Firm Outlines Plan for AZT Distribution System

The first prescriptions for the newly approved AIDS drug AZT are expected to be written by next Monday for those seriously ill patients “who need it the most,” its manufacturer announced Monday.

Under an unusual distribution system that gets under way this week, physicians with patients who have AIDS or AIDS Related Complex can apply to a special center established by the Burroughs Wellcome Co. for an evaluation expected to take one or two days.

“We plan to turn this around very quickly,” said Paul Dreyer, the firm’s product manager for AZT, or azidothymidine, which will be sold under the trade name Retrovir.

Licensed for Marketing

Plans for distribution of the drug, which was licensed Friday by the federal government for marketing in this country, were outlined by company officials at a press conference here.

From the time the physician mails in the patient’s application to the time the patient picks up the drug from the pharmacy should take no more than two weeks, Dreyer said.

Supplies of the drug are expected to be limited at first, company officials said, although the nearly 5,000 patients already receiving AZT under a “compassionate use” program will be automatically enrolled.

There will be enough of the drug immediately available for an additional 10,000 patients, the officials said, with supplies for a total of 30,000 patients expected by the end of the year.

Pneumonia Patients

Patients will be eligible for the drug if they have a history of pneumocystis carinii pneumonia, a parasite-induced respiratory infection common to those with AIDS, or a count of 200 or fewer so-called T-4 “helper” cells per cubic millimeter of blood. T-4 cells, a critical component of the immune system, are the primary target of the AIDS virus.

A normal T-4 count is from 1,000 to 3,000, and patients with fewer than 200 are usually quite ill.

The T-4 requirement will enable many more patients than originally thought to qualify for the drug, because not all AIDS patients suffer from pneumocystis. AIDS patients, with their severely damaged immune systems, are vulnerable to a host of opportunistic infections and rare cancers.

‘Difficult to Deny’

“There will be AIDS patients who have not had pneumocystis who will receive the drug,” said Dr. David Barry, vice president for research. “It would be difficult to deny the drugs to any AIDS patient who’d had an infection other than pneumocystis. . . .”

Once a patient qualifies, the physician will be given an enrollment number for him, which must be written by the physician on the prescription. Without the number, the pharmacist will be unable to fill the prescription, company officials said.

Patients who are eligible, but who apply at a time when there is insufficient drug, will be placed on a waiting list and notified when the drug is available, the company said.

Physicians also will be notified if a patient does not meet the criteria, but they “will be encouraged to submit a new enrollment form if the patient’s condition changes,” Dreyer said.

One-Month Supply

Once pharmacists have verified the patient enrollment number, a one-month supply of the drug will be shipped to the pharmacy for that patient and an additional quantity cannot be ordered for 25 days, company officials said. The pharmacist can continue to reorder the drug for that patient each month.

“Once a patient is started on therapy, we want to continue to provide that patient with the drug as long as it is medically appropriate,” Dreyer said.

The company announced toll-free telephone numbers for physicians, patients and pharmacists seeking information on how to receive the drug. Physicians and patients should call 1-800-843-9388, while pharmacists are asked to call 1-800-332-1887.

Continuing Supply

“This unique system has been put into place to help assure that those who need Retrovir the most will receive a continuing supply,” said Peter A. Reckert, the company’s vice president of marketing. “Although the procedure is more complicated than traditional prescription drug distribution, we are confident that we can make it work to the benefit of the patients.”

He added: “Once an adequate supply is available, we will begin distributing the drug through more conventional means.”

Burroughs officials said this could take from six months to a year. The drug is expected to be very expensive, costing from $7,000 to $10,000 a year for each patient.

Toxic Side Effects

AZT, which has been studied in humans since July, 1985, is not considered a cure for the deadly disease, but it has been shown to have a dramatic effect in prolonging the short-term survival of AIDS patients. It has toxic side effects, however, including bone marrow suppression that results in a decrease in the production of red and white blood cells.

The effects of its long-term use are not known.

As of March 16, there had been 32,825 cases of AIDS in the United States, of whom 19,021 had died. There are also an estimated 100,000 to 200,000 individuals afflicted with AIDS Related Complex, which is frequently just as debilitating and fatal as AIDS.

In this country, acquired immune deficiency syndrome has primarily struck homosexual and bisexual men, intravenous drug users and their sexual partners. It is commonly transmitted through anal and vaginal sexual intercourse, the sharing of contaminated hypodermic needles and by woman to fetus during pregnancy.