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Archive for Science and Medicine

Ghostwriting As Marketing Tool

An article in the latest issue of PLOS Medicine, The Haunting of Medical Journals: How Ghostwriting Sold “HRT”, details the use of ghostwriting as a marketing tool for pharmaceutical companies. It is a chilling discussion of how at least one pharmaceutical company, Wyeth, used the peer-reviewed literature as a method of distributing marketing messages to physicians.

The author, Adriane J. Fugh-Berman, details a practice that cuts at the heart of science-based medicine – the exploitation and distortion of the literature. The medical profession needs to jealously guard the legitimacy and purity of the peer-review process and the medical scientific literature. I am never one to gratuitously bash “Big Pharma” – this is often used as a method of casually dismissing inconvenient scientific evidence. But at the same time, pharmaceutical companies are in the business of making money. While they are a carefully regulated industry, some in the industry seek ways to skirt around regulations that limit their ability to market their products.

While most physicians consider themselves savvy with respect to pharmaceutical marketing, the story told by Fugh-Berman is one of profound naivete. I guess it should not be a surprise that some academics were bamboozled by expert salespersons who spent a lot of time and effort, apparently, figuring out ways to deceive and manipulate them. But now that the story is out, naivete is no longer an excuse. Here is what happened:

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

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WHO Partnering with Traditional Healers in Africa

There is an AIDS epidemic in Africa, and efforts to fight it are hampered by the endemic social problems of that continent. Chief among them are the lack of sufficient modern health resources, the spread of destructive rumors and myths about HIV/AIDS, and even the persistence of HIV denial in Africa (although this last factor is better than in the past).

The World Health Organization (WHO) and the International HIV/AIDS Alliance are teaming up with the Traditional Health Practitioners Association of Zambia (THPAZ) to address the first problem – the lack of health services. Most Zambians use traditional healers for primary health care. The WHO has therefore decided to utilize traditional healers in the fight against AIDS. There are interesting pros and cons to this policy, but it must first be recognized that there is no ideal solution to the problem. The resources to provide optimal modern health care to treat and prevent HIV/AIDS (which would need to include a massive education program) in Zambia and the rest of Africa simply do not exist. One might argue that the world should provide those resources, but let’s put that issue aside and focus on what to do in the meantime.

The arguments given in favor of this WHO strategy are:

Traditional healers far outnumber biomedical workers in the rural areas.

They are consulted, not only because they are closer and more affordable than their Western-trained counterparts, but also because they are embedded, extensively and firmly, within Ugandan culture.

Traditional healers are highly respected and widely consulted by communities.

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Posted in: Public Health, Science and Medicine

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Reflexology. Insert Nancy Sinatra Reference Here.

Note:  I think the following post is perfect in terms of spelling and grammar.  It isn’t.  I am starting to think I have a language processing problem given the typo’s that seem to slip in to each post.  Be that as it may, there is a subset of readers who get their underoo’s in a twist at missing articles and apostrophes.  If you are one of those readers, come back in a day.  This post will be proofread and corrected, at which time this note will be missing and you can read the text without the pain of my poor grammar  skills.

In the last post on acupuncture, I noted that the University of Maryland offered, among other supplements, complementary and alternative medicine (SCAMs), reflexology.  I was uncertain as to the particulars of this SCAM, and this post is a result of those investigations. (more…)

Posted in: Energy Medicine, Science and Medicine

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Why bother?

It can be rather frustrating to refute the same old canards about alternative medicine.  There’s always been argument as to whether this is even useful.  Critics (some verging on “concern troll-ism”) argue that skeptics are convincing no one, others that we are too “dickish”. The first view is overly pessimistic (re: our impact), the second overly optimistic (re: the benign nature of our critics).   The truth always bears repeating, even at the risk of becoming the old guy at the end of the bar who always starts his stories off with, “Did I ever tell you…?”  The answer is always “yes” but if the story is good, and well-told, it may stand up to re-telling.

We tell many versions of the same story over and over, not just to entertain each other, but to refine our thinking, to convince those who can be convinced, and to point out the weakness in thinking apparent in others.  We do this not to be “dicks” but because repeated assaults on reason require repeated defense.   Scientific medicine gives us a powerful tool for analyzing new ideas and old ones dressed up in new clothes.  It allows us to find ourselves to be wrong in particular facts, if not in our overall approach.
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Posted in: Acupuncture, Science and Medicine, Science and the Media

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Does peer review need fixing?

