Political Judo or Karate
for Those With Interest in Conflict?

By

Leonard Zwelling

         Several readers have commented on my letter to The Cancer
Letter and the unsigned MD Anderson response to it. I had originally thought I
would leave the issue be, but, as usual, self-control is not my strongest suit.

         I, too, was very surprised by the Anderson response. I had
anticipated their President or lead counsel would write a point by point
refutation of my letter or at least a detailed description of how the
institution proposed to manage the recent all-stock deal Anderson made with two
biotech companies for the manufacturing and testing of CAR T cells. It is
supposed, at least in the press, that some of those cancer patients upon whom
the new experimental therapy will be tried will be drawn from the MD Anderson
population as human research subjects.

To
me this seemed contradictory to the Conflict of Interest policy. There is no
way to manage what is in the minds of the MD Anderson faculty investigators,
those researchers developing the therapy in the laboratory or those clinicians who
will be administering the cells to real people, when those faculty members know
that the better their results are, the richer the institution gets and the
happier their bosses become. Everyone wants to please the boss, something I never learned all that well.

         The accompanying story in The Cancer Letter about a similar
problem that has placed my other alma mater, Duke, in hot water for not
listening to a medical student who warned the Duke administration and the
relevant research team members of the research misconduct surrounding cancer
trials there and in which the investigators had a large equity stake, makes my
point better than I could myself.  The
lawsuit brought by the survivors of the human subjects from the Duke trials and the attending doctors
goes to trial on Monday in Durham.


http://www.heraldsun.com/news/localnews/x1351411595/Trial-over-flawed-Duke-cancer-research-set-to-start

         It really is this simple.

         You cannot MANAGE conflict-of-interest. Conflict-of-interest
takes place in the human mind, a place described by many, including Freud, as very tricky to manage. The unsigned letter from Anderson does not seem to recognize
this all too simple fact. The letter is quite correct when it says that the
Anderson policy does allow for “management.” It is incorrect in saying I supported
that back in its original version in 2002. I did not. I just lost the argument
to John Mendelsohn who profoundly disagrees with me on this subject as he and I
have had many discussions about human subjects research regulation and
conflict-of-interest. Not surprisingly, he won them all and I got fired.

         The letter from Anderson was also correct in relating my
firing from my next job and for similar reasons. I insisted on a certain level
of excellence in my area of responsibility and would not compromise on it with
those to whom I reported. They were willing to overlook certain shortcomings that I was not.
Expressing that will get you fired and it did.

         All of that is absolutely true.

         So I only have one question left.

         How is MD Anderson going to manage the conflict that has
already been set in place?

         They came at me using the karate at which their President is
known to be skilled. I don’t know any martial arts at all. All I have is a
laptop. Still, I think the public deserves an answer to my question. MD Anderson
is a tax-exempt, state institution. Will it be paying taxes on the capital
gains derived from the increased value of their newly acquired stock, the value
of which they themselves can increase with “good results” from ensuing clinical
trials done at MD Anderson by MD Anderson faculty all of whom report to the
President? Haven’t they been down this road before in 2002 with the drug
developed by Dr. Mendelsohn himself? These seem to me to be the most important
questions of all because if you can be tax-exempt and make capital gains, it
may be time for a “Detroit-type” recall on that CAR T technology being tested
at Anderson.

         Perhaps Senator Grassley needs to take another look at MD
Anderson’s tax status?

         And, by the way: here is a really good analysis of the deal:

http://www.fool.com/investing/general/2015/01/14/why-investors-are-excited-about-intrexon-and-zioph.aspx

Leonard Zwelling