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Most Trials at Hopkins Shut Down

Government officials today suspended essentially all federally funded studies of human subjects at the Johns Hopkins University medical center in Baltimore. The sweeping order came from the Office of Human Research Protections (OHRP), an agency in the Department of Health and Human Services that monitors the safety and ethics of government-financed research on humans. Its stop-work letter identified 31 problems at Hopkins, including some major lapses in a study in which a healthy volunteer died last month. Hopkins responded this afternoon with a fiery statement, calling the suspension of research "unwarranted, unnecessary, paralyzing," "draconian," and "outrageous."

The OHRP letter--delivered to the CEO of Johns Hopkins Medicine, Edward Miller, and others--cites seven alleged deficiencies in a recent experiment designed to model an asthma attack. A healthy volunteer in this study, lab technician Ellen Roche, died on 2 June after inhaling a test chemical called hexamethonium bromide (ScienceNOW, 16 July). In addition, OHRP's enforcement letter cites five "major findings" and 19 other issues gleaned from a review of 60 research protocols approved since 1998 by the Institutional Review Boards (IRBs) at Hopkins.

OHRP concluded that Hopkins made a series of critical mistakes in handling the asthma study. Among other things, university officials began the study before they had obtained published toxicity information on hexamethonium that was "readily available via routine MEDLINE and internet database searches." OHRP also found that hexamethonium has never been approved by the Food and Drug Administration for inhalation, and that Hopkins researchers failed to obtain sufficient information on the "source, purity, quality, and method of preparation and delivery" of the chemical before giving it to volunteers.

OHRP also claims that the IRB allowed the asthma study to go forward without convening a formal meeting with a quorum to review the protocol, as required by federal regulations.

As of today, all federally funded research on humans has been suspended at the following Hopkins facilities: the School of Medicine, School of Nursing, the Hospital, the Bayview Medical Center, the Gerontology Research Center, the Kennedy-Krieger Institute, and the Applied Physics Laboratory. Enrollment of new subjects must cease, except in "extraordinary cases" as permitted by OHRP; and studies with previously enrolled subjects must cease unless "it is in the best interest of individual patients." By 10 August, Hopkins must draw up a list of all affected research protocols, and at the same time, it must prepare a remediation plan. Once OHRP is satisfied, research may resume.

Hopkins officials were not available to comment, but the university's press office released a statement this afternoon saying: "We strongly believe 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." The university claims that OHRP gave no warning that it was contemplating this action, which it labels "an extreme example of regulatory excess."

Related sites

OHRP's letter, sent to Johns Hopkins University officials today (PDF file)
Hopkins's response
Information, compiled by Johns Hopkins, about the death of a research volunteer
Office for Human Research Protections