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The Neurontin Seeding Trial

Any institution that is based upon science is also dependent upon the integrity of the scientific process, and must guard that integrity jealously. That is certainly one of the missions of Science-Based Medicine. A particular challenge is that medicine is a massively expensive enterprise, and growing in both absolute and relative terms. This means that there is a great deal of money at stake (to be potentially earned and spent) and this fact constantly threatens to distort the process of science that is supposed to underlie medicine.

In particular, wherever there are millions or billions of dollars to be made, the motivation to find clever and subtle ways to distort the scientific process is huge. We find such behavior among any industry that has a medical product or service to sell. A recent example of this behavior was recently published in the Archives of Internal Medicine – Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS) Trial.

Krumholz et al. reviewed the documents resulting from Harden Manufacturing vs Pfizer and Franklin vs Warner-Lambert and concluded:

The STEPS trial was a seeding trial, used to promote gabapentin and increase prescribing among investigators, and marketing was extensively involved in its planning and implementation.

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Posted in: Pharmaceuticals

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Magnets and Blood Flow

Over the last week I have received numerous questions about a recent study (yet to be published, but highly publicized in the press) in which it is claimed that the application of a magnetic field can improve blood flow. Physics World declared in the headline that, “Magnetic fields reduce blood viscosity.” This is not a bad summary of the study, but then the first sentence claims:

Researchers in the US claim that exposing a person to a magnetic field could reduce their risk of a heart attack by streamlining the flow of blood around their body.

Science Magazine ran with the also tame headline of “Magnets Keep Blood Flowing” but also had some problems in the text of their report (which I will get to).

The amount of press attention the study is getting is a bit odd. It’s a small proof-of-concept study looking at the effects of strong magnetic fields on blood flow in vitro. I suspect part of the reason is the same as why so many people have been asking me about it – magnets are frequently marketed with health claims and these claims are often justified by the hand-waving explanation that magnetic fields improve blood flow. The concern is that this small study will be abused by huxsters to sell refrigerator magnets with unfounded health claims.

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Posted in: Science and Medicine

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The Value of Replication

Daryl Bem is a respected psychology researcher who decided to try his hand at parapsychology. Last year he published a series of studies in which he claimed evidence for precognition — for test subjects being influenced in their choices by future events. The studies were published in a peer-reviewed psychology journal, the Journal of Personality and Social Psychology. This created somewhat of a controversy, and was deemed by some to be a failure of peer-review.

While the study designs were clever (he simply reversed the direction of some standard psychology experiments, putting the influencing factor after the effect it was supposed to have), and the studies looked fine on paper, the research raised many red flags — particularly in Bem’s conclusions.

The episode has created the opportunity to debate some important aspects of the scientific literature. Eric-Jan Wagenmakers and others questioned the p-value approach to statistical analysis, arguing that it tends to over-call a positive result. They argue for a Bayesian analysis, and in their re-analysis of the Bem data they found the evidence for psi to be “weak to non-existent.” This is essentially the same approach to the data that we support as science-based medicine, and the Bem study is a good example of why. If the standard techniques are finding evidence for the impossible, then it is more likely that the techniques are flawed rather than the entire body of physical science is wrong.

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Posted in: Neuroscience/Mental Health

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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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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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SBM at TAM9

This year The Amazing Meeting 9 (designated TAM9 From Outer Space) will be held in Las Vegas from July 14-17. If you have not registered, do it fast – this year the conference will likely sell out.

Among the many incredible speakers and events at TAM9 there will be a Science-Based Medicine workshop and an SBM panel discussion. The prominence of SBM at TAM9 partly reflects the new collaboration between SBM and the James Randi Educational Foundation (JREF), who organizes TAM.

The SBM website is now a joint project of the New England Skeptical Society (who founded SBM) and the JREF – two non-profit educational organizations dedicated to promoting the public understanding of science. I am delighted that the JREF is making SBM a priority, and we all look forward to working closely with them in promoting high standards of science in medicine and improved public understanding of the relationship between science and the practice of medicine.

As part of this new relationship I have accepted a position at the JREF of Senior Fellow and Director of their Science-Based Medicine project.

