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Open-Access Peer Review: Increasing the Noise To Signal Ratio

Readers of Science Based Medicine are quite familiar with the distressingly common logical leap made by disgruntled healthcare consumers into alternative medicine. It goes something like this: I had a terrible experience with a doctor who [ignored/patronized/misdiagnosed] me and I also heard something horrible in the media about a pharmaceutical company’s misbehavior [hiding negative results/overstating efficacy/overcharging for medications], therefore alternative treatments [homeopathy/acupuncture/energy healing, etc.] must be more effective than traditional medicine.

Much to my dismay, a similar logical leap is being made about online health information. It goes something like this: Peer reviewing is biased and often keeps innovative research hidden to the world at large, therefore the best kind of peer review is open-access where anyone in the world can contribute.

You may feel free to slap your forehead now.

While I have absolutely no doubt that doctors have their shortcomings, and that some have created less than pleasant healthcare experiences for their patients – the solution to these shortcomings is not to dive headlong into snake oil. Moreover, I agree that the current peer-review process has its flaws and limitations – the solution is not to ask Aunt Enid in Omaha what she thinks of the recent meta-analysis of perioperative beta blockers in patients having non-cardiac surgery.

Peter Frishauf, the founder of Medscape, recently published a webcast editorial predicting that:

“Peer review as we know it will disappear. Rather than the secretive prepublication review process followed by most publishers today, including Medscape, most peer review will occur transparently, and after publication.”

He goes on to describe a Wikipedia-like review scenario where:

“Any user can start an article, link it to related sources, and publish revisions with a click of the mouse. Anyone who reads an article can edit it.”

I know and like Peter very much, and his foresight (that publishing should become open-access), combined with the leadership of editorial heavy-weight, Dr. George Lundberg, led to the creation of the first really successful, quality, free online medical journal. This was no small feat, and a sure victory for global medical education efforts.

But the reason for The Medscape Journal’s success is not the “democratization” of peer review – but the democratization of access to trustworthy information. The quality controls are still in place – and must remain so – otherwise its value as a peer-reviewed journal will be utterly lost. Who should trust the edits of unqualified readers? Should science be determined by popular vote? Should all research be published by journals, regardless of its fatal flaws?

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

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Does TV Cause Teen Pregnancy?

I’ll be the first to admit that the quality of TV programming, especially network programs, leaves much to be desired. Critics of television have blamed TV for everything from violence to obesity. Now studies have shown that teens who watch sexy programs are more likely to become sexually active and to get pregnant. I’m not so sure that these studies really show what TV critics think they show. My local newspaper was equally skeptical.

We frequently criticize media coverage of scientific issues, so for once I’d like to offers kudos to the Tacoma News Tribune for publishing this editorial:

TV and teen pregnancy: A lot else is also at work
THE NEWS TRIBUNE
Published: November 5th, 2008 12:30 AM

For parents, the headline was ominous: “Study links TV, teen pregnancy.”
The article that appeared in The News Tribune Tuesday reported on a Rand Corp. study published in this month’s issue of Pediatrics magazine. Researchers say they found a link between higher teen pregnancy rates and watching television shows that have lots of sexual dialogue and behavior – ones like “Sex in the City, “That ‘70s Show” and “Friends.”
“Friends”?
The implication is that if teens watch such racy programming, they’re more likely to become sexually active themselves – and therefore more at risk of getting pregnant or impregnating someone else.
But couldn’t something else also be at work here? (more…)

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Do over one in five breast cancers detected by mammography alone really spontaneously regress?

ResearchBlogging.orgIt figures.

Last Wednesday, right before the four-day Thanksgiving holiday weekend, as I was far more interested in preparing to have family over the next day than in what was going on in the medical news or the blogs, the results of a most fascinating study hit the news. In Medscape, the title of the news report was Mammography Study Suggests Some Breast Cancer May Spontaneously Regress; on WebMD, the story ran under the title Can Breast Cancer Disappear?; on Medical News Today, Mammograms May Identify Cancers That Would Otherwise Just Regress by Drs. Per-Henrik Zahl, Jan Maehlen, and H. Gilbert Welch. Not surprisingly, the study found its way out of the medical news and into mainstream media outlets as well, given how provocative the findings seemingly are. From the Medscape report on this study:

A mammography study from Norway has come up with the controversial proposal that one fifth of breast cancer detected on screening may spontaneously regress. But there is no easy way to verify whether this is the case, say experts.

