More MS news articles for July 2001

Government Lets Johns Hopkins Resume Medical Research

http://unisci.com/stories/20013/0724013.htm

24-Jul-2001

Officials from Johns Hopkins and the NIH Office for Human Research Protections (OHRP) worked together intensively over the weekend to address OHRP's concerns and enable Hopkins' valuable research studies to continue as soon as possible.

OHRP approved a corrective action plan formulated by Johns Hopkins, a plan consistent with the approach Hopkins suggested as a result of its own internal investigation into the tragic death last month of a healthy subject enrolled in an NIH-funded research study.

OHRP's action was triggered by the death of Ellen Roche, 24, of Reisterstown, Md., who died of lung damage and multiple organ failure after inhaling hexamethonium, which had earlier been linked to cases of fatal lung disease.

OHRP also imposed certain conditions on the resumption of research.

The Johns Hopkins' corrective action plan is online at http://www.hopkinsmedicine.org/press/2001/JULY/ActionPlanLetter.htm.

The OHRP response is at http://www.hopkinsmedicine.org/press/2001/JULY/OHRPReinstate.htm.

The Johns Hopkins statement to faculty and staff re OHRP new procedures is at http://www.hopkinsmedicine.org/press/2001/JULY/Facultystaffletter.htm.

Human Research Suspended at Johns Hopkins University

http://cbshealthwatch.medscape.com/cx/viewarticle/403894

July 19 (CBS Evening News) It is among America's most honored hospitals and medical schools. But Johns Hopkins is being cut off, at least temporarily, from federal funds for research on human beings.

For the past 9 years, Johns Hopkins has received the most federal research money of any medical school--$301 million last year alone. But as CBS News medical correspondent Elizabeth Kaledin reports, the death of a volunteer in a research experiment could change all that.

Twenty-four year-old Ellen Roche was healthy when she signed up for the asthma experiment at Johns Hopkins University, but after inhaling the drug hexamethonium, Roche died June 2nd.

As a result of her death and a subsequent investigation of about 60 other trials, the government issued a harsh 12-page letter to the school citing numerous violations of research protocol.

According to the report, "The informed consent document failed to indicate that inhaled hexamethonium was experimental and not approved by the FDA." As a result of the broader investigation the letter concludes, "all federally supported research projects . . . must be suspended."

The move comes at a time of intense public and federal scrutiny of human research projects, perhaps sparked by the death of Jesse Gelsinger, an 18-year-old who died during a gene therapy experiment at the University of Pennsylvania. Human research at Penn was also suspended.

The ruling is a huge blow to Johns Hopkins, which leads the nation in federally funded research projects. The university today called the government's action "draconian" and the suspension of funding "unwarranted . . . unnecessary . . . paralyzing and precipitous in action."

All this comes in a week in which the hospital at Johns Hopkins was named the best hospital in the nation by U.S. News and World Report.