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The Texas Medical Board vs. Stanislaw Burzynski, 2014 edition

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As I begin this post, I’m on a miserably crowded, hot, stinky flight winging my way home from TAM. This puts me in the perfect mood to write about my bête noire to conquer all bêtes noires, namely Stanislaw Burzynski, the Polish expat doctor who claims to have much better results treating deadly brain cancers than conventional oncology, even though he is not an oncologist and has never even completed the prerequisite training for an oncology fellowship, namely an internal medicine residency. Actually, I don’t mean that in the way that you probably think I mean it. This time around, unlike the last time around, writing about Burzynski will put me in a better mood to endure being slapped into a sardine can in coach, barely able to move, barely able to type, but needing to get a blog post out on Monday.

If you remember, the last time I wrote about Burzynski, the Food and Drug Administration (FDA) had caved, and by “caved” I mean that it had lifted the partial clinical hold on Burzynski’s clinical trials. As is usual with the long and winding saga that is Burzynski, I feel compelled to give a brief review for any newbie who might encounter this post. Old hands at this story can skip ahead or just skim.

Two years ago, a child named Josia Cotto died of hypernatremia (elevated sodium level in the blood) due to receiving treatment for a brain tumor from the Burzynski Clinic using Burzynski’s “miracle drug” antineoplastons. Hypernatremia is a known complication of ANP treatment, and, as a result of this child’s death, the FDA put a partial clinical hold on Burzynski’s clinical trials for pediatric patients, which meant that he could continue to treat children already enrolled in his clinical trials but could not enroll any new patients. Six months later, this partial hold was extended to all of Burzynski’s clinical trials, and in early 2013 the FDA inspected the Burzynski Clinic and Burzynski Research Institute (BRI). (more…)

Posted in: Cancer, Clinical Trials, Politics and Regulation

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Medical marijuana as the new herbalism, part 1: Science versus the politics of weed in New York and beyond

A while ago, I wrote about how the Cleveland Clinic had recently opened a clinic that dispensed herbal medicine according to traditional Chinese medicine (TCM) practice. As regular readers of the SBM blog might expect, I was not particularly impressed or approving of this particular bit of infiltration of quackademic medicine into a major academic medical center, particularly given some of the amazingly pseudoscientific treatments espoused by the naturopath who was running the clinic. I also pointed out that, although herbalism is the most plausible (or perhaps I should say the least implausible) of modalities commonly associated with “complementary and alternative medicine” (CAM) or “integrative medicine”, it still exhibits a number of problems, the biggest of which is what I like to call either the delivery problem or the bioavailability problem. In brief, herbs, when they work, are adulterated drugs. The active ingredient is usually a minor constituent, embedded in thousands of other constituents that make up herbs, and it’s almost impossible to control lot-to-lot consistency with respect to content or active ingredients given how location, weather, soil conditions, rainfall, and many other factors can affect how the plants from which the medicines are extracted grow and therefore their chemical composition. To demonstrate the concept, I pointed out that it’s much safer and more predictable to administer digoxin to a patient who needs its activity on the heart than it would be for the patient to chew on some foxglove leaves, given that the therapeutic window (the difference between the doses needed to produce therapeutic effects and the lowest dose that will cause significant toxicity) is narrow.

Which brings me to medical marijuana, a.k.a. medical cannabis.
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Posted in: Cancer, Herbs & Supplements, Politics and Regulation

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The Center for Inquiry weighs in on the FDA’s mishandling of Stanislaw Burzynski’s clinical trials

We interrupt our usually scheduled post for an important announcement. OK, we do nothing of the sort. Scott Gavura’s post will go live a little later this morning. In the meantime, here’s a public service announcement about a frequent topic of mine, Stanislaw Burzynski, that I’d like you to read.

