February 4, 2015 is World Cancer Day. The rapidly increasing cost of cancer drugs should be broadly discussed. The Union for Affordable Cancer Treatment (UACT), a union of people affected by cancer (http://cancerunion.org/) is asking the author and co-author of the “Tufts Cost Study,” –a not-yet-released “study” used to justify high prices of drugs without providing data– to address the following questions:
– On November 18, 2014, a press release and some social media described the DiMasi study 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?
-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?
-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?
A copy of the letter is available here: http://cancerunion.org/actions.html
Here is a brief recap of previous UACT letters re the “Tufts Cost Study”:
On November 24, 2014. UACT sent a letter to Anthony P. Monaco, Office of the President, Tufts University, copies to Michael Baenen, Chief of Staff, and Peter Dolan, Chairman of the Board of Trustees, Tufts University, regarding the Tufts University press conference to announce an estimate of $2.6 billion as the R&D costs for new drugs. The letter asks Tufts to provide more transparency about the funding of the press conference and the study, and to answer several questions about the relevance of the study to new treatments for cancer.
On December 8, 2014. UACT received a brief letter from Anthony P. Monaco, President of Tufts University, in response to our letter requesting more information and transparency surrounding the drug R&D cost study. In his reply, he directed all questions to the principal researchers of the study.
The previous communications and signatures are available here: http://cancerunion.org/actions.html