The Bay Area Reporter - August 1, 1995
Matt Sharp and Virg Parks, ACT UP/Golden Gate Writers Pool

The two earliest pharmaceutical players with compounds in Phase III, and in studies, offer their drugs on some sort of compassionate basis. Saquinavir, Hoffman LaRoche's protease inhibitor, has been in development for two years, and the company plans further trials, as well as a lottery-based expanded access program. The protease inhibitor second furthest in development, Crixivan, is made by Merck, which also plans a lottery for their expanded access, as well as further trials.

Abbott Laboratories is the third major pharmaceutical to enter the protease inhibitor arena and the only one to refuse consideration of an expanded access or compassionate use program. Although several smaller companies are also developing protease inhibitors, none are as far along as those being developed by the three larger companies.

Protease inhibitors do not come without some drawbacks. Although efficacy studies thus far have shown great potential in dramatically reducing viral load, most inhibitors develop viral resistance quickly (sometimes within a few weeks), reducing the drug's effectiveness. Like most antivirals, protease inhibitors also have side effects. In the case of Abbott's drug, ABT-538, side effects recognized thus far appear to include nausea and elevated liver enzymes. Another common complaint is the taste, frequently compared to motor oil. The company is in the process of reformulating the drug.

Expanded access is one of the many changes to the drug development and approval process that have arisen out of the AIDS activist movement. The term "expanded access" includes different programs that can be utilized during different phases of drug development. Generally (with AIDS drugs), "Compassionate Use" applies to drugs with limited safety data, Parallel Track programs which collect additional safety data on the drug used during the efficacy stage (Phase 11 and III) of development, and Treatment IND (Investigational New Drug) for compounds expected to be approved shortly. Prior to AIDS, experimental drugs for cancer and other life-threatening diseases were only offered on the more limited case-by-case compassionate or emergency use basis. AIDS changed all that, as hundreds and thousands demanded speedier access to drugs that may not be the core, but might extend their lives.

The HIVIG history

Abbott Laboratories has a long, stormy history with AIDS activists and chemical researchers. The late Michael Wright, ACT UP/Golden Gate co-founder, was a formidable force in pressuring Abbott to release its promising antibiotic, clarithromycin, in an expanded access program - unfortunately this victory came after months of frustrating deliberations. Later, Michael initiated efforts for Abbott to continue research with their blood product HIVIG (HIV immune globulin). After the company's complete refusal to continue development of HIVIG, and after Wright's death, the issue was put on hold. ACT UP/Golden Gate once again became involved with the product at the request of ACTG (AIDS Chemical Trials Group) researchers. The ACTG wanted to research HlVlG's potential to reduce the risk of mother-to-infant HIV transmission, and Abbott stubbornly refused.

In order to bring public attention to the issue, ACT UP/Golden Gate held a civil disobedience at the Pacific Stock Exchange, shutting down trading for the first time in history. This action, combined with efforts from researchers and other AIDS activists, forced Abbott to sell its rights to HIVIG.

Now Abbott has added insult to injury by not considering any form of expanded access of its promising protease inhibitor, even for people who have exhausted all other options.

As more and more protease inhibitors came down the pipeline, activists nationwide formed a working group to follow and encourage development of - and access to - this promising new tool in the battle against AIDS. Negotiations began with Abbott regarding expanded access in December 1994. After numerous non-productive meetings, ACT UP/Golden Gate sponsored a fax-zap of the Abbott headquarters. Abbott's only response was to change some of their phone numbers.

As of the end of May, no plans for expanded access were forthcoming. Another meeting between working group members and company representatives was scheduled for this week, but was canceled by Abbott with little notice and no explanation.

Abbott's contempt for PWAs

ACT UP/Golden Gate member Dean Knutson, one of the frustrated activists working on this issue, says, "Abbott's cancellation, together with its ongoing refusal to establish compassionate use, demonstrates its contempt for people with AIDS.

"To them, we are only a market to be exploited."

In reaction to Abbott's continued obstinance, ACT UP/Golden Gate and ACT UP/Atlanta decided to strike back at the only weak spot in a corporation's armor: its net income. The groups called for a national "Spill Out" of Abbott products Ensure and Advera on August 2.

The purpose of Wednesday's action was to inform the community of Abbott's disdain toward people with AIDS. ACT UP/Golden Gate held the action in the heart of the Castro, encouraging purchasers of the nutritional supplements to try one of Abbott's numerous competitors - while pouring "Ensure" and "Advera" (or something that looked like them) down the sewer.

History shows that Abbott has been one of the worst pharmaceutical companies in providing access to experimental AlDS drugs. After months of negotiations and the Castro Street Spill Out, activists still need your help and support.
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