says in recent team meetings we've discussed the issue that oxycontin is perceived by some physicians particularly oncologists as not being as strong as MS cotton now oncologists are cancer doctors correct so even the cancer doctors don't think that oxycontin is as strong as MS cotton according to this that's not what this is let me rephrase it you were aware or at least Michael Cullen was advising you that oxycontin is perceived by some physicians particularly oncologists as not being as strong as MS cotton is that correct that's what the words say this perception has had some effect with physicians switching to MS cotton with more severe cancer pain patient it has actually had a positive effect with physicians use in non-cancer pain and there he's saying non-cancer physicians that don't think it's as strong as MS cotton we're having a positive effect from that and I'm assuming he's talking about cells wouldn't you yes he says since oxycodone is perceived as weaker opioid than morphine it has resulted in oxycontin being used much earlier for non-cancer pain physicians are positioning this product where Percocet hydrocodone and Tylenol with coding have been traditionally used so he's saying here physicians are using it because they think it's weaker than morphine correct he's using the word weaker but not meaning less potent than morphine within at this time it appears the people had fallen into a habit of signifying less frightening less threatening more patient acceptable as under the rubric of weaker or more frightening more less acceptable and less desirable under the rubric or word stronger but we knew that that the word weaker did not mean less potent we knew that the word stronger did not mean more potent and we knew that because by this time surely anybody who was using this product recognized it was more potent they knew it was more potent so it's very unfortunate for your understanding as well as anybody else's understanding that all those issues of the stigma of morphine of the frightening nature of morphine of morphine being a cancer drug end-of-life drug it's a very unfortunate for your understanding and for most people's understanding that the word weaker and stronger was used we understood what it meant but let me ask you this you were advised by your senior employees that physicians perceived oxy cotton controlled release as less strong than morphine many physicians perceived it that way correct? Words used but didn't mean that they believed it was less potent because I knew they believed it was more potent their own practice proved they recognized it was more potent as I said before Percocet was 5 milligrams. Did you do any studies yourself or conduct any investigation to determine what percentage of physicians believed that oxy cotton controlled release was less powerful than morphine and we're not aware it was twice as strong as morphine but less potent. Yes I don't know of such studies but in common parlance and discussions with physicians if really a substantial if any substantial number of them believed believed in the believed had an erroneous belief excuse me if any held an erroneous belief and said to a representative oh this is this stuff is less potent than morphine the salesman had ample materials to demonstrate to the physician that he was in error and was instructed to use those and did use it and I wish we had a survey had done a survey to demonstrate it in retrospect but it was so generally accepted that it was at least one and a half times more potent by even the skeptics most skeptics and there weren't many but generally recognized to be twice as potent as morphine it just never occurred to us. Sure and it's your belief that your sales force was telling these physicians that it's actually twice as strong as morphine and correcting that misperception that they had. Absolutely it was in the package insert the promotion in the conversion tables and in the recommended dosing which so promotional pieces your symposiums your review articles your studies would all point that out. I can't say that everyone would point it out in every page but it should have been an important part of most promotional materials. Well let's read the rest of Michael Collins email dated 297 well after the launch of Oxycontin paragraph 3 says since the non-cancer pain market is much greater than the cancer pain market it is important that we allow this product to be positioned where it currently is in the physician's mind if we stress the quote power of Oxycontin in quote versus morphine it may help us in the smaller cancer pain market but hurt us in the larger larger potential non-cancer pain market some physicians may start positioning this product where morphine is used and wait until the pain is severe before using it marketing has decided that by that they're talking about the marketing group correct marketing department marketing department so it says marketing has decided that the effects of the phase 14 should be predominantly focused on expanding Oxycontin use for non-cancer pain and then if you look at the last paragraph it says it is important that we be careful not to change the perception of physicians toward Oxycodone when developing promotional pieces symposia review articles studies etc and what they're talking about there is let's not clear up this misconception that physicians have that Oxycontin is um not as strong as in S-contin correct I object to the point of the question Mr. Thompson you in reading this skipped over two sentences I'll ask that you go back and read this with the two sentences that you omitted the one beginning with the sales force can teach the oncologist oh sure our approach to cancer pain will be to get physicians to use it earlier instead of products such as Percuset, Vicodin or Tylenol-3 the sales force can teach the oncologist the proper dose and titrate Oxycontin to ensure that they stay with it as the pain increases now oncologist are the cancer pain doctors yes correct that doesn't say anything about all the non-malignant for doctors all the doctors that treat non-malignant pain correct but they would be taught the same thing how to titrate because that was the fundamental doctrine of treating pain with opioids start low and titrate and adjust the dose in other words upward well the whole purpose of this email is that you not teach the non-malignant pain physicians that Oxycontin is twice as strong as morphine and let them continue with their perception not correct no not correct let's continue reading the rest of it then last paragraph it is important that we be careful not to change the perception of physicians toward Oxycodone when developing promotional pieces symposia review articles studies etc am I correct that what he is saying in here is let's not clear up the misperception in any of our promotional pieces symposia review articles or studies don't change the personality don't change this to an end of life cancer drug to a drug that shouldn't be used except at the end of life when everything else has been exhausted that was the thrust I may just add something here there's a conflation within this which you wouldn't understand and that was when in the first paragraph which you read where he said that oncologists think it isn't as strong as MS. cotton here the meaning that we understood certainly I understood and anybody who was involved was the cancer doctors who were using the drug were stopping at they had established a notional idea based on their past habit of using Percocet that they shouldn't go above 40 to 60 milligrams a day of oxycodone and the reason they developed that habit that practice limit was not because of the oxycodone it was because of the Tylenol which was the more toxic agent in that combination you're probably aware that recently the FDA has recommended lowering the maximum daily Tylenol dose from 4 grams a day to 3 but even then 4 grams a day was recognized as being the then practical limit so oncologists who were using oxycodone as Percocet were just in the habit well you're getting 40 milligrams a day of oxycodone your pain is coming back rather than titrate those patients to a higher oxycontin level they said well we gotta switch to something else and that was really what was going on and in part why oncologists use of the product had not developed as well as we had wished that it would develop and that was understood and contained within this dialogue not all that documented here let's go back and talk about it a little bit more so in the first paragraph he says we've discussed the issue that oxycontin is perceived by some physicians particularly oncologists as not being as strong as MS-contin although this perception has had some effect on cancer pain it has actually had a positive effect with physicians use in non-cancer pain so what he's saying there if I'm reading this correctly is that because they think it is not as strong as MS-contin when they need a strong drug for cancer pain patients some of the physicians aren't switching to it because they don't think it's as strong and that may hurt sales a little bit there but with the non-cancer pain where you don't want as strong a drug as an end-of-life malignant cancer pain patient might need it's actually helping ourselves that they have this misperception because they are going ahead and prescribing it because they don't think it's as strong as MS-contin is that what that first paragraph is saying? that's what the words say but the meaning of strong here would be effective it is not as effective and the reason they thought it was not as effective is they had a mental notion of a limit and they didn't follow the doctrine of titrating increasing the dose when the pain is getting worse and all of this was really known I mean by 1997 of the people who disagreed and thought that oxy-contin was not 2 to 1 they thought it was 1.5 to 1 that was by far the most common objection still stronger than morphine but not quite as much stronger as we said it was they had been persuaded if they used the drug oh yes particularly those oncologists who switched from MS-contin so then he says since oxycodone is perceived as being weaker opioid than morphine it has resulted in oxy-contin being used much earlier for non-cancer pain so he's saying more people are using it earlier for non-cancer pain because they think it's weaker not less potent more acceptable to the patient not frightening not stigmatized as morphine unfairly was by history that was the meaning and I've lost my thought here could you just repeat your question so I can finish my answer and what he's saying here is the non-cancer pain doctors which is the much bigger market share when you're trying to sell oxy-contin is the non-malignant pain market it's actually helping cells there again as I've testified before the term stronger and weaker was it a very unfortunate term you want to use effective? in the case of here effective yes in the case of cancer because they were using it let me explain one other thing at the time that this product was introduced the World Health Organization had promulgated a step-ladder approach to cancer pain and when oxy-contin was introduced we properly with the agreement of the FDA said that oxy-contin was appropriate for the second step and the third step that's where the start with and stay with theme came from um so I I know that this could cause real confusion reading these documents if you're not involved day to day but there is no way that any of the people on these documents understood stronger to mean more potent, weaker than oxy-contin we had never departed from a strong promotional theme that it was twice as strong as morphine and then down at the bottom he says let's take the middle paragraph since the non-cancer pain market is much greater than the cancer pain market is it important we allow this product to be positioned where it currently is in the physician's mind let him believe that um oxy-contin control release is not as effective as morphine no I said the effectiveness really applied to the oncologists who were saying ah this isn't as effective you know I have to when the pain gets really bad I switch them to something else and that was the one place in which we would have understood it as effective and I've explained that we believe that that was a consequence of them just having a mental limit he says if we stress the quote power of oxy-contin versus morphine and that is it may help us in the smaller cancer pain market let him know that it is more powerful than morphine that will help in the smaller cancer pain market correct that's what he says but hurt us in the larger potential non-cancer pain market some physicians may start positioning this product where morphine is used and wait until pain is severe before using it nothing is coming back probably to the cancer market I'm not sure we always said it was a powerful drug we implied that we wouldn't use the words because words can elicit a whole variety of responses and then the marketing department has decided that the efforts of the phase 4 team should be predominantly focused on expanding oxy-contin use for non-cancer pain that's the group that if you clear up the misperception may be less likely to prescribe according to what he's written here if you change the character of the drug in their mind if you tell them it's a cancer drug it's for end of life care yes, you might change their perception we didn't believe that that was appropriate nor did the FDA nor did the opinion leaders believe it was appropriate it truly was a drug that in appropriate doses could manage moderate and severe and extremely severe pain where patients needed an opioid to manage their pain it's important also that you understand that for 100 years and even today there is no drug that is more effective or safer than opioids for treating pain over the long term and it was a shame that for decades no opioid was used in many most perhaps overwhelming majority of patients who had severe pain do you think it might compromise patient care if Purdue Pharma allowed patients physicians to believe that the drug they are prescribing them is weaker than morphine could you just repeat the question I just want to get the do you think it might compromise patient care if Purdue Pharma was aware that many physicians felt like Oxycontin was weaker than morphine to clear up that misconception no, if they believed it was less potent than morphine we clearly cleared up that misconception we told them it was twice as potent we told them to use doses that were considerably lower than the morphine doses that they might have been accustomed to what we didn't want to do is to turn this into a cancer drug and this is 1997 well after the launch well after your package insert has been put out and all that correct and Michael Cullen says it is important that we be careful not to change the perception of physicians toward Oxycodone when developing promotional pieces symposia review articles studies etc correct is that what he wrote looks like that's what he wrote and did not say no we need to clear up this misconception immediately what you said is I think that you have this issue well in hand if there are developments please let me know that's what I said but the misconception that you're referring to didn't exist the misconception that this was a benign harmless weak drug for treating pain was not the perception that existed so that was not the error that he was I don't know quite what he let me just read what he said here where were you reading from please we've gone through this a number of times so where were you reading from here we were reading from you just read me something from from your top where you said I think that you have this issue well in hand but where you said I was responding where was that where he says it is important that we be careful not to change the perception of physicians toward oxycodone when developing promotional pieces symposia review articles or studies that's correct not change the character of the drug not change not change it into a frightening scary end of life drug all right let me hand you let's mark this as Planes Exhibit 13 this is an interoffice memo dated 1994 and this is from Michael Friedman what was his role in 1994 he was head of marketing and sales and it's to to the three people he reported to and that's Mortimer Sackler Raymond Sackler and Dr. Richard Sackler that's correct and under discussion if you go to page four it says we believe that the FDA will restrict our initial launch of oxycontin to the cancer pain market did you believe that at the time he may have believed it I didn't believe it however we also believe that physicians will perceive oxycontin as controlled release percocet without a set of minifin and expand its use now is oxycontin controlled release percocet without a acetaminophen that would be one way of describing it because there are only two active ingredients acetaminophen and oxycodone is a a sedaminophen it's a sedaminophen it's a sedaminophen oxycodone is oxycontin controlled release more powerful than percocet depends on the dose the initial dose at 10 milligrams twice a day would be equivalent to the standard introductory dose of percocet four tablets one tablet four times a day in other words four so it would be the same dose when you all did studies did you find out that 10 milligrams of oxycontin had the same effect as a placebo and it was really only the 20 milligram that was effective I don't recall that but it's possible we do not want to position oxycontin in a way that will discourage physicians from using oxycontin for the chronic non-malignant pain where are you reading from again next paragraph the next sentence especially when we have studies available that demonstrate efficacy and safety for this indication do you know what your studies showed about non-malignant chronic pain patients developing tolerance or dependency or withdrawal from oxycontin I don't have them immediately in my mind that's been marked correct what do you guys think what are you guys thinking time-wise for lunch do I take it what's going on we are on the record at 11.45 a.m we are back on the record at 11.57 a.m hand you a document it is dated April 23 1997 and on the bottom of paper And on the bottom of page one is an email you sent regarding San Antonio and it says 42297. This is PDD 1701801141. And it's to, looks like Michael Friedman. Michael, I am somewhat surprised that 18 months into marketing significant groups of experts, oncologists for example, believe that Oxycontin has a sealing effect. What did you mean by sealing effect? It has a dose above which it would not be effective. That was what I meant, not be effective. What materials could we pull together that would smash this critical misconception? Can we put together some approaches and test whether they would be potent weapons in this effort? And he writes back and says to you, there will always be misconceptions about drug substances for controlled release drugs. Many of these misconceptions are the result of residual attitudes associated with the immediate release forms. I'll just read the whole thing. For example, morphine has a personality, quote, that was shaped when it was an IV drug. Oxycodone has a personality, quote, that was influenced by many years of Oxycodone use in Percocet. We built a large part of our platform on this personality and it is to differentiate Oxycontin from NS Conson and Dura Jesus. This differentiation has led to much non-malignant business. Marketing is next paragraph. Marketing is not only about what you are, it's about what you are not. We have had success beyond our expectations, that is in part due to the unique personality of Oxycontin. Even as we seek to increase the use of the drug in higher doses, we should be very careful. As you know, the strength of the drug is principally a barrier in malignant pain. If we do not want to change the image in a way that will discourage non-malignant use, a barrage would be ill-advised. You wrote back excellent points. What about rifle shots? Is that correct? That's correct. That's what I wrote. Over here, before that, there's a letter to you from James Lane. He's pointing out that he sat in some oncology focus groups. What page is that? It's page two. The second page of what you handed me. Oh, Jen, yes. Okay. It says, issues affecting the oncologist utilization of Oxycontin are, MDs feel the product dosing has a ceiling, don't feel it is as strong as MS-contin, like and are very comfortable with MS-contin and don't see a need for another product except where MS-contin fails. Interestingly, when asked to describe what they like about Oxycontin, they are, for the most part, decided all the key points our reps are or should be stating in their sales presentation. The anesthesiology focus group was of less, Saturday evening, was of less value. However, their primary concerns were that Medtronic pump being used by the orthopods and the need for Purdue to educate surgeons on proper post-surgery pain management in fears with opioid prescribing. Is that the email that prompted you to write the letter? It might be, I don't recall. I'm sorry, I prompted you to write your email. It could be. Why don't we mark that as exhibit 14? But I'm not sure. There could be another email in which I pointed out the lack of sales development with oncologists as compared to our plan. So I'm not sure that this is, but it would have been around the same time, perhaps. Maybe I looked at the results with oncologists after I read this. I'm nice about this. So this is the 1993. That's already in evidence. It's the May 1993 memorandum. Are we finished with this? Yes, sir. I want to go back to the May 1993 memorandum. And this is the July 92. What exhibit number are we talking about? Wait a minute. Can I see what you have here? Sure. Let me just clear this up. Yeah. It's not enough yet. Okay. Okay. April 2nd, 1993. Yeah. Let's, I'm sorry. Let's jump to the April 2nd, 1993 memorandum. Let's mark this as Sackler 15. What is PFRC at the top of this? Purdue Frederick Research Center. And it's the R&D meeting. R&D meeting. And it is dated April 2nd, 1993, correct? That's what it says. And part I wanted to ask you about, if you go back to page 10, and you were in attendance at this meeting, correct? I don't, let me check that. I certainly don't recollect by date. Are Sackler attending? Yes, that was me. All right. So on page 10, it looks like you're discussing an osteoarthritis study that was being done. Okay. Where on page 10? I am on the third paragraph. Okay. I'm sorry. Fourth paragraph. It says page 10, but it doesn't look like what you have here. Yes, it. Is it? Yeah. Okay. So read along with me. The section over here, RR. Do you know who RR is? Robert Reeder. Okay. What was his job at that time? He was a senior medical researcher. And he says here in this paragraph, the protocol for the placebo-controlled study of these two dose levels in patients with osteoarthritis was discussed with C right. Now, would that be Curtis right? That's what I would understand. And at that time, he was the person who was reviewing Ural's OxyContin submission to the FDA. He was the medical reviewer, that's correct. And he's the guy that actually approved it to be sold or allow you all to sell it from the FDA. That's my recollection. You all ultimately hired him a few years later, didn't you? We did hire him, but not after his tenure at the FDA. He spoke to somebody of Purdue when he was planning on leaving the FDA. And Paul and I discussed it and agreed that we should not hire somebody who had reviewed our product and left. And so he went to another company regrettably for us because he was very, very knowledgeable and very smart. He went there for a short period of time and then came to work for you? I don't remember. It was certainly... My recollection is a couple of years, two or three years, but I don't recall exactly. The record, I'm certain, could be produced. All right, well, let's take a look at page 10. The protocol for the placebo-controlled study versus two-dose levels in patients with osteoarthritis was discussed with C-right. He stated there were very strong opinions of members at the FDA that opiates should not be used for nonmalignant pain. And this study... Let me just follow you if I may. I'm a slow reader. I'm sorry. But I just do want to follow you. Great. Well, I'll read it again. He stated there were very strong opinions of members at the FDA that opiates should not be used for nonmalignant pain. And this study would not be greatly accepted by the FDA as it is written now for that reason. C-right has suggested rewriting the protocol in order to make it clear osteoarthritis is being used as a convenient pain model. He would also like to... the open-label extension to be eliminated from the protocol. What do you refer to as the open-label extension? In many trials of chronic use drugs, after the trial period, which might have been 12 weeks, was completed, the subjects in the trial were given an option to continue being treated and monitored by their physician. It's completely at their election or choice. Some decide that they want to. Some decide that they don't. And we continue them on medication for an extended period of time. This is extremely common in all kinds of trials. P. Goldenheim stated the open-label extension could be done as a post-marketing study. B. Keiko and our reader will meet with P. Lakatur to communicate what is necessary to revise the protocol. The protocol must be clear that we are not going for a general indication for the treatment of osteoarthritis with oxycodone. And then down below that, it says, Dr. Richard Sackler asked if there was consensus within the pain group about the appropriate use of opiates for certain patient groups. B. Keiko stated this is a very controversial area. And most people in the pain group say that well-controlled studies are necessary to investigate the questions. Dr. Sackler, next paragraph, says, Dr. Sackler has suggested a smaller group meet in-house to clarify the political issues. What were the political issues? The political issues would have referred to the preferences and the sometimes prejudices of physicians and other experts. Over whether you should prescribe opioids for nonmalignant pain. And for what conditions in nonmalignant pain? I don't think there were very many people, or any people really, of any reputation who would have proscribed that has prohibited the use of opioids for nonmalignant pain. But there were a lot of opinions when it came to listing one condition or another, or another, or another. Pain is the most common symptom that patients have and present to doctors. And so every doctor has his own opinion as to what is best and what is appropriate for treating pain. Or in some cases, what pains are not appropriate to be treated at all. And this is a highly personal and contentious issue in the medical world and has been so for a hundred years. And that's the reason that morphine was stigmatized and not prescribed generally for nonmalignant pain. It was more reserved by physicians for end-of-life hospice care and cancer pain in the medical community. I don't understand the connection you're drawing. I think the situation with morphine is unique. And it doesn't relate to what we're talking about here. What about heroin? Was it prescribed for pain? It is prescribed for pain in many countries and is part of the pharmacopeia. For example, it is very popular in the UK. Is it controlled? It is, just like morphine. For end-of-life pain, mostly? I can't tell you that because I don't know. But it is, I don't believe that it established itself