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December 14, 2004 - Image 8

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The Michigan Daily, 2004-12-14

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8 - The Michigan Daily - Tuesday, December 14, 2004



U.S. officials warned of concerns against AIDS drug

Health center failed to inform administration
of dangers of drug used to fight AIDS in Africa

WASHINGTON (AP) - Weeks before
President Bush announced a plan to protect
African babies from AIDS, top U.S. health
officials were warned that research on the key
drug was flawed and may have underreported
severe reactions including deaths, government
documents show.
The 2002 warnings about the drug, nevirapine,
were serious enough to suspend testing for more
than a year, let Uganda's government know of the
dangers and prompt the drug's maker to pull its
request for permission to use the medicine to pro-
tect newborns in the United States.
But the National Institutes of Health, the gov-
ernment's premier health research agency, chose
not to inform the White House as it scrambled
to keep its experts' concerns from scuttling the
use of nevirapine in Africa as a cheap solution,
according to documents obtained by The Associ-
ated Press.
"Everyone recognized the enormity that this
decision could have on the worldwide use of nev-
irapine to interrupt mother-baby transmission,"
NIH's AIDS research chief, Edmund Tramont,
reported March 14, 2002, to his boss, Anthony
Fauci, director of the National Institute of Allergy
and Infectious Diseases.
The documents show Tramont and other NIH
officials dismissed the problems with the nevi-
rapine research in Uganda as overblown and were
slow to report safety concerns to the Food and
Drug Administration.
NIH's nevirapine research in Uganda was so
riddled with sloppy record keeping that NIH
investigators couldn't be sure from patient
records which mothers got the drug. Instead, they
had to use blood samples to confirm doses, the
documents show.
Less than a month after Bush announced a

$500 million plan to push nevirapine across
Africa to slow the AIDS epidemic, the Health
and Human Services Department sent a nine-
page letter to Ugandan officials identifying
violations of federal patient protection rules by
NIH's research. Africa accounts for more than
two-thirds of the world's AIDS cases, with 27
million infected.
The NIH research "may have represented
a failure to minimize risk to the subjects," the
Office of Human Research Protections told
Ugandan authorities in summer 2002.
Nevertheless, NIH officials told AP they
remain confident after re-reviewing the Ugan-
da study and other research that nevirapine can
be used safely in single doses by African moth-
ers and children to prevent HIV transmissions
during birth. But they acknowledged their
Uganda research failed to meet required U.S.
As a result, NIH recently asked the National
Academy of Sciences to investigate its science in
the case, and has spent millions in the last two
years improving its safety monitoring and record
"I would say there are many lessons that we
have learned from this review that will help us
do our clinical research, both domestically and
internationally, much better," said H. Clifford
Lane, NIH's No. 2 infectious disease official.
Senate Finance Committee Chairman Charles
Grassley (R-Iowa) has asked the Justice Depart-
ment to investigate NIH's conduct. In a letter
released yesterday, Grassley said he was com-
pelled to do so by "the serious nature of these
allegations and the grave implications if the alle-
gations have merit."
One lesson already derived from a closer
review of the Uganda research is that even single

doses of nevirapine can create instant resistance,
meaning patients may not be able to use the drug
or others in its class again when her AIDS wors-
ens, Lane said.
"It was unexpected, and what it means is nevi-
rapine probably shouldn't be a drug of first choice
if other options are available," Lane said.
Lane said NIH officials were aware in
spring 2002 about the impending White House
announcement on nevirapine but did not tell
presidential aides of the problems because
they were confident, even before reviewing the
Uganda research, that the underlying science
was solid.
The White House - though unaware of the
NIH concerns - also remains confident in
Bush's $500 million plan in 2002 to send nevi-
rapine to Africa. Bush approved $2.9 billion for
global AIDS fighting next year.
"The president's mission is to try to stop the
spread of AIDS in Africa and to come at it from
a new angle, and that is what this is all about,"
spokesman Trent Duffy said.
Nevirapine is an antiretroviral drug marketed
in the United States as Viramune that has been
used since the 1990s to treat adult AIDS patients
and is known to have potentially lethal effects
like liver damage and severe rashes when taken
over time.
In 1997, NIH began studying in Uganda
whether it could be given safely in single doses to
stop mother-to-baby transmissions. That research
showed it could reduce transmission in as many
as half the births.
But by early 2002, an NIH auditor, the agen-
cy's medical safety experts and the drug's maker
all disclosed widespread problems about the U.S.-
funded research in Uganda.
Boehringer Ingelheim, the Connecticut-based

Edmund Tramont, chief of the National institutes of Health AIDS Division, stands in
the Natcher Building on the NIH campus during a break at an AIDS symposium in
Besthesda, Md.

company that makes nevirapine, told NIH it iden-
tified at least one "critical compliance issue" that
compromised the integrity of the study and more
than four dozen issues it described as "serious"
and "major."
Boehringer and NIH auditors cited concerns
such as failing to get patients' consent about
changes in the experiment, administering wrong
doses and delays and underreporting of "fatal and

life threatening" problems.
"It appeared likely, in fact, that many adverse
events and perhaps a significant number of
serious adverse events for both mother and
infant may not have been collected or reported
in a timely manner," Westat Corp. reported in
March 2002. Westat is a professional medical
auditing firm hired by NIH to visit and audit
the Uganda site.

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Continued from page 1
Besides funding, state policymakers also have yet to address INTERESTED IN JOINING
how the state's schools would meet the increased demand for edu-
cation. E'
Courant said the potential influx of students could be s ><, .
absorbed by both new and existing colleges. 7Ta FF.
"I wouldn't expect the Ann Arbor campus to grow much," he
added ix:.: .:S.:.:.°:. :~exa+ ° lQY ~'2" " "
The commission, which includes University President Mary E}ra vaiRIpjslM*
Sue Coleman and many other state educators, was created by PY O INE
Granholm to find many other find ways to double the number of..C.G...Y
Michigan residents with a degree or certification in 10 years.
The state has cut higher education funding over the past C tdFOR MORE ,NF°.
two years. Coleman and the University's Board of Regents COr l FO r M uRi INFO.
have criticized the governor for not making post-second- ':
ary schooling a higher priority.
"I hope this will be the beginning of a change between the
state and public education in the state," Courant said.
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