Death in study halts research at Hopkins
Roche became sick in early May after inhaling hexamethonium as part of a study geared towards understanding how healthy lungs protect against asthma attacks. The principal investigator for the study was Dr. Alkis Togias, M.D.
After receiving medical treatment from Hopkins, Roche died on June 2. The School of Medicine immediately initiated an internal investigation into the circumstances surrounding Roche's death, releasing their report on July 15.
The report claimed that Roche's death was not directly attributable to hexamethonium, suggesting instead that the cause of death was "likely to remain uncertain."
However, the report, prepared by a Med school review committee, admitted that most committee members agreed that the Institutional Review Board should have been more strict in approving the study. They should have required more evidence of hexamethonium safety and a note on the consent form stating that hexamethonium was not approved by the Food and Drug Administration.
The report concluded that the study's protocol was "not in compliance with School of Medicine policies for requiring review of amendments to a research protocol."
Following release of the internal report, the Office for Human Research Protections, part of the national Department of Health and Human Services, suspended government funding for all Hopkins research involving human participants, affecting nearly 2400 studies.
In a press release the same day on July 19, Hopkins argued that the revocation of funds was "an unwarranted, unnecessary, paralyzing and precipitous action." They argued that even temporary suspension of studies in fields such as cancer treatment could be fatal for patients involved in the studies.
Hopkins, along with the affiliated Advanced Physics Laboratory, is the largest academic recipient of government funding.
OHRP allowed studies to continue on July 22, after being individually reviewed.
It was later discovered that hexamethonium had already caused several patient sicknesses in an earlier study at the University of California at San Francisco in 1978. Researchers said that this potential warning sign was apparently overlooked by the study's investigators, although the researchers in the UCSF study said that there were strong reasons to believe that the drug was not related to the participant's illnesses.
The next major development in the chain of events was the release of findings from an independent committee headed by Dr. Samuel Hellman, the former Dean of the University of Chicago School of Medicine. The report chastised what it considered Hopkins' adversarial attitude to oversight procedures designed to protect patients. According to the Hellman Report, "People at Hopkins believe that oversight and regulatory processes are a barrier to research and are to be reduced to the minimum rather then serving as an important safeguard.
Dr. Togias remains suspended, but still on staff. Although many studies have recommenced, individual reviews of some are not yet complete.