As you recall, last week, the FDA inexplicably decided to lift the partial clinical hold on Stanislaw Burzynski’s bogus clinical trials of antineoplastons, which he’s used since the 1990s as a pretext to charge huge sums of money for “case management fees” to patients for a treatment whose efficacy he has never demonstrated. Yesterday, the Center for Inquiry laid in, and has sent a letter to legislators:

“We are frankly stunned to hear that the clinical hold against Dr. Burzynski has been lifted,” writes CFI in its letter. For decades, Dr. Burzynski and the Houston-based Burzynski Research Institute have been trafficking in unproven and scientifically baseless cancer treatments based on compounds known as antineoplastons, derived from human urine, which Burzynski claims — without evidence — can target and destroy cancer cells. He has taken advantage of desperate patients who are at their most vulnerable, and willing to pay any price.

After the death of a six-year-old patient in 2012, the FDA placed a hold on Burzynski’s trials with children, followed by a hold on trials with adults in 2013, prohibiting him from taking on new patients on whom he could experiment and from whom he could extract more money.

Over several decades, his clinic has proven it is unable to properly protect patient rights, adhere to basic ethical or scientific protocols, or even maintain correct patient records. It has also shown it is willing to exploit desperate cancer patients and their families, milking them out of enormous sums of money. But it has yet to show even a shred of evidence that its cancer treatments have any positive effect whatsoever.

“We struggle to see why the FDA continues to enable this deceptive, antiscientific, and unethical medical adventurism and profiteering, even for patients who are terminally ill,” writes CFI. “Given the behavior of Dr. Burzynski and the Burzynski Research Institute over the course of nearly three decades of failed research and trials, and in the face of a complete lack of scientific evidence demonstrating the efficacy of their expensive and dangerous antineoplaston treatment, we find the FDA’s decision perplexing and profoundly disturbing.”

The full text of the letter can be found here.

If only groups like the American Cancer Society would write similar letters. Cancer patients have been taken advantage of for nearly four decades, and Burzynski has made a mockery of the clinical trial process for nearly 20 years. It’s gone on way too long.

Posted in: Cancer, Clinical Trials, Politics and Regulation

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

It’s been a while since I wrote a substantive post for this blog about the Houston cancer doctor and Polish expat Stanislaw Burzynski who claims to have a fantastic treatment for cancer that blows away conventional treatment for cancers that are currently incurable. The time has come—and not for good reasons. The last time was primarily just a post announcing my article about Burzynski being published in Skeptical Inquirer. When last we saw Stanislaw Burzynski on this blog, it was a post that I hated to write, in which I noted that the Food and Drug Administration (FDA) had caved to patient and legislator pressure and allowed compassionate use exemptions (otherwise known as single patient INDs) to continue. The catch? Cynically, the FDA put a condition on its decision, specifically that no doctor associated with Burzynski nor Burzynski himself could administer the antineoplastons. This set off a mad scramble among Burzynski patients wanting ANPs to find a doctor willing to do all the paperwork and deal with Burzynski to administer ANPs. The family of one patient, McKenzie Lowe, managed to succeed.

It’s hard for me to believe that it’s been almost three years since I first started taking an interest in Burzynski. Three long years, but that’s less than one-twelfth the time that Burzynski has been actually been administering an unproven cancer treatment known as antineoplastons (ANPs), a drug that has not been FDA-approved, to patients, which he began doing in 1977. Yes, back when Burzynski got started administering ANPs to patients, I was just entering high school, the Internet as we know it did not exist yet (just a much smaller precursor), and disco ruled the music charts. It’s even harder for me to believe, given the way that Burzynski abuses clinical trial ethics and science, that I hadn’t paid much attention to him much earlier in my blogging career. After all, I’m a cancer surgeon, and here’s been this guy treating patients with advanced brain cancers using peptides that, according to Burzynski, do so much better against what are now incurable tumors than standard of care while charging huge sums of money to patients on “clinical trials.” It might be a cliché to quote the Dead this way, but what a long, strange trip it’s been. Because there has been a major development in this saga whose context you need to know to understand, I’m going to do a brief recap. Long-time regulars, feel free to skip the next couple of paragraphs, as they just try to bring people up to date and include a lot of links for background, or, if you haven’t already, read this summary of Burzynski’s history published earlier this year in Skeptical Inquirer. Newbies, listen up. Read the next two paragraphs. You need to know this to understand why I’m so unhappy. (more…)

Posted in: Cancer, Clinical Trials, Politics and Regulation

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Did Facebook and PNAS violate human research protections in an unethical experiment?

