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Case study 1

 

Dr Wilson and Genovo Inc. (3,5)


Dr Wilson is a prominent U.S. researcher who invented the use of adenoviral-derived vectors in gene therapies. In 1992, he founded the biotechnology company, Genovo Inc. which was licensed to market his scientific inventions. In return, he was to receive royalties from the company’s profits. He also held shares in this company.

In 1993, the University of Pennsylvania recruited Dr Wilson to be the director of its Institute for Human Gene Therapy. However, the university was concerned about his financial affiliations with Genovo and imposed several measures, including:

  • Setting up two special committees to monitor his relationship with the company.
  • Waiving his right to receive royalties from the company’s profits.
  • Setting a 30% threshold on the company shares that he and his immediate family owned, and making his shares non-voting.
  • Prohibiting him from taking up any managerial or advisory positions in the company.
  • Disclosing his COI to any subjects enrolled under the institute’s research programmes, through a written statement in their consent documents.

However, despite such restrictions, Dr Wilson’s integrity was still called into question when the death of one of his subjects, Jesse Gelsinger, came under the spotlight in 1999.

In his reflection on Mr Gelsinger’s death, Dr Wilson described the allegations about his financial interests as ‘one of the most troubling’ to him, and expressed the challenges in managing real or perceived COIs.

While it is important to eliminate any financial COIs, this could be at the cost of impeding scientific advancement, given the increasing reliance of clinical research on private funding.  

Wilson JM. Lessons learned from the gene therapy trial for ornithine transcarbamylase deficiency. Molecular Genetics and Metabolism. 2009 Apr 1;96(4):151–7. Available from: http://www.sciencedirect.com/science/article/pii/S109671920800499X

Steinbrook R. The Gelsinger Case. In: The Oxford Textbook of Clinical Research Ethics [Internet]. 1st ed. New York: Oxford University Press; 2011. p. 110–20. Available from: https://www.uab.edu/ccts/images/steinbrook_Gelsinger_-_Oxford_Textbook_08_3.pdf

Read Dr Wilson’s full reflection: ‘Lessons learned from the gene therapy trial for ornithine transcarbamylase deficiency’ (Wilson, 2009).