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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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A bit of shameless self-promotion: Dr. Gorski interviewed by Point of Inquiry about Stanislaw Burzynski

Every so often, I or one of my fellow SBM bloggers, is interviewed somewhere. This time, it’s my turn, and this time I was interviewed by Lindsay Beyerstein over at Point of Inquiry. In these days when credulous reporters still, in essence, do Burzynski’s bidding with respect to the message he wants to get out, while Burzynski takes advantage of the desperation of patients with incurable cancers, every little bit helps to counter that message.

Hopefully that’s what I’ve done. Please check out the interview.

Posted in: Cancer

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A tale of quackademic medicine at the University of Arizona Cancer Center

Quackademic medicine.

I love that term, because it succinctly describes the infiltration of pseudoscientific medicine into medical academia. As I’ve said many times, I wish I had been the one to coin the phrase, but I wasn’t. To the best of my ability to determine, I first picked it up from Dr. R. W. Donnell back in 2008 and haven’t been able to find an earlier use of the term. As much as I try to give credit where credit is due, I have, however, appropriated the term “quackademic medicine” (not to mention its variants, like “quackademia”), used it, and tried my best to popularize it among supporters of science-based medicine. Indeed, one of my earliest posts on this blog was about how quackery has infiltrated the hallowed halls of medical academia, complete with links to medical schools that have “integrative medicine” programs and even medical schools that promoted the purely magic-based medical modalities known as reiki and homeopathy. It’s been a recurrent topic on this blog ever since, leading to a number posts on the unethical clinical trials of treatments with zero or minimal pre-trial plausibility, the degradation of the scientific basis of medicine, and the acceptance of magical thinking as a means of treating patients in all too many medical centers.

One strong candidate for quackademic ground zero, if there can be such a thing for the phenomenon like quackademic medicine, which is creeping up like so much kudzu in the cracks of the edifice of science-based medicine (SBM), is the University of Arizona. U. of A. is, of course, the home of one of the originators of the concept of quackademic medicine and one of its most famous and tireless promoters, Dr. Andrew Weil. Dr. Weil, as you might recall, has even been the driving force for creating a highly dubious “board certification” in integrative medicine. Sadly, apparently this new board certification has been so popular among physicians wanting to “integrate” a little quackery into their practices, that its first examination has been delayed from May to November 2014, so that the American Board of Physician Specialties can figure out how to accommodate the unexpectedly large number of applicants.

So what happens when a patient arrives at U. of A. for treatment? I found out last week when I received an e-mail, which led to a fairly long e-mail exchange, with a man whose son was diagnosed with leukemia and is being treated at the University of Arizona Cancer Center (UACC). Although this man gave me permission to use his name, I am going to decline to do so because there is a child involved, although anyone involved in his case at U. of A. will likely quickly be able to identify who the man is. It turns out that he is a professor at U. of A. in a humanities department (which is why I’ll refer to him henceforth as the Professor), and, even though he is not a scientist, he clearly knows how to think (which would not be surprising if you knew what department he was in). In his e-mail, he told me how appalled he was at the sorts of treatments being offered to his son:
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Posted in: Acupuncture, Cancer, Chiropractic, Energy Medicine, Medical Academia, Religion

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When healing turns into killing: religious and philosophical exemptions from parental accountability

Parents have a fundamental right to guide the upbringing of their children protected under the Due Process Clause of the U.S. Constitution. This includes the choice of medical care for the child. They also have a First Amendment right to the free exercise of their religious beliefs, including the right to care for their children in accordance with the tenets of their religion. In a better world, these rights would be exercised in a manner that is consistent with a reasoned selection of medical care among choices supported by the best available scientific evidence. If, for example, deeply religious parents choose to forego a treatment that had only a minimal chance of extending their child’s life and terrible side effects in favor of palliative care because they believe that their child would be better off in heaven we could all agree that their choice is constitutionally protected.

