October 26

Students call for ouster of researcher

Subject: Students call for ouster of researcher_AAMC COI guidelines

Date: Tue, 24 Sep 2002 17:03:54 -0400

Students of the University of Pennsylvania reacted to the NBC’s Dateline airing of Jesse Gelsinger’s tragic death–a casualty of a lethal culture. In an editorial in the Daily Pennsylvanian (an independent student newspaper), the students called for the ouster of Dr. James Wilson from the University. In the editorial they said he was “a black mark on Penn’s distinguished history and an embarrassment to its remarkable faculty.”

The students, however, do not appreciate the fact that James Wilson is but one player within a culture of opportunism. Conflicts of interest permeate the entire research enterprise. Marketplace ethics of expediency have pushed aside a culture in academia that placed human values and public responsibility above corporate interests. Those who have embraced the Enron culture of business ethics in human research, put the interests of science and corporate sponsors above the safety of individuals subjects. They think that individual lives are expendable in the pursuit of biomedical discovery.

As has been revealed repeatedly–primarily by investigative reporters–the research enterprise is riddled with abuses: ethical violations are widespread, and the integrity of published research findings is tainted. In an effort to regain public trust in the enterprise, the Association of American Medical Colleges (AAMC) has called for new conflict of interest guidelines that go far beyond the evasive, disingenuous recommendations issued in Aug 2001 by NHRPAC, the advisory committee under the Office of Human Research Protections. [see: http://ohrp.osophs.dhhs.gov/nhrpac/documents/aug01a.pdf ]

The new AAMC guidelines address institutional conflicts (in January AAMC addressed individual conflicts of interest). See: http://www.aamc.org/members/coitf/start.htm See also, The Washington Post. Panel Targets Conflicts In Medical Research. By Justin Gillis http://www.washingtonpost.com/wp-dyn/articles/A57429-2002Sep23.html ]

However, AAMC’s recommendations are not binding, they are optional, and reversible! It will take more than recommendations on paper to restore either public trust or the integrity of research. Nor will paper recommendations protect human subjects from preventable harm. Students can begin the process by raising questions about the ethical standards and methods by which research is being conducted at their institution. And by calling on universities to lift the veil of secrecy that currently envelops institutional review boards (IRB). Since IRB members are almost entirely made up of an institution’s employees, they cannot claim to represent the best interest of the human subjects–particularly when they operate behind a shield of secrecy.

For updated information about ethical violations and harmful research outcomes that are largely the result of conflicts of interest, check our website: http://www.researchprotection.org/ethical/EthicalViolations.html http://www.researchprotection.org/infomail/0902/06.html

Vera Sharav

~~~~~~~~~~~~~~~~~~~~~~~~~~~ http://www.dailypennsylvanian.com/vnews/display.v/ART/2002/09/23/3d8ed10 d979 05 Daily Pennsylvanian

Opinion Staff Editorial: Wilson: three years later The disgraced former gene therapy researcher is an embarrassment to the University

September 23, 2002

Just over three years ago, on Sept. 17, 1999, Jesse Gelsinger died at the Hospital of the University of Pennsylvania. The 18-year-old was part of a study, led by Penn’s own James M. Wilson, and had just received, at Penn’s own Institute for Human Gene Therapy, a massive dose of a modified virus designed to repair a faulty gene.

Of course, as those who watched NBC’s Dateline on Friday night know, the story does not end there. That’s because the study that led to Gelsinger’s death was marred by a mind-boggling array of ethical and moral lapses on the part of Wilson and his team. Their failures as scientists and doctors were truly chilling. And, regardless of their motivation — for financial gain or from a genuine desire to find a cure for Gelsinger’s awful genetic ailment — their actions both before and after Gelsinger’s death were inexcusable.

Wilson no longer leads the I.H.G.T., but he remains on the faculty of the School of Medicine. And Penn continues to defend their embattled researcher, though he can no longer do any research and his credibility as a doctor and academic have been erased by his tragically irresponsible actions.

There is not a single compelling reason why James M. Wilson should be allowed to remain at Penn. He is not only dead weight and an impediment to further gene therapy innovation at this university — he is a black mark on Penn’s distinguished history and an embarrassment to its remarkable faculty.

As we mark the third anniversary of a tragedy that should never have happened, we remember the sacrifice of a brave young man while condemning the outrage that is Wilson’s continuing presence at Penn.

It is becoming a sorrowfully repetitive refrain on this page, but it is no less true today than it was two years ago. For the good of the University and for what’s left of his own honor, James M. Wilson must go, and it is high time that Penn’s leaders took serious action to deal with this most serious of issues. ~~~~~~~~~~~~~~~~~~~~~

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