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Archive for January, 2010

The Tamiflu Spin

I will start, for those of you who are new to the blog, with two disclaimers.

First, I am an infectious disease doctor. It is a simple job: Me find bug. Me kill bug. Me go home. I spend all day taking care of patients with infections. My income comes from treating and preventing infections. So I must have some sort of bias, the main one being I like to do everything I can to cure my patients.

Second, in 25 years I have, to my knowledge, accepted one thing from a drug company. The Unisin (that’s how I spell it) rep, upon transfer from my hospital, sent me a Fleet enema with a Unisin sticker on it. I show it proudly to all who enter my office. I do not even eat the drug company pizza at conference, and I cannot begin to tell you painful that is.

As we leave (I hope) the H1N1 season and enter seasonal flu season, there has been a flurry of articles, originating in the British Medical Journal , questioning whether oseltamivir is effective in treating influenza. The specific complaint at issue is whether or not oseltamivir prevents secondary complications of influenza like hospitalization and pneumonia. Although you wouldn’t guess that was at issue from the reporting.  As always, there is what the data says, what the abstract says, what the conclusion says, and what other people say it says.  Reading the medical literature is all about blind men and elephants.

There is, evidently, going to be an investigation by the European Union Council of Europe  into whether or not the H1N1 pandemic was faked to sell more oseltamivir. Sigh.
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Posted in: Pharmaceuticals, Politics and Regulation, Public Health, Science and the Media

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Reflexive doubt

Those of us who study, practice and write about medicine cherish the hope that explaining the science behind medicine (or the lack of science behind “alternative” treatments) will promote a better understanding of medicine. Certainly, I would not bother to write about medical topics if I did not believe that promoting science based medicine would lead to increased understanding of medical recommendations and decreased gullibility in regard to “alternative” remedies. Nonetheless, lack of scientific knowledge is not the only reason for the current popularity of “alternative health. Indeed, many advocates and purveyors of “alternative” health are impervious to the scientific evidence. What else might be going on?

Belief in “alternative” medicine is a complex social phenomenon. Like any complex social phenomenon, the explanation cannot be reduced to a simple answer. But I would argue that there is an important philosophical component, developed by and promoted by advocates of “alternative” health. That philosophical component is the rise of reflexive doubt. Simply put, among a significant segment of society, it has become a badge of honor to question authority.

As an obstetrician, I am most familiar with its expression among childbirth activists. They recognize that many people hold the common sense belief that modern obstetrical practice has made birth safer, and have worked ceaseless at undermining this common sense view. Craig Thompson, a professor of marketing, has examines this tactic in his paper What Happens to Health Risk Perceptions When Consumers Really Do Question Authority?:
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Posted in: Science and Medicine

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Evolution in Medicine

A recent series of article in the Proceedings of the National Academy of Sciences (PNAS) discusses the role of evolutionary biology in modern medicine. The authors collectively make a forceful point – medicine is an applied science. It is based upon a number of basic sciences, and one of those basic sciences is evolution.

The most obvious example is bacterial antibiotic resistance. Antibiotics place a selective pressure on a bacterial population, often resulting in the emergence of resistant strains. Understanding this “evolutionary arms race” between bacteria and antibiotics allows us to develop strategies for minimizing resistance.

But there are less obvious ways in which evolutionary principles apply to infectious diseases. It has been known for a long time that sickle-cell trait provides resistance to malaria (the blood cells are less hospitable to the P. falciparum protozoan parasite that is one cause of malaria). This explains the persistence of sickle cell disease in populations where malaria is endemic.

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Posted in: Evolution, Science and Medicine

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Faith Healing

Faith healing is based on belief and is about as far as you can get from science-based medicine, but it is not exempt from science. If it really worked, science would be able to document its cures and would be the only reliable way to validate its effectiveness. Miraculous cures continue to be reported on a regular basis: what are we to make of them? In the Healing Rooms Ministry of Bethel Church in Redding, California, people regularly claim to be healed of cancer, broken bones, multiple sclerosis and many other ailments. Page after page of testimonials of cures are listed on their website. Are these cures real? If not, what is going on?

