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The AIDS activist group famous for confrontational protests will bring its crusade to the gates of the Harvard School of Public Health (SPH) today to speed up the release of a new anti-AIDS drug being tested at the school.
Members of the AIDS Coalition to Unleash Power (ACT UP) say the purpose of the demonstration is to bring attention to the urgent need of many AIDS patients for an alternative drug to AZT, currently the most common treatment.
Protesters will call on the pharmaceutical firm Bristol Myers to file an application with the Food and Drug Administration (FDA) for the approval of ddI, a drug currently in the second phase of clinical trials, ACT UP members say.
"There's feeling of consensus that the drug should be out there," said Michael L. Immel, an ACT UP member who sits on the community advisory board that helped design the ddI trials two years ago.
Immel said he expects more than 100 people to participate in the demonstration.
Although ddI is available to the several hundred participants in the clinical trials as well as another 12,000 in an additional expanded access program, there are many AIDS victims who need the drug, but do not have access to it, Immel said.
These people, who often suffer severe side effects from taking AZT, do not qualify for the ddI programs because they do not experience a sharp drop in their blood count, he said.
"For these people, ddI should be an option," he said.
Bristol Myers, which sponsors the ddI research, plans to file an application for FDA approval late this year or early next year, said company spokesperson Susan J. Yarin.
"The company is committed to bringing ddI to market as soon as possible," Yarin said.
Immel, however, said that the company is not working fast enough, because encouraging results from the first phase of the ddI trials have already been published.
And because some AIDS victims could benefit from the new drug, he added that the company should release it now, before it decides exactly how much better or worse ddI is than AZT and what the proper dosage of ddI should be.
ACT UP said in a prepared statement that inaddition to Bristol Myers, it will be pressuringboth the FDA, because the agency is the ultimatelicensor of ddI, and Harvard, because many ddIresearchers are University affiliates. "We callupon [them] to take an early look at the data fromtheir phase II clinical trials."
The FDA will make the review of the trial dataa top priority when Bristol Myers files forapproval of ddl, said FDA spokesperson Brad W.Stone.
"The purpose of the process is not to delayaccess to promising drugs, rather, it's todetermine what drugs out there are promising,"said Stone.
The SPH is not so much a target of the ACT UPdemonstration as a center of attention for thisissue, since the school conducts statistical anddata analysis for the federally funded AIDSClinical Trial Group, the ACT UP statement says.
Professor of Medicine Martin S. Hirsch, thedirector of the Harvard AIDS Clinical Trial Unitwhere the ddl research is performed, said theclinical trials are moving along as quickly aspossible, and ACT UP's protest should be directedat Bristol Myers and the FDA, not Harvard.
Hirsch said that the board that reviews thetrial data will present an analysis of the secondphase early next year.
The demonstration is timed to coincide with aconference on AIDS today at the SPH, which issponsored by the Harvard AIDS Institute
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