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Posts Tagged Clinical Trials

Stanislaw Burzynski’s propaganda victory on antineoplastons: The FDA caves

Mark Crislip, founder of the Society for Science-Based Medicine, whose board of directors I’m proud to be serving on, an organization that you should join if you haven’t already, sometimes jokes that our logo should be an image of Sisyphus, the king of Ephyra whom Zeus punished by compelling him to roll an immense boulder up a hill. However, the boulder was enchanted and, as soon as Sisyphus reached the top, it would roll back down the hill. Sisyphus was thus forced to repeat this action throughout all eternity. The metaphor is obvious. Those of us who try to combat quackery and the infiltration of pseudoscience in medicine often feel a lot like Sisyphus. I always used to argue that, as amusing as it might be to have such a logo as an “in” joke, it’s far too much of a downer to inspire what SSBM wants to inspire: Action in the form of volunteers taking on projects, such as converting Quackwatch into a wiki and then continuously updating and adding to that wiki indefinitely. We have to believe that there is hope of someday succeeding. “Let’s push that boulder up a hill one more time!” does not exactly constitute an inspiring rally cry, although I can definitely understand the feeling at times the older I get and the longer I’ve been doing this. We can all appreciate gallows humor at times, and, besides, I’m not that pessimistic. I can’t afford to be.

Even so, I can understand the Sisyphus analogy right now with respect to an unfortunately frequent subject of this blog, the doctor in Houston who proclaims himself a cancer doctor, even though he has no formal training in medical oncology, isn’t even board-certified in internal medicine, the prerequisite for undertaking advanced training in medical oncology, and has no discernable training in clinical trials management. I’m referring, of course, to Stanislaw Burzynski, MD, PhD, the Polish doctor who since 1977 has been treating patients with substances that he has dubbed “antineoplastons” (ANPs). What are ANPs? Burzynski claimed to have discovered ANPs during his time at Baylor and described them as endogenous cancer-fighting chemicals in human blood and urine. Unfortunately, he soon became convinced that only he could develop them into an effective chemotherapy drug and left Baylor to administer ANPs to his own cancer patients. Patients flocked to him because he claimed to be able to cure cancers that conventional medicine can’t cure.

This led to a series of battles between Burzynski and various authorities, including the Texas Medical Board, the FDA, and various attorneys general, because of his use of ANPs, which are not and never have been FDA approved, as well as for various—shall we say?—issues with insurance companies. Ultimately, in the 1990s Burzynski beat the rap and effectively neutered the FDA’s case against him by submitting dozens of clinical trials to the FDA for approval, which, given how much pressure the FDA was under from Burzynski’s friends in high places (like Texas Representative Joe Barton), the FDA ended up approving. However, as Burzynski’s lawyer himself bragged, these clinical trials were shams designed to allow Burzynski to keep treating cancer patients, not clinical trials designed to produce any real evidence of efficacy. Not surprisingly, although Burzynski has published the odd case report or tiny case series, he has not yet published the full results of even a single one of his many phase II trials. There is, quite simply, no convincing evidence that ANPs have significant antitumor activity in vivo in humans, even after 37 years. Meanwhile, the FDA has found numerous examples of Burzynski’s abuse of clinical trials, failure to keep necessary data, and failure to protect human subjects, while exposés by BBC Panorama and Liz Szabo at USA TODAY have been most unflattering, revealing at least one dead child as a result of the toxicity of Burzynski’s drug and a pattern of minimizing and hiding reports of adverse reactions.
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Posted in: Cancer, Clinical Trials, Politics and Regulation

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The return of the revenge of high dose vitamin C for cancer

Somehow, I’ve a feeling we’re not in Kansas anymore—except that we are, as you will soon see.

