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Archive for August, 2010

Kaiser Rejects Neck Manipulation

Despite quackademia, anti-vaccine propaganda, and other discouraging trends, the news is not all bad. A major HMO has taken a decisive action in support of science-based medicine. 

Kaiser Permanente Mid Atlantic States and Mid-Atlantic Permanente Group recently announced the elimination of neck manipulation from their chiropractic coverage. The revised policy states,

Given the paucity of data related to beneficial effects of chiropractic manipulation of the cervical spine and the real potential for catastrophic adverse events, it was decided to exclude chiropractic manipulation of the cervical spine from coverage. 

Their decision was applauded by some  but was predictably attacked by chiropractors. (more…)

Posted in: Chiropractic

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Avastin and metastatic breast cancer: When science-based medicine collides with FDA regulation

One of the most frustrating aspects of taking care of cancer patients is that in general, with only a few specific exceptions, we do not have good curative therapies for patients with stage IV cancer, particularly solid tumors. Consequently, patients with stage IV disease are viewed as “incurable” because, the vast majority of the time, they are incurable. Over the years, we have thrown everything but the kitchen sink at patients with stage IV disease, largely with dissapointing results. That’s not to say that the few specific exceptions to which I alluded are not a reason for hope. After all, patients with colorectal cancer and liver metastases used to have a median survival of around 6 months, but these days, with newer chemotherapeutic regimens like FOLFOX plus Avastin, median survival has more than tripled. While expecting to live less than two years is cold comfort to cancer patients with this particular clinical situation, the prognosis is far better than it was.

Of course, I specifically mentioned Avastin because it’s been in the news a lot recently with respect to my area of clinical specialty, breast cancer. Specifically, beginning in July there started appearing a spate of stories about the FDA considering revoking the approval of Avastin for advanced breast cancer based on recent studies that demonstrate that it does not prolong survival in these patients. Many lay people and patients find this reconsideration of Avastin to be quite puzzling, given that the drug was granted accelerated approval in 2008 and has since gone on to be used fairly widely. Given that the case of Avastin in breast cancer is rapidly becoming a classic case study of how messy science-based medicine can be when practiced in the public eye and debated among pharmaceutical companies, the government, and patient advocacy groups.
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Posted in: Cancer, Clinical Trials, Pharmaceuticals, Politics and Regulation

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A pox on your bank account: failure to vaccinate and its legal consequences

Here’s a question anti-vaxers may want to consider:

Can the parents of an unvaccinated child be held liable if their child becomes infected with a vaccine-preventable disease which then spreads from their child to another child or children?

Yes, they can.

In fact, for over 125 years, courts in this country have recognized a cause of action for negligent transmission of an infectious disease. In the first reported case (New York, 1884) the defendant infected the plaintiff with whooping cough. Cases since then have run the gamut: smallpox, tuberculosis, unspecified “venereal disease,” typhoid fever, scarlet fever, diphtheria, hepatitis, herpes, gonorrhea, HIV. If your favorite infectious disease is not on this list, don’t worry. The disease may vary, but the legal principles remain the same.
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Posted in: Legal, Medical Ethics, Public Health, Vaccines

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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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Tai chi and fibromyalgia in the New England Journal of Medicine: An “alternative” frame succeeds

It never seems to fail. I go away for a few days, in this case to combine fun with pleasure and pleasure with fun by giving a talk to the Chicago Skeptics and at the same time meeting my brand new (well, by this time three weeks old) nephew for the first time, and something always happens. Before I get to what happened, I just want to point out that the talk actually went pretty darned well. I was utterly shocked that it was pretty much standing room only, with perhaps 50 people there to hear me. Honestly, don’t you people have anything better to do on a beautiful Saturday afternoon in August? But, seriously, the whole thing was a blast, and the assembled skeptics there didn’t even let me off the hook, as at least a couple of them asked some fairly challenging questions, one of which, I must admit, I wasn’t prepared for. In any case, my thanks go out to Dr. Jennifer Newport, skeptical Chicago pediatrician extraordinaire and organizer of my talk and the party at her apartment afterward. Between the two events she raised hundreds of dollars for the vaccination drive going on at DragonCon this weekend, Chicago Skeptics, the Women Thinking Free Foundation, and CFI-Chicago for inviting me and being such fantastic hosts.

Back to business. Science-based medicine (SBM) business, that is.

