Wednesday, August 31, 2011

Panel recommends compensation system for those harmed by medical research

The Cole Legal Group can help if you've been injured from drugs or treatment given in a clinical trial
The United States should create a system to compensate people who are harmed by participating in scientific research, a panel of federal advisers recommended Tuesday.

Many other countries require sponsors of studies and researchers to carry insurance for research-related injuries or have other ways to compensate volunteers who are harmed, making the United States an “outlier,” the subcommittee of the Presidential Commission for the Study of Bioethical Issues concluded.

“The panel felt strongly that it was wrong and a mistake that the United States was an outlier in not specifying any system for compensation for research subjects other than, ‘You get a lawyer and sue,’” said Amy Gutmann of the University of Pennsylvania, who chairs the commission and served on the subcommittee.

The recommendation came on the second day of a two-day public hearing to air the results of a commission probe into medical experiments that the U.S. government researchers conducted in Guatemala in the 1940s.

The recently uncovered studies involved more than 5,500 men, women and children who were unwittingly drafted into tests involving the venereal diseases syphilis, gonorrhea and chancroid. The tests included deliberately — sometimes grotesquely — attempting to infect subjects without their permission or knowledge.

On Monday, the commission revealed that the researchers had obtained consent first before conducting earlier, similar experiments on inmates in Terre Haute, Ind., and hid what they were doing in Guatemala. This, the commission found, clearly showed that the doctors knew their conduct was unethical.

In the government-sponsored studies conducted in Guatemala between 1946 and 1948, doctors tried to infect prisoners, soldiers and mental patients by giving them prostitutes who were carrying the diseases or were infected by the researchers. The researchers also scraped sensitive parts of subjects’ anatomy to expose wounds to disease-causing bacteria, poured infectious pus into subjects’ eyes, and injected some victims’ spines.

On Tuesday, the 13-member commission discussed the 48-page report outlining the findings of a 14-member international subcommittee investigating whether current rules adequately protect people in medical studies from physical harm or unethical treatment internationally.

The experts in bioethics and biomedical research from India, Uganda, China, Russia, Brazil, Argentina, Belgium Guatemala, Egypt and the United States met in London, Washington and Philadelphia and made five broad recommendations.

“The United States should implement a system to compensate research subjects for research related injuries,” said Christine Grady of the National Institutes of Health, who helped present the findings of the subcommittee. “Many countries around the world and some U.S. research institutions have actually moved forward and developed compensation systems.”

One “promising model” for a compensation system could be the U.S. National Vaccine Injury Compensation Program, a no-fault alternative to traditional lawsuits that compensates people injured by vaccines, the panel said.

India and Brazil have bioethics committees that “ensure that research sponsors pay compensation to participants injured in research,” the panel wrote. The University of Washington uses a “self-insured no-fault” system.

President Obama ordered the probe when the experiments were made public in October along with an unusual public apology by his secretaries of state and health and human services.

After filing a report in September, the commission will meet again in November to come up with ways to bolster protections for research subjects internationally and in the United States. It will issue a final report in December. The Guatemalan government is conducting its own investigation, but has twice postponed briefing the commission.

Wellesley College historian Susan M. Reverby uncovered the disturbing experiments while reading papers from John C. Cutler, a doctor with the federal government’s Public Health Service. Cutler participated in the Tuskegee experiment, in which hundreds of African American men with syphilis in Alabama were left untreated to study the disease between 1932 and 1972. Cutler died in 2003.

In the Guatemala case, about 700 of the subjects were treated, but it remains unclear whether their care was adequate. About 83 of the subjects died, but investigators have been unable to determine whether any deaths were caused by the studies.

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source: Washington Post (Stein, 8/30)

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