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Health care reform and primary sources

One thing I always encourage my residents and students to do is to go to primary sources.  If someone tells you that thiazide diruetics should be the first line treatment for hypertension, get on MedLine and see if that assertion is congruent with the evidence.  It’s important to see how we arrive at broad treatment recommendations, how strong and consistent the evidence is, and the best way to do this is go back to the beginning.

This is not an explicitly political blog, and for that reason, I don’t feel it’s appropriate for me to advocate for one or another proposed health care reform plan.  But I do want to encourage everyone to follow health care reform closely, and to go to the primary sources. Certain aspects of the proposed bill will be hard for any of us to understand, especially cost.  There are all sorts of wild claims about how much reform will save us or cost us, and I’m betting that none of these claims is completely congruent with the truth.  But some of  what we’re hearing on the news is so far from the truth that to call them lies would be generous. (more…)

Posted in: Politics and Regulation, Science and Medicine

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Vertebroplasty for compression fractures due to osteoporosis: Placebo medicine

If there’s one thing we emphasize here on the Science-Based Medicine blog, it’s that the best medical care is based on science. In other words, we are far more for science-based medicine, than we are against against so-called “complementary and alternative medicine” (CAM). My perspective on the issue is that treatments not based on science need to be either subjected to scientific scrutiny if they have sufficient prior plausibility or strong clinical data suggesting efficacy or abandoned if they do not.

Unfortunately, even though the proportion of medical therapies not based on science is far lower than CAM advocates would like you to believe, there are still more treatments in “conventional” medicine that are insufficiently based on science or that have never been validated by proper randomized clinical trials than we as practitioners of science-based medicine would like. This is true for some because there are simply too few patients with a given disease; i.e., the disease is rare. Indeed, for some diseases, there will never be a definitive trial because they are just too uncommon. For others, it’s because of what I like to call medical fads, whereby a treatment appears effective anecdotally or in small uncontrolled trials and, due to the bandwagon effect, becomes widely adopted. Sometimes there is a financial incentive for such treatments to persist; sometimes it’s habit. Indeed, there’s an old saying that, for a treatment truly to disappear, the older generation of physicians has to retire or die off.

That is why I consider it worthwhile to write about a treatment that appears to be on the way to disappearing. At least, I hope that’s what’s going on. It’s also a cautionary tale about how the very same sorts of factors, such as placebo effects, reliance on anecdotal evidence, and regression to the mean, can bedevil those of us dedicated to SBM just as much as it does the investigation of CAM. It should serve as a warning to those of us who might feel a bit too smug about just how dedicated to SBM modern medicine is. Given that the technique in question is an invasive (although not a surgical technique), I also feel that it is my duty as the resident surgeon on SBM to tackle this topic. On the other hand, this case also demonstrates how SBM is, like the science upon which it is based, self-correcting. The question is: What will physicians do with the most recent information from very recently reported clinical trials that clearly show a very favored and lucrative treatment does not work better than a placebo?

Here’s the story that illustrates these issues, fresh from the New York Times this week:
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Posted in: Clinical Trials, Science and Medicine, Surgical Procedures

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Functional Medicine III

Let’s look at one example.

A unknown number of Functional Medicine adherents broadcast call-in programs on radio stations. One FM physician, a Dr. “D” in Northern California graduated from UC Davis School of Medicine (Central California’s Sacramento Valley.) I find her program fascinating, requiring some attentive listening.

Dr. D’s recommendations for people’s complaints and conditions are often complex, a chimera of standard explanations and therapies, but painted with a variety of views that are anything but standard. The problem I found was that some of each answer was rational – especially the logic of her differential diagnosis – but suddenly spun out into space with unfamiliar methods or some recognizable as one component or another of sectarianism. Some answers had no relationship to the problem at hand, but seemed to be plucked out of a firmament of independent ideas, theories, ideologies, and personal anecdotes – a medical Separate Reality.

One can be carried along by an answer that sounds on surface reasonable because of the confidence and the delivery’s vocal tone. Her voice is medium-low, sort of a mezzo or contralto. It’s a voice ideal for advice; confidence oozes. Some of her separate reality recommendations she precedes with a biochemical or physiological explanation, so the shifting from standard to “separate reality” grids goes so smoothly, the usual recognizable red flags may not spring up.

