Senate looks at reforming laws governing the use of experimental drugs on patients

Several key senators have begun to champion a new cause: increased protection for patients who are enrolling in experimental drug trials.

During a recent meeting of a Senate health panel, Senators Edward Kennedy, D-Mass., and Bill Frist, R-Tenn., looked to making the rules which govern testing on human subjects more comprehensive and standardized.

This new focus comes after a series of problems in clinical trials over the past few years.

The problems involve incidents at Johns Hopkins University, the University of Pennsylvania, the University of Oklahoma and the Fred Hutchinson Cancer Research Center.

Last year at Johns Hopkins a healthy volunteer enrolled in an asthma study, Ellen Roche, died due to respiratory failure. The respiratory failure came a month after Ms. Roche inhaled a toxic dose of a chemical. Unfortunately, the principal researcher had missed information about the chemical's possible side-effects.

In 1999, Jesse Gelsinger and 18 year old participating in a study at the University of Pennsylvania died. Jesse was part of a gene-therapy study experimenting with the treatment of enzyme disorders. It seems that a conflict of interest may have played a part in the lead researcher's decisions, as he held nearly a one-third stake in the company which owned the licensing rights to the drug in question.

At the University of Oklahoma a study tested a vaccine for melanoma on 94 patients in the advanced stage of that disease. Approximately a third of the patients experienced serious side effects. Controversy ensued when the study was continued on pregnant women, despite warnings on the consent form about possible birth defects.

The Fred Hutchinson Cancer Research Center has been in trouble for quite some time now, for experiments dating back to the 1980s. A year ago the federal Office of Human Research and Protections began an investigation into the Cancer Research Center's experiments. In question was whether or not patients had been deprived of information pertaining to risks as well as the alternatives to the experimental treatment used in the 1980s and 1990s. In addition, patients were not informed of their doctors' financial interests in the experiments being performed. More recently, the federal Food and Drug Administration suspended three clinical trials for various problems. These problems included providing inadequate information to patients.

While research has lead to great advances over the past decades, due at least in part to the recruitment of volunteers for studies, there have been numerous drawbacks. As critics quickly point out, research has truly become a moneymaking business for pharmaceutical as well as biotechnological companies.

Very little attention has been paid to protecting the people volunteering for trials.

Senator Kennedy, who chairs the Health, Education, Labor and Pensions Committee, is a firm supporter of mandatory reforms for clinical trials.

"Numerous expert reports and investigations on our current system of protections have identified serious flaws that must be corrected," he claims.

Senator First, a physician on the other hand, believes that while necessary, reforms should be voluntary.

Moreover, he believes that the more than a dozen federal agencies which currently oversee clinical trials should be amalgamated into a single, independent entity.

"There are too many people using too many different standards with duplication (and) inconsistencies," Frist said.

The supporters of the call for new guidelines believe that the creation of guidelines is of the utmost importance. David Charles, chairman of the National Alliance of Medical Researchers and Teaching Physicians is one such supporter.

Charles worries that the few failures are being given more significance than the successes.

He claims, "Society loses if regulations to protect the public become obstacles to serving the public."

It is not only academic researchers that are realizing the necessity for change.

Charles Johnson, representing the Biotechnology Industry Organization, stated that "Participants in research are volunteers, meaning that we must do all we can to ensure that they have the utmost confidence that they will be protected."

Nonetheless, no matter what the reforms may end up being, Johnson point out that "Medical research has and will continue to lead to cures and treatments for millions of Americans suffering from diseases.