The study was published in the November 24 issue of the Archives of Internal Medicine. It found that the cumulative incidence of invasive breast cancer in a cohort of women, aged 50 to 64 years, who received 3 mammograms over 6 years was 22% higher than in a control group of age-matched women who received only 1 mammogram at the end of a 6-year period.

In their review of possible explanations for the difference in the breast cancer rates between the 2 groups — which had similar risk factors for breast cancer — the researchers write that the “natural course for some screen-detected breast cancers may be to spontaneously regress.”

“I anticipate that many clinicians will react negatively to the possibility of spontaneous regression, said coauthor Jan Maehlen, MD, PhD, professor of pathology at the Ulleval University Hospital, in Oslo, Norway, in an interview with Medscape Oncology.

Before I discuss the study itself, let me briefly discuss why clinicians may have a bit of a problem with the implications of this study, if they accurately reflect the biology of breast cancer.
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Posted in: Cancer, Clinical Trials, Science and Medicine, Science and the Media

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The (Not-So-)Beautiful (Un)Truth about the Gerson protocol and cancer quackery

Note added by editor: The complete movie is now available on YouTube:

The Beautiful Truth

Although this blog is about medicine, specifically the scientific basis of medicine and threats to the scientific basis of medicine regardless of the source, several of us also have an interest in other forms of pseudoscience and threats to other branches of science. One branch of science that is, not surprisingly, critical to medicine is the science of biology, and the organizing theory of biology is the theory of evolution, which was first reported by Charles Darwin and subsequently synthesized with the developing science of genetics in the early 20th century and then with our increasing knowledge of molecular biology, genomics, and proteonomics whose rise ushered us into the 21st century. However, the implications of evolution, namely that humans and apes both evolved from a common ancestor and that humans, for all their belief of being different and superior to animals, are in fact related to animals in the great chain of life going all the way back to single-celled organisms, does not go down well with certain religious fundamentalists, particularly Christian fundamentalists. Whereas I (and I daresay several of my cobloggers) find the interconnectedness of life, including humans, implied by Darwin’s theory to be beautiful and uplifting, many fundamentalists see it as a profound threat to their world view. Consequently, they have attacked the theory of evolution at every turn and tried to insert creationism, particularly the latest incarnation of creationism known as “intelligent design,” into science classes as an “alternative” to “Darwinism.” The manner in which they torture science, logic, and reason to try to cast doubt on a theory that is every bit as rock solid in terms of massive quantities of experimental and observational evidence to support it as any other theory in science, if not more so, is legendary and well documented at blogs such as The Panda’s Thumb and websites such as Talk Origins.

Although one day I plan on writing about how insights from evolutionary theory have led to deeper understandings of human disease and strategies to improve human health in the future, this time I want to concentrate on the similarities in techniques of spreading disinformation between creationists and purveyors of unscientific medical “treatments.” For background, first, you need to be aware of a movie that was released in April. The movie, Expelled!: No Intelligence Allowed was released. Starring Ben Stein at his most unctuous sporting a bullhorn and styling himself as a conservative, buttoned-down version of Angus Young through his choice of apparel in its promotional material, the movie’s main theme is that any academic who “questioned Darwinism” is “expelled” from academia. The basic idea is that “intelligent design” creationism is being “suppressed” by biologists who just can’t accept the thought of the existence of a “designer” (i.e., God). Indeed, the movie goes so far as to equate biologists and scientists who accept the theory of evolution as the best current explanation for the diversity of life to Hitler and the Nazis and their “suppression” of “alternatives” (word choice intentional) to “Darwinism” to Nazi and Stalinist persecution of dissidents and perceived threats to the regime. The movie even features a sequence where Ben Stein visits Dachau and Auschwitz, as though to imply that biologists are busy firing up the ovens for the Brave Maverick Scientists who “dissent from Darwin.”

These Brave Maverick Scientists are a lot like the Brave Maverick Doctors who champion unscientific medicine. After all, Kevin Trudeau has made a cottage industry and sold millions of books based on the claim that there are “natural cures” that “they” (as in doctors, pharmaceutical companies, and the government) don’t want you to know about and that as a consequence the full forces of these groups are being marshalled to “suppress” them and “persecute” the Brave Maverick Doctors who dare to question the “orthodoxy” of “allopathic medicine,” up to and including claims of “Nazi”-like suppression. (Just read those repositories of quackery NaturalNews.com and Whale.to if you don’t believe me.) For the “alternative medicine” movement, it’s all there, in websites, blogs, and books. But one thing that the movement pushing unscientific treatments has lacked, and that’s a movie to call its own, a movie to spread the same message.

