The state of California is establishing its own system to test and perhaps even approve new drugs to treat AIDS to circumvent what state officials say are frustrating delays caused by the federal Food and Drug Administration.
"As of yesterday morning, the state of California is in the business of testing drugs that hold promise for curing or treating AIDS, " California Attorney General John Van de Kamp said. He said the state's action "is a clear statement that, in the midst of a killer epidemic, business as usual in the drug-testing process just isn't good enough."
Van de Kamp said two bills passed Monday by the California legislature and signed by Gov. George Deukmejian (R) will allow the state to begin testing AIDS drugs in California as the FDA does nationally, but more quickly. Van de Kamp said he hoped drugs, such as some illegal compounds now being sought out in Mexico by patients with acquired immune deficiency syndrome, might begin to be tested in California by January.
There are an estimated 300,000 to 500,000 people infected with the AIDS virus in California, and about a quarter of the 40,000 Americans who now exhibit AIDS symptoms live in California.
Van de Kamp said that New York and other states have shown interest in establishing similar programs.
"This is a bold experiment that I hope will prove fruitful," said Dr. Marcus Conant, chairman of the California State Task Force on AIDS. He said that the state hopes to work with companies "in partnership, helping them out, rather than in the adversarial way used by the FDA."
FDA officials had no comment for the record, but unofficially said that the agency has approved 40 AIDS drugs for testing, many in record time. The problem is that it is difficult to test drugs properly and frustrating when they fail to meet expectations.
Some California officials and observers on Capitol Hill expressed reservations about the program. They said that there is a danger that the results will not meet FDA's standards, which would thwart national distribution.
One Capitol Hill observer said there is less problem with slowness than with the small number of AIDS patients who receive drugs in tests. The fault is not FDA's, he said. Pharmaceutical companies, he said, have been unable or unwilling to test larger numbers of patients than necessary to obtain statistically sound data.
California's program will establish drug tests in which many AIDS patients can participate.
Van de Kamp said the idea to have the state begin its own testing program was his. "I was dumbfounded to discover we had the power to do this," he said.
California will require tests for drug safety, proper dosage and effectiveness similar to tests required by the FDA.
Kenneth Kizer, director of the California Department of Health Services and the head of the board that will decide which drugs to test or approve, said that a 1939 California law enables the state to test and approve the intrastate marketing of drugs. California has tested some drugs not designed to treat AIDS to be used only within the state.
The new action authorizes the expenditure of $500,000 to hire a staff and consultants to set up human testing of AIDS drugs.
Kizer said he did not know whether testing in California would move faster than testing conducted under FDA auspices, and he said it remains to be seen whether it will be advantageous for companies to test drugs in California in addition to conducting FDA-approved tests.