Scandal-Plagued VA Hospital in West L.A. Slowly Recovers

Four months after accepting possibly the worst job in American medicine, Dr. Marguerite Hays has made progress toward restoring trust in the disgraced veterans hospital in West Los Angeles.

The 69-year-old nuclear medicine expert stepped in as the hospital’s research chief when Department of Veterans Affairs officials in Washington abruptly shut down the facility’s $45-million research program in March because of failures by hospital administrators to follow regulations safeguarding patients in studies.

Under her guidance, the 1,056-bed medical facility--the largest in the VA health care system--is slowly recovering from the unprecedented sanction, which so shocked researchers that one internal executive memo describes the center as suffering from “post-traumatic stress syndrome.”

Hundreds of complex research projects have restarted, scores of newly diagnosed patients are being enrolled in studies, sunken staff morale is on the rise. And if proposed ethics measures take hold, a hospital only recently excoriated by Congress for violating patients’ rights may soon be on the forefront of protecting them. The measures include:

* Forming a special safety panel,

one of the few of its kind at a public hospital, to closely monitor studies involving patients with mental illnesses.

* Reducing the use of placebos, or dummy pills, in studies involving sick people who need treatment.

* Cutting back on research sponsored by drug companies, which sometimes have rules that conflict with the hospital’s protections for research subjects.

“It sounds as though the medical center is doing innovative things that should be closely watched by other institutions around the country,” said Jonathan Moreno, head of the bioethics program at the University of Virginia and author of a new book, “Undue Risk: Secret State Experiments on Humans.”

“But how the measures play out and whether they become part of the routine of doing research there is the issue,” he said.

Hays, who is on leave from the Palo Alto VA Medical Center, said she hopes to develop “a model program that other VAs could imitate.”

Dr. Dean Norman, the medical center’s acting chief of staff, credited her with “turning around our research program.”

But reform can bring discontent and some West L.A. researchers whose projects remain on hold said in interviews that patients’ needs are being shirked for merely administrative reasons. Others predict a “brain drain,” saying the already difficult job of advancing medical knowledge has become yet more onerous. A couple of researchers complained (anonymously) of a “witch hunt” atmosphere.

Records Audited

Meanwhile, the intense scrutiny of the facility’s research operations has uncovered new problems. The VA inspector general is auditing years of financial records because of charges of misappropriated research funds, Hays said. An internal hospital probe has found that a researcher did experimental tests on bone marrow samples without patients’ permission, according to a hospital spokeswoman’s reply to a Freedom of Information Act request. Such testing may violate federal informed consent laws.

Some observers say the facility’s recent troubles reflect financial pressures on the VA health care system, a vast network of 173 hospitals and 375 clinics. An American Legion study of the West L.A. crisis concluded that the hospital did not set aside enough money to oversee all its research.

“The inadequacy of the VA budget is stretching VA research beyond its limits,” the group argues.

To help rescue this once-proud research center, birthplace of the CT scanner, the nicotine patch and other marvels, VA officials in Washington say they first thought of Hays.

The coauthor of dozens of scientific studies, Hays possesses long experience with the VA, her deep resume a testament to unusual stamina in a bureaucracy strewn with boulders: former director of medical research for the entire agency, high positions at four hospitals, chairwoman of eight VA commissions. Her current stint as a fixer brings a decades-long career full circle. An Indiana native, she got her medical degree at UCLA in 1957 and first joined the VA staff in West L.A.

The research ban prompted outrage in the medical community. Many scientists, the UCLA medical school dean and at least one editorialist criticized it as too sweeping, partly because it halted animal and lab studies in addition to human ones. But Hays defends the action as a “necessary wake-up call.”

A lot of the staff “didn’t understand the issues,” she said, adding with a smile: “But they understand the issues now.”

Evaluating Research Ethics

The main issue concerned the oversight committees known as institutional review boards, or IRBs. These panels of health care providers and laypeople play a vital (if unseen and unexciting) role protecting human and animal research subjects by evaluating the ethics and scientific validity of studies. Federal law states that no study paid for with tax funds can begin or be modified without prior internal review board approval.

