 David Gorski is going to be our first person doing our why we fight part one why we fight part one Stanislaw Brzezinski versus science-based medicine David Gorski is Academic surgeon at Wayne State University School of Medicine. Here's your haiku why we fight is clear Here's part one to tell you why stay tuned for part two. Please welcome David Gorski Hello All right, the title is why we fight and I hope the reason will become obvious as we go on now for those of you Who don't know who I am. I'm the Managing editor of science-based medicine blog with Steve Novella Harriet Hall and the rest of the crew Thank you So let's get started I'm we're gonna start we decided to do this in two parts, and I'm gonna do the medicine and science mainly not exclusively but mainly and Bob will do the Patience now. This is this is a man named Stanislaw Brzezinski the theme of this year's Tam is fighting the fakers now some fakers are easy to tell homeopaths Halda Clark, I don't know how many of you know who Halda Clark was But some are not quite as obvious and in fact, this is a guy who sometimes fools even you know Physicians and he kind of skirts the edges of science-based medicine versus, you know pseudo science so I Thought we would talk about him and he could be a lead-in to the panel so Some of you may have seen this movie or seen of heard of it Some of you may have gone to screenings of the sequel to this movie which just came out a month and a half ago It's a movie called well Brzezinski the movie a great great You know great originality there and the sequel is appropriately enough called part two The first part basically paints Brzezinski is this brave maverick cancer doctor who's curing cancer patients But the man as in the government FDA Texas Medical Board big pharma our reptilian overlords are Keeping him down Part two is more of the same with one exception There is a long segment about the skeptics and And it's it and it really isn't scare quotes and capitalized if you look in the movie I'm not kidding. In fact, it's on Mercola comm for free and if you really want to see a bit of propaganda and see Sort of why we fight and why this can even be convincing to skeptics sometimes take a look, but in any case Not They've also the man who made this film Eric Marola has also been known to attack Skeptics online. So for instance, you can see that I've been called a white supremacist But that's not bad enough I also apparently like to eat puppies Now he took these tweets down in all fairness because I think you they embarrassed even him But there's plenty more where that came from that are almost as bad I must confess though. I haven't quite reached Steve's level of awesomeness and I can't resist this slide Because about three or four years ago Steve novella and you'll see Steve novella Paul Offit and Trini Sideris who's a journalist Being portrayed at a nice Thanksgiving feast now for those of you in the back You probably can't see what is the Thanksgiving feast. It's a baby So Steve's been portrayed as a baby eating cannibal Really you need to up my game But let's get to Brzezinski. He's been promoted in books. There's a whole chapter about him Suzanne Summers book His lawyer Richard Jaffe wrote a book about a half of it is about Brzezinski and a columnist named Thomas Elias wrote a book called the Brzezinski breakthrough which basically is more of the same I do like this part though Yes, if you can't read you may not be able to read it, but it basically says includes clinical trial data I always thought that a medical journal is a place for clinical trial data But that's just me Let's go way back. This is a long time and this is hard. This was really hard to synthesize in just 20 minutes Back to his Baylor years and 90 he arrived in the United States from Poland where he had been born during World War two And he went to medical school in Poland and in 1970 he decided to come to the US because according to him He would have either had to join the army or do whatever the Communist Party told him to do So he says he arrives with 20 bucks in his pocket, I have no reason to disbelieve that but his You know his His pro he showed up and he got a job at Baylor and he actually was during these years. It wasn't bad He was actually a reasonable scientist. He published. He even got an NIH grant But then later in that tenure something seemed to happen But first let's talk about his discovery He called it anti-neoplastons the idea was to him and he's clean He said he first made this observation in Poland as part of his thesis project that there are Substances in the blood amino acids and peptides that are at higher levels in normal people than patients with cancer And he thought that a deficiency in these somehow had something to do with the development of cancer Not unreasonable Might have even been right But it's the problem is what he ended up doing with it So he basically fractionated urine and blood and he originally found 39 fractions And it ballooned the more he fractionated the more he found these things that seem to have anti-cancer activity But the two that you need to know about is as 2.1 Which is a chemical called phenyl acetic acid, which is a byproduct of metabolism that's turned into phenyl acetyl glutamine by the liver and Soluble a-10 is basically the same thing it breaks down to PAG and these are Substances that were actually studied in the 50s and 60s and not found to be particularly Promising but that he didn't know that then Now here's where things start to go off the rails Back in 76 or so. He thought he was ready to test anti-neoplastons in humans Great, right? I mean part of the problem though is So he went to a Baylor's IRB for those of you that don't know and IRB is an institutional review board It's the ethics panel that you know looks at human research to make sure that the patients are protected and According to Elias and Jaffe he didn't he was rejected because he didn't have an IND and IND is just basically an Investigational new drug application and the FDA requires that before you can do a clinical trial That shouldn't be too big of a deal just to apply for that I mean there are a lot of things going on at this time He didn't want to share With Baylor and you know when you work for a