That is, until now.

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Posted in: Cancer, Dentistry, Health Fraud, Science and the Media

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The Infection Schedule versus the Vaccination Schedule

A baby’s body is bombarded with immunologic challenges—from bacteria in food to the dust they breathe. Compared to what they typically encounter and manage during the day, vaccines are literally a drop in the ocean”, and Dr. Offits studies theoretically show an infant could handle up to 100,000 vaccines at one time … safely (6).

It is not the mercury in vaccines, its the vaccine schedule that is the problem. Too many shots, too many antigens, too close together. Our children need to be exposed to fewer antigens, less often, so they don’t get complications from the vaccine like autism and autoimmune diseases. It is all part of greening our vaccines.

That is part of propaganda on vaccines from the More Infectious Diseases for Children, a.k.a. antivaccine groups.

What is the vaccine schedule? How much exposure do children receive from organisms and antigens as part of the vaccination schedule? The entire schedule is at CDC.

In summary there are 5 live attenuated or altered organisms and 21 different antigens by age 6. A couple of vaccines are added from age 7 to 18, but by then it is too late, your child already has autism and autoimmune diseases from the immunologic and toxic scourging of vaccines. BTW. Sarcasm.

Is the vaccine schedule a lot of virus and a lot of antigens? Is this an enormous load on the immune system, sending it spiraling out of control to damage the child? Lets find out.
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Posted in: Public Health, Science and the Media, Vaccines

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Biofeedback and Laser for Allergies

AllergiCare Relief Centers are a chain of franchises started by a man called David Tucker who is not listed as having an MD or any other title. They offer diagnosis of allergies by biofeedback and treatment of allergies by laser acupuncture. They admit that the method is not backed by any science, and they claim that what they are doing is not medical treatment.

Responsible journalism might have investigated this as quackery or practicing medicine without a license. Instead, irresponsible journalism has helped promote these centers and has given them invaluable free advertising.

From one news story:

Tucker said the device works based on biofeedback. The allergy sufferer wears a sensing clip on his finger for testing, and the computer simulates the bio-frequency for 10,000 known allergens. As the body responds to those stimuli, the computer lists which substances are irritants. “This digitized allergen actually matches the harmonic frequency of the actual allergen, making the body believe it is in contact with the real substance,” Tucker said. “The body will react if it is allergic to the particular substance.” ….Once the allergens are identified, a laser stimulates biomeridian points on the body — the same points used in acupuncture and acupressure. Tucker said the idea is to strengthen organs to act properly the next time they encounter the allergen — that is, to treat them as harmless…So far, there is no science to prove the devices work, but Tucker claims a 70 percent positive response rate. (more…)

Posted in: Energy Medicine, Health Fraud, Science and the Media

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On the dangers of using valid placebo controls in clinical trials of acupuncture

ResearchBlogging.orgI don’t recall if I’ve ever mentioned this before on this blog, but there was a time when I was less skeptical of acupuncture than I am now. It’s true. Don’t get me wrong, though. I never for a minute considered that the whole rigamarole about “unblocking” or “redirecting” the flow of that mystical life force known as qi had anything to do with whether or not acupuncture did or did not have efficacy treating disease or other conditions. That was clearly a holdover from the pre-scientific medicine times in which most beliefs about the causes of disease involved either the wrath of the gods or vitalism, the latter of which is, when you come right down to it, the philosophical basis upon which many “complementary and alternative” (CAM) modalities are based, especially the so-called “energy healing” modalities, such as reiki, therapeutic touch, and, of course, acupuncture.

