political nonsense

An influential federal panel of medical advisers has recommended that the government loosen regulations that severely limit the testing of pharmaceuticals on prison inmates, a practice that was all but stopped three decades ago.

Until the early 1970’s, about 90 percent of all pharmaceutical products were tested on prison inmates, federal officials say. But such research diminished sharply in 1974 after revelations of abuse at prisons like Holmesburg here, where inmates were paid hundreds of dollars a month to test items as varied as dandruff treatments and dioxin, and where they were exposed to radioactive, hallucinogenic and carcinogenic chemicals.

In addition to addressing the abuses at Holmesburg, the regulations were a reaction to revelations in 1972 surrounding what the government called the Tuskegee Study of Untreated Syphilis in the Negro Male, which was begun in the 1930’s and lasted 40 years. In it, several hundred mostly illiterate men with syphilis in rural Alabama were left untreated, even after a cure was discovered, so that researchers could study the disease.

Under current regulations, passed in 1978, prisoners can participate in federally financed biomedical research if the experiment poses no more than “minimal” risks to the subjects. But a report formally presented to federal officials on Aug. 1 by the Institute of Medicine of the National Academy of Sciences advised that experiments with greater risks be permitted if they had the potential to benefit prisoners. As an added precaution, the report suggested that all studies be subject to an independent review.

The discussion comes as the biomedical industry is facing a shortage of testing subjects. In the last two years, several pain medications, including Vioxx and Bextra, have been pulled off the market because early testing did not include large enough numbers of patients to catch dangerous problems.

The demand for human test subjects has grown so much that the so-called contract research industry has emerged in the past decade to recruit volunteers for pharmaceutical trials. The Tufts Center for the Study of Drug Development, a Boston policy and economic research group at Tufts University, estimated that contract research revenue grew to $7 billion in 2005, up from $1 billion in 1995.

But researchers at the Institute of Medicine said their sole focus was to see if prisoners could benefit by changing the regulations.

During the Holmesburg experiments, inmates could earn up to $1,500 a month by participating. The only other jobs were at the commissary or in the shoe and shirt factory, where wages were usually about 15 cents to 25 cents a day, Professor Hornblum of Temple said.

On the issue of compensation for inmates, the report raised concern about “undue inducements to participate in research in order to gain access to medical care or other benefits they would not normally have.”

Leodus Jones, a former prisoner who participated in the experiments at Holmesburg in 1966, said of the recommendation, “This moves us back in a very bad direction.” After his release Jones played a pivotal role in lobbying to get the regulations passed.

“I never had these rashes before,”

he said,

“but I’ve had them ever since.”

nytimes
talk left

This entry was posted on Sunday, August 13th, 2006 at 8:56 pm and is filed under civil rights, health, main, scientists say.... You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed.