 My name is Matthew Herter, I'm an associate professor in the Faculty of Medicine, also a part of the Health Law Institute here at Dalhousie. And it's my great pleasure today to introduce Adrian Fueberman and Sharon Bax, our two speakers today. Adrian Fueberman is a full professor in the Departments of Pharmacology and Physiology and Family Medicine at Georgetown University's Medical Center. A physician by training but an activist at heart, Adrian Fueberman has made innumerable contributions to the ever-growing body of research about the interface between medicine and industry. She's the founding director of a group called Firm Out, a research and education project that seeks to promote rational prescribing and expose the effects of pharmaceutical marketing on physician prescribing. Sharon Bax is an agile professor in the Department of Bioethics here at Dalhousie, as well as an independent researcher and writer. One of the four organizers in the Canadian breast cancer patient movement, Sharon's scholarly work has become central to the study of patient advocacy organizations in Canada and beyond. Her forthcoming book, Health Advocacy, Inc., published by UBC Press and due out later this year, is highly anticipated by scholars and I hope patients alike. And so we are very fortunate to welcome Professor Fueberman back here today to present together on the topic of patient advocacy in the drug regulatory process both in the United States and Canada. We're fortunate not only because of their collective expertise but also because they share on the one hand a deep commitment to patient engagement in healthcare but on the other worry greatly over how that engagement can be shaped and controlled by other interests. It's fitting on this perhaps very dark day when the tension between democratic participation and grassroots manipulation is perhaps foremost in most of our minds that professors Fueberman and Bat are here to reveal and contest that same imbalance in the healthcare setting. So without further ado I'll welcome our speakers to the stage. Thank you. We're really excited to be here today and this is actually the first time that we've ever talked about this particular subject and it's the first time we've presented together so we're really thrilled about this. So as Matt pointed out, I direct a project called Farmed Out and we looked at pharmaceutical company and medical device company promotion and we're not really focusing on the overt kinds of promotion. So drug advertising, drug reps, you know at some level doctors do know that drug reps are actually there to sell drugs. There are important methods of promotion but they're not really what we focus on. We're more interested in covert kinds of promotion so that includes ghost written and ghost managed articles in the medical literature and also in consumer literature. It includes continuing medical education, most of which is actually funded by industry, patient education, but also the funding of professional and patient organizations are the use of third parties as mouthpieces for marketing. Not exactly mouthpieces. We decided we had to stand up here together because as we were going through this we just kept arguing with each other so we thought we'd just argue in front of you. We'll talk about the tension over the terms like mouthpieces because there is some. Okay so I don't know how familiar people are probably varies with the whole drug approval process but in Canada and the US we have a similar process for approving a drug. I mean drugs are highly regulated commodities. So the FDA has really taken the lead in setting out the process that drugs have to go through and the idea is you want the drug to be both safe and effective before it goes to market and gets promoted to physicians who are the prescribers. So in Canada it's a division of Health Canada that does this approval process. In the United States it's the FDA and so this is a very important process. It's evolved over time in interesting ways that a lot of people believe it's become less rigorous in the last 15, 20 years. Others would dispute that but another responsibility that the FDA and Health Canada have is they regulate advertising and promotion to health care providers and consumers because again there is concern that there might be distorted presentations of what these drugs can and can't do. And just to point out that drugs aren't just approved for anything. So although it is legal in both countries and in most countries for health care providers, for prescribers to use a drug for anything that they want to use it for it is illegal for a company to promote a drug for something that it has not been approved by the health regulatory agency for. So drugs are approved for specific conditions but after they're approved providers can use them for anything. So we both go back to the days of the 70s and 80s when women's health activists became very concerned about the way medicine was treating women's health. And so there was in both countries a very vibrant women's health movement that contested a lot of the ideas about women's bodies and the kinds of treatments women should have for a whole variety of conditions. And so there's an interesting lack of continuity or over time that we want to bring out. So we were both involved in health advocacy in the 70s and there was huge amounts of activity in both countries and there was a lot of women's health activism around unnecessary use of drugs, unnecessary use of medical procedures. There being too many C-sections. Were apesiautomies necessary? Did women have to be knocked out for childbirth? Access to birth control which was illegal in Canada at the time that McGill medical students create Donna Cherniak and her boyfriend at the time. His name I don't remember. And there were others. And others. It was a whole collective. Yeah. At Bengal. At Bengal Student Society. And so at a time when birth control was illegal in Canada they put out this birth control handbook that not only had huge, had great information about birth control but also put it into a political context. It was so popular and by the way medical students at other schools actually contributed to producing and funding the distribution of this handbook. And I gave it out at free clinics in the 1970s in the US. It was popular in both countries. They distributed 3 million copies of this. That was really amazing. There was a lot of critical analysis about problems with the birth control pill, Barbara Seaman, our bodies ourselves, still being published today with the original copy was cost 40 cents. There were publications as well. Health sharing was a fabulous Canadian publication on women's health. There was a friend indeed with Janine O'Leary Cobb that was for menopausal women. Also a Canadian publication branching out was a feminist publication. Sharon was the editor of that. So there was a real vibrant movement and a lot of examination of existing practices and a lot of efforts towards protecting women from unsafe drugs and unsafe devices and unsafe medical practices that were accepted at the time. There was also really a call for evidence. Where was the evidence that episiotomy is actually eased birth for example? So there were a lot of calls for evidence as well. I'm not sure everybody knows the story of DES, but in the 1970s there was a physician who noticed that he had seen several cases of a very rare cancer called vaginal clear cell adenocarcinoma. It's such a rare cancer. It occurs in 1 in a million cancers that non-colleges could go their