Subject: FDA Orders Halt to Underground Sales Of DDC
Date: Published: 2/10/92 (81 lines)
Source: Wall Street Journal. Copyright Dow Jones & Co. Inc.

    FDA Orders Halt to Underground Sales
    Of Unauthorized Copy of Drug for AIDS
    ----
    By Marilyn Chase
    Staff Reporter of The Wall Street Journal

    The U. S. Food and Drug Administration called a halt to
 underground sales of a popular AIDS drug after agency tests
 found "potentially serious variations in product potency and
 quality."
    The drug, an unauthorized copy of Hoffman-La Roche Inc. 's
 DDC, was used by 8,000 to 10,000 AIDS patients unable to get
 the experimental compound through legitimate channels.
 Company-sponsored clinical tests and giveaway programs now
 supply more than 9,500 patients with the brand-name drug,
 which is awaiting FDA approval.
    The AIDS underground is a loose network of drugstores
 called buyers clubs that offer patients an array of herbs and
 experimental drugs at low cost.  The ersatz DDC, copied by
 cottage chemists using commodity lab supplies, sold for about
 $50 for several months' supply.
    But FDA samples of underground capsules found unreliable
 contents, ranging from no drug at all to twice the labeled
 amount, raising fears of underdosing or overdosing.  Too much
 DDC, an anti-viral drug, causes a painful neuropathy, or
 nerve damage, in the hands and feet.
    "Underground DDC is produced under poor manufacturing
 conditions {and} overall safety and purity of DDC is
 suspect," the FDA said late last week, after asking
 underground drugstores to cease DDC sales.  Previously, the
 regulatory agency had adopted a laissez-faire attitude, as
 long as underground entrepreneurs didn't engage in promotions
 or profiteering.
    Roche, however, alerted regulators after it said it
 learned of potency problems and possible toxic reactions to
 the copycat capsules.  A spokesman said Friday that the
 company "feels the FDA took appropriate action to protect
 public safety."
    About 18 underground drugstores nationwide are covered by
 last week's FDA directive.  Several already have indicated
 they will abide by the agency's request.
    "We're going to comply," said Derek Hodel, executive
 director of the PWA Health Group in New York City.  "But the
 question now is, what becomes of the 8,000 to 10,000 people
 on underground DDC?  "  Many such people failed to qualify for
 company-sponsored programs.  Others went to the underground to
 evade a company rule against taking DDC in tandem with
 Wellcome PLC's AZT, he noted.  Ironically, that combination
 regimen performed so well in clinical tests that Roche, a
 unit of Roche Holding Ltd.  of Switzerland, subsequently asked
 the FDA to approve it.
    Mr. Hodel said his group will press Roche to relax its
 controls over the giveaway program to embrace the
 disenfranchised underground consumers.  On Friday, a Roche
 spokesman didn't rule that out, but repeated the company's
 stand that the best way to serve patients' needs was by
 gaining swift market approval.
    "Even thinking optimistically, we're not going to see
 approval for several months," Mr. Hodel said.  Typically, an
 FDA advisory panel will weigh all the data for and against a
 drug, before giving a recommendation to the FDA commissioner.
 Such a hearing could come as early as April, though no date
 has been set.
    Despite widespread patient anxiety, at least one medical
 consumer advocate said the FDA did the right thing.
    Sidney M. Wolfe, head of the Public Citizen Health
 Research Group, and a frequent critic of the FDA, this time
 said the agency's action was "good."
    "They do the same thing to brand-name drugs," Dr. Wolfe
 said.  "If you look at drug recalls, a major reason is drug
 potency problems.  There's no reason the underground should be
 more protected {from FDA action} than brand-name drug
 companies."

[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
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