Panel I

Remarks by Alan Goldhammer, Biotechnology Industry Organization

Delivered at MIT, Cambridge, MA, March 29, 1999.

I’m here as a representative of the biotechnology industry who’s conflicts and problems probably raise more controversy in the last fifteen years than we’ve seen in the last seventy. However, I posit that these conflicts are not new and one can go back to the late 1920s, when the DuPont Corporation was first getting involved in polymer research and the contract was with a professor of chemistry at Notre Dame University, Dr. Nieuwland to conduct this research. Dr. Nieuwland was a Holy Cross father who had taken a vow of poverty, so the company was in a quandry to want to have the appropriate compensation mechanism to implement should the opportunity arise to commercialize the research findings. So, it was agreed with Dr. Nieuwland and the university that the company would fund the library acquisitions for him at Notre Dame. I think the company ended up paying about a million dollars for a five or six year period for intelletual property that evolved which helped contribute to getting polymer research at DuPont off and running.

One of the issues that we were confronted with early on was the the appropriate disclosure of financial involvement of clinical investigators. There was a well known case that came out of clinical investigations of one of the first early biotechnology products where investigators were compensated with stock. There was a well known article published in the New England Journal of Medicine. The company’s practice changed over night and, in fact, today at the company requires that all clinical investigators divest themselves of all stock in the company for the period of a year after the clinical trial is completed, no new equity investments can be made. When we did a survey of our membership about five years ago in response to a proposed regulation by the Food and Drug Administration requiring disclosure of financial ties of clinical investigators, we found that this was a very common practice among a number of companies.

We weighed in early when the debates were taking place about sponsored research at universities about allowing a period of time for the companies to review the research for the right of filing patents in order to protect intellectual property. We agree there should be a short defined period of time. One of the difficulties we have with 500 corporate members of our trade association is trying to define what that period of time is. I think Lita Nelsen is very familiar in having dealt with a lot of agreements here at MIT, the companies come in and some will say that 30 days is their defined period of time, some will say that 90 days is an appropriate time, others will say that a year is a short period of time. Perhaps the latter pushes the envelope a little bit too much, but I think it points out one of the difficulties that we have in arriving at a consensus as to what is appropriate.

Dr. Deutch raised an interesting issue, and one that we’re confronting in a more immediate issue in Washington, and that is the difference between secrecy and privacy. I think that Dr. Deutch defined it very well for us this morning, where secrecy is looked at as involving groups, privacy is related to the individual. We’re in the process of trying to finalize through our Board of Directors a statement on medical privacy that we can take up to Congress and lobby with during this upcoming session. Issues related to medical privacy are growing and I think are going to be quite significant.

I would only close us on this note and give you a couple of headlines, one from the March 9 New York Times – "Quietly Tests of DNA Transforms Forensics, Techniques Alarm Civil Libertarians." I think we’re all aware of the new techniques of PCR technology, sequencing of the human genome, and so forth can lead to remarkable advances in medicine and yet raise significant ethical issues that we’re going to have to deal with. In the March 4 Wall Street Journal, there was a front page story, "DNA Dreams," big drug companies discussed linking up to pursue disease causing genes and in forming a consortium that would to help identify specific sequences. In response, some of the smaller companies, some that are members of our association, are doing the exact same thing. So, we’ve got to get an understanding of the universe we’re trying to face in relation to the technological advances. My hope is that our discussions today give us a sense of the road map that we should follow.

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