as an analgesic in the United States at any time even when it was an analgesic and was available. I'm going to hand you a memo. Are we finished with this? Yes, we are. Project team meeting minutes of Tuesday, August 17, 1993. It says here under marketing, there's some initial interest in having a 5 milligram and 10 milligram immediate release oxycodone capsule produced. Do you know why marketing wanted those produced? I could guess, but I don't know specifically why they wanted it. Well, if you don't mind, turn back to page four. On page four, what I really want to ask you about is potential studies. And Mike Enorato is the guy we mentioned earlier who was in the marketing department. And he's the guy in charge of perhaps the sales force that goes out and tries to sell. No, he would be in charge of the marketing execution of the strategy. So he would be intimately involved with the promotional materials, secondarily involved with training, and would be the person who would set the direction and themes that would be used. But he wouldn't be a person who would be responsible for sales, although he might go out in the field and he should determine what is happening. Let me rephrase it then. As part of marketing, he's the guy who is supposed to get the word out and hopefully increase sales by advertising the product and convincing people to write prescriptions. Not directly. The salespeople were the principal agents of getting the word out to use your expression of putting the materials in the hands of doctors, etc. I don't recollect that advertising ever played much of a role in the promotion of OxyContin. Let's talk about, if you look at 4.3 potential studies, Mike, I'm going to read that paragraph. Mike Inarato said that an OxyContin vs. Percocet comparative study... Must be. Oh, you weren't reading OK. From potential studies. Sorry, this is so small. It's not so easy. Mike Inarato, and unfortunately that's the way Perdue gave it to us, so we're stuck with it too. Potential studies. Mike Inarato said that an OxyContin vs. Percocet comparative study would be useful for marketing purposes. Now, in trying to decide whether the drug is safe, is it normal to have the marketing people decide what studies will be done? They might be involved in commenting on it or suggesting things, but normally it's the medical department that has the primary responsibility both for the medical research strategy and certainly the implementation. Through such a study, I'm going to read the next sentence. Through such a study, OC881105, has previously been conducted and published in abstract form. It was a single dose study using non-GMP released material. Mike Inarato stated that a multiple dose study would be best to support claims relating to relief of post-surgical pain, low back pain, and herpetic neuralgia pain. For my review of that, it looks like he's got claims he wants to make and is trying to design studies to support him. Is that what that appears to you? No. Half yes, half no. What I think he is doing here in the general is he is in a group meeting presenting ideas for consideration by the group. Certainly, this was not directive and he was not in a position to direct any studies be done or not done. In the next sentence, says Mike Inarato stated marketing would like to position differently than MS-Cotton. Robert Reeder, who is Robert Reeder. He was the senior medical officer in this minute of the meeting. Let me just read, catch up to you. Well, he does tell you this to support claims. Robert Reeder stated that the FDA has suggested that we do not issue claims supporting the general use of a schedule to opioid in patients with non-malignant pain. Robert Reeder indicated that decisions to make additional claims could be developed after the product is marketed. Jim Conover agreed with Robert Reeder, but added that any study conducted in patient with non-malignant pain could be included in the clinical studies section of the package insert. Robert Reeder added that any proposed marketing claims and their supported studies should be first reviewed with our legal and regulatory departments. Perhaps the marketing concepts could be reviewed now. Robert Reeder stated that the marketing could start thinking of a five-year plan on potential marketing studies and strategies. Did I read that correctly? You did. And you have another? This one here. I'm going to hand you this. Are we finished with this? Yes, sir. Exhibit 17. I'm going to move it all these in evidence as exhibits one through 16 and 17. And this appears to be a speech you gave. Is that what this is, or a publication you made? This looks like it was a news paper or magazine-like internal document for the field force principally. I think it was basically the field force. And in-house marketing is salespeople who would like to see their picture there or be quoted or whatever. And it's the winner of 1996. Is that right? That's correct. And if you'll turn to page eight for me, please. I'm sorry. I missed both. I'll turn to page two, please. Oh. Over on the third column. Yes. Halfway down it says the development and launching of OxyContin tablets is the first time that we have chosen to obsolete our own product and we have done it before the competition has slowed our growth of sales. And you were referring to MS-Contin that you obsolete it? Is that correct? That's correct. And then at the bottom it says we have the most powerful selling package insert in the category and in the industry. And is that accurate? I'm trying to see where it is. We have which paragraph in that column? The very last paragraph. We have the most powerful selling package. Yes. Okay. That is correct. And if you'll turn to page eight, it says a speech at the top continued from page two. So I'm assuming this is a speech you gave? It may be, but I don't know. We'll see. OxyContin was brought to NDA. What's NDA? To NDA filing. That's the filing of the new drug application. Right. From early phase one work on time and in an incredibly compressed period of two years time. That's because an NDA usually takes longer, correct? Well... And let me just preface it with the reason it takes longer is because there's a number of studies that have to be done, both animal and human, to determine if a drug is safe and efficacious, correct? Right. In general, that's correct. But in this case, you all got it done in an incredibly compressed period of time of two years. Robert Reeder set the goal in November of 93 to file by December 31st, 95. And we submitted on December 28th, 95, three days ahead of schedule. This didn't, quote, just happen. It was a deftly coordinated, planned event that took dozens of worker years of effort to succeed. True. The most demanding NDA package for any analgesic product ever submitted didn't languish at the agency. Unlike the years that other filings linger at FDA, this product was approved in 11 months, 14 days. Our previous best approval time for other products was measured in years, not months. Much can be attributed to the unparalleled teamwork of the product team and the FDA's approval team, which came into being as responsive our joint desires to operate within the context of a new time frame. Both we and the pilot Doug Division at FDA were motivated by the same goal to set the highest standard NDA with the broadest app indications approved in the shortest possible time frame. Did I read that correctly? You did. Okay. Did you have any questions about that? Nope. I just wanted to know if that was the statement you got and is it accurate? This was a... I believe it is accurate. I'm certain that the facts in there were accurate. The tone was very upbeat. Almost a team enthusiasm building expression. I believe the facts are correct. And I perhaps... I don't regret trying to energize our sales force. I think that was my mission. But this isn't what I would have written if a board had been... or said if the board had been there. I wouldn't have been... The tone would have been more restrained. I'm not embarrassed by the tone. In the context, I think it was very reasonable. Do you have any questions about the reason it was so quick or anything else? No. We got a lot of documents to get through so I'm trying to hit the off points and ask you about... One of the things that they wrote you... Do you have the other pages of this? When you got your approval, if you look at the last page on overall conclusion, and this is a document from the medical officer review, Curtis Wright. This is part of the approval... part of the FDA approval process. He's the guy that now works for Purdue Pharma, correct? No. He hasn't worked for Purdue Pharma for a long time. Okay. Regrettably, but... Hired by Purdue Pharma subsequently, correct? He was hired by Purdue Pharma. And his last... Maybe three years after this. I don't recall exactly. And... Why don't we go ahead and mark this as exhibit 18? His overall conclusion on the last page is CR oxycodone, that's controlled release, correct? Yes. It appears to be a BID alternative to conventional QID oxycodone. And approval is recommended. Care should be taken to limit competitive promotion. What is competitive promotion? I'm not sure what he meant. I could guess that he means promotion comparing this to other agents that are used in various pain conditions. But that's a guess on one part. I think the next sentence explains it. He says, the product has been shown to be as good as current therapy but has not been shown to have a significant advantage beyond reduction in frequency of dosing. So other than you don't have to take it as much, the FDA has concluded that there's no benefit other than it's not been shown to have a significant advantage beyond reduction in frequency of dosing. Not been shown in the NDA, yes. Let's... Probably announcing lunch. Probably so. Let's go off the record. We are off the record at 12.32 p.m. We are back on record at 12.32 p.m. Do you have this one? Mark 22nd. Yes, in case I need another... Okay, if I need another pair of glasses. Yeah, Mark 22nd. Something stronger. I may have stronger ones, you know. Some of these documents are so difficult to read. Yeah, they're difficult. This is the OxyContin Project Team memo. Do you know if you ever reviewed this memo? I wasn't on the project team. I don't know if I reviewed it. I'm curious. I could read through this. Was it sent to me or not? I don't know if it was or not. It looks like I was not on the circulation list. Well, this list down here is... Yeah, there is a circulation list. It appears that it was not. And if you would go over to page 4, the last paragraph down to the bottom, 6.2, Mike Inarato asked if marketing would be able to review the package insert. Do you have any idea of why marketing wanted to review the package insert? Surely. There are many reasons. Robert Reeder stated the package insert will be circulated to marketing and other reviewers at the same time as the protocol review. As I said earlier, the package insert was becoming, originally 20 years prior to this, package inserts were very, very brief and very simple. Over time, the agency wanted them to be more complete documents. And then it had regulatory implications as well. So if you look at the history of use of package inserts, they by this time had become fairly long and extensive documentation for the physician. Their notion of being printed in that tiny format and stuck with every package, in a sense, was inconsistent. So you ended up sometimes having this package insert that was as big as the bottle, adhered to every bottle. But it was available to physicians in a variety of other forms. The physician's desk reference, I think, you must be familiar with, which was the way most physicians then would read a package insert. It was just a compilation of all the approved products package inserts. What is marketing going to add to that? First of all, I have to understand what the package insert is going to say about the product so that they can think of how they're going to present promotional materials. Secondarily, they might, if the package insert is in draft form and under discussion with the agency, turn to the responsible medical officer, as an example, or the regulatory people and say, you know, this could be misunderstood. This could represent a problem. And so they would contribute to the clarity. But the medical department was, and regulatory department, with the principal owners of the document in the company, and the owner of the document for the government was the Food and Drug Administration. And of course, they had determinative power as to what it ultimately ended up as. He'll turn to page 5, under 7.0, Marketing. Yes. It says, Post-Marketing Studies, QQL, Pharmaco-Economic, Percocet, Dura-Jezek. Robert Reeder discussed some of the planned post-marketing studies. These included an OxyContin vs. MS-Contin comparative study, the Dura-Jezek comparative study, which is currently on hold, and a Relative Potency study comparing OxyContin to MS-Contin. Robert Reeder stated that we would need additional studies to recruit several hundred patients in order to get data to support claims for non-cancer pain. This was on March of 1994. Do you know if those studies were done? I'm sure they were done after approval. But I don't know whether any were done before approval. Do you know if they were done before the drug was put on the mark? I don't know. Who is Robert Reeder? He was the senior medical officer on this project at Purdue Frederick. And then it says Mike Inarato, again he's the marketing guy, correct? Right. Stated that a Percocet comparative study would be a benefit to marketing. Mike Inarato replied to Bob Keiko's question and claims by answering that equal efficacy of OxyContin to Percocet with better quality of life would be a beneficial claim. Mike Inarato stated in the future, Tramadol would pose a threat to the OxyContin market. And then down below that, it says 7.2, marketing claims studies desired. Mike Inarato gave a presentation on the results from the focus groups. A copy of the market research results would be issued to the OxyContin team. The results of the focus groups are attached. The results cover issues such as benefits, positioning, and claims. Do you know whether the studies recommended by Robert Reeder were done before it went to market or the studies requested by the marketing guy were done before it went to market? I don't know. Then there is a, if you go to page, the very last page I guess it is, OxyContin presentation 3294 up at the top. Just a second. OxyContin presentation, I see it. And it says down at the bottom, it's got all the list of, OxyContin will be positioned as the only opioid combining the efficacy and safety of OxyCotone with the convenience of a 12-hour schedule which allows for precise and accurate conversion and titration while allowing the patient to lead a more normal quality of life. OxyContin is the opiate to start with for patients who may be on Percocet, Lord Taber-Weichmann, and the opiate to stay with as the disease progresses. Now, that was a marketing campaign, correct? That was correct. Yes. And start with stay with campaign. Do you know who came up with the start with stay with marketing campaign? I wish I could lay claim to it, but no, I don't know who came up with it. And then it says... That was not the launch campaign, in a sense. It may have been a subtext of the launch campaign, which was the old way and the new way. It says at very at the bottom, less potential abuse than other opioids. Do you know where that claim came from? I don't know. Looking at, is this after the package insert? No, no. It was before the package insert was approved. I don't know. Do you know whether OxyContin had less potential abuse than other opioids? I don't know. What this refers to. Do you have this one? Do we mark that one? We did not. Just mark that as 19 Median and Evidence, and here is this one. This is PDD 9520821306. This appears to be the... Do you want to mark it? Yes, let's do that. Now it's 20. Are you keeping these? Yes. Okay, it's number 20. OxyContin Tablets Project Team. Okay. And this is June 22, 1994, correct? That's what it says. And on page 2, Marketing, it says... Wait, wait, I see June 8, not June 22. Oh, the date it sent is June 22 over on the right. Oops, okay, my mistake, okay. So it's Project Team Meetings from June 8, you're correct. On page 2, under 1.0, Marketing, under the OxyContin Tablets Project Team Meeting Minutes, Mike Inaratu gave an overview of the oxycodone market referring to sales and growth charts and prescription data. Mr. Inaratu also presented our current strategy for introducing OxyContin Tablets to the market. OxyContin Tablets will be targeted at the cancer pain market. Was a decision subsequently made not to target, specifically at the cancer pain market? I would infer that, but I don't know when. But at least by June 8th of 1994, the plan was still to target the cancer pain market. Yes. It doesn't say that, however, that we... Let me just read this again. It'll be targeted at the cancer pain market. It doesn't say that it will not be promoted to the nonmalignant pain market. OxyContin Tablets will be targeted at the cancer pain market since it is possible that morphine generic products may soon be in competition with MS-contin tablets. We will target patients who are currently receiving MS-contin as well as those patients who are thought to eventually use MS-contin tablets, i.e. on the analgesic ladder, late step one, step two, and step three. The bulk of opioid business comes from 7,500 physicians, 3,000 of whom are oncologists. That's correct. So you all had market share from MS-contin, correct? Yes. And in order to keep from losing that market share to generics you are going to be priced much lower than MS-contin generally, correct? That was the trend at that time, yes. What you did is put out OxyContin an obsolete MS-contin and if you could keep the MS-contin market through the use of OxyContin you wouldn't lose any market share there and if you could expand it to nonmalignant pain you would gain all of that market share, correct? I object to the form of the question. At the minimum it's compound. Sure. Go ahead, you can answer. So could you just break it into two questions and I'll answer them both. Can you read the question back? And stop after one. What you did was put OxyContin an obsolete MS-contin and if you could keep the MS-contin market through the use of OxyContin you wouldn't lose any market share there. And that's what this seems to say and certainly that was an element of consideration and part of the strategy. What I think might be missing here is any discussion of the nonmalignant pain market which you asked me a question. Could you read question two? And if you could expand it to the nonmalignant pain you would gain all of that market share, correct? We would not gain all of the nonmalignant pain market share but we could augment or add to the cancer pain market nonmalignant pain. And I'm quite surprised actually that this didn't discuss nonmalignant pain as late as June 8th. So for whatever reason the either Mr. Enorado or the person who was writing the minutes didn't seem to include that because I don't think, not to my recollection, was there ever consideration of restricting this product to malignant pain alone. It was widely used, Percodan, Percocet, widely used in nonmalignant pain. Down below that it says marketing has been interviewing potential advertising groups and is close to selecting one. Do you know which advertising group was ultimately selected? I don't know but I'm sure we could find out if that were important. And then under publications right below that manuscripts for studies C90-0708 and OC93-0101 have been sent to Dr. Stansky and Mandima for review as potential authors. Why was Purdue sending out manuscripts to doctors to be potential authors? I can't say for sure but two possibilities arise in my mind. One possibility is that the manuscript had come to us in draft form and we had helped them fill in details such as the references and so forth. That was one of the ways that companies help authors lighten the burden, so to speak, of writing a paper. The second possibility is the first draft might have been written in-house and sent to them for their review and their correction and additions. Well it says as potential authors. It would appear that they authored the manuscript even though it really came from Purdue, correct? Objection. It's a collaborative effort. We can't, we don't impose on any author what they submit. What they submit for publication is submitted from them, by them and totally in their control. Do you know if Dr. Stansky and Mandima were paid by Purdue? I don't know. Do you know whether these manuscripts ultimately identified Purdue Pharma as being any part of the author? I don't know, but it was not infrequent that employees of Purdue Pharma would be co-authors on manuscripts. I don't know whether in this case they were. And then if you'll turn over to page four of this document. It says clinical. Status of core clinical program. Robert Reader, now he's the... Senior Medical Officer on this product. Robert Reader stated that this OC-92-1102 study, OAPain, has been completed and preliminary data is currently being reviewed. It appears that the 10 milligram tablet is similar to placebo in efficacy, but the 20 milligram tablet was significantly different compared to placebo. Were you aware that the 10 milligram tablet was similar to placebo in efficacy? I don't recall that. That would not be unusual in any analgesic trial, however. You have this one before I'll go now. Then I'm going to ask you about the Meetings of the International R&D Meeting. This is... Did we mark that? We did. This is a PDD... I'm sorry. We can go ahead and mark it if you want. PDD 1701824723 Exhibit 21. Which appears to now we're into November of 94, and present was Dr. R. S. Sackler, correct? If that's what it says, I must have been present for the least part of it. And on page 13... Oh, yes, I was probably present for all of it. Page 13, third paragraph. Dr. Ying asked if there were any... Oh, just a second. I'm sorry. Page 13, this one? You're reading from the top here? Yes, I'm reading from the middle of the paragraph. About the eighth line down. Dr. Ying asked if there were any statistically significant results. It was confirmed that the 20 milligram product was significantly better than the placebo, but the 10 milligram product was not. And was that brought up at the meeting? It must have been... This is minutes of the meeting, so I'm sure this was... These minutes were generally of good quality. If you'll turn over to page 11, and this is shortly before the launch of OxyContin, correct? Renowned in November of 90... No, it was not. This is over before the launch. Yeah, November of 94. It says in the third paragraph, halfway down that paragraph... Yes, Dr. Reader? Dr. Reader. It says advantages for OxyContin are that not all patients can be successfully treated with morphine, and that there is a stigma attached to morphine so far as many patients and physicians are concerned. And that stigma is what? It's an end-of-life, in many hands, principally cancer drug associated with a whole bunch of negative associations. Were one of the negative associations side effects addiction, dependency, tolerance build-up? Yes, but the dependency did not differentiate it from any other opioid. It was not more dependence causing or less. And under this, in summary, the efficacy of the product has been demonstrated in... I'm sorry, go to page 12. Okay, thank you. It's therapeutic... Okay, I'm on page 12. Can you help me with the paragraph? From the top or bottom? Yeah, third paragraph from the top. Actually, four. Of course, it's in summary. Yes, thank you. The efficacy of the product has been demonstrated in six double-blind clinical trials involving 713 patients. Therapeutic conclusions are the equivalence of one milligram of OxyCotone to two milligrams of morphine sulfate. That's correct. All right. Number two says equivalence to IR OxyCotone. Immediate release. Yeah. So they're saying controlled release is equivalent to immediate release OxyCotone? The implication here is in terms of potency, I assume. Number three was the need for dose titration. Yes. And number four says the need for the availability of a rescue formulation. And number five said the need for aggressive management of side effects. Why would you need the availability of a rescue formulation? At this time and still today, the doctrine of using opioids is to titrate to effect. But in some conditions, cancer and others, the dose that has in general a good effect may suddenly be insubstantial due to what's called breakthrough pain. And breakthrough pain could be the occasion by movement or trauma or just occasion by the fluctuation in the pain state. Rather than maintaining a patient on the highest number of milligrams of any opioid around the clock just to prevent breakthrough pain, the normal practice, and I think it's the prudent and safest practice, is to give the patient an immediate release form ideally of the same analgesic agent that they can take when they have breakthrough pain on an as needed basis. Were there studies done at Purdue that showed that blood plasma levels, that the medication, instead of lasting for 12 hours, really lasted between 8 and 12 hours? There were blood level studies that showed the profile of blood level, but there is no prediction of what blood level you will need to control what pain. So when we, what we attended to were the clinical results of treating patients at a 12-hour basis, and that was what we've researched. Now, may I just fill in a little bit? Sure, let me ask you this though. What your research actually showed is that Oxycontin-controlled release provides pain relief somewhere between 8 and 12 hours, correct? I think there were some patients who appeared that way, but principally most were 12 hours. Allow me to just elaborate just a bit. Normally people take a Tylenol tablet every, or two tablets every four hours, but they will get essentially the same effect if they take one tablet every two hours. What we had found was in most patients, this was found as the drug was marketed, who complained that at 8 or 9 hours they were back in pain. Yes, they could be treated every three times a day, but if you took that dosage, the daily dose, and divided it twice a day, Q12 hours, they were just as pleased with the pain relief. It was simply that the physician, perhaps by habit or for other reasons, rather than increasing the twice a day dose, increased the daily dose by telling the patient, well, take it every eight hours, and it would work fine. Do you recall Purdue Pharma running into a real problem with their rescue drug, because they were trying to decide how to market it and whether to say it was for three to four hours or for six hours, and there was a real debate at the company of how we're going to market this because we're going to hurt ourselves one way or the other, depending on whether we say our rescue drug is three to four or six, because it's the same and you're marketing it two different ways. Actually, in the form of the question, it consists of multiple questions and parts. You can answer it if you can. I have a vague recollection of it. If you could show me some documents. If you wanted to pursue this with other questions, please show me some documents. I do have a very hazy recollection of a very minor complication, but perhaps it was a big regulatory complication. I don't remember. I couldn't explain it to you. So we'll go back to that in a second. Okay. Let me continue to read from this document. It says, Dr. Keiko reported that file studies, it's a fourth paragraph, undertaking to show that the 10, 20 and 40 milligram tablets were bioequivalent and dose proportional. In normal subjects, it has been demonstrated that at the same total daily dose, the controlled release product given 12-hourly showed the same two-fold fluctuation as the immediate release product given six-hourly and that this held across the four-fold dosage range. And were you all aware of that in 1994? I'm not certain what this means. I'm sorry, but I don't know, I don't know what two-fold fluctuation means. I'm sorry. Did you ask anybody when you were at the meeting? I'm sure I understood it, but I have my best guess is that whoever was taking the minutes somehow perhaps even didn't understand the discussion or may have understood it, but wrote it up in a way that doesn't make any sense to me now. Going down to the fifth paragraph, a clinical study has been undertaken comparing oxycodone BD versus immediate release oxycodone QID in patients previously stabilized to pain relief. And then if you drop down, the study demonstrated that both products maintain baseline pain control and pain intensity was the same throughout the day. The acceptability score was the same throughout the study and the same for immediate and controlled release products. And then if you drop down to the next paragraph, the conclusion from the study was that the 12-hour product was equivalent in efficacy to immediate release oxycodone. And is that why the FDA said other than how many times you take the product, being the dosing requirements, there's really not any other benefit? I can't tell you whether this was the study that convinced the FDA of that, but the finding is completely consistent with that. There may have been other studies that led them to that conclusion with this being just supportive of that conclusion. In pain studies, I might point out that the biggest advance in measuring pain, which of course is a personal experience, no doctor can look at you and say, oh, you've got a pain level of three and you have a pain level of six. There's no way of doing it. You have to depend on the patient's report. And the huge advance that led to all the research in analgesia and pain relief was called the McGill visual analog scale that was developed in the 50s in McGill University in Montreal. 