AIDS Drug Will Be Given Free to Those Unable to Pay : Health: Newly approved DDI is only the second such anti-viral medication OKd by the FDA. It is for patients who are unable to use AZT.

WASHINGTON —  The pharmaceutical firm that is manufacturing DDI, a new anti-viral drug used in the treatment of AIDS, said Wednesday that it will provide the drug free to patients who do not have adequate insurance coverage and cannot afford to pay for it themselves.

The pledge by New York-based Bristol-Myers Squibb Co. followed an announcement earlier Wednesday by the Food and Drug Administration that it had approved DDI--also known as dideoxyinosine and didanosine--for use by patients on whom AZT is ineffective or causes undue side-effects.

DDI is only the second such anti-viral drug to be approved by the federal government. In 1987, the FDA authorized the use of AZT. DDI has been in widespread use since 1989 under a special program that made it available to AIDS patients who could not take AZT.

Bruce Ross, president of Bristol-Myers Squibb’s pharmaceutical group, said the company plans to act in two ways: It will help patients obtain insurance payments to subsidize the cost, and it will provide the drug free to those who have no insurance and cannot afford to pay.

Ross said the drug should be available in pharmacies “within a matter of days.”

The announcement by Bristol-Myers Squibb was regarded as significant, considering the price of the new drug. DDI, which will be marketed under the trade name VIDEX, is expected to cost users an average of about $1,990 a year. The cost will vary depending on the dosage required.

Under the licensing agreement between the FDA and Bristol-Myers Squibb, the federal government will receive 5% of the royalties from DDI sales.

The pricing of AIDS drugs has sparked a controversy almost since their inception. AZT, for example, cost up to $12,000 a year when it was first marketed. But pressure from AIDS activists and lawmakers prompted the manufacturer, Burroughs Wellcome Co., to reduce the price twice.

Sharon Haggerty, a spokeswoman for Burroughs Wellcome Co., said her firm has a similar program that provides the drug free for patients who do not have insurance and cannot afford the treatment. The average cost for a year’s supply of AZT now is $2,500.

Carisa Cunningham, a spokeswoman for the Washington-based AIDS Action Council, said her group would take a closer look at the Bristol-Myers offer, but praised the firm for “its record . . . and its commitment to getting the drug to people who need it.”

“In the past, this is one company that has been exemplary in being sensitive to the human needs of the epidemic,” Cunningham said.

The FDA, which has been under pressure to license an alternative to AZT, approved DDI with less scientific evidence on the drug’s long-term effects than it usually has required before taking such action.

Health officials admitted that there are still many questions about the drug, but FDA Commissioner David A. Kessler said the urgent need for an alternative to AZT outweighed those considerations in this case.

“It is the victims of this dreaded disease who are uppermost in our minds,” Kessler said at a news conference Wednesday.

Clinical trials found that DDI apparently increases a patient’s number of CD 4 cells, or T4 helper cells. These are the white blood cells destroyed by the AIDS virus that are vital to the immune system.

Kessler conceded that researchers have not completed long-term studies on whether DDI will actually increase the survival of AIDS patients.

“We know this drug, DDI, affects CD 4 counts, and we know survival is tied to CD 4 counts,” the FDA chief said.

Kessler said the FDA completed its review of DDI in six months, compared to 30-month reviews for most drugs.