Gorski explains why Burzynski’s urine-derived antineoplaston therapy is worthless; how the doctor strong-armed the FDA into letting him peddle these expensive and potentially dangerous drugs for over 30 years; and how the treatment may have killed a little girl. Gorski also discusses Blaskiewicz’s report on skeptical activists who banded together online to warn the public about Burzynski’s quackery and push back against his attempts to silence his critics.
Links Mentioned in this Episode
- Archive of David Gorski's posts on Stanislaw Burzynski
- Liz Sabo, "Doctor Accused of Selling False Hope to Families," USA Today: Jan 8, 2014.
This is point of inquiry for Monday, March 17th, 2014.
Hello and welcome to Point of Inquiry. A production of a center for inquiry. I’m your host, Lindsay Beyerstein. And my guest today is Dr. Dave Gorski.
Cancer researcher, surgeon and managing editor of a science based medicine blog. He’s here today to talk about two important stories in the latest issue of the Skeptical Inquirer exposing the notorious anticancer quack’s, Dennis La Brezinski. The first story by Dave explains how the Houston doctor strong arm the FDA into letting him give medically worthless urine derived chemotherapy to desperately ill patients for over 30 years under the guise of clinical trials. Possibly killing children. The second piece by Bob Blasco Wittes describes how skeptical activists banded together online to expose Brzezinski’s quackery to the general public and how they pushed back against the doctor’s attempts to intimidate his critics with lawsuits and smear tactics. Dave, welcome to the program. Tell us, who is Dennis Leper’s in ski and what does he claim to be able to do?
Well, Dr. Brzezinski is a doctor who is currently located in Houston. He claims to have discovered these come anticancer compounds in the body is part of the body’s natural resistance against cancer, which he claims to have isolated. And now he uses them to treat cancer among among his claims or that he can. He has better results, considerably better results with what? Our lethal brain tumors for which conventional medicine has relatively little to offer. And as a result, he had had patients from all over the world flocking to Houston over the last 30 some odd years to receive these compounds, cure, which he dubbed Antineoplaston.
And how good is the evidence supporting the efficacy of Antineoplaston as a cancer therapy? What does he bring to back up these these fantastic claims?
Unfortunately not. Not a lot.
There are some you know, he has some cell culture studies. There were some issues early on where there was not. There is really little activity seen in animal experiments, which he explained away by saying that antineoplaston or species specific. There are a lot of anecdotes. He has had a lot of clinical trials, none of which he has published the complete result of. And in fact, only one of which is actually completed. So that is, you know, there’s just not much, if any evidence.
And if you look at it from from a basic science standpoint, there’s not a lot of plausibility to it either.
What’s implausible about it?
Well, I mean, basically, Antineoplaston funds are a mixture of two chemicals that are normal product of metabolism’s, fennel, acid, two glutamine and fennel acetate, which we call the final acid PPA and the central acetyl glutamine, THG. And these have been actually tested on and off before, since the 1950s. And they don’t really have. They’ve never really shown much promise other than in Brzezinski’s hand or at least his client. That’s his claim. These are peptides. And while it’s not implausible that there are anti cancer compounds made by the body, in fact, we know that there are as one of my scientific heroes, Judah Folkman, showed back in the 90s when he discovered in dodginess and thanes eugenic peptides that these are among these compounds is is pretty implausible. And unfortunately, there’s not really any good evidence to back up the concept that they are.
Where did Brezinski find these compounds?
He isolated them from blood and urine back in the 70s. I mean, basically, I mean, he started out with a fairly reasonable and innovative idea, which was that there are these compounds in the blood that can that keep cancer under check and that people who get cancer tend to have lower levels of these. You know, it’s not a bad idea, especially for the 1960s and 70s, though. So what he did is he he basically fractionated blood and tested these fractions against various cancer cells and claimed to finance the cancer activity in them.
You know, he was very vigorous in procuring this urine, wasn’t he?
You know, this this this wasn’t much of an issue until he decided to start treating patients because, you know, to make enough for cell culture doesn’t require that much. But if you’re going to treat patients. When he started treating patients with it, it took something like 30 liters to treat a thing. You know, they treat a single patient. And so he set up it back in the late 70s, early 80s, he was known for having set up collection stations and prisons and various other places. And even according to one of these, one of his biographers at Gilley’s Bar, or Urban Cowboy, was filmed in the early 80s.
