JOHNS HOPKINS under fire over alleged ethics violations in asthma, lead paint studies

Wednesday, August 29th 2001, 12:00 am
By: News On 6

BALTIMORE (AP) _ Johns Hopkins University, one of the world's top medical research institutions, has come under fire over a deadly asthma experiment and a lead-paint study on poor city children that has been likened to the infamous Tuskegee syphilis experiment.

The incidents have raised questions about whether medical 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. ``We need checks and balances, and that's the fundamental flaw in the system.''

After healthy 24-year-old volunteer Ellen Roche died after inhaling a drug in the asthma study in June, the federal Office for Human Research Protections said, among other things, that Hopkins' review board was overworked.

The government shut down most of Hopkins' 2,400 federally funded experiments for five days, an action the university called unwarranted. Regulators are allowing the studies to resume one at a time.

Two weeks ago, the Maryland Court of Appeals condemned a study testing levels of lead-paint exposure in poor children by the Kennedy Krieger Institute, a Hopkins affiliate. The ruling permitted lawsuits filed on behalf of two children who allegedly suffered brain damage to go forward.

In the study, landlords were paid to recruit about 100 families with healthy children to live in their homes during the early 1990s. Children _ who can develop brain damage if they eat lead paint chips _ were to be tested periodically to see how well methods developed to reduce the levels of lead-based paint were working.

Judge Dale R. Cathell likened the research to experiments conducted on prisoners at the Buchenwald concentration camp during World War II and to the Tuskegee Syphilis Study, in which the disease was left untreated in poor black men in Alabama.

All U.S. research institutions are required to have review boards by the federal government, which sets and oversees the guidelines.

The review boards _ which consist largely of university-affiliated doctors and administrators _ are there to weigh the potential risks and benefits of various experiments and to make sure that subjects have been properly informed and have given their consent.

When an institution applies for a federal grant for the research, the federal agency _ the National Institutes of Health, for example _ generally does not get involved in oversight of risks. An exception is when an experimental drug is tested on humans. The Food and Drug Administration then must approve the use.

Tom Tomlinson, a Michigan State medical ethics professor, said more resources need to be devoted to reviewing institutional research.

``With the tremendous increase in the sheer number and complexity of research going on, it's becoming harder and harder for these committees to find the time they need to really look at these protocols carefully,'' he said.

Noble said the review boards are not just stretched thin, but also suffer conflicts of interest rooted in doing ``business as sub-units of the very institution that gets them funded.'' The review boards may even rubber-stamp approval if a researcher's reputation is well-established, he said.

Alan Milstein, an attorney who sued the University of Pennsylvania on behalf of the family of an 18-year-old man who died in a 1999 gene therapy experiment, 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,'' Milstein said. ``That's where the money is, that's where the arrogance is, and that's where the studies are.''

Johns Hopkins stands tall among medical research institutions. Its doctors developed CPR and won the Nobel Prize for discovering enzymes that gave birth to the genetic engineering industry.

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 got $301 million in grants from NIH _ the most in the country.

Following the shutdown of Hopkins' studies, the university announced several steps, including the creation of a fourth review board to oversee experiments. A year ago, it had two.

``If we can demonstrate, and I think we have demonstrated, we are doing everything we need to do to ensure the safety of our patients, then they certainly will continue to trust us,'' Hopkins spokeswoman Joann Rodgers said.

Despite the university's problems, Dr. Jordan Cohen, president of the Association of American Medical Colleges, said Hopkins' reputation _ and federal funding _ are not threatened.

``I think, in the aggregate, Johns Hopkins is such a spectacularly successful research institution that it certainly deserves all the respect that it gets,'' he said. ``There are always risks involved in any research, and bad things happen from time to time.''