whole professional life and never see one. He had seen I think three and wrote this up in a medical journal. And that started this sort of epidemiologic detective story that found out that the reason that these women had this cancer is because their mothers were exposed to diethylstylbasterol, a very strong estrogen DES during pregnancy. So that the women who developed vaginal clear cell adenocarcinoma in their 20s had been exposed as fetuses to this estrogen that caused this. It also caused reproductive tract abnormalities in both men and women. And this drug was given to women during pregnancy in an effort to prevent miscarriages. It didn't work by the way. There was never any evidence that it worked. So it was basically all harm and no benefit. And it was also advertised as promoting healthier babies. Big healthy babies. So the group DES Action, it was actually became a network. There was DES Action Canada, DES in the United States. There were some European DES Action groups. And they were basically patients and mothers and friends of family members who became very conversant with and quite angry about the promotional strategies of drug companies. And this was sort of their case example of how harmful these drugs could actually be. And they were fighting to get compensation and recognition and raise doctors awareness so that they would understand what to do when a patient came in whose mother had been given this drug. And the drug company, well, I don't know, a lot of the records were destroyed. So it's really a very interesting story. But it raised a lot of awareness about drugs and women's health. And drug companies. So then in the 80s, there was a bit of a turn here. The HIV AIDS groups were in large part men, well educated, young in many cases. They wanted drugs. I mean, they had a life-threatening disease. It was horrible. And so they were very strong advocates and developed their own kind of very in-your-phase kind of advocacy actions. But they were taking a different tack than the women's health activists had in that they really wanted to see some kind of drug develop that would keep them from dying. And they worked with the companies. They saw the need to work with the companies. They were also... With drug companies. Yeah, with drug companies. They were also critical of the companies. They were very critical of the FDA, which they felt was standing in the way of rapid drug development. So they had an interesting influence in raising the sort of profile of patient advocates and the role of patient advocates. But with more of a turn to wanting drugs, new drugs developed, and wanting faster approvals of drugs. So very different focus from the women's health movement. So just some of the groups act up and gay men's health crisis that did a lot of work in this area. And they're quite similar. In Canada and the U.S., the movements were quite similar. So this is... Meanwhile, back at the women's health movement. This is a quote from a very, you know, activist, she's still very active, a Canadian women's health advocate who talks... I interviewed her for my book and she talks about how you would never consider if you were involved with a group like DES Action taking money from a drug company. I mean, it would just be unheard of, unthinkable. And so there was some awareness in the 80s with the AIDS movement. And there were some fertility groups in the women's health movement around the same time that were working with the drug companies and accepting money from the drug companies. And so there was a tension there about the whole issue of drug company funding within the grassroots groups. So most of the women's health organizations were not taking pharma money. They considered pharmaceutical companies to be the enemy, but a few did start taking some money and their materials got a lot glossier, better produced. Yeah, so what I've looked at in detail is the breast cancer movement, which grew out of this sort of ferment with HIV AIDS, but also had some continuity with the women's health movement. So it was kind of a mixed bag of a lot of fairly young women being diagnosed with breast cancer, baby boomers who picked up on the idea that we needed to raise awareness of the disease and get better treatments and teach doctors to understand how to talk to us with one of these women. So I can speak in the we. And so the breast cancer movement grew in the United States and Canada that had some elements of the AIDS activism and some elements of the women's health movement. And there was also on the government side, partly because of the work of the AIDS activists, but also a sort of a political turn that it was important to talk to patients that this was both a Democratic principle and it would be good for science to hear what patients were experiencing and what their needs were. Yeah, and to incorporate patient perspectives into the design of clinical trials and into policies. So that was really happening in both countries. There's sort of more power to these patient advocacy groups. Right. So in Canada we have had this tradition starting in the 60s, 70s. And I wish Dr. Paul Prost was here because he's done a lot of the work on this whole, the Canadian experience of government funding advocacy and civil society groups on the basis that it was important for the government to understand what these different segments of population that were agitated about something, what they wanted and incorporate their views into policy. So we have this tradition that goes back to the 60s, 70s of funding advocacy groups to do actually to do advocacy to do research to educate the communities and also to educate policymakers. So when the women's health, the breast cancer movement started in Canada, this tradition was still active and Health Canada provided funding to these new groups that were forming but also seeded money to create a network across the country. Which if you look at this diagram, it's kind of bureaucratic. It's not really what a grassroots movement would look like. But it was useful in that it gave the group some money to get offices and do the kind of work that they wanted to do so that they weren't just working on these shoestring budgets. I remember being completely shocked when I heard that the Canadian government actually funded advocacy groups to be critical and actually give them critical feedback. Like that would never, ever happen in the United States. That's a really interesting difference between them. But the American groups would get more money from foundations. We don't have the same foundation tradition here. So then in the mid 90s, having set up this elaborate system of patient groups, many of you will remember, some of you will remember the 96 budget that was kind of a slash and burn budget. And the groups were told, okay, you're going to have to fund, you're going to have to support yourselves. We're going to phase out your funding and you're going to be on your own. At the same time, the drug companies were noticing that these groups were kind of, they were out there, they were interesting, and they would make overtures. They would come to the public displays if the groups are setting up at conferences and so on and say, we could help you. We hear you're doing a big launch of your new office. Maybe we could give you a bit of money. So this interaction began between the groups and the companies. Well, really it's that they noticed they were being influential. There were now like patient representatives on government committees in both the U.S. and Canada. They