He figured out how to synthesize them and he hasn’t really used urine for 30 years for to make these.
Do they have side effects, anti-nuclear stance?
Well, the biggest side effect that they have when he treats patients with them is he uses very high doses. And these these peptides are sodium salts and they have a lot of sodium in them. Quite a bit of sodium. So much so that hyper neutrino, which is elevated sodium levels, is the most common side effect. Although if you look at some of these patient reports and videos, you’ll find out that there are other side effects like rashes and even fevers and various other other potential side effects. But by far, the most common and dangerous is elevated sodium levels. Life threateningly elevated.
Brzezinski’s acquired something of a reputation for dumping these patients on local hospitals. Right.
There’s a nearby children’s hospital, Texas Children’s Hospital, where he has kind of a bad a bad reputation because children that he is treated, who are often from other states or even countries, they are not from the area, end up getting sick and come, you know, coming to the hospital, ending up in the ICU there. This was reported on a BBC documentary about him last year on Panorama that this happens not infrequently. And it’s it’s a really sad situation because, you know, I imagine these children are hundreds or even thousands of miles from home. I mean, some of them have come from the UK or Australia and suddenly they’re really sick.
And, you know, they’re in a hospital in a foreign country. You know, it’s just overall a bad situation.
Is there evidence that children or patients in general have died because of Brzezinski’s therapies?
Well, towards the end of last November of last year, Louise Abell of USA Today reported about Brezinski.
And in fact, identified a child who had died of hyper made treatment back in the summer of 2012. And in fact, it was that death that resulted in a partial clinical hold, Brzezinski’s clinical trial. You see, the way he is allowed to administer the an angioplasty is to patient to have all these clinical trials that he had set up. And he can’t really give give them outside of a clinical trial unless he gets this special exemption. But in any case, this child, who is six years old, had a brain tumor and had a sodium level over 200, which the normal is between 135 and 145.
So that is that’s also what spurred the FDA to investigate him last year.
So if the FDA stopped giving him the right to run clinical trials, would he be out of business in the United States?
Well, here’s what they. Here’s what the FDA did. The FDA put a hold on his clinical trials, which basically means that he could not enroll any new patients. It started out they first did it for children and then a few months later, they extended the clinical hold to adults. So as of now, Brezinski cannot enroll any new patients in clinical trials, but he can continue to treat the ones that he already has. Well, you know, the problem with that is these patients have stage four nasty tumors and are you know, they’re they’re going to die.
You know, a lot of them, most of them are going to die and eventually he’ll have no patients that he can give antineoplaston to. From what I’ve heard, although I don’t have evidence to back it up at the moment, because all these are reports, his patient volume does appear to be down.
He’s basically pivoted to giving something that he calls gene targeted cancer therapy. What’s that? Basically, he uses a commercial. I investigate this in 2011.
And I even actually before this was before they had decided that I was an enemy of the clinic and wouldn’t contact you, I wouldn’t reply to me anymore. They basically use you as a company, a basically a company that anyone can use to do genetic tests and immunohistochemistry, which is to, you know, to use antibodies sustained for various proteins on the patient’s tumor specimen and find out, you know, they get a report back on the various genetic abnormalities in the tumor. And then the idea is to come up with a cocktail of targeted therapies and chemotherapy to treat the tumor. The problem is. You know, this is a this is actually a really difficult problem to solve.
I mean, you may have heard about that Steve Jobs kind of did the same thing. He had a bunch. But he had a bunch of real scientists doing it.
And they were hard pressed to come up with a good plan, especially since when he did it. This was like at the very dawn of when people were doing this, you know, like a few years ago. This is very pretty recent stuff. In any case, the idea is you find various drug with a target, various abnormalities in cancer cells, you know, targeted therapies, and you mix them together and you give the patients these therapies. And the idea being that hopefully you can individualize the treatment.
It’s called sometimes called personalized medicine. Sometimes it’s called, you know, highly stratified medicine or various other names that it goes by.
Now, that pseudoscientific in itself, that approach.
