1978 Study Had Troubles Like a Fatal Hopkins Test

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http://www.nytimes.com/2001/07/26/health/26RESE.html

JUL 26, 2001

1978 Study Had Troubles Like a Fatal Hopkins Test

By JAMES GLANZ

BALTIMORE, July 25 - Two healthy volunteers in a 1978 asthma study at the

University of California at San Francisco fell sick, one seriously enough to

be treated at a hospital, after inhaling the drug that led to the death of a

young woman in a similar research project at s Hopkins University last

month.

In a statement released today, officials at the University of California in

San Francisco said the problems had not been reported in the published

description of the experiment because the researchers had strong reasons to

believe that the problems were unrelated to the drug, hexamethonium.

The earlier study was used as evidence by the researcher in the Hopkins

experiment that inhaling doses of hexamethonium was safe.

Because of the death of the Hopkins volunteer, Ellen Roche, officials at the

San Francisco university said doubts had arisen among researchers in the

original study as to whether the problems had been caused by hexamethonium.

As a result, the officials said, they have opened a new review of the

earlier work.

" We will pull together all the information that we can find about this and

will make some judgment about what the interpretation of those events might

be in hindsight, " said Zach Hall, executive vice chancellor for the San

Francisco university.

Dr. Homer A. Boushey, a researcher at the university who was involved in the

earlier study, said three of the five members of the original research team

inhaled hexamethonium themselves, with no ill effects, before giving it to

half a dozen volunteers.

One of those volunteers complained of a headache and general malaise and

withdrew from the study, today's statement said, but researchers concluded

the reaction was probably caused by a different drug in the study. But after

completing the study, another volunteer reported to an emergency room with

chest tightness and shortness of breath.

Eventually, doctors outside the study concluded the second volunteer was

probably suffering from viral pneumonia. He was treated with a common

antibiotic and his condition gradually improved.

Dr. Boushey said that regulations at the time did not require reporting such

events, and that in any case, the doctors' reports had convinced him that

the reaction was unrelated to hexamethonium. But today, he said the death at

Hopkins had sown new doubt in his mind.

Despite the new review in San Francisco, Dr. Boushey said, " I still actually

do not know if what transpired in 1978 was a reaction to hexamethonium. "

" I do not, " he repeated.

The revelations raise the question of whether Ms. Roche's death could have

been avoided if the earlier problems had been reported. The researcher who

designed the asthma study in which Ms. Roche died on June 2, Dr. Alkis

Togias, used Dr. Boushey's paper as his principal evidence that

hexamethonium was safe to inhale in large doses - about one gram in both

studies.

" If in fact a very serious adverse lung event that required hospitalization

occurred and was reported in the 1979 study, " said Kracov, a lawyer

for Dr. Togias, " it is unlikely that any of the researchers in the later

hexamethonium studies, including the study at s Hopkins, would have

undertaken their research. "

In the wake of the death, the federal government last week suspended all

federally financed medical research involving human subjects at s

Hopkins Medical Institutes. It lifted the suspension this week, but required

that nearly all of the research be intensively reviewed again.