were getting power. That's what they noticed. Well, I don't know about that. I think that came a little later as I will explain. Okay. So pharma became an important source of funding in both the U.S. and Canada. Okay. So what I was getting at, my disagreement is that I read a lot of the literature that the drug companies developed in this period, say from in the late 90s into the early 2000s. There were quite a few articles about in the drug marketing literature saying things like, you know, we've been following this strategy of just spray and pray, like just throw the money out there and, you know, just give it to whatever group wants money. And these were fairly small amounts of money, typically, maybe $5,000, $10,000 or $1,000 to print your newsletter. And just hope that it does some good and that it will make our company look, it'll be good public relations. They weren't systematically cultivating relationships and expecting anything particular in return other than just good feelings. So that was a spray and pray. But then if you look at the literature, there's a turn around 2000, 2001, 2002 where articles start appearing and books start appearing saying, you know, this is, we should be doing this more systematically. So this is the company in North Carolina that puts out these books for pharmaceutical companies. Any vendor for pharmaceutical companies, you always have to add like a couple of zeros to how much money it costs. If you're selling a 60 page book to a pharmaceutical company, you can charge $4,950. So this is just an example of the kinds of documents that started to come out that really explained that, you know, not all these groups were the same. You know, some of them are more important than others. Some of them were critical of drug companies. Some of them really liked drug companies. You have to understand the community. You have to work carefully so that, you know, that your efforts don't backfire. And that you have this effective relationship that both sides feel is useful, productive. Essentially how to manipulate them. Well. Okay. We'll get to that again. So out of this interaction and this sort of new way of dealing with the groups or working with the groups, there came to an under, there came to be this understanding that again you see it in the promotional literature or the advertising literature and also from the groups themselves. They'll say, what we have in common, what the groups have in common with the companies, is we want rapid access to new treatments and we want those treatments on the formularies and that's good for the drug companies and it's good for the patients. I mean that was the discourse that became widespread throughout the patient advocacy community. And this is just an example of one particular advocate who did a, she did a master's thesis on the whole phenomenon of drug company funding, which she was very much in favor of. So this is the rationale for, you know. So there's a recent article that some of you may have read. We distributed it to Sheila for people who are particularly interested. This has just come out. It's by Barbara Von Tiggerstrom who's in Saskatchewan, a lawyer. And she describes the way the groups have been working primarily in the United States and Europe where the process of regulators working with patient groups has become much more developed and they've really tried to work out a way of making it productive. But she says it's not that the drug companies are telling the patient groups what to say and in my interviews with patients who were taking money from drug companies, they always said they don't tell us what to say. And that's true. Yeah, by and large it's true. It might not always be true. But so in her analysis she says what seems to happen is more what's been called deep capture so that you get, this is sort of a synergy going on where the groups and the funders just start to think the same way and they kind of, you know, that their beliefs and perceptions have become aligned. And it's quite subtle. It's not a matter of the drug company is saying we're going to give you money and we want you to do this. That's not the way it really works. Yeah, and I'm just thinking of an example where a drug company met with a black women's health group and the idea was to identify the problems in that community what were the most important health problems. But the meeting essentially led the group to decide that chronic kidney disease was the biggest health problem facing the black community at that time. They had not come in believing that. But that was a decision that was essentially, that is what this company that convened the meeting wanted them to come out with and they sort of manipulated the meeting in such a way that they got the okay of the women on the result that they wanted. So that, they set the agenda. They set the agenda. Limit the topics and yeah. And so I mean regulatory capture is when, you know, a government agency is being so influenced by an outside force, usually a corporation that they sort of lose their ability to independently function. So this is another, this is sort of a different form where you're actually going several levels down into the actual groups themselves. So an example of what I would call a deep capture is something I looked at. It was an advocacy campaign I looked at in my research. It has several steps. So the drug company GSK gave some money to a national breast cancer group in 2008, I think it was, and it was to do a report on weight times within, for breast cancer patients. So weight times as we know it's a big issue in Canada that patients stress out about. So this report looked across the country, different provinces, how long patients, breast cancer patients waited for their surgery, how long they waited for radiation, and then looked at how long they waited for drugs. And the way it was framed in the report was how long you wait for a new breast cancer drug starts at the point where the drug company makes a submission to Health Canada. And then from that time to approval is the patient's wait time, which is not normally the way we think of these things, but that's what says in this booklet. They redefined wait time. And then again there's another wait time when the drug is approved by Health Canada while the province is trying to decide whether or not to put it on the formulae. So that's another thing that takes time. So there's no specific drug mentioned in this booklet, but there is a reference to these new exciting drugs that are being developed for breast cancer patients, particularly with advanced, I think it's particularly with advanced disease, but anyway, so this booklet comes out, gets quite a bit of press attention. Then in December 2009, there's this front page story in the Globe and Mail about a woman who has advanced cancer, it's advancing very quickly, her oncologist says, you know, there's really no drug out there for this woman, except for this new drug combination, X-Lota plus Tykerb. And Tykerb happens to be a new drug that was developed by GSK that funded the wait times report, but this woman can't get access to the drug because the Ontario committee that decides on drug approvals has not approved payment for the drug. So there's a big hoo-ha, this story comes out in the Globe and Mail a week before Christmas, and the group that got the money to do the wait times report says, whoa, this person is having to wait unreasonably long for this drug to be approved, and they write letters to the committee that makes the decisions about the