ORDA's Wivel Leaves for Penn Post
By Bobbi Bennett
Dr. Nelson Wivel, director of NIH's Office of Recombinant DNA Activities (ORDA), may have retired from the Commissioned Corps on June 30 but he is not retiring from the field of human gene therapy. He immediately started the next phase of his career as deputy director of the Institute of Human Gene Therapy at the University of Pennsylvania School of Medicine in Philadelphia.
Having completed 30 years of service in the corps, Wivel was at a decision point in his career. "I wasn't committed to leave at this time. I was planning to transfer to Civil Service and continue here until I was really ready to retire. But this is such an excellent professional opportunity that I could not pass it up," he said. "I began discussions about this new job far in advance of any of NIH's decisionmaking about the future of the RAC (the recombinant DNA advisory committee)." [On July 8, NIH filed a notice in the Federal Register of its intent to "enhance the mechanisms for NIH oversight of recombinant DNA activity." NIH is proposing to discontinue the RAC and relinquish all approval responsibilities for recombinant DNA experiments to FDA, which retains statutory authority for such approval.]
As the second director of ORDA and executive secretary of the RAC for the past 7 years, Wivel was fortunate enough to be in on the threshold of gene therapy. "It was one of the things that made the ORDA job very attractive back then. It seemed to be an area of research that was going to come to fruition shortly and it certainly did. I was lucky enough to see the very first protocol that was reviewed and what may have been the last [by the RAC]."
Dr. Harold Varmus, NIH director, stated that "Nelson has played a valuable role in guiding the RAC and NIH through the earliest human trials of gene therapy and the initial era of this fledgling technology. I will miss his advice, diplomacy, and good humor."
Wivel's diplomatic skills were especially needed during the three long years from the first submission of huge volumes of information and preclinical data to ultimate RAC approval of the first gene therapy protocol in 1990. The first two patients were then treated at NIH by Drs. Michael Blaese and Kenneth Culver, then of NCI; French Anderson, then of NHLBI; and their colleagues. Blaese, now chief of NCHGR's Clinical Gene Therapy Branch, feels Wivel "will truly be missed by everyone who has worked in the field of clinical gene therapy over the past few years. He was an invaluable source of information and encouragement for neophyte investigators trying to negotiate what seemed an impenetrable morass of regulations. From time to time, when everything seemed to be going nuts, Nelson had a way of calming the situation and keeping everyone focused. And he could always be counted on as a great source for good stories!"
In his new position at the largest entity in this country devoted to gene therapy, Wivel cochairs — with Dr. James Wilson, director of the institute — the research and development committee, which manages everything from the bench to clinical trials. He is also responsible for the clinical pathology labs that support many of the basic science studies.
The institute runs one of the three laboratories recently funded by NCRR and other ICDs to develop new vectors to carry genes into whatever cells are targeted in a study. Wivel will represent his new employer at NCRR's advisory group that reviews and ranks projects, deciding which gene therapy researchers can use the vector facilities. He is also in charge of overseeing toxicology studies of any newly developed vectors.
Wivel plans to stay abreast of the international scene as far as standards and activities in gene therapy are concerned, particularly in Europe, Taiwan and Japan. He expects to work 12-hour days, which are the norm at the institute from the director on down. "There's a real commitment by people there to get things done so I anticipate a pace of work similar to that of ORDA," said Wivel.
Prior to his stewardship of ORDA, Wivel was the chief medical officer for AIDS research in the General Clinical Research Centers program of what was then the Division of Research Resources. Before that, he was an intramural scientist doing research on retroviruses and headed up the ultrastructural studies sections in NCI's Viral Leukemia and Lymphoma Branch and then in the Laboratory of Cell Biology.
In thinking about RAC's history, Wivel feels that the public forum it provided for the open review of human gene therapy protocols, and the concomitant review of science, safety, and ethics, are some of RAC's greatest achievements. Anyone who attended a RAC meeting had to be overwhelmed by the volume of xeroxed materials — protocols, correspondence, and other documents — available to everyone. Wivel quipped about the number of forests that had to be denuded in order to accomplish this. He credits his "incredibly hardworking staff at ORDA for meeting all the deadlines and taking care of all the necessary tasks, especially their reliability and promptness in providing information to investigators, the press and the public. Theirs is not a small task."
As for the status of RAC, Wivel pointed out that, since consolidated review with FDA began in July 1995, "there were very few protocols that represented significant departures from familiar practices and that therefore required full RAC review. In essence, RAC had already reached a point where the number of protocols for it to review were so diminished that the March and June 1996 RAC meetings were cancelled."
Wivel feels that people may have misunderstood the nature of NIH's mandate. NIH is thought by some to be a regulatory agency rather than a research one. "NIH supported RAC for one fundamental reason: to facilitate its research mission and support the safe development of recombinant DNA experiments. I think RAC's contemplated retirement is a measure of its success in reaching these goals."