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Ed. Note: NOTE ADDENDUM

I daresay that I’m like a lot of you in that I spend a fair bit of time on Facebook. This blog has a Facebook page (which, by the way, you should head on over and Like immediately). I have a Facebook page, several of our bloggers, such as Harriet Hall, Steve Novella, Mark Crislip, Scott Gavura, Paul Ingraham, Jann Bellamy, Kimball Atwood, John Snyder, and Clay Jones, have Facebook pages. It’s a ubiquitous part of life, and arguably part of the reason for our large increase in traffic over the last year. There are many great things about Facebook, although there are a fair number of issues as well, mostly having to do with privacy and a tendency to use automated scripts that can be easily abused by cranks like antivaccine activists to silence skeptics refuting their pseudoscience. Also, of course, every Facebook user has to realize that Facebook makes most of its money through targeted advertising directed at its users; so the more its users reveal the better it is for Facebook, which can more precisely target advertising.

Whatever good and bad things about Facebook there are, however, there’s one thing that I never expected the company to be engaging in, and that’s unethical human subjects research, but if stories and blog posts appearing over the weekend are to be believed, that’s exactly what it did, and, worse, it’s not very good research. The study, entitled “Experimental evidence of massive-scale emotional contagion through social networks“, was published in the Proceedings of the National Academy of Sciences of the United States of America (PNAS), and its corresponding (and first) author is Adam D. I. Kramer, who is listed as being part of the Core Data Science Team at Facebook. Co-authors include Jamie E. Guillory at the Center for Tobacco Control Research and Education, University of California, San Francisco and Jeffrey T. Hancock from the Departments of Communication and Information Science, Cornell University, Ithaca, NY. (more…)

Posted in: Clinical Trials, Computers & Internet, Neuroscience/Mental Health, Science and the Media

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John Oliver skewers Dr. Oz for his hawking of diet supplements

As regular readers of this blog know, Dr. Mehmet Oz had a very, very bad day last week, in which he received a major tongue lashing from Senator Claire McCaskill (D-MO) for the scientifically unsupported and irresponsible hyperbole he dishes out day after day on his syndicated daytime television show. Personally, I was tempted to pile on myself, but had to content myself with enjoying a couple of posts from a super secret blog in the run-up to the hearing (inviting Dr. Oz to testify is “like asking Al Capone to testify about U.S. tax policy or Stanislaw Burzynski about clinical trial design and ethics”), right after the hearing, and looking at the fallout from the hearing. I had even thought of asking my “friend” to combine the last two into an SBM-worthy post, but by the time that thought had occurred to me, the moment had passed.

One of the best takes I’ve seen on the whole “Oz-fest” last week comes from John Oliver on his HBO show Last Week Tonight With John Oliver. It’s a really long segment that takes up the last half of his show and features—don’t ask why—George R. R. Martin and a tap dancing Steve Buscemi. It’s hilariously spot on:

Most SBM readers will enjoy it. I promise. Oliver even correctly identifies Sen. Orrin Hatch (R-UT) and Tom Harkin (D-IA) as tools of the supplement industry and explains why dietary supplements in the U.S. are largely unregulated and the FDA and FTC have such limited powers to do anything about them preemptively.