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Posted in: Science and Medicine

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Science-Based Medicine 101: How To Establish A Source’s Credibility

I thought I’d do a little SBM 101 series for our lay readers. Forgive me if this information is too basic… at least it’s a place to start for those who are budding scientists and critical thinkers. :)

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Which news source do you trust more: The New York Times or The National Enquirer? Which news reporter would you trust more: Charlie Gibson or Jerry Springer? As it turns out, medical journals and science researchers run the gamut from highly credible and respected to dishonest and untrustworthy. So as we continue down this road of learning how to evaluate health news, let’s now turn our attention to pillar number one of trustworthy science: credibility.

In medical research, I like to think of credibility in three categories:

1. The credibility of the researcher: does the researcher have a track record of excellence in research methodology? Is he or she well-trained and/or have access to mentors who can shepherd along the research project and avoid the pitfalls of false positive “artifacts?” Has the researcher published previously in highly respected, peer reviewed journals?

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Posted in: Science and Medicine, Science and the Media

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Quack Clinics

Reuters recently reported on the raid of a stem-cell clinic in Hungary. This is welcome news, if the allegations are correct, but really is only scratching the surface of this problem – clinics offering dubious stem cell therapies to desperate patients. And in fact this is only one manifestation of a far greater problem – the quack clinic. They represent a serious problem for patients, doctors, and health care regulation.

Stem Cell Clinics

There is a very disturbing trend in the last few years – the proliferation of clinics offering stem cell therapy for a variety of serious, often incurable, diseases such as spinal cord injury, ALS, Parkinson’s disease, and other neurological disorders. These clinics claim to improve and even cure these diseases by injecting stem cells into the spinal cord or other parts of the body. Treatments typically cost 20-25,000 dollars, plus travel expenses, for a single treatment.

The problem is that these clinics do not have any published evidence that their treatments are valid. There is good reason to think that they are not – stem cell technology is simply not at the point yet where we can use them to cure such diseases. There are many technical hurdles to be overcome first – knowing how to control the stem cells, to get them to survive and become the types of cells necessary to have the desired therapeutic effect, and also figuring out how to keep them from growing into tumors. Basic issues of safety have not yet been sorted out.

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Posted in: Politics and Regulation, Science and Medicine

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Plus ça change, plus c’est la même chose

The more things change, the more they stay the same.

Not every post will be an in-depth, authoritative review of a topic like yesterday’s on Dr. Sears.  A change of pace can be nice, and I have always liked history.

JAMA likes to run articles called “JAMA 100 YEARS AGO” and the reprint from the July 24, 1909 issue is interesting. It is called  BUTTERMILK THERAPY.  They liked all caps at the turn of the century.

1909 was at the very beginning of the biologic sciences and the understanding of disease pathophysiology. Physicians had almost no useful, or more importantly, rigorously tested therapeutic interventions for diseases. So they relied on traditional method of determining what worked: expert opinion and anecdote. And that lead to buttermilk.

“Metchnikoff, Massol and several other authors have recommended fermented sour milk as prepared in Bulgaria, or a similar product, prepared according to Metchnikoff’s method from pure cultures of bacteria, as a panacea for many ills.”

Metchnikoff was a Russian microbiologist who won a Nobel prize in 1908 for discovering phagocytosis and was responsible for many early discoveries in the immune system and in host-bacterial interactions.  As a preeminent scientist of the time, his word was respected and carried weight.  As a side note, when he tried to commit suicide he did  so in a manner that would benefit science: he injected himself with the relapsing fever organisms and proved it could be blood borne, and while he evidently became very ill in the process, it failed to kill him.
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Posted in: History, Science and Medicine

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Cashing In On Fear: The Danger of Dr. Sears

I generally know what’s coming next when a parent asks about altering their child’s vaccine schedule: “I was reading Dr. Sears….”

