Cholesterol, Big Pharma, and Changing the Rules

Millions of Americans take drugs to lower their cholesterol, in hopes of keeping heart attacks, strokes or even dementia at bay. We all assume that when they are prescribed by our physicians, then they are safe, and will do what they say that will do.

Along comes a report from the New York Times about a clinical trial, called Enhance, being held to test two of the drugs, Zetia and Vytorin. The trial has been taking place worldwide for more than two years, yet none of the results have yet been published, even though some were expected by now. Understand that both these drugs are taken by approx 800,000 Americans each day. But no test results have been forthcoming, meaning, when those 800,000 take them, they can't be sure the drugs are doing what they are supposed to do.

Further, it seems that the drug trials are being underwritten by the companies that manufacture the drugs, Merck and Schering-Plough. (Does that name Merck ring a bell? As in the Vioxx scandal?)

AND (this should make you take notice), the companies have decided to change the goal of the trial. Instead of the original three measurements defined at the outset, they will begin by publishing only one of them.

As Howard Brody, author of Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry, blogged, "As a rule such a shift is very suspicious because it raises fears that you are deciding what counts as a successful trial result only after you know what some of the data show. It is analogous to hitting a bull's-eye with a bow and arrow by first shooting the arrow, then drawing the bull's-eye around the arrow wherever it happens to land."

Patients taking these two drugs need to be asking their doctors how safe they are. As a population of patients, we need to wonder how it is these companies, with major financial stakes in the outcomes, are allowed to sponsor their own trials, even while patients are taking the drugs that may not be safe?

Is this just one more example of profits at the expense of patient safety?