However, because unlike so many other “energy healing” methods, acupuncture involved an actual physical action upon the body, namely the insertion of thin needles into the skin to specified depths, it did not seem to me entirely unreasonable that there might be some sort of physiological effect that might produce a therapeutic result. At least, that’s what I used to think until I actually started paying attention to the scientific literature on acupuncture. That’s when I started to realize that “there’s no ‘there’ there,” if you know what I mean. Horribly designed studies with either no controls or utterly inadequate controls tend to be the norm in the acupuncture “literature” (if you can call it that). Moreover, acupuncture was touted as having value for conditions and procedures for which there is no plausible (or even mildly plausible) physiological mechanism by which it could be reasonably postulated to have an effect. Arthritis, allergies, headache, back pain, gastroesophageal reflux disease (GERD), Parkinson’s disease, post-operative nausea, hot flashes in breast cancer patients caused by the anti-estrogen drugs they have to take, infertility, it doesn’t matter. Seemingly acupuncture can do it all; it’s the Swiss Army knife of CAM therapies. Moreover, the “explanations” given to explain “how acupuncture works” seemed increasingly less plausible to me. Most of these explanations involve counterirritation or the release of opioids, and I’ve had an increasingly hard time believing that, even if these mechanisms are at play, they could have anything other than nonspecific effects, with no mechanism to explain how acupuncture could possibly do all things attributed to it. One rule of medical skepticism is that you should be very skeptical of modalities that are touted to be useful for a wide variety of medical conditions that have very different pathophysiology. Indeed, a funny thing happens when rigorous placebo controls are introduced, and that’s sometimes the placebo control does better than the “true” acupuncture; i.e., the evidence for acupuncture, taken in its totality, is completely compatible with placebo effect.

As Harriet Hall put it in her excellent analysis of a study purporting to show that acupuncture is useful for GERD:

This study falls into the category of what I call Tooth Fairy science. You could measure how much money the Tooth Fairy leaves under the pillow, whether she leaves more cash for the first or last tooth, whether the payoff is greater if you leave the tooth in a plastic baggie versus wrapped in Kleenex. You can get all kinds of good data that is reproducible and statistically significant. Yes, you have learned something. But you haven’t learned what you think you’ve learned, because you haven’t bothered to establish whether the Tooth Fairy really exists.

One area that acupuncturists keep needling away at is infertility. Somehow, in the CAM community it’s become conventional wisdom that acupuncture can somehow increase the chance of success for couples undergoing in vitro fertilization (IVF). Indeed, early this year I wrote about a meta-analysis that concluded that acupuncture did actually increase the success rate of IVF and why it did not show what its authors thought it showed. Tooth fairy science, indeed.

Now comes yet another study being publicized in the media that examines once again the question of whether sticking needles into women before they undergo IVF can increase their chances of conceiving. I could not help but be extremely amused by the title given to the ScienceDaily story about it: Placebo Acupuncture Is Associated With Higher Pregnancy Rate After IVF Than Real Acupuncture. You have to love a headline like that, and opening paragraphs like this:
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Posted in: Acupuncture, Clinical Trials, Medical Academia, Science and the Media

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Bad Science: Four Things I Learned From Dr. Ben Goldacre

“You cannot reason people out of positions they didn’t reason themselves into.”

– Ben Goldacre, MD

Dr. Ben Goldacre is the author of the popular Guardian column, Bad Science. He has recently published a book by the same name. Bad Science received a very favorable review from the British Medical Journal and although I was tempted to write my own review for Science Based Medicine, I decided to cherry pick some concepts from the book instead. I hope you’ll enjoy the cherries.

Honesty & Placebos

As you can imagine, any good book about bad science must devote at least one chapter to the concept of placebos. We are all quite familiar with placebos, and how squarely the vast majority (and some would argue all) of complementary and alternative medicines fit into that category.  Ben surprised me with a couple of points that I hadn’t considered previously. Firstly, that alerting patients to the fact that you’re planning to prescribe them a placebo does not necessarily negate its effects, and secondly that no matter how skeptical or intelligent you are – all humans are subject to placebo effects.

Ben references a 1965 study from Johns Hopkins [Park et al., Archives of General Psychiatry] in which patients were explicitly told that they were going to receive a sugar pill (with no medicine in it at all) as treatment for their neuroses. The researchers reported substantial improvements in many of the study subjects’ symptoms.

This is the script that the physicians were to use to explain the placebos to the study subjects:

Mr. Doe… we have a week between now and your next appointment, and we would like to do something to give you some relief from your symptoms. Many different kinds of tranquilizers and similar pills have been used for conditions such as yours, and many of them have helped. Many people with your kind of condition have also been helped by what are sometimes called ‘sugar pills,’ and we feel that a so-called sugar pill may help you too. Do you know what a sugar pill is? A sugar pill is a pill with no medicine in it at all. I think this pill will help you as it has helped so many others. Are you willing to try this pill?