70 years later, we have no advance on that. And needless to say, I suspect everybody in this room has gone to a doctor where they say, do you have pain? And if you say, or to a nurse, when they take your blood pressure, yes, I have pain. And they ask you to rate it. That is clearly better than just saying, patient has pain plus, yes or no. But it's not a lot better. It's not terribly, it's not reproducible. And it is highly influenced by the environment and other factors that affect the report that the patient gives. So very often, you can compare a highly effective pain reliever to a placebo and you get in the study no difference. And that is widely recognized and that probably related to the study that you talked about earlier. The FDA, however, would have required studies that showed a difference and they did before they would approve the product. In other words, the negative was dismissed as a failed study by the FDA. The positive studies control because... Do you recall the study being dismissed as a failed study? I don't know it was dismissed. It was studied, but they must have concluded that that finding is not consistent with either their expectation or ours or more importantly, other studies and experience. And clearly the product's success in treating patients in pain, which is indisputable, would put a lie to anybody who would say, oh, oxycodone is no better than placebo. I don't think any doctor would assert that for treating pain. Maybe they would say in terms of urinary incontinence, it's not effective, but for treating pain. But whether it's effective or not, it also depends on other factors such as abuse. You can kill somebody and take away their pain, but that certainly wouldn't be effective, would it? I don't think that death would be considered a sign of efficacy. Yes, I mean in the extreme, yes, what you say is correct. So just because it takes away pain doesn't mean it's a good drug, does it? No. All right, let's look at Sackler exhibit 13 again. I did want to ask you one question about this. There's always a balance between effectiveness... I'm sorry. There's always a balance between effectiveness and safety. If you go to page 4, 1.4, it says, if physicians perceive oxycontin as controlled release percocet, it is likely that they will start to use it in place of oxycodone combinations. As physicians become more comfortable with the use of oxycodone combination market, it is possible they will start to use oxycontin in place of class 3 hydrocodone or coding combination drugs. And class 3 are not as regulated as class 2, correct? That is correct. Therefore, it is imperative that we establish a literature to support such use. Who at Purdue Pharma was trying to establish a literature to support a class 3 use for oxycontin? Object to the form of the question. The answer to your question is nobody. We had no plan, program or expectation or intention to change oxycontin from class 2 to class 3. In fact, it is not too long ago the FDA has reclassified hydrocodone as a class 2 drug. So you think that where it says therefore it is imperative we establish a literature to support such use is referring to physicians believing where it says physicians perceive oxycontin as controlled release percocet. It is likely they will start to use it in place of oxycodone combinations. Is that what that development of literature is referring to, in your opinion? Probably. Who was trying to develop that literature? I don't know. That would have been a combination. That would have been the medical department to do studies and then have them published. That would have been a research effort. Do you have that? Is that what this is? Are we finished with this one? Off the record, do you want to break through the launch? Do you want to break through the launch? Do they bring launch yet? Yes. We are off the record. I thought it wasn't. We are back on the record at 2.03 p.m. All right. Dr. Sackler picking back up after our break and we've taken a number of breaks but I'll just remind you at any time you need to stop or need a break just let us know. Thank you. We'll stop again. We were talking earlier about this issue of rescue oxycontin. Let me hand you what we're going to mark as exhibit 22. If you go back to the last page there is a memo dated 9.21.95 from Robert Reeder, R-E-D-E-R. He says currently our draft PI that's package insert, correct? Yes. And therefore our sales material have the same dosing of rescue as Q3-4HPRM and that means what? It means every three to four hours as needed. And do you know if the people who were involved in the studies of oxycontin were given oxycontin for rescue pain? Oxycontin? Yes. Or you mean oxycodone? Oxycodone, I'm sorry. I'm sorry. I don't know. It says BK brought this issue up some time ago. It is now surfacing again because of the review of our sales material. Oxy-IR, and is that oxycodone? Yes. Is being promoted as rescue to Q3-4H and that's every three to four hours, right? That's correct. He said while this may be consistent with the oxycontin package insert if it is approved as stands it will be inconsistent with the oxy-IR 5 milligram package insert which uses Q6-H, I mean take it every six hours, correct? That's what it means. He says moreover if we use the Q3-4 hours it will help to validate rock sands change in their package insert. What was the reason that you all did not want to validate rock sands change in their package insert? I would have to read this completely and try to answer your question but I'm not sure this will prompt me to remember. May I? Sure. Okay. I really don't remember this well enough to answer your question. Okay. Let me continue reading here. It says finally it creates a problem for the oxy-IR 10 milligram and 20 milligram capsules as the package insert would have two different dosing intervals depending upon the use. I.e. Q4 for rescue and Q6 for usual pain use. He says one suggestion would be to make everything consistent at Q6 hours. Rescue would then be Q6-PRN as needed as with some acute pain prescriptions. For ATC use it would just Q6 hours. Although I hate the thought of recommending a PI change, a package insert change, I understand FDA may recommend a change or two such as removing the plasma curve graph. At this point we could change the frequency of dosing in the PI. What do you guys think? So what he's saying here is we've got the exact same drug. We've marketed it for two different purposes and we've got two different dosing regimens for the exact same drug, correct? It seems to suggest that, but I can't confirm it. And then Paul Goldenheim, if you turn to the next page and read the next one at the bottom, says who is Paul Goldenheim? He was head of R&D, Research and Development and Medical. He says the issue that won't go away. Robert is right. We need to discuss again. Robert, please arrange a meeting. What's the usual suspects? This is too complicated for email. Then Friedman, and what was his role? He was head of marketing and sales. The head of marketing and sales writes back and says, is it unreasonable to have a Q6H dose, I mean take it every six hours for normal dosing, and a Q34 hour for rescue? So the marketing guy's saying, can't we just take the exact same medication and say, if it's for a normal dosing, take it every six hours, but if it's for rescue, take it every three to four hours. That's what he says. And what he meant was for normal around the clock dosing, rather than rescue, which is one or two or three doses. And that's it, as needed. And then up at the top, you write back and say, second one down, I agree this is too complicated to solve through written exchange. Paul, I think that you should get us together soon. Good pickup, someone. Do you recall writing that email? No, but it looks like I wrote it. Okay. And then Robert Kaikel writes back and says unfortunately soon may be too late. Robert, question mark. As previously, so he's saying I brought this up again. As previously, I recommend we change everything to Q6 hours for immediate release oxycodone products, and he is the head of what? Robert Kaikel. He was in the medical department and he was the project, the research project head for the overall oxycodone project. Okay. So he's saying, it appears to me, perhaps to be a little frustrated in saying soon may be too late. As previously I recommend we change everything to Q6 hours. I can't say why he wrote the first sentence, whether he was frustrated or whether he was actually referring to some sort of deadline, maybe in a clinical trial, maybe on submissions to the FDA. I don't know why. But at least from the appearance of this, even in the head of marketing saying why don't we take the same product and just say take it every six hours and if it's for rescue, it's good for three or four hours. Right. This, essentially to fill in what, the blank here, what he must have meant was have two indications. For regular use of immediate release oxycodone, administer it around the clock every six hours. For rescue use, you can administer the dose every three to four. But that wouldn't be indefinite. This would be for rescue. And for breakthrough, actually for breakthrough pain. And for treatment, the head of marketing is not a physician, correct? That's correct. So he's making a suggestion. Dr. Robert Keiko, the head of the project for OxyContin, is a physician, correct? He is. And he's saying don't do what Friedman's saying. We need to make it Q6 hours for immediate release oxycodone products, correct? First of all, Friedman asks a question here. He's not asserting a proposition. He's asking, explain to me why we can't do this. And I understand why he asked the question. And the only answer could be it might be confusing to a physician. But I think the emphasis should be on might be confusing. And then you write back the next day and say, I don't know how urgent this is but I can't wait till tomorrow. Let us know immediately. I don't have a problem with this change at all. Does anyone question it? And who's Mr. Alfonso? He was head of marketing at the time. So the head of marketing comes back and he says, the way these drugs are written are Q4, 6. The rescue is for Q3-4 hours. And he explains the problem might be that if we go Q3-4 hour root, we will validate the Roxanne dosing. Again, I'm going to ask you, do you know what the problem was with validating the Roxanne dosing and why he thought it was a problem? I don't remember. I don't really think it was a problem. I can't imagine what he was thinking of. Okay, so he writes, the problem might be that if we go the Q3-4 hour root, we will validate the Roxanne dosing and possibly present a challenge to the Oxycontin studies. So if he's validating the Roxanne with the Q3-4, would it appear that perhaps the Roxanne had required, now that's an overseas company, correct? No, Roxanne was an American company. I believe at that time owned by Beringer Ingelein. Okay, did they put a dosing limit on Oxycontin to your knowledge? Oxycodone, you mean? Not an Oxycodone? No, not to my knowledge. I don't think it was an issue of limit. Do you know what Roxanne's dosing was that he's referring to? No. Okay, so he says, the problem might be that if we go the Q3-4 hour root, we will validate the Roxanne dosing and possibly present a challenge to the Oxycontin studies. On the other hand, a much more dangerous scenario can occur if we go the Q6 hour for maintenance and rescue. If we go this route, and price continues to be a major issue when we narrow the value of Oxycontin closer to the IRs, and that's immediate releases? Is that what that is? Yes, IR would be immediate releases. I'm just reading the sentence because I didn't follow what it meant. The next sentence says, in essence, if you can use an IR Q6 hours at a cheap price, then those doctors that use Oxycontin Q8 hours, there will be some, regardless of what we say or do, will not see a benefit over the immediate releases. In addition, our promotional campaign has a visual six cups representing Q4 hours. If we go Q6 hours, we might have to change the visual to four cups, and this will not have as much impact. We need to go Q6 hours for maintenance and Q3-4 hours for rescue so that we can maintain the integrity of our Oxycontin studies. Did I read that correctly? You did. Do you know whether you went Q3-4 hours for rescue and six hours for maintenance? I don't know. Sorry. Let me jump back. Why don't we go ahead and mark that as exhibit 23? This is from you, dated April 20, 2000, so Oxycontin has been on the market over four years at this point, correct? And under number five, it says Oxycontin tablets price increase is the central decision. Every 0.1% is 1M. I'm assuming that's one million? That's correct. One million to the bottom line. What would the risk of having a 4% increase instead of a, what would the risk be of having a 4% increase instead of a 3% increase? The price increase, correct? That's correct. Our average real-life price is constant, suggesting that rebates and other discounts are taking a larger share of our business. 3% annual notional increases seems to hold our per kg. Per kilogram. Price constant in an environment where many prices are going up. Was it true that every time you increased the price 0.1% you added 1M to the bottom line of Purdue Pharma? I don't remember. The answer is no to your question. I don't remember whether this is correct or not when I wrote it, but it certainly wouldn't have been correct every time. Do you have a deposition of Friedman? I'm sorry, Shapiro. We were talking earlier about Purdue Frederick versus Purdue Pharma. Did you ever determine whether the employees, the sales force that engaged in improper conduct as referenced in the felony plea agreement were employees of Purdue Frederick or employees of Purdue Pharma? I object to the form of the question. I don't think it accurately reflects the plea agreement. Could you just restate the question because I kind of lost the thrust. We've talked about Purdue Pharma and Purdue Frederick. Did you ever make a determination whether the employees who engaged in illegal activity as referenced in the felony plea agreement or improper activity as referenced in the felony plea agreement were employees of Purdue Frederick or were employees of Purdue Pharma? I'm not aware of whether such a study was done or anybody focused on that question. They may have been done, but you should be, you should think of this that the felony plea agreement came years after many remedial actions had been taken to retrain everybody to discipline sanction, correct discipline sanction or dismiss employees who had behaved improperly. And those processes which started late in 2000 or early 2001 continued right up to the plea agreement and then after the plea agreement. Sure. Have you looked at the call notes of the reps in Kentucky? I have not seen any except those that were shown to me during my preparation. There were three or four that I saw. Did you review the documents that Mr. Shapiro, the lawyer that you all hired put together for the U.S. Attorney in Virginia? I don't think so. Those don't seem familiar to me. And that was the attorney that you all hired to defend you in the case brought by the U.S. Attorney in Virginia, is that correct? Yes. You all paid him approximately $50 million to defend you on that or paid his firm approximately $50 million to defend Purdue in that case? I can't verify that. It's the first time I've heard a number attached to that. If he testified to that, would you dispute it? I would have no basis to dispute it. And do you know if anybody at Purdue made an effort to determine whether the submission and the call notes that were pulled by the lawyer hired to represent you were accurate or not? I object to the form because I don't know how anyone knows what it is you're referring to. Are you aware that he made a submission on behalf of Purdue to the U.S. Attorney's Office? I am not aware of anything that he's submitted to the U.S. Attorney's Office. You've not reviewed any of the materials he submitted to the U.S. Attorney's Office when he was defending Purdue? I did not. Were you aware of the call notes that he pulled and purported were evidence of improper behavior on behalf of Purdue salespeople? No. Did anyone at Purdue, to your knowledge, Purdue Pharma or Purdue Frederick make any attempt to ascertain what percentage of reps in Kentucky were engaging in the type of behavior that the plea agreement says was improper? I'm not aware of that. Did you ever instruct anybody to do it? To do... Could you be more precise? Did you ever instruct anybody at Purdue to undertake an investigation to find out what percentage of reps in Kentucky and which ones were engaging in conduct that was referenced as improper in the felony plea agreement? I did not. Have you reviewed Hart Shapiro's deposition in this case? I have never seen it. He was asked... Let me read this question in his answer. Mr. Sherrill, before the break we were discussing the Agreed Statement of Facts specifically paragraph 20. One of the questions that I had asked you previously about the conduct described in the Agreed Statement of Facts was did you ever figure out who the employees referenced at Purdue Frederick Company, was it Purdue Pharma LLP, or some other entity? With respect to the employees that we've been discussing and those are employees whose conduct is described in paragraph 20 in its various subparts, did you ever do a determination to determine whether those employees were employees of Purdue Frederick Company who signed the Agreed Statement of Facts or some other Purdue entity? And his answer is, without going into too much work product, once it turned this direction to satisfy ourselves and our client that there were Purdue Frederick employees who engaged in the conduct that's referenced in here and that forms the basis for the guilty plea. Question, were there any employees of Purdue Pharma LLP that are referenced here or any other Purdue entity? Answer. Well, again, and I'm just what I said before, I don't know whether at at which point in time Michael Friedman hired Udell, Paul Goldenheim, whether they were Purdue Pharma or Purdue Frederick or some of them had been one and then the other beyond them there were when we look for instance at the names that are associated with the in the first supplemental responses to whatever that was 23, I think. Did you understand that answer? Mr. Thompson, I object to the question plus could you let the witness have a copy to read because it's very hard to follow when you're reading such a lengthy Sure. Do we have another question and answer? Here, I'll tell you what, you can just read along with me if you want to do that. I'll hold it over here. No, I think he would like to see it. Well, I'd like to see it also. He really can't see that distance. Physically, it's... Here, we'll print out some copies. Yeah, why don't we go off the record and get some copies of this. We are off the record at 2.28 p.m. We are back on the record at 2.29 p.m. Sure, and to save time, I'll let you read it. Can you start with the next question, which was uh-huh, and read the answer? I'll read the answer. The uh-huh doesn't really set up the answer for me. That's page 214, line 27. The uh-huh. Page 21. Yes, I'm sorry. Page 2 214. 14, line 17. Uh-huh is the question. Answer. Of people who were referenced, but not named in some of the paragraphs, I don't believe that we made any effort in whether, at the relevant times, they were Purdue Frederick Company employees or Purdue Pharma employees. And is that testimony accurate? I can't vouch that it's accurate. It's consistent with my knowledge. So the next question says so it could have been either or one or both? Yes. The question is so it could have been one or either or both? You're not sure? The answer is correct. Now, in 2001, who did Michael Friedman work for? I don't know. You don't know if he worked for Purdue Pharma in 2001? My best guess is he worked for Purdue Frederick. But it's a guess and maybe for Purdue Pharma. But I don't really know. How about Howard Udale? Do you know who he worked for? No. What about Paul Goldenheim? I don't know that. Do you know whether you worked for Purdue Pharma or Purdue Frederick in 2001? I don't know for sure. Yeah, this one. So, going back to our Oxycontin launch team, do you want to put a number on this? Yes, let's mark that as Exhibit 25? No, 24. And I've just got a couple of paragraphs I want to ask you about. Surely. So this is dated April 4, 1995 and it says at the first paragraph, second sentence, Mike in a Rotto, Oops, first paragraph on which page? Page one. Second paragraph. Oh, second paragraph, okay. Mike in a Rotto. He's the marketing guy again, correct? Yes. Discuss the marketplace that Oxycontin will enter and how Oxycontin will expand out of the cancer pain market. Oxycontin will be launched in 10, 20, 40 milligram tablet strength, 80 and 160 milligram tablet strength and if you go on down a little bit further, he says Oxycontin will be indicated for the relief of pain with the convenience of Q12 dosing. Oxycontin's primary market positioning will be for cancer pain and the secondary market will be for non-malignant pain, musculoskeletal injury and trauma. It was reinforced that we do not want to niche Oxycontin just for cancer pain and was it for your all marketing strategy not to niche Oxycontin for cancer pain? Not to limit it, yes. Below that it says on the last paragraph in our market research office, focus groups, personal one-on-one interviews and telephone interviews were conducted with more than 500 healthcare professionals. In our focus group findings we learned that MS-contin that's the drug that you already solved, correct? I'm sorry, I didn't hear the question. That's morphine sulfate? Yes. That's the one that you had not had any reports of abuse or diversion with that you could recall, correct? None that I was aware of, yes. And it says we learned that MS-contin is the gold standard for cancer pain. Our creative concept testing showed the likelihood of Oxycontin usage by physician and nurses were 4.6 on a scale of 1 to 5 which is very favorable. Were you aware of this creative concept testing and focus groups that were being conducted? I don't recall. And then if you go to the next page, page 2, last paragraph, our meeting ended with a question and comment period. Michael Friedman emphasized the threat that AB-rated generics pose to MS-contin. We're not sure when AB-rated generics will be launched but we don't think it will be until 1996. Inevitably, the AB-rated generics will arrive and this is why it is extremely timely importance that we must establish Oxycontin. Oxycontin can cure the vulnerability of the AB-rated generic threat and that is why it is so crucial that we devote our fullest efforts now to a successful launch of Oxycontin. Were you aware that was part of the strategy? I'm sorry but what was part of the strategy? That the AB-rated generics were going to arrive and that is why it was extremely timely importance that's the way it's written that we must establish Oxycontin and it was crucial to devote the fullest efforts to a successful launch because of AB-rated generics. Objections of the form the witness can answer. Yes. I was aware of that and the reason is clear and Oxycontin was our most important product at that point and when the sales were eroded and by generics we would have if we had not replaced those sales with other product sales we would have a much smaller company that would cost many people their jobs. Oxycontin product team I've become reminded of it, yes. This mark this is exhibit is it 25? Thank you. And this is minutes of the Oxycontin product team dated the meeting was February 22nd 1996 of the top. Washington's birthday. It says, first paragraph Oxycontin product team met on Friday February 22nd 1996 and topics discussion included the following, number one is marketing's wish list for clinical studies and then it's got a list of studies number one is post operative pain to support the Abbott agreement why did you need studies on post operative pain to support the Abbott agreement? I don't recall. Pharmaco economic what was the reason for pharmacoeconomic studies being needed if you recall? I don't recall that circumstance. And then it says non malignant pain example functional improvement and then the subcategories are low back pain, osteoarthritis long term safety data. Right. Why did you think that marketing was needing on March 7th 1996 after the product had already launched long term safety data? I don't remember precisely but all studies would include or would enhance the data available to support long term safety data if the studies were long term and the studies that were referenced here low back pain and osteoarthritis would surely have been long enough to add to that database. Then can you explain why the head of the Oxycontin or the Oxycontin product team on February 22nd 1996 after the product launched said we need long term safety data. I don't think there was any question about the safety of the drug it was just an addition that it would enhance the dossier that was available. I don't know how you would do a long term safety study devoid of some condition so the long term study would be focused on