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Posts Tagged Cancer

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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pH Miracle Living “Dr.” Robert O. Young is finally arrested, but will it stop him?

pH Miracle Living “Dr.” Robert O. Young is finally arrested, but will it stop him?

Being a cancer surgeon and researcher, naturally I tend to write about cancer a lot more than other areas of medicine and science. It’s what I know best. Also, cancer is a very common area for unscientific practices to insinuate themselves, something that’s been true for a very long time. The ideas don’t change very rapidly, either. Drop a cancer quack from 2014 into 1979, and he would probably be right at home. Of course, part of the reason is because the “elder statesmen” of cancer quackery today were getting their starts in 1979. Still, the same ideas keep recurring even as far back as a century ago and even older, and if you broaden your criteria, these ideas exist on a continuum, either having descended directly from various ancient ideas such as vitalism, miasmas, or humoral theory or branched off somewhere along the way. Others branch off from the progress of science, taking a germ of a seemingly reasonable idea and turning it into quackery. It is the latter with which I plan on concerning myself today, the reason being that over the weekend I heard some truly awesome news. One of the most egregiously practicing non-physicians who claim to be able to cure cancer that I’ve ever encountered was arrested—yes, arrested!—and arraigned on criminal charges. I’m referring to “Dr. Alkaline” himself, he of the pH Miracle Living program and his Articles of Health blog, “Dr.” Robert O. Young. Behold:
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Posted in: Cancer, Naturopathy, Politics and Regulation

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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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No, carrying your cell phone in your bra will not cause breast cancer, no matter what Dr. Oz says

I don’t think very highly of Dr. Oz.

Yes, yes, I realize that saying that is akin to saying that water is wet, the sun rises in the east, and that it gets damned cold here in the upper Midwest in December, but there you go. This year, I’ve been mostly avoiding the now un-esteemed Dr. Mehmet Oz, a.k.a. “America’s doctor,” even though his show could, if I paid much attention to it anymore, provide me with copious blogging material, because I’ve come to the conclusion that he is beyond redemption. He’s gone over to the Dark Side and is profiting handsomely from it. There’s little I can do about it except for, from time to time, writing about some of Dr. Oz’s more egregious offenses against medical science and reason, putting our tens of thousands of readers per day against his millions of viewers per day. It’s an asymmetric battle that we don’t have much of a shot at winning. However, at least from time to time I can correct misinformation that Oz promotes, particularly when it impacts my speciality. Consider it doing something pre-emptively to help myself. When one of my patients ask about something that’s been on Oz’s show, I can simply point her to specific blog posts, as I did the last time around when Oz arguably flouted the human subjects protection regulations of his own university and of the Department of Health and Human Services by running in essence a poorly-designed clinical trial to show that green coffee bean extract can promote weight loss. Of course, it showed nothing of the sort.

This time around, Dr. Oz caught my attention about a week and a half ago. I had planned on blogging about it last week, but the case of the Amish girl with cancer whose parents stopped her chemotherapy after less than two full courses, thus endangering her life, intervened. (It also didn’t help that I hadn’t recorded the show and the segment hadn’t shown up on Dr. Oz’s website by Sunday night last week.) I figured that I probably wouldn’t get back to Oz, but—wouldn’t you know it?—a week later I’m still annoyed at this story. So better late than never. (more…)

Posted in: Cancer, Science and the Media

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An update on the case of Sarah Hershberger: Parental rights trump the right of a child with cancer to live

Five weeks ago, when last I touched on the case of Sarah Hershberger, the now 11-year-old Amish girl from Medina County, Ohio near Akron with lymphoblastic lymphoma whose parents had taken her off of chemotherapy after only two rounds, reports had been coming out of the cancer quackery underground that Sarah’s parents, Andy and Anna Hershberger, had fled to avoid a court order that appointed a medical guardian for her to make sure that she received appropriate science-based therapy. At the time I was unable to confirm these stories in the mainstream press. However, over the last month there have been significant developments in this case and even over the last week; so I thought that now would be a good time to update SBM readers on developments in the case.

The Thanksgiving confirmation

One thing that I didn’t mention a month ago is that David Michael and others have been actively raising money to support the Hershbergers’ legal battles. Then, over the long Thanksgiving Day weekend news reports began to trickle out confirming what the “alternative” health sites had been reporting, namely that the Hershbergers had fled. These reports started with story from a local Medina newspaper, then spread to a northeast Ohio television stations, and then to national news sources (like Good Morning America and CNN) and international news outlets. The Medina Gazette first reported:
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Posted in: Cancer, Medical Academia, Medical Ethics, 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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Do vitamins prevent cancer and heart disease?

