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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?

Facebookfail

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

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

40F MLO DMMG

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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What’s in a name?: NCCAM tries to polish a turd

turdpolish

What’s in a name? that which we call a rose
By any other name would smell as sweet;
So Romeo would, were he not Romeo call’d,
Retain that dear perfection which he owes
Without that title. Romeo, doff thy name,
And for that name which is no part of thee
Take all myself.

William Shakespeare, Romeo and Juliet, Act II, Scene 2

You can clean up a pig, put a ribbon on its tail, spray it with perfume, but it is still a pig.

You can paint a turd red, but it’s still a turd.

There’s a colloquial phrase commonly used to describe an effort to sell or promote something that is so inherently awful or at least so flawed as to be unsalvageable without either a radical rethinking or such a major overhaul that it would be impractical or impossible to do: Polishing a turd. In this, advocates of so-called “complementary and alternative medicine” (CAM) have been very successful. Mark Crislip, in his usual inimitable fashion, just reminded us why CAM is a turd that needs polishing. Unfortunately, on Friday, I learned that the National Center for Complementary and Alternative Medicine unveiled a proposal to help it be more efficient in polishing the turd that is CAM through the clever use of language, and it wants your feedback. There were lots of other things that happened over the last few days that tempted me to write about them that will likely have to appear over at my not-so-secret other blog, but this one caught my attention and held it, given that it goes to the very heart of the deceptive use of language that is at the heart of giving CAM the appearance of legitimacy. In this specific case, NCCAM wants a new name. Dr. Briggs wants to rename NCCAM the National Center for Research on Complementary and Integrative Health (NCRCI). (I have no idea why the abbreviation of the proposed new center name isn’t NCRCIH.) Here’s Dr. Briggs explaining the rationale for the proposal and urging feedback by June 6 at http://nccam.nih.gov/about/offices/od/comments. I urge you to watch the whole video, or at least read the transcript:

Thus does Dr. Briggs propose polishing the turd that is NCCAM.
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Posted in: Clinical Trials, Medical Academia, Politics and Regulation

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The false dilemma of David Katz: Abandon patients or abandon science

Dr. David L. Katz is apparently unhappy with me. You remember Dr. Katz, don’t you? If you don’t, I’ll remind you momentarily. If you do, you won’t be surprised. Let me explain a bit first how Dr. Katz recently became aware of me again.

Last week, I posted a short (for me) piece about something that disturbed both Steve Novella and myself, namely Traditional Chinese herbalism at the Cleveland Clinic? What happened to science-based medicine? Steve had blogged about it as well a couple of days earlier. In actuality, it was a post that had originally appeared at my not-so-super-secret other blog, and, in my characteristically slightly arrogant way, I thought it was good enough that it deserved to be showcased here at Science-Based Medicine. To my surprise, Maithri Vengala over at The Healthcare Blog noticed and asked me if I would mind letting her post it over there. Never being one to turn down a request to showcase my work to a wider (or at least different) audience, I gave her my permission. The result was that my post ended up being published here, and I thought nothing more of it.

Until yesterday, that is.

Yesterday, thanks to the magic of Google Alerts, I became aware that Dr. David Katz was very unhappy with my post. At the very least, he strongly disagreed with it, so much so that he felt the need to respond. Naturally, he chose as his venue The Huffington Post, which is well known as a bastion of quackery, antivaccine pseudoscience, and Deepak Chopra-inspired magical thinking, to respond. Indeed, so bad is HuffPo (as it’s “nicknamed”) that Steve Novella and I have both referred to it as waging a “war on medical science,” and HuffPo has been a frequent topic of discussion on this very blog for its abysmal record of publishing pseudoscience, a record that goes back to its very beginning in 2005, when antivaccinationists flocked to the fledgling blog and news site. And that doesn’t even count all the nonsense from Deepak Chopra and even promotion of outright cancer quackery.
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Posted in: Critical Thinking, Energy Medicine, Herbs & Supplements, Traditional Chinese Medicine

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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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