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Osteoporosis Drugs: Good Medicine or Big Pharma Scam?

A recent story on NPR accused the drug manufacturer Merck of inventing a disease, osteopenia, in order to sell its drug Fosamax. It showed how the definition of what constitutes a disease evolves, and the role that drug companies can play in that evolution.

Osteoporosis is a reduction in bone mineral density that leads to fractures. The most serious are hip fractures, which require surgery, have complications like blood clots, and carry a high mortality. Many of those who survive never walk again. Vertebral fractures are common in the osteoporotic elderly and are responsible for dowager’s hump and loss of height. There is also an increased risk of wrist and rib fractures.

Bone density tends to decrease with age. Postmenopausal women are particularly susceptible to osteoporosis when their production of estrogen declines. The risk is increased in people taking corticosteroids and in people with certain diseases like rheumatoid arthritis. Other risk factors are European or Asian ancestry, smoking, excess alcohol, a family history of fractures, vitamin D deficiency, too much or too little exercise, malnutrition, and low body weight.

When a measurement like bone density varies widely in a population and decreases with age, how can we decide where to draw the line and call it abnormal? When does it become a disease requiring treatment? (more…)

Posted in: Pharmaceuticals

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The anti-vaccine movement strikes back against Dr. Paul Offit

In my five years in the blogosphere, two years blogging for SBM, and over a decade in Internet discussion forums about medicine and “alternative” medicine, I’ve learned a few things. One thing that I’ve learned is that one of the biggest differences between those whose world view is based on science and who therefore promote science-based medicine and those promoting pseudoscience, quackery, and anti-science is that science inculcates in its adherents a culture of free, open, and vigorous debate. Indeed, to outsiders, this debate can seem (and sometimes is) vicious. In other words, if you’re going to be a scientist, you need to have a thick skin because you will have to defend your hypotheses and conclusions, sometimes against some very hostile other scientists. That same attitude of a Darwinian struggle between scientific ideas, with only those best supported by evidence and with the most explanatory power surviving, is a world view that those not steeped in science have a hard time understanding.

Among those who don’t understand science, few have a harder time with the rough-and-tumble debate over evidence and science that routinely goes on among scientists than those advocating pseudoscience. Indeed, in marked contrast to scientists, they tend to cultivate cultures of the echo chamber. Examples abound and include discussion forums devoted to “alternative” medicine like CureZone, where never is heard a discouraging word — because anyone expressing too much skepticism about the prevailing view on such forums invariably finds himself first shunned by other members of the discussion forums and then, if he persists, booted from the forum by the moderators. In marked contrast, on skeptical forums, most of the time almost anything goes. True, the occasional supporter of woo who finds his way onto a skeptical forum will face a lot of criticism, some of it brutal. However, rarely will such a person be banned, unless he commits offenses unrelated to his questioning of scientific dogma, such as insulting or abusive behavior towards other forum participants or trolling. Such people may annoy the heck out of us skeptics sometimes, but on the other hand, they do actually from time to time challenge us to defend our science and prevent us from becoming too complacent. Indeed, that’s what I like about skeptics and being a scientist. Nothing or no one is sacred.
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Posted in: Chiropractic, Politics and Regulation, Public Health, Vaccines

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The life cycle of translational research

ResearchBlogging.orgI’m a translational researcher. To those of you who aren’t familiar with what that means, it means (I hope) that I study potential therapies in the lab and try to translate them into actual therapies that will cure patients of breast cancer — or, at the very least, improve their odds of survival or prolong survival when cure is not possible. Translational research is extremely important; indeed, it is the life blood of science-based medicine, with basic science producing the discoveries and clinical research the applications of these discoveries. When it works, it’s the way that science leads medicine to advance. However, sometimes I think that it’s a bit oversold. For one thing, it’s not easy, and it’s not always obvious what basic science findings can be translated into useful therapies, be it for cancer (my specialty) or any other disease. For another thing, it takes a long time. The problem is that the hype about how much we as a nation invest in translational research all too often leads to a not unreasonable expectation that there will be a rapid return on that investment. Such an expectation is often not realized, at least not as fast and frequently as we would like, and the reason has little to do with the quality of the science being funded. It has arguably more to do with how long it takes for a basic science observation to follow the long and winding road to producing a viable therapy. But how long is that long and winding road?

