SACRAMENTO — California would begin its own program of testing experimental drugs on AIDS patients without waiting for approval by the federal government under an emergency bill proposed Monday by state Atty. Gen. John Van de Kamp and a broad coalition of legislative leaders.
Drug tests on the first of thousands of volunteers who have AIDS or who have tested positive for the AIDS virus could start before the end of the year under the measure by Assemblyman William J. Filante (R-Greenbrae), which quickly won preliminary approval at its first committee hearing Monday.
In a separate legislative attempt to deal with the acquired immune deficiency syndrome epidemic, the Senate passed and sent to Gov. George Deukmejian a controversial bill that would require school districts to give AIDS prevention education to junior and senior high school students.
The Deukmejian Administration has threatened a veto of the AIDS education measure by Sen. Gary K. Hart (D-Santa Barbara). Many Republican members of the Assembly oppose the bill, contending that it would give students a "how-to lesson in homosexual sex."
Van de Kamp argued that the AIDS drug testing program is needed because the federal Food and Drug Administration is not moving quickly enough in authorizing testing of experimental drugs to combat the disease.
"This bill is the state of California's announcement that, in the face of an extraordinary medical emergency, business as usual is not enough," Van de Kamp told reporters, adding that the proposal will "echo like a thunderbolt . . . in the corridors of the federal medical bureaucracy."
The bill could assist California pharmaceutical manufacturers by giving them an alternative to obtaining FDA approval for experiments in humans. It could also offer a sliver of hope to many AIDS patients in the state, some of whom are seeking alternate cures by crossing the border into Mexico.
Filante said he hopes to put the bill on the governor's desk before the Legislature adjourns at the end of next week. It was approved in concept late Monday by the Senate Appropriations Committee but was placed on the suspense file, where it must compete with other bills for limited state revenues.
Greatly enhancing the bill's chance of success, it attracted a wide array of influential supporters, including Assembly Speaker Willie Brown (D-San Francisco), Senate President Pro Tem David A. Roberti (D-Los Angeles), Assembly Republican Leader Pat Nolan of Glendale and Senate GOP Caucus Chairman John Doolittle of Rocklin, the conservative author of legislation to greatly expand blood testing for the AIDS virus.
In Washington, a spokesman for the FDA rejected criticism that the agency has moved too slowly to permit AIDS drug testing. The agency has no applications to conduct tests that it has not acted on, he said.
"The reality is that we have been very quick on all these products," said FDA spokesman Bill Grigg. "In many cases, we have been ready to approve things for testing before the companies have been ready (to test them)."
The FDA, he noted, hurried to approve the drug AZT for treatment of AIDS patients once it was shown by tests in humans to be effective in treating the disease.
'Everybody Is Frustrated'
Neil Schramm, former chairman of the Los Angeles City-County AIDS task force, cautioned that it may not be possible to produce a vaccine or a cure any faster even if California establishes its own alternate testing procedures.
"Everybody is frustrated by the slowness of research, but unfortunately that is part of the problem with quality research," Schramm said. "No amount of rushing things can make good research happen faster."
Under a state law enacted in 1939 and modified in subsequent years, California has the legal authority to test drugs manufactured and distributed solely within the state. The federal government has jurisdiction over drugs sold across state lines but does not have authority over drugs manufactured and dispensed within the same state, according to backers of the bill.
The state is supervising the testing of at least a dozen experimental drugs, including two monoclonal antibodies used in cancer research and 10 radio-pharmaceuticals used in X-ray diagnoses, state officials said.
Van de Kamp's proposal could be of substantial benefit to California drug companies because it could pave the way for millions of dollars in state research grants and could provide an alternative to FDA testing procedures.
Support From Company
One company in particular, ICN Pharmaceuticals of Costa Mesa, is supporting the measure after failing to win FDA approval of the drug ribavirin, which the firm claims is effective against AIDS. After evaluating tests conducted on the drug, the FDA found that there was no evidence to prove that it is effective and questioned procedures used by the researchers for selecting test subjects.