Unethical Health Experiments Done in U.S.
[Courier-Journal]-U.S. government doctors once thought it was acceptable to experiment on disabled people and prison inmates, including giving hepatitis to mental patients in Connecticut, squirting a pandemic flu virus up the noses of prisoners in Maryland and injecting cancer cells into chronically ill people at a New York hospital.
Much of this occurred 40 to 80 years ago, but it is the backdrop for this week’s meeting in Washington of a presidential bioethics commission. It was triggered by the government’s apology last fall for federal doctors infecting prisoners and mental patients in Guatemala with syphilis 65 years ago.
U.S. officials also acknowledged there had been dozens of similar experiments in the U.S. — studies that often made healthy people sick.
An Associated Press review of medical journal reports and decades-old press clippings found more than 40 such studies. Some searched for lifesaving treatments; others hurt people but provided no useful results.
They will be compared to the well-known Tuskegee syphilis study in which U.S. health officials tracked 600 black men in Alabama who had syphilis but didn’t give them adequate treatment even after penicillin became available.
Attitudes about medical research were different when the studies were done. Infectious diseases killed more people, and doctors worked urgently to invent and test cures. Many researchers felt it was OK to experiment on people who did not have full rights in society — prisoners, mental patients, poor blacks.
“There was definitely a sense — that we don’t have today — that sacrifice for the nation was important,” said Laura Stark, a Wesleyan University assistant professor of science in society who is writing a book about past federal medical experiments.
The AP review found:
A federally funded study begun in 1942 injected experimental flu vaccine in male patients at a state insane asylum in Ypsilanti, Mich., then exposed them to flu several months later. It was co-authored by Dr. Jonas Salk, who later invented the polio vaccine.
Some men weren’t able to describe their symptoms, raising serious questions about how well they understood what was being done.
In federally funded studies in the 1940s, Dr. W. Paul Havens Jr. exposed men to hepatitis in experiments, including one using patients from mental institutions in Middletown and Norwich, Conn. Havens, a World Health Organization expert on viral diseases, was one of the first scientists to differentiate types of hepatitis and their causes.
In the mid-1940s, researchers studied the transmission of a deadly stomach bug by having young men at the New York State Vocational Institution, a reformatory in West Coxsackie, swallow unfiltered stool suspension. The point was to compare that way of spreading the disease with having test subjects breathe sprayed germs. Swallowing it was more effective, researchers concluded.
Government researchers in the 1950s tried to infect about two dozen volunteer prison inmates with gonorrhea using two methods in an experiment at a federal penitentiary in Atlanta.
Around World War II, prisoners were enlisted to take part in studies that could help the troops. For example, malaria studies at Stateville Penitentiary in Illinois and two other prisons were designed to test antimalarial drugs that could help soldiers in the Pacific.
About this time, the prosecution of Nazi doctors in 1947 led to the “Nuremberg Code,” a set of international rules to protect human test subjects. Many U.S. doctors essentially ignored them, arguing that they applied to Nazi atrocities — not to American medicine.
The late 1940s and 1950s saw huge growth in the U.S. pharmaceutical and health care industries, and a boom in prisoner experiments funded by the government and corporations. By the 1960s, at least half the states allowed prisoners to be used as medical guinea pigs.
But two studies in the 1960s changed the public’s attitude toward the way test subjects were treated.
The first came to light in 1963. Researchers injected cancer cells into 19 old and debilitated patients at a Jewish Chronic Disease Hospital in Brooklyn, N.Y., to see if they would be rejected.
The hospital director said the patients were not told they were being injected with cancer cells as the cells were deemed harmless. But the experiment upset lawyer 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.
In Staten Island, from 1963 to 1966, a 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 1970s, even experiments involving prisoners were thought scandalous. In widely covered congressional hearings in 1973, pharmaceutical industry officials agreed they were using prisoners for testing because they were cheaper than chimpanzees.
The government initiated reforms. In the mid-1970s, the U.S. Bureau of Prisons effectively excluded all research by drug companies and other outside agencies within federal prisons.
So researchers looked to other countries. Clinical trials could be done more cheaply and with fewer rules there. And it was easy to find patients who were taking no medication, a factor that can complicate drug tests.
Other ethical guidelines have been enacted, and few believe another Guatemala study could happen today
Still, in the last 15 years, two international studies sparked outrage.
U.S.-funded doctors failed to give the AIDS drug AZT to all the HIV-infected pregnant women in a Uganda study even though it would have protected their newborns. U.S. health officials argued the study would answer questions about AZT’s use in developing countries.
A Pfizer Inc. study gave the antibiotic Trovan to children with meningitis in Nigeria, though there were doubts about its effectiveness. Critics blamed the study for the deaths of 11 children and the disabling 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 between 40 percent and 65 percent of clinical studies of federally regulated medical products were done in other countries in 2008. It was also noted U.S. regulators inspected fewer than 1 percent of these sites.
Last October, the Guatemala study came to light.
In the 1946-48 study, U.S. scientists infected prisoners and patients in a mental hospital in Guatemala with syphilis, apparently to see if penicillin could prevent the sexually transmitted disease. The study came up with no useful information.
It nauseated ethicists on many levels. Beyond infecting patients with a terrible illness, it was clear people did not understand what was being done to them or could not give their consent.
That it occurred overseas was an opening for the Obama administration to have the bioethics panel seek a new evaluation of international medical studies.
To focus on federally funded international studies, the bioethics commission has formed an international panel of about a dozen experts. Regarding the Guatemala study, it has hired 15 staff investigators and is working with more historians and consulting experts.
The panel is to send a report to President Barack Obama by September. Any further steps would be up to the administration.



Original investigation on Kaiser Permanente-Medicare joint human experiment on 100,000 kidney failure patients without informed consent posted at http://www.hmohardball.com.