HUM-MOLGEN archive: ETHI: Gene Tests Rushed to Market

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