Subject: Letters to the Editor: The Strange Case of Dr. Kessler
Date: Published: 5/19/92 (97 lines)
Source: Wall Street Journal. Copyright Dow Jones & Co. Inc.

    Letters to the Editor:
    The Strange Case of Dr. Kessler

    David Kessler's tenure as FDA commissioner began with high
 hopes.  He promised faster drug approval, responsiveness to
 people with life-threatening diseases, and a new vision.  What
 Dr. Kessler has delivered, however, is very different.
    Instead of faster drug approval, AIDS patients got a
 lethal 14-month delay in reviewing AZT/ddC combination
 therapy.  There were more stalls on cancer drugs and a
 stubborn impasse on THA for Alzheimer's patients.  Instead of
 new vision, the FDA returned to the consumer protectionism of
 the 1970s.  Instead of judicious reforms, Dr. Kessler gave us
 headline grabbing seizures of orange juice and spaghetti
 sauce.  The enforcement of FDA regulations for underground
 drugs for AIDS and Alzheimer's was shockingly discriminatory.
    Let's take a closer look:
    -- AIDS.  In December 1990, the San Francisco Consortium of
 AIDS Physicians and the American Foundation for AIDS Research
 (AMFAR) petitioned the new FDA commissioner.  Their petition
 asked for immediate review of two promising AIDS treatments,
 ddI and AZT/ddC combination therapy, and an approval decision
 by March 1, 1991.  As a sop to AIDS activists who supported
 Dr. Kessler, ddI was approved in October 1991, after a
 six-month delay.  AZT/ddC combination therapy was recommenced
 for approval early in April by the FDA Advisory Board, but
 actual approval languishes like a desert mirage in the
 distance.
    The superior efficacy of AZT/ddC combination therapy was
 evident at the time of the petition.  It promises a major AIDS
 treatment advance over AZT:  up to three years' added
 survival, compared with only one year's added survival with
 AZT alone.  Those additional years could enable thousands to
 live long enough to benefit from the next generation of
 treatments.  AZT/ddC should have been approved when the San
 Francisco Consortium and AMFAR asked.  It is now one year
 later.  The person who had the undeniable authority to avert
 that deadly and shameful year of delay was Commissioner
 Kessler.
    -- Cancer.  As bad as Dr. Kessler's record is on AIDS, it's
 worse on cancer.  Last summer he cracked down on promotion of
 cancer drugs for uses outside their labeled indications.  This
 was a very harmful decision.  More than half of all current
 cancer treatments involve off-label usage.  Doctors depend on
 pharmaceutical companies to educate them about off-label
 usage.  Without such continuing medical education paid for by
 the drug industry, doctors fall behind the state of the art.
 These considerations were lost on Dr. Kessler, for whom the
 bottom line is a headline, and the fastest route to the front
 page is an enforcement campaign.
    Who demanded Dr. Kessler's new enforcement campaign?  Not
 cancer patients -- they are alarmed about it.  The crackdown
 on off-label usage makes cancer doctors afraid to prescribe
 combinations of drugs that patients desperately need.
 Insurance companies are now refusing to reimburse.  Regulating
 off-label usage was not the administration's idea.  To the
 contrary, Vice President Dan Quayle's Council on
 Competitiveness opposes it as more regulation for
 regulation's sake.  Not even Congress has the stomach for
 dumping new regulatory burdens on cancer patients.
    The demand to regulate off-label usage came from the FDA's
 bureaucratic empire builders who found an eager champion in
 Dr. Kessler.
    -- Alzheimer's Disease.  Clinical trials in the U. S.,
 Sweden and Britain show that the drug THA improves about
 one-third of the Alzheimer patients who suffer this otherwise
 untreatable affliction.  THA also alleviates the suffering of
 their families.  This wasn't good enough for Dr. Kessler.  He
 chose instead to "protect" any patients who might experience
 minor, reversible liver malfunctions with THA. By keeping THA
 on import alert, Dr. Kessler is driving patients' families
 into the crime of smuggling.
    If George Bush wants credibility with AIDS and cancer
 patients and the families of Alzheimer's victims; if he wants
 business to believe his promise to cut regulatory burdens; if
 he expects the electorate to trust him with our health-care
 crisis, then he needs to acknowledge a mistake:  his
 appointment of Dr. Kessler.  Mr. Bush should then appoint a
 commissioner truly committed to rapid drug approval and with
 the courage to overhaul the FDA.  
    William Summers, M. D. 
    Alzheimer's Rights Alliance
    James Driscoll, Ph.D. 
    Vice President
    Direct Action for Treatment Access
    Beverly Zakarian
    President
    Cancer Patients Action Alliance
    Arcadia, Calif.

[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.]