following a condition let's say low back pain or osteoarthritis and at that time the studies were typically 12 weeks and with an open extension at the end they could go on for a year. That is a subcategory of non malignant pain correct? These two studies low back pain and osteoarthritis long term safety would be a general concept that would apply to any kind of study that's long enough to accumulate that data. They've included long term safety data under their marketing wish list under non malignant pain correct? They did. So it looks like they're saying we need long term safety data on prescribing Oxycontin for non malignant pain do you read that the same way or differently? I guess I read it differently than you do just that it wasn't that we needed it it was a wish list, but it was inherent in any long term study we did of any pain condition. And then we talked about the FDA's statement about comparative studies do you remember that or they said you should refrain from comparative analysis? I don't remember so if you could just go forward with the question that would be great. One of the things that the Oxycontin marketing team's wish list has under number five is comparative studies especially versus combination opioids such as hydrocodone combinations during GZIC, MS Contin, Cazdian and Ultram NSAIDs. Those are nonsteroidal anti-inflammatory drugs is that right? Ultram is an opioid drug. NSAIDs are nonsteroidal anti-inflammatory drugs. So they're not the same I don't know why they were the bullet put them together but they're different. I'm asking you is that what NSAID stands for? Yes Has it been marked? It's been marked 25. Now let's go to the launch plan and this is dated September 27, 1995 and if you'll go to page 42 of the launch plan under 5851 under public relations at the top it says the objective of the public relations campaign is to create broad awareness of the launch of Oxycontin. This awareness will be directed at the consumer and healthcare professionals through various media channels such as print, TV and radio. In an effort to create a quote media hook in quote that would coincide with the launch of Oxycontin a consumer survey conducted by companies such as the Gallup poll is being proposed. This survey would focus on the prevalence and problems of chronic pain both malignant and non malignant. The release of the results of such a survey would be publicized along with the recent FDA approval of the new controlled release Oxycodone preparation Oxycontin. This is a classic problem solution strategy to create a need for the launch of a product such as Oxycontin. Did I read that correctly? You did. Do you know if a poll was conducted by someone such as the Gallup poll? I don't know what the poll is precisely. Then the next paragraph says five eight five two. It says in an effort to continue the publicity about the launch of Oxycontin, approximately two to three months after the initial public relations campaign another campaign would be launched focusing on the expansion of Purdue Frederick's partners against pain program developed to improve pain management knowledge among health care professionals and patients caregivers. Partners against pain was a creation of Purdue Frederick, correct? That's what it says. And there were no partners, correct? No, I think there were partners in the meaning of the campaign. Physicians, nurses, other health care workers or our partners. Oh, okay, so but as far as setting it up there weren't any other partners involved in setting up partners against pain. The government wasn't involved in partners against pain. I don't know whether other health care companies were involved but the government would not have been involved in setting up this program. And it says this campaign would reiterate the prevalence and problems uncovered in the consumer survey and explain how Purdue Frederick has made a commitment to improving the level of health care for patients suffering in pain. In addition, the campaign would expand the recent launch of Purdue Frederick's newest partner against pain, OxyContin. Excuse me, I think he's just made an error in reading. He said it would explain, not would expand. I thought I said explain. Then the next paragraph says in addition to the above public relations campaigns we are exploring the possibility of Purdue Frederick sponsoring a pain management foundation in association with an organization such as Gilda's Club. Do you know if you sponsored a pain management foundation? I do not but I I I don't know if we did that. I don't think we did but that's a vague recollection. Can we agree that the main way you marketed your and promoted OxyContin was with your sales force? Yes. And those are the people that actually go out to the physicians' offices and pharmacies and to the communities and sell OxyContin, correct? They don't actually sell but they promote OxyContin. The distinction being that they don't actually take orders and arrange deliveries and collect any money. Okay. And you would consider them the most valuable resource that Purdue had to sell OxyContin, correct? It was the most valuable resource that we used. We thought it was the most efficient resource and that's why we used them. Whether other approaches or resources would have been more valuable I can't say. At some point did you figure out that the key to getting physicians to prescribe and keep prescribing OxyContin was through regular visits from the sales force? That would be typical of any pharmaceutical sales force, yes. And was there a realization that developed that certain physicians, so-called core physicians, were more likely to prescribe OxyContin? I'm not sure. I think it was the other way around. Our most significant prescribers were called core. Not that we identified a core and then they became important prescribers. And how many companies were sending sales representatives to physicians' offices to talk to them about opioids during this time? Three to five. It's a guess on my part. I don't recall any survey that counted that up. But it's a guess based upon my recollection of what was being actively promoted. And you compensated your sales force very well based predominantly on how much OxyContin they sold. Is that correct? The successful, the most successful salespeople a majority of their income was bonus. The average salesman I certainly when we launched the product the overwhelming majority of their income was their salary and the benefits that they received. And for the average salesman I think it would have been 50% of their income or 70% of their income salary and the balance and bonus. But I don't remember this in detail and of course it changed over time. The way the sales scheme was set up if they sold more OxyContin they made more money. Yes, the same as almost every other company in the industry. And then you all gave your reps an additional incentive because you de-centivized them to sell MS-Contin but you increased the incentive to sell OxyContin. Is that true? Yes. And then you had one of the highest paid sales forces in the country, is that accurate? I've heard that said for one or two years certainly wasn't the case or hasn't been the case during the history of OxyContin. Do you know if reps that promoted and sold OxyContin sometimes ended up making that was the case, I'm sure it was unusual. And then your top sellers were rewarded with trips to Bermuda or London in what was called the Toppers program, is that correct? Yes. And during the first five years of OxyContin's release Purdue more than doubled the size of its sales force, correct? That's correct. And do you know how much of this was produced by Frederick versus Purdue Pharma employees? I don't know. At some point where sales people designated, all new hires designated Purdue Pharma as opposed to Purdue Frederick? I believe that that's the case. But you're not sure what date that started? No. Do you know if it was after the creation of Purdue Pharma that that started? It would have had to have been. If Purdue Pharma didn't exist we couldn't have hired somebody. Immediately after that, once it was created all reps were hired by Purdue Pharma as opposed to Purdue Frederick? I don't know. Who would know that at Purdue? I don't know. At Purdue now? Yes. At Purdue Pharma? Yes. Well the people who were there at that time might recall it but I don't know who today would know it. And in addition to targeting providing initiatives to the sales force, you also targeted wholesalers, correct? Wholesalers were called upon by the salesman, yes. And in fact I think if you go to page 27 of the initial launch plan the last paragraph it says promotional efforts for the retail distribution of OxyContin will focus on the incredible success that Purdue Frederick has achieved and sustained with MS-Contin product line. Wholesale pharmaceutical buyers and retail pharmacists should be reminded of how MS-Contin created such a large market for the use of sustained release opioids for the treatment of pain. This in turn created profits for pharmacists helping to grow their businesses. Promotional copies should focus on the market potential for OxyContin and patient populations to be targeted, including the number of prescriptions written for Class II and Class III opioids every year. The Executive Director of National Accounts should work with drug wholesalers in developing programs to utilize the wholesaler sales representatives to ensure adequate distribution. Considerations should begin given to advertisements in drug wholesaler and computer programs. Were the sales force told to emphasize with pharmacists that they could make more money with OxyContin prescriptions? I don't think though they would have been encouraged to say that. The objective when any product is launched and certainly any medicine is launched is to be is to minimize the number of times a patient number of patients who get prescriptions from their doctor and go to the pharmacy and the pharmacist says I don't have that or even worse I never heard of that for obvious reasons. So in order to reduce that one tries to stock all three strengths in as many pharmacies as possible but to begin with there's no demand so there's a bit of tension there in order to supply the pharmacist the wholesalers have to have enough stock on hand for the ones who buy it early and a sufficient backup stock both to supply the early buyers and the later adopters and that was all that we needed to accomplish and there's not much more I can say about it except that however we did it was ethical and proper. And let me go back to my question where it says wholesale pharmaceutical buyers and retail pharmacists should be reminded of how MS cotton created such a large market for the use of sustained release opioids for the treatment of pain. This in turn created profits for pharmacists am I reading that incorrectly you're reading it correctly what you're telling what this launch plan sales force under the title sales force allocation and representative delivered promotional materials is saying hey remind them they're making a bunch of money selling our product as opposed to not selling any product. It says a cooperative direct mail advertising sales sheet offering a rebate on the initial order of oxycontin to retail pharmacist will be mailed every month during the first three months of launch. What was the rebate you all were offering to pharmacist? Some discount on their early orders to encourage them to stock the product in advance of seeing any prescriptions or one or two prescriptions and like the rest there was nothing innovative in this program this was standard programming in the pharmaceutical industry and in other industries. Well like some of your other literature talks about you all had an unprecedented marketing campaign have you ever seen another company that instituted more broad ranging marketing campaign than you all did for oxycontin? I think this was conventional unprecedented perhaps for us but not unprecedented in the industry this is conventional standard textbook this is how you do it. You all also were involved with third party organizations partners in pain they were referenced in the launch campaign and did you use partners in pain to drum up demand for oxycontin? No I think the partners in pain was principally designed to inform doctors about the proper use of our drugs our medicines and to encourage patients who may have had pain sometimes for years inadequately treated or not treated at all to present themselves to their physicians there was also Purdue funded a variety of so called pain societies the American Pain Society was that funded by Purdue Pharma? We donated money to the American Pain Society Did you also fund the American Association for Pain Management? It wouldn't surprise me I don't remember Did you also fund the Appalachian Pain Society? I don't know that I wouldn't have known it but if that's what the record shows there was a figure we looked at a while ago that said there was basically the target market for physicians was about 7,500 physicians including the cancer malignant pain and the non malignant pain across the U.S. Do you remember seeing that? No Do you think the market was more than 7,500 physicians? Much larger Pain is the most common presenting symptom for physicians in total and very few physicians would have a different experience perhaps ophthalmologists or dermatologists may but every other physician it would be the most common or the second most common presenting complaint Do you recall whether Pradoom Pharma set up a Speakers Bureau in which it allowed physicians who were recommended by salespeople to be put on the so-called Speakers Bureau? Yes, such a program existed Not everybody who was recommended was put on the Speakers Bureau They were vetted by internal experts to determine their qualifications Do you recall that there were over 3,000 physicians on the Speakers Bureau? I don't recall it, but it wouldn't surprise me Do you think somebody vetted all 3,000 physicians internally that were on the Speakers Bureau? We had quite a large organization to do that and to manage the Speakers Bureau I think everyone should have been vetted with no excuse for not validating their degrees and confirming that they were licensed to practice in the place that they were practicing and so forth I don't know precisely how they were vetted but they definitely should have all been vetted Do you think putting these 3,000 doctors on your Speakers Bureau caused them to write prescriptions for OxyContin? I don't think it would have had an effect And there were also individuals you started a program called Train the Trainers where you would fly physicians around the country to speak on behalf of Purdue, do you recall that? Actually the physicians who attended and spoke were trainers and some of them were in-house people and some were outside physicians And would these take place at resorts like in Florida and Arizona of these meetings? Certainly might have And you also But to my knowledge, I don't think anybody would go more than once and they were trained in what they could say, what they couldn't say and they were given materials to use in the presentations for a while slides and then I guess eventually PowerPoint presentations so as to create some control to see hopefully that they would not go off-label And did Purdue pay for that or did they pay their own way? At the time it was started Purdue paid for it This was again customary in the industry Who told you that was customary in the industry? I don't remember who told me but I can tell you that sometimes I go to hotels and I'd see events sponsored by Pfizer sponsored by J&J and they were precisely either they were speaking engagements in which somebody spoke and occasionally they were trained the trainer kind of ideas where the company in question other companies in that case trained physicians you can say this and this and this beware you shouldn't say that and that and that Do you know whether pharmaceutical companies and medical device companies have come under criticism for giving incentives to doctors to write prescriptions or use their medical devices? I'm aware of that The answer is they have come under criticism for that Yes Was Russell Portnoy one of the speakers that spoke on behalf of Purdue Pharma at these meetings? Oxycontin I don't know In addition to the stuff we've just talked about you also hired a number of third parties to assist in the marketing of Oxycontin such as marketing firms, correct? I don't know Do you know if Purdue retained Lion's Lavy to market Oxycontin? I've heard the name but I don't know that it was Oxycontin Do you know if public relation firms were also hired to assist in the marketing and the expansion of the market? I don't know You've got to let me finish my question That's okay We've got a video but we also have a court reporter stenographer taking it out Apologies She can't get it if we both talk at the same time So my question is do you know Can you read my question back? Do you know if public relations firms were also hired to assist in the marketing and the expansion of the market? For Oxycontin I don't know Have you heard of a company called Fleshman Hilliard? That's a vaguely familiar name but I don't know whether they were ever hired by Purdue Frederick or Purdue Pharma Do you recall at some point being notified of a problem with abuse occurring with Oxycontin and Purdue Pharma hiring a crisis management firm? Yes Do you recall when that crisis management firm was hired? All precisely Have you ever read the interview Michael Friedman gave to the crisis management firm? No And in addition to all that you also put out videos Are you familiar with the I Got My Life Back video? I've heard the title I'm not familiar with it Did you ever do any follow up to find out whether the participants in the I Got My Life Back video actually got their life back up having problems with dependency on Oxycontin? No, I did not Did Purdue also give away coupons so people could get a weeks free supply of Oxycontin? I don't know but that would be common in the industry And all of the things we've just discussed would be done these marketing efforts to sell more Oxycontin Correct? To see to it the appropriate patients had access to Oxycontin Yes Were you aware that there was a direct link between the number of sales representatives that were out promoting Oxycontin and how much Oxycontin would be prescribed? Could you just ask that again? Yeah, was there a link, a direct link between the number of sales representatives that were out promoting Oxycontin and how much Oxycontin would be prescribed? I don't think direct link would capture the concept So the answer is no Do you believe that the number of sales representatives that promoted Oxycontin would increase the more sales representatives that promoted Oxycontin the more prescriptions would be written? I don't think anybody thought of it that way We had a product that had tremendous potential and our principal means of getting it used was to convince physicians to convince physicians that he had in his practice appropriate patients to use it but the linkage there is very loose Was there also a correlation between the number of times a sales representative called on a physician to how much Oxycontin that physician would prescribe? Again, that would be a loose correlation and there would be clearly if he called not at all there'd be nothing to correlate and I am sure there was a practical limit on how many calls he could make I don't know whether there was any kind of specific relationship between calling every quarter or every month or more frequently or less frequently Why don't we mark the Oxycontin watch plan as 27 26, I'm sorry 26 This is for you This is going to be 27 Mr. Thompson, I know that exhibit 27 there is some material that's been a good deal of material that's been bracketed and I've seen that on other documents that you've marked My assumption throughout is that the brackets were not on the original and this is something that you guys added The brackets were produced that way It came to you with the brackets that have writing on them were produced that way If the email ends and it's only half an email that's also the way that they were produced What if the document was highlighted in yellow? If it was highlighted in the context that I just gave it to him I would have added that highlighting just now but in terms of attachments that are connected to the emails that's because we didn't get them from Purdue I'm trying to explain to you Tony, it's okay We're not adding Sackler exhibit 27 and this is an email from you faced for OxyContin 10 minutes dated 10 23 96 and you have a copy of it and so this would have been after the launch of OxyContin correct? Yes And it says here Michael the OxyMen12 said What was the OxyMen12? I don't know Reef that it says Results showed the following Physicians who attended the dinner programs or the weekend meetings wrote more than double the number of new prescriptions for OxyContin compared to the control group and this was sustained over the three month post-meeting evaluation period weekend meetings had the greatest impact increasing new prescriptions for OxyContin by a factor between 2.16 and 2.62 These results will be presented in more detail at a later date This is very encouraging although I must allow that a proportion of the percentage without the associated absolute numbers is inherently meaningless I don't remember of increased prescriptions commercially significant if so what would the cost per increased prescription be assuming that the absolute difference persisted when will a more complete report be available and was that your You read it correctly Did you ever get a more complete report? I don't remember And then above that Alfonso was Alfonso was head of marketing and he says interesting comments from Dr. Richard I also wonder if there was a bias in the form of representatives increasing calls to the selected physicians would we get the same ROI is that return on investment in prescriptions would we get the same return on investment in prescriptions as a result of the representatives increasing the call rate to the selected group regardless of dinners I don't have the list therefore I don't know if there was a selected preference toward this group in the part of the reps it's reasonable that these core doctors were already receiving special attention which would have generated an increase in prescriptions if this is the case the cost of the dinners would unnecessarily increase the cost per prescription to sell OxyContin I don't remember let's mark this and this says $6999 Dr. Richard Sackler subject promotion of OxyContin by Abbott and if you go down to the bottom it says in close for your information is a memorandum that Mark Alfonso that describes a substantial increase in Abbott's field force allocation toward OxyContin $120 Abbott reps previously selling Eurokinase which has been temporarily withdrawn from the market will be assigned full time to OxyContin this will be totally at Abbott's expense and should have a very positive effect on OxyContin's sales that is from Michael Friedman right what was the agreement reached with Abbott to sell OxyContin I don't recall the details of the agreement and then up at the top it says sender Dr. Richard Sackler so this would be I think your reply to that and it says that sounds very good for the brand I just hope that we can supply the surge that may follow this program and were you referring to a surge of OxyContin sales yes the expectation that these sales representatives were going to create a surge in OxyContin sales I didn't know I said let's hope and then this is a document that I wanted to bring to your attention because we were talking earlier than today where you said when I was pointing out to you the documents that from your officers that said OxyContin is believed by other physicians to be not as strong as morphing remember us having that discussion I recall and this is a phase 2 OxyContin tablets team meeting June 13, 1997 so this would be well over a year after a year and a half after OxyContin has been launched and on the marketplace correct yes about a year and a half maybe a little less and if you could go to the it says marketing and sales update first paragraph Mike Cullen discussed in detail marketing's positioning of OxyContin he explained we want to expand extensively in the non-cancer market segment because the one to start with in cancer pain and the one to stay with through proper titration and the next paragraph reads we can show that we are as effective as morphine but do not want to say OxyContin is as powerful as morphine now did I read that correctly you read the words words such as powerful may make some people think the drug is dangerous to be reserved for the more severe pain if I can interject for a moment sir while you are reading it correctly what you haven't included is the fact of the word powerful as some quotes yes we'll read it again and include that second paragraph we can show that we are effective as morphine but do not want to say OxyContin is as powerful in quote as morphine words such as quote powerful may make some people think the drug is dangerous and should be reserved for the more severe pain this could have a negative effect in the much larger non-cancer pain market Mike reminded the team that we should keep this positioning in mind as we develop future marketing programs symposia clinical study manuscripts and any other items that discuss the use of OxyContin thank you did I read that correctly are you asking me I believe you did were you aware that your marketing and sales team were being careful and did not want to say that OxyContin is as powerful as morphine I don't recall if I was aware of this and in fact it's twice as powerful as morphine correct no it's not we've gone through this quite a few times and here powerful as in quote sometimes the words stronger weaker powerful are not in quotes but here it is very clear that it was specifically the word powerful that he did not he was advising people to stay away from it had nothing to do with potency when you go in and see a doctor and you say if they say OxyContin is not as powerful as morphine what do you think the doctor thinks he was not supposed to say that and I don't think he did say that that would create confusion he was warning not to use the word powerful in any context but it clearly didn't mean potency because potency was declared as twice as potent as morphine from day one of marketing to yesterday and today in every piece of material in all the conversion charts and was recognized and understood by physicians go ahead we'll come back to that do you want to take a break now it's almost 3.30 we could speak at time and take a short break we are off the record at 3.27pm we are back on the record at 3.42pm okay a while ago when we were talking about salespeople making calls did I understand you to say that you did not believe the number of calls made by salesperson affected the number of prescriptions for OxyContin I didn't mean to communicate that in fact Purdue had requirements on their salespeople that they had to make a certain number of calls every day to physicians correct there was a standard of number of calls yes and before we broke we were discussing this phase 2 OxyContin tablets team meeting and to kind of put this in perspective there was this email dated 6.297 so that's June 2nd we were discussing earlier where we discussed that physicians did not think OxyContin was as strong as MSContin and that perceptin was out there and noted that it was important to be careful