October 1, 2010
David S. Morgan
The U.S. government has formally apologized for a secret study conducted in the 1940s in which Guatemalan prisoners, service members and mental hospital patients were secretly infected with gonorrhea and syphilis without their knowledge or consent, calling the program “clearly unethical.”
In a joint statement issued Friday by Secretary of State Hillary Rodham Clinton and Secretary of Health and Human Services Kathleen Sebelius, released in English and Spanish, the government apologized to Guatemala and to those involved in the study, conducted by the U.S. Public Health Service (PHS) between 1946 and 1948.
The results of the Sexually Transmitted Disease Inoculation Study were uncovered by a Wellesley College researcher, Susan Reverby.
The story is uncomfortably similar to the “Tuskegee” Syphilis Study in the 1960s, in which the PHS monitored, but did not treat, hundreds of African American men suffering from syphilis.
Unlike that case, however, subjects in the Guatemala study were intentionally infected with sexually transmitted diseases, and then given penicillin, to help determine the efficacy of the drug to cure or even vaccinate against STDs.
Reverby wrote that the Guatemala syphilis inoculation project was run by a PHS physician, Dr. John C. Cutler (who would later oversee the Tuskegee, Ala., study two decades later).
The study’s doctors chose as subjects men incarcerated at the Guatemala National Penitentiary, as well as army service members, and men and women confined in the National Mental Health Hospital. There was a total of 696 people in the study. Guatemalan authorities (and not the individuals themselves) granted permission, in exchange for supplies.
According to Reverby, who studied Cutler’s records in the University of Pittsburgh archives, doctors used infected prostitutes to pass the disease on to prisoners (conjugal visits were allowed in Guatemalan jails). Direct inoculations of syphilis bacteria were made to other subjects. Treatment by penicillin was also administered, though not always successfully.
Cutler seemed to recognize the delicate ethical quandaries their experiments posed, particularly in the wake of the Nuremberg “Doctors’ Trials,” and was concerned about secrecy. “As you can imagine,” Cutler reported to his PHS overseer, “we are holding our breaths, and we are explaining to the patients and others concerned with but a few key exceptions, that the treatment is a new one utilizing serum followed by penicillin. This double talk keeps me hopping at time.”
Cutler also wrote that he feared “a few words to the wrong person here, or even at home, might wreck it or parts of it … ”
PHS physician R.C. Arnold, who supervised Cutler, was more troubled, confiding to Cutler, “I am a bit, in fact more than a bit, leery of the experiment with the insane people. They can not give consent, do not know what is going on, and if some goody organization got wind of the work, they would raise a lot of smoke. I think the soldiers would be best or the prisoners for they can give consent.”
Apparently difficulties in transmission, as well as in replicating results, added to concerns over the study, and it was dropped after two years.
Cutler went on to participate in another Syphilis Study at Sing Sing Prison in Ossining, N.Y. (although in that case the subjects were informed about the nature of the inoculations administered to them).
“Although these events occurred more than 64 years ago, we are outraged that such reprehensible research could have occurred under the guise of public health,” today’s State Dept./DHS statement said. “We deeply regret that it happened, and we apologize to all the individuals who were affected by such abhorrent research practices.
“The conduct exhibited during the study does not represent the values of the United States, or our commitment to human dignity and great respect for the people of Guatemala. The study is a sad reminder that adequate human subject safeguards did not exist a half-century ago.”
The officials also announced an investigation into the specifics of the case from 1946, and will also convene a meeting of international experts to devise methods that effectively ensure all human medical research meets rigorous ethical standards.
July 18, 2009
by Mike Stobbe
ATLANTA — The last time the government embarked on a major vaccine campaign against a new swine flu, thousands of people filed claims contending they suffered side effects from the shots. This time, the government has already taken steps to prevent that.
Vaccine makers and federal officials will be immune from lawsuits that result from any new swine flu vaccine, under a document signed by Secretary of Health and Human Services Kathleen Sebelius, government health officials said Friday.
Since the 1980s, the government has protected vaccine makers against lawsuits over the use of childhood vaccines. Instead, a federal court handles claims and decides who will be paid from a special fund.
The document signed by Sebelius last month grants immunity to those making a swine flu vaccine, under the provisions of a 2006 law for public-health emergencies. It allows for a compensation fund, if needed.
The government takes such steps to encourage drug companies to make vaccines, and it has worked. Federal officials have contracted with five manufacturers to make a swine flu vaccine. First identified in April, swine flu has so far caused about 263 deaths, according to numbers released by the Centers for Disease Control and Prevention on Friday.
The CDC said more than 40,000 Americans have had confirmed or probable cases, but those are people who sought health care. It’s likely that more than 1 million Americans have been sickened by the flu, many with mild cases.
The virus hits younger people harder than seasonal flu, but so far hasn’t been much more deadly than the strains seen every fall and winter. But health officials say the virus could mutate to a more dangerous form, or at least contribute to a potentially heavier flu season than usual.
“We do expect there to be an increase in influenza this fall,” with a bump in cases perhaps beginning earlier than normal, said Dr. Anne Schuchat, director of the CDC’s National Center for Immunization and Respiratory Diseases.
On Friday, the Food and Drug Administration approved the regular winter flu vaccine, a final step before shipments to clinics and other vaccination sites could begin.
The last time the government faced a new swine flu virus was in 1976. Cases of swine flu in soldiers at Fort Dix, N.J., including one death, made health officials worried they might be facing a deadly pandemic like the one that killed millions around the world in 1918 and 1919.
Federal officials vaccinated 40 million Americans during a national campaign. A pandemic never materialized, but thousands who got the shots filed injury claims, saying they suffered a paralyzing condition called Guillain-Barre Syndrome or other side effects.
“The government paid out quite a bit of money,” said Stephen Sugarman, a law professor who specializes in product liability at the University of California at Berkeley.
Vaccines aren’t as profitable as other drugs for manufacturers, and without protection against lawsuits “they’re saying, ‘Do we need this?’” Sugarman said.
The move to protect makers of a swine flu didn’t go over well with Paul Pennock, a prominent New York plaintiffs attorney on medical liability cases. The government will probably call on millions of Americans to get the vaccinations to prevent the disease from spreading, he noted.
“If you’re going to ask people to do this for the common good, then let’s make sure for the common good that these people will be taken care of if something goes wrong,” Pennock said.