Beginning in 1993, the U.S. Office for Protection from Research Risks found that the medical center’s internal review boards had flouted regulations on many occasions, allowing potentially dangerous research to proceed. Among the deficiencies were repeated failures to explain in writing to psychiatric patients about all the possible hazards of participating in drug studies. And numerous internal review board meetings, where hundreds of vital research decisions were made, included too few members to be valid.

Then, after six years, the risk office ruled that the medical center had not shown enough progress fixing those and other problems, and canceled its umbrella contract to do federally funded clinical studies.

That prompted VA headquarters in Washington--which had previously put the hospital on probation for financial mismanagement in the research division--to halt all research activities, though patients and animals already in studies could keep participating if stopping the research would cause harm. The action also covered research at the hospital’s San Fernando Valley branch, the Sepulveda Ambulatory Care Center.

Within days of the shutdown, the VA appointed Hays. She put together a team to expand and strengthen the hospital’s review boards. As of this past weekend the boards had evaluated and restarted all 322 laboratory and animal studies at West L.A. and Sepulveda. They also had authorized 153 of the 352 clinical studies to resume. About 40 clinical studies await review by the federal risk office. Other studies are being held up for a variety of reasons, Hays said.

The delays have caused turmoil. At least two drug companies have canceled studies outright, abandoning patients in mid-treatment, one VA researcher said.

A key source of conflict between researchers and the newly emboldened review boards is the move to cut back on placebos. It is standard, even superior, scientific practice to compare the effects of dummy medications and experimental ones on similar groups. But patient advocates have criticized it as inhumane in some instances.

The hospital will discourage placebo use when possible, Hays said, giving patients who are not receiving experimental treatments other approved treatment instead. But every ethical advance generates new quandaries, and she said even that seemingly easy step is complicated: Many more patients may have to receive an experimental drug than would be necessary in a study using placebos, and experimental drugs can be risky.

“It’s a difficult dilemma and we’re debating it quite actively here,” she said.

Distinct from the review boards is the new ethics panel for monitoring mental health studies. Originally mandated by the federal risk office, it is supposed to avoid the potential conflict of interest that arises when a patient’s primary physician also is a researcher seeking subjects.

The special monitoring panel, said the head of the team that revamped the review boards, Dr. Charles Haskell, will help ensure that patients with mental illnesses “are being offered legitimate and appropriate research opportunities.”

Experimental Treatments

The initiative to cut back on drug company sponsorship would appear to be a brave one, given the bottomless need for research funds and the undeniable value of drug company studies, which typically pay multi-thousand-dollar fees for each patient enrolled. Currently, the West L.A. and Sepulveda facilities carry on about 125 drug company studies, and in fiscal year 1998 upward of $10 million came from drug companies and other private sources, according to medical center records.

But the money often comes with strings attached, in that companies often strictly design the studies to ensure uniformity among many participating research centers.

Also, Hays said, drug studies, while they benefit many veterans by providing access to experimental treatments that turn out to be beneficial, do not foster scientific creativity among the research staff. “We don’t want to be in the position of simply using our facilities to make money,” she said.

Money troubles, it turns out, threaten the medical center’s recovery somewhat. The entire VA health care system is coping with sharp declines in usage, as the veteran population dwindles and also as older veterans opt for private insurance or Medicare. Highlighting the issue was a recent report by the U.S. General Accounting Office, which estimated that the VA health system wasted $1 million a day on unused buildings.

To trim expenses, VA officials in Washington have ordered the West L.A. and Sepulveda facilities to eliminate 400 jobs, according to medical center sources. The looming cuts, which will affect the research division along with patient care and other staff, are adding insult to the injury of scandal.

Then again, other West L.A. researchers say they can outlast the crisis, even learn from it. “I think a lot of good is going to come out of this,” said Raj Batra, a medical geneticist. “It forced me to learn more about the administration side of research.”

“The research program here is very important,” Hays said, explaining why she took on the task of righting the hospital. “There aren’t that many chances to take something that was basically good that has problems and try to straighten it out.”