From: [email-masked]
Date: Wed, 7 Sep 1994 22:43:05 -0500 (EST)

A C T  U P
                      AIDS COALITION TO UNLEASH POWER

P R E S S   R E L E A S E   9 / 1 / 9 4             FOR IMMEDIATE RELEASE
CONTACT: KATE SORENSEN, ACT UP/PHILADELPHIA: (215) 731-1844, BOX 8

     MASSIVE NATIONAL PROTEST TRANSFORMS FDA HEADQUARTERS INTO PUBLIC

                                COURTROOM:

  ACT UP WOMEN AND SUPPORTERS DEMAND GENDER PARITY IN CLINICAL RESEARCH!

     TUESDAY, SEPTEMBER 20 * NOON * 5600 FISHERS LANE * ROCKVILLE, MD

A thousand loud and angry demonstrators from across the country will march
to the headquarters of the Food and Drug Administration (FDA) to protest
the agency's continued indifference towards women's health concerns. High
noon will mark the dramatic unfolding of a tale of criminal neglect, as
women living with life-threatening diseases testify against FDA
Commissioner David Kessler in a graphic public trial.

The FDA is responsible for the approval of all drug research and therapies
in the United States, yet the FDA has refused to create regulations to
address the crucial issue of women's access to drug trials and gender-based
analysis of new drugs. In July 1993, after years of pressure from women and
other activists, the FDA released new guidelines for the "study and
evaluation of gender differences in the clinical evaluation of drugs." This
document acknowledges that the effect of drugs in women's bodies cannot be
determined through research based on men.

However, these toothless guidelines still do not mandate inclusion of women
in research. Women are routinely excluded from research simply because of
their "childbearing potential!" Women with cancer, AIDS, and other serious
diseases still cannot get access to potentially life-saving new drugs.
Drugs are still being approved and marketed with no data on how they will
affect women's bodies. In other words, every woman who takes a drug is an
"experimental subject"; decisions about the safety and appropriate doses of
drugs are based almost entirely on male trial participants!

Women living with HIV are attending a preliminary meeting with Kessler and
Assistant Commissioner Ruth Merkatz on September 9. But the time to trust
the FDA is over. A Citizen's Petition against the FDA, filed by the HIV Law
Project in New York, has clearly stated new, reasonable standards for
regulations on women's access to trials. We are protesting on September
20th to demand immediate implementation of regulations guaranteeing women's
equal access to clinical trials and data collection demonstrating any
differences according to gender.

Press are invited to join the demonstrators at 11:00am at the Twin Brook
Metro station, Rockville, Maryland. Photo opportunities will be copious.