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Science-based medicine, skepticism, and the scientific consensus

Editor’s note: This weekend was a big grant writing weekend for me. I’m resubmitting my R01, which means that between now and July 1 or so, my life is insanity, as I try to rewrite it into a form that has a fighting chance of being in the top 7%, which is about the level the NCI is funding at right now. This weekend, I buried myself in my Sanctum Sanctorum and tried like heck to try to pound the revision into a really good draft that I can distribute to my colleagues for feedback. Fortunately, I have some old posts that I can pull out, tart up (i.e., update a bit, as in correcting the parts that led me to groan as I reread them, thereby hopefully making them better). I think they’re quite good, if I do say so myself; so hopefully you will too.

There are some arguments made in blogs, articles, or books that strike me so hard that I remember them, even three and a half years later. Sometimes I even file them away for later use or response if the issue raised by them is interesting, relevant or compelling enough to me. Although this topic is a bit broader than many of the topics I write about for this blog, I think it also goes to the heart of science-based medicine and communicating scientific skepticism about medicine to the masses. A few years back, a Swedish blogger named Martin Rundkvist made a rather provocative observation about skepticism. Specifically, he argued that a “real skeptic always sides with scientific consensus.” Among his reasons was this one:

Science presupposes that all participants have a skeptical frame of mind and arrive at conclusions through rational deliberation. If a large group of knowledgeable people working in this way arrive at a consensus opinion, then there is really no good reason for anybody with less knowledge of the subject to question it. Informed consensus is how scientific truth is established. It’s always provisional and open to reevaluation, but as long as there’s informed consensus, then that’s our best knowledge. Humanity’s best knowledge.

Although at the time I saw where Martin was coming from, I found this viewpoint somewhat disturbing, leading me to echo Martin’s own words in response to his own rhetorical question asking whether accepting a scientific consensus is nothing more than “kowtowing to white-coated authority”: Well, yes and no.
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Posted in: History, Medical Academia, Science and Medicine

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The impact of antivaccination lobbying

Here’s an excellent news report from Australia on the human costs of the anti-vaccine movement:

The video features Viera Scheibner, who has nothing good to say about vaccines and thinks that vaccines are dangerous and infectious diseases in childhood are good. It also features the stories of children who caught vaccine-preventable diseases. This is how it’s done.

Posted in: Science and the Media, Vaccines

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Failed Flaxseed and Bad News Brownies

Well, it’s been a tough month for herbs since my last monthly soiree here at SBM.

Just last week at the American Society for Clinical Oncology (ASCO) meeting, a group out of the Mayo Clinic presented data from a study showing that a well-characterized flaxseed extract was ineffective against hot flashes in postmenopausal women. But as Steve Novella noted here earlier this week, negative clinical trials data on supplements rarely influence the behavior of those who continue to advocate for their herbal use.

Flaxseed, known to contain phytoestrogen compounds such as secoisolariciresinol diglucoside (SDG) and enterolactone, has been purported to relieve hot flashes.

But I think the hypothesis was flawed in the first place: while these compounds bind the estrogen receptor, they have largely been shown to be estrogen receptor modulators that act in a negative manner. Work from the group of Dr. Lillian Thompson at the University of Toronto has repeatedly shown in an estrogen-dependent animal model of human breast cancer that flaxseed components act in a predominantly anti-estrogenic manner. One might suspect that hot flashes would be made worse by flaxseed, although this was not the case in the study presented as ASCO.

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Posted in: Cancer, Clinical Trials, Herbs & Supplements

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Placebos as Medicine: The Ethics of Homeopathy

Is it ever ethical to provide a placebo treatment? What about when that placebo is homeopathy? Last month I blogged about the frequency of placebo prescribing by physicians.  I admitted my personal discomfort, stating I’d refuse to dispense any prescription that would require me to deceive the patient. The discussion continued in the comments, where opinions seemed to range from (I’m paraphrasing)  “autonomy, shmatonomy, placebos works” to the more critical who likened placebo use to “treating adults like children.”  Harriet Hall noted,  “We should have rules but we should be willing to break them when it would be kinder to the patient, and would do no harm.” And on reflection, Harriet’s perspective was one that I could see myself accepting should I be in a situation like the one  she described. It’s far easier to be dogmatic when you don’t have a patient standing in front of you. But the comments led me to consider possible situations where a placebo might actually be the most desirable treatment option. If I find some, should I be as dogmatic about homeopathy as I am about other placebos?

Nicely, Kevin Smith, writing in the journal Bioethics, examines the ethics of placebos, based on an analysis of homeopathy. Homeopathy is the ultimate placebo in routine use — most remedies contain only sugar and water, lacking a single molecule of any potentially medicinal ingredient. Smith’s paper, Against Homeopathy — A Utilitarian Perspective, is sadly behind a paywall.  So I’ll try to summarize his analysis, and add my perspective as a health care worker who regularly encounters homeopathy.
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Posted in: Homeopathy, Medical Ethics

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Black Cohosh and Hot Flashes

Black Cohosh, an herbal “supplement” (i.e. unregulated drug) remains popular for the treatment of hot flashes and other autonomic symptoms resulting from menopause. This product is yet another good example of the double standard that the supplement industry and ideological promoters are allowed to employ.