Amanda Winters, a journalist doing a series of articles on Bethel Church, interviewed me for a scientific view of these faith healings. She asked me some very incisive questions and understood my answers. She wrote what I thought was a balanced article, quoting me fairly and at more length than reporters usually allow.

Her article features a patient who believed his flat feet would be healed (bones would crack and form an arch). Healers poked him, blew a shofar at his feet, and covered him with a blanket when he collapsed on the floor. When he got up, his feet were unchanged. But

his faith was not shaken, he said, because he felt so loved and maybe the physical healing was secondary to the spiritual experience he had. (more…)

Posted in: Faith Healing & Spirituality

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On the “individualization” of treatments in “alternative medicine”

One of the claims most frequently made by “alternative medicine” advocates regarding why alt-med is supposedly superior (or at least equal) to “conventional” medicine and should not be dismissed, regardless of how scientifically improbable any individual alt-med modality may be, is that the treatments are, if you believe many of the practitioners touting them, highly “individualized.” In other words, the “entire patient” is taken into account with what is frequently referred to as a “holistic approach” that looks at “every aspect” of the patient, with the result that every patient requires a different treatment, sometimes even for the exact same disease of very close to the same severity. Indeed, as I have described before, a variant of this claim, often laden with meaningless pseudoscientific babble about “emergent systems,” is sometimes used to claim that the standard methods of science- and evidence-based medicine are not appropriate to studying the efficacy of alternative medicine. Of course, this is, in nearly all cases, simply an excuse to dismiss scientific studies that fail to find efficacy for various “alt-med” modalities, but, even so, it is a claim that irritates me to no end, because it is so clearly nonsense. As Harriet Hall pointed out, alt-med “practitioners” frequently ascribe One True Cause to All Disease, which is about as far from “individualization” as you can get, when you come right down to it. More on that later.

A couple of years ago, before I became involved with this blog, I was surprised to learn that even some advocates of alt-med have their doubts that “individualization” is such a great strength. I had never realized that this might be the case until I came across a post by naturopath Travis Elliott, who runs a pro-alt-med blog, Dr. Travis Elliott and the Two-Sided Coin, entitled The Single Most Frustrating Thing About (Most) Alternative Medicine. In this article, Elliott referred to a case written up by a fellow naturopath, who used an anecdote about the evaluation and treatment plan by a naturopath of a pregnant woman with nausea to show what is supposedly the “unique power of our medicine.” Unexpectedly (to me at least at the time), Elliott did not quite see it that way:
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Posted in: Clinical Trials, Energy Medicine, Homeopathy, Science and Medicine

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You can’t hide in the herd

Can you hide in the herd?  Well, I suppose the title has given away the punch line.

Herd immunity is a fascinating effect, and one of the mainstays of a public vaccination effort.  The idea is that if enough people in the community are immune to a particular disease, then those who are susceptible will rarely come into contact with a person who is contagious, and the disease will be unable (or find it difficult) to spread.  This results in a greatly reduced risk of infection for the entire population regardless of their individual immunity.

This has lead to the belief that because of the protection of the herd’s immunity, individuals now have the option to avoid even the minimal cost and risk of vaccination while having the same reduced risk of infection as if they had vaccinated.

Let’s set aside the fact that that there are people who have no choice but to rely upon herd immunity as their sole line of protection against these infections.  Forget that there is a threshold below which herd immunity collapses, and that our current vaccination rates tend to be right on the cusp of that threshold.  Pay no attention to the fact that the personal decision to not vaccinate deprives others of their sole protection from these infections.  Finally, ignore the ethics and self-defeating nature of benefiting from the sacrifice of others while simultaneously eroding the efficacy of the herd immunity being exploited.  On a small enough scale, doesn’t the tactic of hiding in the herd provide the same protection as getting vaccinated without incurring the minimal risk of vaccination?