Wow. I was under the impression that the efficacy of the placebo was in the person’s belief that it was a legitimate medicine/therapy. Perhaps it only matters that the prescribing physician believes it might help? Perhaps snake oil salesmen are wasting their time on linguistic and pseudoscientific mental gymnastics?

Of course, the “gymnastics” do help. Other research has shown that the more complex the associated placebo ritual, the more potent its effects (such as piercing the skin with fine needles in many different locations). Nonetheless, I was surprised that an honest and accurate description of a placebo does not necessarily negate its effects.
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Posted in: Book & movie reviews, General, Herbs & Supplements, Science and the Media

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Robert F. Kennedy, Jr., vaccines, the EPA, and the interface with science-based medicine and public policy

This blog is entitled Science-Based Medicine for a reason, and that’s because we here at SBM believe that the best method to result in the most efficacious treatments for the most people is through the application of science to the evaluation of the biology, pathophysiology, and treatment of disease and disorders.

I may (or may not) be departing a bit from the views of my co-bloggers with this belief, but for purposes of this blog I consider “medicine” to go far beyond what we as physicians do when we undertake to treat patients. In fact, in my view, the purview of science-based medicine should not be so limited but should include any area where decisions, actions, or policy have a direct impact on health. Thus, my definition of science-based medicine encompasses environmental policy, because of the profound effect on human health environmental pollution and toxins can have. Unfortunately for those of us who don’t like its messiness, such a view drives me even more directly into politics than previous issues I’ve taken on. Like Dr. Novella, I rarely write about politics, but when it directly impacts science-based medicine. Mostly, such discussions here on SBM have involved the regulation of the medical profession by government, as Dr. Atwood discussed recently (1, 2, 3) in the context of the difficulties medical boards have in preventing quackery to my discussion of how a quack like Dr. Rashid Buttar could continue to practice in North Carolina, despite his despicable preying upon desperate cancer patients and the parents of children with autism, not to mention the frequent criticisms of the National Center for Complementary and Alternative Medicine. Dr. Sampson, on the other hand, was more than willing to examine a much more explicitly political issue, namely the number of Iraq War dead (1, 2), and that provoked a bit of disagreement with our commenters, not to mention me.

Recently, hot on the heels of the election of Barack Obama in the Presidential election last week, an issue relevant to several aspects of where science-based medicine intersects public policy popped up. Steve Novella has already commented on it on his own blog, as have numerous other medical bloggers, science bloggers, and political bloggers but I feel justified in commenting on it here, for the reasons that I’ve just mentioned. The controversy is that antivaccine activist and true believer in the scientifically discredited notion that mercury in the thimerosal preservative in vaccines causes autism, Robert F. Kennedy, Jr., is being seriously considered by Barack Obama either to head the Environmental Protection Agency or even to be Secretary of the Interior. Like our fearless leader Steve, I believe that such a selection would be an unmitigated disaster for science policy in government.
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Posted in: Politics and Regulation, Public Health, Science and the Media, Vaccines

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Breast cancer and migraines–what is risk, anyway?

ResearchBlogging.orgOne of the questions most often asked in the medical literature is “what is the risk of x?”  It’s a pretty important question.  I’d like to be able to tell my patient with high blood pressure what their risk of heart attack is, both with and without treatment.  And risk is a sexy topic—the press loves it.  Whether it’s cell phones and the “risk” of brain cancer, or vaccines and the “risk” of autism, risk makes for cool headlines.  Take this one for example:

Migraines cut breast cancer risk 30 percent: study

What does this mean?  Should I tell my wife to go out and find some migraines?  I have a feeling one or more of my colleagues will give a more detailed critique of this study, but I’d like to talk to you a bit about what we mean by “risk”.

Risk, in the most basic sense, is a causal association.  If, for example, I find that members of the “Thunderstorm-lovers Golf Association” have a higher incidence of being struck by lightning than golfers who don’t belong to this odd club, I may have stumbled upon a measurable risk.  There is both a measurable association, and a plausible reason to causally link the associated variables.   If I find that members of the National Association of Philatelists have a higher incidence of heart disease than other folks, I may or may not have stumbled on a risk.  Is there a reason that philatelists should have more heart disease?  Is it a coincidence?  Is it worth investigating further?  Is there a confounding variable, e.g. are philatelists in general older, and did I fail to control for this?

Then there is the question of the degree of risk.  How strong is the risk observed?

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