Posted in: Herbs & Supplements, Humor, Nutrition, Science and the Media

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Ketogenic diet does not “beat chemo for almost all cancers”

One of the difficult things about science-based medicine is determining what is and isn’t quackery. While it is quite obvious that modalities such as homeopathy, acupuncture, reflexology, craniosacral therapy, Hulda Clark’s “zapper,” the Gerson therapy and Gonzalez protocol for cancer, and reiki (not to mention every other “energy healing” therapy) are the rankest quackery, there are lots of treatments that are harder to classify. Much of the time, these treatments that seemingly fall into a “gray area” are treatments that have shown promise in animals but have never been tested rigorously in humans or are based on scientific principles that sound reasonable but, again, have never been tested rigorously in humans. (Are you sensing a pattern here yet?) Often these therapies are promoted by true believers whose enthusiasm greatly outstrips the evidence base for their preferred treatment. Lately, I’ve been seeing just such a therapy being promoted around the usual social media sources, such as Facebook, Twitter, and the like. I’ve been meaning to write about it for a bit, but, as is so often the case with my Dug the Dog nature—squirrel!—other topics caught my attention.

I’m referring to a diet called the ketogenic diet, and an article that’s been making the rounds since last week entitled “Ketogenic diet beats chemo for almost all cancers, says Dr. Thomas Seyfried.” Of course, when I see a claim such as that, my first reaction is, “Show me the evidence.” My second reaction is, “Who is this guy?” Well, Dr. Seyfried is a professor of biology at Boston College, who’s pretty well published. He’s also working in a field that has gained new respectability over the last five to ten years, namely cancer metabolism, mainly thanks to a rediscovery of what Otto Warburg discovered over 80 years ago. What Warburg discovered was that many tumors rely on glycolysis for their energy even in environments with adequate oxygen for oxidative phosphorylation, which generates the bulk of the chemical energy used by cells. I described this phenomenon in more detail in a post I did four years ago about a drug that looks as though its anticancer properties come from its ability to reverse the Warburg effect. (more…)

Posted in: Basic Science, Cancer, Nutrition, Science and the Media

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Vani Hari (a.k.a. The Food Babe): The Jenny McCarthy of food

NOTE ADDENDUM – Ed.

I’ll admit it: I’m a bit of a beer snob. I make no bones about it, I like my beer, but I also like it to be good beer, and, let’s face it, beer brewed by large industrial breweries seldom fits the bill. To me, most of the beer out being sold in the U.S., particularly beer made by Anheuser-Busch and MillerCoors can easily be likened to cold piss from horses with kidney disease (you need protein to get beer foam, you know), only without the taste. I have to be mighty desperate and thirsty before I will partake of such swill. I will admit that there is one exception, namely Blue Moon, which is manufactured by a division of MillerCoors, but that’s the only exception I can think of. Ever since I discovered Bell’s Oberon, a nice local (well, statewide, anyway) wheat ale, I can do without Blue Moon. Sadly, Oberon is only brewed during the spring and summer months; so when I want a similar bit of brew during the winter months sometimes I’m tempted by Blue Moon. Otherwise, I’m generally happy with one of the many craft and microbrews made by local brewers such as Short’s Brewing Company (whose brewpub I had the pleasure of visiting about a month ago) and Bells Brewery.

Despite my general hostility to Anheuser-Busch and MillerCoors products as examples of everything that is wrong with American beer, I have to say that I almost feel sorry for the people running those corporations right now. Unfortunately, they’ve fallen victim to the latest quack making a name for herself on the Internet by peddling pseudoscience. As is my wont, I’ll go into my usual excruciating detail shortly. But first, to whom am I referring?

FBhari

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Posted in: Nutrition, Science and the Media

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“Integrative oncology”: The Trojan horse that is quackademic medicine infiltrates ASCO

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You might have noticed that I didn’t produce a post last week, something that’s unusual for me, given how prolific I have been in the blogosphere. One reason was personal. The other reason was that last weekend I was attending the annual meeting of the American Society of Clinical Oncology (ASCO) meeting in Chicago. I also must confess that, while I was there, I caused a bit of a stir on the meeting hashtag (#ASCO14) in the name of science-based medicine (SBM) on Twitter under my handle @gorskon. (What? You aren’t following me on Twitter? Get thee hence to my Twitter feed and add me. I’ll wait. Did you do it yet? Good. Now we can move on.) Of course, I know what you’re thinking: Cuddly, lovable me? Causing trouble? Making sure that I’ll almost certainly never be invited to be an official social media doc or to participate in panels on social media at ASCO, despite my extensive experience blogging, using Twitter, and just in general being a pain in the rear online to those who promote quackery and quackademic medicine? Perish the thought!

