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The perils and pitfalls of doing a “vaccinated versus unvaccinated” study

The anti-vaccine movement is nothing if not plastic. It “evolves” very rapidly in response to selective pressures applied to it in the form of science refuting its key beliefs. For instance, when multiple studies looking at the MMR vaccine and autism failed to confirm the myth that the MMR causes autism or “autistic enterocolitis,” most recently late last year, it was not a problem to the anti-vaccine movement. Neither was it a major problem to the movement when multiple studies similarly failed to find a link between mercury in the preservative thimerosal that used to be in most childhood vaccines and is no more (except the flu vaccine) and autism. No problem! Andrew Wakefield is alleged, based on strong evidence, to have falsified his data alleging a link between the MMR vaccine and “autistic enterocolitis”? Fuggedabouddit! The anti-vaccine movement simply pivoted neatly, de-emphasized points that the evidence was so clearly against that even they couldn’t spin it to a positive anymore, and found new bogeymen. These days, it’s the “toxins” (such as formaldehyde and the latest antivax bogeyman, squalene), and “too many too soon” (a gambit given seeming respectability by Dr. Bob Sears and Dr. Jay Gordon, apologists for and supplicants to the anti-vaccine movement both.

However, there is one trait of the anti-vaccine movement that, however its camouflaging plumage may evolve, never, ever changes. It is as immutable as believers say that God is. That trait is that, whatever other claims, the anti-vaccine movement makes, at its core it is always about the vaccines. Always. No matter how often science fails to find a link between vaccines and autism or vaccines and whatever other horreur du jour the anti-vaccine movement tries to pin on vaccines, no matter how many studies do not support the viewpoint that vaccines cause autism, no matter how much the anti-vaccine movement tries to deny and obfuscate by saying that it is not “anti-vaccine” but rather “pro-safe vaccine,” at its core the anti-vaccine movement is about fear and loathing of vaccines. Always. When inconvenient science doesn’t support their views, anti-vaccine activists either ignore the science, distort the science, or launch ad hominems against the people doing the science or citing the science. And, as I said before, the claims of the anti-vaccine movement evolve. Never again will the anti-vaccine movement make the horrific mistake of yoking itself to a hypothesis that is as easily testable as the hypothesis that mercury in vaccines causes autism. The claim that mercury in vaccines causes autism predicted that, if thimerosal were removed from vaccines or reduced to pre-”epidemic levels” of the early 1990s, then autism rates should plummet. Thimerosal was removed from nearly all childhood vaccines (the sole exception being some flu vaccines), reducing infant mercury exposure from vaccines to levels not seen since the 1980s; yet autism rates continue to rise. This is about as resounding a refutation of the hypothesis that mercury in vaccines is a major cause or contributor to autism that even the anti-vaccine movement has backed away from the pure claim, which has now evolved to unnamed “environmental toxins,” either in concert with mercury or with other nasty things, as being the Real One True Cause of Autism.

It’s evolution in action. These new claims are much “fitter” because they are much harder to falsify through scientific research, epidemiology, and clinical trials.
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Posted in: Clinical Trials, Medical Ethics, Public Health, Science and Medicine, Vaccines

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Science versus pseudoscience

I know this one’s been floating around the blogosphere for a while, but it finally made its way to me at a time when I needed something lighthearted and amusing (warning: some profanity and at least one use of the “F” word):

Best quotes:

“Well, science doesn’t know everything.” Well, science knows it doesn’t know anything, otherwise it would stop … But just because science doesn’t know everything doesn’t mean you can fill in the gaps with whatever fairytale most appeals to you.”

…”nutritionist” isn’t a protected term. Anyone can call themselves a nutritionist. “Dietitician” is the legally protected term. “Dietician” is like dentist, and “nutritionist” is like tootheologist.”

“I’m sorry if you’re into homeopathy. It’s water. How often does it need to be said? It’s just water. You’re healing yourself. Why don’t you give yourself the credit?

I just wish more comics did routines like this. Sometimes humor can get the message through where analysis can’t.

Posted in: Health Fraud, Homeopathy, Humor, Science and Medicine, Science and the Media

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Functional Medicine IV

When I started this series on Functional Medicine, David Gorski suggested looking at Mark Hyman’s web page, which I had seen months before, but thought did not reveal much. That was a wrong. It shows a lot, and I suggest bloggers et al review it.

So I decided on a fourth “functional medicine” (FM) installment, in search of what it FM really is. On the Mark Hyman web page and in his Public TV monolog fund-raiser,  Hyman follows a seven point outline of what he believes Fuctional Medicine (“FM”) is. If one follows the 7 “keys” as he writes, optimum health, “ultra-wellness” happens. Here are the points:

  1. Environmental inputs
  2. Inflammation
  3. Hormones
  4. Gut & digestive health
  5. Detoxification
  6. Energy/Mitochondria/Oxidative Stress
  7. Mind body

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Posted in: Energy Medicine, Herbs & Supplements, Science and Medicine

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Science-Based Medicine 101: Reproducibility

So far I have explained why most research (if not carefully designed) will lead to a false positive result. This inherent bias is responsible for many of the illusionary treatment benefits that we hear about so commonly through the media (whether they’re reporting about CAM or Western medicine), because it is their job to relay information in an entertaining way more so than an accurate manner (i.e. good science makes bad television).Then I explained a three step process for determining the trustworthiness of health news and research. We can remember these steps with a simple mnemonic: C-P-R.

