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AP IMPACT: Past medical testing on humans revealed
Question of the Day
The hospital director said the patients were not told they were being injected with cancer cells because there was no need _ the cells were deemed harmless. But the experiment upset a lawyer named William Hyman who sat on the hospital’s board of directors. The state investigated, and the hospital ultimately said any such experiments would require the patient’s written consent.
At nearby Staten Island, from 1963 to 1966, a controversial medical study was conducted at the Willowbrook State School for children with mental retardation. The children were intentionally given hepatitis orally and by injection to see if they could then be cured with gamma globulin.
Those two studies _ along with the Tuskegee experiment revealed in 1972 _ proved to be a “holy trinity” that sparked extensive and critical media coverage and public disgust, said Susan Reverby, the Wellesley College historian who first discovered records of the syphilis study in Guatemala.
By the early 1970s, even experiments involving prisoners were considered scandalous. In widely covered congressional hearings in 1973, pharmaceutical industry officials acknowledged they were using prisoners for testing because they were cheaper than chimpanzees.
Holmesburg Prison in Philadelphia made extensive use of inmates for medical experiments. Some of the victims are still around to talk about it. Edward “Yusef” Anthony, featured in a book about the studies, says he agreed to have a layer of skin peeled off his back, which was coated with searing chemicals to test a drug. He did that for money to buy cigarettes in prison.
“I said ‘Oh my God, my back is on fire! Take this … off me!’” Anthony said in an interview with The Associated Press, as he recalled the beginning of weeks of intense itching and agonizing pain.
The government responded with reforms. Among them: The U.S. Bureau of Prisons in the mid-1970s effectively excluded all research by drug companies and other outside agencies within federal prisons.
As the supply of prisoners and mental patients dried up, researchers looked to other countries.
It made sense. Clinical trials could be done more cheaply and with fewer rules. And it was easy to find patients who were taking no medication, a factor that can complicate tests of other drugs.
Additional sets of ethical guidelines have been enacted, and few believe that another Guatemala study could happen today. “It’s not that we’re out infecting anybody with things,” Caplan said.
Still, in the last 15 years, two international studies sparked outrage.
One was likened to Tuskegee. U.S.-funded doctors failed to give the AIDS drug AZT to all the HIV-infected pregnant women in a study in Uganda even though it would have protected their newborns. U.S. health officials argued the study would answer questions about AZT’s use in the developing world.
The other study, by Pfizer Inc., gave an antibiotic named Trovan to children with meningitis in Nigeria, although there were doubts about its effectiveness for that disease. Critics blamed the experiment for the deaths of 11 children and the disabling of scores of others. Pfizer settled a lawsuit with Nigerian officials for $75 million but admitted no wrongdoing.
Last year, the U.S. Department of Health and Human Services’ inspector general reported that between 40 and 65 percent of clinical studies of federally regulated medical products were done in other countries in 2008, and that proportion probably has grown. The report also noted that U.S. regulators inspected fewer than 1 percent of foreign clinical trial sites.
Monitoring research is complicated, and rules that are too rigid could slow new drug development. But it’s often hard to get information on international trials, sometimes because of missing records and a paucity of audits, said Dr. Kevin Schulman, a Duke University professor of medicine who has written on the ethics of international studies.
By Michael P. Orsi
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