Research ethics require action and vigilance

Allen M. Hornblum is the author of Acres of Skin and Sentenced to Science and is working on a book dealing with institutionalized children as research test subjects

This month in the nation's capital, the Presidential Commission for the Study of Bioethical Issues heard testimony on human-subject protection in the aftermath of recent revelations that high-ranking American doctors and public-health officials, including the surgeon general of the United States, purposely infected hundreds of Guatemalans with syphilis in the late 1940s.

The panel's final report on this repugnant example of unethical scientific research will be released later this year, but one thing is already clear: The government's response can be counted on to be underwhelming, and the panel's lukewarm recommendations - if any - will be as fleeting as the news reports that American doctors used syphilitic prostitutes to infect Guatemalan prison inmates.

Government expressions of shock and regret regarding wrongdoing are a familiar drill at this point. Unfortunately, the American medical establishment has given little more than lip service to human-subject protection, and research ethics remain an orphan rather than the centerpiece of medical-school curriculum. Although we like to trumpet our superiority as ethical advocates and cultivate our reputation as defenders of the proper way to do medical research, an honest historical accounting illuminates numerous instances of physician, university, and pharmaceutical company self-interest trumping prudent and ethical decision-making.

No better example of this hypocritical approach may exist than the Doctors Trial after World War II, in which the United States put 23 high-ranking Nazi doctors and administrators on trial for their brutal and deadly medical experiments on concentration-camp prisoners. Prosecutors and medical experts harangued the defendants for months on end, and after they won convictions, seven doctors were executed and others were sentenced to long prison terms.

To underscore their commitment to safeguarding the lives and rights of test subjects, American jurists drafted the Nuremberg Code of medical conduct for researchers. Many believe the 10-point code - that begins with "The voluntary consent of the human subject is absolutely essential" - is the best document of its kind.

Regrettably, however, an argument can be made that the ink on the code wasn't even dry before the U.S. government, the medical establishment, and individual researchers started to distance themselves from its principled tenets. For example:

Japanese military scientists such as Lt. Gen. Shiro Ishii were offered a deal after WWII. If they turned over the records of their biological- and chemical-warfare experiments in northern China - which killed many more people than the Nazi experiments - the United States would not put them on trial. Not surprising, Ishii and his ruthless accomplices accepted the offer and went on to have comfortable careers in Japanese academia. This dubious decision to put one set of barbaric researchers on trial but not another allows critics to argue that Nuremberg was our version of a Soviet show trial.

For 1932 to 1972, doctors with the U.S. Public Health Service refused to treat 399 black Alabama sharecroppers who had syphilis. Despite periodic medical journal articles about the Tuskegee experiment and the dozens of government doctors and officials who knew about the program, no one blew the whistle on the loathsome project.

Plutonium and radioactive-isotope experiments on feeble-minded children, pregnant women, hospital patients, and other vulnerable populations were occurring at the same time we were scolding the Nazis about their abhorrent research practices. If the isotope experiments had been done by Nazis, they would have been part of the bill of indictment at Nuremberg.

In the 1950s and '60s - known as the gilded age of medical research - there was an explosion of clinical trials, experimental research, and numerous ethical breaches. Retarded children, senile patients, and numerous schoolchildren and orphans were used as grist for the research mill in a host of vaccine, diet, and Cold War studies.

As one Boston Herald critic wrote at the time of the isotope experiments by Harvard and MIT, "For half a century Uncle Sam has been waving the flag with one hand and burying the truth with the other."

Boston-area colleges, however, are not the only prestigious institutions that have put convenience and the lure of fame and fortune over the code. In our own backyard, the University of Pennsylvania has earned a terrible record of using vulnerable populations to further their scientific quests. The death of Jesse Gelsinger in a gene-therapy experiment gone bad and the decades-long experimental reign of Albert M. Kligman, a noted Penn dermatologist who routinely used mentally challenged children, senior citizens, and prisoners in a dizzying array of research studies, are enough to shake anyone's confidence in the best and the brightest.

That less-than-stellar record makes Barack Obama's choice of Penn president Amy Gutmann as chairwoman of the national bioethics commission that much more cynical and troubling, even though the Gelsinger and Kligman cases occurred before Gutmann's watch. If Obama wanted a university or medical-school president to lead the commission, he would have sent a more powerful message by selecting someone from an institution with an unblemished record on ethics issues.

Medical excesses and breaches of research ethics are not just things of the distant past. They still occur and will continue until the penalties exceed the incentives to cut corners and break the rules. The national bioethics commission can foster that goal by not only explaining what went wrong 60 years ago, but by also aggressively pushing recommendations that punish transgressors, keep a vigilant eye on clinical trials both here and abroad, and encourage medical schools and others to bring research ethics out of the basement and into the classroom.