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]]]]]]]]]]]]] 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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