[Ip-health] UACT letter to Tufts

Manon Ress manon.ress at cancerunion.org
Tue Nov 25 04:59:14 PST 2014


The Union for Affordable Cancer Treatment (UACT) has written Anthony
Monaco,  the President of Tufts University, and Peter Dolan, the Chairman
of the Tufts Board of Trustees, asking for more transparency of the funding
of the Tufts drug development cost study and the press conference.  The
letter also asks for more information about the still unavailable study
that was the subject of the press conference. This includes five questions
about the study methodology and data. The UACT letter was signed by 18
persons living in 10 countries.

(for more about UACT, see: http://cancerunion.org/about.html),


The text of the letter follows:

(Also available as a pdf here:  http://cancerunion.org/actions.html)


November 24, 2014

Anthony P. Monaco
Office of the President
Tufts University
Ballou Hall, 2nd Floor
Medford, MA 02155
617-627-3300

CC: Michael Baenen, Chief of Staff
Via email: michael.baenen at tufts.edu
CC: Peter Dolan, Chairman of the Board of Trustees

Dear President Monaco,

We are writing on behalf of the Union for Affordable Cancer Treatment
(UACT) to express concerns about the recent press conference held by the
University in connection with research regarding the cost of drug
development. This press conference was held on November 18, 2014, by the
Tufts Center for the Study of Drug Development (CSDD) to announce "Cost to
Develop and Win Marketing Approval for a New Drug Is $2.6 Billion."[1]

The main point of the press conference was to establish that drug
development costs were $2.6 billion for a new drug, a number that was more
than a billion higher than a 2012 AstraZeneca funded study by the Office of
Health Economics[2], and 3.2 times higher than an earlier estimate
published by the CSDD in 2003.

Many observers will undoubtedly read the new "Tufts" study as a
justification of high drug prices, including the very high prices for new
drugs to treat cancer, a characterization that fits the two previous
studies[3] on this topic published by Joseph DiMasi and this co-authors.[4]

Our concern is that Tufts University organized a press conference to
announce the results of a study without providing transparency over who
funded the study or the press conference, and more importantly, without
providing the public the study itself, or even many of the details used to
justify the new result.

Following the press conference, Tufts only provided a press release and a
few powerpoint slides,  and failed to address several questions about the
reasonableness or relevance of the results so loudly promoted by the
University.

The lack of transparency regarding the data used to make the estimates, and
the failure to disclose the study itself, creates a situation where the
public is being asked to trust the study authors and Tufts University on an
issue that is often used to justify high drug prices.

Since Tufts is soliciting funding from pharmaceutical drug manufacturers,
and the authors often are consultants to the pharmaceutical industry, we
have ample reason to be skeptical of the balance and objectivity, and also
of the manner in which the study will be used by the pharmaceutical
industry, including to justify high prices for cancer drugs.

We would like you and the Tufts University Office of the President to
respond to the following five points:

Funding. Tufts is an academic institution and as such should provide basic
information regarding who paid for the press release, press conference and
researchers and what amount. Not only are there no details on the data and
substance of the study (or even a report!) but we have no details about
Tufts financial interests nor do we not know if the peer reviewers for
example have any conflict of interest themselves.

Secret study data. Tufts should provide information on the data on trials
on which the final figures are based. In particular, how many patients were
in the trials, how much money was spent on the trials included in the
"study," and what were the per patient costs?  In the absence of the
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. FDA medical reviews for new approvals disclose the number of
patients in trials used to support drug registration, and the numbers of
cancer drugs are substantially lower than for non-cancer 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. 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?

We look forward to your responses to these questions and requests for
information.


Sincerely,

Ilze Aizsilniece, MD, MSc, Health Projects for Latvia and University of
Latvia
Thiru Balasubramaniam, Sri Lanka
Joyce Bichler, ACSW, Deputy Director, Breast Cancer Action, USA
Michael H.Davis, Professor of law, Cleveland State University,
         Progressive Intellectual Property Law Association, USA
Ophira Ginsburg, MSc, MD FRCP Medical Oncology, Public Health,
        University of Toronto, Canada
Andy Gray BPharm MSc(Pharm) FPS FFIP, South Africa
Ellen 't Hoen, LLM, The Netherlands

Caroline Izambert, France
Jordan Jarvis, Young Professionals Chronic Disease Network
        (YP-CDN) & Harvard Medical School, USA
Sandeep P. Kishore, M.D., Ph.D. Young Professionals Chronic
          Disease Network (YP-CDN) & Yale School of Medicine, USA
Gaelle Krikorian, France
Ruth Lopert MD FAFPHM, Australia
Marcus Low, TAC, South Africa
Kirsten Myhr, Norway
Manon Ress, USA
Judit Rius, Spain
Philippe Rivière, France
Joy Spencer, USA

Footnotes

1. http://csdd.tufts.edu/news/complete_story/pr_tufts_csdd_2014_cost_study

2. Jorge Mestre-Ferrandiz, Jon Sussex And Adrian Towse, The R&D Cost Of A
New Medicine, Office Of Health Economics, December 2012

3. DiMasi, J. et al. (1991) Cost of innovation in the pharmaceutical
industry. Journal of Health
Economics. 10(2), 107-152; DiMasi, J. et al. (2003) The price of
innovation: New estimates of drug development costs. Journal of Health
Economics. 22(2), 151-185.

4. For example, during litigation in India over a compulsory license of
patents on the cancer drug Sorafenib, Bayer consistently cited the 2003
DiMasi study to an attempt to rebut actual data from SEC filings on the
costs of R&D for Nexavar, the Bayer version of this drug (we could add many
more examples).



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