The NCCAM website gives this summary:

Black cohosh, a member of the buttercup family, is a plant native to North America. It has a history of use for rheumatism (arthritis and muscle pain) but has been used more recently to treat hot flashes, night sweats, vaginal dryness, and other symptoms that can occur during menopause.

While the information is available if you look through the links below, their summary makes no mention of the fact that their own studies show black cohosh is ineffective. In their “at a glance” summary they characterize the scientific evidence as “mixed.”

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Posted in: Herbs & Supplements

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Another Anti-Vaccine Book

I was asked to review the book Make an Informed Vaccine Decision for the Health of Your Child by Mayer Eisenstein with Neil Z. Miller. Fortunately my public library had it so I didn’t have to buy a copy. Reading it was a painful déjà vu experience. I can honestly say it met all my expectations: I expected that its concept of “informed decision” would equate to deciding not to vaccinate, and that it would rely on the same tired old fallacious arguments that have been heard before and rejected by knowledgeable scientists. The only thing that surprised me was a warning/disclaimer statement that admitted

this book tends to find fault with vaccines, therefore readers are advised to balance the data presented here with data presented by “official” sources of vaccine information, including vaccine manufacturers, the FDA, CDC and World Health Organization.

The fact that the book omitted all that balancing data undermines its pretense that it is intended to help readers make a truly informed decision.

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Posted in: Book & movie reviews, Vaccines

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The ultimate in “integrative medicine,” continued

It’s been a recurring theme on this blog to discuss and dissect the infiltration of quackademic medicine into our medical schools. Whether it be called “complementary and alternative medicine” (CAM) or “integrative medicine” (IM), its infiltration into various academic medical centers has been one of the more alarming developments I’ve noted over the last several years. The reason is that “integrative” medicine is all too often in reality nothing more than “integrating” pseudoscience with science, quackery with medicine. The most popular modalities that medical schools and academic medicine centers can’t seem to resist are acupuncture and various forms of “energy” healing, such as reiki and therapeutic touch. Unfortunately, when you “integrate” something like reiki or therapeutic touch (TT), which basically assert that there is mystical, magical energy source (called the “universal source” by reiki practitioners, for example) that practitioners can tap into and channel into patients for healing effect, you are in essence integrating a prescientific understanding of the world with science, religious faith healing (which, let’s face it, is all that reiki is), and magic with reality.

Why would medical institutions ostensibly based on science do that?

I don’t know, but I know it’s happening. There are many forces that conspire to insert sectarian versions of medicine into bastions of scientific medicine. These include cultural relativism leading to a reluctance to call quackery quackery; financial forces such as the Bravewell Collaborative, which funds a number of IM programs at academic centers; the National Center for Complementary and Alternative Medicine (NCCAM); and a variety of other factors. It’s been a depressing slide, and periodically I wonder just how much more pseudoscience can be “integrated” into medical schools and academic medical centers or how much further medical schools can go in pandering to nonsense. I’m not wondering anymore, at least for now, not after learning about a cooperative agreement between Georgetown University and the National University of Health Sciences:
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Posted in: Chiropractic, Medical Academia, Naturopathy

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Ambiguity

Some people have made the mistake of seeing Shunt’s work as a load of rubbish about railway timetables, but clever people like me, who talk loudly in restaurants, see this as a deliberate ambiguity, a plea for understanding in a mechanized world. The points are frozen, the beast is dead. What is the difference? What indeed is the point? The point is frozen, the beast is late out of Paddington. The point is taken. If La Fontaine’s elk would spurn Tom Jones the engine must be our head, the dining car our esophagus, the guard’s van our left lung, the cattle truck our shins, the first-class compartment the piece of skin at the nape of the neck and the level crossing an electric elk called Simon. The clarity is devastating. But where is the ambiguity? It’s over there in a box. Shunt is saying the 8:15 from Gillingham when in reality he means the 8:13 from Gillingham. The train is the same only the time is altered. Ecce homo, ergo elk. La Fontaine knew his sister and knew her bloody well. The point is taken, the beast is moulting, the fluff gets up your nose. The illusion is complete; it is reality, the reality is illusion and the ambiguity is the only truth. But is the truth, as Hitchcock observes, in the box? No there isn’t room, the ambiguity has put on weight. The point is taken, the elk is dead, the beast stops at Swindon, Chabrol stops at nothing, I’m having treatment and La Fontaine can get knotted.

— Art Critic

Ambiguity. Medicine, like art, is filled with ambiguity, at least the way I practice it. Most of my practice is in the hospital. I am sometimes called to see patients that other physicians cannot figure out. And that puts me at a disadvantage, because the doctors who were referring patients to me are all bright, excellent doctors. Often the question is ‘Why does the patient have a fever?’ or ‘Why is the patient ill?’ Sometimes I have an answer. Most of the time I do not.

