Death suspends Johns Hopkins study

From Christy Feig and Saundra Young
CNN Medical Producers

WASHINGTON (CNN) -- A federal agency is investigating the death of an asthma study volunteer at Johns Hopkins Medical Institutions.

The volunteer, a woman in her 20s, was participating in an experiment designed to understand the body's natural defenses against asthma. As a result of the death, the study has been suspended.

The Office for Human Research Protections under the U.S. Department of Health and Human Services is investigating the volunteer's cause of death.

At the request of the patient's family, much of the information surrounding the incident is not being released, a Johns Hopkins media advisory said.

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She was the third volunteer in the study. The first volunteer reported coughing a day after participating in the study, but the cough was resolved within a few days. The second volunteer suffered no ill effects.

Before being accepted, the woman signed a consent form and underwent a battery of tests, Johns Hopkins officials explained in a letter to HHS. The tests included lung function tests, and she was deemed healthy and without conditions that would have excluded her from the study.

Johns Hopkins officials reported her death in a June 6 letter to the Office for Human Research Protections, which oversees the safety of federally funded research studies. CNN was not able to determine when the woman died.

The last time a research participant died at Hopkins from complications related to an experiment was 15 or 16 years ago, a spokeswoman for the institution said.

'A serious adverse event'

During the tests, the woman received a drug called hexamethonium by inhalation, according to the hospital. On May 7, 24 hours after participating in the study, she developed a dry cough, difficulty breathing during exertion and muscle aches. Doctors reported the volunteer had developed flu-like symptoms. (More on the drug)

In a May 9 letter to the Johns Hopkins Institutional Review Board, the doctors wrote that the symptoms had not resolved and the woman was asked to return for further evaluation. A chest X-ray showed inflammation in her right lung, she had a 101-degree fever (39 degrees Celsius) and the oxygen level in her blood was 92 percent. A normal reading is 100 percent.

After walking a short distance, her oxygen level dropped to 84 percent, which doctors describe as critically low -- a point at which they would consider intubation if supplemental oxygen did not raise the levels.

"This obviously qualifies as a serious adverse event," explained Dr. Alkis Togias, who was the principal investigator in the study. The patient was hospitalized.

The experiment, which was funded by the National Institutes of Health, was not a clinical trial designed to test a specific therapy. Instead, it was a "baseline physiological test" -- a study intended to help doctors understand how the body functions and how it fights disease, in this case asthma.

An autopsy has been performed on the woman, but Johns Hopkins officials would not release the results. The school and the Office for Human Research Protections are investigating whether hexamethonium played a role in her death, or whether the drug or equipment may have been contaminated.

A Hopkins letter dated June 6, to the Office of Human Research Protections at NIH, said the hexamethonium used in the study was confirmed by Fluka, the pharmaceutical company that provided the drug for the trial, to be 99.6 percent pure.

Study participants were told they would receive up to $365: $25 for each visit in the first phase, and $60 for each visit in the second phase.