The C stands for credibility- in other words, “consider the source” – is the research published in a top tier medical journal with a scientifically rigorous review process?

The P stands for plausibility- is the proposed finding consistent with known principles of physics, chemistry, and physiology or would accepting the result require us to suspend belief in everything we’ve learned about science to date?

And finally we arrive at R – reproducibility. If the research study were repeated, would similar results be obtained? (more…)

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

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Why We Need Science: “I saw it with my own eyes” Is Not Enough

I recently wrote an article for a community newspaper attempting to explain to scientifically naive readers why testimonial “evidence” is unreliable; unfortunately, they decided not to print it. I considered using it here, but I thought it was too elementary for this audience. I have changed my mind and I am offering it below (with apologies to the majority of our readers), because it seems a few of our readers still don’t “get” why we have to use rigorous science to evaluate claims. People can be fooled, folks. All people. That includes me and it includes you. Richard Feynman said

The first principle is that you must not fool yourself–and you are the easiest person to fool.

Science is the only way to correct for our errors of perception and of attribution. It is the only way to make sure we are not fooling ourselves. Either Science-Based Medicine has not done a good job of explaining these vital facts, or some of our readers are unable or unwilling to understand our explanations.

Our commenters still frequently offer testimonials about how some CAM method “really worked for me.” They fail to understand that they have no basis for claiming that it “worked.” All they can really claim is that they observed an improvement following the treatment. That could indicate a real effect or it could indicate an inaccurate observation or it could indicate a post hoc ergo propter hoc error, a false assumption that temporal correlation meant causation. Such observations are only a starting point: we need to do science to find out what the observations mean. (more…)

Posted in: Science and Medicine

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The Microbial Metagenome

First some background.  I was first directed to the Marshall protocol by a reader who wondered about the information the found on the web.  So I went to the web and looked at the available information, much as any patient would, and discussed what I found there.

I have subsequently been lead to believe that none of the information on the website http://www.marshallprotocol.com can be considered up to date or accurate.  As as result of,  I have told that my post is chockablock with errors, although, outside of writing doxycycline where I should have put minocycline, I am left in the dark as to exactly what my errors are.  I am told that it is my responsibility to locate the errors in the last post, yet I can find none when compared to the website.

However, to remedy the deficiency of having reviewed inaccurate and out of date material,  I have been sent 6 articles that I am informed represent the state of the art in understanding the science behind the Marshall protocol.  Ah, the peer reviewed medical literature.  An opportunity to carefully read and critique new  ideas.  It is one of the reasons people publish: to see if their ideas can withstand the scrutiny of others.

Several of these papers concern Vitamin D,  the Vitamin D receptor, and olmesartan which I will review, perhaps, another time.  I don’t find them a compelling read, but it not an area about which I have more than a standard medical knowledge. The other papers concern the role of infection in autoimmune diseases, which I will discuss here.  It is easier as an infectious disease doctor  to read this literature as I am, as least as far as the American Board on Internal Medicine is concerned, a specialist in the field.  Alternatively, I am a closed minded tool of the medical industrial complex who only seeks to push his own twisted, narrow agenda at the expense of suffering patients (1).  We can’t all be perfect.
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Posted in: Basic Science, Medical Ethics, Science and Medicine

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The Rise of Placebo Medicine

It is my contention that terms such as “complementary and alternative medicine” and “integrative medicine” exist for two primary purposes. The first is marketing – they are an attempt at rebranding methods that do not meet the usual standards of unqualified “medicine”. The second is a very deliberate and often calculating attempt at creating a double standard.

We already have a standard of care within medicine, and although its application is imperfect its principles are clear – the best available scientific evidence should be used to determine that medical interventions meet a minimum standard of safety and effectiveness. Regulations have largely (although also imperfectly) reflected that principle, as have academia, publishing standards, professional organizations, licensing boards, and product regulation.

With the creation of the new brand of medicine (CAM and integrative) came the opportunity to change the rules of science and medicine to create an alternative standard, one tailor made for those modalities that do not meet existing scientific and even ethical standards for medicine. This manifests in many ways – the NCCAM was created so that these modalities would have an alternate standard for garnering federal dollars for research. Many states now have “health care freedom laws” which create a separate standard of care (actually an elimination of the standard of care) for self-proclaimed “alternative” practices.

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Posted in: Politics and Regulation, Science and Medicine

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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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