Subject: Letters to the Editor:  Drugs, Data and Death
Date: Published: 10/6/88 72 lines
Source:  Wall Street Journal.  Copyright Dow Jones & Co. Inc. 

    Letters to the Editor:  
    Drugs, Data and Death

    Your editorial plea for an end to the stultifying Food and
 Drug Administration's policies ("Relief From Suffering,"
 Sept. 19) correctly focuses on the sacrosanct statistical
 criteria that ignore qualitative improvement to life and
 obscure survival benefits for important factions of patients
 with life-threatening illnesses.
    "Meta-analysis," the latest such rigid statistical
 gimmick, muddies the waters by lumping together, instead of
 splitting, various types of clinical trials in cancer and
 other diseases.  The pooled data include all trials whether
 poorly conceived with inadequate dosage or unstratified as to
 risk category.  For example, in 1985 meta-analysis arrived at
 a ridiculously low 4% to 8% survival benefit for combination
 chemotherapy of breast cancer and an only 8% to 10% for the
 anti-estrogen agent tamoxifen (Nolvadex).  The true benefits
 of optimum treatment in several designated-risk categories
 actually have been in the 12% to 38% range, representing
 increased survival for thousands of women.
    This statistical method resulted in the conservative
 recommendations of the National Institutes of Health
 Consensus Conference on Breast Cancer in 1985 denying
 lifesaving therapy for 35,000 new Stage II post-menopausal
 women and 70,000 Stage I node-negative women annually.  At
 stake were at least 10,000 to 15,000 lives a year in the U. S. 
 alone.
    This miscarriage of clinical therapeutics was suddenly
 reversed when the National Cancer Institute on May 21, 1988,
 issued an unprecedented, historic cancer "alert"
 simultaneously to 11,000 oncologists and the news media.  The
 obvious clinical benefits of tamoxifen and chemotherapy
 forced the NCI to bypass the FDA and even the New England
 Journal of Medicine.
    Perhaps this illustrates why the American Medical
 Association poll you cited indicated that physicians are more
 in favor (88%) of loosening up the FDA regulations than the
 general public (68%).  The public is still suffering from the
 bureaucratic overkill that followed the tragic thalidomide
 (deformed baby) crisis spawned in Europe in 1964.  It is
 noteworthy that thalidomide has been rereleased recently in
 Europe for clinical use in specific clinical indications.  The
 FDA's bureaucratic methods have driven most pharmaceutical
 companies to engage in new-drug development outside of the
 U. S. initially.
    Statisticians or bureaucrats should not be the final
 arbiters of clinical therapeutics.  Who but the practicing
 physician can determine which patients are likely to respond
 to therapy for life-threatening illness or which pre-terminal
 patient should be offered a careful and hopeful trial of a
 new investigative drug?  
    Extramural pressure must be maintained on the FDA, which
 has persistently resisted reform, cherished restrictions on
 new drugs, and arbitrarily relied on inappropriate
 statistical criteria even when dealing with life-threatening
 and often pre-terminal illnesses such as AIDS and cancer.
    Ezra M. Greenspan M. D. 
    Medical Director
    Chemotherapy Foundation
    Clinical Professor of Medicine (Oncology)
    Mount Sinai School of Medicine
    New York

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