Unfortunately, that is not the case. Religious believers and those whose “philosophy” favors pseudoscience in child medical care (surveys bloviating about the popularity of CAM to the contrary) are in fact a tiny minority of the American population who influence public policy in a manner that far exceeds their actual numbers. This influence allows these special interest groups to cause needless suffering and death among children and their families. As well, their actions siphon off medical and legal resources that could more properly be directed toward the common good when states and medical institutions are put in the position of having to go to court to protect children from their parents. And, by giving parents false choices between a belief in magic and standard medical care, unnecessary complications are introduced into what are already difficult and heart-wrenching decisions by parents who truly want to act in the best interests of their children. (more…)

Posted in: Cancer, Epidemiology, Legal, Medical Ethics, Politics and Regulation, Religion, Vaccines

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“Right to try” laws and Dallas Buyers’ Club: Great movie, terrible for patients and terrible policy

One of my favorite shows right now is True Detective, an HBO show in which two cops pursue a serial killer over the course of over 17 years. Starring Woody Harrelson and Matthew McConaughey, it’s an amazingly creepy show, and McConaughey is amazing at playing his character, Rustin Cohle. I’m sad that the show will be ending tomorrow, but I really do want to see how it ends.

Unfortunately, as much as I like Matthew McConaughey as an actor, he is in part responsible for re-inspiring a movement that has the potential to do profound harm to patients and cancer research. That’s because his other big role over the last year has been in an Oscar-nominated movie, Dallas Buyers Club, where he plays Ron Woodroof, an early AIDS patient who in the 1980s smuggled unapproved pharmaceutical drugs into Texas when he thought he found them effective at alleviating his symptoms, distributing them to fellow sufferers by establishing the “Dallas Buyers Club” while battling the FDA. I haven’t seen the movie, and I really don’t want to, given that, from everything I’ve heard about it, it’s basically the story of a “brave maverick” who bucks the FDA, complete with all the tropes about indifferent bureaucrats who don’t care if these brave patients die. That might not be so bad if it weren’t also riddled with inaccuracies and misinterpretations of the AIDS crisis in the 1980s. Worse, the real Woodruff rejected the one truly promising drug at the time, AZT, as hopelessly toxic and instead smuggled drugs like Peptide T, which never panned out. Basically, what Woodruff appears to have smuggled as part of his activities for the “Dallas Buyers Club” was a mixture of useless supplements, experimental drugs that were never approved, and a handful of experimental drugs that showed promise. Meanwhile, the movie portrays the FDA as the implacable enemy of these sorts of activities, jackbooted thugs not unlike the stereotype promoted by “health freedom” quacks who don’t like the FDA preventing them from selling their quackery. As far as I can tell without actually seeing the movie, the overall message is a typical uplifting story of an underdog who fights the power and in doing so finds redemption. (more…)

Posted in: Cancer, Clinical Trials, Politics and Regulation, Public Health

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The illusions of “right to try” laws

[Ed. Note: For additional commentary on why "right-to-try" laws are such a bad idea, see “Right to try” laws and Dallas Buyers’ Club: Great movie, terrible for patients and terrible policy and The false hope of “right-to-try” metastasizes to Michigan.]

There is nothing like a touching anecdote to spur a politician into action. And those who want to try investigational drugs outside the FDA’s clinical trial process have touching anecdotes in spades. If I, or a loved one, had a terminal cancer, I’d probably be right there with them, telling my story and hoping to get my hands on an investigational drug, no matter how slim the chance for improvement it offered. But a less emotion-driven analysis of so-called “Right to Try” bills currently before several state legislatures reveals some sobering truths about the false promises behind these bills, promises which in some cases appear to be driven more by political ideology than genuine concern for patients.

“Right to Try” bills are pending before four state legislatures: Colorado, Louisiana, Arizona and Missouri. We’ll get to the details of these in a bit. Legislators in other states have expressed an interest in filing similar bills. On February 26th, a Missouri legislative committee “heard emotional debate from supporters of a bill that would allow makers of investigational drugs, biological products or devices to make them available to eligible terminal patients.” Among those testifying were the parents of a young girl with a brain tumor and the father, a physician, of a patient with metastatic colon cancer. These stories are hard to hear and make it hard to say no.