Because I’m the resident cancer specialist on this blog, it usually falls on me to discuss the various bits of science, pseudoscience, and quackery that come up around the vast collection of diseases known collectively as “cancer.” I don’t mind, any more than my esteemed colleague Dr. Crislip minds discussing infectious diseases and, of course, vaccines, the most effective tool there is to prevent said infectious diseases. In any case, there are certain things that can happen during a week leading up to my Monday posting slot on SBM that are the equivalent of the Bat Signal. Call them the Cancer Signal, if you will. One of these happened last week, thus displacing that post I’ve been meaning to write on a particular topic once again. At this rate, I might just have to find a way to write an extra bonus post. But not this week.

In any case, this week’s Cancer Signal consisted of a series of articles and news reports with titles like:

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Posted in: Basic Science, Cancer, Clinical Trials

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Stanislaw Burzynski: Using 1990s techniques to battle the FDA today

It figures that I couldn’t go three weeks into 2014 without the topic of Stanislaw Burzynski rearing its ugly head. I had hoped to make it to February or even beyond before feeling the gravitational tug of the wretched hive of ignominious and unethical behavior, but here we are, only 20 days into the new year. So be it.

2013 finished with serious setbacks for Stanislaw Burzynski and his unproven cancer treatment that he dubbed “antineoplastons” (ANPs) way back in the early 1970s. As you might recall, in November, two things happened. First, the FDA released its initial reports on its inspection of the Burzynski Clinic and Burzynski Research Institute (BRI) carried out from January to March 2013. They were damning in the extreme, pointing out the shoddy operating methods of the institutional review board (IRB) used by the BRI to approve and oversee Burzynski’s “clinical trials” (and I use the term loosely) of ANPs. Violations included using expedited approvals to review single patient protocols, something so far outside the purview of what the expedited approval process was intended for, namely approving minor tweaks to human subjects research protocols without requiring a full meeting of the IRB, that the FDA called Burzynski out for it. Other violations included failure to report serious adverse events (SAEs) and adverse events (AEs) to the FDA and/or the IRB, failure to follow proper informed consent procedures, failure to determine that risks to subjects were minimized and that risks to subjects were reasonable in relation to anticipated benefits, if any, and a lot of other violations, which are listed in my previous post on the subject. (more…)

Posted in: Cancer, Clinical Trials, Politics and Regulation

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The Skeptics for the Protection of Cancer Patients need your help

We at SBM don’t normally ask our readers for much, if anything, other than to read and for the subset of you who like to be active in the comments to have at it. However, given the story of Stanislaw Burzysnki, which I’ve been covering with frequent blog posts for over two years now, how could I not listen to the appeal of my friend and co-conspirator (note to Burzysnki fans: that “co-conspirator” bit was sarcasm) to take action in the wake of the USA TODAY story that ran two and a half weeks ago. Despite the disingenuousness of Burzynski’s response, unfortunately he’s still managing to find his way into legitimate scientific meetings.
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Posted in: Cancer, Clinical Trials, Politics and Regulation

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“Low T”: The triumph of marketing over science

A man on TV is selling me a miracle cure that will keep me young forever. It’s called Androgel…for treating something called Low T, a pharmaceutical company–recognized condition affecting millions of men with low testosterone, previously known as getting older.

The Colbert Report, December 2012

 

And now for something completely different…sort of.

After writing so much about the latest developments in the ongoing saga of the cancer doctor who is not an oncologist and not a legitimate cancer researcher, plus a rumination on what’s up with President Obama’s nominee for Surgeon General and our favorite form of unscientific medicine, so-called complementary and alternative medicine (CAM), also known as “integrative medicine,” I thought it was time for a change of pace. I wasn’t sure what I was going to write about as Sunday rolled around, but fortunately, as sometimes happens, the New York Times dropped a topic right in my lap, so to speak, both figuratively and literally. It comes in the form of a long article on something that directly concerns men of a certain age, which unfortunately happens to mean men of my age and older. I’m referring to what pharmaceutical company advertising campaigns have dubbed “low T,” short for low testosterone. It’s not clear how the term “low T” originated but Dr. Abraham Morgentaler, founder of Men’s Health Boston, claims to have coined the term when his patients were embarrassed by their difficulty pronouncing the word “testosterone.” Other sources report that it was Solvay Pharmaceuticals that coined the phrase. It doesn’t really matter where the term “low T” came from. The term has stuck, even though the more “correct” medical term would be hypogonadism, as in a man’s testes not working.
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Posted in: Clinical Trials, Pharmaceuticals, Science and the Media