university and to discover something usually the university takes the rights And you just get a cut But I also reading between the lines that tend to think there was probably also a lack of preclinical evidence There was an astounding at a lack of animal work, which he dismissed as by saying that anti-neoplastons were species specific There are ways of getting around that And think about it. He didn't know what they were then they were fractions from urine You probably should purify them more and figure out what what's in them before you start giving them to humans So he actually went out on his own now He had actually started treating patients according to both Elias and Jaffe before he left Baylor And Baylor didn't like that for reasons that should be obvious. He treated patients in a private clinic So he left Baylor He also lost his NIH grant around this time too and he started out in a relatively small storefront But I'm sorry office, but he it was not very long before he had built up this really amazing Institute and clinic I mean this this this version you know the clinic in the lower left-hand corner is his clinic and Those other pictures are pictures of his manufacturing facility where he now synthesizes anti-neoplastons. It's actually pretty amazing now Around this time he started to get some publicity and One place where you got national publicity for a very perhaps the first time was that fine medical journal penthouse By an art an article by a guy by the name of Gary Null. How many people know who Gary Null is? he's You know, he's very big in the alternative industry, and I think he was just a a young a young quack starting out in my opinion And it was an article called the suppression of cancer cures and Stanislav Brzezinski was portrayed as The brave maverick doctor who was curing cancer even though the man was keeping him down and Baylor kicked him out Remember this was just two years after he left Baylor So and around this time he became known as the urine doctor for some obvious reasons it took leaders of urine leaders upon leaders upon leaders of urine to make this stuff and Early on before he used to get him from blood and in fact He was kind of not the greatest party guest in the world because he'd show up with blood drawing equipment and try to get People to let him draw their blood so that he could isolate anti-neoplastons He didn't get invited to too many parties pretty quickly And people started to kind of avoid him But He then went to prisons public parks and One of my favorite sources of all Gillies bar now this was at the height of the urban cowboy craze and One has to wonder if perhaps John Travolta contributed his own little small way to you know to anti-neoplaston research Now ethics were the big problem here was research ethics from the very beginning and It continued. He's been visited by the FBA visited. He's been investigated by the FDA a couple of times In the last 13 years and there are a bunch of problems And I'm not going to go through all of these but some of them not reporting adverse events That's a real no-no in clinical research Failure to follow proper informed consent procedures research approved without determining whether the risk to subject was minimized and One thing I can't figure out how he gets away with is an old buddy of his from Baylor is The is the chair of his IRB He's also the chair of the he's the chairman of the board of directors of the Brzezinski Research Institute Imagine if a pharmaceutical company did that Okay Over the next 15 years the story continued Battle after battle with various regulatory agencies including the Texas Medical Board The National Cancer Institute isn't a regulatory agency, but it tried to work with him in the 90s to see if there was anything to this stuff and it Never quite worked out. I think a lot of it was Brzezinski's ego A lot of it was also that every time they tried to bring You know safety and they wanted to lower the dose to make sure it was a safe dose that Brzezinski would resist and it You know basically things broke down the FDA of course Etna and other insurance companies Patients were trying to get these paid for by insurance. So this caused a problem And in late 1995 he was indicted by a federal grand jury for insurance fraud Transport you know shipping unapproved drugs over state lines administering unapproved drugs In a variety of other charges The trial was in 1997 early 1997 He beat the rap. Okay. He it was a hung jury and Some of the reason may have been at least his powerful allies remember Joe Barton. We just heard about Joe Barton Before he became a climate denier he was helping Brzezinski and He in 1996 he held hearings where he brought patients Brzezinski to tell their stories in front of Congress and They you know remember these patients honestly believed that Brzezinski was their only hope to live or the only hope for their family member So it was like they were crying they were like they were afraid they were gonna die because they were gonna shut down Brzezinski It was very effective political theater Dan Burton who is fortunately no longer in Congress and of course the patients They were probably his most effective tool. Oh, he had one other I don't know if you can call him an ally But I love this picture, so I'm just gonna show it for a second He met the Pope There was there were rumors that he was treating the Pope, but they they turn out not to be true So what about all these clinical trials right now if you go to clinical trials gov? There are 61 clinical trials under Brzezinski's name If you you can't read it, but most of those if you see them they show either Closed or unknown status, but you say okay. He had 61 clinical trials. This must be science, right? Oh, they wouldn't let him do this otherwise would they? I'm not so sure The reason these clinical trials exist it turns out is a 1998 consent agreement between the Texas Attorney General and Brzezinski that tells him he could not distribute unapproved drugs in Texas He can only use anti-neoplastons if it's part of an FDA approved clinical trial Unless the FDA approves it obviously and he can't advertise them for the treatment of cancer You know it goes on there were some other conditions, but that's the gist of it so