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

OzCurtain

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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Precision Medicine: The Coolest Part of Medicine

QuellosOne size rarely fits all. Most medical knowledge is derived from studying groups of subjects, subjects who may be different in some way from the individual who walks into the doctor’s office. Basing medicine only on randomized controlled studies can lead to over-simplified “cookbook” medicine. A good clinician interprets study results and puts them into context, considering the whole patient and using clinical judgment to apply current scientific knowledge appropriately to the individual.

CAM practitioners claim to be providing individualized treatments. Homeopaths look up symptoms like “dreams of robbers,” “sensation of coldness in the heart,” and “chills between 9 and 11 AM” in their books, and naturopaths quiz patients in great depth about their habits and preferences; but they don’t have a plausible rationale for interpreting the information they gather. And they have not been able to demonstrate better patient outcomes from using that information.

A new concept, “precision medicine,” was recently featured in UW Medicine, the alumni magazine of my alma mater, the University of Washington School of Medicine. Precision medicine strives to provide truly individualized care based on good science. It identifies the individual variations in people that make a difference in our ability to diagnose and treat accurately. Peter Byers, MD, director of the new Center for Precision Diagnostics at the University of Washington, calls it “the coolest part of medicine.” (more…)

Posted in: Basic Science, Cancer, Diagnostic tests & procedures

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A formal request for retraction of a Cancer article

I am formally requesting that Cancer retract an article claiming that psychotherapy delays recurrence and extends survival time for breast cancer patients. Regardless of whether I succeed in getting a retraction, I hope I will prompt other efforts to retract such articles. My letter appears later in this post.

In seeking retraction, I cite the standards of the Committee on Publication Ethics (COPE) for retraction. Claims in the article are not borne out in simple analyses that were not provided in the article, but should have been. The authors instead took refuge in inappropriate multivariate analyses that have a high likelihood of being spurious and of capitalizing on chance.

The article exemplifies a much larger problem. Claims about innovative cancer treatments are often unsubstantiated, hyped, lacking in a plausible mechanism, or are simply voodoo science. We don’t have to go to dubious websites to find evidence of this. All we have to do is search the peer-reviewed literature with Google Scholar or PubMed. Try looking up therapeutic touch (TT).

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I uncovered unsubstantiated claims and implausible mechanisms that persisted after peer review in another blog post about the respected, high journal-impact-factor (JIF = 18.03) Journal of Clinical Oncology. We obviously cannot depend on the peer review processes to filter out this misinformation. The Science-Based Medicine blog provides tools and cultivates skepticism not only in laypersons, but in professionals, including, hopefully, reviewers who seem to have deficiencies in both. However, we need to be alert to opportunities not just to educate, but to directly challenge and remove bad science from the literature. (more…)

Posted in: Cancer, Clinical Trials, Neuroscience/Mental Health

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How “they” view “us”

Over the weekend, I was perusing my Google Alerts, along with various blogs and news websites, looking for my weekly topic, when I noticed a disturbance in the pseudoscience Force. It’s a phenomenon I’ve noticed many times before, but, as far as I can tell, I haven’t actually blogged about it here, at least not specifically, although I have mentioned it, particularly in posts about Stanislaw Burzynski. I have, however, blogged about it over at my not-so-super-secret other blog, which means that some of the thoughts (if you can call them that) that I plan to lay down in this post will likely seem familiar to some of you, but I think this is an important enough topic that I should cover it here, too. As arrogant as I might sometimes seem, even I’m not so deluded as to think that the fraction of SBM readers who are regulars at my not-so-super-secret other blog is anything greater than a clear minority, and even for those of you for whom there’s overlap I’ll try to make things different enough to be interesting.

On Friday, Sharon Hill published a post over at Doubtful News entitled Chiropractors get their spine out of place over critique. It’s about how chiropractors have reacted to a post by Steve Salzberg over at Forbes entitled New Medicare Data Reveal Startling $496 Million Wasted On Chiropractors. Salzberg’s blog post was basically about just that, namely the amount of money billed Medicare by chiropractors, information that’s possible to obtain since the government released Medicare billing data for individual practitioners. Salzberg pointed out that half a billion dollars is a lot of money, more than twice as much as what is wasted every year on the National Center for Complementary and Alternative Medicine (NCCAM) and the National Cancer Institute’s Office of Cancer Complementary and Alternative Medicine (OCCAM). The result was rapid. Chiropractors swarmed, complaining to Forbes.com, and making the usual threats to sue, much as they actually did sue Simon Singh and, fortunately, saw their lawsuit blow up in their faces.

