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To: HUM-MOLGEN@NIC.SURFNET.NL
Subject: ETHI: Gene Tests Rushed to Market
From: Hans Goerl <GENETHICS@delphi.com>
Date: Mon, 27 Oct 1997 11:09:43 -0500

A former dental supply company has announced plans to sell predictive
genetic tests for three serious late onset medical diseases as well as
periodontal disease. The California company, now called Medical Science
Systems, recently filed a prospectus with the US Securities and Exchange
Commission.

The URL for the prospectus is
http://www.sec.gov/Archives/edgar/data/1037649/0000892569-97-002786.txt

According to the prospectus, the company is now exclusively dedicated to
developing and selling predictive genetic tests. It intends to sell
predictive susceptibility genetic tests for:

1) Periodontal Disease (already on the market and being marketed to
periodontists and dentists)

2) Osteoporosis (1998)

3) Coronary Artery Disease (1999)

4) Diabetic Retinopathy in diabetics (1999)

No research results underlying the company's osteoporosis, CAD and Diabetic
Retinopathy tests have yet been published. The tests apparently involve as
yet undisclosed polymorphisms or mutations. Other, independent scientists
have not had a chance to evaluate the soundness of the findings and evaluate
the risks and benefits of testing. This process should take several years
after the results are first made public.  Nevertheless the company has
already announced its intention to offer these tests and market them
intensively to the medical community as well as to the public. Such actions
would be highly irresponsible.

It is extremely unlikely that enough research has been done, even on the
periodontal test, to comply with the recommendations of the ELSI Task Force
on Genetic Testing which can be found at: http://www.med.jhu.edu/tfgtelsi

The company's prospectus makes no reference to any published scientific
analysis of the risks and benefits of any of its tests.

None of the company's officers has a degree in genetics.

In extensive discussions of its plans for marketing, sales and processing of
tests, the company never once mentions any plans to utilize genetic
counselors or provide counseling to assist patients who must decide whether
to be tested.

Unfortunately, there is no law in the US to stop this, or any other company
from selling what it claims to be predictive genetic tests for any of
hundreds of different diseases. The FDA has refused to utilize its
regulatory authority to require that genetic tests have clinical validity
and clinical utility as long as they are performed in a HCFA licensed
laboratory. HCFA concerns itself only with analytical validity.


The company has what can only be described as an intimate relationship with
Sheffield University in the UK. Various licensing schemes and the payments
to Sheffield for research services are described in detail in the prospectus
and exhibits. I highly recommend that anyone interested in the deal-making
process in the biotech/university complex download and review the
prospectus.  Excerpts will shortly be placed on HUM-MOLGEN's website.

Among other financial incentives, Sheffield has been granted a substantial
number of stock options in the company and also stands to profit greatly
from royalties and license payments if the company is successful.

Set forth below are some relevant provisions of the Master Agreement between
Sheffield and the company concerning the publication of research results.
All of Sheffield's researchers, students and consultants are effectively
prohibited from publishing any information about the mutations, their
effects or their lack of effects without the company's agreement. Another
section of the agreement appears to grant the company an exclusive license
to any commercially useful mutation discovered by Sheffield entire molecular
genetics department.

In my opinion, by entering into these various agreements, Sheffield has
severely damaged its reputation for academic independence and its molecular
genetics department should be considered little more than a wholly owned
subsidiary of this company.

Unfortunately agreements similar to this one are commonplace. The
combination of entrepreneurial universities, profit hungry biotechnology
companies and government agencies unwilling or unable to protect the public
from premature use of novel technologies is dangerous to the public health.

As always, contrary or concurring opinions are solicited and will be
published.

Hans Goerl
ETHI editor
**********************************************************
PUBLICATION
5.2 (a) Each party recognizes that publication of research results is an
important part of the mission of the University and is important to
scientific researchers at the University and at MSS. However, the parties
acknowledge the intent of this Agreement is to maximize the
commercialization potential of Project Technologies and Products, and that
publication should not unduly interfere with that goal. Consequently, the
parties agree that publication issues will be determined mutually in good
faith in recognition of these interests. In particular, the parties will
submit in advance and review jointly proposals for publishing any
information relating to any Project Technologies or Products and determine
whether in each instance publication is in the best interests of the parties
and the scope, authorship (e.g., individual or joint) and timing of such
publication. The Project Agreements may further define procedures for the
clearance of such publications with respect to any particular Project.
Neither party, nor any person who participated in the development of Project
Technologies or Products shall submit for publication, submit abstracts of,
publish or present at any academic seminar, professional society meeting or
similar event any Project Technologies or Products unless it has complied
with the provisions of this Section 5.2 and any applicable provisions in the
relevant Project Agreement.
(material deleted)
 Each party will ensure that its faculty, staff, students, employees and
consultants comply with the requirements of this Section 5.2


   
 
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