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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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More Dialogs

There is no alternative medicine. There is only scientifically proven, evidence-based medicine supported by solid data or unproven medicine, for which scientific evidence is lacking. JAMA

Just just because there are flaws in aircraft design that doesn’t mean flying carpets exist. Ben Goldacre

Wiser heads than I have commented on “Invitation to a Dialogue: Alternative Therapies” in The New York Times. So why add my two cents? Partly because The New York Times wanted brief responses and I don’t do brief. Partly because I write for me; nothing focuses the mind like putting electrons to LCD, except, perhaps, a hanging. Partly we do need a dialog, just not of the kind suggested by the writer. And partly, life has been so busy of late I needed a topic that required no research. (more…)

Posted in: Basic Science, Clinical Trials, Critical Thinking, Science and Medicine

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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).

mind-over-body

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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CureCrowd – Crowdsourcing Science

curecrowd-HAA new website came to my attention that promises to “Discover what truly works.” The idea is to essentially crowdsource anecdotal reports about what treatments work for specific conditions.

This is an interesting idea, that can harness the power of information flow over the internet to do what is essentially an observational, uncontrolled, and unscientific study about treatment effects. At its best, this type of information would consist of what we call a pragmatic study – an open-label study of the real-world application of specific treatments.

Pragmatic studies have their place – they add information about the practical applicability of various treatments. Pragmatic studies, however, are not efficacy trials – they cannot and should not be used to make efficacy claims. It has recently come into vogue for proponents of various CAM treatments to rely on pragmatic studies to make efficacy claims, when actual efficacy trials have failed to show effectiveness. (more…)

Posted in: Clinical Trials, Computers & Internet

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Cochrane Reviews: The Food Babe of Medicine?

There are two topics about which I know a fair amount. The first is Infectious Disease. I am expert in ID, Board Certified and certified bored, by the ABIM. The other, although to a lesser extent, is SCAMs.

When I read the literature on these topics, I do so with extensive knowledge and, in the case of ID, 30 years of clinical experience. The extensive knowledge, and, one hopes, understanding, has led me to read meta-analyses with a grain of salt substitute. They average meta-analysis and systematic review is good for gaining a general understanding of the topic within, as well as, and here is the key phrase, the limitations of the included studies.

And like all the published literature, when writing a meta-analysis, those with an axe to grind will grind it. Even, or perhaps especially, the Cochrane reviews.

Just because something is labelled as a systematic review does not mean it is any good. We have to be just as vigilant now as ever. Even a review with a Cochrane label does not make its true. Four out of 12 Cochrane reviews on acupuncture were wrong. Caveat lector rules, OK? (more…)

Posted in: Basic Science, Clinical Trials, Critical Thinking, Pharmaceuticals, Science and Medicine

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The Compassionate Freedom of Choice Act: Ill-advised “right to try” goes federal

Not too long ago, I expressed alarm at a series of bills that were popping up like so much kudzu in various state legislatures, namely “right to try” bills. Both Jann Bellamy and I warned that these bills gave a false illusion of hope to patients with terminal illnesses. Basically, these laws claim to grant the “right” of patients with terminal illnesses to access promising experimental medicines that have not yet been approved by the FDA. Indeed, these investigational drugs need merely to have passed phase I trials, and these “right to try” laws would allow them to be used in pretty much any human with a terminal illness who can persuade a pharmaceutical company to let them have such drugs. Of course, as I pointed out, such laws are based on a false premise, namely that there are lots of promising drugs out there that could save lots of lives of terminally ill patients, if only the hidebound FDA would get out of the way and let the people try them. The problem (besides the false assumption behind such laws) is that they are all state laws, and the FDA and federal law still trump state laws with respect to drug approval.

Apparently, advocates of “right to try” laws have gotten around to trying to take care of that little obstacle, too. I’m referring to a federal law under consideration in the House of Representatives and championed by the usual suspects, including the Alliance for Natural Health USA, a “health freedom” group that has yet to see a pro-quackery bill it doesn’t like.

