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Are guidelines for calcium and vitamin D rooted in evidence, or vested interests?

B0003853 Osteoporotic bone - fully focused image Credit: Professor Alan Boyde. Wellcome Images images@wellcome.ac.uk http://images.wellcome.ac.uk Scanning electron micrograph of osteoporotic bone. This sample shows the 4th lumbar vertebra of an 89 year old woman with osteoporosis showing very thin, and some fractured trabeculae. This SEM image has been reconstructed from a series of images in different focal planes to give a completely focused picture of the bone. This enables a much clearer picture to be gained of the osteoclast resorption activity within the bone. The field of view is 2.7mm wide. Scanning electron micrograph Published:  -   Copyrighted work available under Creative Commons by-nc-nd 2.0 UK, see http://images.wellcome.ac.uk/indexplus/page/Prices.html

Osteoporotic bone. Are the mainstay treatments for osteoporosis prevention, calcium and vitamin D, truly useless?

Do osteoporosis guidelines overstate the benefits of calcium and vitamin D supplements? And is their continued presence due to vested interests and conflicts of interest? That’s the provocative argument made by Andrew Grey and Marc Bolland, two endocrinologists who recently detailed their analysis in The BMJ, in a paper entitled “Web of industry, advocacy, and academia in the management of osteoporosis” [PDF]. They introduce their case by noting:

For many years, recommendations for prevention and treatment of osteoporosis have included increasing calcium intake (by diet or supplements) and use of vitamin D supplements. Since the average dietary calcium intake in most countries is much less than that recommended by guidelines, many older people are advised to take calcium supplements to prevent osteoporosis. The recommendations have been implemented successfully: over half of older Americans take calcium and vitamin D supplements, either prescribed or over the counter, and bone health is the most common specific motivation for use of nutritional supplements. However, this behaviour does not reflect evidence that has emerged since 2002 that such supplements do not reduce the risk of fracture and may result in harm. Guideline bodies also continue to recommend calcium and vitamin D supplements. Here, we argue that change is made difficult by a complex web of interactions between industry, advocacy organisations, and academia.

Osteoporosis is a medical condition for which supplements have been considered an accepted part of conventional medicine for some time. Are conflicts of interest trumping good science? And are calcium and vitamin D supplements truly useless? Like many clinical questions, there is evidence to  support a range of opinions, and it’s very  difficult to state, with certainty, that one position is the correct one. Despite this, that’s the case that Grey and Bolland make in their analysis. (more…)

Posted in: Herbs & Supplements, Science and Medicine

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Conflicts of Interest

When an article is published in a medical journal, the authors must disclose any conflicts of interest. This is important, because even if they think owning stock in the drug company won’t influence their scientific judgment, we know that subtle biases can creep in to somehow affect the findings of studies. It has been shown that studies funded by drug companies are more likely to get positive results for their drug than studies funded by independent sources. Andrew Wakefield, author of the infamous retracted Lancet study suggesting a relationship between MMR vaccine and autism, was severely chastised for not disclosing that he received money from autism litigators and expected to earn a fortune from his own patented products if the MMR vaccine could be discredited.

I was recently contacted by an acupuncturist who plans to critique an article I wrote. It was a commentary in the journal Pain that accompanied a systematic review of systematic reviews of acupuncture by Ernst et al. For details of Ernst’s and my articles, see my previous post. He challenged my statement that I had no conflicts of interest to report. He apparently thinks I should have said I have a conflict of interest in that I am anti-CAM and anti-acupuncture. When he writes about my article, he plans to attack me for not declaring this alleged conflict of interest and he plans to set a good example with a conflict of interest statement of his own, divulging that he makes his living practicing acupuncture, has financial investments in it and many personal relationships, that his self-identity and prestige are dependent on his belief in acupuncture’s efficacy, and that he is biased towards constructivism and away from positivism. (I think this is a fancy way of saying he favors experience over the scientific method.) I agree that he has conflicts of interest, but was I wrong to say I had no conflicts of interest? I don’t think so. (more…)

Posted in: Science and Medicine

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In which Dr. Gorski once again finds himself a target of the “pharma shill” gambit

EDITOR’S NOTICE: NOTE THE DISCLAIMER. Also note that there is a followup to this post entitled The price of opposing medical pseudoscience that is highly recommended after you read this post.

The “pharma shill gambit”: The quack’s favorite flavor of ad hominem argument

One of the very favorite and most commonly used tactics to attack criticism in the armamentarium of pseudoscientists, cranks, and quacks (not to mention politicians) is the ad hominem fallacy. In this fallacy, rather than addressing the actual evidence and science that demonstrate their favorite brand of woo to be nothing more than fairy dust, the idea is to preemptively attack and discredit the person. The ad hominem is not just insults or concluding that someone is ignorant because, well, they say ignorant things and make stupid arguments (in which case calling someone stupid or ignorant might just be drawing a valid, albeit impolitic, conclusion from observations of that person’s behavior), but rather arguing or insinuating that you shouldn’t accept someone’s arguments not because their arguments are weak but because they have this personal characteristic or that or belong to this group or that. Truly, the ad hominem is right up there with demanding public “debates” with skeptics as a favored defense strategy of cranks of all stripes.

