Important note: Information in this article was accurate in 1989. The state of the art may have changed since the publication date.
Health official's pledge on AIDS restrictions to curb drug profiteering
San Francisco Chronicle - Saturday October 14, 1989
Randy Shilts, National Correspondent
The federal government may try to force down the prices of expensive AIDS drugs and has already moved to ensure that manufacturers do not profit excessively from the next major AIDS treatment, a top Washington health official said yesterday. Saying that some drug manufacturers appear not to be "socially responsible" about pricing life-saving treatments, Dr. James Mason, the assistant secretary of the U.S. Department of Health and Human Services, said he was involved in "constant talks" about how to bring drug prices down. "The companies have to be socially responsible," said Mason, the assistant secretary for health and acting surgeon general. "They have to realize that if they try to get a return on their investment that is unconscionable, the public isn't going to be happy." Mason's comments came at the National AIDS Update Conference, a gathering of health-care professionals, in San Francisco yesterday. The remarks come after recent uproars about the cost of the two most important AIDS drugs now in use: AZT, which is the only drug licensed to combat infection with the AIDS-causing virus, and aerosolized pentamidine, which prevents the lethal Pneumccystis pneumonia, which is a major killer of AIDS patients. GROWING MARKET FOR AZT The potential market for AZT jumped in recent months after new studies found that it can stave off the progression of AIDS among the several hundred thousand people infected with the virus but not yet seriously ill. Under severe criticism from AIDS researchers and advocacy groups, Burroughs-Wellcome recently cut the drug's price by 20 percent, but critics have charged that the company is still reaping exorbitant profits. A similar controversy has enveloped aerosolized pentamidine, which sells wholesale for about $100 a vial in the United States but which is available in Europe for about $30 a vial. Last week, a group of New York City AIDS patients said it will establish a network to import the drug from England if the American manufacturer, Lyphomed Inc., does not reduce the price. Mason said he does not believe the government could move against Burroughs-Wellcome or Lyphomed because the companies already have exclusive marketing rights and "changing the rules halfway through the game" would be unfair. But he supported changes in the Orphan Drug Act that have enabled companies to obtain monopolies on drugs such as AZT. When first enacted, the drug law was meant to encourage the production of drugs for people with rare diseases and offers the seven-year monopoly for treatments that will go to fewer than 200,000 patients. When AZT was licensed two years ago, it was granted orphan drug status because AZT was considered beneficial only for people with full-blown AIDS, a number then in the tens of thousands. Now, federal officials estimate that as many as 400,000 infected Americans could benefit from the drug. Mason said yesterday that no monopoly on the drug should be allowed when the number of patients grows so large. Mason also said that the administration already has moved to ensure that Bristol-Myers does not unfairly price ddI, the drug regarded by many researchers to be the most promising treatment now on the horizon. 'LEARNING AS WE GO ALONG' Because ddI was developed by the National Cancer Institute, federal officials were able to require that Bristol-Myers, the company that will market the drug, disclose information about production and research costs. That way, Mason said, the government can determine whether the price reflects the actual recovery of company investment. "We're learning as we go along too," Mason said in an interview with The Chronicle. "This was a new process for the government to spit out a drug like that. It hasn't happened before except for drugs that really have been little orphan drugs for rare cancers. This is the first time we've been involved with major drugs." Mason cautioned that the government needed to take a "balanced" and "even-handed" approach to the drug companies, so they were not frightened away from developing AIDS drugs. In other presentations at yesterday's conference, the official in charge of the World Health Organization's global program on AIDS said that Asia, which has so far avoided a serious AIDS problem, appears to be newly "vulnerable." "The world picture remains grim," said Dr. Jonathan Mann, who heads the international fight against AIDS in Geneva. "Worldwide, AIDS isn't under control." In Thailand, the rate of occurence of the AIDS-causing human immunodeficiency virus among intravenous drug users has increased from just 1 percent two years ago to more than 40 percent this year. Among prostitutes, the infection rate rose from about one-tenth of 1 percent two years ago to as high as 30 percent in one region, he said. In India, a country which has so far remained largely untouched by AIDS, a recent study found that between 3 percent and 7 percent of prostitutes in the southeastern part of the country were HIV-infected. "What happens if AIDS really takes off in a country like India?" asked Mann. "The current projections (of future cases) would be dwarfed."
Keywords: US; SF; CONFERENCES; AIDS; DRUGS; COST; JAMES MASON; NATIONAL AIDS UPDATE CONFERENCE; AZT
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