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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, Herbs & Supplements, Science and the Media

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The Debate About Off-Label Prescriptions

So-called off-label uses of prescription drugs is an enduring controversy – probably because it involves a trade-off of competing value judgments.The FDA is considering loosening its monitoring of off-label prescriptions, but critics are charging that, if anything, regulations should be tightened. Many issues of science-based medicine are at the core of this controversy.

In the US the FDA (Food and Drug Administration) regulates the sale of drugs. In order for a pharmaceutical company to get a drug on the market they must complete FDA monitored clinical trials and demonstrate adequate safety and effectiveness for a specific indication. The specific indication for which a drug is approved is the on-label indication, and all other uses are off-label.

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Posted in: Pharmaceuticals

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Statins Are Better on JUPITER

Over 26 million Americans are taking statin drugs. Some people think they should be available over-the-counter without a prescription, and it has even been facetiously suggested that they should be added to our drinking water. The protective effect of statins in cardiovascular disease and in high-risk patients with high cholesterol levels is well established. But what about people with no heart disease and normal cholesterol levels – can they benefit too?

The New England Journal of Medicine has pre-released an important new study on statins online prior to its planned publication date of November 20, 2008. It is certain to stir up a lot of controversy, and the International Network of Cholesterol Skeptics will not be happy, because it contradicts some of their favorite arguments. They have claimed that statins do more harm than good, that reducing cholesterol levels is harmful to health, that the benefits of statins and/or cholesterol lowering do not extend to women and the elderly, and that studies showing benefits of statins are meaningless because they do not show reduction of overall mortality. This study indicates otherwise. (more…)

Posted in: Clinical Trials, Pharmaceuticals

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Does alternative medicine have alternative ethics?

Kimball Atwood has an interesting series of posts on the ethics of alternative medicine which I strongly encourage you to read.  He does a great job examining the ethical implications of certain alternative medicine practices, and has a terrific dialog with Peter Moran, a frequent commenter here.   At my other online locale, I make frequent forays into the morass of medical ethics, with an emphasis on specific clinical scenarios.  Today, though, I’d like to take a step back and examine the nature of medical ethics as they apply to so-called alternative medicine.

First, and perhaps most important, I am not an ethicist.  I do not have the depth of reading, the knowledge of terminology, or the specific education to lead a formal discussion on ethics.  What I am is a practicing internist, who must make ethical decisions on a daily basis. Most of these decisions are of necessity made “from the heart”, but it is not infrequent that I must evaluate a situation more formally and fall back on some of the ethical principles of my profession.

Ethics are not static.  They are not a divine gift bestowed on each of us as we don our white coats.  They are a living part of our specific cultures, and of the profession we serve.  Some of the modern principles of medical ethics are newer than others.  Beneficence, non-maleficence, and confidentiality are ancient principles of medical ethics, which continue to be relevant today.  Patient autonomy is a more recent value, reflecting a shift in how society views the relationship between patient and physician.  These ethics must be mutable, as the profession itself is ever-changing.  Despite this fluidity, there is an identifiable line of “doctor-hood” that has existed for at least the last century, and the members of this guild have always tried to adhere to some type of code of behavior.

Alternative medicine poses real challenges to the principle of medical ethics.  First, we’ll discuss who, in fact, is bound by these principles, then the way in which alternative medicine is or is not compatible with medical ethics. (more…)

Posted in: Medical Ethics, Science and Medicine

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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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“It’s just a theory”

I am afraid that the experiments you quote, M. Pasteur, will turn against you. The world into which you wish to take us is really too fantastic.

La Presse, 1860

It’s just a theory. Not evolution. Germ theory. Just a theory, one of many that account for the etiology of diseases.

I should mention my bias up front. I am, as some of you are aware, an Infectious Disease doctor. My job is simple: me find germ, me kill germ, me go home. I think there are three causes of disease: wear and tear, genetic, and germs. Perhaps a bit of an exaggeration, but not much. My professional life for the last 22 years has been spent preventing, diagnosing, and treating the multitudinous germs that a continually trying to kill or injure us. It is a fundamentally futile job, as in the end I will be consumed by the organisms I have spend a lifetime trying to kill.

I would have though that the germ theory of disease was a concept that was so grounded in history, science and reality that there would be little opposition to the idea that germs (a broad term for viruses, bacteremia, fungi, parasite etc) cause infections and some other diseases.

Wrong. There are people who deny the validity of germ theory. Add there are people who deny gravity. And evolution.

Opponents of germ theory come in two flavors:

  1. Germ theory deniers.
  2. Those who propose alternative mechanisms of disease.

There is great overlap between the two categories, and the division serves more as a literary device for the sake of exposition than a true description of reality.
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Posted in: Acupuncture, Chiropractic, Homeopathy, Science and Medicine, 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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Posted in: Science and Medicine, Science and the Media

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Wyeth vs. Levine: Should Drug Label Standards Be Determined By Juries?

It is with some degree of trepidation that I enter the fray on the Wyeth vs. Levine case. I’ve been watching the media frenzy about the lawsuit with interest – mostly because (for the first time in a while) I think that the pharmaceutical company is in the right on this one – and that most journalists (and even medical journal editors) have missed the salient points.

I think that a close review of the case is instructive in two ways. It shows: 1) the dangers of making legal decisions based on the perspective of the victim (a risk of harm equal to 1 in 20 million is unacceptable to that one person who suffered the consequence, but tolerable to the other 19,999,999 others) and 2) that a simple case of medical malpractice has made it all the way to the US Supreme Court because (as I discussed in my last post) a democratization of knowledge (juries reading a drug label) was believed to democratize expertise (how a physician would understand the label).
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Posted in: Pharmaceuticals, Politics and Regulation, Public Health

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Rainman – Link Between Precipitation and Autism

A new study published in the Archives of Pediatrics and Adolescent Medicine shows a positive correlation between counties in California, Oregon, and Washington with greater precipitation and a higher incidence of autism. While the results of this study are interesting, it needs to be put into proper context. Also of note, the authors had presented early results from this data previously.

Correlation is not Causation

This type of study is a correlational study, which means it asks whether or not there is a statistical correlation between two variables – in this case the rate of autism and the amount of precipitation.  This type of data is extremely useful to medical science, but it has known limitations, which can be summarized by the statement that correlation is not causation.

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Posted in: Neuroscience/Mental Health

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Why we don’t prescribe bark for cancer

My valued colleague, Dr. Antonio Baines, recently invited me to speak for his graduate course in Toxicology.  Dr. Baines’ course is one of the most highly-regarded graduate classes at North Carolina Central University for M.S. students in Biology and Pharmaceutical Sciences.  Antonio asked that I discuss the pharmacology and toxicology of herbal and non-botanical dietary supplements but pretty much gave me free reign as to the mechanism by which I would do so.

In the past, I have often introduced herbal supplements to students who already know a bit about drug and toxicant action by taking the example of the anticancer drug, taxol (Note: Little “t” taxol was the name originally given to this chemical by its co-discovers but the corporate sponsor used it as a registered trademark for the brand name, big “t” Taxol, and the USAN proposed the use of the cumbersome paclitaxel as the generic name.).  As I noted in my previous post, taxol is an anticancer drug isolated from the bark of the Pacific yew tree, Taxus brevifolia, and was the first compound shown to kill cancer cells by promoting microtubule polymerization (and preventing depolymerization).

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Posted in: Herbs & Supplements, Science and Medicine

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