[Letter to Donald S. Burke from Shepherd Smith]

4...,-,:1. r- -M Tci - t r 7fl 1 1 1 4F, C I TT G3 - 1818--"4040:3;#3 5571095.0443.003 Americans for a Sound AIDS/IHIV Policy 'P.(). Box 17433 * WasInuton, D.C 041 * 7 3/471-7350 MEMORANDUM FOR THE RECORD FOR Donald S. Burke, Col., M.D. DATE: Nov. 17, 1992 FROM: Shepherd Smith SUBJECT: Incorrect interpretation by Dan Lucey and Maryanne Vahey of my call of August 24, 1992 (attachments: past letters on same subject) It should be noted that after repeated requests for copies of the memoranda by Lucey and Vahey made to Col. Burke that none were ever produced. This comes as a great shock because of our longterm support of WRAIR, exceeding five years, and close association with you--always giving you personally our utmost respect. The setting for the call in question may help answer why the copies have never been supplied, since I have subsequently become aware of a memo written by a William McCarthy about gpl60 trial presentations made by Dr. Redfield in Amsterdam. The memo was dated August 20, 1992; two working days before my call. The preceding week was described to me by Dr. Vahey as one where Drs. Vahey, McCarthy, and Burke were sequestered for large parts of each day going over possible combinations that Dr. Redfield may have presented in Amsterdam. She called this "statistical exploration". Since Dr. Redfield was on leave at the time (as well as Dr. Brundage) the context of these meetings may have had some secretive nature to the participants. Under the circumstances, it is understandable how my call out of the blue came as a big surprise to Dr. Vahey, as well as Dan Lucey, an apparent compatriot of McCarthy's and vahey's. As I have mentioned before, my purpose for making the call was as a courtesy, as well as out of curiosity about several aspects of the Phase I data. It occurred oxily because I happened to be filing some published material on vaccine therapy at that particular moment, and because I wanted to extend friendship to Dr. Vahey. I did it without the knowledge, consent, or concurrence of Dr. Redfield, nor with the knowledge that any internal discussions were occurring concerning his Amsterdam presentation while he was on leave.

~'.' E: XEFOr TELECOP IER 7011 8- 1-93 1: 14PM ~T C:-' I TT i - 11 18 4904O3; # 4 P 04 AS I recall from the parts of the memo read to me, Dr. Lucey wrote his memo nearly immediately after the call was made, indicating that Dr. Vahey conveyed all the information Dr. Lucey had to go on. Therefore, it is heresay at best, but should reflect Maryanne's memo as well. Any discrepancies between the two should indicate a lack of veracity of either one or both of the parties (Vahey and/or Lucey). Again, I go back to the extremely unusual reaction to the call. I have made literally hundreds of these calls to government officials over the years, and never experienced anything like this. My questions were very simple and straightforward. They concerned two basic points: 1.) Had the non-responders been compared to the responders, and 2.) was patient #1 an anomaly. To a lesser degree, I felt it important to have some form of comparison in data available to average folks like me since Salk's presentation in Amsterdam with no comparative data was basically useless. The take-away by Dr. Vahey and Dr. Lucey, however, seemed quite different at least by Dr. Lucey's portrayal of it. Here is my opinion of his points as I recall them: 1.) I never suggested anyone report on any specific number of patients as Dr. Lucey stated. That is absurd. I could care less; nor was that the point of my call. Two patients, four patients, seven patients, etc. may have value if they show a trend over time, but to suggest I wanted certain patients presented is totally false since I have virtually no knowledge of what the patient data base looks like. I have only recently seen the August 20 memo he referenced in the beginning of his memo more than two months later. (That, incidentally, meant Dr. McCarthy was giving broad distribution to his memo immediately after it was written, which I personally believe to be inappropriate under the circumstances.) If Dr. Vahey raised the issue of presenting all patients I may have asked "why?" out of curiosity, but not for any other reason as Dr. Lucey seems to insinuate. Again, I was unaware that that was a major issue at that time to Vahey, McCarthy, Lucey, and Burke. 2.) Clearly, I conveyed my favorable impression of the WRAIR program. I have testified before Congress to the fact that I think NIH is behind in its response to studying vaccine therapy. I have told Dr. Fauci the same thing in face-to-face meetings. I also shared that the closer this got to potentially proving efficacy, the more pressures would come on folks associated with the trial and gave encouragement to hang tough. I made similar encouraging statements to everyone at WRAIR when I spoke at Ed Tramont's retirement dinner a year or so earlier. Little did I know my words to Dr. Vahey would be prophetic for Dr. Redfield with the exception that I didn't believe the bulk of the assault would come from within. 3.) Dr. Lucey made one particular totally untrue statement when

