Don't 'Game' Clinical Drug Trials

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Why aren't potential problems with prescription drugs more clearly established during lengthy clinical trials? Forcing researchers to answer to many gatekeepers was the original game plan. But people have started gaming the system.


Problems with drugs are supposed to show up in clinical trials. Commentator Ruth Levy Guyer says the trials themselves are fraught with problems.

RUTH LEVY GUYER reporting:

For several years I was a member of a medical center's institutional review board. The IRB evaluated every experiment that researchers at the hospital proposed to do with humans. We would discuss the science behind the experiment, it's medical value, the study's design, its likely benefits and risks, and whether we felt the researchers clearly understood the best interests of their participants.

We rarely approved someone's plans for a clinical trial without requiring some jiggering of the protocol. Often the change was small but sometimes a control was missing or we felt the study was misguided or dangerous. Sometimes the researcher hadn't been clear in explaining the purpose of the study or it's risks. And occasionally the language of the protocol seemed dismissive of the safety or emotional concerns or the trial's patients and healthy volunteers.

We forced researchers to jump through scientific, medical, ethical language and legal hoops. But this serious up front scrutiny was our assignment, our contribution to ensuring that the trial would be ethical and its results would be meaningful and valid. The clinical trial was itself the hoop that each new pill, vaccine, device and therapy had to jump through for approval for general use in the United States.

The trial system had been set up with many gatekeepers besides the local institutional review board: federal oversight committees, medical editors and reviewers, even the trial's fully informed volunteers. With all keeping watch, only safe and effective drugs and therapies should come to market. Or that was the original game plan anyway. But then people started gaming the system. Researchers, doctors, pharmaceutical companies, Wall Street investors and analysts, journals and journalists all found ways to get rich or famous from clinical trials.

Even some volunteers, the inelegantly named bio-pimps began lying about their medical histories and roaming from trial to trial earning good livings. The upshot is that now more than in the past drugs and devices are recalled and patients are harmed. Trials are moving from clinics to courtrooms. Patients, family members, researchers, drug companies, investors, doctors and others are suing and being sued. In meantime, the sick stay sick, awaiting new medicines and vaccines.

No one benefits from an unethical clinical trial. Even the biggest profiteers in the world, when faced with their own mortality, are likely to wish that their windfalls had been small effective pills rather than big bucks. We should not be naive about medicine. Not every condition can be cured or treated and not every pill works for everyone. Even when the efficacy of a treatment is 99.999%, some people will still be in that .001% group for whom the medicine does not work. Every time we take a pill a small experiment is underway. In fact, we are all experimental animals, but what we hope is that our medicines make us feel like lucky ducks, not human guinea pigs.

ELLIOTT: Ruth Levy Guyer teaches courses in bioethics and infectious diseases at Haverford College.

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