San Francisco Chronicle - Thursday June 15, 1989
Randy Shilts, National Correspondent

"This issue is giving everyone at HHS a lot of diarrhea now because it's going to cost a lot - and I mean a lot - of money," said the HHS official who is part of the planning. "This is going to be a huge watershed in the history of this epidemic," said the source, who asked not to be identified. National Institutes of Health officials believe that their studies may show within the next six months that AZT is so effective at subverting the human immunodeficiency virus that it will delay the onset of AIDS among HIV-infected people, government sources said. Doctors working on the study of AZT in healthy HIV-infected gay men say it will be two or three more months before they have tabulated the interim results on the drug's effectiveness.

Nevertheless, top National Institutes of Health officials have been privately telling those involved in AIDS policy both within and outside the federal government that some field researchers believe that AZT does seem to thwart the advance of AIDS among HIV-infected men. Such results, if borne out by the research, would inevitably lead to calls for vastly expanded use of the drug.

Wider use of this expensive treatment would cost the federal government billions and could set off feverish politicking. Such expansion would conflict with the Bush administration's intention not to substantially increase health spending, particularly AIDS expenditures.

The prediction of costs of such widespread use of AZT follows the disclosure last week that the federal government will soon issue guidelines to standardize the use of aerosolized pentamidine, a drug used to prevent AIDS-related pneumonia. "Into the Billions of Dollars'

Federal officials have already conceded that government costs for the pentamidine and necessary immunological tests could run "well into the billions of dollars." That disclosure, during the international conference in Montreal, was made before word leaked about the frenzied politicking around the study on AZT.

The National Institutes of Health study that is the center of Washington planning is the largest and, by most estimates, the most important AIDS study in the nation. Since 1987, the National Institutes of Health have enrolled about 3,100 gay men who are infected with AIDS-causing HIV but do not show any symptoms of the disease.

Participants in the 35-center study were put into three groups, said Dr. Paul Volberding, director of AIDS Activities at San Francisco General Hospital and the coordinator of the study. One group received no treatment, a second group received a low dose and a third received a full dose of AZT, the only drug approved to counter HIV.

Because most researchers believe that most, if not all, untreated HIV-infected people will get AIDS, a finding that AZT can slow the progression to AIDS would have huge implications for the 1 million Americans estimated by the government to be HIV-infected.

Volberding said interim results from the study are now being tabulated. Analysis Not Complete

Even though the analysis isn't finished, Volberding said, the federal government should begin planning now for the possibility that the test will succeed.

Other National Institutes of Health doctors have been saying privately that some researchers already believe that AZT's effectiveness is pronounced enough to warrant ending the study and pushing for wider use before more HIV-infected people yield to AIDS. Their prediction that the National Institutes of Health might take such action before the end of the year is what led to the federal planning of possible AZT costs.

The federal government now pays 40 percent of the nation's AIDS health-care bill either through the Medicaid program or Medicare. Many AIDS patients lose their health insurance after falling ill.

Many people may turn to the government because their health insurance does not cover prescription drugs. Currently, the federal government spends about $60 million a year subsidizing the costs of AZT for such AIDS patients who would not qualify for Medicaid reimbursement of their drug costs.

Congressional leaders who support government reimbursement said it's better to pay for the drug than to make people quit their jobs and spend their assets until they qualify for the federal Medicaid program. Moreover, Democrats say, the cost of providing AZT as a preventative is much less than the expenses patients incur if they get AIDS.

The costs of such a subsidy to hundreds of thousands of HIV-infected people would be far greater than the current subsidies - perhaps even double or triple the federal government's current AIDS budget of about $2 billion a year. The treatment at full dose costs about $8,000 per year per patient.

The U.S. Centers for Disease Control tomorrow are set to issue joint CDC-National Institutes of Health guidelines on the use of new drugs to prevent the development of Pneumocystis carinii pneumonia, the major cause of death among AIDS patients.

What remains unclear is whether the Bush administration will be willing to put up the billions of dollars that will be necessary to pay for the treatment.

Always watch for outdated information. This article first appeared in 1989. This material is designed to support, not replace, the relationship that exists between you and your doctor.

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