Fw: U.S. Cuts Off Medical Research Aid to s Hopkins

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From: " ilena rose " <ilena@...>

Sent: Friday, July 20, 2001 9:35 AM

Subject: U.S. Cuts Off Medical Research Aid to s Hopkins

> http://dailynews./htx/nm/20010720/ts/health_suspension_dc_2.html

>

> Friday July 20 8:18 AM ET

>

> U.S. Cuts Off Medical Research Aid to Leading School

>

> By Will Dunham

>

> WASHINGTON (Reuters) - Faulting one of the world's top medical research

> centers in the case of a healthy volunteer who died in an asthma

> experiment, the U.S. government has suspended all federally funded

> research on people at s Hopkins University School of Medicine in

> Baltimore.

>

> The Office for Human Research Protections (OHRP), part of the Department

> of Health and Human Services (HHS), sharply criticized the prestigious

> university for failing to outline possible risks to volunteers and

> neglecting promptly to report that an earlier volunteer also became ill.

>

> HHS officials notified the institution of the action in a letter written

> after the June 2 death of Ellen Roche, 24, of Reisterstown, land.

>

> Roche died of lung damage and multiple organ failure after inhaling the

> drug hexamethonium, which had been linked to cases of fatal lung disease

> in the 1950s and 1960s and was no longer approved for human use by the

> U.S. Food and Drug Administration.

>

> In a statement on Thursday, the school condemned the funding suspension as

> an ``unwarranted, unnecessary, paralyzing and precipitous action.''

>

> s Hopkins gets $301 million a year in grants from the National

> Institutes of Health (NIH), more than any other medical school. The

> research that triggered the suspension was funded by the NIH.

>

> ``UTTER DISREGARD OF PATIENTS' HEALTH''

>

> ``We strongly believe that this action was taken in utter disregard of

> patients' health and potentially of life,'' the statement said.

>

> ``Even a temporary interruption in therapeutic clinical trials, such as

> those involving cancer patients, could be devastating. In addition, the

> OHRP letter forbids us from enrolling new, sick patients in these

> trials.''

>

> The HHS letter said the government was particularly concerned that

> investigators involved in the study continued to provide the drug despite

> the persistence of coughing and shortness of breath in the first

> volunteer. Roche became ill within days of taking part as the third

> subject in the study.

>

> Government officials faulted the school for failing to tell volunteers the

> drug was no longer FDA approved. OHRP also criticized the school for

> allowing changes in the experiment that did not have the approval of an

> independent review board.

>

> OHRP said the s Hopkins investigators failed to obtain published

> literature about the association between lung damage and hexamethonium

> prior to receiving the go-ahead for the study from an institutional review

> board. The letter said such information was ``readily available'' on the

> Internet.

>

> A s Hopkins review committee on Monday released a report saying the

> cause of Roche's death likely will remain uncertain, but probably was due

> to exposure to inhaled hexamethonium. The drug was first used 50 years ago

> to treat high blood pressure, but the FDA in 1972 pulled it from the

> market because of its lack of effectiveness.

>

> The school has suspended studies with human subjects conducted by Dr.

> Alkis Togias, who led the ill-fated research at the s Hopkins Asthma

> and Allergy Center. Roche was an employee at the center when she

> volunteered for the study.

>

> Dr. , dean of the medical school, has said the school ``takes

> full responsibility for what did happen.''

>

> ``To the best of our knowledge, in our entire history, we have had only

> one death of a healthy research volunteer out of tens of thousands who

> have participated in such research,'' the school's statement said.

>

> ``We agree that this is one too many, and that is why we announced earlier

> this week the steps we are taking to strengthen our processes. In light of

> this, the OHRP's action seems to us to be an extreme example of regulatory

> excess.''

>

> ( Richwine contributed to this story)

>

>

>