To: John F. Dowd who wrote (622 ) 4/22/1998 11:40:00 AM From: James A. Winters Read Replies (1) | Respond to of 1202
I went back to the FDA transcript from last July and located these excerpts. Dr. Stuhlmuller is/was? a member of the FDA panel. Excerpt One: DR. STUHLMULLER: The following announcement addresses conflict of interest issues associated with this meeting and is made a part of the record, including the appearance of any impropriety. The conflict of interest statutes prohibit special government employees from participating in matters that could affect their or their employers' financial interests. To determine if any conflict existed, the agency reviewed the submitted agenda and all financial interests reported by the committee participants. It was determined that no conflicts exist. In the event that the discussions involve any of the filings or firms not already on the agenda but which an FDA participant has a financial interest, the participant should exclude him or herself from such involvement and the exclusion will be noted for the record. With respect to all other participants, we ask in the interest of fairness that all persons making statements or presentations disclose any current or previous financial involvement with any firm whose progress they may wish to comment upon. Excerpt Two: Dr. Swain, (acting chairperson for the meeting is speaking): Dr. Stuhlmuller has two letters to incorporate. DR. STUHLMULLER: To be included in the record are two letters that were received by panel members. One dated letter from Dr. Thomas H. McConnell and a letter dated June 25, 1997, from Dr. Arthur Fields, state their opposition to the use of transmyocardial revascularization for the treatment of coronary artery disease. In addition, I am also entering follow-up letters written to FDA by Dr. McConnell and Dr. Fields. In his letter dated June 25, 1997, Dr. McConnell states that he has taken a short position and a financial interest opposite to the sponsor. Dr. Fields in his undated follow-up letter to FDA states that he has no financial interest in the sponsor or any competing laser companies. So, it was the letter from Dr. McConnell and its incorporation into the record that I remember reading. Dr. McConnell was NOT a member of the panel. Dr. Stuhlmuller stated that there was NO conflict of interest on the part of the FDA panel members JW