In any case, at the time I originally learned about this bill, HR 4475, which was introduced by Rep. Morgan Griffith (R-VA) and entitled “The Compassionate Freedom of Choice Act of 2014,” its text hadn’t yet been published to the Congressional website. I did learn that the bill has been floating around for a while in various forms (for instance, former Representative Ron Paul (R-TX) apparently introduced it.) Now its text has been published, as Guy Chapman has noted. He calls it a “quack’s charter,” and he’s only off by a bit. The bill doesn’t go quite as far as he believes, but the bill is still plenty bad, man. If enacted, HR 4475 would amend the Food, Drug, and Cosmetic Act by inserting after section 561 (21 U.S.C. 360bbb) the text of HR 4475. This section of the Food, Drug, and Cosmetic Act is entitled “Expanded Access to Unapproved Therapies and Diagnostics,” and it’s the section of the act that regulates exactly that. The interesting thing is that this particular section of existing law is the framework under which the whole system of single patient INDs (also known as “compassionate use exemptions”) is already based. As I’ve described before, single patients can receive promising unapproved drugs under what’s known as a single patient IND, which has to be approved by the Institutional Review Board and the FDA and allows single patients to receive unapproved drugs. You can (and many have) argued that the single patient IND process is too cumbersome and restrictive, but HR 4475 seeks to (mostly) nuke this requirement. You’ll see what I mean in a minute.
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Posted in: Clinical Trials, Politics and Regulation

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Curing Hepatitis C: A Success Story and a Price Tag

Most people know about hepatitis B; babies get vaccinated for it at birth. But fewer people know about hepatitis C. C is actually more common than B, but most chronically infected people don’t know they have it. You might think ignorance is bliss, but patients who have no symptoms today may have liver cancer or a liver transplant in their future. Until recently, treatment for this stealth disease was disappointing, but according to three recent, large controlled studies published in The New England Journal of Medicine, the virus has been tamed. A short course of a new antiviral drug with few side effects was 99% effective in removing the virus from the blood.

History

In the beginning, there was jaundice. Patients turned yellow, developed flu-like symptoms, and sometimes died. Eventually doctors figured out that jaundice was a sign of liver disease and the condition was named hepatitis; and by the time I graduated from medical school in 1970, scientists had identified two viruses that caused infectious hepatitis: hepatitis A and B. Hepatitis A infection was transmitted by the fecal-oral route, usually by contamination of food; hepatitis B was transmitted by needles and blood products. Prevention was limited to good hygienic practices; treatment of acute hepatitis was limited to bed rest, supportive care, and IV fluids. Contacts could be given gamma globulin. In fulminant cases and chronic hepatitis, steroids were used. No treatment was very effective. Death and cirrhosis often ensued.
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Posted in: Clinical Trials, Pharmaceuticals

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Gluten-free skin and beauty products: Extracting cash from the gullible

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Even though yesterday was Easter, and, as unreligious as I am, I was still thinking of taking it easy, there was one target that popped up that I just couldn’t resist. My wife and I were sitting around yesterday reading the Sunday papers and perusing the Internet (as is frequently our wont on Sunday mornings), when I heard a contemptuous harrumph coming from her direction. She then pointed me to an article in our local newspaper entitled Gluten-free beauty products in demand among some customers. Now, I must admit that I haven’t been keeping up with the gluten-free trend, other than how easily it fits within the niche of “autism biomed” quackery, where, apparently, nearly every “biomed” protocol for autistic children demands that gluten be stripped completely from their diets, lest the evil molecule continue to infect them with the dreaded autism. I’ve kept an eye the literature, but haven’t really written about gluten. That’s why I could immediately tell why my wife had called my attention to the article:

Amy Soergel’s lip gloss was making her sick. The problem, she realized, was gluten — hydrologized wheat protein, to be exact. Then she went to the hairdresser who used a shampoo that made her neck burn. Again, it contained gluten.

“There’s hidden gluten in many places you may not consider,” including stamp and envelope glues, toothpaste and lip balms, said Soergel, who has a store, Naturally Soergel’s, near Pittsburgh that caters to people with allergies. Indeed, for people with celiac disease, a bit of gluten that might get swallowed from a lipstick or a stream of shampoo in the shower can be enough to cause illness.

A slew of gluten-free skin care products have come on the market, including items from well-known companies such as Murad, Dr. Hauschka, EO, MyChelle, Suntegrity, Acure and derma-e. Many are sold in Whole Foods and other health food stores. If they’ve been certified by a third-party agency, an icon usually appears on the packaging.

Whole Foods. Of course, it had to be Whole Foods (among others). Let’s take a look at the whole gluten-free movement and then at the end I’ll revisit the question of gluten-free cosmetics and skin products.
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Posted in: Basic Science, Clinical Trials, Nutrition

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New evidence, same conclusion: Tamiflu only modestly useful for influenza

Tamiflu

Does Tamiflu have any meaningful effects on the prevention or treatment of influenza? Considering the drug’s been on the market for almost 15 years, and is widely used, you should expect this question has been answered after 15 flu seasons. Answering this question from a science-based perspective requires three steps: Consider prior probability, be systematic in the approach, and get all the data. It’s the third step that’s been (until now) impossible with Tamiflu: Some data was unpublished. In general, there’s good evidence to show that negative studies are less likely to be published than positive studies. Unless unpublished studies are included, systematic reviews are more likely to miss negative data, which means there’s the risk of bias in favor of an intervention.