Yes and no. M.D. Anderson and a lot of Cancer Institute two are very interested in personalized medicine. Gene, targeted therapies. The problem is figuring out how to do it and to do it right, which means clinical trials. And it also it’s also a challenge to existing clinical trial structure because, you know, in your existing clinical trial, you take one group of patients given one drug, you know, and another group of patients give them placebo, perhaps, although in cancer therapies, a group getting only placebo is rare. Most of the time, if you test the standard of care versus the standard of care plus the new drug. But in, you know, personalized therapy, each patient will presumably come up with a different set of recommendations. So how to test that and how to validate it? These are major challenges in oncology right now to think that Brezinski has solved them.
Where M.D. Anderson and Memorial Sloan Kettering and many other cancer centers have as yet not, is stretching believability a bit.
And he’s not doing clinical trials for this genetically targeted therapy. Right. He’s just now watching existing drugs and dictating that people should take them in certain combinations and cocktails according to his whims.
Exactly. And a lot of you know, a lot of these drugs, it’s not known what the you know, what the synergistic side effects might be when they’re mixed together. They’re very expensive. They are pharmaceutical drugs, which, you know, and there are. And because they’re new and targeted and, you know, the latest greatest thing, a lot of them, they’re not cheap. It it boggles my mind that Burzynski is somehow the hero of the, quote, unquote, natural medicine movement, because one antineoplaston, as far as I’m concerned, are chemotherapy. You know, they they they are their drugs given intravenous lead to treat cancer. And to this gene targeted therapy that he gives, even if you can convince yourself that somehow antineoplaston are more natural than chemotherapy. The gene targeted therapy is chemotherapy. You know, it’s a mixture of the idea of being he’d give low dose chemotherapy plus these targeted agents. Now, it’s not like like I said, it defies belief that he can do this right when it’s still experimental. And the biggest cancer center is the most respected cancer centers in the world. Haven’t yet practice not. And in fact, he’s very arrogant about it. He published an article a couple of years ago where he claimed to be a pioneer in targeted therapy and that. And in one of the movies about him, which, you know, which we’ve talked about before, he even you know, he claimed that he’s pioneered this stuff. And M.D. Anderson is now following his lead. You know, when when M.D. Anderson created it. It’s the latest Genetics Institute for Personalized Medicine.
A couple years back, three well-connected guy cutting to congressman. Can you tell us a bit about that?
Well, I don’t know how well connected he is now, but back in the 90s, he certainly was well connected, particularly Joe Barton, who was then is a very powerful representative here who’s chaired multiple committees in the House of Representatives. And in fact, Joe Barton was the one who in the 1990s held hearings on the FDA and used to routinely drag the FDA commissioner in front of his. Many and castigate him for harassing, you know, quote unquote, harassing Brezinski just because the FBI was actually trying to stop him from using this unapproved therapy that hadn’t at that had no real evidence or efficacy. I’m not sure how connected he is now, but he was definitely connected back in the day.
Did you see a lot of evidence of political influence peddling inside the FDA in your investigation in terms of why he keeps getting kept getting these bogus clinical trials?
This is a real tough one. And even, you know, I’ve actually even been in contact with Lizzie Laboe, who is USA Today reporter, who did the story two months ago. And I honestly don’t know and she doesn’t know either. It’s very, very hard to get information out of the FDA. I do know in the 1990s that the FDA was highly pressured by Joe Barton and his committee. And in fact, that’s part of the reason there are all these clinical trials back then. So it’s a long, kind of complicated issue that I can’t I can’t really explain briefly other than to say basically there is a lawsuit. There is a prosecution going on. And the judge ruled that if Brezinski, the Brezinski could give his antineoplaston, but only as part of a clinical trial. The FDA didn’t want to let him open any clinical trials. But the pressure from Barton in his committee led the FDA to buckle. And they said, OK, fine, we’ll consider your clinical trials. So basically, Brezinski deluged with about the like 70 some odd clinical trials that were basically very much the same, just different cancers. And just basically buried the FDA and in clinical trial applications for phase two trials.
And the FDA ended up approving most of them, pretty much all of them.
And it’s something that approving the trials, not around the clinical trials, it’s not the drug.
