AIDS Researcher Falsified
Report
The Desert Sun
The Associated Press December 18th, 2004
WASHINGTON -- The government's chief of AIDS
research rewrote a safety report on a U.S.-funded drug study to
change its conclusions and delete negative information. Later, he
ordered the research resumed over the objections of his staff,
documents show.
Dr. Edmund Tramont, chief of the National Institutes of
Health's AIDS Division, took responsibility for both
decisions. He cited his four decades of medical experience and
argued that Africans in the midst of an AIDS crisis deserved some
leniency in meeting U.S. safety standards, according to
interviews and documents obtained by The Associated Press.
Tramont's staff, including his top deputy, had urged
more scrutiny of the Uganda research site to ensure it overcame
record-keeping problems, violations of federal patient safety
safeguards and other issues that forced a 15-month halt to the
research into using nevirapine to prevent African babies from
getting AIDS from their mothers.
AP reported Friday that NIH knew about the problems in early
2002 but did not tell the White House before President Bush
launched a plan that summer to spread nevirapine throughout
Africa. Now, officials have new concerns the drug may cause
long-term resistance in the hundreds of thousands of African
patients who received it, foreclosing future treatment
options.
"I am not convinced that the site is indeed prepared to become
active," Dr. Jonathan Fishbein, an expert NIH hired to improve
the agency's research practices, wrote Tramont in July
2003.
Fishbein contended he should be given time to review
Uganda's capabilities and safety monitoring before letting
the site reopen, or NIH would risk being "toothless" in its new
efforts to clean up sloppy research practices. He added that
professional safety monitors hired by NIH had reservations about
the site.
Tramont dismissed the safety monitors' concerns, saying
he didn't believe they fully understood AIDS.
"I am convinced that this site is ready to resume given the
limitations of doing research in any resource-poor,
underdeveloped country," Tramont wrote July 8, 2003, in response
to Fishbein.
"I want this restriction lifted ASAP because this site is now
the best in Africa run by black Africans and everyone has worked
so hard to get it right as evidence by the fact that their lab is
now certified," he wrote.
NIH officials acknowledge Tramont rewrote the report and
overruled his staff on the reopening, but said he did so because
he was more experienced and had an "honest difference of opinion"
with his safety experts. They noted he had no financial interest
in nevirapine and that the troubled study began well before he
joined NIH in 2001.
Those who raised objections "were part of a large team of
which Dr. Tramont was the head, and it is important that the
people involved in that team should express their opinion and
there should be discussion," said Dr. H. Clifford Lane, the
NIH's No. 2 infectious disease specialist and one of
Tramont's bosses. NIH designated Lane to speak to AP on
Tramont's behalf.
"But at the end of the day the final responsibility lies with
the head of the team and it is his job to put that together the
way he sees it," Lane said.
Lane said an internal NIH review concluded Tramont had not
engaged in scientific misconduct. Separately, the National
Academy of Sciences continues to investigate whether the Uganda
research was valid.
NIH believes it helped save hundreds of thousands of African
babies by allowing nevirapine to be used in single doses to block
the AIDS virus, Lane said. But he acknowledged the research was
imperfect, and NIH now believes nevirapine should no longer be a
first choice for newborn protection -- if other options exist --
because of the newly discovered problems about resistance.
Tramont wrote in 2003 e-mails that he reopened the clinics
because he didn't want NIH "perceived as bureaucratic but
rather thoughtful and reasonable" and that it was important to
encourage Africans' fight against AIDS "especially when the
president is about to visit them."
Bush visited the continent a few days after Tramont ordered
the clinics reopened.
Tramont's actions, however, drew a blunt reply from his
top deputy.
"I think we are cutting off our noses to spite our face here,"
AIDS Division Deputy Director Jonathan Kagan wrote. "...We should
not be motivated by political gains and it's dangerous for
you, of all people, to be diminishing the value of our
monitors."
Tramont prevailed and the research resumed. A few days later,
Tramont sent a note to his staff ordering the end of an
18-month-long debate inside NIH over whether the science from the
Uganda trials was valid and safe. That debate began in early 2002
when two audits divulged widespread problems with the
research.
The Uganda trial "has been reviewed, re-monitored, debated and
scrutinized. To do any more would be beyond reason. It is time to
put it behind us and move on," Tramont wrote in a July 13, 2003
e-mail instructing his staff that future issues about the drug be
handled directly by his office.
Five months earlier, Tramont surprised one of his own medical
officers who had written a report summarizing safety concerns
uncovered during a second review of the Uganda trial.
Dr. Betsy Smith's report, finished in January 2003, said
the Uganda trial suffered from "incomplete or inadequate safety
reporting" and that records on patients were "of poor quality and
below expected standards of clinical research."
She strongly urged NIH not to make sweeping conclusions about
nevirapine based on the Uganda research. "Safety conclusions from
this trial should be very conservative," she wrote.
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