It is a triumph of marketing over evidence that millions take supplements every day. There is no question we need vitamins in our diet to live. But do we need vitamin supplements? It’s not so clear. There is evidence that our diets, even in developed countries, can be deficient in some micronutrients. But there’s also a lack of evidence to demonstrate that routine supplementation is beneficial. And there’s no convincing evidence that supplementing vitamins in the absence of deficiency is beneficial. Studies of supplements suggest that most vitamins are useless at best and harmful at worst. Yet the sales of vitamins seem completely immune to negative publicity. One negative clinical trial can kill a drug, but vitamins retain an aura of wellness, even as the evidence accumulates that they may not offer any meaningful health benefits. So why do so many buy supplements? As I’ve said before, vitamins are magic. Or more accurately, we believe this to be the case.

There can be many reasons for taking vitamins but one of the most popular I hear is “insurance” which is effectively primary prevention – taking a supplement in the absence of a confirmed deficiency or medical need with the belief we’re better off for taking it. A survey backs this up – 48% reported “to improve overall health” as the primary reason for taking vitamins. Yes, there is some vitamin and supplement use that is appropriate and science-based: Vitamin D deficiencies can occur, particularly in northern climates. Folic acid supplements during pregnancy can reduce the risk of neural tube defects. Vitamin B12 supplementation is often justified in the elderly. But what about in the absence of any clear medical need? (more…)

Posted in: Herbs & Supplements, Nutrition, Science and Medicine

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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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USA Today versus Stanislaw Burzynski

This is an SBM public service announcement—with blogging! Think of it as a bonus post, and don’t forget to read Mark Crislip’s regular biweekly offering, as it’s about an article in Skeptical Inquirer that particularly irritated him—and me, as well. Because, as we all know, the world needs more Mark Crislip.

I’ve made no secret of how much I despise Stanislaw Burzynski, the self-proclaimed cancer doctor and medical researcher who has been treating patients with an unproven, unapproved chemotherapeutic agent since 1977, seemingly slithering around, under, over, and past all attempts to investigate him and shut him down. Indeed, just type his name in the search box of this blog, and you will see copious evidence of my disdain for the man. Over 37 years, Burzynski has become a hero to the cancer quackery industry, touted as the man who can cure incurable cancers that science-based medicine can’t, even though his treatment, antineoplastons, allegedly peptides isolated from blood and urine that normally keep cancer in check in healthy people, are by any reasonable definition chemotherapy. Indeed, they are toxic, with a number of side effects reported, the most common and dangerous of which being life-threatening hypernatremia (elevated sodium levels in the blood). All you have to do is to type Burzynski’s name into the search box of this blog, and you’ll find copious documentation of the abuses of patients, science, and clinical trials perpetrated by Stanislaw Burzynski and the cult of personality that has evolved around him. He’s even acquired his very own film propagandist, a credulous fellow named Eric Merola, who has made two astoundingly bad documentaries that are nothing more than unabashed hagiographies of the brave maverick doctor curing cancer where no one else can. They’re chock full of misinformation, pseudoscience, spin, and obvious emotional manipulation, and the first one at least, was very popular.

For the longest time, I’ve been hoping that major mainstream news organizations would take this story on. It’s happened from time to time, but until 2013 it hadn’t happened in a long time. Earlier this year, the BBC featured Burzynski in an episode of its long-running series Panorama. It was a mixed bag that took the fairly easy path of making it all about the patients and never really delved into what I believe to be the central mystery of the four-decade-long Stanislaw Burzynski story, and that’s how he’s managed to keep his medical license and register clinical trials right up until 2012. That was a disappointment, although much of the rest of the Panorama episode was very good. He still has his medical license, but as I’ve pointed out several times, the FDA placed a partial clinical hold on Burzynski’s antineoplaston phase II clinical trials back in the summer of 2012. A partial clinical hold means that no new patients could be enrolled, but patients already on them could continue to receive treatment. In 2012, apparently a child died on antineoplastons, and so a partial clinical hold was placed on the trials involving children. That clinical hold was extended to adults in January 2012, with much wailing and gnashing of teeth among Burzynski apologists, as the FDA investigated between January and March. We now know the results of that investigation, but we never knew much about how that partial clinical hold came about.

Now, thanks to Liz Szabo at USA Toda, we know from her article “Doctor accused of selling false hope to families“:
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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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