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How Reliable are Research Studies?

From , former About.com Guide

Created: July 6, 2006

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Every few days, new research studies come across my desk. While it is exciting when one of those studies reports on a drug or therapy that holds promise for effectively treating fibromyalgia (FM) or chronic fatigue syndrome (CFS), history has taught me to be skeptical.

A History of Deception

A couple of years ago the pharmaceutical giant GlaxoSmithKline found itself in hot water when it was discovered they had withheld some of the results of research studies done on their antidepressant Paxil. Apparently they had released the studies with positive results and withheld those that revealed serious negative effects.

A similar situation occurred when Merck and Pfizer waited until last year to reveal clinical trial results showing that the Cox-2 inhibitors Vioxx, Celebrex and Bextra could pose cardiovascular risks. I wish I could say these were isolated incidents. Unfortunately, we don’t know what we don’t know.

A Newer Study

Recently I awoke to a TV newscast reporting that a study had shown Tylenol could cause liver damage when taken according to the maximum dosage recommended on the package. I was naturally concerned since many people with FM and CFS take Tylenol (acetaminophen) either alone or in prescriptions that combine acetaminophen with another medication (Ex. Ultracet). However, my internal caution light was flashing, so I began to dig for more information.

I discovered that the reported study was conducted using a very small number of participants for a very short period of time, and that previous studies conducted by the manufacturer had yielded quite different results. Although I have no reason to question the validity of the study itself, it is a small study and doesn’t give the whole picture. I don’t think it’s sufficient information on which to make a decision.

Paid Endorsements

We all know that pharmaceutical companies pay for much of the medical research that is done. We also know they pay physicians to write professional articles promoting the positive aspects of their various drugs. What you may be surprised to learn is that now, according to a May 9 article in The New York Times, they are also paying doctors to write professional articles pointing out the negative aspects of their competitors’ drugs.

What Is Being Done?

Concerning the “scientific” articles, many doctors and health care advocates are calling for full disclosure of the link between pharmaceutical companies and medical authors, up to and including the amount of the fee paid to the doctor writing the article. As for the pharmaceutical companies revealing all of their research results, after the Paxil incident, drug makers promised to provide more research information. While some drug companies have significantly increased their reporting, others are dragging their feet.

Until we have regulations requiring full disclosure, the best we can do as patients is to check every research study to see who conducted it, where it was conducted and, most importantly, who funded it. We should look at any medical article with a skeptical eye. If there seems to be an obvious bias pro or con, I would be hesitant to give it much credibility.

Sources: Watkins, P.B., et al. Journal of the American Medical Association, July 5, 2006; vol 296: pp 87-93. “Study suggests possible risk from Tylenol.” MSNBC, July 4, 2006. Carlat, Daniel. “Generic Smear Campaign.” The New York Times May 9, 2006. Berenson, Alex. “Despite Vow, Drug Makers Still Withhold Data.” The New York Times May 31, 2005.

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