I am happy, however, to be able to tell the patient what they don’t have. I can often inform the patient and their family that whatever they have is probably not life-threatening or life-damaging, just life-inconveniencing, and most acute illnesses go away with no diagnosis. I always put the ‘just’ in air quotes, because illnesses that require hospitalization are rarely ‘just.’ Just without quotes is reserved for the antivaccine crowd and applied to the small number of deaths from vaccine preventable diseases in unvaccinated children. John Donne they ain’t.

We are excellent, I tell them, at diagnosing life-threatening problems that we can treat, and terrible at diagnosing processes that are self-limited. Of course diagnostic testing is always variable. No test is 100% in making a diagnosis, and often with infections I cannot grow the organism that I suspect is causing the patient’s disease. So for hospitalized patients, ambiguity and uncertainty are the rule of the day. (more…)

Posted in: Clinical Trials, Science and Medicine

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Anti-vaccine warriors vs. research ethics

Three weeks ago, the anti-vaccine movement took a swing for the fences and, as usual, made a mighty whiff that produced a breeze easily felt in the bleachers. In brief, a crew of anti-vaccine lawyers headed by Mary Holland, co-author of Vaccine Epidemic: How Corporate Greed, Biased Science, and Coercive Government Threaten Our Human Rights, Our Health, and Our Children, published a highly touted (by Generation Rescue and other anti-vaccine groups, that is) “study” claiming to “prove” that the Vaccine Injury Compensation Program (VICP) had actually compensated children for autism. As is typical with such “studies” generated by the anti-vaccine movement, it was bad science, bad law, and just plain bad all around. The authors intentionally conflated “autism-like” symptoms with autism, trying to claim that children with neurological injury with “autism-like” symptoms actually have autism. Never mind that there are specific diagnostic criteria for autism and that, if the children actually had autism, many of them would have been given a diagnosis of autism. Never mind that what they were doing was akin to claiming that all patients with “Parkinson’s-like symptoms” have Parkinson’s disease. (Hint: They don’t.) Never mind that all they did was to demonstrate a prevalence of autism spectrum disorders among the VICP-compensated children that was clearly within the range of what would be anticipated if there were no relationship between vaccines and autism. Never mind all that. This was Holland’s big chance, but it went over like the proverbial lead balloon. No one bit, other than FOX News.

The study rapidly faded into the obscurity it so richly deserves, in spite of mighty efforts by Generation Rescue, SafeMinds, and the likes of Ginger Taylor to keep it alive and use it as a rallying point to persuade legislators to pass anti-vaccine-friendly legislation. You could feel the frustration in its backers as Holland’s study, into which groups like Generation Rescue had apparently poured their hopes of being vindicated, crashed and burned.

However, there’s one aspect of this study that I didn’t discuss. In fact, I thought of it as I read it, but I wasn’t sure. What I (and others) have noticed is that there was no statement in the article that approval had been obtained from the relevant institutional review boards (IRBs) to do human subjects research. For those not familiar with what an IRB is, an IRB is a committee that oversees all human subject research for an institution. It is the IRB’s responsibility to make sure that all studies are ethical in design and that they conform to all federal regulations. Basically, IRBs are charged with weighing the risks and benefits of proposed human subject research and making sure that

  1. risks are minimized and that the risk:benefit ratio, at least as well as it can be estimated, is very favorable;
  2. to minimize any pain, suffering or distress that might come about because of the experimental therapy; and
  3. to make sure that researchers obtain truly informed consent.

During the course of a study, regular reports must be made to the IRB, which can shut down any study in its institution if it has concerns about patient welfare.
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Posted in: Medical Ethics, Neuroscience/Mental Health, Public Health, Vaccines

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Pragmatic Studies – More Bait and Switch

The course of research into so-called alternative medicine (CAM) over the last 20 years has largely followed the same pattern. There was little research into many of the popular CAM modalities, but proponents supported them anyway. We don’t need science, they argued, because we have anecdotes, history, and intuition.

When media attention, which drove public attention, was increasingly paid to CAM then serious scientific research increased. A specific manifestation of this was the National Center for Complementary and Alternative Medicine (NCCAM). CAM proponents then argued that their modalities were legitimate because they were being studied (as if that’s enough). Just you wait until all the positive evidence comes rolling in showing how right we were all along.

But then the evidence started coming in negative. A review of the research funded by NCCAM, for example, found that 10 years and 2.5 billion dollars of research had found no proof for any CAM modality. They must be doing something wrong, Senator Harkin (the NCCAM’s major backer) complained. They engaged in a bit of the kettle defense – they argue that the evidence is positive (by cherry picking, usually preliminary evidence), but when it is pointed out to them that evidence is actually negative they argue that the studies were not done fairly. But then when they are allowed to have studies done their way, but still well-controlled, and they are still negative, they argue that “Western science cannot test my CAM modalities.”

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Posted in: Clinical Trials, Science and Medicine

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