[Ip-health] Letter from UACT to Professor DiMasi, with 5 questions about the Tufts Cost Study
manon.ress at keionline.org
Wed Feb 4 04:37:22 PST 2015
Please find UACT February 3, 2015 letter to Prof. DiMasi regarding the
Tufts Sturdy .
The previous communications and signatures are available here:
February 3, 2015
Center for the Study of Drug Development
75 Kneeland Street
Boston, MA 02111
cc: Anthony Monaco, President, Tufts University; Kenneth Kaitin, Director
of CSDD; Henry Grabowksi, Duke University; Ronald Hansen, University of
Dear Dr. DiMasi:
At the suggestion of Tufts University President Anthony Monaco, the Union
for Affordable Cancer Treatment (UACT) would like to obtain from you
some clarifications regarding the recent "Tufts Drug Development Cost
Study" and the November 18, 2014 press conference during which the
conclusions of that study were presented.
We wrote to Dr. Monaco to ask who funded the study and the press conference
that announced the results of a study, without providing the public the
study itself, nor many of the details used to justify the new result.
Many observers will undoubtedly read the new study as a justification of
high drug prices, including the very high prices for new drugs to treat
cancer, an outcome that occurred following the release of the previous two
iterations of the study. Indeed, the $2.6 billion study number was cited
by John Castellani, the CEO of PhRMA, in a January 26, 2015 letter to the
New York Times where he specifically defended high prices for cancer drugs.
As per President Monaco's suggestion, we are asking you to provide
information on five points:
Funding. The press release and the social media described this as the
"Tufts Cost Study." Tufts is an academic institution. Can you tell us who
paid for the press release, the press conference and the researchers, and
what amount? Can you also let us know whether the peer reviewers of the
study include persons whose research is paid for by drug companies?
Undisclosed study data. Tufts University should provide information on the
data on trials on which the final figures are based. Can you tell UACT the
number of patients in each of the trials in the database, and in
particular, the number of patients associated with the trials for each drug
in the study? Can you tell us how much money was spent on the trials
included in the study, and what the per patient costs were? In the absence
of these details it is impossible to evaluate the reasonableness or
relevance of the study sample to the R&D costs for drugs that are the
center of pricing disputes.
Cancer Drugs. The FDA medical reviews for new drug approvals disclose the
number of patients in trials used to support drug registration. For at
least the past ten years, the number of patients in trials for new cancer
drugs are substantially lower than for non-cancer new drugs. How does the
study data relate to the facts for drugs for cancer? How does the Tufts
study deal with these differences, and should we consider the study even
relevant to products for cancer?
Orphan Drug Tax Credit. A majority of new cancer drugs qualify for the
orphan drug tax credit, which subsidizes 50 percent of the costs of
clinical trials. In 2014, 9 of 10 new cancer drugs were approved as orphan
products. How did the study account for this subsidy, or was it ignored?
Public funding of research. The annual budget for the NIH National Cancer
Institution is nearly $5 billion per year, and governments and charities
around the world fund cancer research. How does the study take this into
account? When the NIH provides funding for grants and contracts for work
on the development of a particular drug, does the dataset show lower
pre-clinical expenses from the private companies?
Since Tufts University highly publicized the results of the study, and
PhRMA and others are already using the study to defend high cancer drug
prices, we ask that the study itself be made available now, so it can be
evaluated by third parties for relevance, context, balance and accuracy.
We look forward to your response to these questions about the study and to
our concerns regarding the press conference, which you can send to Manon
Ress at info at cancerunion.org.
(In alphabetical order)
Andy Gray BPharm MSc(Pharm) FPS FFIP, University of KwaZulu-Natal, South
Ellen 't Hoen, LLM, The Netherlands
Gaelle Krikorian, France
Ilze Aizsilniece, MD, MSc, Health Projects for Latvia
Kalyani Menon-Sen, The Campaign for Affordable Trastuzumab, India
Kirsten Myhr, Norway
Manon Ress, USA
Margaret Ewen, Health Action International
Ophira Ginsburg, MSc, MD FRCP Medical Oncology, Public Health, University
of Toronto, Canada
Ruth Lopert MD FAFPHM, Adjunct Professor Dept of Health Policy, George
Washington University, USA
 More information about UACT is available on our web site at
Manon Ress, Ph.D.
Knowledge Ecology International, KEI
manon.ress at keionline.org, tel.: +1 202 332 2670
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