One of the most important aspects of science is the publication of scientific results in peer-reviewed journals. This publication serves several purposes, the most important of which is to communicated experimental results to other scientists, allowing other scientists to replicate, build on, and in many cases find errors in the results. In the ideal situation, this communication results in the steady progress of science, as dubious results are discovered and sound results replicated and built upon. Of course, scientists being human and all, the actual process is far messier than that. In fact, it’s incredibly messy. Contrary to popular misconceptions about science, it doesn’t progress steadily and inevitably. Rather, it progresses in fits and starts, and most new scientific discoveries go through a varying period of uncertainty, with competing labs reporting conflicting results. To achieve consensus about a new theory can take relatively little time (for example, the less than a decade that it took for Marshall and Warren’s hypothesis that peptic ulcer disease is largely caused by H. pylori or the relatively rapid acceptance of Einstein’s Theory of Relativity) to much longer periods of time.

One of the pillars of science has traditionally been the peer review system. In this system, scientists submit their results to journals for publication in the form of manuscripts. Editors send these manuscripts out to other scientists to review them and decide if the science is sound, if the methods appropriate, and if the conclusions are justified by the data presented. This step of the process is very important, because if editors don’t choose reviewers with the appropriate expertise, then serious errors in review may occur. Also, if editors choose reviewers with biases so strong that they can’t be fair, then science that challenges such reviewers’ biases may never see print in their journals. The same thing can occur to grant applications. In the NIH, for instance, the scientists running study sections must be even more careful in choosing scientists to be on their study sections and review grant applications, not to mention picking which scientists review which grants. Biases in reviewing papers are one thing; biases in reviewing grant applications can result in the denial of funding to worthy projects in favor of projects less worthy that happen to correspond to the biases of the reviewers.

I’ve discussed peer review from time to time, although perhaps not as often as I should. My view tends to be that, to paraphrase Winston Churchill’s invocation of a famous quote about democracy, peer review is the worst way to weed out bad science and promote good science, except for all the others that have been tried. One thing’s for sure, if there’s a sine qua non of an anti-science crank, it’s that he will attack peer review relentlessly, as HIV/AIDS denialist Dean Esmay did. Indeed, in the case of Medical Hypotheses, the lack of peer review let the cranks run free to the point where even Elsevier couldn’t ignore it any more. One thing’s for sure. Peer review may have a lot of defects and blindnesses, but lack of peer review is even worse. It’s no wonder why cranks of all stripes loved Medical Hypotheses.
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Posted in: Medical Academia, Science and Medicine

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How to make a difference – Responsible vaccine advocacy

I lost a patient this season, an infant, to pertussis.  After falling ill he lived for nearly a month in the intensive care unit on a ventilator, three weeks of which was spent on a heart/lung bypass machine (ECMO) due to the extent of the damage to his lungs, but all our efforts were in vain.  The most aggressive and advanced care medicine has to offer couldn’t save his life; the only thing that could have saved him would have been to prevent him from contracting pertussis in the first place.

He was unvaccinated, but that was because of his age.  He was part of the population that is fully dependent on herd immunity for protection, and that is exquisitely prone to a life-threatening course once infected.  This is a topic we’ve covered ad nauseum, and I’m not inclined to go into greater depth in this post.  Suffice it to say his death is a failure at every level; we, both as medical professionals and as a society at large need to do a better job of protecting our children from preventable diseases. (more…)

Posted in: Public Health, Science and Medicine, Vaccines

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Homeoprophylaxis: An idea whose time has come—and gone

One of the strengths of modern medical education is its emphasis on basic science.  Conversely, the basic weakness of so-called alternative medicine is its profound ignorance of science and its reliance on magical thinking.  Nowhere is this more apparent than in the attempts of altmed cults to conduct and publish research.  From “quantum water memory” to “almost as good as placebo”, the altmed literature is filled with basic failures in the proper formulation and testing of hypotheses.

One of the finest examples of these failures was just published in the journal Homeopathy.  Leaving aside for the moment the absurdity of a journal devoted to magic, let’s see what they did here. (more…)

Posted in: Science and Medicine

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Alchemy Is Back

Alchemy is alive and well! Yes, that medieval precursor of chemistry, that chimerical search for the philosopher’s stone and the transmutation of lead to gold. Modern alchemists have found the philosopher’s stone and are selling it and teaching people how to make it themselves out of dew and Celtic sea salt.