The Right to Try bill has been christened with another catchy name (Warning! Link to credulous media report!) – the Dallas Buyer’s Club bill after the terrific movie which just won Matthew McConaughey and Jared Leto Academy Awards for best actor and best supporting actor, and deservedly so. It depicts a macho, homophobic, HIV-infected cowboy (McConaughey) who saves the day battling the evil, bureaucratic FDA and the medical establishment. He skirts the law to bring life-saving drugs to AIDS patients at a time when AIDS was pretty much a death sentence. The plot even includes a delicensed American doctor who supplies the unapproved drugs from his Mexican clinic. And dietary supplements, of course. (You’d be tempted to suspect Stanislaw Burzynski, Hulda Clark and a naturopath co-authored the script.) But no matter its merits as a movie, it is just that, a movie. It is based on a true story but its interpretation of events has been called into question. (Orac also deconstructs the factual inaccuracies on Respectful Insolence today.) Nevertheless, it is a public relations boon to the Right to Try promoters, although, considering their decidedly right-leaning political inclinations, there has to be a certain amount of squeamishness in associating their cause with a movie featuring raunchy, sexually-explicit scenes, lots and lots of cussing, and a colorfully dressed trans-gender person (Leto) as its most sympathetic character. (more…)

Posted in: Cancer, Clinical Trials, Legal, Politics and Regulation

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Eric Merola and Ralph Moss try to exhume the rotting corpse of Laetrile in a new movie

Note: Some of you have probably seen a different version of this post fairly recently. I have a grant deadline this week and just didn’t have time to come up with fresh material up to the standards of SBM. This left me with two choices: Post a “rerun” of an old post, or recycle something. I decided to recycle something for reasons explained in the first paragraph of this post.

As I was deciding what to write about this week, I realized that, surprisingly, there is precious little on Science-Based Medicine about the granddaddy of modern cancer quackery, Laetrile. Given that the final nails were placed in the coffin of the quackery that was Laetrile more than 30 years ago in the form of a clinical trial that didn’t show a hint of a whiff of benefit in cancer patients, many of our younger readers might not even know what Laetrile is. But, as I explained when I wrote about Stanislaw Burzynski’s early years in the 1970s, which happened to be they heyday of Laetrile, in cancer quackery everything old is eventually new again, and Laetrile is apparently soon to be new again. True, it’s never really disappeared completely, because, again, no matter how discredited a cancer quackery is, someone somewhere will keep selling it and some poor cancer patient somewhere will be taken in. In any case, it occurred to me that we at SBM have discussed the politics of Laetrile. Indeed, Kimball Atwood once referred to it as the “the most lucrative health fraud ever perpetrated in the United States.” Moreover, Kimball makes a convincing case that the Laetrile controversy was an important precursor that laid the groundwork for advocates of “alternative medicine”—or, as it later became known, “complementary and alternative medicine” (CAM) or “integrative medicine—to successfully lobby for the founding at the National Institutes of Health of what later was named the National Center for Complementary and Alternative Medicine (NCCAM). However, there didn’t appear to be a post dedicated to discussing Laetrile itself, and something happened last week that allows me to rectify that situation.

