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Quick Approval Sought for AIDS Drugs : Medicine: Health workers ask FDA to speed up bureaucratic process and make two promising treatments available.

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<i> From Associated Press</i>

In a rare citizens petition to the Food and Drug Administration, dozens of doctors, nurses and medical aides urged the government to cut red tape and hustle two promising AIDS drugs onto the market.

About 180 San Francisco-area medical workers said their patients cannot wait the usual six months to a year it would take for dideoxynosine and dideoxycytidine, DDI and DDC, respectively, to clear bureaucratic hurdles.

“There are patients who cannot tolerate or have developed resistance to AZT (the only licensed AIDS drug),” said Dr. Donald Abrams, head of the Community Consortium, made up of doctors and other health workers who treat victims of AIDS.

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“For them, it’s like being back in 1985 when people with AIDS had no options,” he said.

The unusual citizens petition to the FDA urges the federal government to review studies and decide by March 1 whether to approve them for the market.

If the FDA agrees, it would be would be an unprecedented approval by the agency, which has never taken such a shortcut in licensing a drug. The manufacturers of DDI and DDC have not even submitted the drugs for licensing.

The doctors demanded the FDA order the makers to submit the drugs by Feb. 1 and that the FDA decide on their value by March 1.

The petition argued that early results indicate both drugs are effective in slowing the progress of the deadly HIV virus, which causes AIDS.

Both drugs, considered cousins of AZT, appear in preliminary results to improve the human immune system’s level of CD4 cells, which battle infection. The virus does not appear to become resistant to either DDI or DDC as quickly as it does AZT.

The group said access to the drugs is important to healthier AIDS victims who cannot take AZT and would not qualify for the new drugs under rules allowing compassionate use of experimental drugs.

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About five in every 100 infected people “fall through this crack in medical care,” said Dr. William Owen, an AIDS specialist.

The petition was joined by Bay Area Physicians for Human Rights, a group made up mostly of gay doctors.

In sending the petition, the doctors joined a growing movement of AIDS activists attempting to see the drugs on the market by early 1991.

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