Monday, Oct. 02, 1989

How Much for A Reprieve From AIDS?

By CHRISTINE GORMAN Dick Thompson/Washington and Cheryl P. Weinstock/New York

To someone suffering from AIDS, the drug AZT (azidothymidine) can mean the difference between a precipitous death and a few more months of hope. The drug blocks the AIDS virus from reproducing, thereby cutting dramatically the amount of virus circulating within the blood. At the same time, a victim's ravaged immune system can replenish some of its chief defenders, called helper T cells, which may double in number during AZT treatment. Yet the drug has two notorious drawbacks. One is its side effects, which can include severe anemia. But the more bitter issue is its cost. A year's supply for a person who takes twelve capsules a day has run upwards of $8,000. For patients who lack full health insurance or other financial resources, the chance to prolong life seems cruelly out of reach.

The high price of AZT, sold under the trade name Retrovir, has become one of the most passionate controversies of the AIDS epidemic. Activists have accused Burroughs Wellcome, the drug's manufacturer, of taking unseemly advantage of desperate AIDS patients. AZT, which is being taken by more than half the 42,000 people with AIDS in the U.S., ranks as one of the most expensive drugs on the market. The debate comes at a particularly crucial time for 7,000 AIDS patients who have depended on federal help to buy the drug. The $20 million program to provide them with AZT expires at the end of this week.

In its defense, the North Carolina-based pharmaceuticals maker, a subsidiary of Britain's Wellcome P.L.C., cites the high cost of research and development. In an attempt to defuse the cost crisis, the company said last week that it will cut the wholesale price of AZT 20%, to $1.20 a pill. One reason the company is able to do so is that the potential market for the drug has grown substantially in recent weeks with the discovery that AZT can help a far larger group. A Government study released in August concluded that the drug, besides helping people who have AIDS, can also postpone the appearance of the disease in people who are infected by the AIDS virus but are not yet ill. Since no other antiviral drug has been approved to fight AIDS, the finding increases to 600,000 the number of potential AZT customers in the U.S.

While Burroughs Wellcome said it had been planning the cut for some time, the announcement came on the heels of angry protests. Well-organized AIDS activists condemned AZT's high price at stock exchanges in London, New York and San Francisco, chanting such slogans as "Be the first on your block to sell your Burroughs Wellcome stock." Senate staffers in Edward Kennedy's office began researching possible ways to nationalize the drug by invoking a law, dating from World War I, that allows the Government to revoke exclusive patents and licenses in the interest of national security. And the House Subcommittee on Health and the Environment launched an investigation into possible "inappropriate" pricing of the drug. Burroughs' decision to cut prices last week "is a good first step," said Henry Waxman, the subcommittee's chairman. "But I think the company can do better."

Burroughs Wellcome refuses to disclose its profit on AZT, but industry analysts believe it could range from a low of $25 million to a high of $100 million on this year's sales of $200 million. When the costs of overhead and continuing research are factored in, "the average operating profit from all the sales of Burroughs Wellcome is 20%. Though they have a 30% operating profit margin on AZT, it's still within the bounds of the pharmaceutical industry," says Jo Walton, who follows the industry for Shearson Lehman Hutton in London.

Critics argue, however, that AZT should not be subject to the usual practices of the pharmaceutical industry. The drug was first synthesized in 1964 by a Government-funded scientist in Michigan who was searching for a cancer treatment. Although that application never panned out, investigators at the National Cancer Institute, along with scientists from Burroughs Wellcome, discovered in 1984 that the drug blocks the AIDS virus from reproducing. By some estimates, the help provided by the Government scientists eventually allowed Burroughs to hold its development costs to less than $100 million, in contrast to $125 million for the average drug.

Yet in 1984 no one was manufacturing AZT, in part because of the colossal expense of producing a drug that would be helpful only to a relatively small group of people. Scientists believed at the time that AZT would be effective only for those suffering from full-blown AIDS, and they were confident that more effective AIDS drugs would soon supplant AZT. As a result, the Government invoked the Orphan Drug Act, a law passed in 1983 to give pharmaceuticals makers financial incentives to develop treatments for rare diseases. The law allowed the Government to give Burroughs Wellcome an exclusive seven-year license, to commence when AZT reached the market.

; For its part, Burroughs Wellcome made some crucial breakthroughs in developing AZT. The company designed and executed a six-step manufacturing process to convert a key ingredient, thymidine, a biological chemical first harvested from herring sperm, into AZT. Contends company spokeswoman Kathy Bartlett: "We're the ones who turned this useless chemical into useful medicine."

Even if Burroughs refuses to reduce its price further, some patients may begin paying less for AZT treatment. Doctors are discovering that combining the potent antiviral drug with such other formulas as interferon (an immune- system booster) or probenecid (an antigout drug) lowers the dose of AZT necessary for effective treatment. In addition, people who are infected with the AIDS virus but show no symptoms need only about half the full-strength dose to slow the course of the disease.

The desperate search for other AIDS treatments has not flagged. Last week a group of San Francisco AIDS activists announced the results of their highly controversial underground test of Compound Q, a chemical derived from a cucumber-like Chinese plant. Although many of the 34 patients tested with the drug seemed to show marked improvement, three have died. The deaths have not been directly attributed to Compound Q, but the uncertain results proved once again how important AZT has become to AIDS patients as a life-giving drug and a symbol of hope.