Subject: AIDS Patient Advocates Ready For Hearing on Drug Development Suit
Date: Published: 12/11/87 116 lines
Source:  WALL STREET JOURNAL. Copyright Dow Jones & Co. Inc. 

    AIDS Patient Advocates, U. S. Square Off
    For Hearing on Drug Development Suit
    ---
    By Marilyn Chase
    Staff Reporter of The Wall Street Journal

    AIDS patient advocates and government attorneys are
 squaring off for a hearing in federal court next week on a
 lawsuit challenging the government's handling of drug
 development against acquired immune deficiency syndrome.
    The lawsuit, filed earlier this year by National Gay
 Rights Advocates, a public interest law firm specializing in
 homosexual-rights cases, is styled as a class action by
 patients who have AIDS along with some who have earlier
 stages of the viral infection.
    The complaint criticizes the Department of Health and
 Human Services as too slow to approve experimental drugs for
 the fatal viral disease, which so far has stricken 48,139
 Americans and killed 27,235 of them.
    The government estimates an additional 1.5 million
 Americans may carry the virus without symptoms, an estimate
 now being tested nationwide in an anonymous, hospital-based
 blood sampling program.
    The suit further alleges that the Food and Drug
 Administration, which swiftly approved the drug AZT for AIDS,
 acted "arbitrarily and capriciously" to delay or withhold
 other drugs from patients.  AZT, manufactured by
 Burroughs-Wellcome Co., a unit of Wellcome PLC of Britain,
 was approved in March after it was proven to prolong the life
 of patients with AIDS and severe AIDS-related complex, a
 precursor condition.
    A major focus of the complaint is the stalled status of
 the drug ribavirin, made by ICN Pharmaceuticals Inc. of Costa
 Mesa, Calif.  Ribavirin's makers contend it can delay the
 progression from AIDS-related complex to AIDS, and it has a
 devoted following among patients who purchase the drug in
 Mexico.  As previously reported, the FDA refused to approve
 ribavirin after it was disclosed that tests were biased in
 favor of the drug.  Studies are continuing.
    The suit charges that the government's sluggish pace
 deprives patients of their constitutional rights, and asks
 that the department and its units be ordered to publish rules
 providing for swifter handling of drugs.
    Attorneys for the government have denied the suit has
 merit and filed a response that characterized plaintiffs'
 demands as "preposterous."  The hearing, set for Wednesday in
 U. S. District Court in Washington, D. C., comes on a motion by
 government attorneys to dismiss the suit.
    Another focus of the complaint is the allegation that
 AZT's swift approval resulted from FDA favoritism because of
 a $50,000 grant from Burroughs-Wellcome to the National
 Cancer Institute Laboratory of AIDS researcher Samuel Broder.
 The grant was used to fund the position of a postdoctoral
 fellow, Makoto Matsukura, and it came just as the FDA granted
 "orphan drug" status to Wellcome for AZT. National Gay Rights
 Advocates attorney Leonard Graff said this constitutes
 conflict of interest.
    The National Cancer Institute Laboratory is a unit of the
 National Institutes of Health.
    Orphan drug status gives a company certain tax breaks and
 guarantees of a period of exclusivity along with other
 benefits in exchange for developing a drug for a rare
 disease.
    In its court filing, government attorneys replied that
 such grants, far from being prohibited, are encouraged by the
 federal Technology Transfer Act, which states, in part, that
 government laboratories may "accept, retain and use funds,
 personnel, services and property from collaborating parties
 and provide personnel, services and property to collaborating
 parties."
    The "FDA didn't know of the status of my fellow," Dr. 
 Broder said.  "AZT wasn't approved because of some inside
 track but because it prolonged life.  Because it worked.
 Period."
    NIH researchers, while permitted to secure such lab
 operating grants from corporate collaborators, are prohibited
 from taking personal payment from any companies with whom
 they collaborate.
    Such isn't the case in academia, however.  Many university
 scientists accept consultant's fees from the companies whose
 drugs they are testing.  Such relationships, regulated only by
 local university disclosure rules, raise broader questions of
 potential conflicts of interest.
    Jerome Groopman, an AIDS physician-researcher who has
 tested AZT and other drugs at Boston's New England Deaconess
 Hospital, also works as a consultant for Genetics Institute
 Inc. 
    "Frankly, no one can sustain the costs of this work (AIDS
 research) on federal funds alone," he said.  "That's why the
 marriage between academia and industry is such a good one."
 Whether conflicts arise, he said, "depends on what vows you
 make at the altar."
    Given the sometimes adversarial relationship between the
 FDA and NIH, he added that the scenario depicted in the suit
 reflects "a Rube Goldberg vision of cause-and-effect," he
 said.
    One prominent ribavirin researcher, Peter Mansell, of the
 University of Texas M. D. Anderson Hospital in Houston,
 acknowledged he has received consultant's fees from ICN
 Pharmaceutical.  But Dr. Mansell, director of Houston's
 now-closed Institute for Immunological Disorders, took
 umbrage at a reporter's questions about such public-private
 sector relationships.  "Frankly," he said, "I don't think it's
 any business of yours."
    National Gay Rights Advocates said it hadn't received any
 funding support from ICN or its executives.

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hope that it will be of some help to those who are suffering 
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