formularies, and they send a notice out to all their members saying, you know, this is a really important case and, you know, please write letters. And by the end of December, the formularies committee had approved the drug. So it's in days. So that's sort of an example. I mean, there are variations on this that I've seen play out in different provinces with different drugs. It's hard to say, well, you know, because the drug company funded the group, that's why they did it, but there's something, there's a dynamic there that's quite interesting. And the woman in the story had metastatic breast cancer. I mean, at that time there were no cures for metastatic breast cancer. We still don't have cures for metastatic breast cancer. Yeah, and in the messages that the breast cancer group sent out, they talked about how this was a potentially life-saving drug, which the drug company wouldn't say that because, you know, they're more careful. They're not allowed. So in the U.S. last year, for controversial drugs, the FDA will sometimes hold advisory committee meetings. They are not bound to follow the advice of their independent advisory committees, but they almost always do, probably about 95, 97% of the time. They follow the advice of an advisory committee meeting. There is a drug called a teplorcin or a sirepta that was used for Duchenne muscular dystrophy, a genetic disease. It only affects boys. Most of them die by, they die very young by the time they're 20. It's very sad. And this company developed a drug. They tested it in about a dozen kids. It was a poorly designed clinical trial that doesn't really fit the, it's just not a reliable clinical trial. And it didn't even work within this really bad clinical trial that they did. However, the drug went to an advisory committee meeting. The hearing room was packed with hundreds of families of children with Duchenne's and the families of children with Duchenne. They look a little similar because they're all on steroids and have the sort of moon face that you get with steroids. And these were children and their families who got up to the microphone and said things like, please don't let me die. Please approve this drug. The advisory committee was torn. They did vote against approving the drug, but it was really a split vote. And the FDA overruling both its medical officers, the medical officers who assessed the drug said this drug doesn't work. It should not be approved. The advisory committee narrowly voted against approving the drug. And the higher ups at FDA overruled both of these and approved this drug, a point at which I think ended effective drug regulation in the U.S. And so besides giving money to and in some cases creating patient advocacy groups, pharmaceutical companies also invent diseases and conditions. And so one of these that was invented by drug companies is female sexual dysfunction. And then later sort of the daughter of FSD was hypoactive sexual desire disorder. And that was actually, it was developed in order to sell a testosterone patch that ultimately failed in approval in the U.S. And I don't think it was ever approved in Canada either. And there's this wonderful book by a Canadian, Australian and American researcher that sort of spells out the whole story of sexual dysfunction drugs in women. But here is the definition of this invented disease, hypoactive sexual desire disorder characterized by persistently or recurrently deficient sexual fantasies and desire for sexual activity that causes market distress or interpersonal difficulty. So even if the woman is not actually bothered by her low libido, if her partner is bothered by the low libido, she gets to be diagnosed with a disease. And this came along with some patient tests. This is my favorite one that doctors could give to patients. The female sexual function index is my favorite question, which asks, how often do you feel sexual desire interest? This is on a five point scale. Okay, if you respond that you feel sexual desire 50% of your waking hours, you only score a three. In order to score a five, you have to say that you feel sexual desire all or almost all of your waking hours. Something I think is pretty inconsistent with, say, having a job or going to school, just saying. So phlebancer is actually a failed antidepressant. It was tested as an antidepressant. It didn't work. But a few people in the trial said, must have said things to the researchers that made them think that, oh, maybe this drug actually boosts libido. So they then developed the drug as a libido-boosting drug for this imaginary condition, hypoactive sexual desire disorder. They brought it to the FDA and the FDA rejected it on safety reasons. So then the company that developed it, Berlinger Engelheim, they dropped the drug. They just dropped it. It's fine that it's safety reasons. They're interesting. Sorry? Oh, what the safety reasons are. Sudden fainting, excessive sedation, which actually might be part of the reason the drug has an effect. It's been shown that getting an hour's more sleep a night really helps your sex life. Just free tips. So Berlinger Engelheim dropped the drug. It was picked up by this tiny husband and wife team, a pharmaceutical company called Sprout Pharmaceuticals. They brought it to the FDA again. And the FDA rejected it again, similar reasons. So they created this fake consumer campaign, which I'll tell you about, and brought it to the FDA again. And this was a really clever marketing thing. One of the founders of Sprout Pharmaceuticals was a former drug rep. Wait, I think of pictures. Yes, this is her Cindy Whitehead. And they had their signature color pink, and they developed this campaign called Even the Score. And they actually hired a well-known feminist to go to women's groups, mainly women's groups that were actually clueless about FDA drug regulation, and to convince them that there were 26 drugs that were approved for male sexual dysfunction and there were zero for women. And this was an unfair feminist issue. We needed to even the score, 26 to zero. That was their call. And in fact, there has never been any drug approved to increase male libido. And then at this time, there was never any drug that was approved to treat female libido. There were some drugs, there are drugs like Viagra, for example, that were helpful for sexual dysfunction and actually work. But there are also drugs that are approved for sexual dysfunction in women, and there's also non-drugs like Lubricant, for example, that can be effective for certain kinds of sexual problems. So it was never true that this score was 26 to zero, but they created this incredible media campaign and they actually had some women's groups like the National Organization for Women, which doesn't usually do health work and doesn't know anything about the FDA to support them on this. They got senators to write letters, et cetera. And they brought this drug to an FDA advisory committee and the third time it was actually approved despite the fact that this drug causes sudden prolonged unconsciousness requiring medical intervention. Blood pressure drops of about 40 points. Excessive sedation. You can't ever have alcohol when you are taking this drug and of course alcohol and sex have nothing to do with each other. And it interacted with a lot of common migraine medications and other medications as well. In fact, the physicians who prescribe the drug have to take an educational module about its dangers. Pharmacists who give it out also have to take an educational module about this. So this is an incredible