University Daily Kansan / Thursday, October 10, 1991
5
FDA approves drug for AIDS treatment
The Associated Press
WASHINGTON — The Food and Drug Administration approved a second AIDS-fighting drug yesterday despite lingering questions about its safety and effectiveness.
AIDS activists hailed the approval of didanosine, or DDI, as a milestone in the effort to get new drugs from the laboratory to patients. But some scientists said the FDA had set a dangerous precedent in its drug-approval process.
The approval was based on less scientific data than normally required, but FDA Commissioner David Kessler said that had to be balanced against the needs of dying AIDS patients.
"It is the victims of this dreaded disease who are uppermost on our minds," Kessler said.
DDI was approved to treat AIDS patients who don't respond to or can't tolerate AZT, the only other fully approved anti-AIDS drug. Both drugs act similarly to slow progress of AIDS, but neither cure the disease and each can have serious side effects.
The drug was developed by the National Cancer Institute and has been licensed to Bristol-Myers Squibb Co. Bristol-Myers said it had two programs to help people with limited resources get the drug.
The AIDS Action Council, an activist group, said the FDA had "sensitively balanced a strict scientific standard against the needs of people with no treatments for a life-threatening illness."
But Dr. Deborah Cotton, a
researcher at Boston's Beth Israel Hospital and a member of the FDA's advisory committee that recommended approval of DDI in July, said the benefit of making the drug available "is not balanced by the real loss we've created in credibility by peeking into clinical trials not yet concluded."
"The precedent we've set is a bad one," said Cotton, who voted against approving DDI. "We will see more drugs approved on the basis of very little data and we will have less ability to know how to choose among them or to use them in combination."
In clinical trials DDI was shown to increase the number of white blood cells, called CD-4 cells. Those cells have been shown to be important to immune system function, which is weakened by AIDS.
"We know this drug, DDI, affects CD-4 counts, and we know survival is tied to CD-4 counts," Kessler said. "There is somewhat of a leap there, but patients are dying and we think that extrapolation makes a lot of sense and in patients' interests."
The FDA based its decision on early findings of clinical trials involving more than 2,500 AIDS patients and an expanded access program that made the drug available to more than 22,000 people at no charge.
Bristol-Myers said its factory price for a year's supply of the most common dose, 400 milligrams per day, would be $1.745. The price from retail pharmacies would be $1.990. Company officials based the price on a 14percent increase they said was typical for AZT.
Wendi Groves/KANSAN
Brent Owens of Topeka tosses back a small catfish at the Clinton Lake spillway. Owens, Janice Williams of Topeka, and his friends came yester day to Lawrence to fish and enjoy the nice weather.
Too small
DINESH D'SOUZA
MONDAY OCTOBER 14,1991 AT8:00 PM
The Politics Of Race and Sex on Campus
IN THE KANSAS UNION BALLROOM
ADMISSION $3.00 TICKETS AVAILABLE AT SUA BOX OFFICE
The lecture will be followed by a reception and booksigning in the association with the Mt. Oread Boodshop
CALL
843-3131
For the Best Prep