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Threats to science-based medicine: When clinical trials for new drugs are designed by the marketing division

ResearchBlogging.orgTHREATS TO SCIENCE-BASED MEDICINE

The theme of this blog is science-based medicine. It’s even the name given the blog by our fearless leader, Steve Novella. By “science-based” medicine we generally mean medicine that is both grounded in scientific plausibility based on our best understanding of human physiology and disease as well as in strong evidence from well-designed clinical trials, both of which are extremely important We SBM bloggers tend to concentrate mainly on so-called “alternative,” “complementary and alternative,” or “integrative” medicine because it does indeed represent a major threat to the consensus among medical professionals that medicine should be science- and evidence-based. Moreover, the infiltration of pseudoscientific and antiscientific woo into medical schools, academic medical centers, and medicine at large, coupled with large amounts of money going to promote CAM, both from the government and wealthy private foundations, does represent an extremely worrisome trend that makes all of us, who range from mid-career to retired physicians, fear for the future generation of physicians and their ability to apply science and critical thinking to the evaluation of implausible health claims, such as reiki, homeopathy, applied kinesiology, and the large variety of woo that falls under the rubric of CAM. Worse, this trend began not long after a concerted push to make medicine more science- and evidence-based and less dogma- and authority-based.

Unfortunately, though, the antiscience of implausible health claims is not the only threat that science-based medicine faces. We bloggers here at Science-Based Medicine concentrate on it because its resurgence and infiltration into the very heart of academic medicine represent a sea change in the culture of scientific medicine, which once rightly and without reservation rejected much of what CAM represents as quackery. Also, I can’t speak for others, but pseudoscience interests me; it brings up questions of why people believe irrational and clearly false propositions. That being said, at the risk of ruffling a few feathers among my co-bloggers, I have observed that, if there is one thing that this blog has not to this point emphasized sufficiently, it’s that the commerce of medicine, the very manner in which we develop new therapies, can, if not carefully observed and regulated, represent a threat to science-based medicine even more potent than Andrew Weil, David Katz, and their all-out assault on the very foundations of scientific medicine and drive to return medicine to the days of anecdote-based rather than science-based medicine.

I’m talking about pharmaceutical companies. I’m also about to destroy any opportunity I might ever have to work for or receive any funding from Merck & Company. C’est la vie. A skeptical doc’s got to do what a skeptical doc’s got to do. Not that I won’t at least partially protect myself by adding the disclaimer that the following represents my opinion, and my opinion alone. It does not represent the opinion of my university, cancer institute, or partners.

Now that that’s taken care of, let’s start with a little primer on a pernicious phenomenon known as the “seeding trial.”
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Posted in: Clinical Trials, Medical Ethics, Pharmaceuticals, Politics and Regulation

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Science, Reason, Ethics, and Modern Medicine, Part 5: Penultimate Words

My Discussion with Dr. P

After last week’s post, Dr. Peter Moran answered with more salient points. I’ll spend this week discussing those, because I share Dr. Moran’s “interest in examining the kind of messages we are putting out.” Acknowledging the inequality inherent in his not being the blog author, I’ll offer the last word to Dr. Moran by ending this series* and letting whatever comments he may have in response to today’s post be the last, at least for now.

Here is Dr. Moran’s response to my response:

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Posted in: Medical Ethics, Politics and Regulation, Science and Medicine

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Politics of N of 1 pseudoscience

More Politics

Medicine’s ethics and basis in science hang by a thread at times. At least in the US of A. I will present a few examples and illustrate them with correlates from other fields in which decisions with wide effects are sometimes made by the whim of one person. And that’s not just the declaring of war or whatever we call it these days.Start with an anecdote of mine from the mid-1970s or so. I somehow got involved in a dispute with the staff of then Gov. Jerry Brown over his proposal to de-license medical practice. He sent out early holistic medicine vibes and viewed health and medicine as fields open to anyone to practice by simply hanging out a shingle. I asked to meet with my state assemblyman and complained about the situation. I stated that physicians determined what medical practice is. He smiled benevolently and broke the news. “No, doc, we (in state government) do.“

I immediately recognized what he was saying. All licensure is granted by the state, and all regulations and laws referring to each occupation’s license are determined essentially by a majority vote and a governor’s signature. All those heroes in the history of medicine and science not withstanding. It was an awakening.

Jerry Brown’s vision did not materialize and he came to recognize holistic and alternative medicines as so much goofy stuff and quackery, as he later confided at a fund-raiser (yes, I went.)

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Posted in: Medical Ethics, Politics and Regulation, Science and Medicine

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Animal rights terrorists endanger science-based medicine

I’m a bit ticked off right now, enough that I thought I’d break with tradition and do an extra post today. Don’t worry; it’ll be brief. It will also be angry, more so than you are perhaps used to hearing on this blog. However, I think my anger is justified, and I hope that Steve Novella–and you–will understand. I view the problem that I am about to discuss to be at least as serious a threat to science-based medicine as any infiltration of woo into medical schools or residency programs.