public relations campaign and it was presented in the media because there were a number of women's health groups, the ones who didn't take money from pharmaceutical or didn't take money from pharma who were against this drug, who testified against this drug. I've testified against this drug at the FDA. So the groups that weren't taking money from pharma were all against the drugs. The groups that did take money from pharma were all for the drug. And that did not come across in the media. It was like, oh, women's groups, they're in a cat fight, as opposed to, no, follow the money. If you separate them out by the money, it's very clear that the evidence-based groups and the ones that did not take pharma money were all against the drug. So Farmed Out was pretty involved in this. There was a congressional briefing where they were handing out flyers. The score is 26 to zero. We're handing out flyers saying the score is zero to zero. We even copied their font and everything. So it looked very similar. And we put out a lot of materials, educating women about the facts. And I have to say, and other women's health organizations, the National Women's Health Network, and other organizations were also putting out materials. And I think we're pretty effective at actually educating women. So although the PR campaign was millions of women are demanding these drugs, and the media didn't seem to notice that the company never had one woman who was a paid spokesperson who was talking to reporters. It's like, where are these other millions of women? There seems to be this one woman, really. Anyway, the drug was approved within two days of its approval. Sprout sold this drug to Valiant Pharmaceuticals for $1 billion, one drug, $1 billion. Possibly the worst decision that Valiant made, although they kind of made a lot of bad decisions. So they launched the drug in October 2015. And I don't have recent numbers, but they're basically selling like a few hundred prescriptions a month. That women have actually completely voted with their feet on this drug. It's a dangerous drug. And it's also not very effective. Like I said, its main effect may be just getting women more sleep, but there's not really good evidence that does anything for libido specifically. So it's really been sort of a disaster in the marketplace, but lucky you, it's now under review at Health Canada. So there's many things besides hyperactive sexual desire disorder. Pharmaceutical companies have either invented or redefined many conditions. And there's a concept in industry called condition branding, where you create a drug disease duo. If you can redefine the disease, then by pushing the disease, you're pushing a specific drug. So that's condition branding. These are some just, I'm not going to go over all these, but so for example, for redefined condition bipolar disorder, for example, that used to be when I was in medical school, bipolar disorder was when you cycle between being depressed and being manic. Well, there's not a lot of people who really have classic bipolar disorder, so it's not a big enough market for the companies. They wanted a bigger market. So they essentially redefined bipolar disorder to mean cycling between depression and normalcy, which is what we used to call depression, whatever. So that would be an example of sort of redefining. So here's an example of an invented disease. We've been talking a lot about women's health, so we don't want the men to be left out. And by the way, just informed consent, you may have walked into this room thinking you were a healthy human, but you were going to go out with a disease. So here's one of the low T. Testosterone was sold to consumers through low T for physicians. You know, we don't, it's a little too informal a term, so it was called late onset hypogonadism in the way that it was sold to physicians and why you should test all your patients for a low T. And I've written a lot on this if people are interested, but they had these self-diagnosis things on the web. And, you know, they say things like, are you sad and or grumpy? Or have you noticed a recent deterioration in your ability to play sports? Sometimes that's put as, has your sports performance decreased in the last five years? Which, you know, I think would probably apply to anyone over say, I don't know, 20, 25, or some of them say, do you fall asleep after dinner? Well, yeah, how long after dinner? Do you have a lack of energy? Like, nobody actually thinks they have enough energy, so that's always like a really good thing to put on these, you know, these quizzes. Do you feel fatigued? Do you ever get headaches? You know, so these are, this is an example, like a test that you are meant, you are meant to fail. I have this disease, binge eating disorder. So binge eating certainly can be a sign of depression, obsessive compulsive disorder. I mean, binge eating can be problematic like starts eating frozen hot dogs out of their freezer or whatever. That's definitely a problem. But is it a separate disease? Well, the company that sells a vivance, which is an addictive amphetamine, needed a new indication after the patent started to run out on their drug for treating attention deficit disorder. So they created this disease, binge eating disorder. And this is defined as regularly eating far more food than most people would in a similar time period under similar circumstances. I mean, just last night I convinced Matt and Sharon to order all of the desserts at Elliott and Vine because I wanted to taste all of them. You know how people are like, let's order one dessert and let's all share it. And I'm like, no, let's order three desserts and share them. Anyway, so I think I qualify. I don't know what else has to happen more than it has to take place at least once a week. How about three times a day? I mean, some of us just eat more than other people. That's okay. But anyway, but no, now I have a disease. Or I accidentally cut off the top of this. But this is a disease pseudobulver affect. Now, this is actually, this is a neurologic disease. Sometimes when people have a lesion in a particular part of their brain, they suddenly start laughing or crying for no reason. And it's not actually connected to an emotion that they're feeling. Really rare. Okay? There's not a lot of people who are going to be eligible for the drug that's been developed for binge eating disorder, which by the way is really just an over-the-counter cough medicine, but whatever. It's going to be an expensive pharmaceutical. You're talking about this one, the binge eating one? No, no, this is the pseudobulver affect. Yeah, I just accidentally cut off the heading. It says pseudobulver affect. Okay, but here, but there is a test on the web that you can take to see, so they wanted to expand the market. So there is a test on the web that you can take to see if you have pseudobulver affect. Others have told me that I seem to become amused very easily or that I seem to become amused about things that really aren't funny. I find that even when I try to control my laughter, I'm often unable to do so. I'm hearing laughter. Or I find that even when I try to control my crying, I'm often unable to do so. So Sharon and I were talking this morning, we're like, wait, isn't that kind of like the definition of laughing or crying? It's really something you necessarily control. There are times when I won't be thinking of anything happy or funny at all, but then I'll suddenly be overcome by funny or happy thoughts. So now we're beyond funny, right? You ever suddenly have happy thoughts? You might be ill. So I've given this test to a bunch of people. I find that almost all women fail it and about 70% of men. So this is like, you might need to go ask your doctor whether you have PBA for short, Pseudo-Vulver-Afric. I think you're... So there have been a lot of surveys to see how many groups are funded by the pharmaceutical industry and they tend to range from maybe 30% of all patient advocacy groups to 70%. It's really hard to get an exact figure, but there are lots of them. There was a... It's just a sample. There was an article that just came out in the medical press a couple of days ago saying there were, what was it, 78,000, do we have that figure? Yeah, I think it was 7,600, more than 7,000, almost 8,000 groups just in the U.S. Patient advocacy groups. 