pc Y iRXTELECI:PIER?7011 1-9T 1: 1EFC CC, I TT ' -; i C;494O3; # P 05 he said I had heard Dr. Vahey was having second thoughts about doing Phase II viral burden data in her lab. This is now in the ozone in reality checks. I have no idea who, how, or where viral burden data is gained. Either Dr. Vahey fabricated this point or Dr. Lucey manufactured it for his or their (it's hard to tell where Lucey ends and Vahey begins) purposes since there isn't an ounce of truth to it. Again, absurd. Dr. Vahey was helpful, however, in sharing rather extensively her analysis of various patients (for example, I knew absolutely nothing about patient 7 before the call), and concluding that the study design certainly showed vaccine therapy--regardless of any scientific debate--had value. We both agreed it would be Phase II data that would, or would not, prove efficacy. 4.) The overall impression Dr. Lucey conveys is that I am much more informed on this issue than I actually am. I am a little flattered by that, but it might convey I have more access to WRAIR information than I do. It should surprise no one, however, that I am well-informed on the issue since I have probably attended more public meetings where this has been discussed than anyone else I know--maybe even more than you. However, I have never asked for, nor received, proprietary information on any aspect of research there or from MicroGeneSys. Quite frankly, I don't want it from anyone. To put it another way, I have received as much information on WRAIR activity from you as I have from anyone there, and you know that's never been of a confidential nature. Don, you also know us very well and know we never ask for material that has not first been shown publicly. The most non-published data I've ever received was actually from Maryanne in this short twenty-minute or so call. I am amazed, though, at the amount of confidential information that is leaking out of WRAIR today, both to media and non-media people. Because we taped the Chantilly presentation (I was at the CDC case definition meeting in Atlanta that day and I asked Anita to tape it for me), we can trade that with any number of people for nearly any internal document from folks outside of WRAIR who have been sent or faxed WRAIR documents. It's sad. 5.) Finally, any discrepancies between my statement and their's indicates to me these folks aren't playing with their hands above the table. I shared with you when we met on this, and you did not disagree, that I have been scrupulously honest about every aspect of our relationship with you and anyone at WRAIR. Since you haven't produced Dr. Vahey's memo for me after numerous requests, I will leave it up to you to see if there are differences. Clearly, Dr. Lucey was trying to put in writing what Dr. Vahey had conveyed to him. As I've said before, I think something is very much amiss, and I don't think in respect to this issue it has anything to do with me. Further, I think if concerns by other parties have been dealt with in a similar fashion it's little wonder things have gotten out of hand. This whole memo is totally unnecessary. We could have sat down with all parties, as requested months ago, and put this behind us.

SRC BY: XEROxF' TELECOPIER 7011; 8- 1-93 I:16PM 1 CCITT 53- 18183490-403; 5 P 06 Don, if these same folks are some of Dr. Redfield's accusers, I think everyone should view anything they say with great suspicion. Clearly they are capable of rewriting history, or constructing any scenario they want without basis in fact, There seems to be an orchestrated movement there which I am convinced will ultimately be shown to be little more than sour grapes; without merit, with the root being professional jealousies and inter-service rivalries. Needless to say, this has certainly been one of the stranger sagas I've been involved with to date on this issue. Because you have not responded to my past requests I shall send this to others in the command structure so that I can be sure it gets recorded against the ridiculous statements written about the call. In closing, I would say my dad's rule of "keep it in the chainof-command" while he served in the Medical Corps was real wisdom. Had scientific questions and any complaints of Dr. Redfield been correctly directed to him, rather than allowed to be skirted around him, I believe much of the harmful fuss going on today could have been avoided, including the utter nonsense of their reaction to my call. And while I didn't have the courtesy of receiving Maryanne's memo from you, it really doesn't matter what it said since Lucey wrote his memo in full concurrence and compliancq with her. I don't believe either should be believed, nor do I understand why you have gone to such extremes to protect them. This whole affair is ludicrous and regrettable.