The absence of a full data set on Tamiflu (oseltamivir) and the other neuraminidase inhibitor Relenza (zanamivir) became a rallying point for BMJ and the AllTrials campaign, which seeks to enhance the transparency and accessibility of clinical trials data by challenging trial investigators to make all evidence freely available. (Reforming and enhancing access to trial data was one of the most essential changes recommended by Ben Goldacre in his book, Bad Pharma.) In 2009, Tamiflu’s manufacturer, Hoffman-La Roche committed to making the Tamiflu data set available to investigators. Now after four years of back-and-forth between BMJ, investigators, and Roche, the full clinical trials data set has been made freely available. An updated systematic review was published today in BMJ (formerly The British Medical Journal), entitled “Oseltamivir for influenza in adults and children: systematic review of clinical study reports and summary of regulatory comments.” This will be a short post covering the highlights. As the entire study and accompanying data are freely available, I’ll await continued discussion in the comments. (more…)

Posted in: Clinical Trials, Pharmaceuticals, Public Health

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

Mark Crislip, founder of the Society for Science-Based Medicine, whose board of directors I’m proud to be serving on, an organization that you should join if you haven’t already, sometimes jokes that our logo should be an image of Sisyphus, the king of Ephyra whom Zeus punished by compelling him to roll an immense boulder up a hill. However, the boulder was enchanted and, as soon as Sisyphus reached the top, it would roll back down the hill. Sisyphus was thus forced to repeat this action throughout all eternity. The metaphor is obvious. Those of us who try to combat quackery and the infiltration of pseudoscience in medicine often feel a lot like Sisyphus. I always used to argue that, as amusing as it might be to have such a logo as an “in” joke, it’s far too much of a downer to inspire what SSBM wants to inspire: Action in the form of volunteers taking on projects, such as converting Quackwatch into a wiki and then continuously updating and adding to that wiki indefinitely. We have to believe that there is hope of someday succeeding. “Let’s push that boulder up a hill one more time!” does not exactly constitute an inspiring rally cry, although I can definitely understand the feeling at times the older I get and the longer I’ve been doing this. We can all appreciate gallows humor at times, and, besides, I’m not that pessimistic. I can’t afford to be.

Even so, I can understand the Sisyphus analogy right now with respect to an unfortunately frequent subject of this blog, the doctor in Houston who proclaims himself a cancer doctor, even though he has no formal training in medical oncology, isn’t even board-certified in internal medicine, the prerequisite for undertaking advanced training in medical oncology, and has no discernable training in clinical trials management. I’m referring, of course, to Stanislaw Burzynski, MD, PhD, the Polish doctor who since 1977 has been treating patients with substances that he has dubbed “antineoplastons” (ANPs). What are ANPs? Burzynski claimed to have discovered ANPs during his time at Baylor and described them as endogenous cancer-fighting chemicals in human blood and urine. Unfortunately, he soon became convinced that only he could develop them into an effective chemotherapy drug and left Baylor to administer ANPs to his own cancer patients. Patients flocked to him because he claimed to be able to cure cancers that conventional medicine can’t cure.

This led to a series of battles between Burzynski and various authorities, including the Texas Medical Board, the FDA, and various attorneys general, because of his use of ANPs, which are not and never have been FDA approved, as well as for various—shall we say?—issues with insurance companies. Ultimately, in the 1990s Burzynski beat the rap and effectively neutered the FDA’s case against him by submitting dozens of clinical trials to the FDA for approval, which, given how much pressure the FDA was under from Burzynski’s friends in high places (like Texas Representative Joe Barton), the FDA ended up approving. However, as Burzynski’s lawyer himself bragged, these clinical trials were shams designed to allow Burzynski to keep treating cancer patients, not clinical trials designed to produce any real evidence of efficacy. Not surprisingly, although Burzynski has published the odd case report or tiny case series, he has not yet published the full results of even a single one of his many phase II trials. There is, quite simply, no convincing evidence that ANPs have significant antitumor activity in vivo in humans, even after 37 years. Meanwhile, the FDA has found numerous examples of Burzynski’s abuse of clinical trials, failure to keep necessary data, and failure to protect human subjects, while exposés by BBC Panorama and Liz Szabo at USA TODAY have been most unflattering, revealing at least one dead child as a result of the toxicity of Burzynski’s drug and a pattern of minimizing and hiding reports of adverse reactions.
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Posted in: Cancer, Clinical Trials, Politics and Regulation

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