Among the very favorite flavors of ad hominem attack used by quacks, cranks, and pseudoscientists is the fallacy of poisoning the well. This particular fallacy alludes to the medieval European myth that the Black Plague was caused by Jews poisoning town wells. Not surprisingly, this myth was used as a justification for pogroms and the persecution of the Jews. The idea is to poison how others view your opponent by preemptively attacking them. Well do I know this fallacy, having been at the receiving end of it many times! Basically, it involves invoking something bad or biased about a person’s situation or personality and then using a phrase something like, “Of course he (or she) would say that” to dismiss a person’s arguments, the implication being that the person receives such benefits from holding the position being attacked or has such a personality that he couldn’t argue otherwise regardless of the evidence. In my admittedly anecdotal experience, far and away the most common use of the ad hominem from quacks and pseudoscientists is what I once described as “the pharma shill gambit.” The idea behind this gambit when it comes to attacking those of us who promote science-based medicine is to tar one’s opponent as being a “shill” for big pharma or claiming that we have a conflict of interest so blatant that “of course we would say that.” In most cases, the bogey man is big pharma, in whose pockets we SBM bloggers are supposed to be safely (and profitably) ensconced, blogging away in our underwear for big bucks and, following the orders of our supposed paymasters, attacking anything that has even a whiff of being “alternative” or that “questions” the safety and/or efficacy of vaccines.

While I realize that there is such a thing as an “astroturf” campaign, in the vast majority of cases, the pharma shill gambit is nothing more than the variant of the ad hominem fallacy known as poisoning the well. I also realize that conflicts of interest (COIs) matter, particularly undisclosed COIs. Indeed, I wrote a rather lengthy post (I know, I know, do I write any other length of post?) about 8 months ago laying out my views regarding COIs in science-based medicine. The short version is that we all have COIs of some sort or another, be they financial, belief-based, or emotional, and more disclosure is usually better, to let the reader decide for himself. As far as COIs related to big pharma or finances, I think Mark Crislip put it quite well in his most recent Quackcast when he said that if a study is funded by big pharma, he decreases the strength of the evidence in his mind by a set amount. However, evidence is evidence, and, although it is reasonable to increase one’s level of skepticism if there is a major COI involving the authors, be it big pharma or otherwise, it is not reasonable to use that COI as the sole reason for rejecting its findings out of hand. That’s just an intellectually lazy excuse to dismiss the study, nothing more. Indeed, one prominent difference between a scientist and a pseudoscientist or quack is that in general scientists understand this and struggle to assign the correct degree of skepticism due to a COI when analyzing scientific studies, while quacks and pseudoscientists do not. It’s far easier for them just to put their fingers in their ears and scream “Conflict of interest! Conflict of interest!” and then use that to dismiss completely their opponent’s argument. It’s simple, neat, and it doesn’t require all that nasty thinking and weighing of evidence..
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Posted in: Medical Ethics, Neuroscience/Mental Health, Public Health, Vaccines

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WHO, H1N1, and Conflicts of Interest

On June 11, 2009 Dr Margaret Chan, the director general of the World Health Organization (WHO) declared that the H1N1 flu that was then spreading around the world was an official pandemic. This triggered a series of built-in responses in many countries, including stockpiling anti-viral medications and preparing for a mass H1N1 vaccination program. At the time the flu was still in its “first wave” and the fear was that subsequent waves, as the virus swept around the world, would become more virulent and/or contagious – similar to what happened in the 1918 pandemic.

This did not happen. At least our worst fears were not realized. The H1N1 pandemic, while serious, simmered through the winter of 2009-2010, producing a less than average flu season, although with some worrisome difference.

The Centers for Disease Control (CDC) estimates:

  • CDC estimates that between 43 million and 89 million cases of 2009 H1N1 occurred between April 2009 and April 10, 2010. The mid-level in this range is about 61 million people infected with 2009 H1N1.
  • CDC estimates that between about 195,000 and 403,000 H1N1-related hospitalizations occurred between April 2009 and April 10, 2010. The mid-level in this range is about 274,000 2009 H1N1-related hospitalizations.
  • CDC estimates that between about 8,870 and 18,300 2009 H1N1-related deaths occurred between April 2009 and April 10, 2010. The mid-level in this range is about 12,470 2009 H1N1-related deaths.

