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Angry response: Dr. Edward D Miller, dean and chief executive officer of the Johns Hopkins University School of Medicine, voices objections to the action of the Office for Human Research Protection (Sun photo by Chiaki Kawajiri / July 19, 2001) |
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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.
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.
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