A lot longer than many, even many scientists, realize. At least, that’s the case if a paper from about a year ago by John Ioannidis in Science is any indication. The article appeared in the Policy Forum in the September 5 issue and is entitled Life Cycle of Translational Research for Medical Interventions. As you may recall, Dr. Ioannidis made a name for himself a couple of years ago by publishing a pair of articles provocatively entitled Contradicted and Initially Stronger Effects in Highly Cited Clinical Research and Why Most Published Research Findings Are False, which Steve Novella blogged about a couple of years ago.

Dr. Ioannidis lays it out right in the first paragraph:
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Posted in: Clinical Trials, Science and Medicine

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Causation and Hill’s Criteria

Causation is not so simple to determine as one would think. A mantra at SBM is ‘association is not causation’ and much of the belief in the efficacy of a variety of quack nostrums occurs because improvement occurs after use of a nostrum, therefore improvement occurs because of use of a nostrum. It is why vaccines as a cause of autism are so compelling to some. Vaccines are given at the same time autism starts to manifest. It would require more intellectual power than I have not to conclude, wrongly, that vaccines caused the autism. Concluding causation from sequential events is how the human mind works, and reality, as we know and ignore, constantly conspires to fool us into making false causal connections. In Infectious Diseases I see the error almost daily. The patient had a fever, patient was given antibiotics, fever went away. Therefore the antibiotics treated an infection. Well, maybe, maybe not. One of my mantras is ‘antibiotics are not antipyretics’ and you must be very careful before concluding that the fever went away because of the penacephalone. (more…)

Posted in: Science and Medicine

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Oppose “Big Floss”; practice alternative dentistry

We survived almost all of human history without it. Yet in the last 100 years people have allowed themselves to be hoodwinked by a huge corporate conspiracy into believing that we “need” their products. They cite studies and claim we don’t understand science; they ignore ancient folk wisdom and have no respect for our intuition. They peddle their products without regard to the dramatic increase in chronic diseases and weakened immune systems of recent decades. I’m speaking, of course, of “Big Floss.”

It’s time to take our mouths back from corporate domination. It’s time for alternative dentistry.
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Posted in: Humor, Science and Medicine

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Ginkgo biloba – No Effect

Another one bites the dust.

The National Center for Complementary and Alternative Medicine (NCCAM) is generally a waste of taxpayer money, but they have sponsored several well-designed large trials of popular herbal supplements. And one by one these studies have shown these popular products, such as echinacea for the common cold, to be ineffective.

To add to the list, published in JAMA this week are the results of the largest and longest trial to date of Gingko biloba for the improvement of cognitive function and to treat, prevent, or reduce the effects of Alzheimers disease or other dementia. The results of the study are completely negative.

The study was very rigorous – a consensus trial designed to address all the criticisms of prior smaller studies. It was a direct comparison of Gingko biloba at 120mg twice a day, double blind, randomized, multi-center trial involving 3019 subjects aged 72-96 for a median of 6.1 years. Subjects were followed with standardized tests of cognitive function.

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Posted in: Herbs & Supplements

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The Graston Technique – Inducing Microtrauma with Instruments

The Graston Technique® is a modification of traditional hands-on soft tissue mobilization that uses specifically designed instruments to allow the therapist to introduce a controlled amount of microtrauma into an area of excessive scar and/or soft tissue fibrosis, hoping that this will invoke an inflammatory response that will augment the healing process. It is also intended to reduce the stress on the therapist’s hands.

graston instrumentsGraston treatment

Microtrauma? Hurting people to make them better? I know sometimes an improperly healed bone must be re-broken so it can re-heal in proper alignment, but this is different. It bothers me that they are further injuring already damaged soft tissues and hoping (1) that the new injury will heal, (2) that that will help the older injury heal, and (3) that it can somehow avoid stimulating the deposition of just that much more scar tissue and fibrosis. It seems to violate the “primum non nocere” principle. It is unpalatable. Of course that wouldn’t matter if the evidence showed it was effective. Does it? (more…)

Posted in: Science and the Media

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The “pharma shill” gambit

Editor’s note: Since I happen to be on vacation (sort of–in reality I plan on spending most of next week holed up in my Sanctum Sanctorum at home writing a grant that’s due in February) and because readership tends to be down during the week between Christmas and New Years’ Day, I thought I’d resurrect something from well over three years ago and revise it to fit this particular blog. In doing so, I hope to provide you with something amusing to read, as well as something to link to time and time again whenever you want to refer to a particular gambit beloved by promoters of quackery and pseudoscience. I present here….The “Pharma Shill” Gambit! Enjoy!