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Posted in: Public Health

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Conflicts of interest in science-based medicine

The topic of conflicts of interest among medical researchers has recently bubbled up to the public consciousness more than usual. The catalyst for this most recent round of criticism by the press and navel-gazing by researchers is the investigation of Senator Charles Grassley (R-IA) of nine psychiatric researchers, one of which held $6 million in stock in a company formed to bring a drug for depression to market, but had allegedly concealed this, even though he was an investigator on an NIH grant to study the drug he was developing. From my perspective, there is more than a little politics going on in this story, given that for the last decade federal law, specifically the Bayh-Dole Act, and policy have actually encouraged investigators and universities to co-develop drugs and treatments with industry, but it does bring into focus the issue of conflicts of interest, in particular undisclosed conflicts of interest. There are two articles of note that recently appeared in the scientific literature discussing this issue, one in Science in July (about the Grassley investigation) and an editorial in the Journal of Psychiatry and Neuroscience by Simon N. Young, PhD, the Co-Editor-in-Chief of the journal and faculty at McGill University. I was more interested in the latter article because it takes a much braoder view of the issue. Science-based medicine (SBM) depends upon the integrity of the science being done to justify treatments; so it’s useful to discuss how conflicts of interest intersect medical research.

In most public discussions of conflicts of interest (COIs), Young notes, the primary focus is on payments by pharmaceutical companies to investigators. Make no mistake, this is a big issue, but COIs are not just payments from drug companies. Indeed, I’ve written about just such COIs that have arguably impacted patient care negatively right her on this very blog, for example seeding trials (in which clinical trials are designed by the marketing division of pharmaceutical companies), a case of fraud that appeared to have been motivated by COIs. What needs to be understood is that every single scientific and medical investigators have COIs of one sort or another, and many are not financial. That’s why I like Young’s introduction to what COIs are:
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Posted in: Clinical Trials, Medical Academia, Politics and Regulation, Vaccines

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Harvard Medical School: Veritas for Sale (Part I)

Several years ago I stumbled upon disturbing information regarding my alma mater, the Harvard Medical School (HMS).† Its professed commitment to investigate implausible medical claims had somehow metamorphosed into the advocacy of such claims. I’ve previously mentioned some of this on SBM (here and here). A couple of pertinent essays appeared in the public domain in 2002 and 2003, but the full story was much more involved than those pieces revealed. In the wake of recent posts on SBM about medical schools exposing students to uncritical portrayals of pseudomedicine, it seems appropriate to tell more of it. I’ve also decided to name names, which is something that I would have been reticent to do a few years ago. The basis for that decision will become clear over the next few posts, I trust. This topic will require at least three posts.

My discovery that HMS had begun promoting pseudoscientific medical claims was occasioned by my experience on the Massachusetts Special Commission on Complementary and Alternative Medical Practitioners, which met from the fall of 2001 to the winter of 2003. Another member of that commission was David Eisenberg, the Director of the Harvard Medical School Center for Alternative Medicine Research and Education (CAMRE) and of the new Osher Center for Complementary and Integrative Medical Therapies. Dr. Eisenberg is best known for his 1993 article reporting the use of ‘unconventional therapies’ by Americans. He had been appointed to the commission by the MA Commissioner of Public Health at the time, Dr. Howard Koh–whom President Obama has recently nominated to be Assistant Secretary of HHS. I assumed then, and still do, that Dr. Koh presumed Dr. Eisenberg to be an objective expert on “CAM,” since that was the persona presented by HMS and by Dr. Eisenberg himself. I had my doubts, but before then I’d not bothered to look into the matter.

It was during commission meetings, when I had the opportunity to hear what Dr. Eisenberg and his surrogate had to say or not to say and when I examined some of their writings and funding sources, that I began to realize how far his project was deviating from what I imagined to be the agenda of HMS. Some of what I saw amounted to frank dishonesty: failure to disclose obvious conflicts of interest to the Commission, for example. I also discovered public promotions of dubious “CAM” practices and practitioners by the CAMRE, in spite of its formal purpose being that of investigating “CAM” practices in an attempt to find out if any might be useful. I was concerned enough to look at other “CAM” information offered in the name of Harvard, and I found more worrisome examples.

I also attended the Feb., 2001 Harvard Complementary and Integrative Medicine Course, directed by Dr. Eisenberg (here is a link to the similar 2002 course brochure). A few of the talks were reasonable, if banal. I did my best to give them the benefit of the doubt, because I still could not accept that HMS would seriously consider homeopathy, ‘life-force,’ and ‘subluxations’ as being worthy of study, much less advocacy. After attending a semi-rigorous talk on raw herbs as medicines (the presenter discussed some studies but not the looming question of why whole herbs might be preferable to purified molecules), I ran into Eisenberg and did my best to be polite and encouraging. I shouldn’t have, because most of the content of the course was misleading and pseudoscientific. Overall, its tone was more like a political rally or a religious revival than a scientific conference.

At that course I ran into Russell Phillips, who had been in my group of interns at the Beth Israel Hospital (Boston) in 1979. I’d seen him around from time to time over the years, and I’d known that he’d stayed on at the BI after his residency. I was surprised, however, to learn that he was now the Director of the Harvard CAMRE Fellowship program. I was even more surprised to learn, during a short conversation with him, that he was innocent of the chiropractic ‘subluxation theory’ and that he’d never heard of Quackwatch. It seemed to me that there was either a surprising naïveté among this crowd or an attempt by some to shun unpleasant information. (more…)

Posted in: Medical Academia, Science and Medicine

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