Hopkins' Reputation Bears Brunt of High-Profile Research Blunders

Article excerpt

Byline: John Biemer

BALTIMORE - One of the world's premier medical institutions is nursing its own black eye after three research mishaps left a volunteer dead and a judge comparing a study to Nazi tests on concentration camp prisoners.

The asthma, cancer and lead-paint poisoning studies at issue not only blemished Johns Hopkins University's once-unassailable reputation, but also caused some to ask whether institutions undertake more research than they can safely monitor.

"It's unfortunate that the premier medical research institute in the U.S. . . . has all of these problems conducting basic peer review and review of the ethical component of the research it's conducting," said John H. Noble, a Catholic University health policy professor and member of the Alliance for Human Research Protection.

"When this size of an iceberg reveals itself, and they say two-thirds of an iceberg is hidden, what can you say about the rest that is hidden?"

After healthy 24-year-old Ellen Roche died in the asthma study, the federal Office for Human Research Protections (OHRP) said Hopkins' institutional review board was overworked.

It then shut down most of Hopkins' 2,400 federally funded experiments for five days, an action Hopkins called "unwarranted, unnecessary, paralyzing and precipitous."

The review board consists of physicians and other staffers who volunteer - on top of their full-time jobs - to scrutinize and approve studies on human subjects.

Alan Milstein, a New Jersey lawyer who has defended human-research subjects, said centers such as Hopkins are "conducting more studies than they can possibly monitor."

"What I've been saying all along is where we're going to see the problems is the top institutions," Mr. Milstein said. "That's where the money is, that's where the arrogance is, and that's where the studies are."

Mr. Milstein represented the family of an 18-year-old man who died in a 1999 gene-therapy experiment at the University of Pennsylvania.

Johns Hopkins stands tall among medical research institutions. For the 11th year in a row, U.S. News & World Report ranked it the top American hospital. Its medical school ranked second to Harvard.

Last year, Hopkins earned $301 million in grants from the National Institutes of Health - tops in the country.

Tom Tomlinson, a Michigan State medical ethics professor, said the national attention Hopkins attracted after Miss Roche's death may influence whether people participate in future studies. …