Not so much. (more…)

Posted in: Science and Medicine, Vaccines

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Don’t Believe The Hype: Cholinesterase Inhibitors As A Treatment For Dementia

Don’t Believe The Hype: Cholinesterase Inhibitors As A Treatment For Dementia
I distinctly remember the day I attended a “drug lunch” (as a PM&R resident in New York City) to learn about the value of donepezil (aricept) for the treatment of dementia. I was astonished by the drug’s lack of efficacy – the graph displayed in the PowerPoint show demonstrated a 2-point improvement on the Mini Mental State Exam (MMSE), an effect that began after 6 months of donepezil use, and persisted for only 6 months after that. A 2-point difference on the MMSE has no clinical relevance of which I’m aware. The drug’s common side effects include: nausea, vomiting, diarrhea, loss of appetite, tiredness, drowsiness, trouble sleeping, or muscle cramps. That day I vowed never to prescribe the drug to my elderly patients.
Nonetheless, I was dumbfounded by the number of patients who came to the hospital already on the medication. Over and over again I heard the same story: “mom is becoming forgetful so our doctor started her on this medication to help her memory.”
When I asked if the family if they thought the medicine helped, the response was equally predictable: a shrug and then “what else can we do?”
Here we have a classic example of a medical problem with no satisfactory treatment or cure – and a desperate desire on the part of patients and family members to do something – anything – about it. Many times people in these predicaments turn to alternative medicines, herbal supplements and faith –based remedies. And sometimes they turn to FDA-approved drugs.
The Cochrane Collaborative has reviewed the scientific literature on the use of cholinesterase inhibitors (like donepezil) in mild dementia, and has found:
There is no evidence to support the use of donepezil for patients with mild cognitive impairment (MCI). The putative benefits are minor, short lived and associated with significant side effects. http://www.cochrane.org/reviews/en/ab006104.html
So how did this drug get approved? Well, there do seem to be some small improvements (of dubious clinical significance in my opinion) in measures of cognitive impairment in patients with Alzheimer’s dementia in particular. http://www.cochrane.org/reviews/en/ab005593.html
AHRQ states:
The evidence is mixed, however, about the effects of cholinesterase inhibitors on functional measures such as instrumental activities of daily living (i.e., ability to use the telephone, mode of transportation, responsibility for medication, and ability to handle finances). In general, the studies show little or no effect on functional decline after 6 months of treatment and a small but statistically significant difference from placebo after 12 months of treatment.
Research has found no clinically important differences between people taking cholinesterase inhibitors and those taking placebo in the development of behavioral and psychological symptoms… Studies rarely addressed other important health outcomes such as utilization of health care services, injuries, and caregiver burden.
http://www.ahrq.gov/clinic/3rduspstf/dementia/dementsum.htm
Pfizer’s press release (when they received FDA approval to market Aricept in 1996) noted:
Alzheimer’s disease is a family tragedy. ARICEPT will benefit patients and families alike by improving or maintaining patient function, which in turn may help ease the burden for caregivers and help maintain personal dignity… “ARICEPT represents a significant step forward in addressing the therapeutic needs of the Alzheimer’s disease community…This therapy will help to change the approach to the management of Alzheimer’s disease.
http://www.pslgroup.com/dg/e2aa.htm
Global sales of Aricept were approximately $1.1 billion for 2008 alone.
Me-too cholinesterase inhibitors have seen similar global profits, with sales of namenda at about $1 billion as well in 2008. http://www.businessweek.com/magazine/content/04_14/b3877629_mz073.htm All this while the AHRQ can find no clinically relevant difference between the drugs in this class, and the effects they have are small and short lived.
There are pharmaceutical innovations that have changed the course of history (imagine where we’d be without the polio or smallpox vaccines), while others leverage the tiniest statistically-significant effects to drive global drug empires driven by public feelings of helplessness in the face of currently incurable diseases.
It’s no wonder that the public has a mistrust of pharma – their marketing engines drive sales of drugs that have vastly different clinical value. That means it’s up to physicians and scientists to tease out the legitimate enthusiasm from the marketing hype. And judging from all the patients with mild dementia that I see on cholinesterase inhibitors, I give us a failing grade.