Before this though, they had been very smart Let you know you listen to Brzezinski's lawyer and and I swear I don't understand like why Brzezinski would let him let his lawyer say stuff this damning in his own book But he does so get a load of some of these quotes Referring to one of the clinical trials. He said it was a joke There could not be any possibility of meaningful data coming out of the so-called clinical trial It was all an artifice that you know designed so that they could keep giving the treatment The FDA wanted all of his patients to be on an IND. So that's what we did and There was someone and they went beyond this Realizing this that a cancer clinic cannot survive on existing patients It needs a constant flow of new patients again. Imagine if something like I said that about my cancer Institute They'd be all over me But in any case Brzezinski personally put together 72 protocols to treat every type of cancer the clinic had treated Everything Brzezinski wanted to treat in the future All of Brzezinski's patients are now on FDA approved clinical trials. He could treat anyone. He wanted to treat Oh and charge tens of thousands of dollars to hundreds of thousands of dollars to do it So let's look at the clinical trial record So it's of these 61 clinical trials How many of them how many completed trials have been published you know completed trials in the peer reviewed literature Zero You know now here. Here's here's what he does have though and he has a lot of these He has testimonials and I've done whole talks on evaluating cancer testimonials But if you boil it down to the main points, there are a couple of rules Dead patients don't give testimonials You can't argue with that there are always outliers Who do better than expected and sometimes? Rarely but not impossible. They're spontaneous remissions. Now you ask you have to ask some questions about these testimonials Was the cancer there? This is not always easy to tell when you look at the testimonials It really isn't you might think this is a really basic question, but it's not always easy to answer Did it go away? This is also not always easy to answer Was the treatment the only one used? Sometimes these cancers actually do get better or go away because of the conventional therapy that was given and then Alternative therapy came later Again, I could go through a whole bunch of patients, but we just don't have time so I picked one This is a patient. This is a teenager by the name of Tori Marino She was born in 1998 and she was diagnosed with a inoperable brainstem glioma within weeks of being born and This is her on high-dose steroids. So that's why she looks looks That way and the bottom is her page her page on the brzezinski patient group page where she is now, you know Apparently healthy 15 year old So she was treated by brzezinski and she seems to have gotten better So what happened? well, you have to look at two possibilities one possibility is the story is as advertised you can't deny that's possible or Another possibility it turns out she never got a biopsy now This is not an unreasonable approach and most a lot of brain tumors don't get biopsied because brain biopsies are invasive Dangerous procedures, and if they're not going to make a difference in the treatment. It's no reason to do it Here's the problem Okay, there are occasional false positives things that show up on MRI that look for all the world like a glioma and turn out to be something different inflammatory masses Various other things It's not real common. Maybe five percent tops, but it happens And what about anti-neoplastons here's their advertises being a natural non-toxic treatment Well, not so much. They're very sodium rich and The freak a frequent complication is hypernatremia and in fact the Texas Children's Hospital Which is not too far from the brzezinski clinic The director of the ICU there the pediatric ICU is is quite familiar with brzezinski patients showing up with hypernatremia Life-threatening sometimes Other lesser ones there's rashes now that these are photos that I took that that screen captures of Hannah Bradley who's Partner filmed her Journey she's a young woman with a with a brain tumor who went to brzezinski clinic She had all sorts of miserable complications And there have been occasional deaths and in fact right now the brzezinski clinic is it has a temporary clinical hold Placed on anti-neoplastons. It cannot Enroll new patients on anti-neoplastons, although it can keep treating the ones that already are there So what you got to remember and and this is a picture to kind of demonstrate that is that anti-neoplastons are chemotherapy? If they work their chemotherapy if they don't work their ineffective chemotherapy Last thing Lately over the last five years or so brzezinski is kind of his Gotten into what he calls personalized gene targeted therapy This I you know And here's the how it's sold and this is Eric Marola again He's saying don't tell MD Anderson that they're they're following his brzezinski's lead and The link here is to the present is to the MD Anderson personalized gene target, you know personalized cancer therapy page as if MD he thought of the idea and MD Anderson is following his lead and that you see this time and time again on brzezinski sites This is not what he this is what he does. He uses a commercial gene test from Keras Technology that anyone can order. There's nothing unique about it if they do various tests They do some next-generation sequencing. They produce a list of genes that are overexpressed and They suggest targeted therapies. He makes up a bunch of target He picks a bunch of targeted therapies gives them to the patient without regard for whether there's synergistic toxicity and boom. There you go. I call it Gene targeted therapy for dummies because it's really not anything unique or anything innovative So let's finish with a question before Bob comes out quack or not He's had 36 years to prove that his treatment works. Is he a quack? It's It's it's not it's it's it's difficult and we can talk about that a little on the panel in the meantime I will thank you Ask you to go to science-based medicine and follow us on Twitter and let Bob come out and finish the story Dave Gorski David Gorski part one is done