7,865. And widespread funding of, you know, they did a survey and they found, you know, a lot of these groups were funded by pharma companies. May I would argue that it's not so important to know what proportion are funded but which important groups are being funded by pharma because not every patient advocacy group is going to have an impact on policy. Yeah, one of the big ones. Yeah, so we made up lists of the groups we knew of in Canada and the U.S. The patient or health advocacy groups don't take pharma funding and there are a number of groups that have taken a position that they will not take pharma funding. So these are the ones we could think of in the United States and in Canada. You may never have heard of these groups because they tend to work on a lower budget. They don't have the same kind of profile. They may or may not be consulted by the FDA or Health Canada on issues. But the thing is that they get drowned out by these many groups now that are pharma funded. And so the message tends to be skewed, these groups that are concerned about safety and messaging that is in line with the research that are concerned about rapid approvals that they may not be... A lot of those drugs are having to be withdrawn, the ones that are approved very quickly because there's supposedly a great need for them. It turns out they have safety issues that are not immediately apparent. So you don't hear that line very often from patient groups. Yeah, and I want to say, these are just samples of the 7,865 groups in the U.S. that are not counting Canada. These are all the groups that we think exist. So we're talking 7,685 to 8. And maybe we missed one. This isn't just what we came out of our head. We've actually asked other people, do you know of any other groups? And this is all anyone can come up with. So maybe we've missed one or two, but we're talking under 10 in each country. And as Sharon said, not necessarily that popular. So there's been a fair bit of debate within the groups about pharma funding, whether it's beneficial to patients or not. This was a good pairing of two articles that was published in the BMJ in 2007. And it brings out the arguments that groups on both sides make quite effectively. And the BMJ has been very good in following conflict of interest issues. Although I would say, I mean, this was a cover story that they ran a couple of years ago about patient groups. And the fact that it's often not apparent whether a group is taking pharma money or not. So there's a transparency issue. We think the transparency issue has been overplayed, but that was a theme in this article. Because... Carl. Yes, as Carl Elliott likes to say, if you're married and you're having an affair, does it solve the problem to come home and say to your partner, honey, I'm having an affair. That's disclosure. It's transparency. It's transparency. Does it solve the problem? So we think you have to go further to... Once you have the transparency, which is essential, it's necessary, then you have to look to see whether there's an effect. What the effects are. Transparency is necessary, but not sufficient. Yeah, so... Canada has done some sort of sporadic made efforts to include patient representatives in the drug approval process, but there's a very good article by a Saskatchewan lawyer. Well, we mentioned this before, Barbara von Tegerstrom, about how really it's the United States and Europe that have made a systematic attempt to include patient representatives in the drug approval process. It's proven quite difficult to do. There's just all kinds of reasons why it... Well, we've talked about some of them. Who does this particular patient represent in the end? How typical or how representative are their concerns? Are they conflicted by conflicts of funding? There are just a lot of questions about how you go about selecting these patients and what weight you put on the concerns that they raise. Canada hasn't done this very often. There are a couple of efforts that they made. I think it was in 2006 with breast implants and cox two inhibitors. With the breast implants, there were, I think, seven patients that came to the public hearing. They were asked to fill out, you know, to disclose whether or not they had funding from one of the breast implant companies. And I think all seven had been flown in by the companies. I'm not absolutely sure I'm trying to verify that through Access to Information Act because it's one of those things that got lost in history. And in both countries at these regulatory hearings, advocates may be asked to disclose, but they're not required. It doesn't prevent you from testifying if you don't. So at the full banter in hearings, the female viagra here at the advisory committee, at the FDA advisory committee, everybody was asked to disclose. And this is what every person who was flown in by the company said. I have no financial interest in the outcome of this meeting, which, of course, totally doesn't say anything about whether you were paid to be there, right, or whether your expenses were paid to be there. But you're not even required to say that. You are not required. You are requested politely to disclose. So even that low level, we don't think transparency is enough, but even that low level of transparency is not required. And when, well, there's a group that I've been involved with, Women in Health Protection, which has been defunded and doesn't really exist anymore, but in the mid-2006 or 7, I think, we raise concerns with people we were meeting with Health Canada about the fact that there were, you know, they seemed to be consulting a lot with pharma funded groups and giving a lot of weight to their points of view. And they came up with this thing called the voluntary, the VSI, Voluntary Statement of Information, which is kind of a strange term for declaring your financial conflicts. But, you know, they said that it's completely voluntary, whether you fill it out. And if you do fill it out and say you have some conflicts, that doesn't have to be disclosed. You can request that be kept between you and the government. And it also doesn't preclude you being, you know, part of the process. We want to make sure we have time for questions and answers and comments. So we're going to wrap up pretty quickly. Okay. Yeah, we think there needs to be more awareness and discussion of these issues. And it has started to hit the headlines in the states, I think because of a couple of the cases that Adrian has gone over. There's started to be news reports. Transparency is important, but we need to understand that it's not the answer. And there needs to be funding for groups that are not taking pharma money. In Canada, we could go back to this tradition of government support. In Germany, they