The philosopher’s stone apparently is an elixir of life that you have to take on a regular basis. According to Nicholas Collette, it “completely eliminates the pharmaceutical industries by curing EVERY disease, and opens the mind to it’s [sic] full potential.”   It extends the life span, reverses the aging process, and opens the door to psychic power.

Instructions for making it are detailed on this website. It takes time and is complicated, but the starting ingredient is simple: morning dew.  (more…)

Posted in: Health Fraud, Science and Medicine

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Can it get any worse?: industrial bleach as cancer and HIV cure

On the heels of Scott Gavura’s superb post yesterday on dietary supplement regulation in the US and Canada, I bring you one of the most egregious and obscene product cases I have seen in 15 years of teaching on botanical and non-botanical products: Miracle Mineral Solution. Please accept my apologies in advance for not having a scholarly post for you today – this is just too unbelievable not to share with Science-Based Medicine readers.

On July 30, the FDA released this warning:


FDA NEWS RELEASE

For Immediate Release: July 30, 2010
Media Inquiries: Elaine Gansz Bobo, 301-796-7567, elaine.bobo@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA Warns Consumers of Serious Harm from Drinking Miracle Mineral Solution (MMS)
Product contains industrial strength bleach

The U.S. Food and Drug Administration is warning consumers not to take Miracle Mineral Solution, an oral liquid also known as “Miracle Mineral Supplement” or “MMS.”  The product, when used as directed, produces an industrial bleach that can cause serious harm to health.

The FDA has received several reports of health injuries from consumers using this product, including severe nausea, vomiting, and life-threatening low blood pressure from dehydration.

Consumers who have MMS should stop using it immediately and throw it away.

MMS is distributed on Internet sites and online auctions by multiple independent distributors. Although the products share the MMS name, the look of the labeling may vary.

The product instructs consumers to mix the 28 percent sodium chlorite solution with an acid such as citrus juice. This mixture produces chlorine dioxide, a potent bleach used for stripping textiles and industrial water treatment. High oral doses of this bleach, such as those recommended in the labeling, can cause nausea, vomiting, diarrhea, and symptoms of severe dehydration.

MMS claims to treat multiple unrelated diseases, including HIV, hepatitis, the H1N1 flu virus, common colds, acne, cancer, and other conditions. The FDA is not aware of any research that MMS is effective in treating any of these conditions. MMS also poses a significant health risk to consumers who may choose to use this product for self-treatment instead of seeking FDA-approved treatments for these conditions.

The FDA continues to investigate and may pursue civil or criminal enforcement actions as appropriate to protect the public from this potentially dangerous product.

The FDA advises consumers who have experienced any negative side effects from MMS to consult a health care professional as soon as possible and to discard the product. Consumers and health care professionals should report adverse events to the FDA’s MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm.


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Posted in: Cancer, Science and Medicine

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Supplement Regulation: Be Careful What You Wish For

A recurring theme at SBM is the regulation of supplements, and the impact and consequences of the Dietary Supplement Health and Education Act of 1994 (DSHEA). As one of SBM’s international contributors, I thought it might be helpful to look at how the DSHEA stacks up against the equivalent regulations of its neighbor to the north, Canada. Given the multiple calls for overhauls and changes to DSHEA, an international comparison may help focus the discussion around what a more science-based framework could look like.

Briefly, the DSHEA is an amendment to the U.S. Federal Food, Drug and Cosmetic Act that establishes a regulatory framework for dietary supplements. It effectively excludes manufacturers of these products from virtually all regulations that are in place for prescription and over-the-counter drugs. The FDA notes:

Generally, manufacturers do not need to register their products with FDA nor get FDA approval before producing or selling dietary supplements. Manufacturers must make sure that product label information is truthful and not misleading. FDA’s post-marketing responsibilities include monitoring safety, e.g. voluntary dietary supplement adverse event reporting, and product information, such as labeling, claims, package inserts, and accompanying literature. The Federal Trade Commission regulates dietary supplement advertising.

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Posted in: Herbs & Supplements, Politics and Regulation, Science and Medicine

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