Bad Medicine for the Poor
There’s an ugly history in this country of unethical medical research, most notoriously the long-running Tuskegee experiments, begun in 1932, that allowed poor African American men to develop end-stage syphilis so government scientists could research the progression of the disease.
That history makes it all the more crucial that researchers in hospitals serving poor and minority populations uphold the highest standards when conducting clinical trials. One such center is the Charles R. Drew University of Medicine in South Los Angeles, the only black-operated medical school west of the Mississippi and a national leader in studying problems particular to poor, urban Americans, such as the growth of HIV infections among African Americans and Latinos.
The recent voluntary shutdown of 250 research studies at Drew and its affiliated Martin Luther King Jr. Hospital, however, makes it clear that some of its researchers were not sufficiently heeding history. Federal inspectors found researchers concealing their studies from the scrutiny of the required Institutional Review Board and denying patients the information they needed to make an informed decision about whether to volunteer as research subjects. The problems could undermine patient confidence in a medical facility that provides desperately needed care in South Los Angeles.
To be sure, none of Drew’s violations approach those of Tuskegee, but they are emblematic of what was found in studies by the federal inspector general earlier this month and by the Food and Drug Administration and the General Accounting Office last year: Researchers, not just at Drew but nationally, have skirted safety protocols required by the government since 1974 by failing to submit their studies’ designs to a review board and not fully informing patients of the treatment’s benefits and risks.
Researchers, under intense pressure to enroll ever larger numbers of patients in clinical trials for the burgeoning drug and biotechnology industries, complain about review-board bureaucracy. But research protocol violations are often far from trivial. Reform clearly is needed. Last month, for example, a Florida jury awarded $3.8 million to a group of mostly indigent women who had been told that they had to submit to several potentially dangerous amniocentesis procedures to keep their babies from dying when, in fact, all of the babies were healthy.
The immediate solution is for Congress to increase funding for federal oversight, which hasn’t remotely kept pace with the explosive growth in the drug and biotechnology industries in the last two decades.
Over the longer term, Congress should consider some systemic changes. Currently, federal regulators--the few there are--conduct on-site visits of research centers only after complaints of egregious violations. The best idea comes from USC law and medicine professor Alex Capron, an advisor to previous presidents and a member of President Clinton’s National Bioethics Advisory Commission. Capron proposes an independent body to accredit each university’s system of research oversight, much as an outside group now accredits hospitals. Until reforms are in place, the 5 million Americans participating in medical trials should think about getting a second opinion from a medical expert with no stake in the research. Until federal oversight improves, some patients may have to protect themselves.
It’s a shame to suspend the research conducted at Drew. But better to lose some research than the trust of a community.
