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U.S. halts Hopkins research
Most experiments on human subjects ordered suspended; Federal funding witheld; Oversight agency decries safety lapses in volunteer's death
By Jonathan Bor and Tom Pelton
Sun Staff
Originally published July 20, 2001

Seven weeks after the death of a young woman in an asthma study, the federal government suspended human medical experiments at the Johns Hopkins University yesterday because of what regulators characterized as widespread lapses in safety procedures.

The federal Office for Human Research Protection said Hopkins conducted the asthma experiment without discovering and warning patients about reports of sometimes fatal drug reactions that were readily available on the Internet and in medical textbooks.

In sweeping and often stinging criticisms, the agency also referred to a pervasive pattern of safety lapses, saying the review boards that approve experiments were overwhelmed with work, didn't adequately warn patients about risks and failed to rigorously evaluate research proposals.

Discussions of continuing research were "not substantive nor meaningful," the agency said.

"The bottom line is we found serious problems with their procedures to protect human lives during trials," said Bill Hall, an agency spokesman. "This is not a paper-pushing procedure. This is about protecting people's lives."

The suspension covers 2,400 federally funded human experiments involving at least 15,000 patients and volunteers. The action affects the medical school, Hopkins hospital, Bayview Medical Center, Applied Physics Laboratory and some research at the Kennedy Krieger Institute.

The federal order does allow some studies - those involving experimental treatments of patients with life-threatening illnesses - to continue.

Dr. Edward D. Miller, Hopkins' medical dean and chief executive officer, appeared before the Hopkins dome on North Broadway and angrily defended his institution's safety record.

"We are outraged by the actions of the OHRP," said Miller, referring to the year-old federal agency created to protect human lives in experiments.

"We find it hard to understand how a new agency would take a draconian measure against an institution that has been conducting trials for thousands of patients over many years ... and providing medical care for more than a century."

In its response to the federal action, Hopkins described the suspension as "unwarranted, unnecessary, paralyzing and precipitous."

Miller said he expected that the university would be able to address criticisms and persuade the federal agency to lift its ban within three or four days - a time line an agency official said was possible.

But Miller said he was concerned that during the delay, patients with life-threatening illnesses would not be able to enroll in new experimental treatment programs.

"Patients who come here looking for hope will not be able to receive it," Miller said.

The Hopkins medical institutions received $419 million in research funding from the National Institutes of Health last year - the largest sum given to any medical center in the country. Of the total, about $277 million is for experiments involving human subjects, according to an agency official.

The suspension came as a stunning blow to Hopkins, which is considered to be one of the world's pre-eminent medical institutions. Walls around campus are plastered with posters boasting of Johns Hopkins Hospital's recent selection as the nation's top medical center for the 11th straight year by U.S. News & World Report.

Earlier this week, an internal panel that investigated the death of the research subject, Ellen Roche of Reisterstown, criticized the asthma researchers and the review board that approved the experiment but said the institution was improving safety procedures.

It had already added a third review board to evaluate the large volume of research proposals each month.

The Hopkins investigators concluded that Roche, a 24-year-old lab technician at Hopkins' Bayview campus, died from inhaling hexamethonium, a chemical scientists administered to help them understand how the lungs of healthy people protect against asthma attacks. It apparently caused Roche to develop a progressive lung illness.

But the federal agency was far harsher in its criticism of the flawed experiment.

While Hopkins panel said the principal investigator, Dr. Alkis Togias, made "a good faith effort" to uncover any previous injuries linked to the chemical, the federal agency said the scientist failed to discover published reports of toxic effects that were readily available on the Internet and in recent textbooks.

It also found fault with the review board for not uncovering the dangers itself.

In the reports, several patients who had received hexamethonium for the treatment of hypertension in the 1950s suffered respiratory failure. Some died.

Also, in the consent form that patients signed, researchers called hexamethonium a "medication" when, in fact, it was no longer approved by the Food and Drug Administration, the agency said. Researchers should have told volunteers that the chemical, which lost FDA approval in 1972, was being used experimentally.

Even when hexamethonium was an approved medication, it was never approved for use in an inhaled form, the agency said.

The federal agency criticized not only the researchers but also the Institutional Review Board, saying "an adequate evidence base did not exist for the IRB to be confident that inhaled hexamethonium was safe for use in research subjects."

But in suspending research, the federal agency said Hopkins had failed to adequately supervise human experiments throughout the institution - even after being warned Oct. 3 that problems existed. Those deficiencies emerged from an agency inspection.

Yesterday, federal officials said many of the same problems remained. Most involved the supervision given by the Institutional Review Boards, which are required under federal law to make sure that experiments protect the safety of human volunteers.

The federal investigators found "multiple instances" in which the risks outlined in applications for IRB approval were different from those in the consent forms shown to volunteers. The language used in the consent forms was "complex" and difficult for subjects to understand, the report said.

