Jay D. Amsterdam: The Paroxetine 352 Bipolar Study Ethical Conduct

19. Attachment V (Letter to the Office of Research Integrity – Lawyer’s letter excerpt)

            On July 5, 2001, Dr. Gyulai sent a letter of apology to Dr. Amsterdam. In that letter, Dr. Gyulai explained that control of the paper had been taken away from him and that GSK published the paper without circulating the draft to all the participants and only allowed him (Dr. Gyulai) to see a near-final draft "when only minor changes could be done." (Attachment L.)

       Fourteen days later, Dr. Amsterdam sent an email to Dr. Rickels stating that the apology was not sufficient in light of the "deliberate misappropriation and publication of [his] data" without his knowledge. Dr. Amsterdam was insistent that some sort of reprimand was necessary to ensure "plagiarism" of a colleague's data never happens again. (Attachment U.)

        The following day, July 20, 2001, Dr. Rickels sent Dr. Amsterdam a letter stating "it is unfortunate that [GSK] did not circulate the manuscript to you and I regret that Dr. Gyulai did not share it with you. Once again, as Dr. Gyulai's Program Director, I have expressed my belief that he should have done so." (Attachment V.)

Attachment V

UNIVERSITY OF PENNSYLVANIA MEDICAL CENTER

University of Pennsylvania School of Medicine Hospital of the University of Pennsylvania

Karl Rickels, M.D.

Stuart and Emily B. H. Mudd Professor

Chief, Mood and Anxiety Disorders Section Department of Psychiatry

July 20, 2001

Jay Amsterdam, M.D.

Director Depression Research Unit 3535 Market Street, Suite 3039 Philadelphia, PA 19104

Dear Jay:

I am responding to your recent e-mail regarding the SmithKline bipolar paper. I trust you know that I really want to resolve this situation. As I indicated to you before, I regret that Dr. Gyulai did not discuss the issue of authorship of the paper with you.

I do want to indicate my understanding of how the study was conducted here at Penn

. From my perspective, Dr. Gyulai was the principal investigator here at the Penn site. When it became clear that Dr. Gyulai was not recruiting at a rapid enough pace for the successful conduct of the study, I suggested that he discuss asking you to be involved with the study to increase the enrollment. From my memory, this occurred at a time when your program was in need of increased clinical trial activity and you were appropriately financially compensated for your work. I agree that you were very successful in recruiting subjects, but I do not believe Dr. Gyulai intended “deliberate misappropriation and publication’,’ of data.

Again, I regret that Dr. Gyulai did not discuss the authorship with you, and as Dr.

Gyulai’s Program Director, I made this very clear to him.

I also agree that it is unfortunate that Smith-Kline Beecham did not circulate the manuscript to you and I regret that Dr. Gyulai did not share it with you. Once again, as Dr. Gyulai’s Program Director, I have expressed my belief that he should have done so.

I would be happy to sit and discuss this with you further, and I would be happy to involve Dr. Gyulai in this discussion with you if you’d like.

Sincerely,

Karl Rickels, M.D.

cc: Dwight L. Evans, M.D. Laszlo Gyulai, M.D.

December 9, 2021

December 9, 2021