Estate of Gelsinger v. Trustees of University of Pennsylvania

NON-FINANCIAL AND FINANCIAL CONFLICTS OF INTEREST 4

Author’s name

Non-Financial and Financial Conflicts of Interest

The case of Jesse’s death was an eye opener to the policymakersand regulators of medical research involving human beings. The deathwas Jesse Gelsinger, was as a result poor and unethical protocol incarrying out gene therapy. His death slowed down gene therapy, aprocess that had picked momentum attracted numerous scientificresearchers (Wilson, 2009). The participants in the research such asWilson, Raper and Batshow were finally blamed for the death of Jesse.Wilson, in particular was identified as having some financialinterests in the whole experiment. The company that was sponsoringthe research has Wilson as one of the shareholders. Even if Wilsondid not have the right to vote, it is evident that he accrued moneyfrom the company. It is clear that the gene therapy company thatfunded the research called Genovo had financial links with Wilson,one of the lead researchers in this phase one trial of the virus.

The policy makers together with the regulators have a primary roleto distinguish non-financial and financial interests of the people orinstitutions involved in medical trials involving human beings. It isevident from the case of Jesse that the successful result of thetrial would have earned Wilson, as well as the University ofPennsylvania a substantial amount of money. The people involved insuch trials are bound to overlook various aspects and protocols ofthe trials in a bid to avoid its cancellation. For instance, thiscase clearly indicates that there were a number of protocols thatwere ignored, which culminated to the death of the young boy. It isclear that the researchers never revealed to the boy and to hisfather Paul Gelsinger that there were monkeys which had died as aresult of adenoviralvector (Wilson, 2009). It is also evident from theconsent form that the researchers have presented conflictinginformation with regard to the benefits that the subject will accruefrom the trial. At some point in the consent form, the researchershave clearly indicated that the subject will not benefit whatsoeverfrom the trial. Surprisingly, the researchers have asserted to Paulthat patients of ornithine transcarbamylase deficiency showed 50%improvement in ammonia excretion. This is a clear indication that thetrial did not follow the right protocol.

It is evident that successful medical research outcomes attractprestigious awards and recognition. Policy makers and regulators mustnot have any non-financial or financial interests in such research.The university of Pennsylvania institutional review board (IRB)approved the trial and the consent forms (Johnson, 2009). The foodand drug administration (FDA) also approved the consent forms.However, some sections of the forms were later edited to remove thesections informing participants of the death of three monkeyspreviously involved in the trial. The Institute for human genetherapy at Penn University was to receive enormous funding if thetrial succeed (Wilson, 2009). This was beside the prestige and thefame that the university was receive. Additionally, it is assertedthat the university was to cement its relationship with Wilson, whowas renowned and respected gene therapy superstar.

These are the non-financial and financial interests in the trialthat led to various mistakes that resulted to the death of Jesse. Thepolicymakers and regulators such as the food and drug food and drugadministration (FDA) and the National Institute of Health (NIH) mustdistinguish between these interests and find out the effects theyhave on trials and medical experiments involving humans (Johnson,2009). It is abundantly clear that the death of Jesse would have beenprevented if the university and Wilson had no interests whetherfinancial or non-financial towards the success of the trial.

References

Wilson, R. F. (2009). Chapter 11. Estate of Gelsinger v. Trusteesof University of Pennsylvania.

Johnson, S. H. (2009). Health law and bioethics: Cases in context.Austin: Wolters Kluwer.