(2 of 9)
The lesson would have been a lot less shocking if McGee's vaccine trial had been run out of a back-alley clinic or a storefront in Tijuana. In fact, the study was conducted at the St. John Medical Center in Tulsa, Okla., and co-sponsored by the respected University of Oklahoma Health Sciences Center. It had been approved by the university's institutional review board, or IRB, a body set up to ensure that such trials meet federal standards for experimental design--including the obligation to inform participants of any safety issues. And it had been given the green light by the FDA itself.
Unusual as it is, the Oklahoma case isn't an isolated incident--and in many ways, it isn't even the worst. Clinical trials are usually pretty safe; the vast majority of subjects are not hurt in any way. But so many problems--and such serious problems--have surfaced in recent years that doctors and hospital administrators are starting to wonder whether there is something dangerously wrong with the clinical-trial system.
Nobody is suggesting that it be shut down completely. Clinical trials are a vital and necessary part of America's vaunted medical research system. They are its primary mechanism for testing potential drugs and separating the ones that work from the ones that are useless or actively harmful. Yet the very nature of human testing involves risk; nobody can tell in advance whether a new medicine carries unforeseen dangers. And so clinicians are forced to walk an ethical and scientific tightrope. Make the rules protecting patients too lax, and subjects will suffer and even die needlessly. Make them too strict, and lifesaving medications won't make it out of the lab quickly enough to help the people who need them most.
But precisely where the balance lies is a matter of serious, even bitter debate. At one extreme are those who believe that most trials are tainted because they play on the fears of desperately ill patients, involve some sort of subtle coercion like money or free medicine or fail to warn patients of the very real dangers they face. Some critics argue as well that there are simply too many trials, as pharmaceutical companies looking for a share of the blockbuster drug market pump out copycat medicines that no one really needs.
On the other side are clinicians who feel they are already burdened with too much regulatory paperwork. Tighter rules will just take time and energy away from what they should be doing--developing and testing desperately needed medications. A few mishaps today, they say, may be the price we pay to save thousands of lives tomorrow.
Still, something is clearly wrong with the system as it now operates. Over the past three years, more than 60 institutions, including several of the world's most prestigious research centers, have been criticized by the U.S. government for failing to protect human subjects adequately. McGee's patients were very sick, so in a sense they couldn't be made much worse by his treatments. But federal records show that since 1999 at least four people who entered clinical trials in reasonably good health wound up dead--including two infamous cases, at Johns Hopkins Medical Center and the University of Pennsylvania.