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Posted in: Announcements

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Delusional Parasitosis

A new study looks into the disorder known as delusional parasitosis, which many dermatologists believe is the true diagnosis behind the controversial disorder called Morgellon’s disease. Morgellons is a controversial disorder because many patients with symptoms believe they are being infected by an unusual organism, causing excessive itching, but no offending organism has been found. Some patients claim they have strange fibers exuding from the sores in their skin.

The term “Morgellons” was coined in 2002 by Mary Leitao, who was trying to find a diagnosis for her son who was suffering from skin lesions. Since then it has become a grassroots diagnosis – used by some patients to describe themselves but not accepted by the medical community.

Most dermatologists, rather, feel that the disorder is actually a manifestation of delusional parasitosis – a mental disorder. This has set up an unnecessarily confrontational situation. And of course, some charlatans are exploiting the situation by taking the side of the patients and offering them their nostrums as a cure.

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Posted in: Neuroscience/Mental Health

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Autism Prevalence Higher than Thought

Crossposted from NeuroLogica Blog

Over the last 20 years the prevalence of autism (now part of autism spectrum disorder, ASD) has been increasing. The medical community is largely agreed that this increase is mostly due to expanding the diagnostic category and greater efforts at surveillance. There remains some controversy over whether or not these factors explain all of the measured increase, or if there is a small real increase hidden in there as well. But largely – we are finding more children with ASD because we are casting a wider net with smaller holes.

If this is true, then we do not yet know what the true prevalence of ASD is. There must be a pool of undiagnosed children out there. Eventually the measured prevalence will hit the ceiling of the true prevalence (unless, of course, we expand the definition further) – but where is the ceiling?

That is the question researchers recently set out to answer, and they did so with a comprehensive 5 year study conducted in South Korea. The results surprised even them:
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Posted in: Neuroscience/Mental Health

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European Union “Ban” On Herbal Products

Regulations have just gone into effect in the EU regarding the sale of herbal products. The regulations seem reasonable, but they have sparked near hysteria on the part of herbal sellers and advocates of “natural” medicine. They are calling the regulation a “ban” on herbal products, which much of the media has parroted, but it is not a true ban, just a requirement for registration.

The law was sparked by cases of toxicity from over-the-counter herbal products. For example, aristolochia is a toxic plant species that is either used deliberately or can be accidentally or carelessly substituted for other plant species. It is known to cause kidney damage – even leading to kidney failure is some cases. Another herb, kava, has been linked to liver damage.

The new EU law, which went into effect May 1, 2011, will require herbal products to be licensed, or prescribed by a licensed herbal practitioner. In order to be licensed evidence for safety of the product must be presented. It is estimated that it will cost between 80,000 and 120,000 British pounds to get an individual herbal product licensed.

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Posted in: Herbs & Supplements, Politics and Regulation

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A Skeptic In Oz

UPDATE 4/27/2011: Here’s the online video of Dr. Novella’s appearance on The Dr. Oz Show:

  1. Controversial Medicine: Alternative Health, Part 1
  2. Controversial Medicine: Alternative Health, Part 2
  3. Controversial Medicine: Alternative Health, Part 3

I must say I was a bit shocked two weeks ago when I was contacted by a producer for The Dr. Oz Show inviting me on to discuss alternative medicine. We have been quite critical of Dr. Mehmet Oz over his promotion of dubious medical treatments and practitioners, and I wondered if they were aware of the extent of our criticism (they were, it turns out).

Despite the many cautions I received from friends and colleagues (along with support as well) – I am always willing to engage those with whom I disagree. I knew it was a risk going into a forum completely controlled by someone who does not appear to look kindly upon my point of view, but a risk worth taking. I could only hope I was given the opportunity to make my case (and that it would survive the editing process).

The Process

Of course, everyone was extremely friendly throughout the entire process, including Dr. Oz himself (of that I never had any doubt). The taping itself went reasonably well. I was given what seemed a good opportunity to make my points. However, Dr. Oz did reserve for himself the privilege of getting in the last word—including a rather long finale, to which I had no opportunity to respond. Fine—it’s his show, and I knew what I was getting into. It would have been classy for him to give an adversarial guest the last word, or at least an opportunity to respond, but I can’t say I expected it.
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Posted in: Acupuncture, Herbs & Supplements, Homeopathy, Science and the Media

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