This, of course, can be looked upon as a purely mercenary protection of turf and livelihood not unlike how Daniel Kopans attacks any study that finds mammography to be less effective than thought (or even ineffective) in decreasing deaths from breast cancer. There is, however, a form of backlash against criticism of pseudoscience that is different and, when I first encountered it, more disturbing to deal with. It’s a level of pure, visceral hatred that is difficult to understand; that is, until you try to put yourself into your “enemy’s” shoes. Consider this post an exercise in doing just that, an exercise that will no doubt shock at least one of our readers.
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Posted in: Cancer, Chiropractic, Critical Thinking, Genetically modified organisms (GMOs), Science and the Media, Vaccines

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What Whole Foods Markets Doesn’t Tell You

Whole Foods Market is a relentlessly hip American supermarket chain which prides itself on organic fruits and vegetables, gluten-free just-about-everything, and high-end touches like wine bars and exotic take out items (roasted yucca, anyone?). The health products aisle is stocked with Bach Flower and homeopathic remedies. For example, in-house brand Flu Ease: “an established homeopathic formula that should be taken at the first sign of flu for temporary relief of symptoms including fever chills and body aches.”

Selling Flu Ease and like products certainly exhibits a lack of appreciation for scientific evidence, not to mention basic science. But I recently saw a product in the checkout line that was so filled with over-the-top quackery and so shocking in its disregard for the public’s health that I haven’t been back to Whole Foods since. And I won’t be going back.

The product? A glossy, slickly-produced magazine with the conspiracy-minded title What Doctors Don’t Tell You. The April 2014 issue promises, in banner-headline font size, a “New Light on Cancer.” It features the well-known symbol of fighting breast cancer, a loop of pink ribbon, but with a tear in the middle of the loop. We’ll look into this “new light” in a bit.

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Posted in: Cancer, Critical Thinking, Faith Healing & Spirituality, Health Fraud, Herbs & Supplements, Homeopathy, Nutrition, Science and the Media

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Mammography and the acute discomfort of change

As I write this, I am attending the 2014 meeting of the American Association for Cancer Research (AACR, Twitter hashtag #AACR14) in San Diego. Basically, it’s one of the largest meetings of basic and translational cancer researchers in the world. I try to go every year, and pretty much have succeeded since around 1998 or 1999. As an “old-timer” who’s attended at least a dozen AACR meetings and presented many abstracts, I can see various trends and observe the attitudes of researchers involved in basic research, contrasting them to that of clinicians. One difference is, as you might expect, that basic and translational researchers tend to embrace new findings and ideas much more rapidly than clinicians do. This is not unexpected because the reason scientists and clinical researchers actually do research is because they want to discover something new. Physicians who are not also researchers become physicians because they want to take care of patients. Because they represent the direct interface between (hopefully) science-based medicine and actual patients, they have a tendency to be more conservative about embracing new findings or rejecting current treatments found not to be effective.

While basic scientists are as human anyone else and therefore just as prone to be suspicious and dismissive of findings that do not jibe with their scientific world view, they can (usually) eventually be convinced by experimental observations and evidence. As I’ve said many times before, the process is messy and frequently combative, but eventually science wins out, although sometimes it takes far longer than in retrospect we think it should have, an observations frequently exploited by advocates of pseudoscience and quackery to claim that their pseudoscience or quackery must be taken seriously because “science was wrong before.” To this, I like to paraphrase Dara O’Briain’s famous adage that just because science doesn’t know everything doesn’t mean you can fill in the gaps with whatever fairy tale that you want. But I digress (although only a little). In accepting the validity of science that indicates either that a medical intervention that was commonly used either doesn’t help, doesn’t help as much as we thought it did, or can even be harmful, they have to contend with the normal human reluctance to admit to oneself that what one was doing before might not have been of value (or might have been of less value than previously believed) or that, worst of all, might have caused harm. Or, to put it differently, physicians understandably become acutely uncomfortable when faced with evidence that the benefit-risk profile of common treatment or test might not be as favorable as previously believed. Add to that the investment that various specialties have in such treatments, which lead to financial conflicts of interest (COI) and desires to protect turf (and therefore income), and negative evidence can have a hard go among clinicians.
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Posted in: Cancer, Diagnostic tests & procedures, Public Health, Science and the Media

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