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The Burzynski Empire strikes back

You might have noticed that I was very pleased last Friday, very pleased indeed. Given the normal subject matter of this blog, in which we face a seemingly-unrelenting infiltration of pseudoscience and quackery into even the most hallowed halls of academic medicine, against which we seem to be fighting a mostly losing battle, having an opportunity to see such an excellent deconstruction of bad science and bad medicine in a large mainstream news outlet like USA TODAY is rare and gratifying. As you might recall, USA TODAY reporter Liz Szabo capped off a months-long investigation of Dr. Stanislaw Burzynski and his Burzynski Clinic with an excellent (and surprisingly long and detailed) report, complete with sidebars explaining why cancer experts don’t think that Burzysnki’s anecdotes are compelling evidence that his treatment, antineoplastons, has significant anticancer activity and a human interest story about patients whom Burzynski took to the cleaners. Most of this, of course, is no news to SBM readers, as I’ve been writing about Dr. Burzynski on a fairly regular basis for over two years now. It’s just amazing to see it all boiled down into three articles and ten short videos in the way that Szabo and USA TODAY did, to be read by millions, instead of the thousands who read this blog. Szabo also found out who the child was who died of hypernatremia due to antineoplastons in June 2012, a death that precipitated the partial clinical hold on Burzynski’s bogus clinical trials, about which both Liz Szabo and I have quoted Burzynski’s own lawyer, Richard Jaffe, from his memoir, first about Burzynski’s “wastebasket” trial, CAN-1:

As far as clinical trials go, it was a joke…it was all an artifice, a vehicle we and the FDA created to legally give the patients Burzynski’s treatment. The FDA wanted all of Burzynski’s patients to be on an IND, so that’s what we did.

And Jaffe’s characterization of the six dozen phase II clinical trials that Burzynski submitted in the late 1990s was this:

A cancer clinic cannot survive on existing patients. It needs a constant flow of new patients. So in addition to getting the CAN-1 trial approved, we had to make sure Burzynski could treat new patients. Mindful that he would likely only get one chance to get them approved, Burzynski personally put together seventy-two protocols to treat every type of cancer the clinic had treated and everything Burzynski wanted to treat in the future…Miracle of miracles, all of Burzynski’s patients were now on FDA-approved clinical trials, and he would be able to treat almost any patient he would want to treat!

I’m just repeating those quotes again, because they can’t be emphasized enough. Quite frankly, if I were Burzynski, I’d fire Jaffe for having published such statements in his book. But that’s just me. In the meantime, let’s take a look at the counterattack and why Burzynski’s excuses regarding the deficiencies found in the FDA reports do not ring true.
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Posted in: Cancer, Clinical Trials, Science and the Media

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Revealed by the FDA: The results of the most recent inspection of the Burzynski Clinic

After posting the talks that Bob Blaskiewicz and I gave at TAM this year, I realized that it’s been a while since I’ve written about the topic of those talks, namely Stanislaw Burzynski, the Houston cancer doctor who inexplicably has been permitted to continue to administer an unproven cancer treatment to children with deadly brain cancers for nearly 37 years now. Beginning in 1977, when he left Baylor College of Medicine and opened up the Burzynski Clinic, Burzynski has administered a cancer therapy that he calls antineoplastons to patients. After nearly four decades and several dozen phase II clinical trials started, he has never published a completed phase II trial. The only evidence he’s published consists mainly of cell culture studies, case reports, and couple of preliminary reports of his phase II clinical trials. Of course, Burzynski’s lawyer, Richard Jaffe, even dismissively admitted that these clinical trials are designed solely to allow Burzynski to keep giving antineoplastons.

