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Johns Hopkins officials scrambled yesterday to improve safety practices in medical experiments in hopes of persuading a federal agency to lift a suspension of government-funded studies.
Hopkins will order additional training for officials who review experiments and will re-evaluate studies to make sure they are safe, according to a letter sent yesterday to the federal Office for Human Research Protections. Top administrators said they would work over the weekend to complete an action plan to satisfy the agency's concerns by next week.
After consulting with federal officials, Hopkins adminstrators told doctors they could continue experimental treatments that would be "in the best interests" of patients. These could include treatments for life-threatening diseases, as well as any that could prolong life or ease suffering.
Swamped by phone calls from anguished patients and thousands of e-mails from doctors, Hopkins officials tried to identify yesterday which of their 2,400 studies involving perhaps 50,000 people could be continued.
"It's been utter confusion - just about all activity has stopped, trying to deal with it," said Dr. Donald R. Jasinski, chief of the center for chemical dependence on the Hopkins Bayview campus.
The suspension was imposed Thursday by the federal agency, which found widespread deficiencies in Hopkins' system of reviewing the safety of experiments. The agency said Hopkins should not have approved an asthma study that ended with the June 2 death of a healthy volunteer.
Ellen Roche, a lab technician at the Hopkins asthma center, was the first healthy person in memory to die in a medical experiment at what is widely regarded as one of the best medical schools in the world.
The suspension follows similar actions in recent years against Duke, the University of Pennsylvania and other medical schools as federal officials have become more aggressive in policing the burgeoning number of experiments on humans.
Dr. Edward Miller, dean of the school of medicine, said yesterday that he thought the suspension was disproportionate to what he sees as procedural issues raised by the agency.
"To have a blanket stopping of all clinical trials seems excessive," Miller said. "I think it was more than what was warranted."
"What should be remembered in all of this is that Hopkins has a long history of safety. We have had more than 100 years of research without a single death of a healthy subject, except Ellen," Miller said. "One death is too many, of course."
He added: "We are working right now to go through all of the issues that [the agency] raised. We will have a corrective action plan for them."
Miller said that he hoped that the agency would allow Hopkins to resume its studies - supported by about $277 million in federal money - by Tuesday or Wednesday of next week.
Bill Hall, a spokesman for the federal agency, said that his office would review Hopkins' actions and lift the ban as soon as possible.
He said that his agency had not over-reacted to Roche's death. "Suppose Hopkins waited another month to fix their systemic problems and another patient died?" Hall asked. "Wouldn't you say we should have shut them down a month ago? We shut them down because there was risk to patient safety."
Among the problems outlined in the agency's report, investigators said that Hopkins' internal review boards were overburdened and understaffed, and offered neither "substantive nor meaningful" evaluations of experiments. The agency also said that Hopkins researchers did not adequately warn volunteers of the risks of participating in studies.
Hopkins officials vigorously denied accusations that their experiments were casually reviewed. To improve protections that officials said were already strong, Hopkins added a third review board this winter.
Elaine Freeman, a spokeswoman for the university, said: "To say that [Hopkins review boards] have not carefully reviewed each of these experiments is just not true."
In the letter that Hopkins sent to the agency's director of compliance, Dr. Michael Carome, a university official said Hopkins was working rapidly to answer concerns about the safeguards for human experimentation.
Hopkins will order additional training for officials who review experiments and will re-evaluate studies to make sure they are safe, according to a letter sent yesterday to the federal Office for Human Research Protections. Top administrators said they would work over the weekend to complete an action plan to satisfy the agency's concerns by next week.
Swamped by phone calls from anguished patients and thousands of e-mails from doctors, Hopkins officials tried to identify yesterday which of their 2,400 studies involving perhaps 50,000 people could be continued.
"It's been utter confusion - just about all activity has stopped, trying to deal with it," said Dr. Donald R. Jasinski, chief of the center for chemical dependence on the Hopkins Bayview campus.
The suspension was imposed Thursday by the federal agency, which found widespread deficiencies in Hopkins' system of reviewing the safety of experiments. The agency said Hopkins should not have approved an asthma study that ended with the June 2 death of a healthy volunteer.
Ellen Roche, a lab technician at the Hopkins asthma center, was the first healthy person in memory to die in a medical experiment at what is widely regarded as one of the best medical schools in the world.
The suspension follows similar actions in recent years against Duke, the University of Pennsylvania and other medical schools as federal officials have become more aggressive in policing the burgeoning number of experiments on humans.
Dr. Edward Miller, dean of the school of medicine, said yesterday that he thought the suspension was disproportionate to what he sees as procedural issues raised by the agency.
"To have a blanket stopping of all clinical trials seems excessive," Miller said. "I think it was more than what was warranted."
"What should be remembered in all of this is that Hopkins has a long history of safety. We have had more than 100 years of research without a single death of a healthy subject, except Ellen," Miller said. "One death is too many, of course."
He added: "We are working right now to go through all of the issues that [the agency] raised. We will have a corrective action plan for them."
Miller said that he hoped that the agency would allow Hopkins to resume its studies - supported by about $277 million in federal money - by Tuesday or Wednesday of next week.
Bill Hall, a spokesman for the federal agency, said that his office would review Hopkins' actions and lift the ban as soon as possible.
He said that his agency had not over-reacted to Roche's death. "Suppose Hopkins waited another month to fix their systemic problems and another patient died?" Hall asked. "Wouldn't you say we should have shut them down a month ago? We shut them down because there was risk to patient safety."
Among the problems outlined in the agency's report, investigators said that Hopkins' internal review boards were overburdened and understaffed, and offered neither "substantive nor meaningful" evaluations of experiments. The agency also said that Hopkins researchers did not adequately warn volunteers of the risks of participating in studies.
Hopkins officials vigorously denied accusations that their experiments were casually reviewed. To improve protections that officials said were already strong, Hopkins added a third review board this winter.
Elaine Freeman, a spokeswoman for the university, said: "To say that [Hopkins review boards] have not carefully reviewed each of these experiments is just not true."
In the letter that Hopkins sent to the agency's director of compliance, Dr. Michael Carome, a university official said Hopkins was working rapidly to answer concerns about the safeguards for human experimentation.