What happened while I was away could almost be characterized by the New England Journal of Medicine (NEJM) singing “Oops, I did it again.” Three weeks ago, the hallowed pages of the NEJM hosted a truly execrably credulous review article about acupuncture. So bad was the article that it “merited” the incredibly rare triple beat-down from this very blog, with posts by Steve Novella, the ever-irascible Mark Crislip, and myself in rapid succession applying the clue-by-four. As I was preparing to leave for Chicago on Thursday, I happened to look at the very latest issue of the NEJM hot off the presses, and what to my wondering (and watering–it is ragweed season) eyes should appear but an article reporting a study on the use of tai chi in treating fibromyalgia. Entitled A Randomized Trial of Tai Chi for Fibromyalgia, the study comes out of the Tufts University School of Medicine and the Newton-Wellesley Hospital in Boston and was carried out by a team led by Chenchen Wang, MD, MPH. Not surprisingly, the study has gotten a lot of play in the media, for example, in this story in the L.A. Times, which is at least reasonably restrained, probably because it an AP wire story by Marilynn Marchione, who has written some excellent articles about “alternative” medicine before. Even the usually reliable GoozNews seems smitten with this study beyond what it rates, characterizing it as “rare victory for the National Institute of Health’s National Center for Complementary and Alternative Medicine and Sen. Tom Harkin (D-IA), who routinely comes under fire for pushing funding for these types of studies.”

I’m less impressed. You’ll see what I mean in a few minutes, I hope. First, however, let’s look at the study itself.
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Posted in: Clinical Trials, Medical Academia, Science and the Media

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Peer Review and the Internet

Peer-review has been the cornerstone of quality control in academia, including science and medicine, for the past century. The process is slow and laborious, but a necessary filter in order to maintain a certain standard within the literature. Yet more and more scholars are recognizing the speed, immediacy, and openness of the internet as a tool for exchanging ideas and information, and this is causing some to question the methods of peer review. A recent New York Times article discusses this issue.

This issue is very relevant to Science-Based Medicine as this is in part an experiment – an attempt to produce a high quality, editorially filtered, but not peer-reviewed, online journal. Our process here is simple. Outside submissions are reviewed by two or more editors and typically are either accepted with minor revisions or rejected. In addition we have a staff of regular contributors – those who have a proven track record of producing high quality articles. There is no pre-publication review for their submissions, and they are able to post directly to SBM.

Because many of the issues we cover are timely, we emphasize speed of publication. Therefore copy-editing is done post-publication – the notion being that our readers can tolerate a few typos in order to gain access to material more quickly.

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Posted in: Medical Academia

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Antioxidant Supplements for Macular Degeneration

Age-related macular degeneration (AMD) is one of the major causes of visual impairment in the elderly: it affects central vision, impairing the ability to read and recognize faces while preserving some peripheral vision. It comes in two forms: wet and dry. Dry macular degeneration is by far more common, but wet macular degeneration, involving the proliferation of blood vessels, is more severe. 

There is evidence that antioxidant vitamin supplementation may slow the progression of the dry type when it is already established and moderately severe, but the published evidence does not support the use of these supplements for prevention or for patients with early stages of the disease. Some people are using it for prevention, but there is concern that the risks might exceed any benefit. Of more concern, it appears that a manufacturer’s (Bausch & Lomb’s) advertising has gone way beyond the available evidence.  (more…)

Posted in: Herbs & Supplements, Ophthalmology

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High Fructose Corn Syrup: Tasty Toxin or Slandered Sweetener?

The perils of fructose:

High fructose corn syrup (HFCS) has, over the past few decades, gradually displaced cane and beet sugar as the sweetener of choice for soft drinks, candy and prepared foods. In recent years, there have been a growing number claims that HFCS is a significant health risk to consumers, responsible for obesity, diabetes, heart disease and a wide variety of other illnesses. 

In fact, there are large amounts of experimental data supporting the claims that high levels of fructose in the diet can cause hyperlipidemia (high levels of fats — triglycerides primarily — in the blood), obesity and insulin resistance and may lead to cardiovascular disease and type 2 diabetes (for a good recent review, see [1]). A high-fructose diet is thought to cause hyperlipidemia (and probably visceral obesity) because fructose is preferentially “sent”  to fatty acid synthesis and it also reduces the activity of lipoprotein lipase (for a good review, see [2]). The mechanisms by which fructose causes insulin resistance and cardiovascular disease are less clear (see, for example [3], [4] and [5]), but there is no shortage of hypotheses. Despite the fact that some of the underlying mechanisms are not clear, the evidence seems pretty solid that there are real risks to high fructose consumption.

However, the question remains — is HFCS more of a health risk than other sweeteners? Many of the sources that demonize HFCS list alternative sweeteners — cane sugar, honey, agave syrup, etc. — that they claim are healthier than HFCS, but those claims usually rest primarily on the fact that these alternatives to HFCS are “natural” rather than any actual data showing that they are safer than HFCS.  (more…)

Posted in: Nutrition, Public Health

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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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