Hoover Daily Report

Vioxx's Runaway Jury

Wednesday, September 21, 2005

You'd think that a reputable company has at least the same chance of a fair trial as an accused murderer. But as the recent Angleton, Texas, jury's verdict against Vioxx shows, you'd be wrong.

The horrible effect of this verdict will be that people like you and me, who badly want medicines to help us with pain or even save our lives, will have fewer options. For instance, Merck's new COX-2 inhibitor, Arcoxia, is available only outside the United States.

Consider the flimsy evidence the Texas jury used to find against Vioxx. First, one clinical trial by Merck showed an elevated risk of heart attack in patients who took heavy doses of Vioxx for at least eighteen months. But Robert Ernst died after taking Vioxx for only eight months. Second, the coroner, Dr. Maria Araneta, found that Ernst died of arrhythmia, or irregular heartbeat, not of a heart attack. It's true that Araneta later reversed herself but in a speculative manner. She testified that it may have been an undetected blood clot that caused his death. Not only did the coroner fail to find the smoking gun, but also, to continue the analogy, she failed to find a bullet.

Consider the consequences for us. Many of us would be willing to sign in a heartbeat, so to speak, a contract with reputable drug companies giving up our right to sue in various circumstances in return for the right to buy promising new medicines. But because the courts are so "concerned" for us, they won't enforce such contracts. As a result, reputable companies such as Merck know that courts and juries will second-guess them and impose heavy penalties if the companies make decisions that we would gladly have them make but that juries might disagree with after the fact. The cases they subsequently lose could cost tens of billions of dollars.

Merck and other reputable drug companies are likely to respond in two ways to this threat from runaway juries. First, before releasing new drugs, companies will probably be even more cautious. According to the Tufts University Center for the Study of Drug Development, since the 1960s the total time required for drug development—from synthesis or discovery in the laboratory to delivery to the patient—increased from 8.1 years to 15.2 years. Expect another year or two on top of that. This means that some of us will die or live in pain while companies do studies on thousands of subjects to further reduce the probability that miracle drugs have low-probability side effects.

Second, pharmaceutical companies will develop only clear winners. Medicines that serve small markets or may have some awkward problems will be skipped. Good riddance? Not so fast. Like Vioxx, many of the drugs we rely on, including aspirin, can cause serious side effects. The medicines we will do without are ones that many of us would love to have.

Oh yes, there's another difference between Merck and an accused murderer. No one thinks the murderer was out to help the victim. Merck was.