Friday, January 25, 2008

Negative Drug Trials Unreported

That headline covered a story under "Briefly" in Monday's Los Angeles Times Health section. I thought it was a joke to see if I was paying attention to what I was reading. Days after the debacle over Zetia and Vytorin study results not being reported by Merck and Schering-Plough, it seemed too coincidental that more drug studies were either kept secret, or worse yet, fudged to cover up the deleterious effects of the drugs:

Nearly one-third of antidepressant drug studies are never published in the medical literature, and nearly all happen to show that the drug being tested did not work, researchers reported Wednesday in the New England Journal of Medicine.

And in some of the studies that are published, unfavorable results have been recast to make the medicine appear more effective than it really is, said the research team led by Erick Turner of the Oregon Health & Science University.

Even if not deliberate, they wrote in their report, "Selective publication can lead doctors to make inappropriate prescribing decisions that may not be in the best interest of their patients."

Yesterday and today Merck and Schering-Plough took out two-page ads in the Los Angeles Times touting the wonders of Zetia and Vytorin and recommending following the advice of physicians with the assumption that the almighty result of lowering ldl cholesterol was a sufficient end in itself, regardless of the unhappy build-up of the killer plaque in arteries was also caused by these drugs.

High cholesterol levels in the blood have been blamed through the years on higher cases of arterial disease based largely on statistical correlation. The exact mechanism of plaque build-up in arteries is still not completely understood. Systemic "inflammation" may be a culprit, as well as high cholesterol levels, and the statin drugs may also have an effect on this inflammation which is helpful along with the lowering of serum cholesterol levels. And just which element of the cholesterol picture--low density lipoproteins (ldl) or high-density lipoproteins (hdl) or very low density lipoproteins (vldl)--is the "good" or "bad" cholesterol is all based on educated theory, some empirical and some statistical.

The Zetia/Vytorin ads state unequivocally that the ldl cholesterol is "bad" cholesterol. While this is probably true, it would be beneficial to the consumer in order to be well-informed, to know of the theoretical essence of such a statement.

I have received some antagonistic emails in the past in response to my commentary on pharmaceutical companies' deceitful practices. They were not published because of their inflammatory nature and uninformed opinions. However, when media reports continue to grow about the greed and illegal activities of drug manufacturers, it seems specious to argue about how wonderful these products really are. The one thing that is for sure, is that the bottom line for big pharma is the big buck, not public health.

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