not to change the perception by physicians toward OxyCone when developing promotional pieces Mr. Thompson did you refer to it or the document did you identify it we've already talked about it I'm just asking a question right now but you're asking a question based on the earlier document of reading I won't read from it then do you recall us having that conversation I'm not sure it's document I've seen a lot of documents but I do recall talking about this many times yes and your comment was we're not saying that it's not as strong we're saying it's not as effective I'm sorry your comment was we're not trying to convey that it's not as powerful is that correct no what I thought I communicated perhaps I didn't do it well was that the meaning of that word strong was not that it was a weak drug weaker than morphine it was not that meaning the meaning related to the stigma of morphine and to the fear of morphine and precisely in this case I believe that efficacy of the drug and I really would like to see the document if I might if we're going to talk about it because I'd like to refresh my memory not only as to the document as to what I had meant to say if I didn't say it clearly here's the one we were talking about when we wrote what exhibit is that sir 29 it's on the bottom 29 and they've actually used two words here that are in quotes correct one is effective and one is powerful the sentence reads we can show that we are as effective as morphine but we do not want to say oxycontin is as powerful as morphine did I read that correctly that's correct the have you reviewed the oxycontin abuse and diversion and efforts to address the problem that was put out in December 2003 by the GAO no I did not review that you've never seen that document is that correct do you want to mark it as the exhibit I will but have you ever seen that document I don't recollect seeing that document if you return to page 9 I'm looking at the second paragraph last two sentences in both 2001 and 2002 oxycontin sales exceeded 1 billion 1 billion and prescriptions were over 7 million the drug became produce main product accounting for 90% of the company's total prescriptions sales by 2001 is that information correct so the best of my recollection it's correct or very close to correct and if you'll turn to page 17 under the heading Purdue focused on promoting oxycontin for treatment of non-cancer pain and if you go down to the last sentence of the second paragraph it says one of Purdue's goals was to identify primary care physicians who would expand the company's oxycontin prescribing base sales representatives were also directed to call on oncology nurses consultant pharmacist hospices hospitals and nursing homes and is that information accurate proposition yes it doesn't include oncologists I don't think in the spirit I think it's accurate and then down second sentence from the bottom Purdue has stated that by 2003 primary care physicians had grown to constitute nearly half of all oxycontin prescribers based on data from IMS health and information service providing pharmaceutical market research is that information accurate I can't vouch for the accuracy of this the next sentence says DEA's analysis of physicians prescribing oxycontin found that the scope of medical specialties was wider for oxycontin than five other controlled release scheduled to narcotic animal Jesus DEA and is that the drug enforcement agency I believe it would be DEA expressed concern that this resulted in oxycontins being promoted to physicians who were not adequately trained in pain management do you recall the DEA expressing that concern next two sentences produced promotion of oxycontin for the treatment of non-cancer pain contributed to a greater increase in prescriptions for non-cancer pain than for cancer pain from 1997 through 2002 according to IMS health data the annual number of oxycontin prescriptions for non-cancer pain increased nearly 10 fold from about 670,000 in 1997 to 6.2 million in 2002 is that information accurate I don't know I just don't have these numbers in my mind if you go to page 20 second paragraph by more than doubling its total sales representatives produced significantly increased the number of physicians to whom it was promoting oxycontin each produced sales representative had specific sales territory and is responsible for developing a list of about 105 to 140 physicians to call on who already prescribed opioids or who are candidates for prescribing opioids in 1996 the 300 plus produced sales representatives had a total physician call list of approximately 33,400 to 44,500 by 2000 nearly 700 representatives had a total call list of approximately 70,500 to 94,000 physicians each produced sales representative is expected to make 35 physician calls per week and typically calls on each physician every 3 to 4 weeks each hospital sales representatives is expected to make about 50 calls per week and typically calls on each facility every 4 weeks was that to your knowledge accurate information about how Purdue was marketing oxycontin through its sales force? without quibbling it isn't really you're asking me to vouch for the accuracy of this I just don't carry these numbers in my mind so I can't agree or disagree but this is a count of physicians and a description of the standards of calls but I don't but that really doesn't describe how we were marketing it to use your questions I'm not trying to quibble with you sir but I just don't know and if you'll go down to the middle of the next paragraph the total amount of bonuses that Purdue estimated were tied to oxycontin sales increased significantly from about 1 million in 1996 when oxycontin was first marketed to about 40 million in 2001 do you recall do you have any reason to disagree with the 40 million number for bonuses paid out to your marketing in 2001 I don't know the number so I don't have any reason to disagree and then if you go to the next page last paragraph it says according to DEA's analysis of IMS health data Purdue spent approximately 6 to 12 times more on promotional efforts during oxycontin's first 6 years on the market than it had spent on its older product MS cotton during its first 6 years or then had been spent by Janssen Pharmaceutical or one of oxycontin's drug competitors during GC did you see that yep, yes I did is that accurate I don't know I have no reason to agree with it or disagree I just don't know do you believe Purdue's marketing was overly aggressive no do you believe Purdue's marketing was appropriate I believe so it says here on page 30 oxycontin's wide availability may have increased opportunities for illicit use I'm sorry what page are you reading page 30 yes where should I look last paragraph the large amount of oxycontin available in the marketplace may have increased opportunities for abuse and diversion both DEA and Purdue have stated that an increase in a drug's availability in the marketplace may be a factor that attracts interest by those who abuse and divert drugs oxycontin if you go on down oxycontin became the top selling name brand narcotic pain reliever in 2001 is that accurate I don't know but I just don't know so let's mark that as exhibit 30 have you ever seen an article called what happened to the poster children of oxycontin no that doesn't sound familiar nobody has ever provided that to you at Purdue pharma when was it published September 8th 2012 no I wouldn't necessarily have been provided to the board but I don't I really I'm not familiar with it do you recall a time when Purdue's oxycontin was considered so successful that other companies were thinking about whether they could make their own version of oxycontin just just ask the question again so I can answer it do you recall a period of time where oxycontin was considered so successful that other companies were considering making their own version of oxycontin I can't say that they did it because it was quote so successful but I do recall that I did hear that other companies were trying to copy oxycontin yes so this is an email chain that was provided let's go ahead mark that as 31 so if you go to page 2 it's a subject press release or similar promotion author Dr. Richard Sackler 82396 just let me catch up with you 82390 the bottom of the page okay I'm with you and it says I think it is noteworthy to release information on oxycontin tablets and success in the market and the tremendous reception it received in Vancouver basically the newsworthy occasion is that this product has achieved our first year sales projection four months early and that by the end of the year we should have from 130,000 to 150,000 per salesman of sales the objectives of this release would be stimulate interest in the US community medical community of the US to recognize the tremendous success of oxycontin tablets clinically and the ratification commercially we want many more physicians than have presently used it to become aware of its availability and importance in their practice it would be hoped that this would lead to greater use by those currently prescribing and broaden our prescribing base in the US and Canada and do you know whether that press release took place and then above that it looks like there's a response to your email from Robert Reeder given the diverse and both short and midterm goals I would recommend a full flash PR firm with a one to three year contract that way this can be coordinated actively to achieve all goals rather than a one shot flash is this a departure from traditional PF and that's Purdue Frederick slash Purdue Pharma LP strategy correct and you wrote back and said I don't see this as a quote departure from policy and then it looks like and perhaps this is Friedman who says my view is different if you want to use PR to signal our market as to our development pipeline I have no problem I do not want to spend money on PR to increase sales we do not need to have an agency in our pockets I have learned my lessons and then you write back on page one and say I agree about the agency I want to signal the licensing in market for the product around the world get an audience for our patent infringement suits so that we are feared as a tiger with claws and teeth and balls and build some excitement with prescribers that oxycontin tablets is the way to go and what was your concern there about licensing and patent infringement licensing in market meant the get the attention of companies that had products that might be attractive for us to license you recall Howard Udell making a trip down to Kentucky to meet with Attorney General Greg Stumbo and other members of the of his staff I don't recall it no this is a letter dated May 17th 2005 and that would be prior to the felony plea agreement Frederick entered into correct I'm not I think I'm clear on the dates and that that would be correct please correct somebody here correct me if I'm wrong and I'll turn to page six this is appears to be a letter from Howard Udell dated May 17th 2005 to Greg Stumbo the Attorney General of Kentucky and he points out that none of the federal courts in Kentucky has found any misconduct on the part of Purdue correct I'm not sure just where you're reading I'm on page five oh page five I'm sorry I was on the wrong page and where are you reading from the third paragraph down it begins I believe that even this brief I'm reading the middle of the paragraph significantly Howard not one of these courts has found any misconduct on the part of Purdue okay please bear with me while I try to find this you see that right above the case sites I'm sorry in the paragraph that has a list of cases yes so significantly however thank you yeah Purdue answered and all of these cases and claim they had never done anything improper or wrong isn't that true I don't know are you aware prior to the I don't know whether we filed in all these cases or whatever that's what I mean when I say I don't know are you aware of Purdue ever admitting to doing anything improper prior to the plea agreement where the company played guilty to a felony of misbranding a drug with the intent to defraud or mislead just ask the question before the plea am I aware of anyone at Purdue ever admitting they did anything improper prior to entering into the plea agreement where the company pled guilty to misbranding a drug with the intent to defraud or mislead I am not aware of anybody and then if you go to page 6 the middle of the second paragraph from the bottom it says first any suit bought under the act requires proof that a defendant engaged in a practice of violation of CARES 367-170 an insurmountable obstacle since Purdue has committed no unlawful act did I read that correctly you did were you aware that Howard Udell had communicated with Greg Stumbo that Purdue had committed no unlawful act on May 17, 2005 I think he was writing for Purdue Pharma just for clarity but I was not aware of this yeah May 17, 2005 did Purdue Frederick exist I don't know do you know if the companies were merged at some point I don't believe they were let's talk about the agreed statement of facts one more quote from the letter and the agreed statement of facts yeah it's a good idea the letter is going to be exhibit 32 and the agreed statement of facts is going to be exhibit 33 hand this out by the letter you said with Udell yeah May, 2005 who was in charge of preparing and approving the sales and marketing materials at the time of Oxycontin's release I'm sorry at the time of Oxycontin's release release meaning launch launch Michael Friedman I believe and at that time at the time of the launch who was in charge of the marketing department it's the best of my recollection Mark Alfonso okay and Michael Friedman the person who ultimately was appointed CEO of Purdue he was Purdue Pharma is he one of the individuals who played guilty to the misdemeanor at the time of the plea agreement yes do you recall whether Purdue had received warning letters about its marketing of MS. Contin I don't recall you don't recall six warning letters coming in from MS. Contin no I don't recall the instances do you recall Purdue getting warning letters with respect to the way it was marketing MS. Marketing Oxycontin I don't recall do you know if Purdue consistently denied it was doing anything wrong with respect to marketing Oxycontin I'm not sure I would think that we denied doing anything wrong but that's a guess on my part I don't really know I don't recollect were you involved in approving the agreed statement of facts or the guilty plea the board voted in favor of management's recommendation that we have that we plead guilty under a plea agreement of attorney and just so there's no confusion the board voted to adopt the agreed statement of facts is that correct I don't know I don't remember is the agreed statement of facts accurate I believe it is in addition to the guilty plea of a felony for misbranding a drug we plead and that drug is Oxycontin I believe it is these three individuals Howard Udell, Michael Friedman and Paul Goldenheim also led guilty to misdemeanors correct yes and Howard Udell was Purdue's executive vice president and chief legal officer he was the president and CEO of Purdue at the time of the guilty plea I believe he was and Paul Goldenheim was the former executive vice president for worldwide research and development and chief scientific officer correct I believe so by 2006 Dr. Goldenheim had already left Purdue correct did he leave voluntarily what reason did he provide you regarding why he was leaving Purdue he was leaving Purdue in order to be CEO of another company have you seen this agreed statement of facts before before today yes did you provide comments on this document no I did not were you surprised by any of the allegations in the document I didn't read the whole document so I can't say if there are allegations that would surprise me I had understood that this was a settlement document and that people in the company who investigated thoroughly said to the board that the statements in the document were true and when you say I didn't read the document as we sit here today have you ever read the entire document no at the time this was signed in May 7th and 8th of 2007 what was your position in the company I was a director of the company did you have any other role at that time not to my recollection for a period of time after I ceased to be CEO in early 2003 I was co non-executive chairman of the board but that came to an end more or less around this time but I don't remember whether it was before the play or after you ceased to be CEO in 2003 when were you first notified that the U.S. attorneys for the western district of Virginia were investigating Purdue I can't recall precisely we were as a board notified that the U.S. attorney was investigating oxy cotton abuse and diversion and that the law department in general and Howard Udell in particular were providing any documents he wished voluntarily to help his investigation that the investigation turned on Purdue was a surprise but I don't remember when that happened was it before you left as CEO I don't recall do you recall there being issues about addiction dependency tolerance buildup abuse and diversion prior to your leaving as CEO yes not all of those but abuse and diversion yes do you recall there being issues with addiction yes same time as I was informed about possible abuse and diversion and when were you first informed about possible abuse and diversion sometime in 2000 an article was published in a newspaper in Maine that very graphically described the impact of abuse and diversion of individuals who were using oxy cotton that was the first the first time I became aware of the possibility let me see do you recall receiving a letter being notified about a letter from a hospital in Pikeville or Hazard concerning problems with patients who were on oxy cotton I don't recall a letter was it directed to me I don't believe so I think it came to Purdue let's go back to the play agreement I'll try to get through this are you aware that we've requested Purdue to identify the names of documents referenced in the agreed statement of facts I'm not aware of that are you aware we've asked them to identify the individuals who are referenced in the agreed statement of facts no paragraph we can go to paragraph 13 of the agreed statement of facts paragraph 13 says that December 28th, 2004 Purdue submitted an oxy cotton NDA to the FDA the NDA included clinical trials showing that oxy cotton when dosed every 12 hours was as safe and as effective as immediate release oxy codon dosed every 12 hours every 6 hours yes that's what it says in paragraph 14 says the NDA did not claim that oxy cotton was safer or more effective than immediate release oxy codon or other pain medications and Purdue did not have and did not provide the FDA with any clinical studies demonstrating that oxy cotton was less addictive less subject to abuse and diversion or less likely to cause tolerance and withdrawal than other pain medications and is that paragraph correct that's what it says I don't know if it's correct but I wouldn't differ with it and then there are some medical officer reviews correct yeah I believe those are within the FDA and those also did not state that oxy cotton was more effective than or superior to safer had less opioid effects or cause fewer adverse events than any other marketed product correct and let me back up a minute do you know when sales people go call on physicians what type of information the physician usually asks the sales person I would not be able to comment on that you don't know whether they want to know if there's any studies there's any contraindications to the medicine any problems reported that makes sense I vote you meant in more that's a very general thing they want to understand what is the medicine for what kind of condition who are the patients what are the what is the effectiveness they might ask for comparative effectiveness if it exists and if it doesn't exist the answer is we can't give you any they might ask about safety they might ask about anything related to what they feel they should know when they were they to use the medicine one of the things they might ask is why is it better than what I'm already using why should I switch is that reasonable perfectly reasonable one of the things they might ask is you got any studies that show it's better another thing that comes up they might paragraph 16 says the medical officer review of the ISS included these statements and the blood level data and clinical use suggest the opioid effects would be of oxycontin and immediate release oxycodone would be similar and to your knowledge is that clinically correct well it's an inference and I certainly can't differ with the inference but it may not be correct under D it said withdrawal is possible in patients who have their dosage abruptly reduced or discontinued is that your understanding of the characteristic of the drug absolutely and then it said care should be taken to limit competitive promotion oxycontin has been shown to be as good current therapy but has not been shown to have a significant advantage beyond reduction in frequency of dosing and is that your understanding of the characteristic of the drug no it is my understanding that that statement is correct but the reason I said that what may not be the case was the very surprisingly large number of reports from the field that I heard second and third hand that early in the life of the product doctors spontaneously volunteered that the drug was better than we said it was and this was so frequent and so unusual that it raised in my mind and continues to raise the question maybe it is actually superior but we were never able to demonstrate using the methods that would be generally accepted that this was the case it was an impression that doctors developed on their own any studies retrospective studies of that nature that would support that statement no I said we could never prove it so if you go on here under the heading misbranding of oxycontin and when we talk about misbranding that's just really making claims and statements that aren't true about a drug that's called misbranding the drug is that correct no I wouldn't say it's that a different meaning in the regulatory world it's stating things that are not strictly in the package insert they may be true but if they're not in the package insert they're misbranding do you know if Purdue had information that physicians were concerned about the abuse potential for oxycontin? I did not have that it wouldn't surprise me that physicians would be concerned about that as with any other strong opioid or in fact any other opioid let me refer you to paragraph 20 it says here beginning on or about December 12th 1995 and continuing on or about June 30th 2001 and that is the time frame that the U.S. Attorney's office looked into the conduct at Purdue correct? I don't know certain Purdue supervisors and employees with the intent to defraud or mislead marketed and promoted oxycontin as less addictive less subject to abuse and diversion and less likely to cause tolerance and withdrawal than other pain medications as follows under A it says that you train Purdue sales representatives when I say you mean Purdue the company train Purdue sales representatives and told some healthcare providers that it was more difficult to extract the oxycodone from an oxycontin tablet for the purpose of intravenous abuse although Purdue's own study showed that a drug abuser could extract approximately 68% of the oxycodone from a single 10 milligram oxycontin tablet by crushing the tablet stirring it in water and drawing the solution through cotton into a syringe were you aware that Purdue trained sales representatives to make that misrepresentation? No is that a misrepresentation that would cause a physician to be more likely to use to write prescriptions for oxycontin or less likely to write prescriptions for oxycontin? I couldn't guess the implication is that it would be more likely but I don't know and then number B says told Purdue sales representatives they could tell healthcare providers that oxycontin potentially creates less chance for addiction than immediate release opioids were you aware that Purdue told sales representatives they could tell healthcare providers that there was less chance for addiction with oxycontin than with immediate release opioids? No I was not aware of that under C it says sponsored training that taught Purdue sales supervisors that oxycontin had fewer peak and trough blood level effects than immediate release opioids resulting in less euphoria and less potential for abuse than short acting opioids were you aware that they were teaching sales supervisors to make that misleading Absolutely not statement under D it says told healthcare providers that patients could stop therapy abruptly without experiencing withdrawal symptoms and that patients who took oxycontin would not develop tolerance to the drug I object to the form of the question in reading D you omitted the word certain which appears before healthcare providers Let me read it again under D Purdue told certain healthcare providers that patients could stop therapy abruptly without experiencing withdrawal symptoms and that patients who took oxycontin would not develop tolerance to the drug were you aware that certain healthcare providers were being told that they could stop therapy abruptly without experiencing withdrawal symptoms and that patients who took oxycontin would not develop tolerance to the drug No and that statement is false correct No it's not clear to me it's false but I am eager not to contend with it it says certain healthcare providers and it the rest of it is conditioned really in large measure on in the first case the dose that the patient is on and the second case and the duration of the patient is on but reading between the lines as I suspect those who shape this did and understood with the government I can accept it as being a reasonable expression of improper conduct that is certain healthcare providers might have been told regardless of dose or regardless of duration but had I known about this I would have alerted our attorneys were negotiating this that this ought to be a little bit more specific because it's going to be difficult to agree with it the way it's written but I won't quibble with it Well there was actually a whole lot of back and forth on this document There may have been but it wasn't with me and a lot of the things brought up the U.S. Attorney's Office said no we've reviewed the documents and we're not changing this stuff is that what happened I don't know Just to be clear in the document we're reading the agreed statement of facts Purdue refers to the Purdue Frederick Company which is the practice we've had in this deposition from the outset that you use Purdue to refer to Purdue Frederick Yes, yes because nobody at Purdue is able to say which employees were Purdue Frederick which employees were Purdue Pharma as far as I've been able to ascertain in any of the depositions I've read so far including ones taken in the past but we'll cover that later Under E here it says that Purdue certain Purdue supervisors and employees with the intent to defraud or mislead told certain health care providers that OxyContin did not cause a quote buzz in quote or euphoria calls less euphoria had less addiction potential had less abuse potential was less likely to be diverted than immediate release opioids and could not be and could be used to quote weed out addicts and drug seekers and were you aware that those statements were being made to health care providers and then the next section is misbranding of OxyContin use of