Subject: (Editorial):  California to Test Drugs for AIDS
Date: Published: 10/5/87 90 lines
Source:  WALL STREET JOURNAL. Copyright Dow Jones & Co. Inc. 

    REVIEW & OUTLOOK (Editorial):  
    Rx:  Prop. 13

    Impatient with delays at the Food and Drug Administration,
 the state of California will now begin to test drugs
 manufactured in California for the treatment of AIDS. The
 state also believes it has the authority to license these
 drugs for sale in California.  At least two other states have
 talked to California officials about doing the same thing.
 And, according to individuals close to the new program, drug
 companies located outside California have been calling AIDS
 researchers in the state to see if means can be found to
 include their AIDS treatments in the new testing program.
    This is the beginning of the drug revolt.  It is happening
 in the same state that started the tax revolt with
 Proposition 13.  Up to now, defenders of the status quo have
 dismissed critics of the FDA as wishing to return to the days
 of laetrile and thalidomide or of wanting to subvert the
 Hippocratic oath.  These arguments are red herrings.  The real
 issue is whether the research and approval system created and
 financed by the federal government has over time come to put
 bureaucratic interests ahead of the imminent needs of
 desperately sick Americans.  The fastest way to get past the
 abstractions in the red-herring arguments is to ask a victim
 of AIDS, Alzheimer's or heart disease what he or she thinks
 of the status quo.
    California's action comes just as the FDA is about to
 announce a major reorganization of its drug-approval
 divisions.  This is a welcome recognition of a problem, but
 the agency has attempted to streamline the system before.
 Experience suggests that moving the bureaucratic boxes around
 won't solve the problem.  The ultimate solution at the federal
 level is to leave the issue of a drug's efficacy to the
 research community and its professional journals, letting the
 FDA stick to policing safety rather than trying to tell
 American doctors what drugs they should prescribe.
    Until now, no politician or public official has had the
 courage to challenge the federal drug-approval system.  It
 appears that the drug revolt has found its Howard Jarvis.  He
 is California Attorney General John Van de Kamp.  Mr. Van de
 Kamp, a Democrat, met with AIDS patients and advocates in
 May.  One group had filed a lawsuit against the FDA and the
 National Institutes of Health to speed the testing and
 approval process.  The attorney general asked his staff to
 investigate the possibility of testing and approving drugs
 independently in California.
    The resulting bill passed the state Senate 38-0.  Gov. 
 Deukmejian signed it last week.  A five-person committee will
 help the state's Department of Health Services select the
 drugs to be tested.  Dr. Marcus Conant, an AIDS investigator
 and member of the committee, says, "We're going into the
 process in collaboration with California companies and
 investigators to get answers as quickly as possible and to
 eliminate the bureaucratic adversity that has arisen with an
 agency like FDA.  "
    California's resources in this area are enormous.  There
 are at least 150 biotechnology companies located in the
 state.  Some, most prominently Genentech, are familiar with
 bureaucratic adversity and the FDA. But the state's program
 should also appeal to smaller companies for which the
 financial costs imposed by the FDA approval process are
 insurmountable.  A speedier, more patient-oriented system may
 also liberate ideas that now die inside the minds of
 researchers who have no desire to enter Washington's
 labyrinth of rules (the story of biotechnologist!Wary Strobel
 of Montana State University revealed the high price of
 challenging those regulatory disincentives).
    An official with a drug company working on AIDS told us
 last spring that if we really wanted to hear anger and
 frustration we should talk to AIDS doctors who have to tell
 their patients why the experimental drug they were supposed
 to start receiving is still under discussion by officials at
 NIH.  "These AIDS researchers have been conscripted to be part
 of steering committees," she said.  "We have committees
 reporting to committees reporting to committees."
    Such sentiments are now finding their recognition in
 California, just as that state was the first to rebel against
 overtaxation.  Once again California has taken the lead, with
 an important step toward a more humane reordering of this
 country's priorities in drug development.

[This article is made available here by Dow Jones Co. for the 
personal and non-commercial use of callers to this bbs, in the 
hope that it will be of some help to those who are suffering 
from the disease and others who are seeking to help them.]