Of course, it was for just that reason that I was making a bit of a stir on Twitter. ASCO is one of the biggest (if not the biggest) and most organized oncology meetings out there, and there were several people considered “social media rock stars” in the world of oncology such as Mike Thompson, Deanna Attai, Matthew Katz, and Robert Miller live Tweeting the meeting, along with those viewed, correctly or incorrectly, as lesser lights, such as myself. In any case, on Sunday I noticed that a lot of people, including the official ASCO Twitter feed @ASCO, were Tweeting and re-Tweeting a link to this official story from ASCO, “Integrative Oncology Can Add Benefit to Traditional Cancer Treatments.” It was a description of a session that had been held on Saturday morning, Integrative Oncology: The Evidence Base, which, unfortunately, I had missed due to circumstances entirely beyond my control. Fortunately, however, ASCO is benevolent (not to mention that it also justifies the high cost of meeting registration) by providing immediate access to recordings of every major session, not to mention the slide sets used. If I couldn’t be there in person, at least I could cruise on over to the ASCO website and use my access to the 2014 virtual meeting to see what sort of quackademic medicine was being featured at ASCO. (more…)

Posted in: Acupuncture, Cancer, Medical Academia, Traditional Chinese Medicine

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In which Dr. Gorski is taken to task by an eminent radiologist for his posts on mammography

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Introduction: An unexpected e-mail arrives

One of the consequences of the growing traffic and prominence of this blog over the last few years is that people who would otherwise have probably ignored what I or my partners in blogging write now sometimes actually take notice. Nearly a decade ago, long before I joined this blog as a founding blogger, if I wrote a post criticizing something that a prominent academic said, it was highly unlikely that that person would even become aware of it, much less bother to respond to whatever my criticism was. I was, quite simply, beneath their notice, sometimes happily, sometimes unhappily.

It appears that those days might be over. Last week Dr. Daniel Kopans, a prominent Harvard radiologist and well-known long-time defender of screening mammography, sent me a rather unhappy e-mail complaining about my “attack” on him on this blog, a charge that he repeated in a subsequent e-mail. Before I publish his initial e-mail verbatim (with his permission), I would like to point out that, while it’s true that I did criticize some of Dr. Kopans’ statements rather harshly in my post about the Canadian National Breast Screening Study (CNBSS), even characterizing one statement as a “howler,” I would hardly characterize what I wrote as an “attack.” That to me tends to imply a personal attack. Using Dr. Kopans’ apparent definition, what he has said and written about investigators like those running the CNBSS, as documented in my post, about H. Gilbert Welch, who published a large study in 2012 estimating the extent of overdiagnosis due to mammography, and the U.S. Preventive Services Task Force (USPSTF), the group that in 2009 suggested changing guidelines for routine screening mammography in asymptomatic women to begin at age 50 instead of age 40, would appear to also qualify as “attacks.”

Be that as it may, I also wondered why Dr. Kopans hadn’t noticed my CNBSS post until more than three months after it had originally appeared. Then, the day after I received Dr. Kopans’ e-mail, my Google Alert on mammography popped up an article in the Wall Street Journal by Dr. Kopans entitled “Mammograms Save Lives: Criticism of breast-cancer screenings is more about rationing than rationality.” That’s when I guessed that someone probably had either posted or e-mailed Dr. Kopans a link to my previous post in response to that article. Given the confluence of events, I think it’s a perfect time to discuss both Dr. Kopans’ e-mail and his article, because they cover many of the same issues. (more…)

Posted in: Cancer, Clinical Trials, Diagnostic tests & procedures, Public Health

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