have a model where health insurers pay a small percentage per year per individual insured that then can go into, it goes into a pot and health consumer groups that aren't taking money from pharma can apply for money from this pot. Or another idea that's been floated is you have some kind of independent body that could get money from multiple sources, whether it's government, private, whatever. And then there'd be a system for applying for that money. The groups do need money and there is a problem with them not having, there's no real source they can go to other than pharma. Yeah, so, oh, so that's, yeah, a recommendation. One is to make money available, restrict the participation of indecisions regarding drugs and medical devices to the independent groups. And if you want to testify on these committees, we think you should not be getting money from the industry. And there needs to be some kind of regulation or oversight because the way it is now, I mean, patient groups can make these claims like such and such a drug is potentially life-saving when it's pretty clear that it's not. And there's nobody monitoring that. And then these quotes can end up in the media and it kind of disseminates this misunderstanding, which, again, the drug companies can't make those kinds of remarks. So it seems to me there's a need for some kind of, I don't know how you would put it in place, but maybe the lawyers in the room could suggest what might work. And I just wanted to mention that Farmed Out is holding a conference at Georgetown in June. I'd like to invite all of you to. And I think it's $25 for students and it's more for non-students. But we're going to actually be doing a lot on this subject of consumer advocacy groups and Sharon's going to be one of our speakers. We're doing a lot on drug costs. We're doing things on opioids. It's going to be really great. It's a really fun conference. So I just wanted to invite you. And also I just wanted to mention Sharon's book that will be coming out soon, at least if she ever finishes writing it. No, actually that's not, I shouldn't, that's a little unfair. It's going through very extensive legal vetting. So she is having to rewrite a lot. So even though she's way more moderate than I am, apparently she's not quite moderate enough for the lawyers. So as soon as that process is finished, it's going to be really great. And yeah, I have some forms that people want to order it in the next 10 days. You can get 20% off. But it's not coming out till July. So I think we're going to end there. Thank you very much. Questions, comments? I really enjoyed that. And I'm very happy you mentioned Valiant Pharmaceuticals because they're like, it's like a clown show. And no, they published the, you know, the Pearson, the guy who received the old evidence. We made $108 million last year. And the stock is tanking. And they buy bad drugs. And this is what we call the pharmaceutical industry in Canada. They are, you know, they're the biggest drug in the universe. And I'm basically holding up to the version of London again. We just ended a time away. And I was, like, just out of the cold of nothing else. I was doing other research this week. And I went down my old, I found Harry Frankfurt. I don't know if that made him, but he's professor emeritus philosophy at Princeton right now. And he's still doing well. And his seminal paper is just called On Bullshit. And he brought the word bullshit into public discourse because basically that's what you've been talking about all morning is bullshit. In fact, because it's an academic word now, I can say it. It was hard to hear it. I said, look, it's academically acceptable. It's the highest I need level you can find. And you're talking about fake news. And I understand our American residents themselves are changing their government this morning or something like that. Yeah, don't mind me. And all this fake news. You're talking about the firewood version of fake news which the Russians used in the Crimea to change things. Look at all the Western citizens this year. It's just a general vibe of fake news coming from huge piles of money somewhere in the clouds where those people sit on top of those things. So I'd just like to thank you for a very entertaining presentation. Oh, thank you. Yep, thanks. I'm a social worker and I've worked for ten years as a pharmacist now for a year. So I worked at the cancer center for helping patients for the funding for very expensive treatments. Sometimes we would market. All was post-cruel. I was at the intersection between pharma patients, patient groups, funders, business insurance, pharmacists. And it's a little different in Canada. I had an interesting window on all of this that you're talking about. And it is a little deeper than just that pharma is one of the most vulnerable patient groups. There is a patient in Canada who has a lot of people who are in mental wonders whether they should fund a drug or not. They do have a formal process that patient groups still do. Both to say whether a drug should be funded but what is the value of this drug to them. What are the side effects they should be doing and what is the effect of what they should be doing. And that is terrible to me. But my worry is with the expansion of the Canada we have had a process for patient groups and what that might mean for some of this deep capture type of approach. Because the way I see it happen now is not so much a here's something we have some funding for you if you have a need, let us know. That does happen. You mean with the drug companies? The drug companies, okay. And in that building a relationship where it's not so much the benefits of the drug it's the positive brand of the company. The caring company, the company that will and many people do care in the industry. They don't see right. No, for sure. But the overall drivers profit and the way it is framed is around the brand and that relationship. But I also see from the patient group side we right now live in a society that's based on demand. Patients want drugs and they want them now. As soon as those drugs are approved they want access to them but we have longer and longer delays to when funders actually will fund them. So the pressure actually is not in the approval stage as much. Yeah. Approval action happens for a long time. That takes a while, one to two years but it happens. It's the approval of funding piece where I see a lot of that pressure being put forth. They don't really have a question. It's more of a comment that I think we can easily get into it either or one's bad and there's not a type of approach. But really I've seen patient groups approach start now and say we'll load that for your product if you can help us. We have a need. Have you seen them say your drug is too expensive why don't you bring down the costs and maybe it'll go more quickly under the formularity? Yeah, that's a whole other process. That's more of their lecture. Yeah. But yeah, there's the... Really a lot of this is based by... The way I see it is this is very much fueled by our society today that wants a quick fix, wants an answer, wants that next best thing and it gets talked about on social media and volumetric proportion not always fed by the media that's coming from pharma but sometimes the patients group themselves and people talking. Oh yeah. But I would argue that this course is very much affected by pharma and the things that advocacy groups used to demand have changed that one of the things that pharma funding buys from groups is silence and I'm quoting