Subject: (Editorial): Who Gives Consent?  
Date: Published: 5/6/92 (121 lines)
Source: Wall Street Journal. Copyright Dow Jones & Co. Inc.

    REVIEW & OUTLOOK (Editorial):
    Who Gives Consent?  

    Polymathic FDA Commissioner David Kessler, who earned a
 law degree from the University of Chicago while attending
 medical school at Harvard, has now made himself America's
 leading authority on breast cancer.  This extraordinary
 achievement has been accomplished while also overseeing the
 nation's production of orange juice, directing drug
 development for Alzheimer's and AIDS, reshaping the financial
 structure of the biotechnology industry and, almost as a
 sidelight, revealing to neurosurgeons heretofore unknown
 problems in the methods they use to treat aneurysms.
    We draw your attention in the columns nearby to one of the
 most remarkable products of Dr. Kessler's energies at the
 Food and Drug Administration.  It is the scary consent form
 that breast-cancer patients must now sign before receiving an
 implant for breast reconstruction following mastectomy.  Read
 it to experience life as it is lived by those who must
 actually do business with the FDA mind-set.
    One paragraph of the consent form, raising the bizarre
 possibility that mastectomy patients may be running the risk
 of producing children with birth defects, may be altered.
 This will be the result of a hearing held last Friday by
 Congresswoman Marilyn Lloyd on what the FDA's virtual
 destruction of the breast-implant business means for women.
 Of the consent form itself, she said:  "There is no tangible
 evidence to link cancer, autoimmune disease or birth defects
 to implants.... I don't want to needlessly scare any
 woman."
    Rep. Lloyd's hearing was unprecedented.  Normally
 Representatives such as Ted Weiss, John Dingell or Henry
 Waxman rip the FDA Commissioner for not driving some therapy
 off the market.  And for once, real consumers spoke -- not the
 usual gaggle of Naderites, clients of contingency-fee lawyers
 and other tribunes of "consumer protection."
    In the world of intelligent adults, life is more
 complicated.  Peggy Funk, a marketing consultant from Los
 Angeles, described to Rep. Lloyd how she was diagnosed with
 breast cancer last November.  Ms. Funk didn't make her
 treatment decision lightly.  A key factor was the availability
 of implants to prevent permanent disfigurement.  Her surgeon
 walked her through all the risks, including those now cited
 by the FDA.  The agency "slammed the door on my course of
 treatment while I was effectively still lying on the
 operating table," she said.
    Rosemary Locke, who runs the YMe Breast Cancer Support
 Group, faced a similar call seven years ago.  If implants
 hadn't been available, she would have chosen a less radical
 treatment for her small lump.  But she opted for mastectomy.
 Because of the surgery, her doctors discovered what X-rays
 had missed:  Her cancer was more virulent and advanced than
 previously suspected.
    Breast implants, despite the impression left by coverage
 of this controversy, are not a post-operative afterthought.
 They're an integral consideration when women and their
 doctors plan their cancer-fighting strategies.  The way they
 approach that treatment decision has been completely
 transformed by the FDA's actions.  About 180,000 women will be
 diagnosed with breast cancer this year.
    Rep. Lloyd noted that "one of the frightening aspects of
 the FDA decisions is that we are going to run off our
 manufacturers, and indeed this is what has happened."  Two
 major implant-makers have already quit the business.  Rep. 
 Lloyd and her fellow patients worry that the two surviving
 firms will be discouraged from investing in product
 improvement.
    How could they not be after hearing Dr. Kessler describe
 to the committee his vision of a perfect world:  "The
 availability of silicone gel-filled breast implants for
 clinical studies will be divided into three phases."  Doctor
 and patient "must agree to abide by the conditions of the
 protocol approved by the FDA.  "  "Protocols are being developed
 ...by the manufacturers with the FDA ...seeking and
 receiving input from consumers and health professionals."  "We
 are working with HCFA" on insurance reimbursement.
    Dr. Scott Spear of Georgetown Hospital, speaking at the
 hearing on behalf of plastic surgeons, said that hundreds of
 lawsuits alleging harm from breast implants have been filed
 since the FDA's moratorium in January.  (Ads by
 contingency-fee lawyers trolling for clients appear regularly
 in newspapers.)  
    Dr. Spear said that among the infinity of afflictions that
 science has not proved implants innocent of causing, "the
 consent document singles out birth defects, more or less
 randomly."  Dr. Spear testified that by listing this
 "possibility," the FDA virtually assures that "some day,
 somewhere" a plaintiff will blame implants for causing birth
 defects.
    Of the consent form itself, Dr. Spear said:  "By forcing
 physicians to use this document with their patients, the FDA
 is dictating that inaccurate information be provided, which
 is actually a deviation from the accepted standards of care
 as related to informed consent."
    In the meantime, Peggy Funk's ordeal goes on.  In theory,
 her treatment can now proceed under special dispensation
 because she is what the FDA designates an "urgent need" case.
 But the FDA defines "urgent," as it does so many things,
 according to its own lights.  Her custom-fitted implant has
 been held up in a separate dispute over manufacturing
 practices between the FDA and McGhan Medical Corp., one of
 the rapidly shrinking universe of implant makers.
    No other federal agency more obviously needs radical
 reconstruction than the Food and Drug Administration.  It
 grinds everything it touches into endless complexity,
 condemning patients to wander through mindless labyrinths of
 the agency's devising.  We commend Congresswoman Lloyd's
 sustained effort to stand up to the FDA on behalf of women.
 We wonder why the many men of official Washington show no
 such courage or energy.

[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.]