graphical depictions by sales representatives and it says data from Purdue's clinical studies was used to create the following graphical demonstration of the difference in the plasma levels at steady state between patients who took OxyContin every 12 hours and patients who took immediate release OxyContin every 6 hours and it says that on October 12, 1995 Purdue requested comments from the FDA's division of drug marketing advertising communication about its proposed launched marketing materials which included the following graph and text showing OxyCodone plasma concentration provided by OxyContin on a logarithmic scale along with a statement that OxyContin's OxyCodone blood plasma levels provided fewer peaks and valleys than immediate release OxyContin OxyCodone OxyCodone, I'm sorry per graph it says on December 20, 1995 we're going, I'm sorry term page? Yes. Okay, thank you on December 20, 1995 after reviewing the proposed OxyContin launch materials DDMAC what is DDMAC? DDMAC it's the division of the FDA I don't know what the letters stand for but it is the division of the FDA that reviews promotional materials and comments on their agreement that they are reasonably reasonable and accurate and consistent with the package insert or they differ with them and recommend changes or elimination of things. To sort of cut through it what they did is they said if you wish to compare blood levels in this text we suggest that the blood levels for both dosage forms be presented in the graphic so that the reader can accurately interpret this claim they felt it was misleading the way it was, correct? No, I don't think so. I think they had a suggestion that we should add that and I don't know why it wasn't there we certainly had the data as shown above so I assume we added the data. And then it says, paragraph 24 on or about January 11th, 1996 Purdue told DDMAC that it had quote deleted the statement fewer peaks and valleys than with immediate release oxycodone and they took the statement out, correct? That's what it says I don't know why it was true but I have no knowledge of the dialogue between them or why they took it out. Did you review any of the studies that were done I mean actually get down and look at the data in the studies that were done prior to the launch? I looked at the analysis of studies but I didn't look at the data that is the individual case report forms and as we sit here today have you ever seen the data of the studies themselves? No, that would be voluminous and I don't think it would be necessary for a senior executive to do that because every study is subject to extremely rigorous validation of the database with a paper record the paper record that exists with the doctor's own records and so this approach which has been standard in the industry and I believe part of good laboratory practices or one of the other standards that the FDA has promulgated is extremely exhaustive which is one of the reasons that studies take so long because the validation of the data can take anything from a month to a year. Are you saying that your studies that you did before putting Purdue on the mark were extremely exhaustive? They were certainly appropriate for a molecule that had been in use at that point 80 years or more that was believed then to be safe and effective as a molecule and that had no at that time no long-term toxicities that hadn't been well developed and so a lot of that information was brought into the package insert whether we observed them in the trials or not so the standards for this kind of an approval which has its own designation are easier to meet they're called 505B2 NDA and draw upon in this case a vast public literature as I said extended back 80 plus years so for that it was very extensive in those kind of applications but when you took a controversial opioid and expanded it to nonmalignant pain at pills that contain high dosages of opiate you didn't do any addiction studies before putting it on the market, correct? I object to the form of the question first of all the compound oxycodone was mostly used in nonmalignant pain before we entered the market that was where the market the great bulk of the market existed so there was no innovation or change and are bringing it to the nonmalignant pain market the second thing was that we assumed that it was potentially addictive that it could be subject to abuse and diversion and the package insert then and through many changes has not denied that in fact has called it out explicitly in several places including right in the front of the label when we said it was a class 2 narcotic and every doctor knows that class 2 narcotics are among the most abusable products a class 2 narcotic that your own records show there was a belief among physicians that it wasn't as strong as morphine, correct? no that it wasn't as stigmatized as morphine was they knew it was if you would ask them is it more potent than morphine many physicians knew it was more potent if they use both drugs they knew that they would always start with a much lower dose of oxycodone than they would with morphine so you think physicians most physicians knew it was more potent than morphine yes they also knew what doses to use it in would you just mark this exhibit is this 34? let me refer you to the first paragraph of this document in January 26, 2001 we're now five years after oxycodone has been on the market, correct? which part of this should I read from? yes, the date is around five years from marketing and it says up here this is from Mark Alfonso the first paragraph says I think it will in the mind of the physicians hydrocodone gives them a great degree of comfort physicians rank the drugs based on the position that they have created in their mind as a result of prescription prescribing habit and promotion and promotion would be do pharma? no what do you think it means when it says promotion is the promotion of everybody in the industry from going back years and years it says for them morphine and hydro-morphone are the most potent followed by oxycodone and then hydrocodone I see it were you aware that in January 25, 2001 Mark Alfonso and what was his role at Purdue? he was head of marketing the head of marketing felt like physicians did not feel like oxycodone was as potent as morphine we've gone through this before it was that was a term of that didn't refer to relative potency it just didn't it didn't include fentanyl in this which is the most potent but is often used before hydrocodone or morphine let me ask you this I'm just saying I realize that you've changed the meaning that was intended and understood by the recipients you've changed the meaning of the word potent not the word the meaning of the word no, you've changed it when you try to use it as though it means relative potency when we first discussed the first group of documents you said no they're just talking about effectiveness not strength the second group of documents where they said it's stronger than morphine you said no they just mean strong in a general sense they don't mean potent here they use the word potent do you just not think it's as strong as morphine that's what they keep saying they don't want to clear up in the physician's mind that it's as strong as morphine this is a hierarchy here Mark Alfonso said here that if following your reasoning if your reasoning were correct physicians would see morphine as the most potent of all these drugs it was the for them morphine and then hydrocodone and in most places oxycodone and then hydrocodone the facts are that hydro morphone is 3 to 8 times more potent than morphine but that isn't how we listed it and hydrocodone and oxycodone are close to equal potent but he didn't say potent he said powerful in this case has to do with the hierarchy that they place drugs morphine was the last because it was the most stigmatized so when he says here remember that we tried to reposition oxycodone as powerful as morphine and we could not finally we decided not to mess with this perception since it was helping us in the non-cancer market did you see where he wrote that I see where he wrote it let's go back to the plea agreement how do we need to mark that document it's marked 3rd November 34 paragraph 25 of the agreed statement of facts says honor about December 1998 produce sponsored training for all its district sales managers now it wasn't some of them it's all of them correct it says all meaning a pharmacist retained by Purdue do you know who that pharmacist was no a pharmacist retained by Purdue to conduct a portion of the training used the following graphical demonstration parenthesis instead of the graphical demonstration of the actual clinical data described in paragraph 21 of this agreed statement of facts falsely stated that oxycodone had significantly fewer peak and trough blood level than immediate release opioids resulting in less euphoria and less potential for abuse than short acting opioids and they've got a graph that was used at the training for Purdue I would call that a cartoon not a graph and it says on paragraph 26 beginning in or around 1999 some of Purdue's new sales representatives those would be Purdue Pharma sales representatives in 1999 correct I can't say Purdue was defined in this document as Purdue Frederick yeah but it says new sales representatives so are we talking about Purdue Pharma or Purdue Frederick the document on its face is talking only about Purdue Frederick yeah the guy that helped put the document together the lawyer we took his deposition have you seen his deposition yeah and he says he doesn't know if they're Purdue Pharma or Purdue when he refers to this I'm telling you this document on its face defines Purdue as Purdue Frederick I don't care what anyone else said sure and I'm asking him if it's correct and he's saying you don't know correct no let's go I said I don't know who employed these new representatives okay it says some of Purdue's new sales representatives were permitted during training at Purdue's headquarters to draw their own blood level graphs to falsely represent that oxycontin unlike immediate release or short acting opioids did not swing up and down between euphoria and pain and resulted in less abuse potential and were you aware that the sales reps were doing that no and then it says during the period 1999 through June 30, 2001 Purdue reps used graphical depictions similar to the one described in paragraph 25 of this grid statement and fault agreed statement of facts and falsely stated to some healthcare providers that oxycontin had less euphoric effect and less abuse potential than short acting opioids were you aware that they had no engaged in that conduct no I'm sorry and then to go on with the conduct paragraph 28 says misbraining of oxycontin misleading use of article to claim no withdrawal or tolerance and it proceeds to discuss how Purdue well let's go ahead and read it I'll try to shorten this a little bit Purdue had an osteoarthritis study okay you don't have to rush are you familiar with that may I read it if you don't want to read it into the record can I just read it and then respond it'll save time I'll read it into the record honor about January 16, 1997 certain Purdue supervisors and employees sent to the FDA the results of a clinical study pertaining to the use of low doses of oxycontin by osteoarthritis patients it's to call it the osteoarthritis study and a final report that included in a section pertaining to respite periods the statement parenthesis no investigator reported withdrawal syndrome as an adverse experience during the respite periods in a section entitled adverse experiences by body system during respite periods the report summary of the major results listed the most frequently reported adverse experiences and respite periods insomnia, nausea, pain anxiety, depression, and diarrhea followed by the statement 28 patients 26% had symptoms recorded during one or more respite periods did I read that correctly I think so I was kind of reading ahead of you and then it says paragraph 29 honor about May 29, 1997 certain Purdue supervisors and employees stated that while they were well aware of the incorrect view held by many physicians that oxycodone was weaker than morphine they did not want to do anything quote, to make physicians think that oxycodone was stronger or equal to morphine or to quote take any steps in the form of pronomotional materials, symposia clinicals, publications, conventions or communications with the field force that would affect the unique position that oxycodone had in many physicians mind in quote and did I read that correctly you read the words correctly was that part of the agreed statement of facts it is and then it goes on to say honor about February 12, 1997 certain supervisors and employees of a United Kingdom company affiliated with Purdue provided certain Purdue supervisors and employees with an analysis of the osteoarthritis study together with another clinical study this analysis included a list of 8 patients in the osteoarthritis study and 11 patients in the other study who had symptoms recorded that may possibly have been related to opioid withdrawal including one patient in the other study who required treatment for withdrawal syndrome did you ever review that study? no the discussion section of this analysis include the following quote it's not surprising that some patients in the clinical trials developed some degree of physical dependence and consequently experienced withdrawal symptoms as a result of abrupt discontinuation of oxycodone tablets all patients who were expected to have withdrawal symptoms have been reported but this may have resulted in a falsely high incidence of the patients who participated in the osteoarthritis study in which patients entered respite periods without oxycodone tablets many symptoms suspected to be due to opioid withdrawal may simply have resulted from the return of pain after withdrawal of oxycodone tablets patient 6007 complained of nervousness patient 2004 complained of insomnia and felt restless patient 220 and 228 were restless and anxious since these are symptoms which often accompany the return of significant pain it may be wrong to label these as withdrawal symptoms nonetheless the instance of withdrawal syndromes in patients treated with oxycodone tablets is a concern and it is safer to overreport than under report this problem this analysis conclusions included this statement as expected some patients did become physically dependent on oxycodone tablets but this is not expected to be a clinical problem so as long as abrupt withdrawal of the drug is avoided were you aware that certain Purdue employees participating in the final draft of the article regarding the osteoarthritis study that was published in a medical journal on or about March 27, 2000 were you aware they participated in that publishing of that study? No. The results section of the article I'm reading from paragraph 31 the following three statements pertaining to the instance of withdrawal syndrome and withdrawal symptoms experienced by study patients quote one patient was hospitalized for withdrawal symptoms the patient who was hospitalized with withdrawal symptoms had completed the study on the previous day and had been receiving CR oxycodone 70mg symptoms resolved after three days a second patient received 60mg CR oxycodone experienced withdrawal symptoms after running out of study medication the patient had not reported withdrawal symptoms during scheduled respits from doses of 30 or 40 withdrawal symptom was not reported as an adverse event for any patient during scheduled respits adverse experiences reported by more than 10% of patients during scheduled respits were nervousness 9 patients and an insomnia 8 patients paragraph 32 says the article included a comment section summarized the the three statements and the results and further suggested that patients taking low doses could have their oxycodone treatment abruptly discontinued without experiencing withdrawal if their condition so warranted were you aware they were making that claim? No. If you go over to paragraph 34 it says on about June 2016, certain Purdue supervisors and employees sent a full text of this osteoarthritis study article do you know which supervisors and employees sent the full text of this article? No. Do you know if it was the marketing group? I don't know. It says together with a quote marketing tip to Purdue's entire sales force the marketing tip stated that a reprint of the osteoarthritis study article was available for use in achieving sales success the marketing tip also included as one of the article's 12 key points there were two reports of withdrawal symptoms after patients abruptly stopped taking CR oxycodone at doses of 60 or 70 withdrawal syndrome was not reported as an adverse event during scheduled respots indicating that CR oxycodone at doses below 60 milligrams can be discontinued without tapering the dose if the patient conditions so warrants it says on or about February 13, 2001 certain Purdue supervisors and employees received a review of the accuracy of the withdrawal data in the osteoarthritis study and stated now this is Purdue's own people reviewing this data correct? That's how I would read it and it says quote upon a review of all comments for the enrolled patients it was noted that multiple had comments which directly stated or implied that an adverse experience was due to possible withdrawal symptoms this was followed by a list of 11 study patients who reported adverse experience due to possible withdrawal symptoms during these periods 106 patients initially participated in the osteoarthritis study 32 of them withdrew because of severe I'm sorry because of adverse events not necessarily related to withdrawal and 38 patients remain in the study at 12 months next paragraph reads on or about March 28, 2001 so this is a month and a half later a Purdue employee emailed a Purdue supervisor regarding the review of the withdrawal data described in paragraph 35 of the agreed statement of facts asking do you think the withdrawal data from the osteoarthritis study is worth writing up parenthesis and abstract or would this add to the current stress that should be deferred the supervisor responded I would not write it up at this point and no abstract was prepared do you see that I see it so am I correct that Purdue was using the marketing material from this article improperly and not reporting the adverse effects and was allowing their sales force to use it I object to the form of the question let's break that into one question at a time please sure was Purdue's marketing department using this article that's what it says here and were they using it inappropriately that's what it says here and when somebody pointed out that the withdrawal data from the arthritis study was actually different than how the sales force was using it and asked should we write it up add to the current negative press and should be deferred the person supervisor said I would not write it up at this point correct? do you know if it ever got written up? do you know if any of these doctors that were shown this were ever told that it actually wasn't correct? I don't know do you know if anybody at Purdue made an effort to go tell these doctors that all of these marketing things that have been brought up in the facts were not correct? I don't know did you yourself ever tell anybody to go inform doctors that these marketing statements that had been used by Purdue's employees that were not accurate were in fact not accurate? I was not aware of this story the study or the marketing materials or statements and as the director of Purdue Pharma you were not made aware of any of this? I object to the form of the question you can answer I do not recall whether we were you're talking about at the time of this document being written I don't recall and at the time that this conduct went on from 96 to 2001 the time period investigated by at least this U.S. Attorney under this agreed statement of facts you were in fact the CEO of Purdue Pharma correct? during 2000 very very late 99 until early 2003 I was the CEO yes so if this conduct occurred on May 18th 2000 June 22nd 2000 February 13th 2000 and on March 18th 2001 this employee was told not to write up the withdrawal data because of negative press and that it should be deferred you would have been the CEO during this time period correct? yes from 1999 until this what was Robert Reader's role at Purdue? Senior Medical Officer next paragraph says so between June 26th 2000 and June 30th 2001 certain Purdue supervisors and employees distributed copies of the reprint of the osteoarthritis study article to all of Purdue sales representatives for use in the promotion and marketing of Oxycontin to healthcare providers including the distribution of 10,615 copies to certain Purdue sales representatives between February 13th 2001 and June 30th 2001 so it looks like on March 28th the supervisor tells the employee don't write up the withdrawal data from the osteoarthritis study it would add to the current negative press and should be deferred and between February 13th 2001 and June 30th 2001 10,615 copies of the osteoarthritis study were distributed to sales representatives correct? it says was the purpose of submitting it to the sales representatives so they could show it to the physicians that they called on? I don't know there's only 800 sales reps at Purdue's highest volume of sales reps during this period of time, correct? it's the best of my recollection that's approximately true so if you wanted to give a copy to each sales rep for their own use you'd probably only need 800 but they printed off 10,615 copies distributed, yes is it reasonable to conclude that you're showing these to the doctors? it's reasonable to conclude that some sales reps may have shown them to doctors, yes to some doctors you know if Purdue ever got any of this 10,615 copies of the osteoarthritis article I don't know if this, when this was found by sales or marketing management or medical department it would have been the practice to recover them, yes but I don't know if it was found and I don't know if it was done this all came to light in 2006 or 2007 so I don't know it could have been long past but I don't know it says during the period June 26, 2000 through June 30, 2001 certain Purdue sales representatives distributed the reprint of the osteoarthritis article to some health care providers and falsely or misleadingly stated that patients taking oxycontin at doses below 60 milligrams per day can always be discontinued abruptly without withdrawal symptoms and that patients on such doses would not develop tolerance and that's not an accurate statement is it? I don't believe so and then on with regard to misbranding of oxycontin use of reduced abuse liability claims and marketing it says oxycontin packaging sort of proved the FDA stated by the FDA stated delayed absorption as provided by oxycontin tablets is believed to reduce the abuse liability of the drug that's called the reduced abuse liability statement certain Purdue supervisors employees instructed Purdue sales representatives to use this statement to market and promote oxycontin paragraph 40 says certain Purdue sales reps while promoting and marketing oxycontin falsely told some health care providers that they reduced abuse liability statement meant that oxycontin did not cause a quote, buzz or euphoria cause less euphoria had less addiction potential had less abuse potential likely to be diverted than immediate release opioids and could be used to weed out addicts and drug seekers and it says by March 2000 various Purdue supervisors and employees in different parts of the company had received reports of oxycontin abuse and diversion occurring in different communities and that on or about November 27th 2000 certain Purdue supervisors employees introduced abuse liability statement to say that delayed absorption as provided by oxycontin tablets when used properly for the management of pain is believed to reduce the abuse liability of the drug and instructed Purdue sales reps to use the amended statement to promote and market oxycontin do you know why that statement was changed I'm not sure, no I don't and I'm not certain where it was changed in the package insert I don't know if it was in the package insert then that had to be submitted to the FDA and to get approval in advance of using it but I just don't know what this refers to well when Purdue found out that oxycontin was being abused and diverted they changed their packet insert kind of cleverly really if you read it right when used properly for the management of pain do you know what they meant by that I don't know what the people who wrote it meant by that or what the FDA understood because I was not involved in rewriting it next paragraph says from March 2000 through June 30, 2001 certain Purdue sales representatives while promoting and marketing oxycontin falsely told some healthcare providers that they reduced abuse liability statement and the amended statement meant that oxycontin did not cause a buzz or euphoria cause less euphoria, had less addiction potential had less abuse potential was less likely to be diverted than immediate release opiates and can be used to weed out addicts and drug seekers and those statements are not correct no, they're not correct introduction of misbranded oxycontin into interstate commerce and that is actually the guilty plea pardon? points out that Purdue manufactured and sold oxycontin into interstate commerce from various locations are you reading? I'm just sorry to interrupt you sir, just tell me which number I should be following the very next paragraph which is 44? yes and that's just pointing out that Purdue sold oxycontin all over the US correct? let me read it and I'll tell you if I agree yeah, that's not what it says I don't if you're reading from 44 yeah, you're right I'll withdraw the question okay did Purdue farm a cell oxycontin all over the US? during what time period? 