So how is Laetrile about to become new again? Remember our old buddy Eric Merola? He’s the guy who made two—count ‘em—two conspiracy-laden, misinformation-ridden, astonishingly bad bits of “great man” propaganda disguised as documentaries about a Houston cancer doctor peddling unproven cancer treatments and charging his patients tens and even hundreds of thousands of dollars for the privilege of being under his care while receiving this magic elixir, known as antineoplastons. Over the last several months, ever since he unleashed Burzynski: The Sequel on an unprepared and uninterested world, Merola has been hinting about his next project. Given Merola’s involvement in Zeitgeist: The Movie and his primary role in throwing together two hack propaganda pieces that were so blatantly worshipful of Burzynski that Leni Riefenstahl, were she still alive and able to see them, would have told Merola to cool it with the overheated hero worship and portrayal of his movie’s subject as a god-man a bit, I knew his next movie would be more of the same. I also knew it would not be about Burzynski.
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Posted in: Basic Science, Cancer, Clinical Trials, Politics and Regulation

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The Canadian National Breast Screening Study ignites a new round in the mammography wars

The last couple of weeks, I’ve made allusions to the “Bat Signal” (or, as I called it, the “Cancer Signal,” although that’s a horrible name and I need to think of a better one). Basically, when the Bat Cancer Signal goes up (hey, I like that one better, but do bats get cancer?), it means that a study or story has hit the press that demands my attention. It happened again just last week, when stories started hitting the press hot and heavy about a new study of mammography, stories with titles like Vast Study Casts Doubts on Value of Mammograms and Do Mammograms Save Lives? ‘Hardly,’ a New Study Finds, but I had a dilemma. The reason is that the stories about this new study hit the press largely last Tuesday and Wednesday, the study having apparently been released “in the wild” Monday night. People were e-mailing me and Tweeting at me the study and asking if I was going to blog it. Even Harriet Hall wanted to know if I was going to cover it. (And you know we all have a damned hard time denying such a request when Harriet makes it.) Even worse, the PR person at my cancer center was sending out frantic e-mails to breast cancer clinicians because the press had been calling her and wanted expert comment. Yikes!

What to do? What to do? My turn to blog here wasn’t for five more days, and, although I have in the past occasionally jumped my turn and posted on a day not my own, I hate to draw attention from one of our other fine bloggers unless it’s something really critical. Yet, in the blogosphere, stories like this have a short half-life. I could have written something up and posted it on my not-so-secret other blog (NSSOB, for you newbies), but I like to save studies like this to appear either first here or, at worst, concurrently with a crosspost at my NSSOB. (Guess what’s happening today?) So that’s what I ended up doing, and in a way I’m glad I did. The reason is that it gave me time to cogitate and wait for reactions. True, it’s at the risk of the study fading from the public consciousness, as it had already begun to do by Friday, but such is life.
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Posted in: Cancer, Clinical Trials, Diagnostic tests & procedures, Public Health

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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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Animal rights activism: Petitions aren’t science

I had originally planned on writing about a different topic today, but, as is so often the case in blogging, something came up that caught my attention, much as the errant thought of a squirrel distracts Dug the Dog. It’s no big deal. My original topic is not time-sensitive, and I’ll get to it next week (that is, unless something like this happens again). In any case, my tendency towards blogging ADHD notwithstanding, the “inspiration” for this post began on Friday morning, making it timely. Let me tell you what happened, and then I’ll delve into the topic.

We all have our daily rituals, and I’m no different. When I wake up in the morning, I usually check my iPhone to see how many e-mails I’ve gotten overnight. If there’s time before I have to leave for work, I’ll frequently go through them all right then, answering ones I can answer quickly and filing for later responses those that I can’t. If I don’t have time (as in I overslept), I’ll check them whenever I get an opportunity. Last Friday, I was rather surprised to see that the little badge on the Mail app showed well over three times the usual number of messages I get overnight, even accounting for e-mail notifications of comments on the blogs and the usual smattering of mailing list messages and the odd junk spam that got through the filters. So having that many messages in my unread mail queue caught my attention. Even when a new troll shows up in the comments of one of the blogs, I usually don’t get that many notifications. I figured I’d better go and check to see what was going on right then, rather than waiting until later. What I found was something that I never would have guessed.

As odd as it seems to me now, I had apparently been targeted by a Change.org petition Animal Experimenters – JUSTIFY YOUR SCIENCE CLAIMS. (more…)

Posted in: Basic Science, Cancer, Evolution

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