Dr. Sears is a genius. No, not in an Albert Einstein or Pablo Picasso kind of way. He’s more of an Oprah or a Madonna kind of genius. He’s a genius because he has written a book that capitalizes on the vaccine-fearing, anti-establishment mood of the zeitgeist. The book tells parents what they desperately want to hear, and that has made it an overnight success.

Dr. Robert Sears is perhaps one of the best-known pediatricians in the country. The youngest son of Dr. Bill Sears, the prolific parent book writer and creator of AskDrSears.com, Dr. Bob has become the bane of many a pediatrician’s existence. He has contributed to his family dynasty by co-authoring several books, adding content to the family website, and making myriad TV appearances to offer his sage advice. But Dr. Bob is best known for his best-selling The Vaccine Book: Making the Right Decision for your Child. This book, or at least notes from it, now accompanies many confused and concerned parents to the pediatrician’s office. Parents who have been misled by the onslaught of vaccine misinformation and fear-mongering feel comforted and supported by the advice of Dr. Sears, who assures parents that there is a safer, more sensible way to vaccinate. He wants parents to make their own “informed” decisions about whether or how to proceed with vaccinating their children, making sure to let them know that if they do choose to vaccinate, he knows the safest way to do it. And for $13.99 (paperback), he’ll share it with them.

In the final chapter of his book (entitled “What should you do now?”), after reinforcing the common vaccine myths of the day, Dr. Sears presents his readers with “Dr. Bob’s Alternative Vaccine Schedule.” He places this side-by-side with the schedule recommended by the American Academy of Pediatrics and the CDC’s Advisory Committee on Immunization Practices. He then explains why his schedule is a safer choice for parents who chose to vaccinate their children. Without a doubt, the alternative vaccine schedule is among the more damaging aspects of this book. It’s the part that gets brought along to the pediatrician’s office and presented as the the plan going forward for many parents today. But the book is also dangerous in the way in which it validates the pervasive myths that are currently scaring parents into making ill-informed decisions for their children. Dr. Sears discusses these now common parental concerns, but instead of countering them with sound science, he lets them stand on their own as valid. He points out that most doctors are ill-equipped to discuss vaccines with parents, being poorly trained in the science of vaccine risks and benefits. He then claims to be a newly self-taught vaccine expert, a laughable conceit given the degree to which he misunderstands the science he purports to have read, and in the way he downplays the true dangers of the vaccine-preventable diseases he discusses in his book. He then provides parents with what he views as rational alternatives to the recommended vaccination schedule, a schedule designed by the country’s true authorities on vaccinology, childhood infectious disease, and epidemiology.

So what does Dr. Sears have to say, exactly, about the risks of vaccines, and just how out of touch is he with medical science and epidemiology? (more…)

Posted in: Book & movie reviews, Public Health, Science and Medicine, Vaccines

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Beware the Spinal Trap

Last year Simon Singh wrote a piece for the Guardian that was critical of the modern practice of chiropractic. The core of his complaint was that chiropractors provide services and make claims that are not adequately backed by evidence – they are not evidence-based practitioners. In response to his criticism the British Chiropractic Association (BCA) sued Simon personally for libel. They refused offers to publish a rebuttal to his criticism, or to provide the evidence Simon said was lacking. After they were further criticized for this, the BCA eventually produced an anemic list of studies purported to support the questionable treatments, but really just demonstrating the truth of Simon’s criticism (as I discuss at length here).

In England suing for libel is an effective strategy for silencing critics. The burden of proof is on the one accused (guilty until proven innnocent) and the costs are ruinous. Simon has persisted, however, at great personal expense.

This is an issue of vital importance to science-based medicine. A very necessary feature of science is public debate and criticism – absolute transparency.This is also not an isolated incident. Some in the alternative medicine community are attempting to assert that criticism is unprofessional, and they have used accusations of both unprofessionalism and libel as a method of silencing criticism of their claims and practices. This has happened to David Colquhoun and Ben Goldacre, and others less prominent but who have communicated to me directly attempts at silencing their criticism.

This behavior is intolerable and is itself unprofessional, an assault on academic freedom and free speech, and anathema to science as science is dependent upon open and vigorous critical debate.

