Robbery -- and felony murder

An interesting juxtaposition of essays in the latest New England Journal of Medicine. First, Jerry Avorn tells a tale that ought to put the nail in the coffin of the current system of industry-financed pharmaceutical development. As most of you probably know, the issue with cholesterol is more complicated than just the total level of serum cholesterol. So-called Low-Density Lipoprotein, LDL, is the bad stuff, but another kind of cholesterol, High-Density Lipoprotein, actually protects against the artery-clogging effects of LDL.

Statin drugs are good at lowering LDL, but now Pfizer has come up with a drug that raises HDL. It sounds like a possibly useful combination. The problem is, Pfizer is going to test this stuff, called torcetrapib (the names just keep getting weirder and harder to pronounce) in combination with their own, patented statin, Lipitor. What will then get FDA approval is the combination of torcetrapib and Lipitor. It will be impossible for doctors to prescribe torcetrapib except as part of a combination pill. If you want torcetrpib, you will have to take Lipitor. You won't be able to use another statin, even if you can't afford the much more expensive Lipitor, you can't tolerate it (I can't -- it makes me sick, so I take a generic called lovastatin), or you don't need it. But that's the deal folks, take it or leave it, even if it kills you.

On the next page, an actual good guy, Rep. Henry Waxman, discusses the Cox-2 inhibitor Vioxx from his seat on the Government Reform Committee. As we now know, Vioxx approximately quadruples the risk of heart attacks. But as Waxman tells us, the pharmaceutical industry spends $5.5 billion a year to market its products to doctors. The FDA told Merck in Feb. 2001 that it needed to warn doctor's of a trial showing that Vioxx increased the risk of heart attacks. So what did Merck do? They sent a bulletin to their sales representatives saying, "DO NOT INITIATE DISCUSSIONS OF THE FDA ARTHRITIS ADVISORY COMMITTEE . . OR THE RESULTS OF THE . . . STUDY." It told the reps to refuse to discuss the study with doctors, but to show them a card which claimed that Vioxx was associated with 1/8 the cardiovascular death risk of other anti-inflammatory drugs -- a lie. Merck consistently instructed its reps to show doctors only study results that were favorable to its drugs.

As we know, many people -- exactly how many, nobody knows for sure, but quite possibly hundreds -- died after being prescribed this class of medications inappropriately. Aggressive marketing to consumers as well as doctors contributed to massive overprescribing, and this continued even after the drug companies knew about the risks, even after the FDA knew about the risks. The motive was to make money. If you kill people in order to steal their money, there is a word for that.