Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
Newsday - January 18, 1996
Laurie Garrett - Staff Writer
In an unusual publicity maneuver aimed at changing Food and Drug Administration policies on AIDS drug licensing, the U.S. and Swedish pharmaceutical giants Upjohn and Pharmacia released their results yesterday to AIDS activists and the news media.
At stake for the two drug companies is quick FDA approval of a new type of anti-HIV drug they've developed called delaviridine.
At the same time, the announcement aims to change the primary biological basis of current FDA licensing of HIV-targeted drugs. Now, the FDA decides whether to speed approval of drug sales based on short-term studies of the candidate drugs on so-called CD4 cells, key components of the human immune system. Typically, people infected with HIV experience a deterioration in their CD4 levels, and with that a collapse of their overall immune systems.
But there are plenty of exceptions, including people who have survived years with extremely low CD4 counts. Now Sweden's Pharmacia and Upjohn of Kalamazoo, Mich., have joined forces to argue that the efficacy of their drugs is best demonstrated not through CD4 cells but through direct measurement of the amount of HIV genetic material (RNA) present in patients' blood, as measured periodically for over a one-year period.
Dr. William Freimuth, who monitored the study for the companies, said it showed that "all patients that achieved a sustained reduction in viral burdens were less likely to progress to AIDS-defining events or death."
The blood test used by Freimuth's group was developed three years ago by Nobel laureate David Baltimore of the Massachusetts Institute of Technology. Last year Dr. David Ho, director of the Aaron Diamond AIDS Research Center in Manhattan, used the basic methodology to show that people infected with HIV manufacture more than a billion HIV viruses every day.
Pharmacia and Upjohn refused to provide the press with hard data that could be used to assess the validity of their claims, but AIDS activists who were shown the results yesterday in a private meeting were enthusiastic.
The FDA declined to comment on the Upjohn-Pharmacia announcement.
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