19 96 to 2001 yes now as part of the reason Purdue was able to get away with making these misrepresentations is because Purdue was aware that physicians did not understand the complex processes of treating pain I don't think so should I answer it? sure I don't think so did Purdue's own focus groups show that doctors didn't understand whether oxycontin was stronger than morphine? I don't know what about the treatment of pain? did you feel like doctors understood or physicians understood prescribing practices that should be utilized for the treatment of pain? you'd have to put a time frame to that or ask the question with more color and more details isn't that the reason you always claiming that you needed to spend so much money educating physicians because they didn't understand pain prescribing? some physicians learned how to prescribe for pain from materials that we produced or information that sales reps gave them others knew how to treat pain and they would be more interested in trying this agent in comparison to how they were treating pain before. we entered the pain market in 1985 in the U.S. there was almost abysmal in a sense not ignorant so much as ignoring pain in patients doctors just didn't want to deal with it and left patients inadequately treated would you agree that the only way to get a large sales force to use a marketing message is to instruct them explicitly and unmistakably to do so? I don't understand the question Mr. Shapiro has testified I want you to peace testified that the only way to get a large sales force to use a marketing message is to instruct them explicitly and unmistakably to do so would you agree with that? I don't understand it once again if you're reading from a transcript please show it to me I want you to assume he's testified to that but I don't understand I don't understand I don't have a transcript in front of me I'm asking you for my own memory oh okay I don't understand I don't understand that statement so I really can't agree or disagree with it do you believe there's evidence of improper training that has occurred at Purdue based on the agreed statement of facts? I would have to review it it's my recollection as you read as we read through it was that one or two things involved improper training but I can't affirm that until I reread it did you ever do you know as we sit here today what percentage of your sales force was using statements to educate physicians about prescribing OxyContin? no I don't know whether it was 100%, 50%, 10% you don't have any idea do you know if anybody at Purdue tried to find out how many of their sales force had given physicians improper and incorrect information? I know as I said before that from 2000, sometime in 2000 as we became convinced that there was a problem many efforts were launched to train, retrain and to determine whether sales reps were following company policy and that effort goes on to this day we put in place for example a whole compliance department in 2003 or 2004 with many employees who reported independently to the board and have continued to report independently to the board to in a sense back up the sales department and marketing department own efforts to assure proper training and compliance with training but I don't know of any attempt to measure who said what and how many times when people were properly trained and they deviated from that or went beyond that they were sanctioned and many of them were dismissed we also had a whole downsizing in the field force from about 2003 or 2004 until about 2007 or 2008 in which the 800 eventually went down to something like 200 so I don't think there are too many survivors from this period because they were selectively weeded out because on average three quarters of them would have been gone but I don't I can't answer that I know of any attempt to assess blame in that sense or to count. Yeah and that's not really my question. My question is did anybody at Purdue Pharma attempt to go back and find out which reps specifically had made comments to physicians that were improper or misleading about the attributes of OxyContin. And the answer is I don't know. Would you agree that giving making the statements the improper statements that are referred to in the agreed statement of facts could compromise patient care? Some of them, yes in some patients obviously not all patients but in some patients some of the statements could compromise care I would like to say sub-optimize care. And if I understand correctly you have not reviewed any of the call notes that were pulled by Mr. Shapiro when he was doing his investigation. As far as I know I was shown a few call notes I didn't ask were these shown to Mr. Shapiro? Was there a recommendation made by somebody right about that same time that the call note system be changed? At about what time? About the same time he was doing his investigation and reviewing the call notes. I believe it was. And do the call notes not contain as much information as they used to back in 2000? That I don't know. But the biggest change was to make the first and second line supervisors audit a substantial percentage of the call notes in their span of control. If the call notes have less information in them is it more difficult to audit them? I would I couldn't possibly guess what they were before or after. They were very sketchy notes. The ones I saw they were selected and shown to me but the ones I saw were in some cases almost indeterminate. You could not know what was happening. How many did you see? Six Eight. No more. I think probably fewer than six or eight I'll say six. Who showed those to you? I was shown during the preparation for the deposition. I'd never seen them before. Were the call notes you were shown call notes from Kentucky reps? My recollection is somewhere. Did you hire anybody or ask anybody to review Mr. Shapiro's investigation for accuracy? I did not ask that his investigation be audited for accuracy. There were many people in the law department then a compliance department who may well have done so but I don't know. And would you expect if we did our own investigation we would have essentially about the same number of improper call notes that he found? That would be my expectation. That's, of course, two thousand four. You want to take a short break? Sure, that's fine. We are off the record at five twenty-six p.m. on the record at five fifty-five p.m. No, I'm going to pick up somewhere different. So let me show you an email to go to page two of this email. This is from Jim Speed. dated Tuesday November 30th let's mark this as what am I going to say? It says it's thirty-five. dated November 30th, 1999. Second period. During physician calls this issue is a topic of hot discussion between me and the physician. While many salespeople have sold controlled release opioids as having less abuse potential the current situation has placed us in an awkward situation. I feel like we have a credibility issue with our product. Many physicians now think oxycontin is obviously the street drug all the drug addicts are seeking. Issues like purposely crushing the 40 milligram and 80 milligram tabs to, quote, get high have been expressed. I have heard from physicians that pharmacists that on the streets people are finding ways to extract the oxycodone from the tablet and are using a cotton ball to filter the talk as they draw it up in a syringe for, quote, mainlining, end quote. Were you aware that that was a concern in November of 1999? No. When did you first become aware that oxycontin was being diverted or abused? In the winter best of my recollection winter of 2000 that is early in the year 2000. Who is Dr. J. David Haddix? Dr. Haddix is a both a dentist and an MD he's an expert in both analgesic pain use of analgesics and pain management in general and also I think is a recognized expert on addiction and treatment of addiction. Did he work for Purdue Pharma? He did. And what about Rena Golden and Wendell Fisher? What were their jobs? Rena Goldman I don't know and Wendell Fisher was a sales manager but I don't recall how high up he was in sales management. I think he was a regional manager at that point. And what about Jim Speed? I've recognized the name but I can't tell you what his position was. He was a field sales person I don't know whether he was a manager or not. Is it true that Wendell Fisher was a regional manager with oversight for the districts and territories located in Kentucky? I don't know. Is it true that Oxycontin does produce a buzz or euphoria just like the controlled release just like the immediate release? When used in pain patients or when abused? When used in pain patients. I don't tell you the percentages I'm sure there are some people who might say that they feel a sense of euphoria I really don't know what buzz means when people say they have a buzz. I'm not familiar. But there may be a brief period of time in which they feel some euphoria or sensation. Whether you feel a buzz or euphoria does that have to do with how quickly the drug works? That's an element but it has to do also with the dose and also with the patient's familiarity. If they've been on the same dose for a while I would think it's far less likely and then there's individual patient variation finally. And with respect to peaks and valleys to the peaks and valleys that are referred to in all the marketing materials or a number of the marketing materials does that have to do with whether somebody experiences a euphoria from taking oxycontin? If they have any psychological experience like euphoria it's most likely to be at the peak blood level. So the fewer the peaks the fewer the periods of euphoria. But I'm just generalizing I'm not telling you that we've ever measured that. When did you first become aware that Purdue had marketed and promoted oxycontin as having less abuse potential? Not until the investigations were done. And I can't tell you which investigation or when but I certainly didn't know that people were saying that until I was told by management that they had done investigation and found that some people had said that. Let me ask you about patients who have not had a prior incidence of addiction or abuse but just someone who's put on oxycontin and has never had an opioid in the past. Do you know if they're put on a 20 milligram dose of oxycontin twice a day how long they would have to take it before developing dependency? I can give you a guess but I don't know. There's enormous individual variation here. So you can't say with any one person or predict that this person will develop dependency or that person won't at 40 milligrams a day. I assume that's the presumptive daily dose you're asking me about. Do you know if Purdue ever conducted any studies to determine how long a non-malignant pain patient who's never had an opioid before would have to be on the drug before they develop dependency or addiction? I'm not aware of those studies being conducted. Is it fair to say that if Purdue wanted to do a study to make that determination that could be done? Dependency that is physiologic dependence I think would be an achievable study that could be done. Addiction remains to be seen. A lot of people would say it's almost impossible to do that. But Purdue and other industry partners are on the cusp of trying to do that with a number of studies. Could you do a retrospective study or could you have done a retrospective study if you had wanted to look at patients? I would have to think about whether I could figure out a retrospective study. It would be an interesting question but I don't know the answer to it. What was Robert Reader's role? Robert was a senior medical scientist in the medical department. I want you to assume he's testified that Purdue lacked any evidence that Oxycontin had a lower abuse potential. If that's true, would you have testified to that? Would you agree with that statement or disagree? If you could just repeat the statement so that I can concentrate on it. He testified Purdue lacked any evidence that Oxycontin had a lower abuse potential. I object to the question. It's a very odd hypothetical question. I don't know of any study that was done but I don't know of any study that was done. I can't tell you for sure. You're referring to Purdue Frederick and you're referring to the time frame up to the 2007 or 2010? Yes. I just want to do it. I don't know. My answer is the same but I just want to be sure that my answer conforms. Has Purdue Pharma done a study since then? On abusability of many formulations and that we did them in the course of trying to develop and then select amongst several formulations. These were studies that were pioneered by Purdue with outside investigators and they attempted to and I think quite would be considered today state of the art to discern how easily practiced drug abusers might be able to defeat the delivery system and abuse it. Have you ever seen the deposition of Curtis Wright in the Poston case? In the Poston P-O-S-T-O-N? No, I've not. Did you ever discuss with Curtis Wright whether studies could have been done on the abuse potential of OxyContin prior to the release of OxyContin? No. If he testified those studies were possible and could have been performed prior to the release of OxyContin would it surprise you? I would have to know more before I've registered surprise or not. I would have to know what he meant what kind of studies and perhaps he said we could have attempted to do it that would surprise me less than if he said absolutely it could have been done so I just have to know what he's talking about. This email this is an email here for the Richard Sackler on 82797 to Craig A. McManema in Utah that's a doctor, is that right? No, he's not instantly familiar to me. If you will go to the why don't we mark this 36? If you'll go to the bottom of the second paragraph you write to him I am drawing your attention to our newest product OxyContin tablets controlled release Oxycodone HCI and have included some literature most important to your practice time of onset of OxyContin is as rapid as immediate release Oxycodone but duration is a full 12 hours and the patient reaches full blood levels in just two doses one day was it your belief that the time of onset of OxyContin was as rapid as immediate release Oxycodone? That was what our data showed more or less almost as immediate I believe in the study that I was referencing but didn't reference in the note I think it was 41 minutes for immediate release and 45 minutes or something like that for OxyContin now I recognize who he is he was a doctor who a friend in Utah was using and he must it looks like he may have asked through his friend for me to send him some Betadine he was a DPM doctor of podiatric medicine and they do a lot of surgery and Betadine is a necessary part of any surgical procedure at least it's an antiseptic an antiseptic is a necessary part I'll give you a copy of this and this is if we can mark this as 37 this is an email dated May 15, 1996 looks like it was received by P. Goldenheim MD but he does work for Purdue Pharma, correct? Yes, he was and it looks like you were also included by facts Dr. Richard Sackler and if you go to the third page it says Professor Dair did not see any major problems regarding registration of OxyContin in Switzerland some specific points need to be clarified the monitored release approval as for DHC may be a possibility in parentheses he considers the following subjects as important and would need further investigations the first paragraph says information about the abuse addiction potential versus other opioids because of the rapid onset of action of OxyContin do you read that correctly? You did do you know OxyContin in Switzerland? I believe we did and did you provide him with the information about the abuse addiction potential versus other opioids because of the rapid onset of action of OxyContin that he requested? I'm not clear that he was actually requesting it just saying that it was his opinion it was necessary for registration but I don't know anything was produced I doubt anything was produced here that was not produced for the FDA or the other European agencies who approved OxyContin if anything was produced that was different that his additional studies they would have also gone to the FDA do you know why he was concerned about the rapid onset of action of OxyContin with respect to abuse and addiction? I don't know with respect to the claims about peaks and valleys did you ever review the information to see what peaks and valleys were present in the plasma blood levels with respect to OxyContin? in the five month did you say? no did you ever review that? with respect to peaks and valleys the claim that there are peaks and valleys are different did you ever review the literature regarding that? I was familiar with some studies that demonstrated that it was to some extent an obvious characteristic since the drug was taken twice a day you'd have two peaks whereas the immediate release was taken four to six times a day and so you'd have four to six peaks do you know if the level of peaks and troughs are similar or different? my recollection is that they are about the same but that's a fuzzy recollection and I would need to see the data myself and be sure but I think you my recollection is they were close do you know whether the controlled release because it maintained a higher level and didn't have as much trough during the day would be more likely to cause addiction or less likely to cause addiction? my impression is that the average blood level was the same and I'm not certain so your question is given that the average blood level is the same if I'm correct and that's a recollection I haven't seen that data for a very long time the only difference in the blood level the remarkable difference would be half as many or a third as many peaks and valleys and to the extent that somebody was seeking the drug or enjoying that element of the drug the peak effect I would think that the drug would be less attractive but it's a conjecture it's not knowledge because I don't think we ever did a study that I'm aware of if somebody has a controlled release and maintains a higher level during the day with respect to valleys they don't have as many valleys is that more likely to make them become addicted or less likely do you know? I don't think the valleys were about the same too so I don't think that the valleys or the height of the peak would have been any difference the principal difference I think would have been and you saying addicted would have been fewer peaks and all of this presumes that they were using the drugs as they were made and presented and if they use it as made and presented they would also be taking drugs for breakthrough pain potentially correct? will be have gotten two prescriptions from the physician right the study show that it lasts from 8 to 12 hours and if it lasts 8 or 9 hours in a patient and doesn't last till 12 he may need an additional prescription rescue prescription for that also correct? possibly I would have told the physician use the rescue compute the daily dose and try giving that dose as oxycontin twice a day that is half of that dose twice a day do you know was there any study done to determine whether patients who were given a controlled release oxycodone and then had to take another one because it didn't last 12 hours were more likely to develop addiction or less likely to develop addiction? I know of no such study and I don't recollect that anybody ever suggested such a study or such a hypothesis I would have asked them why do you think that they are more prone or less prone to addiction I wouldn't think it would make a difference again not based on a study based on a conjecture so I really would have to understand what is the reasoning why taking the drug three times a day would be more likely to cause addiction or less likely can we go up the record one second sure we are off the record at 6.20 p.m. we are back on the record at 6.33 p.m. what I like to do is have you sift through these documents and with the exception of the GAO report are all of these documents that are kept in the ordinary course of business at Purdue? no they would not all have been kept to my knowledge in the ordinary course of business we would have had some sort of destruction policy but we have been engaged in litigation for so long and so many different matters that basically at least my documents I don't think anything has been thrown away are these all documents that were generated in the ordinary course of business at Purdue? or at Purdue Frederick or in other companies or some of the overseas companies yes Purdue Pharma and Mundy Pharma Purdue Pharma, Mundy Pharma Purdue Frederick whatever then are all of these business records? I don't know that you know I'm not a lawyer I'm not sure it is can you answer the question? okay are they business records? I really don't understand what that term means it's not a term I've ever used they are what they are I mean I asked you about the Oxycontin 20 milligrams prescription to your knowledge was anything done to determine how many people put on 40 milligram 80 milligram or 160 milligram prescriptions would become addicted or dependent if they took it for a certain period of time no sitting here today after all you've come to learn as a witness do you believe Purdue's conduct in marketing and promoting Oxycontin in Kentucky caused any of the prescription drug addiction problems now plaguing the commonwealth? I don't believe so sitting here today after all you've come to learn as a witness do you believe that Purdue's conduct in Kentucky has led to an excessive or unnecessary of opioids being located throughout the commonwealth of Kentucky? I don't believe so do you believe that any of Purdue's conduct has led to an increase in people being addicted in the commonwealth of Kentucky? no do you agree that education information presented by a drug company to physicians needs to be fair and balanced? yes and do you agree if a company learns that a physician does not understand a drug that is being sold by the company that they have a responsibility to educate them properly about the drug? yes do you think Purdue has an obligation to provide physicians with truthful information? yes do you believe Purdue provided any of the physicians in Kentucky with information that was not truthful? no I don't believe that do you believe any of the sales reps engaged in the conduct that is any of the sales reps in Kentucky engaged in the conduct that is described in the felony plea agreement? that's my belief I don't have any facts to inform the otherwise and you never checked did you? I don't know how I would have checked that you have looked at the call notes from your sales people in Kentucky to see what they were telling physicians and whether it was the same information referenced in the felony plea agreement? I could have looked at the call notes but I believe that all the call notes were reviewed at least once and probably multiple times by many people and why do you have that belief? because I know of the number of investigations and the extensive training and retraining that was done I believe it would have surfaced any evidence of wrongdoing and inactionable but as I said I've only seen a few call notes and the ones I've seen are so cryptic and imprecise and unclear in their references often you don't even know who's saying what these were memory joggers that I've seen they were written by a person who had a conversation who wanted to recall that conversation two, four, six weeks later and when the call notes say I told the doctor about less abuse or I told the doctor the drug had less euphoria or emphasize that that would be improper, correct? if such call notes existed and they were that explicit yes I didn't see any like that did it ever occur to you to check and see whether the the people you hired and paid $50 million for to do a presentation and defend Purdue in the US Attorney's office in the western district of Virginia gave accurate and truthful information to the US attorneys regarding the call notes I object to the floor for the question you can answer it wouldn't occur to me that any attorney that we hired would give false information to any other attorney and much less so to the US attorney and his deputies when doing a call note search did you ever find out how they went about it? I'm sorry? when the people you hired did their call notes search did you ever find out how they went about it? at the time it was described in fairly explicitly but that was years and years ago almost 15 years ago I think any further questions along this line will really impinge on the attorney's line probably so I object was a breakdown of the results ever provided to you? in a way yes when you say in a way how was it provided? I was told that I'm sorry I think your questions are really leading the witness into attorney client communications to direct them not to respond to those questions well certify the question and we'll talk to the judge about it I think I'm entitled to go into it if the judge says no then of course we can't so here's a call on a Mark Dubrick in Lexington, Kentucky from a K period boils do you know who that is? I don't know either of those people okay under a notes memo it says got to convince him to counsel patients that they won't get buzz as they will with short acting now would that be an appropriate thing to do counsel the doctor that the patients tell the doctor convince the doctor to counsel patients that they won't get buzz as they will with short acting again if you're reading from a document please show it to the witness they have a copy this is the only copy this is pretty easy to read this is not small so could you repeat the question? yes would it be inappropriate to counsel the doctor to convince the doctor to counsel his patients that they would get less buzz with oxycontin versus well what it says here is that they won't get a buzz and I don't think that telling a patient I don't think you'll get a buzz is harmful because if they do I would think that the patient would report it and he would know oh I don't know why he would have told this to a patient but I think that it actually could be helpful because many patients won't get a buzz and if he would like to know if they do he might have had a good medical reason for wanting to know that do you know whether telling patients telling doctors patients won't get a buzz was one of the things prohibited by the in the statement agreed statement of facts in the felony please yes but that isn't what it says he said we don't know what the conversation was between the doctor and the rep but as I testified just a minute ago I could see that this could have been not only not harmless but helpful here's one are you going to mark that as an exhibit I'm just going to ask him about these here is one you're asking questions about them and then we go forward from here have no record of what it is he was looking at well this is my only copy that's why I don't want to why don't you mark it as an exhibit don't give me a copy if you want to mark it later you can but I'm going to ask you my questions right now so I can get out of here you can object I don't have to mark it if I don't want here's Ellen Ballard in Louisville Kentucky sales rep Mark Curran here it says talked of less euphoria and more convoluted with oxy would it be inappropriate to tell patients they get less euphoria with oxy we really don't know what was said as I said this is a memory jogger he might have said there may be less euphoria or some people have less euphoria or we just don't know what was said here if all he said was there may be less euphoria that could be true and I don't see the harm if you promise less euphoria it shouldn't have been said and the greed statement of facts doesn't say you have to promise less euphoria it says if you mention to a doctor or infer that it causes less euphoria that's improper correct that was what we agreed to yes but this was 1998 long before there was an agreed statement of facts what difference does that make if it's improper in 2007 wouldn't it be improper in 1998 not necessarily well the improper conduct at the agreed statement of facts the time period was 1996 to 2001 correct yes and if this is 1998 it's within that time period correct yes so by what kind of twisted logic are you saying that saying this in 1998 wouldn't be improper because the agreed statement of facts is in 2007 I object to the form of the question and it isn't a question it's argumentative and it's really uncalled for if you can answer go ahead I think I should stand on what I said well let me ask you this tell me all the basis you have believing that saying this in 1998 to talk of less euphoria with oxy would somehow not be a problem because the agreed statement was in 2007 I don't know what he said in 1998 I know what he wrote but I don't have quotes on it I don't have a dialogue I wasn't present I don't know what he said and I don't even know whether this was a document upon which the agreed statement of facts was constructed for all I know this document was tossed away as inexact or inexplicit let me ask you about this document James Donnelly is the doctor at the Trover Clinic in Madisonville Kentucky who was called on by Holly Will and the notes