Boos come with the job for U.S. rules enforcer

Watchdog: Like an umpire, Gary Ellis makes tough calls - protecting people in scientific research - and hears complaints.

May 28, 1999|By Douglas Birch | Douglas Birch,SUN STAFF

ROCKVILLE -- Back in college, Gary Ellis worked summers as an umpire at Little League baseball games, explaining the rules to puzzled kids and furious parents. Today, he is chief of the federal office charged with protecting people who serve as the subjects of scientific experiments.

Umpiring has a lot in common with his current job, he's found. "The similarities extend to being cursed at and disliked by most, while believing one is doing an important thing," he says.

But Ellis is in the big leagues now. This month, he shut down 2,000 studies at Duke University Medical Center for several days, saying the center's board that oversees research failed to guarantee the safety of its subjects. The move, which drew national attention, followed similar suspensions of research hospitals in Los Angeles and Chicago in the past six months. For those institutions, it was like being thrown out of the game.

Today, academic officials across the country are anxiously re-examining their policies. Scientists experimenting on people are checking their consent forms. Researchers who might have cut corners, some say, may now think twice.

"The Duke story has had a very beneficial effect outside of Duke," says David J. Rothman, professor of social medicine at Columbia College of Physicians and Surgeons.

In the name of science, U.S. researchers have sometimes engaged in shameful acts. Decades ago, they injected children with plutonium and hepatitis, and put cancer cells in elderly men. In the infamous Tuskegee study, physicians watched and did next to nothing as 399 African-American men were infected with syphilis for 40 years. More than 120 died of the disease.

More recently, researchers have tested new drugs and procedures on unconscious trauma victims, then sought their "consent" after the fact. And they have deliberately withheld anti-psychotic medications from schizophrenic patients to see how quickly they became sick again.

Staff stretched thin

Ellis is responsible for preventing the outrages of 25 years ago from happening again. He and his tiny staff -- four investigators, two of them half-time -- police studies at 4,000 institutions supported by the National Institutes of Health, which spends more than $15 billion a year on medical research.

"He's given a pittance," says Rothman. "Four people to govern all of human experimentation in this country? The notion is absurd."

With his limited budget, Ellis can't do in-depth investigations. Instead, his staff is restricted to reviewing forms and booklets, protocols and procedures, to make sure they conform to federal regulations. In other words, they enforce the rules.

Scientists, it seems, can have a hard time following those rules. Each year, a score of institutions ask if Ellis will waive the requirement that they review ongoing human experiments once a year. His answer is always no.

"The regulations say at least annually," he says. "This is neither hard to interpret, nor hard to comply with, except for the calendrically impaired."

Like any good umpire, Ellis is despised by partisans on both sides. Some scientists accuse Ellis and his Office of Protection from Research Risks of nit-picking, wasting time and money. "They're rigid and inflexible on matters that, in my view, have almost nothing to do with the protection of human subjects," says one researcher, who says he fears retribution if his name were used.

Some patient-rights advocates, on the other hand, grumble that Ellis is too willing to cajole and conciliate -- and too reluctant to impose sanctions. They point out that Ellis and his staff have negotiated for years with some negligent institutions.

"They did not enforce those rules in prior years," says Adil E. Shamoo of the University of Maryland's School of Medicine, editor of a journal about ethics in research. Among administrators, he says, that record "has generated a lack of concern and maybe even cavalier attitudes."

Ellis will say only that he has to balance the need for medical research with protection of research subjects, and the best way to do that is to make sure that everyone abides by the letter of the law.

The boyish biologist-turned-bureaucrat has always sweated the details. Growing up in Cleveland, he read the dictionary cover to cover. He was a very obedient child. Told by his mother not to eat between meals, he still won't nibble on doughnuts that co-workers bring to the office. Asked to pose for a photo recently with chin in hand, Ellis, 44, refused: his mother had told him never to put his hand on his face because it was unattractive.

Mona Lisa tie

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