Sharon here. Why should I quote you? Go on about that. Oh, well that was what I was raising with the pricing. The pricing has just become a huge issue in the policy field and among physicians and you don't hear the patient groups talking about, protesting it. They may be... When I interviewed people they'd say, well we talk about those things to the company representatives when we're meeting with them but they don't come out publicly and say, we think this drug is too expensive. Yeah, and I would say... Are you saying some of them do? But it's not just pricing either. It's like silence on issues of other things that should be looked at and things in the doctor-patient relationship and the fact that drugs that are already out there or in the process might be too harmful or might not be effective enough. They're not holding the company's feet to the fire and when they do, they are punished and I know this more from the influencing the physician's angle than patient advocacy groups but for example I was giving a farmed out talk at a hospital in Albuquerque and it was funded... It was a cardiology for primary care practitioner's conference that was funded by Pfizer and I guess they hadn't known either that I was going to be speaking or what I was going to say but I said, I talked about a lot of these covert and overt marketing techniques and Pfizer withdrew its funding from the conference and also by the way all of the drug companies that had booths packed their booths and left in response to my talk so this is supposed to be... that conference is supposed to be funded by an unrestricted educational grant it's unrestricted as long as you don't say something they don't like and that also holds true advocacy groups and regulations around that I'm not defending one or the other I'm just saying there's a lot more in this conversation and on this issue there's also in Canada what we're seeing now is we're seeing the creation of broader based patient organizations that aren't disease specific that talk about things like drug access and those are the organizations where I really question who's behind it like Best Medicines Coalition and you know now I'm in the front end for RG but there's other organizations that are driving the access you're talking about the reverse incentives and then you suggest that government funding would be a solution but doesn't government also from time to time act on reverse incentives? it can, yeah to take for cheap medicines that a lot of people need that may be worthless and not pay for a few expensive medicines that may be valuable for someone so how do you get around the reverse incentives regardless of the fund you're in? and that is something actually that the patient groups taking pharma funding will say well any source of funding is going to provide an influence I think your idea of having a group that's independent collecting money to divert sources but government won't participate in the same way that pharma won't participate that's part of the point I wanted to make about how we've evolved a different culture within government now government very much when they give money to a group they expect the group to be on side with government policy whereas it used to be it was viewed as helpful to government to hear critique and that culture is gone so I don't know whether we can recreate it I mean from time to time Trudeau says things like it's good to have dissent I mean I'm hoping that he'll continue that and I would also argue that it's really in government's business in interest to promote public health and that is a different incentive than profit Thank you Thank you very much it's very informative especially from historical perspective so I didn't know that so many patient groups are paid by the government but I wonder why to any example that they're actually very smart and then quite so it looks like your story is that in a pharma once you get the money it's just then they influence you whatever you think and you don't think you're thinking but you're actually influencing you and it's so difficult and maybe it's so dangerous so stay on it so that seems to be the picture again but is it the entire story so isn't there some group that is very clever and try to manipulate back or something like that so it's not just like they're vulnerable but is there any example that when you saw it like you might be doing something interesting that's taking pharma money but is also doing good National Breast Cancer Coalition yeah I think that's a big breast cancer group in the United States that's run by a very savvy group of women and they do take pharma money I don't quite understand why they take pharma money but they do but they do really good work a lot of the groups do good work in the sense of support but we would still say that some of their views are affected by the money that they take and some of their silences are affected by the money that they take and I think there are also examples in the AIDS community people I didn't study the AIDS community but I talked to various people who've been active in it over the years and they feel that the critical voice within the AIDS community has dissipated the more recent activists are not as critical or politicized as the earlier ones were but I think there has been this kind of love-hate culture within the AIDS community yeah and I just wanted to mention you might be interested in an article that I wrote with some former students called former marketing people with hemophilia hemophilia is really it's a very interesting area where pharmaceutical companies that make the factor that people with hemophilia need actually target individuals because a person with severe hemophilia can use between a hundred thousand dollars and a million dollars worth of factor a year so each person is controlling market share and each person has drug reps assigned to them by every company possibly at birth and they fund the groups and there have been questions raised about whether the slowness of the national group to respond to the tainted blood crisis when in the 1980s when many people with hemophilia died from HIV tainted blood whether their slowness to respond was because of the amount of money that they're taking but this is a discussion that's really going on in that community now because of this article that we wrote but anyway there's a fair number of examples and things in that article it's freely available on PLOS medicine thank you there's one last question thank you our speakers but just before I do that I wanted to just bring to everyone's attention our next seminar it's on February 10th and everyone has seen the asylum history and reconciliation in mental health and that will be delivered by Professor Erica Dick at the University of Saskatchewan who will be visiting us here at Dow and just an additional reminder that if you're interested in sharing work in particular and potentially acquire in her book there's those copies that you can secure a discount through up front if you'd like to grab one of those but most importantly I'd just like to thank our speakers again for the really enlightening talk I think many of us might walk out of here wondering about whether certain conditions that we may have been done I don't think they're actually real I don't think they were alerted to that kind of concern going forward and that's certainly a service for us all but also sort of laying on the table the very hard work of advocacy and how sort of complex that is and so thank you again for a really wonderful seminar today