Statement of John I. Gallin, M.D. Director Warren G. Magnuson Clinical Center National Institutes of Health
Mr. Chairman and Members of the Committee: I am Dr. John I. Gallin. I am a physician and it has been my privilege to be employed by the National Institutes of Health for over 31 years. Thank you for inviting me here today to discuss important issues related to NIH.
During my career at NIH I have served 8 years as Scientific Director of the National Institute of Allergy and Infectious Diseases (NIAID) and ten years as Chief of the Laboratory of Host Defenses of NIAID.
In 1994, I was invited by the then Director of NIH to be Director of the Warren G. Magnuson Clinical Center. As Director of the NIH Clinical Center my job is to assure that the NIH Clinical Center provides a safe environment for patients volunteering for our research studies and that the necessary resources are available for the NIH institutes to carry out their intramural clinical research programs. Let me emphasize, I have no responsibility for the awarding or oversight of grants to the extramural community, including industry.
My research has focused on children with inherited abnormalities of the white blood cells called phagocytes. In addition to my administrative and research activities, I continue to care for children and adults with these rare diseases. Our work has ranged from the description of newly discovered diseases to defining their genetic basis and recently to developing new therapies. One therapeutic approach of our laboratory is gene therapy that attempts to correct the inherited defects in the patients’ white blood cells.
On December 7, 2003 the Los Angeles Times published an article “Stealth Merger: Drug Companies and Government Medical Research” by David Willman that included a sidebar about me. Unfortunately, a key aspect of this sidebar showed a fundamental misunderstanding of the relevant facts. In his article Mr. Willman claims a conflict of interest existed between my laboratory activities related to a gene therapy study and a company called Cell Genesys. Mr. Willman ignored important historical and chronological information that I provided to him on two occasions.
A brief review of the historical facts follows.
In October 1994, my Deputy Laboratory Chief established a cooperative research and development agreement with a company called Somatix Therapy Corporation. This new biotechnology company specialized in designing viral vectors; we needed a viral vector to carry a normal gene into the adult stem cells of our patients. Specifically, the cooperative research and development agreement with Somatix Therapy Corporation was required to implement a protocol designed to correct the defect in children with a rare and devastating disease called Chronic Granulomatous Disease of Childhood. In early 1995, a vector prepared by Somatix Therapy Corporation was ready to give to patients and in spring 1995 the first patient with Chronic Granulomatous Disease was given gene therapy. In December 1995, the last patient in our study received gene therapy. The patients were followed for over a year to evaluate the response to the gene therapy.
In February 1997, my laboratory Deputy drafted the manuscript describing the findings. I was the last author of that paper. Like all NIH manuscripts, the draft paper went through intense internal review at NIH and was completed in June 1997. The manuscript was submitted for publication in the Proceedings of the National Academy of Sciences, USA early July 1997. In June 1997, eighteen months after we administered gene therapy to our last patient and after our manuscript was ready for submission for publication, Somatix Therapy Corporation was purchased by Cell Genesys. Following the purchase of Somatix Therapy Corporation, Cell Genesys leadership insisted that we recognize their company in our manuscript even though the research project was completed before Cell Genesys had acquired Somatix Therapy Corporation. Because we were informed that we were obligated legally to honor their request, Cell Genesys was recognized in the front of the paper. In protest, however, we added a footnote at the end of the paper, which stated the industrial collaborator in the project was Somatix Therapy Corporation. Again, the Committee should know that these facts were shared with Mr. Willman before he wrote his December 2003 article.
In September 1997, because of my general expertise in immunology and inflammation, I was asked to join the Scientific Advisory Board of a new company called Abgenix Inc., a spin off of Cell Gensys. At the time I was asked to consult for Abgenix Inc. I was not aware that there was some degree of ownership by Cell Genesys. But, I should note again that Somatix Therapy Corporation and Cell Genesys were not affiliated at any time during our gene therapy study. Therefore, there was no conflict between my consulting work for Abgenix Inc. and the clinical research study that my laboratory did with Somatix Therapy Corporation.
This was the first and only time during my career at NIH that I agreed to serve on a Scientific Advisory Board for a company. I agreed to serve on the Abgenix Inc. Scientific Advisory Board for several reasons: I thought Abgenix Inc. had an exciting vision; I was very impressed by the outstanding quality of the other scientists from the extramural community invited to serve on the Board; and, I thought serving on the Board would broaden my perspective in my area of scientific expertise and enrich and enhance my service to the NIH. Participating on the Abgenix Inc. Scientific Advisory Board did not represent a conflict of interest and I believed that it was consistent with other outside activities I participated in during my career at NIH. These other activities have included serving on the Scientific Advisory Board of the Rockefeller Brothers/Culpepper Foundation to select young medical scientist investigator awardees, volunteer service on the Medical Center Operating Board of the University of Virginia Hospital, serving as a co-editor of three editions of a text book Inflammation,or editing the text Principles and Practice of Clinical Research. Importantly, all my outside activities, including serving on the Scientific Advisory Board for Abgenix Inc., were reviewed by senior NIH leadership and approved as compatible with NIH Policy.
To conclude Mr. Chairman, I am proud of my service at NIH. I am proud of the progress we are making at the Clinical Center. The Los Angeles Times article, strongly implied that my consulting relationship with Abgenix Inc. was a conflict with Cell Genesys because of my laboratory’s relationship with Somatix Therapy Corporation. As I have explained above, I want the Committee to know that Somatix Therapy Corporation was acquired by Cell Genesys well after my laboratory completed studies using the Somatix Therapy Corporation’s viral vector. There was simply no connection between my membership on the Scientific Advisory Board of Abgenix Inc. and the gene therapy study.
Thank you for the opportunity to testify today about this important topic. I would be pleased to answer your questions.
