Desperate for life-prolonging treatments for AIDS, activists around the country demanded Wednesday that two promising drugs receive early government approval.
"The basic problem is you have tens of thousands of people failing AZT (the only government-approved drug to fight the AIDS virus) either because it is not working for them or it is too toxic or their bodies have become resistant to it. And these people are in desperate need of access to these drugs," said David Gold of the AIDS Coalition to Unleash Power.ACT UP joined the Gay Men's Health Crisis in New York, San Francisco's Project Inform and other groups in a plea for faster action from the government and the manufacturers of the two drugs - dideoxyinosine or DDI and dideoxycytidine or DDC.
Hoffman-LaRoche in Nutley, N.J., which makes DDC, had no immediate comment on its plans for getting the drug licensed.
But a spokeswoman for Bristol-Myers Squibb in New York said the firm plans to submit an application for approval of DDI "in the first quarter of 1991."
That means, if previous experience is repeated, it could take more than six months from now for DDI to win full government approval.
The Food and Drug Administration, which took 31/2 months to approve licensing for AZT in 1987, could not say how long approval of either new drug would take once the manufacturers submit their applications.
FDA spokesman Brad Stone said, "AIDS drugs get top priority, so when it comes time for the agency to take action, they get reviewed immediately."
Both DDI and DDC have been available through clinical trials, as well as through a special expanded access program which has reached about 15,000 people, most of whom have received DDI.
But activists said those programs still leave thousands of patients unable to obtain the drugs, which may be their only hope for surviving longer with the acquired immune deficiency syndrome.
"I am HIV-infected and have been taking AZT for over a year. Recently I discovered that AZT was causing muscle deterioration, a common side effect, and I had to stop taking it. However, because the problem has not reached a serious stage, I am not eligible for the DDI expanded access program. said David Barr, assistant policy director for Gay Men's Health Crisis.
"I should not have to wait until I cannot walk in order to get DDI. There are thousands of other people just like me. We need this drug available immediately so that our doctors can prescribe it before we get any worse," Barr said.
DDI and DDC are chemically related to zidovudine or AZT, but preliminary results indicate neither drug causes the severe anemia that frequently troubles patients taking AZT.
However, DDI is associated with inflammation of the pancreas, and both DDI and DDC can trigger a painful nerve disorder in the feet and hands. It is hoped their toxicities can be tempered by using lower doses of the drugs in combination with each other.
"What the feeling is now is that enough is known about these two drugs for people to make informed choices," ACT UP's Gold said.