Remember back in February, when I discussed how animal rights terrorists had been harassing a researcher at the University of California Santa Cruz (UCSC)? At the time, protesters attempted a home invasion of a researcher, leading to a police response where a home was searched by the police. This time around, however, these animal rights thugs have turned violent–again:

SANTA CRUZ — The FBI today is expected to take over the investigation of the Saturday morning firebombings of a car and of a Westside home belonging to two UC Santa Cruz biomedical researchers who conduct experiments on animals.

Santa Cruz police officials said Sunday the case will be handed to the FBI to investigate as domestic terrorism while local authorities explore additional security measures for the 13 UCSC researchers listed in a threatening animal-rights pamphlet found in a downtown coffee shop last week.

“The FBI has additional resources and intelligence into groups and individuals that might have the proclivity to carry out this kind of activity,” police Capt. Steve Clark said. “The FBI has a whole other toolbox of tools for this kind of investigation.”

The front porch of a faculty member’s home on Village Circle off High Street was hit with a firebomb about 5:40 a.m. Saturday, police said. The bomb ignited the front door of the home and filled the house with smoke, police said. About the same time, a Volvo station wagon parked in a faculty member’s on-campus driveway on Dickens Way was destroyed by a firebomb, police said.

Clark described the bombs as devices, which he said investigators have seen used by animals rights activists in the past, as “Molotov cocktail on steroids.”

That no one was seriously injured or died, especially the researcher’s children, is incredibly fortunate. As in previous cases, these two firebombing attacks were the culmination of a campaign of intimidation:

This appears to be the latest in a string of incidents targeting UCSC researchers and others in Santa Cruz.

Fliers identifying 13 UCSC scientists, some of whom use mice, fruit flies and other nonprimate creatures in their research, were discovered at a downtown coffee shop Tuesday. The fliers say, “Animal abusers everywhere beware; we know where you live; we know where you work; we will never back down until you end your abuse.” The names, home addresses, home phone numbers and photos of researchers were published on the fliers.

Fruit flies? Drosophila? How messed up do you have to be to threaten violence over Drosophila experiments? Why aren’t they threatening violence over the trillions upon trillions of E. coli or yeast that die in the name of science in molecular biology labs every day?
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Posted in: Basic Science, Medical Academia, Politics and Regulation, Science and Medicine

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HPV vaccination misinformation and bias in Medscape

Like many physicians, I often peruse Medscape. It’s generally been a convenient and quick way to catch up on what’s going on in my field not directly related to my research, for which I tend to rely on pre-configured RSS feeds for PubMed searches to highlight any articles related to my areas of interest. Since these searches routinely flag hundreds of articles a week whose titles and abstracts I end up perusing, sometimes only cursorily to identify the articles I might want to read, it is impractical for me to rely on this approach for areas that are even only a bit out of my field. That’s where, at least so I thought, services like Medscape came in handy. I could look over stories and quickly find out about research and medical of interest to me, only occasionally needing to look up the actual journal articles. Like a fair number of physicians, I rely on it fairly regularly. I should also point out that Medscape sometimes even tries to go against the tide of woo, as it did when it published an article by authored by two of my co-bloggers, along with two others. The article, authored by Kimball C. Atwood IV, MD; Elizabeth Woeckner, AB, MA; Robert S. Baratz, MD, DDS, PhD; and Wallace I. Sampson, MD, entitled Why the NIH Trial to Assess Chelation Therapy (TACT) Should Be Abandoned, was a tour de force deconstruction of why TACT is bad science and unethical to boot.

So how to explain an article published in Medscape last week and authored by Alison Gandey entitled HPV Vaccine Adverse Events Worrisome Says Key Investigator?
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Posted in: Politics and Regulation, Public Health, Science and the Media, Vaccines

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Parody beats political analysis

When out of town this past week I was bereft of tantalizing subjects, with our 5 other bloggers covering so many topics so well. I was about to toss in an empty towel, when two news absurdities fell into my driveway in the pages of the SF Chronicle. One was this morning’s (7/23) report that one Dragan Dabic, an alternative medicine healer had been captured in Belgrade, Serbia. He was Radovan Karadzic, former Serbian Prime Minister and acknowledged immediate archtect of the 1990s massacres of Bosnia-Herzagovena Muslims. Like Saddam Hussein, he had been a fugitive for years, and was found in an unusual place in an unusual disguise. What more need be said about this former psychiatrist and presumed war crimes mass murderer changing occupations in midlife to alternative healing? Complete with full beard and pony tail, yet. Does this give some clue to some personality types that drift toward junk medicine? One could say the disguise was intentional and had nothing to do with personality. Perhaps. Perhaps. But the situation reinforces my theory that most “CAM”mers are at least intellectual psychopaths – renegades from reason. The picture of Karadzic brings to mind pictures of others with full beards and hidden finger salutes to reason and authority.