And in fact, by Brzezinski’s lawyer, even bragged about this in a book, which I tend to talk about in my article, where he you know, he basically said it was all an artifact, an artifice, a vehicle we and the FDA created to legally give patients Brzezinski’s treatment. The FDA wanted all of Brzezinski’s patients to be on an A&E.
And so that’s what we did. And A&E is an investigational new drug application. You know, it’s basically the permission that the FDA gives for you to test the drug.
We’ll be right back with more dirt on Brezinski. But first, I want to tell you about the third annual Women in Secularism conference sponsored by the Center for Inquiry. The folks who bring you point of inquiry, it’s all happening May 16th, the 18th in Alexandria, Virginia, right outside Washington, D.C. Women and secularism three will bring together some of the brightest and bravest, freethinking women in our movement to discuss the religious assault on women’s rights and women’s representation in secularism. Speakers include former Puli guests Rebecca Goldstein, Susan Jacoby and Katha Pollitt, as well as myself, your P.O. I co-host. We’ll also hear from funny woman Lindy West of Jezebel and many others to learn more about this exciting event. Go to women in secularism, dawg. That’s women in secularism, dawg.
Are there other pseudo scientists out there who are using this loophole, pressuring the FDA to give them unlimited clinical trials so they can keep prescribing dubious drugs?
If there is, I’ve never come across one. He he did Brzezinski appears to be unique in this.
So he is an innovator in one sense. Oh, he’s an innovator and a lot of sense. I think, unfortunately, most of them not good.
So, yeah, it’s it’s amazing that he’s managed to. Do what he’s done and I still. Marvel that he’s still practicing. I mean, he’s still doing what he’s been doing.
And it’s like, you know, thirty seven years later, pretty much close to it.
He’s run into some snags with the Texas Medical Board over the years, right?
Yes. And in fact, I think he I think they’re taking another look at him this year.
The problem with the Texas Medical Board, I think from my from my perspective, it would be hard to imagine a state that would be more friendly to someone like Brezinski, because it’s the Texas Medical Board is unfortunately pretty toothless and. And it’s kind of set up that way almost by intent and. Part of me and. Basically, the other thing is, you know, there’s thanks to tort reform patients. You know, it’s not even worth it for most patients to sue because there’s a cap on. And pain and suffering damages. So he. Like, he couldn’t have picked a better state probably to be in in here, in here with his treatment. I don’t fault the Texas Medical Board so much for intent because it’s basically underfunded, overworked and weak by design.
But and the board has tried several times over the last, you know, over the last four decades to take away his license. It’s just that it’s failed every time.
What are some of the allegations that he’s been facing before the board?
Well, you know, administering unapproved drugs.
For one thing, I am sure he you know, he was accused in the 1990s of insurance fraud, which he basically beat that one, too. He in various other issues, like having to do with billing and and. Practicing below the standard of care in these sorts of things.
This he’s in trouble for some kind of hip, a violation, too, right? The privacy law.
I don’t know if that’s going to be that. That’s recent. And that was something that blasco it. And a couple other skeptics noted on the Facebook page, one of someone from the Brezinski Clinic actually gave out medical information to a patient and in a public forum, which was stupid.
And Pergo posted someone’s lab charts online. Right. It was it was a lab value, if I recall.
It’s pretty sure was the real doctor would never have an ethical like you would never do anything like that. Right.
And ethical doctors should not do something like that. Yes, it would. But basically what they did, it was someone from his clinic gave out information about a lab result to a patient over. You know, on a on a Facebook page that was publicly accessible.
Instead of calling them on the phone or sending them an email or something, he just decided the smart thing to do would be to post this on Facebook so everyone could see it.
Well, it was it was done.
I would call it more out of exuberance because it was you she was telling a patient that her lab result was normal. But even so, you don’t do that.
Skeptics have been getting organized to oppose Brezinski. You’re Bob Boscoe, which is a companion article to yours in the Skeptical Inquirer about that. What kind of things have they been up to?
Well, Bob has really been the pioneer in that. I kind of look at it this way. I was I was blogging about the site, you know, the science or lack thereof of Brzezinski’s treatment.
And he’s the one I started to get active. It all began pretty much to little more than two years ago when one of Brzezinski’s agents, shall we say it, was a guy that they had hired for to help them with their social media image. And what he did spectacularly backfired because he threatened various skeptics who had written about prisons. He was various legal threats for libel and stuff like that, which kind of got it, which is kind of when I became aware ever since the bloom is now.
