Subject: FDA Approves Roche's DDC, For AIDS Treatment With AZT 
Date: Published: 6/23/92 (89 lines)
Source: Wall Street Journal. Copyright Dow Jones & Co. Inc.

    Technology & Medicine:
    FDA Approves Roche's DDC,
    For AIDS Treatment With AZT
    ----
    By Marilyn Chase
    Staff Reporter of The Wall Street Journal

    The Food and Drug Administration approved the sale of
 Hoffmann-La Roche Inc. 's drug Hivid, or DDC, for the
 treatment of AIDS, when used in combination with the drug
 AZT.  
    It is the first drug sanctioned under the FDA's
 accelerated approval process, as well as an official
 vindication of combination antiviral therapy against human
 immunodeficiency virus -- which experts long anticipated
 would emerge as a major strategy.
    The regulatory green light makes DDC the third antiviral
 drug cleared for use in the epidemic, giving an added
 treatment option for patients who haven't fared well on
 standard therapy.  DDC follows the approval of Burroughs
 Wellcome Co. 's AZT in 1987, and Bristol-Myers Squibb Co. 's
 DDI in 1991.  Roche, based in Nutley, N. J., is the U. S. unit
 of Swiss-based Roche Holding Ltd.
    Roche set a price of $1,826 a year wholesale, placing it
 in the same league as Bristol's DDI, priced last fall at
 $1,745.  AZT, after two price cuts, now sells for about $2,200
 to $2,600 a year.  The price of the AZT-DDC combination
 regimen is expected to top $3,400 a year.
    While AIDS activists weren't surprised by Roche's pricing,
 they warned DDC's pricetag will inevitably be compared with
 the $480 to $600 a year pricetag of a bootleg version of DDC,
 which activists estimated was consumed by as many as 10,000
 patients at the height of a flourishing underground a year
 ago.
    "Everyone expected they'd peg their price to DDI," said
 activist Martin Delaney of Project Inform.  "The problem is a
 lot of people were getting it more cheaply.  You can't really
 compare the two prices because the underground suppliers
 didn't pay to conduct clinical trials.  But that's how people
 will feel."
    "The knockoff might be less expensive, but no one knows
 what's in those tablets," a Roche spokesman responded.  "Our
 quality is assured."  The spokesman said Roche's price also
 reflects the cost of a drug giveaway to thousands during
 DDC's testing period, and he added the company will assist
 indigent patients in obtaining the drug.
    The bootleg product suffered variations in purity and
 potency leading FDA to call for a halt in underground sales.
 Despite that, underground markets persisted because, Mr. 
 Delaney said, strictures on DDC's corporate giveaway left
 some patients without the drug.  But now that DDC is widely
 available, Mr. Delaney speculated that demand for bootleg DDC
 may fade.
    Many scientists and consumer advocates said the real news
 in DDC's approval is the endorsement by the FDA of
 combination antiviral therapy.  AZT and DDC, members of the
 same family of drugs, both insert false building blocks of
 DNA to halt replication of the AIDS virus.  However, tests
 showed their combined use brought much higher, and
 longer-lasting peaks in the number of disease-fighting immune
 cells than either AZT or DDC alone.
    "This is a milestone in terms of how drugs of this class
 can be combined," said Whaijen Soo, Bristol's assistant vice
 president and senior director of virology and AIDS research.
 "The next step is to move beyond" drugs like AZT and DDC.  
    However DDC itself isn't through with regulatory scrutiny.
 FDA Commissioner David Kessler said in a news conference that
 DDC's early approval was based on two small studies that
 looked at immunecell levels.
    The results of continuing tests, expected in six to 12
 months, will tell whether more practical clinical benefits --
 such as fewer infections or longer survival -- confirm the
 trends in immune cells.  However, if such studies fail to
 confirm DDC's benefits, the agency can withdraw approval.
    "I'm saying, upfront, we may be wrong," Dr. Kessler said.
 "In some ways, we're pushing the limits of the drug approval
 process ...But the riskiest thing we can do when it comes
 to AIDS is to be unwilling to take any risks."
    ---
    Walt Bogdanich contributed to this article.

[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.]