ju st o u t ▼ n o vem b or 10, 1 9 9 4 ▼ 9
O U TSID E IN and PHOENIX RISING join the youth of
Cautious optim ism
October meeting o f Clinton’s AIDS drug task force
an improvement over others
in thanking you for making our work possible! In the past year, we have made connections
with over 200 young people-to build queer youth community and provide HIV outreach
and prevention services on the streets of downtown Portland.
▼ Mark Stucker and the Community in support of the 1994 VOICES AUCTION
autious optimism is perhaps the best
way to describe the aura surrounding
the National Task Force on AIDS
Drug Development meeting which
took place Oct. 27 and 28 near Wash
ington, D.C. The group is a major initiative by the
Clinton administration, through Health and Hu
man Services Secretary Donna Shalala, to facili
tate development and approval of AIDS-related
therapies.
“I think the last two days were definitely better
than our July meeting,” said Peter Staley, a mem
ber of the task force and of the Treatment Action
Group in New York City. “Up until now I have
been very frustrated with the task force’s work,
because we have kind of been all over the map and
not come up with any hard recommendation on
specific issues, with the exception of gene therapy
and the regulatory process.”
C
▼ Linda Kliewer
▼ The Pride Foundation
T Hot Lips Pizza
▼ Tia Plympton
▼ Vista Spring Café
▼ Gerry Taylor
▼ J im Clay/Multnomah Commission
on Children & Families
▼ Fish Grotto Restaurant
by Bob Roehr
ness and analysis in order to gain approval of new
drugs.
AIDS and women’s advocates want more. ACT
UP demonstrated outside the FDA in September
and several dozen members from around the coun
try were back for this hearing. They held up posters
reading “Guidelines are not enough. Access now,”
and "Killing time is killing women.”
Dr. Maxine Wolfe, a researcher and member of
ACT UP, was invited to speak from the audience.
She called the current policy “totally unwarranted
paternalism.” She pushed the government to move
beyond simply dropping restrictions, to formulate
an affirmative mandate to include women in all
phases of clinical trials, and to put resources into
enforcement of those guidelines.
Theresa McGovern, attorney with the HIV
Law Project and a member of the task force, was
encouraged by the direction in which the panel was
▼ Rocco’s Cafó
▼ Art Capers
▼ Michael O'Shea/Mult. Co. Health Dept.
(aka Lotta Luv)
HIV Outreach Project
▼ Christopher Craske/HVRP
▼ Just Out
▼ Portland Police Bureau
▼ Osmyn
▼ Meyer Memorial Trust
▼ Lanny Swerdlow/The City Nightclub
▼ The Atheist Community Center
▼ Tri-County Youth Services Consortium
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Discussion of protease inhibitors, the most
promising family of next generation anti-viral
medications, highlighted the first day’s activities.
Staley is encouraged that the next full meeting of
the task force, in February, will be dedicated to
“looking comprehensively at development of pro
tease inhibitors.”
“We are going to haul in all of the top execu
tives of all of the companies who are developing
protease and try to knock some heads together and
get everybody working together. We don’t want to
repeat the mistakes that we made with the nukes
[nucleoside analogs such as AZT].”
Women and clinical trials opened the second
day and extended into twice its allotted time. A
1977 Food and Drug Administration regulation
had barred women of child-bearing potential from
early Phase I and II clinical trials of experimental
drugs.
That was challenged in December 1992 by the
HIV Law Project. Both the FDA and National
Institutes of Health subsequently lifted their gen
der-biased restrictions on enrollment for clinical
trials of drugs for life-threatening illnesses, except
where there is “medical justification.” They have
also issued guidelines calling for gender inclusive-
moving. However, she noted there were "no teeth”
in monitoring and enforcement provisions, those
need to be built into the system. She called upon the
FDA to “use its regulatory power.” Both women
pushed for “by gender analysis” of drug effects in
trials, something which is only now being imple
mented.
Staley called the FDA response “unfortunate,”
as they knew the debate was coming. He wants
them to mandate and enforce nonexclusionary
policies in all phases of drug trials. “That puts the
burden of responsibility on the trial participant,
where it always is anyway on these issues.”
That burden can include death, as it did with
FIAU. Last year the experimental hepatitis B drug
killed five of the first 10 people enrolled in the
Phase II trial at NIH. Most were gay men.
The FDA published new regulations Oct. 27,
designed to shift the most basic presumptions in all
clinical trials. “The data needs to be seen with as
much skepticism as optimism,” said FDA spokes
man Jim O’Hara.
It was a stark reminder that clinical trials are
just that—experiments, not treatment. They often
do not work and sometimes have unanticipated,
even disastrous effects.
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