I’ve mentioned before on this blog at least once that I cut my skeptical teeth, so to speak, on Usenet, that vast untamed and largely unmoderated territory full of tens of thousands of discussion newsgroups which used to be a lot more active before the rise of the World Wide Web and then later blogs. These days, few ISPs even offer much in the way of Usenet access; it’s become pretty much irrelevant since Google archived Usenet in the form of Google Groups. My forays into skepticism started out with combatting Holocaust denial on a newsgroup known as alt.revisionism (as good an excuse as any to remind you that nearly all Holocaust “revisionism” isn’t historical revisionism but is actually denial) and then branched out into more general skepticism, particularly about the claims of creationists and, of course, promoters of “alternative” medicine, the latter of which ultimately led me to being the editor of this wild and woolly thing we call the Science-Based Medicine blog. After I began to participate in the debates in the main newsgroup where alternative medicine is discussed, misc.health.alternative, it didn’t take me long to encounter a favorite tactic of promoters of alt-med who were not happy with one who insists on evidence-based medicine and who therefore questions claims that are obviously not based in valid science: The “Pharma Shill” Gambit. This is a technique of ad hominem attack in which a defender of “alternative” medicine, offended by your questioning of, for instance, his/her favorite herb, colon or liver flush technique, zapper, or cancer “cure,” tries to “poison the well” by implying or outright stating you must be in the pay of a pharmaceutical company, hired for nefarious purposes.

Since I entered the blogosphere several years ago under another guise, I’ve only occasionally checked back at my old stomping ground, mainly because blogging is so much less constraining than posting to Usenet, where mostly I used to respond to the posts of others, rather than writing about what I wanted to write about. A while back, though, out of curiosity I checked back and found this interesting little tidbit from a poster calling himself PeterB that demonstrated such a perfect example of the “pharma shill” gambit that I thought it might serve as a perfect example of the sort of thing I’ve had to put up with ever since I started speaking out against quackery:
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Posted in: Humor, Science and Medicine, Science and the Media, Vaccines

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Buteyko Breathing Technique – Nothing to Hyperventilate About

A reader recently sent in a link to a New York Times article that discussed an alternative breathing technique developed in Russia for the treatment of asthma called the Buteyko Method, or the Buteyko Breathing Technique (BBT), and asked for an evaluation of the claims on SBM.  This post will attempt to be a reasonably comprehensive evaluation of Buteyko and his therapy so that subsequent discussions, should they be necessary, may be more terse.

The NYT article is primarily an anecdote of a friend of the author who suffered from severe asthma, but who had improved since he began using the BBT.  The author briefly discusses asthma, the history and theory behind Buteyko and hyperventilation before wrapping up with an attempt to provide evidence to support the legitimacy of the story.  The friend’s pulmonologist is quoted to confirm that “based on objective data, his breathing has improved…”  She cites controlled clinical trials “in Australia and elsewhere” where patients have reduced their use of medications, including a purported British study of 384 patients where patients had a 90% reduction in rescue inhaler use and 50% reduction in steroids.  She ends by pointing out that the British Thoracic Society has given BBT a “B” rating, and an admonition to “the pharmaceutically supported American medical community to explore this nondrug technique.”

Never having heard of BBT before, the NYT article left me with several questions.  Who was Buteyko?  How did he develop the BBT?  What is BBT, what does it claim to do, and how does it claim to work?  Is the evidence as presented in the NYT article accurate? And finally, what evidence exists within the literature that BBT is an effective treatment for asthma?

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Posted in: Science and Medicine

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2009′s Top 5 Threats To Science In Medicine

As 2009 comes to an end, it seems that everyone is creating year-in-review lists. I thought I’d jump on the list band wagon and offer my purely subjective top 5 threats to rational thought in healthcare and medicine.

Of course, it strikes me as rather ironic that we’re having this discussion – who knew that medicine could be divorced from science in the first place? I thought the two went hand-in-hand, like a nice antigen and its receptor… and yet, here we are, on the verge of tremendous technological breakthroughs (thanks to advances in our understanding of molecular genetics, immunology, and biochemistry, etc.), faced with a growing number of people who prefer to resort to placebo-based remedies (such as heavy-metal laced herbs or vigorously shaken water) and Christian Science Prayer.

And so, without further ado, here’s my list of the top 5 threats to science in medicine for 2009 and beyond:
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Posted in: Politics and Regulation, Science and Medicine, Science and the Media

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