memo says quick reminded him that oxy gives flat blood levels so less buzz than lore tab is that the type of statement that's prohibited by the agreed statement of facts I don't know that that's what she said if you're asking a hypothetical I would say that this is not neither accurate nor appropriate it doesn't actually give flat blood levels as you know and as our rep knew as any doctor who had been properly presented the product would know but nevertheless even though it is demonstrably wrong it would be still inappropriate to say on two bases on the basis of the agreed statement of facts and also on the basis of some true but again I have to emphasize these are not transcripts these are about as distant from transcripts as anybody can get this is a memory jogger and I don't know what she said and I find it hard to believe that she said anything like this this was to remind her of a discussion have you ever spoken to her no this is Dr. David Parks in Bowling Green Kentucky who was called on by Phillip Gross love the idea of giving effective pain relief but not euphoria to get rid of druggies if it was discussed with him that it gives effective pain relief but not euphoria and he loved the idea would that be inappropriate comments to make yes if our rep made it if the doctor made it I don't think that it's maybe erroneous but it isn't improper and I don't know who made the statement in fact even what statement was made I have not I don't remember seeing any of these notes by the way but these are typical they are fragments of fragments of fragments of a conversation that are designed to remind the rep of a conversation that he or she had two three four five six weeks prior so they mean a lot but without asking the person who wrote them what it meant we don't sit here have any idea what it means if the if the Purdue sales rep calls on a doctor in Kentucky and explains to him that oxy has less potential for abuse due to its sustained release would that be improper in the type of statement that was agreed was improper in the agreed statement of facts when Purdue played guilty to a felony okay state the well I could he just restate the hypothetical question sure if Purdue called I want you to assume a hypothetical if Purdue called on a doctor and said oxy cotton has less potential for abuse due to its sustained release would that be the type of statement that would be inappropriate and when was that said or you're going to set a time limit to it or a time period to that hypothetical I'm just trying to get an idea of what statements you consider inappropriate appropriate would that be an inappropriate statement for a rep to tell a doctor today yes from 1996 to 2009 I'm not sure because I'd have to look at the package insert and see was that in the package insert or was it reasonably the same as what was in the package insert I'd have to do a textual analysis it's close to what was in the package insert very close but it might have drifted away from the package insert so that at that time it was inappropriate but I'm not sure because I'd have to read the two hypothetical statements you put forward and the package insert to give you an opinion as to whether it has drifted away from the package insert it'd be pretty easy to tell if we looked at the agreed statement of facts because they outlined the comments they felt were improper between 1996 and 2001 correct I didn't memorize the agreed statement of facts but yes if that statement was an example of an inappropriate statement obviously it would have we agreed it was inappropriate and these call notes you all actually required your representatives or sales people to do call notes and instructed them to do them within minutes of completion of the call correct that's correct and that's because the information recorded is generally more accurate when it's recorded immediately after the sales call while the events of the call are fresh in the representative's minds correct I don't think that that would be true in the way these call notes were used written or used when reviewed I don't think it would have mattered if they had done it that evening but the system was when that policy was established whoever established it probably had a different use in mind and expected them to be much much more much closer to a he said I said he said I said he's interested in this I have to get him an answer for that the notes I've seen so far depart so far from that that I don't think it mattered whether they did it in a minute an hour or a day so long as the conversation was fresh in their mind they sketched some notes to remind them of the conversation a few weeks later two to six weeks later when you discipline people how did you make a determination which ones needed to be disciplined sales reps needed to be disciplined I didn't discipline anybody and so I was not asked to make a determination do you know if the people who did make that determination relied on the call notes in determining whether discipline should take place? I don't know do you know if the reps in Kentucky were disciplined for having inappropriate call notes reflected their conversations with physicians I don't know if a sales rep went to a doctor and said discuss lack of buzz and thus won't be drug seeking would that be an inappropriate comment to make? would you form the comment for me since as hypothetical as a sentence and then I'll respond to it if a sales rep went to a physician and said you don't get a buzz with OxyContin would that be an inappropriate comment? yes if a sales rep went to a physician you're going through a whole line of questioning where you have documents you purport to be reading from them you're not showing them to me you're not showing them to the witness I'm asking him what types of questions a sales rep says whether I've got notes or documents or I've got them in my head doesn't matter I get to ask my question you can follow up if you want if a salesman went in and discussed abuse potential and benefits of OxyContin I'm sorry and at not giving a euphoria would that be inappropriate? I believe that would be inappropriate if he tells them that there's less euphoria with OxyContin or he or she sales rep says there's less euphoria with OxyContin would that be inappropriate? less amount of euphoria or less likely to be euphoria or something else either of those I believe that today that would definitely be inappropriate would it have been inappropriate in between 1996 and 2006? I would have to study the package insert let me let me go back and talk about what maybe this one will help us here under misbranding of OxyContin there were several things that were brought up that were were in inappropriate and it says with the intent to defraud or mislead I'm reading from page 5 of the agreed statement of fact what number is that? it's exhibit 33 is this it? yes where are you reading from please? page 5 paragraph 20 with the intent to defraud or mislead produce supervisors and employees between December 12, 1995 again you left out the word certain I'll just read it in its entirety then beginning on or about December 12, 1995 and continuing on or about June 30, 2001 certain produced supervisors and employees with the intent to defraud or mislead marketed and promoted OxyContin as less addictive less subject to abuse and diversion less likely to cause tolerance and withdrawal than other pain medications did I read that correctly? I think so it's getting late I might have missed too and it was a review of the call notes by the U.S. Attorney's Office that formed the basis of this plea agreement correct? I don't know that do you view any of the documents filed by the U.S. Attorney's Office in the case where Purdue pled guilty to the felony? no I didn't alright and it says here they didn't footnote these documents so I don't even know if the documents they reviewed millions of documents I don't know whether they referenced any of the documents to this I certainly couldn't have reviewed millions of documents no one person could have done that under number subparagraph E it says told certain healthcare providers that OxyContin did not cause a buzz or euphoria and that would be improper correct? depends on did not cause yes that would be inappropriate caused less euphoria had less addiction potential had less abuse potential was less likely to be diverted than immediate release opioids and could be used to weed out addicts and drug seekers in its totality it's inappropriate and one of the things that it points out in here when we went on was the osteoarthritis study do you remember us talking about that I do here's Carol Neal Heisel sales rep this is William Yates Doctor Florence Kentucky and the notes memo says brought osteoarthritis studies that show non-addiction discussed how he could use oxy to deter addictive behavior less pills less potential for abuse would you agree that those comments would be improper improper and inappropriate if they were quotes of the transcript of what he said yes this is inappropriate and in its totality it's inappropriate are you planning to mark this as an exhibit I was not going to mark it and it says here Purdue states that I'm reading from the reply of the United States to defend its response to blue cross blue shield of Tennessee and other private third party repair request for restitution this is a new document right is this an exhibit I just want to ask you about some of the information in here can we just you're not going to mark this as an exhibit either I wasn't going to could you identify it so we'll know what it is I thought I did it's a reply of the United States response to blue cross blue shield it's I'm looking at the third paragraph Purdue states an analysis of the notes that Purdue sales representatives kept from their visits to physician revealed that less than 0.2% contained any evidence of statements that were arguably improper and were you aware that they had claimed that 2 tenths of 1% of the sales notes were arguably improper they actually here in their response were even arguably improper but the U.S. Attorney says this bare statistical reference does not provide a complete picture of the magnitude of the unlawful activity described in the information in the agreed statement of facts in fact these very same notes show the pervasive nature of the false and misleading statements for example according to the notes in at least 41 states were informed that addicts would not like OxyContin or that OxyContin could be used to weed out drug seekers because addicts would not like it in at least 49 states physicians were informed that OxyContin produces no quote buzz or euphoria and in 50 states physicians were informed that OxyContin had less abuse potential than other opioids would all of those comments be improper those comments would be improper yes and it says in addition once Purdue learned of the investigation it conducted training that cautioned sales representatives to avoid including references to the false and misleading statements in their call notes eventually Purdue changed the call note system altogether to preclude such references by allowing sales representatives to choose only from pre-selected menu items that not surprisingly omitted and misleading statements that the employees had previously that the employees previously had previously spontaneously recorded in the notes were you aware of that I objected for that question you're showing the witness an argument written by the government and submitted to the court in a brief because witnesses don't seem they government arguments and you're asking if he was aware of it I'm asking if he was aware of that activity what activity once Purdue learned of the investigation it conducted training that cautioned sales representatives to avoid including references to the false and misleading statements in their call notes were you aware they did that I don't think they did that and it says eventually Purdue changed the call note system altogether to preclude such references by allowing sales representatives to choose from a pre-selected menu items that not surprisingly omitted the false and misleading statements that the employees had previously spontaneously recorded in their notes were you aware that that had occurred well I object you're assuming that something occurred based upon an argument of one party do litigation in a brief can I verify that this occurred I can't the statements referenced in the agreed statement of facts under misbraining of oxycontin you don't even see a date on this yeah okay the statements are we on the same document no I'm asking about the agreed statement of facts now okay we're back to the statement under misbraining of oxycontin what page or what number page 5 you've read paragraph 20 in its entirety correct correct I had read it but it might help me to read it again but why don't you pose your question are those the statements that were improper and constituted the guilty plea Purdue Frederick can I hear the question again the statements outlined in paragraph 20 are those the improper and misleading statements that were made with intent to defraud by Purdue's sales force does that set them forth I don't know to me this is almost a legal question and I'd like to know whether our attorneys would agree with this or not these are some of the statements that are in here I think there are others so I'm not sure that you mean is this all and nothing else I just mean on paragraph 20 would that constitute examples of inappropriate and misleading statements I object to the question it's been a long exam late in the day we'll be going over the agreed statement facts again and asking the witness what the agreed statement facts says what it says is written in the agreed statement facts I don't know where this is getting this late hour I think it's starting to border on our harassment can you read my question back I just mean under paragraph 20 would that constitute examples of inappropriate and misleading statements should I answer I object that you can answer yes if a sales rep told a doctor that using oxycontin would provide smoother blood levels would that be an appropriate statement I don't know if smoother blood levels was not in the package insert it may not it might be an inappropriate statement but I'm not sure that it wasn't in the package insert although it might be inappropriate I don't know it would have been true depending upon what was meant by smoother smoother is not a medical term or a pharmacokinetic term it's an opinion of it's a term that somebody might apply to a graph it's a smoother line it's not a smoother line but it's not really a clear statement and thus I can't say it's clearly right or clearly wrong it would have been fine if that terminology was in the package insert I don't know where it was what information did you review to prepare for your deposition today documents which documents not too many of the ones you've shown me this agreed statement of facts we've reviewed in part am I supposed to answer this I mean I don't yes any other documents that you review that I recall and can describe to you yes no you did say you reviewed six less than eight call notes is that right and that was the first time you'd seen call notes yes this was the second time and as I said they are both both experiences are the same they are so fragmentary that they can mean it's impossible to know really what was said that's why you had to pose hypothetical statements yes Purdue Pharma LP Purdue Pharma Inc the Purdue Frederick Company Purdue Pharmaceuticals LP PF Laboratories Inc do you know if they have the same directors or are there different directors for those entities I don't know do you currently practice medicine not practice in the sense that I have an office and see patients by appointment no I don't when is the last time that you practice medicine 1974 during my residency from 1999 to 2002 you were the president of Purdue Pharma LP from the very last days of 99 until March 2003 were you also at some point the president of Purdue Frederick I don't think so no did you have any office title at Purdue Frederick I did I was a senior vice president did you relinquish that title I don't recall but it probably was either simultaneous with ending my presidency at Purdue Pharma or before there are different types of corporations there are not for profit corporations and there are for profit corporations would I be correct that Purdue Frederick and Purdue Pharma are for profit corporations they're for profit businesses but not all of the companies that you've named are corporations that's a good distinction would I be correct that Purdue Frederick or Purdue Pharma are for profit not for profit they're for profit go off the record off the record at 7.18 camp we are back on the record at 7.39 camp let's go back through I'll hand you a document at the top let's mark this as exhibit 38 it's from Richard Sackler did you recognize that I recognize the name okay was this an email that you sent to Michael Friedman and it says here under importance down below importance low but down below it says why don't you guys plan a presentation about addiction that could be given first by R.R. or B.K. and who are those individuals Robert Reeder or Bob Keiko and eventually by our senior managed health care people next paragraph I think that Paul has a good point but we should consider that quote addiction maybe a convenient way to quote just say no and when this objection is obliterated they will fall back on the question of cost unless we can give a convincing presentation that see our products that's controlled release products yes are less prone to addiction potential abuse or diversion than I.R. products that immediate release I think that this can be done but I defer to B.K. and R.R. and other experts yes and what were you trying to accomplish there by trying to show that controlled release products are less prone to addiction abuse or diversion than immediate release products well I wasn't trying to show anything I was basically asking a question and if the answer were yes we can put together a good effective and medically correct presentation I thought it would be useful to do so but I was asking them can we do that do we have the information do we have the data and obviously if we had contrary information or data then obviously you couldn't do that are you aware of any presentation showing that controlled release products are less prone to addiction potential abuse or diversion than immediate release products no I don't think so but I don't remember how this came to an end I put on low in importance to indicate it was not something that was urgent it was an idea I had and I said can we do this another email can you mark this as exhibit 39 and this is dated looks like at the bottom analgesic plans Dr. Richard Sackler at Norwalk and is this an email that you sent it's quite a dense email if you go back to page 3 the email that preceded it was from John Stewart who is John Stewart who is the general manager in Canada PF Canada and is that a Purdue Pharma affiliate it's an affiliated company yes does the Sackler family own PF Canada yes he says under the first paragraph in my opinion the action that will produce the greatest sales gains are the acquisition of IMS practice quartile data and the resulting improvement and targeting of our sales and marketing activities what does that mean in the United States from the inception of the launch of OxyContin we focused our salesman's attention to physicians who were based on their history physicians whose practice and their practice was to use write a lot of prescriptions for opioids we didn't go to people who didn't write them we went to people who did and I don't recall whether this practice was or was not done in PF but I might have learned in a meeting that they were not doing it and they could not purchase the same data source from IMS in Canada but they appear to have had something that would have been similar where they divided physicians into quartiles okay and if you look at your response to him on 927.96 you say your most important question to me was have physicians been reluctant to use OxyPRN what does OxyPRN mean I assume that Oxy referred to Oxycontin PRN would mean as needed in place of IR forms of Oxycodone and that's immediate release Oxycodone correct I've not asked this question but judging from the very strong sales performance and continuing growth I would guess that this has not been a problem I think that were this the case it would be because of the very rapid rate of onset parenthesis as fast as IR Oxycodone that is 45 minutes versus 41 minutes for the IR form not even close to a significant clinical or statistical difference and was it your understanding when you wrote this that Oxycontin controlled release did not have a significant clinical statistical difference with rate of onset when compared to Oxycodone immediate release that's correct this was drawn from a study that was done onset is not defined here but it was a medical term in the trial that I believe John Stewart had either been given or was familiar with which basically recorded the first instance that the patient said oh I'm beginning to feel better, my pain is less that was meant by onset that was the meaning of onset in that trial and that was what I was quoting from and it says here the fast rise character now quote parenthesis now a patent in the U.S. in parenthesis of the drug combined with familiarity and a marketing program that emphasized that IR was the old was I think that's supposed to be a way and Oxycontin tablets are the new way to treat moderate to severe pain has resulted in our success did I read that correctly you read very correctly what is written here when it says the fast rise character you're referring to Oxycontin having a fast rise as far as when relief occurs correct yes and then down below that if you go to about the fourth paragraph the overall schema that marketing here has worked our four three of the four I think that's out of three of the four should probably be but it's written the overall schema that marketing here has worked our four three of the four is Oxy one IR old way Oxycontin tablet new way emphasizing the BID was Q4H versus BID versus Q4H and underscoring the similarity of onset other differential benefits are emphasized such as range of doses the very small tablets etc and then Oxy2 your second point with regarding Oxy is in cancer and severe non-malignant pain the ones to start with and the one to stay with here we are going directly after the MSC business what is MSC MS Contin and Dura Jezik who made Dura Jezik J&J and you say clearly this is highlighted or capitalized clearly this strategy has outperformed our expectations market research and fondest dreams yes I read that correctly you did alright last one I want to ask you about there's no question when you say it outperformed your fondest dreams you're talking in terms of market share and what it was earning is that correct it's the overall sales trajectory and then one more email to ask you about who was oh I'm sorry let's mark this as number 40 did you read the sales bulletins when you were the when these were sent to you I was senior vice president not generally I might have scanned this I didn't read them carefully they were very carefully crafted by sales and marketing people and and others who didn't usually read them who is Russ Gasdia Russ was then either a district manager or a regional manager and this is January 25th 1999 prescription sales force does that mean it went out to everybody no it probably means it went out to salesmen who were doing who were selling prescription products would it have gone to everyone selling oxy cotton I believe so yes the first paragraph says effective with the first quarter 1999 MS cotton sales volume first paragraph I see as was announced okay as was announced at the national meeting right okay you just effective with the first quarter 1999 MS cotton sales volume and growth as well as quota will be calculated at 50 cents okay I'm not following you can you just show me where I don't know where you're reading from the first paragraph okay I'm looking for effective oh I see okay sorry yeah these are small and I can't read them that fast I'm not following you okay let me give you this one and we'll make it the exhibit okay I'm following you now sure so let's read the first paragraph as was announced at the national sales meeting effective with the first quarter 1999 MS cotton sales volume and growth as well as quota will be calculated at 50 cents for every one dollar what does that mean I I'm I can't be sure but I think that we were reducing the bonus for MS cotton I'd have to read the whole thing to be sure of that would you like me to read it all that's all right I'm going to read it with you here okay next sentence then oxy cotton sales volume and growth as well as quota will be calculated at one dollar and 15 cents for every one dollar again it was de-emphasizing MS cotton sales growth and increasing the incentive by a small amount on oxy cotton sales growth and then the next paragraph says early estimates indicate that the fourth quarter 1998 bonus payout will be another record payout remember this record payout came at a time when we were utilizing a factor of 55 cents for every MS cotton dollar and a dollar 15 for every oxy cotton dollar as we continue to drive more business toward oxy cotton each of you will benefit significantly from the factoring of a one dollar and 15 cent for every one dollar of oxy cotton again is that referring to de-incentivizing MS cotton sales and incentivizing oxy cotton sales yes we were moving the incentive program to focus on oxy cotton and every time you take an incentive program reduce it you have at least in some of the people who are affected some strong negative feelings and that's probably why there was a small increase to oxy cotton looks like it was 15% but I'm interpolating here I don't recall I certainly didn't read this and I don't recall the details of the incentive compensation well enough to be sure and then it says as pointed out your priority is to sell sell sell and that's in bold oxy cotton right and is that what the sales force was instructed to do that's what he said they were instructed to do but they were instructed to do their best to sell oxy cotton yes this was a sales force related kind of raw, raw piece it also says in the last paragraph remain focus on positioning oxy cotton as the opioid to start with and stay with in chronic malignant pain states in addition continue to aggressively position oxy cotton for use in osteoarthritis, low back pain post neuropathic neuralgia and post surgical applications where appropriate finally continue to highlight the advantages of oxy cotton especially for use in the elderly if you have any questions regarding the bonus calculations for the first quarter of 1999 please contact your district manager that tells me he was a regional manager have you made any effort or as we sit here today do you know how many patients who took oxy cotton in Kentucky became dependent or addicted do you believe that an inappropriate number of patients or an excessive number of patients who took oxy cotton in Kentucky became addicted or dependent do you know or has Purdue made any effort to ascertain how many people who were started on oxy cotton wound up becoming dependent and moving on to heroin at some point I think it's all questions I have Dr. Sackler thank you very much are you finished or maybe not I don't know you're done thank you that is the conclusion of the step decision it is we're off the record at 7.58pm just to see