Say It Ain’t So, Ron: Conflict of Interest 202

Say It Ain’t So, Ron:
Conflict of Interest 202

By

Leonard Zwelling

(for Jesse Gelsinger)

         All of you fond of Enron and ImClone memorabilia surely
remember the Sunday morning in June of 2002 when the Washington Post’s Justin
Gillis revealed to the world that 195 patients receiving Erbitux on clinical
trials at MD Anderson first learned that the President of MD Anderson, John
Mendelsohn, who supervised all of the doctors overseeing the trials, was making money from the patients’ participation in the trials. These human subjects had not been informed of the President’s
conflicted interest in their well-being prior to that moment. As the VP for
Research Administration, neither had I. Mendelsohn also made about $6M on
October 29, 2001 when he sold 90,000 shares of ImClone stock to Bristol Myers
with other ImClone board members.

http://irbforum.org/read.php?2,8689

         This led the ever-nimble JM to form a committee to rewrite
the Anderson conflict of interest policy. Paul Mansfield and I led this effort.

         If you go on the MD Anderson web site now, there are lists
of all of the conflicts or potential conflicts courted by the current faculty
including the President. I guess saying your conflicted excuses it.

         In today’s Houston Chronicle Todd Ackerman reports another deal and this one is a
doozie. But let’s drop back a second and all get on the same conflicted page.

         A conflict of interest exists when a person or organization
is serving two masters. Usually one of these is money. The other can be impartiality,
dispassion or just truth telling.

         In academic medicine, ever since the passage of the
Bayh-Dole Amendment in 1980, this has become an ever larger issue. Researchers previously loyal to scientific truth only, could line their pockets
forming companies using venture capital (or NIH grant money), then use the results of their
laboratory or clinical trial work by declaring that work be “ground-breaking” and
watching the founders’ stock they own jump in value. The question is, how can
we be sure of the honesty of the research when the researcher has ulterior financial motives
for making it look as good as he or she can? Answer: eliminate the conflict. 

Conflicts do not arise on paper. They arise in minds when a human tries to both
be an objective scientist and also determine, “what’s in it for me?” This is a
dangerous set of circumstances (usually called “the fox guarding the chicken
coop”) and cannot be managed as my colleagues on the Conflict of Interest
Committee that I established in 2002 claim. You cannot manage the mind of a
human. Thus, the conflict has to go.

         If you want to take money from Pfizer for your research,
sign the contract so the money goes to MD Anderson not you. If you can make a
boat payment with the money, don’t take it. Take no stock. No gifts. No food.
The last person who fed you because they loved you was your mother.

         Am I an extremist on this issue? You better believe it
because I have met Paul Gelsinger, Jesse Gelsinger’s father. Jesse died while on
a clinical trial at the University of Pennsylvania where everyone around his
bedside and up the ivy halls were conflicted with the company doing the “gene
therapy” for Jesse’s non-malignant disease. There is no being a little pregnant.
There is no being a little conflicted. Mr. Gelsinger could not tell me the exact number
of the settlement from Penn except he said it was in 8 figures.

http://www.houstonchronicle.com/news/houston-texas/houston/article/M-D-Anderson-to-earn-100-million-for-6013593.php

         So today MD Anderson announced a new deal with ZIOPHARM and
Intrexon for $50M each in stock for the CAR T cell technology developed at
Anderson (is that in Minnesota now?) So I have only one question. If MD
Anderson has all of this stock that is worth $100M now but zero (e.g., Aveo) if
the therapy is a bust, why should the investigators say it doesn’t work if it
doesn’t? It would cost them a fortune and cost MD Anderson as well. I guess the
Aveo example was insufficiently heuristic for the leadership. That’s because to
teach an old dog new tricks you don’t wag a finger. You roll up a newspaper.

         It should be fun watching all this transpire and God knows I
hope this new therapy works. But I remember Paul Gelsinger sitting in my office
and I can assure you that no amount of money, even 8 figures, was enough to
compensate him for the loss of his son at the hands of greedy doctors and
university administrators.