Panel Would Speed Drugs to Market : Medicine: Presidential advisers urge sweeping changes. ‘Time is running out’ for AIDS, cancer patients, they note.

A presidential advisory panel Wednesday recommended sweeping changes to speed the delivery of new drugs to cancer and AIDS patients--revisions that go beyond those that already have occurred in response to the AIDS epidemic.

“For cancer and AIDS patients, time is running out,” said the report by a special committee that is part of the President’s Cancer Panel, which is headed by Armand Hammer. “Regulatory personnel . . . must adapt to these new needs and take a positive attitude toward such innovation.”

Hammer, chairman and chief executive officer of Occidental Petroleum Corp., presented the report to President Bush at a White House meeting Wednesday morning. The committee began its work in 1988 at the request of then Vice President George Bush, who was also chairman of the presidential task force on regulatory relief.

Pressure from AIDS activists has been largely responsible for a dramatic change in recent years in the philosophy governing the study of experimental drugs for life-threatening diseases. The change has brought an increasing willingness to make such drugs more quickly accessible to the desperately ill, even before critical scientific questions have been answered.

“In my entire medical career, I’ve never found any patient advocacy group as effective” as the AIDS activists, said Dr. Louis Lasagna, dean of the Sackler School of Graduate Biomedical Sciences of Tufts University, who is chairman of the special committee. “They are smart. They are willing to be obnoxious. And they are adept at playing the political circuit.”

As a result, “there has already been a big improvement” in the drug approval process, but much more needs to be done, he said.

It takes an average of seven years for a typical drug to make its way through the approval process from the earliest studies to market approval. In recent years, in part because of the climate created by AIDS, the process has been shortened, but critics say not nearly enough.

“The sick need neither hostility nor the bogging down in the quagmire of micromanagement,” Lasagna said.

The committee recommended that a permanent policy and oversight committee be established by the secretary of health and human services to monitor the work of the FDA.

“This committee should not have just the function of monitoring and prodding the FDA, but also of fighting for it when it is attacked from other quarters for doing the right thing,” Lasagna said.

Further, the committee said that a national policy should be adopted “to foster the development of new drugs” for these diseases. No improvements in the process “will come up with the drugs we so desperately need” if there aren’t any candidate drugs to “deliver the goods,” Lasagna said.

The committee suggested new ways to further accelerate drug review. It proposed that the criteria for judging the effectiveness of a new drug be modified to include earlier so-called “endpoints.”

For example, proof of prolonged survival has been the main endpoint currently used in many studies to assess whether a drug is having an impact. The committee suggested that others be used, such as tumor shrinkage in more than 20% to 30% of cancer patients in a study, or an increase in an AIDS patient’s T4 helper cells, the immune system cells that are the primary target of the human immunodeficiency virus.

The committee proposed also that at least one preapproval study phase be eliminated--the phase that compares the experimental drug to drugs already on the market. “Such studies should be delayed until the marketing phase of drug development,” the committee said.

The committee recommended also that:

Congress “give prompt attention to the inadequate resources, staff and facilities of the FDA.”

Medicare, Medicaid and private insurers “give identical coverage” for experimental drugs and “all ancillary medical care for cancer and AIDS patients” and that the coverage should not vary from region to region or carrier to carrier.

Drug sponsors have the option of paying the FDA for outside review of new drug applications by “qualified experts with no conflict of interest.”

The FDA increase its flexibility by relying more frequently on the opinions of qualified experts who serve on its advisory committees.

There be more “informal, free, open interactive communication” between the FDA and drug sponsors, such as drug companies.

The panel’s official name is the National Committee to Review Current Procedures for Approval of New Drugs for Cancer and AIDS.