AEGiS-NEWSDAY: FDA Approves Drug for AIDS Patients NewsdayImportant note: Information in this article was accurate in 1988. The state of the art may have changed since the publication date.
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FDA Approves Drug for AIDS Patients

Newsday - November 22, 1988
Laurie Garrett


The Food and Drug Administration yesterday announced approval of a drug for treatment of Kaposi's sarcoma, an AIDS-related cancer.

The drug, known as alpha interferon, diminishes, and in some cases eliminates, Kaposi's sarcoma skin tumors that often accompany AIDS, according to a study conducted by Dr. Clifford Lane of the National Institute of Allergy and Infectious Diseases.

Although the details of Lane's study are being held in embargo by the British medical journal Lancet until Saturday, Lane said that patients with advanced AIDS were not helped by the drug, but patients who had no symptoms other than the purple Kaposi's lesions responded extremely well.

In a statement released yesterday, Dr. Anthony S. Fauci, director of the institute, said that "Dr. Lane's study also found evidence that alpha interferon may, to some extent, diminish AIDS virus activity."

Lane is conducting further studies to determine whether the drug can slow the spread of the AIDS virus throughout the body.

To be effective against Kaposi's sarcoma, the drug must be taken in very high doses - doses that are both dangerous and expensive. According to Lane, alpha interferon's side effects "were substantial," and included flu-like symptoms, suppression of bone marrow production of blood cells, and cardiovascular problems. Because patients rarely die of Kaposi's sarcoma, and the side effects are so serious, Lane said, "it's a real question that remains to be answered" as to whether the drug is worth taking simply to eliminate the purple lesions.

Alpha interferon is a natural protein manufactured by cells in the human body. Two major American pharmaceutical companies, Hoffman-La Roche and Schering Corp., manufacture genetically engineered forms of it, marketed as Roferon and Intron-A, respectively.

Several thousand AIDS patients have undergone alpha-interferon therapy experimentally, and physicians have generally been enthusiastic about the drug's effect on Kaposi's sarcoma. Depending on the stage of AIDS the patient was in during alpha-interferon therapy, 30 to 50 percent witnessed a marked reduction in tumor lesions, or complete disappearance, the FDA said yesterday.

Hoffman-La Roche said a year's supply of the drug will cost AIDS patients $9,800, which it says is a bargain price.

(****The following appeared in C Edition: Most of the patients taking this drug would also take AZT, which typically costs $10,000 a year.)


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