The second absurdity was in a recent cartoon subtitled, “The lies behind the truth and the truth behind those lies that lie behind that truth…” So reads the title explanation for Don Asmussen’s “Bad Reporter” comic in the SF Chronicle.

Asmussen parodies headlines by combining them absurdly with commentaries that “explain” the absurd headlines with even more absurd hypothetical events. In these days of absurd happenings, I find Asmussen the right stuff remedy for us perplexed realists who “…cannot believe this is happening.” My mental health now depends on Asmussen and nighttime doses of Phil Hendrie Show. Nothing like satire to put into perspective interest in “alternative medicine” and qualifications and characteristics of presidential candidates.

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Posted in: Nutrition, Politics and Regulation, Science and the Media

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Resistance is futile? Hell, no! (A call to arms)

Well, I won’t back down
No, I won’t back down
You can stand me up at the gates of hell
But I won’t back down

Gonna stand my ground
Won’t be turned around
And I’ll keep this world from draggin’ me down
Gonna stand my ground
And I won’t back down

From “I Won’t Back Down” by Tom Petty, 1989

This week, in a little bit of a departure, I have a minor bone to pick with our fearless leader and his podcast partner in crime Rebecca Watson (a.k.a. the Skepchick), who both managed to annoy me a bit the other day. (Don’t worry, Steve and Rebecca, I still love you guys…)

I’ll explain. You see, I had originally had a much different topic in mind for this week. Indeed, I even had my post mostly written by Saturday morning, when I had to take care of some mundane personal business, namely getting an oil change and some minor work done on my car. Since I need my car to commute to work and the maintenance needed was relatively minor, I decided to wait for the work to be done. As is my wont when sitting in waiting rooms with nothing much else to do, I decided to plug my earphones into my iPhone and catch up on some podcasts. Since the dealer also had free wifi, I brought my laptop along as well, the better to finish up my originally intended post.

The first thing I realized as I perused the list of unlistened-to podcasts was that I had fallen far behind in listening to one of my favorite podcasts, The Skeptics’ Guide to the Universe. To begin catching up, I decided to start with what was at the time the most recently available episode, specifically the July 9 podcast, figuring I could work my way back to through the earlier ones and thereby catch up with at least two episodes before my car was ready. In the second segment (beginning around 14:31 minutes into the podcast), Steve Novella and crew discussed a bit the recent news that the National Institute of Mental Health was trying to resurrect a dubious and highly unethical clinical trial proposed to test chelation therapy as a treatment for autism, referencing his excellent post on this very blog about why the trial is scientifically dubious (at best) and totally unethical. So far, so good.

Then the conversation veered into another area that I agree with, namely the utter uselessness of National Center for Complementary and Alternative Medicine (NCCAM) and how its main purpose is more proselytization for “alternative” and “complementary” medicine than actual rigorous scientific research, as I pointed out before in one of my earliest posts for SBM. As Steve pointed out that, for all the hundreds of millions of dollars spent by NCCAM, not a single new medicine or treatment has been added to the armamentarium of modern medicine, nor, even more importantly, have CAM practitioners abandoned a single bit of unscientific medicine due to any of the negative studies. Indeed, their enthusiasm hasn’t been dampened in the least. This line of discussion led to the question of whether we, as skeptics and advocates of science- and evidence-based medicine need to rethink and refocus our efforts.
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Posted in: Medical Academia, Politics and Regulation, Science and Medicine, Science and the Media

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Another State Promotes the Pseudoscientific Cult that is “Naturopathic Medicine.” Part 4

The “Science” and Ethics of “Natural Medicines” (and Nutrition) cont.

This is the continuation of a discussion concerning the explicit claim of “naturopathic physicians”* to being experts in the use of “natural medicines,” defined as “medicines of mineral, animal and botanical origin.” Last week’s post established that the cult has chosen to profit from the “retail selling of medications,” as evidenced by the relevant Position Paper of the American Association of Naturopathic Physicians (AANP) and by that organization’s having made a deal with a drug company to make profits for both itself and its members.

The Position Paper observes that such selling “could be construed as a conflict of interest on the part of the physician.” That is true, if embarrassingly understated: anyone representing himself as a physician, who both recommends and sells the same medications for a profit, has conflicting interests. The conflict undermines his claim to offering responsible advice regarding those medications, and as such is a breach of medical ethics.

