Author reply (1997)

I was quite disturbed to receive a copy of the letter from Dr. Rosner regarding the "ethical standards" of the scientific articles that appeared in the Cancer supplement (vol. 78, no. 3; August 1, 1996) entitled "The Management of Pancreatic Carcinoma . . . A Continuing Challenge." His implication that certain drug companies solicited the articles and had control over their intellectual content is completely unfounded. The manuscripts in the supplement were part of a symposium held in Newport, Rhode Island in July 1994. The symposium had an international scope, including participants from Japan, Europe, and numerous cancer centers throughout the U.S. All of the participants were required to present a manuscript. Selected manuscripts were revised for compilation into the Cancer supplement. In developing this symposium, we solicited support from a variety of sources, and required that there be no strings attached, i.e., that these would be moneys provided as an educational grant. At the symposium, there were opportunities for the sponsoring agencies to occupy exhibit hall space. However, there were very strict guidelines imposed by the Brown University Office for Continuing Medical Education and the awarding of CME credits for attendance at the symposium. Even the location of the exhibit hall in relation to the lecture hall was restricted, allowing for a total hands-off relationship between any exhibitor and the conference participants. The major cost of this symposium was provided by the Beauregard family, in memory of a member of their family who had been a former patient of our chief of radiation therapy, Dr. Arvin S. Glicksman. We also had educational grants from several surgical and drug companies. As I personally was responsible for the invitation of the participants, I can assure you that we solicited the major players from around the world to participate in this conference. The Cancer supplement resulted from an effort to disseminate the material rapidly from a selected group attending this conference and we were thankful for the support of our sponsors in allowing this to take place. The selection of the manuscripts was based on their timeliness and scientific interest and basically covered some of the major controversial areas that exist with this disease. We emphasized the questions relating to preoperative and intraoperative therapy, palliation, pain control, and psychologic issues, different concepts on clinical trial monitoring, and conventional and experimental chemotherapeutic agents, as well as the newer or theoretic approaches for this disease. The selection of authors and indeed their contributions were very focused and represented the cutting edge in this subject. I believe that in the third paragraph of the introductory statement, p. 579, we specifically stated that the opinions expressed by the authors of individual manuscripts represented their opinions alone and did not represent the opinions of any of the sponsors of this program, including the Division of Surgical Oncology at Brown University.1 Dr. Rosner's comments that the sponsoring drug company was consulted on manuscripts to verify accuracy and completeness of scientific information was unfounded. Only those manuscripts specifically related to research done by a specific company were reviewed as spelled out on page 579. They did not participate in the selection of the author's writing for the Cancer supplement, nor in the composition of the symposium program. On the last page of the supplement is a listing of the authors who received research support and honoraria. I and several of the authors are listed on this page. Dr. Clark and I received institutional support for the entire symposium conference in the form of an educational grant. At the end of the symposium, a minisymposium was convened under separate sponsorship of Eli Lilly and Company to examine some of the support issues facing patients with advanced pancreatic carcinoma. These included a discussion of psychosocial support, therapeutic endpoints, symptom assessment, and the use of quality of life instruments in the evaluation of the patient. This is stated fully in the article developed from this roundtable meeting by Dr. Mace Rothenberg et al.2 Dr. Rothenberg, of the University of Texas Health Science Center in San Antonio developed a manuscript representing a consensus of the discussions held during this minisymposium. Dr. Rosner's implication of unethical involvement of the authors with a pharmaceutical company and other allegations of "ghostwriting," control of intellectual or scientific publication rights by a pharmaceutical company, is unequivocally misstated, inflammatory, and damaging. Although Dr. Rosner may be acting in good faith from his own perception of the genesis of this symposium, the allegations he raises are both damaging and unacceptable. I am only sorry that Dr. Rosner did not attend the symposium, because I feel he would have been enlightened at the effort we made to focus on a highly catastrophic disease in the most comprehensive way possible. I appreciate the opportunity to review Dr. Rosner's unfortunate damaging comments. Harold J. Wanebo M.D.