HUM-MOLGEN archive: ETHI: Responses to Sheffield and BRCA me

This ETHI posting contains 5 submessages. The first concerns BRCA testing and the next 4 are responses to the post concerning premature marketing of predictive genetic tests and questionable confidentiality agreements. Hans Goerl ETHI editor ************************************************************************ 1) From: IN%"PandaGroup@aol.com" Frankly, I see absolutely no use for BRCA1/2 testing. I had this discussion with a vice president of one of the major testing operations producing/conducting these tests at a CHI conference in San Francisco last February. BRCA1/2 testing cannot be used as a screening tool. It is far too expensive. Nobody in their right mind would reimburse a test that picks up such a small percentage of the potential breast cancer population. Assuming you found the gene in a woman, what would you do? Well, you could do a radical prophylactic mastectomy .. what a joy for the woman .. and I know of no surgeon who would guarantee that NO breast cells might be left behind, resulting in a later malignancy anyway. Moreover there have already been reports of unnecessary mastectomies following false positive BRCA tests. So this really means that increased survellance of the patient is the most likely step to be employed. Let's go back to the test. SInce it's too expensive to use for screening, how does one decide who will be tested? Simple, by family history. So, if a woman has a family history of breast cancer, the BRCA1/2 test is administered ... the primary action taken post-test being increased patient surveillance. Aha, but what criteria are now used to employ increased patient surveillance .. why, family history. So, family history is used to administer an expensive test to tell us to do what the family history would have told us to do anyway. Brilliant .... ! Ken Krul, Ph.D. ***************************************************************************** **** 2) From: Don Ball <biotech@VT.EDU> Recently the URL for the ELSI Task Force on Genetic Testing report was posted to HUM-MOLGEN. This URL led to the report without appendices. The following URL not only has the full report but also the appendices. Don The full final report, including appendices, is available at: http://www.nhgri.nih.gov/ELSI/TFGT_final/ If you have trouble let us know and we can mail hard copy. Neil Holtzman ***************************************************************************** ***** 3) From: rroush@waite.adelaide.edu.au (Rick Roush) Thanks for the following message, which I found incredible. I agree with all of Goerl's opinions, except that I don't think that the agreements similar to that between Sheffield and the company are yet commonplace. This is by far the most extreme I have ever even heard of. I can say without fear of contradiction that such an agreement would not be accepted at my former employer, Cornell University, and I suspect that it would not be accepted at any other US public university or my current university. Rick Roush Richard T. Roush ***************************************************************************** ***** 4) From: IN%"dcurtis@hgmp.mrc.ac.uk" The prospectus seems to acknowledge that a lot more work will need to be done, and that there are therefore major risks for investors at this stage. I don't see that there is necessarily a risk taht the tests will be released prematurely. The main ethical concern is that the commercial interests of the company may delay publication and clinical utilisation of results. It is not clear how serious this problem is. If the company can file patents to protect its new discoveries then hopefully publication can proceed without too much delay. -- Dave Curtis Tel : +44-171-377-7729 Dept Adult Psychiatry Fax : +44-171-377-7316 3rd Floor Outpatient Building Email : dcurtis@hgmp.mrc.ac.uk Royal London Hospital WWW : EDITOR'S NOTE: It seems to me that the main ethical concern is that negative results may never see the light of day. HG ***************************************************************************** ************* 5) From: Thomas Lavin <tlavin@GENSIS.COM> thank you very much. but ...(a large public university in California)... has likely been doing this for years. ONly few US universities try to separate acedemics from money, and I take my hats off to those that do. **************************************************************************** -------------------------------------------------------------------- HUM-MOLGEN - Internet Communication Forum in Human Genetics E-mail: HUM-MOLGEN@nic.surfnet.nl To SUBSCRIBE: send "subscribe hum-molgen" to listserve@nic.surfnet.nl To change your TOPICS send "set topics + ____" or "set topics -____" to the same address. WWW: http://www.informatik.uni-rostock.de/HUM-MOLGEN/ http://linkage.rockefeller.edu/hum-molgen/ Phone: 020-566 4598 (The Netherlands), (206) 386-2101 (USA) Fax: 020-691 6521 (The Netherlands), (206) 386-2555 (USA) --------------------------------------------------------------------