King/Drew Medical Research Suspended

The Charles R. Drew University of Medicine and Science and its affiliated health care center, Los Angeles County’s Martin Luther King Jr. Hospital, have stopped hundreds of clinical studies after federal officials found more than two dozen violations of regulations and rules protecting people who take part in research.

The university’s unusual order, issued in conjunction with a visit by officials from the U.S. Office for Protection From Research Risks, centers on flaws in the legally required oversight meant to ensure that studies are scientifically credible. The regulations also are supposed to ensure that patients and other subjects are fully informed of the risks of participation and thus are protected from undue harm.

Medical center officials suspended research activities two weeks ago, the day after federal officials confronted them with a long list of violations both large and small, according to interviews and internal hospital documents.

Drew University’s president, Dr. Charles Francis, did not return a call for comment.

About 250 studies have been halted, officials say, though they could not pinpoint how many subjects that affected. The King/Drew Medical Center in Willowbrook receives $32 million annually in federal research grants, which could be jeopardized if the self-imposed suspension is prolonged. Studies whose interruption would harm patients will be allowed to continue.

Although the suspension may threaten the millions of dollars in federal research funds, Drew officials said they believe that the problems will be resolved before any financial troubles befall the institution.

Drew officials said the research operations will be overhauled and fully restored by the end of May. A few studies already have been reevaluated and will resume shortly.

Those include a project to measure blood levels of lead in pregnant women, another to track the health of patients with high blood pressure and kidney disease who are at risk for dialysis treatment, and another educating children with asthma to better manage the disorder.

The officials said they voluntarily suspended the research because they are sensitive to the institution’s role in serving the vulnerable, mainly poor populations of South Los Angeles.

“No subject has ever had an adverse effect” from Drew research, said Dr. Tony Strickland, associate dean of research. “Clearly, as an institution that is committed to an underserved population, we hold the protection of human subjects at a highest regard.”

Strickland said that about 20 ongoing research projects will continue because halting those studies could harm patients, and other studies may be revived if researchers find similar dangers in stopping them.

Studies Attract National Attention

Studies at Drew, some of which have drawn national attention, include testing new treatments for HIV and hypertension, as well as studies of different diagnoses of dementia in the African American and Latino populations. All 250 research projects involving human subjects are conducted by Drew’s more than 600 faculty members.

Earlier this month, according to documents obtained by The Times, federal inspectors at the medical school found that, contrary to federal regulations, some research projects were not reviewed by the internal committee charged with approving them, a “major violation.”

Among the other violations listed in documents, the medical center lacks adequate guidelines for conducting research on the most vulnerable of subjects: prisoners and children. Consent forms omitted information necessary for prospective subjects to make informed decisions. Some forms were not in Spanish, the native language of many subjects. And the forms did not always include all the procedures that a patient would undergo.

Hospital spokeswoman Mary Schnack said the risk office’s mid-April visit to the medical center was prompted by concerns that had been raised by university officials.

But other sources pointed out that the risk office already had been investigating possible problems with the university’s compliance with human research regulations for nearly two years.

Similarly, a Drew University statement released late Wednesday described the shutdown as resulting from a “self-study of policies and procedures,” which Strickland said had been completed earlier this year. But an internal document listing the 28 findings of problems in procedures is titled “OPRR Citations to Drew.”

Strickland said the weaknesses in reviewing human subject research may be the result of an increase of studies at Drew and King/Drew. “We used to be just a clinical campus, and now our thrust has been toward being leaders in urban medical research,” he said.

Drew University’s College of Medicine is the only black-operated medical school west of the Mississippi. Many of its 600-plus faculty members also work across the street at King/Drew, a 480-bed, county-run facility that is the only major hospital and trauma center for much of South Los Angeles.

Physicians at King/Drew deal with a host of urban woes and run one of the busiest emergency rooms in the county. The hospital has come under repeated fire for inadequate care, and its physicians last year spearheaded a successful attempt to unionize county doctors, the nation’s largest unionization of physicians in the past decade.

The suspension of research has rocked the faculty and hospital staff. “More bad news,” one grumbled Wednesday.

Drew’s shutdown feeds into the growing national concern over the poor performance of the research review committees that are supposed to protect people in clinical studies.

Known as institutional review boards, the legally mandated committees consist of physicians, other health care providers, researchers and laypeople. The boards evaluate proposed studies for scientific validity and ethical standards and monitor continuing studies. Any midstream change to a study requires board approval.

Review Boards Overwhelmed

A scathing 1998 report from the U.S. Department of Health and Human Services declared that the nation’s 3,000 to 5,000 research review boards were overwhelmed and dramatically losing effectiveness. And a follow-up report this month said little has changed in the past two years--with the notable exception of increased vigilance by the federal risk office.

Over the last two years, the federal risk office made news and generated controversy by shutting down research activities at seven medical centers, including Duke University and the University of Illinois. In March 1999, it canceled the federal research contract at the Veterans Affairs Greater Los Angeles Healthcare System, prompting VA officials in Washington to take yet more sweeping action--a move from which the West Los Angeles facility and affiliated centers are still recovering.

Dr. Donald Thomas, associate director of the county’s health department, said that because Drew officials voluntarily halted research, the situation there is far less severe than at other facilities that have had trouble with federal regulators. “A lot of very reputable institutions have gotten smacked that way with involuntary cessation, so it’s pretty good that didn’t happen to them,” he said.

Drew’s voluntary research shutdown is virtually unprecedented, experts on human research rules said Wednesday. Whether the risk office would have stopped research activities at the medical center anyway is not known, but sources insisting on anonymity said the regulators were poised to cancel or suspend the medical center’s federal research contract.

Some medical center insiders saw the move by university administrators as an attempt to preempt such a drastic action and avert the ensuing negative publicity.

George Annas, a professor of health law at Boston University, said the problems with Drew’s review boards typify the failure of many medical center officials to take seriously the regulations and procedures for protecting research subjects’ physical health and rights of self-determination.

But a violation cited by Drew (and described to Annas by a reporter) was rather extreme--especially the admission that clinical studies went ahead without any prior review from the research review board. “That’s a major problem,” he said. “That’s the only reason [the boards] exist.”