U.S. eases constraints on Hopkins

Sun Staff

A federal agency lifted a suspension of human medical research at the Johns Hopkins University yesterday but frustrated school officials by imposing severe restrictions that will likely delay full resumption of research for months.

While regulators accepted Hopkins' plan to improve safeguards for research volunteers, they are requiring that internal review boards reconsider most of the 2,400 federally funded studies on humans.

Many sick patients will be allowed to continue receiving experimental treatments that are deemed in their "best interests." In contrast, studies that hold no immediate benefit for patients remain suspended until Hopkins completes its review.

Voicing a mixture of relief and exasperation, doctors said it could take four months to complete the required reviews and free all trials from constraints.

"If you're my patient, you shouldn't expect to get a hold of me," said Dr. David Cornblath, a neurologist who heads one of three institutional review boards at Hopkins. "This means rescheduling of patient appointments because we're not available. It means dropping whatever we're doing to get this research back up and running."

On its face, the decision was a victory for Hopkins. But as officials sifted through the new requirements imposed by the agency, many expressed disappointment that the institution must clear many bureaucratic hurdles.

"Frankly, we remain concerned that the conditions imposed on the resumption of research by the regulators will create an enormous paperwork burden," said Gary Stephenson, a Hopkins spokesman.

The conditions, he said, "will delay the start of new studies and prevent some patients from entering valuable clinical studies that could be their only hope."

The decision late Sunday by the federal Office for Human Research Protections to approve the university's "action plan" came three days after the agency suspended most of Hopkins' studies. The suspension affected Johns Hopkins Hospital and medical school, Bayview medical center, the nursing school, Kennedy Krieger Institute and Applied Physics Laboratory.

Yesterday, the agency lifted the suspension for an estimated 600 studies that are considered of minimal risk - analyses of blood samples or patient surveys, for example - and qualify for expedited review under federal law.

But the remaining studies will have to be sent back to the Hopkins review boards for reconsideration, the agency said. The boards, composed largely of physicians from a variety of specialties, must discuss and vote on each project.

"They have a tremendous number of studies that need to be re-reviewed, and this may take some time," said Bill Hall, spokesman for the federal agency. "The pace of it will depend on Hopkins."

Hall said the full suspension, although limited in duration, served an important purpose.

"The point of the suspension was that we found systemic problems in the protection of human subjects," Hall said. "We wanted to make sure that no other volunteers were placed at potential risk of severe adverse events."

The agency suspended the studies after finding widespread deficiencies in Hopkins' system of protecting people in medical experiments.

Though regulators had expressed concerns about Hopkins' safeguards in October, their scrutiny intensified when Ellen Roche, a previously healthy lab technician from Reisterstown, died June 2 after inhaling a chemical in an asthma experiment.

In that case, the agency faulted scientists for not discovering and warning research volunteers about severe lung toxicity among patients exposed to the drug in the 1950s. It also criticized the Bayview review board for approving a consent form that disclosed only mild side effects.

Yesterday, review boards began what promised to be weeks of meetings, taking up studies in order of medical necessity, Cornblath said. Each project could take from 10 minutes to a half-hour to review, he said. The boards are also fielding thousands of requests from doctors wanting to continue treating patients.

"Based on the experience at other centers, it will take about four months to get back to where we were a week ago," Cornblath said. "We've calculated that the review process alone ... will take thousands of physician-hours just in the meeting process."

Dr. George Dover, director of the Johns Hopkins Children's Center, said he was relieved that Hopkins was again on course to make its own decisions.

"They've given us our [internal review board] privileges back, but we're starting over again," he said.

In its action plan, Hopkins said it would create a fourth review board to handle the large volume of cases, and planned to begin audits of human experiments that are in progress.

It also promised to develop a standard to determine whether scientists have fully assessed risks.

And though it took issue with the government's criticism that review boards didn't individually discuss each proposal, Hopkins promised that all proposals would be "presented individually, discussed individually."

Hopkins officials submitted a draft action plan to the federal agency Friday night, then negotiated through the weekend to ensure a speedy resolution.

Politicians lobbied behind the scenes, though an agency spokesman said it had no effect. Mayor Martin O'Malley and Gov. Parris N. Glendening had their staffs call Washington lawmakers on Hopkins' behalf late last week.

Administrators from Hopkins' president, Dr. William R. Brody, on down and well-placed trustees also worked the phones. "I think a lot of people decided very spontaneously to get involved and make calls to people that they knew," said Thomas Etten, director of Hopkins' Office of Federal Relations.

In Washington, Sen. Barbara A. Mikulski called Tommy G. Thompson, secretary of Health and Human Services, urging him to hear out Hopkins officials. Thompson called Edward Miller, dean of the medical school, Friday.

Doctors who were treating severely ill patients with experimental treatments were relieved yesterday that they could continue without interruption, even though they had to get approval from the beleaguered review boards.

"It's certainly making it easier for patients already on study protocols to continue," said Dr. Joel Gallant, associate director of the Hopkins AIDS Service.

"At least in our area ... I doubt that patients are noticing any difference," he said. Last week, "We worked hard to make sure there was no interruption in treatment" of patients who needed visits or medication in the next few days.

Likely to wait the longest for approval are "non-therapeutic" studies - those that may advance knowledge but provide no immediate benefit to patients.

"One of my projects in our little group measures glucose in diabetes," said Dr. Christopher Saudek, a diabetes researcher and chief of Hopkins' General Clinical Research Center.

"It will make an enormous difference to people with diabetes, but participants are not getting any individual benefit from it," he said. Until Hopkins' internal review boards can reconsider the study protocol, "it's stopped cold."

"A significant number of studies are not going to be able to resume," Saudek said. For them, "this has been more of a disruption than one might think."

Though doctors can continue treating patients in clinical trials with internal review board approval, they must get permission from the federal agency to enroll patients in trials. Those must be "extraordinary cases" to qualify, according to the federal order - presumably cases in which a patient's life may be at stake.

Yesterday, Dr. Georgia Vogelsang worried that she might have to advise two leukemia patients not to fly to Baltimore to receive a treatment for an illness that strikes people whose bodies reject bone marrow transplants.

"This treatment is just vital to these people," Vogelsang said. "People die of this disease."

The agency may eventually grant Vogelsang the permission she requested to enroll the patients if it finds that they have no other option for treatment.

"I need to make these individual calls to patients to explain what's going on, and it's not easy," Vogelsang said. "Most of these patients I work with fly in from all over the country and all over the world for these treatments."

Sun staff writers Michael Stroh and Frank Roylance contributed to this article.

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