US researchers broke rules in Guatemala syphilis study

WASHINGTON, (Reuters) – U.S. government researchers  must have known they were violating ethical standards by  deliberately infecting Guatemalan prison inmates and mental  patients with syphilis for an experiment in the 1940’s,  according to a U.S. presidential commission.

The U.S.-funded research in Guatemala did not treat  participants as human beings or even the same as those who  participated in similar studies in the United States, the  commission’s investigators said yesterday.

The United States apologized last year for the experiment,  which was meant to test the drug penicillin, after it was  uncovered decades later by a college professor.

President Barack Obama’s Commission for the Study of  Bioethical Issues investigated the syphilis experiment and  discussed its key findings in Washington on Monday. A final  report is due in December.

“The people who were in the know, did want to keep it  secret because if it would become more widely known, it would  become the subject of public criticism,” said commission  chairwoman Amy Gutmann, president of the University of  Pennsylvania.

The commission’s conclusions have consequences for U.S.  diplomacy and will impact the ethical discussion surrounding  how new drugs are tested on patients, as manufacturers  increasingly conduct clinical trials abroad.

Guatemala condemned it as a crime against humanity and said  last year it would consider taking the case to an international  court. It is conducting its own investigation. Victims of the  study are suing the U.S. government.

The commission’s investigators said the study of sexually  transmitted diseases like syphilis was an important scientific  goal at the time.

But they said they found no reasonable excuse for the way  in which the Guatemala study was conducted, noting that  researchers deceived its participants, never published results,  kept poor notes and conducted experiments in illogical order.

“It was bad science. Regardless of the ethical issues …  from a purely scientific standpoint, I found this body of  science bereft of any point,” said commission member Dr. Nelson  Michael of the Walter Reed Army Institute of Research.

Some 700 people were infected with syphilis in the  Guatemala study.

These included inmates exposed to infected  prostitutes brought into prisons and male and female patients  in a mental hospital. Some subjects had bacteria poured on  scrapes made on their genitals, arms or faces.

The patients were given antibiotic penicillin to test its  ability to cure or prevent syphilis. The infection can cause  genital sores and rashes and, if left untreated, damage  internal organs and cause paralysis, blindness or death.

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