]]]]]]]]]]]]]    WHY YOU CAN'T TAKE AN AIDS TEST       [[[[[[[[[[ 
                   IN THE PRIVACY OF YOUR HOME        (1/18/1989)
                     By Elliott J. Millenson

[Mr Millenson is a management consultant  based in Rockville,Md.]
    From The Wall Street Journal, 17 January 1989, p. A20:3

             [Kindly uploaded by Freeman 10602PANC]

   Two years  ago, I  formed University  Hospital Laboratories to
develop a home  AIDS test.  Although  the company recently ceased
operations, its failure was due not to problems with the product,
but  rather  to  lack  of   progress  with  the  Foods  and  Drug
Administration.
   In  December 1987,  after  completing product  development and
testing,  we submitted  a  marketing-approval application  to the
FDA.  We cited successful clinical trials, compelling research on
the public health benefits of home testing, and detailed findings
in  such key  areas as  counseling  and confirmation  of positive
results.
   My  company's home  AIDS test  differed from  traditional home
tests, such as home pregnancy tests,  in that it allowed users to
take a blood sample  and then send the  sample anonymously to our
laboratory.  Our company would test specimens using the identical
method that doctors and hospitals use -- the ELISA screening test
and Western  Blot confirmation according  to the  protocol of the
American Association of  Blood Banks.  The  test user would phone
an 800  number and identify  himself by  the coded identification
number provided  in the  kit.  Results,  counseling and follow-up
referrals would be  provided over the  telephone by our company's
medical staff trained in AIDS counseling, crisis intervention and
telephone counseling.
   (We did  not feel  that rapid  screening methods,  such as the
recently  FDA-approved   Cambridge  BioScience   test,  would  be
appropriate for home use, because we wanted to guarantee that all
users received counseling and education,  and that there would be
the lowest possible level of false positives.)
   By statute, Congress has given the FDA 45 days to confirm that
a marketing  application is  complete and  acceptable for filing.
Once the FDA  has made that  confirmation, it then  has up to 180
days to consider the application on its merits.
   Last March, 91  days after our  application was submitted, the
FDA informed  us that it  was refusing to  accept our application
for filing and  would not undertake  the full substantive review.
In his March  letter, Paul Parkman, director  of the FDA's Center
for  Biologics Evaluation  and  Research, explained  the agency's
decision by  stating that it  sought ``the advice  and counsel of
various  advisory   groups  and   interested  parties.''    As  a
consequence of those  discussions, the FDA  had concluded that it
would review applications only for  those AIDS test products that
were ``for  professional use  only within  a comprehensive health
care environment,'' and provided for  the collection of the blood
sample by ``one who  is recognized by a  state or local authority
to perform such procedures.''  Translation:  no FDA review of any
home AIDS test applications.
   While  the FDA  would not  review  any such  applications, the
agency did say in March that  it planned to ``seek further public
comment'' so that it could develop a policy on home AIDS testing.
In  early September,  responding to  a July  inquiry I  made, FDA
Commissioner Frank Young wrote me  and reiterated that the agency
``intends to hold a public meeting  in the near future to provide
an opportunity for all interested  parties to express their views
[which will be] considered in the development of policy. ...''
   The FDA continues to maintain that hearings will be held soon,
even as  a study  conducted in  mid-1987 for  University Hospital
Laboratories concurrent with the clinical trials showed that more
than 30%  of respondents  said that the  only way  they would get
tested  for  AIDS  would be  via  a  home test  like  the  one we
developed, due to a desire for anonymity.
   The FDA's  unwillingness to  study the  evidence on  home AIDS
tests  apparently  is  mostly  due  to  pressure  form  some AIDS
activist groups.   These groups oppose  the sort of  home test my
company developed, even though it provides identical results to a
test given in a medical  environment, contending it is impossible
to provide AIDS counseling and support over the telephone.
   There are  many examples  of the  successful use  of telephone
counseling  in  crisis  intervention,  drug  counseling,  suicide
prevention  and  poison control.   Additionally,  many physicians
already routinely provide laboratory test results, including AIDS
test results and counseling, by telephone.
   Out home AIDS  test assured that  education and counseling are
always provided with test results -- something that is not always
the  case  with current  AIDS  tests.  Some  people  receive test
results by mail,  while others receive  results face-to-face with
no explanation as to their  meaning.  The Journal of the American
Medical Association reported in early 1988  on a study in which a
significant number of  patients did not  receive counseling or an
explanation of AIDS test results.
   Many people are reluctant to  get tested for AIDS because they
fear test results will  not be kept confidential.  Embarrassment,
waits of up  to three months  to be tested  or mandatory pre-test
group  counseling  at  some  clinics  discourages  others.   As a
result,  they  may  be  spreading  the  AIDS  virus  unknowingly.
Patients  are  not alone  in  their fear.   Some  physicians will
provide tests only when forms  are signed releasing them from any
liability if  test results  are revealed.   But a  home AIDS test
using a  coded identification number  can be  taken privately and
anonymously, eliminating these objections.
   Since December 1987, when  we submitted our marketing-approval
application, more that  30,000 new cases  of full-blown AIDS have
been reported in the U.S.  Recently the General Accounting Office
studied the  government's AIDS  education efforts  and criticized
its  ``slow implementation  of  key activities.''   This prompted
Barbara Boxer  (D., Calif.), head  of the  House Budget Committee
AIDS Task  Force, to  call the  government's program  a ``how not
to'' guide  to the  implementation of  public education programs.
Home  AIDS  tests could  provide  an alternative  source  of AIDS
education and counseling  -- as well  as testing --  for the many
people who might not otherwise receive these services.
   The FDA should treat home AIDS  tests like it treats any other
proposed test  -- review the  evidence from  research studies and
then reach a decision based on the scientific evidence presented.
The  FDA's   ``just  say  no''   policy  on   the  acceptance  of
applications establishes a guideline that is not only bad for the
nation's  public health  but is  a bad  precedent for  science as
well.  With  it, the  agency charged  with reviewing  data before
granting approval  for the marketing  of any new  drug or medical
test has indicated that it doesn't need to study medical evidence
before reaching a decision.
   Nothing  is  more  vital  in  business  than  the  ability  to
distinguish  between  the possible  and  the likely  and  then to
adequately assess  resources, risk  and reward.   Success demands
the ability to  rise dispassionately above  the landscape, like a
helicopter  over  a  congested highway,  and  determine  the best
course.  My company's course  was set in the  belief that the FDA
would put science before politics.  We were wrong.

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