Saturday, October 03, 2009

Dr. MacDougall's Jaundiced View of Studies

From his August 2007 Newsletter:

Drug Companies Rig Research—I Don’t Know How to Prescribe

Factors associated with findings of published trials of drug-drug comparisons: why some statins appear more efficacious than others by Lisa Bero, reported in the June 2007 issue of PLOS Medicine found, “RCTs of head-to-head comparisons of statins with other drugs are more likely to report results and conclusions favoring the sponsor's product compared to the comparator drug. This bias in drug-drug comparison trials should be considered when making decisions regarding drug choice.” The authors looked at 192 randomized controlled trials published between 1999 and 2005 of one brand of statin drug compared to another statin or a non-statin drug. There was a 20 times greater chance of positive results and a 35 times greater chance of positive conclusions when the trial was sponsored by the pharmaceutical company of the cholesterol-lowering statin drug being tested.

Methods to accomplish bias include:
Selecting nonequivalent doses of drugs for testing.
Selective publication of favorable outcomes.
Multiple reports of studies with favorable findings.
Lack of patient-related clinical outcome measures.
Poor study design, implementation, and analysis.

Comment: Doctors, like me, rely on the medical journal research articles to guide us to properly prescribe medications for our patients. Unfortunately, most of this research is, pure and simple, advertisements for the pharmaceutical companies—the patient be damned. In my younger years I was confused by looking over medical publications, like the Journal of the American Medical Association, and finding pages of colorful expensive advertisements clustered in the beginning and at the end of the magazine, with the scientific papers in the middle section. I thought, “How stupid, who would waste their time looking at these beginning and end advertisements.” I was the dim-witted one. I failed to realize that the real advertisements were in the middle—the research papers paid for by the pharmaceutical companies were the real advertisements.

Pharmaceutical influence includes establishing official sounding educational programs and guidelines for doctors to follow. In this PLOS Medicine article the authors discussed the National Cholesterol Education Program, which published the Adult Treatment Panel III guidelines. “To achieve the goals in the guideline, millions of Americans would need to be placed on cholesterol-lowering medication in higher doses and for a longer period, thereby increasing the number of prescriptions for statin drugs. Eight of the nine members of the National Cholesterol Education Program panel had financial ties with pharmaceutical companies that manufactured statin drugs.”

Because the research is so tainted, I do not feel confident that what I am prescribing for my patients is based on the truth—in fact, I am certain most is distorted sufficiently to cause my patients harm. So I take my best guess based on what I know—and I always reserve the right to change my mind about the drug prescriptions I write. This kind of disclosure should encourage you to make all strides to stay off of or discontinue medications whenever possible. Sick people take medications—change your diet and lifestyle to become healthy and avoid the drug controversies.

Bero L, Oostvogel F, Bacchetti P, Lee K.
Factors associated with findings of published trials of drug-drug comparisons: why some statins appear more efficacious than others.
PLoS Med. 2007 Jun;4(6):e184.

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