Mark Stephens, is that is that right?
We’re talking with even those whose name. But, you know, believe it or not, before around 2011.
I hadn’t really paid much attention to him. That’s what got me interested in Brezinski in any case. You know, he’s he’s they’ve he’s. Bob’s done a number of things. For instance, he was the he was the one who came up with the idea to give Brezinski a seventieth birthday party last year in which he challenged skeptics to raise money for a real cancer research institute, namely St. Jude’s Children’s Research Hospital. The goal being to raise thirty thousand dollars to the cost of starting on one of present these clinical trials. He didn’t quite get the thirty thousand dollars, but they did present a check to St.. Jude’s and Dr. Brzezinski’s name for his birthday, which I thought was for tens of thousands of dollars.
It was putting to the figured it was 14000, something like that, which is still pretty impressive.
He’s also he’s the guy who started the website, the other Brezinski patient group, where he talks about there’s a Web site called the Brezinski Patient Group, which is basically all of these patients who think that Brezinski has saved their lives. And they tell their and their stories. And it’s really hard to evaluate their stories, to flick a lot of cancer care. Testimonials to Bob’s idea was that this was the source that most people came to when they’re looking for information about Brezinski, all these glowing stories of how he supposedly cured incurable cancers. He thought that there needed to be a bit of balance, a source of information where you know, where the more typical story was told.
It’s people who paid thirty thousand dollars and didn’t get better.
I mean, I don’t know how he does it because these are all pretty much patients who had bad experiences and almost all bad outcomes, namely ultimately death from despite being treated, you know, treated by Brezinski.
Now, in all fairness, you know, these patients had terminal brain cancer.
The point is not so much that, you know, they died because they were gone. That was going to happen almost certainly. Anyway, the point was it Brezinski, despite all of his claims otherwise, couldn’t save them.
And he took her two thousand dollars from them before they died. Right.
Well, thirty thirty thousand dollars is actually cheap. That’s just the start. There have been patients who racked up hundreds of thousands of dollars worth of charges. So, you know, thirty thousand is just to get started.
So there are a lot of people who die of brain cancer destitute who might not otherwise have had they not. Wow.
So, Brezinski, whether they’re destitute or not, it’s hard to say because a lot of these patients and this is another disturbing aspect of the present ski phenomenon. A lot of these patients get on the media, they start fundraising campaigns and they get a lot of attention and money because people donate and people want to help. And unfortunately, this is not the way to help.
Couple of instances, a couple of famous instances in the UK back, which were also part of what got my attention, where some rather famous UK performers held a benefit to raise money to send patients to the Brezinski, to send a patient to the Brezinski Clinic. More recently there. There’s a patient, there’s a young Jewish boy by the name of Bill I should call in Houston who is right? Yeah, who’s got a he’s got a bad brain tumor. And his family has been rallying the Jewish community both here and in Israel to raise money for him. But beyond that, they’ve been having. Petitions and trying to get people to pressure their legislators to let the pressure of the FDA to let him be treated under a compassionate youth exemption or otherwise more officially known as the single patient Ayanda with Antineoplaston.
And this this. They started this. I became aware of them. And not long after. Lose Abels story appeared in November and they’ve been basically lobbying representatives and running change that or petitions and that sort of thing to try to pressure Congress to pressure the FDA.
Basically, if they were to succeed, would that set a precedent that would put Burzynski back into the Antineoplaston business?
Clearly, I think Brezinski is trying to replay the 1990s here because this is the sort of thing that he did in the 1990s and it worked with Joe Barton.
But I am not aware of anyone in Congress who’s championing him now the way Barton did then. I mean, there are a couple other notable cases right now. For instance, the coalbed, who is the wife of Sammy Hagar, the drummer who put up a YouTube video of Teil because she has a brain tumor as well, and she wants to get you pastimes. And Sammy Hagar even had a benefit concert for her, which it’s hard it’s hard to to say it.
It’s kind of like, OK, he’s he thinks he’s doing the right thing. You know, he’s doing what he thinks is a good thing. But unfortunately, he doesn’t realize that it’s probably not.