I distinctly remember the day I attended a “drug lunch” (as a PM&R resident in New York City) to learn about the value of donepezil (Aricept) for the treatment of dementia. I was surprised by the drug’s lack of efficacy – the graph displayed in the PowerPoint show demonstrated a 2-point improvement on the Mini Mental State Exam (MMSE), an effect that began after 6 months of donepezil use, and persisted for only 6 months after that. A 2-point difference on the MMSE has no clinical relevance of which I’m aware. The drug’s common side effects include: nausea, vomiting, diarrhea, loss of appetite, tiredness, drowsiness, trouble sleeping, or muscle cramps. That day I realized that the risk-benefit profile did not support its use.

Nonetheless, I was perplexed by the number of patients who came to the hospital already on the medication. Over and over again I heard the same story: “Mom is becoming forgetful so our doctor started her on this medication to help her memory.” (more…)

Posted in: Pharmaceuticals

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Big Placebo says Medicine never cures anything

Kudos to Lindsay Beyerstein of Majikthise for coining a new appellation “Big Placebo.” Big Placebo is the alternative health counterpart to Big Pharma. Both are special interest groups designed to promote their products, whether they are worthy of promotion or not. There is one big difference between them: Big Pharma makes products that usually work (though not always, and sometimes not safely). Big Placebo hawks books and products that never work.

Big Placebo is unsatisfied with the $40 billion it takes in every year on treatments that don’t even work. They’re aiming for a much larger piece of the healthcare pie and to do so they are criticizing modern medicine.

To hear Big Placebo tell it, virtually all illness can be prevented and anyone who gets sick deserves it because of poor lifestyle choices. If only that were so. Unfortunately, most illness and disease is caused by factors beyond people’s control, including infectious agents, genetic defects and inherited predispositions.
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Posted in: Science and Medicine

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$10,000 reward not offered for scientific proof of supplements and alternative medicine therapies and effectiveness

Inspired by a post today

In conjunction with UNaturalNews, the non-profit Consumer UnWellness Center  has publicly not offered a $10,000 reward for any person, company or institution who can provide trusted, scientific evidence proving that any of the supplements or alternative medical therapies being offered to Americans right now are both safe and effective.

Supplement or alternative medical therapies promoters keep citing their “science” in claiming that supplements or alternative medical therapies are safe and effective. UnNaturalNews asks one simple question: Where is this science?

The $10,000 reward will not be issued to anyone who can produce scientific evidence meeting the following criteria: (more…)

Posted in: Herbs & Supplements, Humor, Vaccines

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e-Cigarette Safety

Ever since news of the harmful effects of tobacco smoke hit the public consciousess around the middle of the 20th century the tobacco industry and others have been looking for a “healthy” alternative. Are e-cigarettes just latest in a list of failed attempts to make smoking safe?

In case you are a new visitor to our planet (welcome) using tobacco products has been determined to be a significant risk factor in developing certain kinds of lung cancer and vascular disease, including strokes and heart attacks (the top three killers).  The tobacco industry initially tried desperately to deny or downplay the scientific evidence for the health risks of smoking, engaging in a campaign of doubt and confusion, but those efforts ultimately failed.

Some companies marketed light, low tar, and filtered cigarettes with the claim, direct or implied, that they were a more healthful alternative to regular cigarettes. However, there has never been convincing evidence that such cigarettes are less of a health risk. Still, the marketing stuck and now 90% of all cigarettes sold are filtered.

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Posted in: Public Health

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