Last June, a volunteer participant in a federally funded experiment at Johns Hopkins Asthma and Allergy Center died after inhaling a chemical administered as part of the study.
PR NEWS spoke with Hopkins' Elaine Freeman, executive director of communications and public affairs, about the specifics. (Editor's Note: As of press time, Johns Hopkins faces a
new crisis. The federal agency that monitors research on humans has opened an investigation into a lead paint study held in the mid-'90s in which healthy children were recruited
to live in lead-contaminated houses in Baltimore.)
PRN: The crisis snowballed after the death of Ellen Marie Roche.
Why?
Freeman: It was not just the unfortunate death, but the government's
response to it, which created enormous problems. Although we had an internal
review committee that developed a corrective action plan, the Office for Human
Research Protection [a division of HHS] came in and essentially shut down our
research operations. The shutdown only lasted about 72 hours, but there was
a whole cascade of follow-up required after that.
PRN: The crisis wasn't simply a matter of responding to inquiries
about the death?
Freeman: No. There hasn't been just one news cycle to this story. Articles
focused on the death, but then turned to the government action. And that story
is ongoing. As we speak, there's another part of HHS to be heard from. We're
awaiting an FDA report.
PRN: Some stories in the media have criticized Hopkins for not fully
disclosing details about the death right away.
Freeman: We reported the [volunteer's] sickness and then her death,
immediately, to federal authorities. But we did not put out a statement to the
press right away because of the family's wishes.
PRN: What aspects of this crisis do you feel were handled well?
Freeman: We had a good crisis management team, including our legal counsel,
the head of university, the head of Hopkins Medicine and the research dean.
We had to involve people from the university side and the hospital/health system.
After the death, all communication with the family was conducted through lawyers.
Our community relations and government relations staffs disseminated information
to their respective constituencies - largely with personalized letters and phone
calls. We also have a very robust Intranet, which we relied on to reach faculty
and staff.
PRN: What steps did you take to stay ahead of the curve once the
crisis began?
Freeman: We developed contingency statements in connection with various
trigger points. So much of that kind of information is sensitive and has to
go through approvals, so giving people advance time to review materials was
helpful. It was important to be ready for worst case scenarios - although everybody
was surprised when [HHS] came in and shut down our research. No one saw that
coming.
PRN: Did you take any cues from other medical institutions?
Freeman: Yes, we spoke with people at Duke and at the Association of
American Medical Centers. Duke had a [similar] shutdown - only in their case,
it was over procedural matters.
PRN: How have you measured the effectiveness of your crisis response
so far?
Freeman: There was enormous spike in the use of our Web site (both Internet
and Intranet), although a lot of this traffic may have occurred because we were
ranked No.1 in U.S. News & World Report's "Best Hospitals" rankings for
the eleventh year in a row. Those results came out on Friday the 13th, the same
day George Bush and [HHS secretary] Tommy Thompson were here giving a speech
about Medicare. On [the following] Monday, we held a press briefing to announce
[the death and resulting action] so everything was compacted. Our VP for nursing
said they had [noticed an] increase in the number of people [applying for nursing
jobs] online, as a result. But we don't know if it was because of all the [crisis]
publicity, or because of the ranking report.
Ironically, this [crisis] has helped more people internally get used to coming to the Intranet every day for news. It's not the way I would have chosen to make that happen, but
it has been an interesting side effect.
(Elaine Freeman, Johns Hopkins Medicine, 410/955-3194, [email protected])