The AANP’s deal with MotherNature.com was even worse: by promoting such peddling in a formal, institutional fashion, NDs and their national organization went beyond the already widespread problem of practitioners hawking drugs. It is unclear whether the deal still exists, by the way: MotherNature.com was a victim of the “dot com” bust of a few years ago. It has since been resurrected, but a quick perusal of its new website fails to reveal the old AANP relationship. Nevertheless, I have seen no evidence to suggest that the AANP has changed its view of that sort of deal.

Are NDs Truly “Learned Intermediaries” in the Use of “Natural Medicines?”

This entry discusses the other part of the claim of expertise: that, aside from their conflicting interests, NDs have real knowledge of “natural medicines.” It will become clear during the discussion that the purported naturopathic expertise in nutrition—another standard claim—is also under review. I will include or cite abundant evidence for my assertions, because I’ve found that a predictable response of representatives of the highest levels of “naturopathic medicine” is to flatly deny them. I apologize again for including excerpts from previously published material.

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Posted in: Book & movie reviews, Health Fraud, Herbs & Supplements, Medical Ethics, Nutrition, Politics and Regulation

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Chiropractic Strokes Again! A Landmark Lawsuit in Canada

Sandra Nette is a prisoner, condemned to spend the rest of her life in the cruelest form of solitary confinement. Her intact mind is trapped in a paralyzed body and she is unable to speak. She can move one arm just enough to type on a special keyboard. She cannot swallow or breathe on her own, and must be frequently suctioned. She feels sensations and is in pain. Her condition is known as “locked-in syndrome” and has been described as “the closest thing to being buried alive.” She is suing those responsible for her cruel fate and I hope she wins.

She was a healthy 40 year old woman who wanted to stay healthy. She did all the right things like watching her weight, eating right, and not smoking. She followed the advice of a chiropractor to include regular maintenance chiropractic adjustments in her health regimen. On September 13, 2007 she had the last adjustment she would ever have.

There was nothing wrong with her. She didn’t see the chiropractor for headaches, neck pain, back pain or any other complaint. She went for a “tune-up” that she thought would help keep her healthy. The chiropractor did a rapid-thrust adjustment on her neck. Right afterwards, she complained of feeling “sore, dizzy and unwell.” She tried to leave but had to sit down. The chiropractor failed to recognize the medical emergency, and instead of calling an ambulance he recommended that she would benefit from purchasing massage therapy from his clinic. He let her leave the office and drive home alone. She only made it part way. (more…)

Posted in: Chiropractic, Health Fraud, Politics and Regulation

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Another State Promotes the Pseudoscientific Cult that is “Naturopathic Medicine.” Part 3

The “Science” and Ethics of “Natural Medicines”

This and the next entry in the current “Naturopathic Medicine” series* deal with the cult’s claim of expertise in “natural medicines” or “natural remedies.” These include herbs (“botanicals”), glandular extracts, vitamins, and minerals. A large fraction of the Textbook of Natural Medicine (TNM), “the most thoroughly researched and carefully referenced text on natural medicine,” is devoted to these agents.[1] They are keys to the practice of naturopathy and to a core claim of “naturopathic physicians” that legislators tend to swallow: that NDs offer something that most MDs do not.

During the deliberations of the Massachusetts Special Commission, NDs produced Dr. Alan Trachtenberg, a fresh-faced ingenue who had briefly been Acting Director of the federal Office of Alternative Medicine, to testify on their behalf. He suggested to the Commission that naturopaths could be the “learned intermediaries” that the public needed to help make sense of the myriad “natural remedies” that became freely available in the wake of the Dietary and Supplement Health and Education Act of 1994 (DSHEA). This is from his written testimony:

Another advantage of state licensure, is that the holder of a professional license who provides or recommends a product, then becomes responsible for the quality and safety of a product. In an unregulated marketplace, such a learned intermediary can be invaluable to the consumer. Since naturopaths do often provide dietary supplements and herbal products directly to their patients, it is vital that they have an enforceable code of professional ethics. Such a code of ethics becomes enforceable with State licensure.

It is also beneficial for the patient to have a practitioner who knows enough about biochemistry, physiology, pharmacology, and physical diagnosis to adequately assess a patient’s clinical response to a product. These products are essentially complicated but unregulated drug mixtures. My understanding is that licensable naturopathic doctors have all taken these courses during their four years of training and passed standardized exams that test their mastery. There is no such quality assurance for the other kind of naturopathic practitioner.

Instead of relying on Dr. Trachtenberg’s “understanding,” let’s submit his two assertions—that of a “code of ethics” and that of “mastery” of the topic of “natural medicines”—to real scrutiny. In doing so I confess that I have plagiarized, to some extent, pieces that I’ve written elsewhere.

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Posted in: Health Fraud, Herbs & Supplements, Medical Ethics, Politics and Regulation

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