Johns Hopkins disaster

[8675309]

http://dailynews.yahoo.com/h/nm/20010720/sc/health_suspension_dc_2.html

or go to Yahoo News and look under Science stories

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 Johns Hopkins University School of Medicine in Baltimore.

The Office for Human Research Protections (OHRP), part of the Department of Health and Human Services (news - web sites) (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, Maryland.

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 (news - web sites).

In a statement on Thursday, the school condemned the funding suspension as an ``unwarranted, unnecessary, paralyzing and precipitous action.''

Johns Hopkins gets $301 million a year in grants from the National Institutes of Health (news - web sites) (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 Johns 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 Johns 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 Johns Hopkins Asthma and Allergy Center. Roche was an employee at the center when she volunteered for the study.

Dr. Edward Miller, 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.''

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[Aoshi]

Glad I didn't bother applying there...

 

[6-8 Weeks]

I applied, perhaps one less secondary. But seeing as how the media is biased at times, I will research both sides of the argument and decide for myself.

 

[lilycat]

I guess the main question if you are a prospective applicant would be how long will the suspension of funds last. If you are really into research, or considering MSTP programs, it could be a significant hinderance. However, research abuses occur at LOTS of medical institutions, and most schools are just lucky that they never get caught.

 

[imtiaz]

Sheiiiit, if you all don't apply then I sure will because that means they'll have to make due with people like me. HAHAHAHAHA

 

[grasshopper]

I brought this up to my reserach mentor, himself an MSTP alum (not a JH). Basically, he says there's no reason whatsoever to think twice about applying because of this, including for MSTP applicants, because it's just a matter of paperwork and lawyers and quite a bit of money, which they have before things are back to normal.

 

[doepug]

The recent ban at Hopkins has been unfortunate, but it will likely be over by early next week. The entire Hopkins community is shocked and outraged... most, if not all, people here think the OHRP's actions were completely unwarranted. This action should in no way impact the long-term academic or financial integrity of Hopkins research programs, especially by the time any prospective applicants will matriculate.

It's all sort of ironic... last week, Hopkins was named the best hospital in America by US News for the 11th consecutive year. Anyhow, I have attached the hospital's response below... if anyone is interested in hearing the institution's official response to the OHRP.

Despite this recent problem, Hopkins is still a fantastic institution. While the death of a research volunteer is truly unfortunate, I don't think this incident presents a valid image of Hopkins. I hope that anyone considering applying to Hopkins for medical school (or otherwise) will take time to consider the institution's merits.

Please e-mail me ([email protected]) should anyone have any questions that I could help answer.

Thanks,
doepug
(MSII, Johns Hopkins)

In what Johns Hopkins believes to be an unwarranted, unnecessary, paralyzing and precipitous action, the Office of Human Research Protection (OHRP) has today suspended all federally supported medical research projects involving human subjects at almost all of our institutions. We strongly believe that this action was taken in utter disregard of patients' health and potentially of life. 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.

Hopkins believes the OHRP's draconian action is outrageous because we addressed the criticisms of our procedures noted in today's OHRP letter in a letter we sent to the agency on December 28, 2000. Despite the passage of seven months, we never received any indication –not a word – that our responses did not in all respects satisfactorily address the agency's concerns.

Equally outrageous from our standpoint is that in its letter today, OHRP suggests that careful review of our research protocols does not take place at Hopkins. Nothing could be further from the truth. As we have pointed out to OHRP, every Institutional Review Board (IRB) member reviews each protocol thoroughly, comments on that protocol and has the opportunity for all questions to be answered by the investigator prior to final approval by the full IRB. We would have worked with the agency to address any remaining concerns if it had indicated its dissatisfaction in any way. This suspension was entirely unnecessary to accomplish what both the agency and Hopkins want: to protect human subjects. We remain committed to working with the OHRP in constructive ways.

We want to reassure patients enrolled in our clinical trials, or considering enrolling in them, that we are committed to putting their health and interests first and to continuing our care of them. Their safety and their health is of paramount importance to us.

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. 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.

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