[Congressional Record Volume 140, Number 100 (Wednesday, July 27, 1994)]
[Extensions of Remarks]
[Page E]
From the Congressional Record Online through the Government Printing Office [www.gpo.gov]


[Congressional Record: July 27, 1994]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]

 
               THE FDA MUST PLACE PATIENTS ABOVE POLITICS

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                          HON. CHRISTOPHER COX

                             of california

                    in the house of representatives

                        Wednesday, July 27, 1994

  Mr. COX. Mr. Speaker, one of my constituents, Mr. Steve Coonan of 
Coonan Clinical Labs in Costa Mesa, CA, has been fighting the Food and 
Drug Administration for approval to market a kit that would allow 
individuals to test themselves for antibodies to the AIDS virus in the 
privacy of their own home.
  Despite the obvious health benefits of allowing such a product to 
come to market, the FDA has--for more than 5 years--effectively barred 
such HIV home test kits from the marketplace.
  I commend to my colleagues the following Forbes magazine article by 
the Manhattan Institute's Peter Huber, which discusses the broader 
implications of the FDA's murderously paternalistic behavior with 
respect to HIV home testing.
  Given that HIV infection is in some measure treatable and that the 
spread of the virus is certainly preventable, it's high time that the 
FDA remove the bureaucratic obstacles it has placed in the way of 
people who want to learn vitally important things about their own 
health.

                  [From Forbes magazine, Aug. 1, 1994]

                              Blood Tests

                            (By Peter Huber)

       To dramatize the gay artist's problems, Ron Athey sliced 
     into another man's back during a theater performance and 
     splattered blood everywhere. Whether or not federal taxpayers 
     should fund such shows, a performer almost certainly does 
     have a First Amendment right to draw a bit of blood in the 
     name of his art.
       It's equally clear why O.J. Simpson had to hand over to the 
     police blood and hair samples that could incriminate him. 
     Courts resolved long ago that compelling tests like these 
     does not violate the Fifth Amendment right against self-
     incrimination.
       Why then are we forbidden to test our own body fluids, at 
     our own expense, for no one's entertainment or edification 
     but our own? You didn't know you couldn't? Well, you can't. I 
     refer to the do-it-yourself blood test for antibodies to the 
     AIDS virus. This test has been effectively barred from the 
     market by the Food & Drug Administration for over five years.
       The stock objections are familiar and wholly unconvincing. 
     Learning by phone (after you send your home-test sample to a 
     lab) that you have been infected by the human 
     immunodeficiency virus may indeed be more of a shock than 
     learning face-to-face. But discovering a signature AIDS 
     lesion on your arm, or testing positive in a hospital after 
     you come down with strength-sapping pneumonia, or after 
     you've infected your best friend, is surely worse. Face-to-
     face counseling may indeed help when you're getting horrible 
     news. But HIV infection is in some measure treatable, and the 
     spread of the virus is certainly preventable, so developing 
     information as quickly and cheaply as possible must surely be 
     the paramount objective.
       The very thought that we should limit when and how people 
     learn vitally important things about their own health, just 
     because they might otherwise rush to the arms of Dr. 
     Kevorkian, seems murderously paternalistic. Sure, knowledge 
     has its perils. But not knowing is more dangerous. If free-
     speech rights protect Ron Athey's expressive blood, they 
     ought certainly protect occasions where free speech could 
     save lives immediately.
       Quite apart from the pragmatic calculus of saving lives, 
     there's a much larger principle at stake. Home medical test 
     kits provide information, no more. They trigger a dialogue 
     between the willing testee and a willing lab technician at 
     the other end of a phone line. If we didn't live in such 
     statist times, and weren't so preoccupied by virtuosi like 
     Athey, state attempts to bar such dialogue would shock anyone 
     even vaguely interested in civil liberty.
       But principle doesn't seem to matter much when political 
     constituencies are weak, and they are here. The communities 
     most vulnerable to HIV infection have long been ambivalent 
     about testing. They fear (correctly, no doubt) that 
     information in the wrong hands promotes paranoid 
     discrimination. Meanwhile, David Kessler's FDA is popular in 
     liberal circles, and many ``liberals'' suddenly turn big-
     brotherish when the cause of individual freedom is served by 
     big business operating at a profit. So the HIV home-test kit 
     stays off the market.
       If the FDA tried to outlaw, or even drag its bureaucratic 
     feet on, a home fertility or pregnancy test, women's rights 
     groups would see to it that Kessler was fired. Pregnancy can 
     be tremendously upsetting; when the blue stick turns pink, 
     some women's thoughts might turn to Kevorkian. Too bad; a 
     woman's right to find out conveniently, and privately, far 
     outweighs her rights to be protected from the hazards of 
     knowing. Government officials can undoubtedly see to it that 
     tests perform as promised, just as doctors and hospitals are 
     licensed to deliver effective therapy, not snake oil. But 
     barring reliable diagnostic information because it might 
     badly frighten someone is unconscionable in a free society. 
     One might equally well ban confessionals, because discussions 
     of the hereafter are sometimes pretty grim.
       As HIV home-test kits sink unnoticed into viscous 
     Washington bureaucracies, where are the people who so 
     vigorously defend the teenager's constitutional right not 
     only to discuss abortion with her doctor but to act on the 
     discussion? A ``right to privacy'' that covers a curette in 
     the uterus but not a needle in the thumb is no right at all.
       The only way to find out which kind of principle we're 
     dealing with--a constitutional one or a raw political one--is 
     to go to the Supreme Court and ask. No big drug company is 
     going to risk the FDA's enduring wrath by carrying home-
     testing to the Supreme Court. But others can and should. An 
     individual hemophiliac, for example, would surely have legal 
     standing to do so. At stake here is your right to attend to 
     your own health, on your own time, in the privacy of your own 
     home, when David Kessler can't make a house call to look 
     after you.

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