Search terms: Anil Potti Duke University
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FC is traveling at the moment. I am posting without either analysis or comment a statement from Chancellor Victor Dzau sent to all Duke medicine employees -- a highly unusual communication just after noon on Saturday. FC work on other, very critical developments in the Potti matter, promised earlier in the weekend, is not yet complete. Check back.
Text:
As many of you may know, investigations related to work done by Dr. Anil
Potti and others are continuing in earnest. A research misconduct
investigation is proceeding and several of the pivotal scientific papers
related to this work have now been retracted from the medical literature.
Additionally, Duke is cooperating fully with a major national review of
this particular research and of the field of genomic-guided research
generally, initiated by the Institute of Medicine (IOM).
Periodic news reports continue to follow the ramifications of this
discredited work and I anticipate that a significant article will appear in
the local media tomorrow.
I believe it is important to reinforce that Duke’s approach to this
situation has, from the beginning, been focused foremost on a concern for
the patients who were enrolled in these clinical studies. Many steps were
taken, including in the original design of these trials, to engage expert
opinion to minimize potential risks to our patients, including
recommendations for how patients on actively guided study therapies should
be managed, and assessments about the safety, efficacy and appropriateness
of the arms to which patients could have been assigned in these studies.
Therefore, even as we regret these circumstances, we believe that
appropriate steps were taken to minimize risk to our patients.
Last fall when it became apparent that data integrity issues were at the
root of the problem and these studies were closed, there was mutual
agreement between the clinicians and administration that the treating
physicians should discuss these issues with the patients who were enrolled
in the trials. At this time, Duke administrators are also reaching out to
these patients and their families, to express our apologies and answer any
remaining questions.
We are also a learning organization, so great emphasis has been put on
learning as much as possible from this experience. To that end, I
established a committee comprised of Duke's leading scientists to develop a
quality framework for genomic research intended to improve the checkpoints
and validation of such science before reaching patient studies -- that
work is nearly complete and will better position Duke to prevent similar
incidents.
I want to again say how proud I am of our basic and clinical researchers,
and of our cancer care teams and clinicians. We have taken the issues
raised by this research issue very seriously; patients and our community
can be assured that Duke's cancer care and research programs remain among
the most respected in the country and will be strengthened by the lessons
of this experience.
