Responding to a crisis in access to its key drug, the Hoffmann-LaRoche Pharmaceutical Co. yesterday announced an unprecedented program to provide the experimental drug, ddC, free to thousands of people infected with the human immunodeficiency virus.
Two weeks ago the federal Food and Drug Administration, which approved the distribution, announced that ddC obtained through underground distributors was unreliable - some samples contained no active drug, while others had too much ddC. The agency advised AIDS groups to cease underground distribution.
Hoffmann-LaRoche, of Nutley, N.J., already provides didioxycipidine, or ddC, free to a small number of people who are unable to tolerate the other leading anti-HIV drug, AZT. But the benefits of AZT are enhanced when taken with ddC, recent studies show, and the majority of ddC users in the United States are taking the drug in combination with AZT. The government does not allow the combined use of the two drugs, following the testing guidelines designed by both the government and the company. This has forced, patients to turn to underground distributors for ddC. Application for approval of the drug is pending before federal regulators.
Yesterday Hoffmann-LaRoche announced two strategies. Within two weeks, some people will be able to get ddC free to take with AZT. These are the more seriously ill, who have immune systems that have been damaged so that the count of CD4 cells, which are crucial to the immune system, is less than 300. Their physicians will not be required to monitor the patients or deal with lots of paperwork, according to company spokesman Paul Oestreicher.
At some unspecified time in the future, the company also will initiate a second program, through which healthier individuals, with CD4 counts up to 500, will be allowed to obtain ddC to take with AZT.
"We anticipate at least five thousand to ten thousand people will take ddC through these programs," Oestreicher said. "We're trying to meet the needs in the community. There's a need for the drug out there now, before it has received FDA approval. And we're providing a bridge."
But the company's plans may not meet the AIDS community's needs, according to New York Buyers Group representative Derek Hodel.
"The first program does not pick up the majority of patients who are taking ddC [in combination with AZT]," Hodel said. He applauded the company's action in principle, but said the announcement comes months late and fails to guarantee quick access to ddC. He noted that the company's second program does not now exist.
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