What those who will attempt to silence their critics through this type of bullying must understand is that such attempts will only result in the magnification of the criticism by several orders of magnitude. That is why we are reproducing Simon Singh’s original article (with a couple of minor alterations) on this site and many others. Enjoy.

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Posted in: Chiropractic, Science and Medicine, Science and the Media

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Senator Tom Harkin and Representative Darrell Issa declare war on science-based medicine

In discussions of that bastion of what Harriet Hall likes to call “tooth fairy science,” where sometimes rigorous science, sometimes not, is applied to the study of hypotheses that are utterly implausible and incredible from a basic science standpoint (such as homeopathy or reiki), the National Center of Complementary and Alternative Medicine (NCCAM), I’ve often taken Senator Tom Harkin (D-IA) to task, as have Drs. Novella, Lipson, and Atwood. That’s because Senator Harkin is undeniably the father of that misbegotten beast that has sucked down over $2.5 billion of taxpayer money with nothing to show for it. NCCAM is the brainchild of Senator Harkin, who foisted it upon the National Institutes of Health not because there was a scientific need for it or because scientists and physicians cried out for it but rather because Senator Harkin, who believed that alternative medicine had healed a friend of his, wanted it, and he used his powerful position to make it happen, first as the Office of Unconventional Therapies, then as the Office of Alternative Medicine, and finally as the behemoth of woo that we know today as NCCAM. The result has included a $30 million trial of chelation therapy in which convicted felons were listed among the investigators and a totally unethical trial of the Gonzalez therapy for pancreatic cancer. It’s not for naught that Wally Sampson called for the defunding of NCCAM, as have I and others. Not surprisingly, alternative medicine practitioners are appalled at this idea.

Most recently, Harkin has been most disturbed by the observation that NCCAM’s trials have all been negative, going so far as to complain that NCCAM hasn’t produced any positive results showing that various alternative therapies actually work. This is, of course, not a surprise, given that vast majority of the grab bag of unrelated (and sometimes theoretically mutually exclusive) therapies are based on pseudoscience. One of the only exceptions is the study of herbal remedies, which is a perfectly respectable branch of pharmacology known as pharmacognosy. Unfortunately, as David Kroll showed, in NCCAM the legitimate science of pharmacognosy has been hijacked for purposes of woo. Meanwhile, earlier this year, Senator Harkin hosted a hearing in which Drs. Dean Ornish, Andrew Weil, Mehment Oz, and Mark Hyman (he of “functional medicine“) were invited to testify in front of the Senate. Add to that other powerful legislators, such as Representative Dan Burton (R-IN), trying to craft legislation in line with his anti-vaccine views and pressure the NIH to study various discredited hypotheses about vaccines and autism. Clearly, when it comes to quackery, there are powerful legislative forces promoting pseudoscience and studies driven by ideology rather than science.
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Posted in: Acupuncture, Chiropractic, Homeopathy, Politics and Regulation, Science and Medicine

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‘Acupuncture Anesthesia’ Redux: another Skeptic and an Unfortunate Misportrayal at the NCCAM

A Neglected Skeptic

Near the end of my series* on ‘Acupuncture Anesthesia’, I wrote this:

Most Westerners—Michael DeBakey and John Bonica being exceptions—who observed ‘acupuncture anesthesia’ in China during the Cultural Revolution seem to have failed to recognize what was going on right under their noses.

I should have added—and I now have—Arthur Taub’s name to that tiny, exceptional group. Taub, a neurologist and neurophysiologist at Yale, was a member of a delegation of Americans sent to China to observe ‘acupuncture anesthesia’ in May of 1974, about a year after Dr. Bonica‘s visit. The delegation included several prominent anesthesiologists. Their report,  Acupuncture Anesthesia in the People’s Republic of China: A Trip Report of the American Acupuncture Anesthesia Study Group, was published in 1976 and is available in its entirety here. Excerpts follow (emphasis added):

Pain is a subjective experience. Judging whether an individual is in a state of pain depends on observations of the subject’s behavior, including verbal reports to the observer…When there is no evidence of pain, the observer can adopt one of three positions: (more…)

Posted in: Acupuncture, Medical Academia, Science and Medicine, Science and the Media

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