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CNN Live At Daybreak
Johns Hopkins Doctors Attempt to Explain Volunteer Death
Aired July 16, 2001 - 07:28 ET
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
THIS IS A RUSH TRANSCRIPT. THIS COPY MAY NOT BE IN ITS FINAL FORM AND MAY BE UPDATED.
COLLEEN MCEDWARDS, CNN ANCHOR: Doctors at Johns Hopkins in Baltimore have a medical mystery on their hands. They're trying to find out what caused the death of a woman who was taking part in a clinical study.
CNN's Christy Feig reports the results of their investigation will be released later today.
(BEGIN VIDEOTAPE)
CHRISTY FEIG, CNN CORRESPONDENT (voice-over): Hopkins researchers told the National Institutes of Health about the death of Ellen Roche in a June 6 letter.
It read: "It is with deep regret that I report the death of the subject."
It wasn't a clinical trial; she wasn't sick. She was a healthy volunteer helping doctors at Hopkins learn why some people suffer from asthma and others don't. She was the third person to participate in the study. Her family has requested Hopkins keep many of the details private, including her photo.
What is known is, she reported to doctors on May 7 that 24 hours after inhaling a drug called hexamethonium, she developed dry cough, muscle aches and difficulty breathing during exercise.
In a May 9 letter to the Johns Hopkins Institutional Review Board, doctors wrote the symptoms had not resolved. The doctors asked her to come back. A chest X ray showed inflammation in her right lung. Her fever was 101. And her oxygen level was extremely low.
At that point, Dr. Alkis Togias, the principal investigator in this study, wrote: "This obviously qualifies as a serious adverse event." They also put the study on hold. Then, as the June 6 letter reports, she died. What isn't known yet is what caused her death.
Christy Feig, CNN, Washington.
(END VIDEOTAPE)
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