Miller said his institution responded soon after the critical October letter, detailing ways it planned to improve its review process. Yesterday, he complained that the agency had never responded nor given Hopkins an opportunity to address any remaining concerns.

Blasting the federal agency for shutting down potentially life-saving experimental treatments, he characterized many of the complaints as bureaucratic, such as the length of time it took Hopkins review boards to type the minutes of their meetings.

"It's an administrative, bureaucratic nightmare," said Miller.

But Hall said the agency took the rare step of suspending research at the nation's largest medical research institution not for trivial reasons, but because widespread safety problems at Hopkins were putting people's lives at risk.

"We don't do this lightly," Hall said. "In this case, they [the OHRP investigators] found broad systematic problems throughout the Hopkins institutions. Because of the potential risk to human lives, we had to suspend the trials."

U.S. Sens. Barbara A. Mikulski and Paul S. Sarbanes faxed letters yesterday to the secretary of the Department of Health and Human Services, Tommy G. Thompson, urging him not to suspend the Hopkins research projects until officials could explain themselves.

Last night, Hopkins administrators and doctors were sorting out how their research and how patients' treatment might be affected. For example, at the Hopkins Children's Center, physicians were rushing around, holding emergency meetings to figure out whether they will be able to continue experimental chemotherapy today for children with cancer.

"Everyone is very concerned about this," said Emily Burwell, a lab technician in the unit. "People are wondering if there are kids in their hospital beds who face the prospect of not getting their medications."

Meanwhile, Dr. John W. Griffin, director of neurology, said he and others were reviewing dozens of trials to identify which patients might be at risk if medications are stopped.

"Right now, all the focus is on identifying patient care issues," said Griffin. "A number of trials involve quite ill patients."

The Johns Hopkins School of Public Health was the only health-related institution within the university that was not covered by the suspension. Even so, staffers were sorting through their projects to identify those that were joint projects with the medical school, and therefore might be stopped.

"This is going to prove extremely disruptive for all concerned: faculty, patients and study subjects," said Dr. Alfred Sommer, the school's dean, in an e-mail from Buenos Aires.

Ruth Faden, who heads the Hopkins bioethics institute, said that hundreds of patients get their medical care through clinical trials.

"There are a lot of people whose medical care is going to be confused, if not interrupted," Faden said. Even though some patients will be allowed to stay in their trials, she noted that it's complicated "who makes the call as to what is life-threatening and what is life-sustaining."

Faden, who led a national committee six years ago that investigated problems in human subject research, said she was stunned by the federal action.

"You don't do this lightly at a place like Hopkins, that has this kind of volume of ill patients in research," she said. "It's a dramatic action. It's a huge action. It is very troubling."

Sun staff writers Diana Sugg and Eric Siegel contributed to this article.

Copyright © 2001, The Baltimore Sun


Also see
 

Photos
Dr. Edward D. Miller, dean and chief executive officer of the Johns Hopkins University School of Medicine.
Dr. Edward D. Miller, dean and chief executive officer of the Johns Hopkins University School of Medicine. (Sun photo by Chiaki Kawajiri)
Jul 19, 2001

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Shutdowns have wide effect on programs
Cutting-edge treatments become unavailable; funding, name damaged
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Source documents and reaction

Hopkins responds to OHRP suspension of research

U.S. eases constraints on Hopkins
Suspension is lifted, but new restrictions to delay human tests; Doctors fear for patients; Most of 2,400 studies to need approval of school review boards
Jul 24, 2001

Hopkins vows to improve research safety
Changes outlined in letter school sent to federal agency; 'It's been utter confusion'; Lifting of suspension sought by next week
Jul 21, 2001

Despite suspension, Hopkins researchers continue vital tests
Doctors, nurses rush to reassure patients, appeal research bans
Jul 21, 2001

U.S. halts Hopkins research
Most experiments on human subjects ordered suspended; Federal funding witheld; Oversight agency decries safety lapses in volunteer's death
Jul 20, 2001

Shutdowns have wide effect on programs
Cutting-edge treatments become unavailable; funding, name damaged
Jul 20, 2001

Hopkins faults safety lapses
Panel says volunteer likely died from drug used in asthma study; Board, researcher blamed
Jul 17, 2001

Respected doctors confront a tragedy
Experiment: With a research subject's death, two distinguished scientists confront what colleagues say is the worst imaginable outcome.
Jul 8, 2001

Asthma study violated safety rules, FDA says
Hopkins experiment ended with death of volunteer, 24
Jul 3, 2001

Hopkins panel to study death of volunteer
School's physicians, outside experts to seek tragedy's cause; Final report by July 13; Web site statement first detailed account of action on incident
Jun 23, 2001

Asthma study patient who died worked at Hopkins lab
Jun 17, 2001

Research volunteer dies in Hopkins asthma study
Medical school experiment focused on how lungs work
Jun 14, 2001

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