He’s Brezinski getting rich from these from these expensive over.
I don’t know how much money he has, but I don’t know if you’ve seen some of the pictures of his house that have appeared on various Web sites. But it’s a six million dollar house that has the golden gates with his initials on them.
And we should link to that idea point of in his website. People can check it out.
Yeah. I mean, yeah, we could put that. If you can’t find that, I can find it for you. But, you know, he’s very well off. He is.
And his operation is pretty impressive. You know, he has this if you’ve seen pictures of his clinic, which you can see on his Web site, it’s a pretty big office building in in Houston, glass and steel, you know, with big word prisons, clinic across the top.
He has a manufacturing facility, which, you know, would be, you know, where he makes the of Plass tons of flickery regular.
It’s the regular pharmaceutical manufacturing, you know, small pharmaceutical company, basically, although it’s listed as a nonprofit prison research institute, it basically for making Antineoplaston it function like a small pharmaceutical company. He had he’s had more than one hundred people working for him at times.
I’ve heard through the grapevine that that’s been that there have been layoffs, which tells me that he’s probably hurting. But now he’s had a big operation. He’s made quite a bit of money on it.
My final question is, what are some of the lessons that we as skeptics can take away from the present ski case?
Here and there, there are several that I’ll try to winnow it down. Perhaps one of the biggest one of the biggest lessons is scientists somehow can fall into this bad practices. Scientists can say if you come to believe in something and I think Brzezinski probably does believe in his antineoplaston. He frequently reacts very badly when criticized. He has a tendency to like to invoke Nazi analogies, analogies and refer to people who criticize him as hooligans and hired assassins.
Any sign, I think any scientist can go bad. Another thing is. The FDA is pretty toothless when it comes to this sort of thing. It’s not as though the FDA, FDA hasn’t been trying to shut them down since the 1980s. Only recently has it been able to and then not completely. There is a partial clinical hold. The back could be lifted that the FDA could decide to lift that and he would be in business again. The partial clinical hold also allows him to keep treating his existing patients. And that goes for the and it goes to the Texas Medical Board as well.
I mean, the Texas Medical Board has been pretty much powerless to do anything about him, despite trying multiple times. All it’s really managed to do is maybe rack up a bunch of legal charges and force Brezinski to pay a lawyer to defend himself and go through all sorts of contortions to defend himself. But in the end, Brezinski is the one every time.
Is there anything that readers can do in terms of writing the FDA or Texas Medical Board to pressure on to put countervailing pressure on them?
If you live in. If you live in Texas, it would you could certainly write your state legislature fully in your state legislators regarding Texas. You know, the weakness of the regulation of physicians in your state.
You can write to your Congress people and senators at the federal level about Brezinski in particular, more about strengthening the FDA.
I think the FDA has been burned so many times that I really suspect that a gun shy and it doesn’t really want to go to the mat. But no, that has to it knows it has to do something. And what it’s done right now is essentially a half measure and that it hasn’t completely shut Brezinski down and told them that, you know, no more Antineoplaston period. It’s basically just said you can’t enroll anymore patients. And I highly doubt that Brezinski were to submit anymore clinical trial applications that they would be approved. Of course, all the FDA does is regulate drugs in the United States, at least relevant to Brezinski. It can just regulate drugs. So all it can do is stop them from using Antineoplaston. It couldn’t necessarily stop him from continuing to do his gene targeted therapy. All right.
And it really it probably can’t stop him from using a drug called sodium cental butyrate, which luckily for Buzinski, when you take sodium final victory, it actually is metabolized into P.A. DGM, if I remember correctly. So it basically is being advertised as a pro drug for Antineoplaston and that if you take it, it’s like taking oral antineoplaston. And so he’s been prescribing that off label for cancer patients along with his cocktails of targeted therapies. It’s a tough problem, and I hope we never see present gives, like again, that he’s done he’s done things that I’ve haven’t really seen any other practitioner accomplish before. In a way, you almost have to, you know, express grudging admiration for what he’s accomplished.
But unfortunately for cancer patients, it’s it’s a disaster.
Hey, thanks so much for coming on the show today.
Thank you for inviting me.
This has been a point of inquiry. You can follow us on Twitter at point of inquiry. Tune in next week.