Subject: FDA Is Testing Popular Substitute Of AIDS Drug 
Date: Published: 1/30/92 (73 lines)
Source: Wall Street Journal. Copyright Dow Jones & Co. Inc.

    Technology & Medicine:
    FDA Is Testing
    Popular Substitute
    Of AIDS Drug
    ----
    By Marilyn Chase
    Staff Reporter of The Wall Street Journal

    SAN FRANCISCO -- After reports of potency and safety
 problems, the U. S. Food and Drug Administration is testing
 samples of a popular bootleg AIDS drug from underground AIDS
 drugstores here and in three other cities.
    The drug is a cheap knockoff of DDC, an antiviral drug
 being developed by Hoffmann-La Roche Inc., Nutley, N. J. 
 Hoffmann is the U. S. unit of Roche Holding Ltd.  of
 Switzerland.
    In Rockville, Md., an FDA spokesman stressed that the
 actions didn't constitute a seizure or raid.  The spokesman
 said the agency asked the underground drugstores, or buyers'
 clubs, to provide the drugs voluntarily on Friday after
 "serious" public safety questions had arisen.
    The underground buyers' clubs, which offer an array of
 low-cost vitamins and experimental treatments to AIDS
 patients, have been selling the knockoff version to a market
 of more than 10,000 people.  The buyers' clubs, which sell
 drugs not yet approved as safe and effective, have so far
 operated in a gray area.  While not specifically sanctioned by
 U. S. regulators, they so far have been allowed to operate as
 long as they present no threat to public health.
    Hoffmann-La Roche says cases of accidental overdosing with
 the knockoff drug have cropped up in the past six months.
 "We've received calls from physicians and patients reporting
 serious adverse reactions to the underground drug," said a
 company spokesman.  "Most {cases} appear to be what one would
 expect from taking too much DDC.  There was some neuropathy
 and at least one case ended up in the hospital."  Neuropathy
 -- DDC's main side effect -- refers to pain, tingling and
 numbness in the hands and feet caused by nerve damage.
    The company said "concerned physicians" sent Hoffmann some
 underground samples of the knockoff drug.  Company spot checks
 of the samples disclosed erratic potency levels that could
 explain cases of accidental overdosing among AIDS patients
 using the knockoff drug.
    However, Hoffmann declined to comment on rumors that the
 potency of the underground drug swung wildly, from as low as
 half of normal strength to as high as three times stronger
 than the Hoffmann-La Roche product.
    In San Francisco, one buyers' club voluntarily halted
 sales until results of the FDA's tests are known.  Richard
 Copeland of the Healing Alternatives Foundation said the club
 had cooperated with FDA agents and had given them samples of
 the drug to test.  He wouldn't elaborate.
    In New York City, another buyers' club was skeptical of
 the potency problems.  "We'd be as concerned for public safety
 as the agency if the problems were credible," said Derek
 Hodel of the PWA Health Group.  But he said he doubted the
 problems were real, based on the club's own safety testing.
 And he added, "Roche has been very vague" about its sources
 of the underground samples.
    DDC was recently shown to be less effective than its
 chemical cousin, Wellcome PLC's AZT, in a head-to-head study
 of the two as first-line treatments for patients with AIDS
 and AIDS-related complex.  Roche is seeking FDA approval to
 market the drug as a second-line therapy for people who can't
 tolerate or who don't benefit from AZT.  

[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.]