So Burzynski operated from the late 1990s until summer 2012, charging exorbitant “case management” fees to enroll patients in his clinical trials, working with a credulous filmmaker who wanted to make a movie about him—twice—and flouting regulations designed to protect human subjects involved in clinical trials. Meanwhile, he branched out to “personalized gene-targeted cancer therapy,” which he promoted through Suzanne Somers; to AminoCare, which is basically antineoplastons sold as an antiaging nostrum (or, as Burzynski puts it, a “genetic solution to aging“); and to selling an orphan drug as a “prodrug” for antineoplastons.

So what happened in the summer of 2012? Apparently, there was a treatment-related death of a child, which led the FDA to issue a partial clinical hold on the Burzynski Clinic that prevented him from enrolling any new children on his clinical trials, although he could keep treating existing patients and enroll new adult patients. That partial clinical hold was extended to adults in January 2013, at which time the FDA arrived at the Burzynski Clinic to investigate. It was an event that was included at the tail end of Eric Merola’s second propaganda film about Stanislaw Burzynski and represented as, in essence, jackbooted fascists trying to keep the cure for cancer from The People. None of this stops credulous reporters from writing misleading articles with titles like Young mother with brain cancer given just a year to live BEATS the disease and gets married after having controversial treatment in the US, which is a story about Laura Hymas, a woman whose good fortune is most likely not due to Burzynski. Not long before that, there was another credulous article featuring another Burzynski patient, Hannah Bradley, as one of four patients treated for cancer with alternative therapies who are allegedly doing well. Again, Hannah Bradley’s good fortune is highly unlikely to be due to Burzynski’s nostrums.

All of this is why those of us who follow Burzynski have been waiting with the proverbial bated breath to find out what the FDA concluded. Just before the government shutdown the first shoe dropped, when the FDA released a warning letter to the Burzynski Research Institute (BRI). Then last week, the second shoe dropped, when the FDA released the original forms describing its findings regarding the inspection. The findings are, to put it mildly, damning in the extreme. In fact, now, more than ever, I wonder how on earth Burzynski has been allowed to continue to run clinical trials—or even practice—for so long. The findings include massive deficiencies in the Burzynski institutional review board (IRB), the committee responsible for making sure that regulations designed to protect human subjects in research are adhered to.
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Posted in: Cancer, Clinical Trials, Medical Ethics, Politics and Regulation

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The difference between science-based medicine and CAM

“Alternative medicine,” so-called “complementary and alternative medicine” (CAM), or, as it’s become fashionable to call it, “integrative medicine” is a set of medical practices that are far more based on belief than science. As Mark Crislip so pointedly reminded us last week, CAM is far more akin to religion than science-based medicine (SBM). However, as I’ve discussed more times than I can remember over the years, both here and at my not-so-super-secret-other blog, CAM practitioners and advocates, despite practicing what is in reality mostly pseudoscience-based medicine, crave the imprimatur that science can provide, the respect that science has. That is why, no matter how scientifically implausible the treatment, CAM practitioners try to tart it up with science. I say “tart it up” because they aren’t really providing a scientific basis for their favored quackery. In reality, what they are doing is choosing science-y words and using them as explanations without actually demonstrating that these words have anything to do with how their favored CAM works.

