Glaxo-Wellcome Blocks Drug Access to People with AIDS in Dire Need.
Glaxo-Wellcome is once again putting greed before people's lives. By announcing that only 2,500 people worldwide will be given access to its new anti-HIV drug, Abacavir (1592), before official approval, Glaxo is threatening the lives of thousands of desperate people with AIDS who need this drug NOW. No expanded access program has yet been announced for a drug that is relatively easy to make. Other "expanded access" programs in the past have made drugs available to tens of thousands of people with AIDS who can't wait for FDA approval if they are to stay one step ahead of HIV.
In addition, Glaxo-Wellcome has failed to develop its protease inhibitor 141 W94 which it purchased from Vertex. Even Vertex has been surprised and dismayed about the slow development of their drug. No plans have been announced for expanded access to this powerful protease inhibitor.
Glaxo-Wellcome's slow development of 1592, a drug invented in 1989, is due to the pharmaceutical giant's desire to market AZT, its cash cow, until its patent runs out. So far, AZT has reaped an astonishing $2.6-billion in sales. And though sales of AZT and its newer anti-HIV drug 3TC skyrocketed in 1996, Glaxo has slapped a 3% price increase on these already over-priced drugs now priced at $3785 and $3054 a year!
Even though women make up 26.5% of new cases of AIDS in urban areas like NYC, no AIDS drug has been tested in enough women to determine safety and efficacy. Effective drug doses in women have sometimes been shown to be different than men, which has meant that the women receiving them have gotten substandard treatment. While the FDA has issued non-binding guidelines to address this problem, Glaxo-Wellcome has failed to test its drugs in pregnant or non-pregnant women in meaningful numbers. While Glaxo-Wellcome is preparing to do dosing trials for 1592 in infants, a pregnant woman who needs the drug for her own health will not be able to access it just like any other PWA will be unable to access it.
AIDS drug currently on the market, including many protease inhibitors, are already failing more than ten thousand people with AIDS. For these people, drugs like abacavir and 141 are the only hope. These drugs must be released for expanded access to all who need them now.
We demand that Glaxo-Wellcome:
1.) _Immediately launch an expanded access program for abacavir (1592) open to ALL in need. Glaxo's current criteria are too strict. A viral load above 30,000 or a tripling of viral load, and CD4 cells below 100, is adequate evidence of treatment failure. Lotteries to determine who gets the drug are NOT acceptable. Immediately design and implement plans for an expanded access program for 141W94 along the same lines as above.
2.)_ Make future drugs available to people with AIDS who have failed the approved drugs not after months of community pressure, but rather on a consistent timetable, after safety and preliminary evidence of efficacy have been completed.
3.)_ Test all of its drugs in women in numbers large enough to determine if there are gender specific differences in dosing, toxicity and effectiveness.
4.)_ Test its drugs in combination with drugs from other companies when such combinations are likely to be treatment advances.
5.)_ Lower the prices of AIDS drugs dramatically.
You should call Glaxo's CEO Robert Ingram at (919) 248-2100 to demand that he immediately act on these demands.
We will not tolerate the lives of people with AIDS held hostage for drug-company profits!
Glaxo-Wellcome Office Take-Over
see more 1592 info off-site at PWA Healthgroup