ETHI: Johns Hopkins and Oncormed

[Hans Goerl <GENETHICS@delphi.com>]

The following are excerpts from a recent news release, which was run in many
newspapers in the US.

********************************************
Headline:
              ONCORMED ANNOUNCES CLINICAL VALIDATION STUDY
             OF BREAKTHROUGH BLADDER CANCER DIAGNOSTIC TEST

    OncorMed, Inc.  announced today that it is beginning a clinical
validation study in conjunction with The Johns Hopkins University School of
Medicine of a new test that could dramatically improve the way bladder
cancer is diagnosed and treated.     The new test uses urine samples to
detect bladder cancer.......The new test, which was shown to be 95% accurate
in a small pilot study of patients with suspicious bladder lesions, is
noninvasive and could prove to be much less expensive than cytology.     The
validation study is being directed by an independent physician, Dr. Mark
Schoenberg, Assistant Professor of Urology at the Brady Urological Institute
of Johns Hopkins Hospital.  The study is designed to verify the test's
accuracy and clinical usefulness on a large group of patients.  The test
analyzes DNA from cells present in the urine to spot genetic alterations
that are indicative of bladder cancer.  This technology may also be
developed into diagnostic tests for other types of cancer in the
future.......

An estimated 50,000 new cases of bladder cancer are diagnosed each year in
the United States.  It is more common in people who smoke or are exposed to
certain chemicals in the workplace.  The test could potentially be used for
routine evaluation of people with blood in their urine, smokers and
individuals exposed to certain carcinogens on the job, as well as people
with prior tumors. ***********************************************


Conspicuously absent from this release (and of course from most newspaper
articles running the story) is any mention of the intimate financial
relationship between Johns Hopkins, Oncormed and its parent, Oncor. As
stated in a footnote to the research article in SCIENCE magazine, (February
2, 1996, page 662) reporting on the new test, both Johns Hopkins and Dr.
David Sidransky (a Johns Hopkins professor) hold substantial stock in Oncor.
In addition, Johns Hopkins and Dr. Sidransky are entitled to royalties on
sales of the test in question.

The question, then, is, of all the universities in the world capable of
doing "independent" confirmations of this test's accuracy, why did Oncor
select Johns Hopkins? And why did Johns Hopkins, an institution of great
repute, accept this assignment?

Where does Hopkins end and Oncor begin?

If Dr. Schoenberg's results begin to look equivocal or negative, will he
face pressures, perhaps subtle to rethink the work he is doing? And, of
course, will his results be published and accompanied by the same Public
Relations fanfare that accompanied the original article?

If the results of Schoenberg's study are positive, should they be entitled
to the same credibility and weight as results from an institution with no
possible motivation other than scientific accuracy?

Hans Goerl
ETHI editor