A more important fundamental difference between CAM and real medicine is that CAM practices are not rejected based on evidence. Basically, they never go away. Take homeopathy, for example. (Please!) It’s the ultimate chameleon. Even 160 years ago, it was obvious from a scientific point of view that homeopathy was nonsense and that diluting something doesn’t make it stronger. When it became undeniable that this was the case, through the power of actually knowing Avogadro’s number, homeopaths were undeterred. They concocted amazing explanations of how homeopathy “works” by claiming that water has “memory.” It supposedly “remembers” the substances with which it’s been in contact and transmits that “information” to the patient. No one’s ever been able to explain to me why transmitting the “information” from a supposed memory of water is better than the information from the real drug or substance itself, but that’s just my old, nasty, dogmatic, reductionist, scientific nature being old, nasty, dogmatic, reductionist, and scientific. Then, of course, there’s the term “quantum,” which has been so widely abused by Deepak Chopra, his acolytes, and the CAM community in general, while the new CAM buzzword these days to explain why quackery “works” is epigenetics. Basically, whenever a proponent of alternative medicine uses the word “epigenetics” or “quantum” to explain how an alternative medicine treatment “works,” what he really means is, “It’s magic.” This is a near-universal truth, and even the most superficial probing of such justifications will virtually always reveal magical thinking combined with an utter ignorance of the science of quantum mechanics or epigenetics.
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Posted in: Clinical Trials, Homeopathy, Medical Academia

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Do clinical trials work? It depends on what you mean by “work”

Introduction

(Skip to the next section if you want to miss the self-referential blather about TAM.)

As I write this, I’m winging my way home from TAM, crammed uncomfortably—very uncomfortably—in a window seat in steerage—I mean, coach). I had been thinking of just rerunning a post and having done with it, sleeping the flight away, to arrive tanned, rested, and ready to continue the battle against pseudoscience and quackery at home, but this seat is just too damned uncomfortable. So I might as well use the three and a half hours or so left on this flight to write something. If this post ends abruptly, it will be because I’ve run out of time and a flight attendant is telling me to shut down my computer in those cloyingly polite but simultaneously imperious voices that they all seem to have.

I had thought of simply recounting the adventures of the SBM crew who did make it out to TAM to give talks at workshops and the main stage and to be on panels, but that seems too easy. Even easier, I could simply post my slides online. But, no, how on earth can I reasonably expect Mark Crislip to post while he’s at TAM if I’m too frikkin’ lazy to follow suit? I’m supposed to lead by example, right, even if what comes out is nearly as riddled with spelling and grammar errors (not to mention the occasional incoherent sentence) as a Mark Crislip post? Example or not, lazy or not, I would be remiss if, before delving into the topic of today’s post, I didn’t praise my fellow SBM bloggers who were with me, namely Steve Novella, Harriet Hall, and Mark Crislip, for their excellent talks and insightful analysis. Ditto Bob Blaskiewicz, with whom I tag-teamed a talk on everybody’s favorite cancer “researcher” and doctor, Stanislaw Burzynski. It’ll be fun to see the reaction of Eric Merola and all the other Burzynski sycophants, toadies, and lackeys when Bob’s and my talks finally hit YouTube. Sadly, we’ll have to wait several weeks for that. (Hmmm. Maybe I will post those slides later this week.)
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Posted in: Cancer, Clinical Trials

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BBC Panorama investigates Stanislaw Burzynski

Last week, I reviewed a long-expected (and, to some extent, long-dreaded) documentary by Eric Merola, a filmmaker whose talent is inversely proportional to his yen for conspiracy, pseudoscience, and quackery. Through a quirk of fate that couldn’t have worked out better if I had planned it myself, a long-expected investigation of the Burzynski Clinic by the BBC aired on its venerable news program Panorama last Monday. It was entitled, appropriately enough, Cancer: Hope for Sale? Ever since learning that the BBC was working on this back in January or February, skeptics have been looking forward to it with a mixture of anticipation and dread, anticipation because we expected that the Panorama crew would “get it” (in the interests of full disclosure, I will mention that I was interviewed over the phone by a Panorama producer and exchanged e-mails to answer questions and suggestions), but a bit of dread because we feared the bane of all news reporting on issues of science and medicine: false balance.

So now that the report was finally aired, how was it? You can either watch it on iPlayer (if you’re in the UK) or on YouTube (if you’re not, assuming it’s still there):

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Posted in: Cancer, Clinical Trials, Science and the Media

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