NIH rulemaking on transparency of clinical trials

The NIH has a notice about a proposed rule that “clarifies and expands requirements for the submission of clinical trial registration and results information to the ClinicalTrials.gov database.” Comments are due on or before February 19, 2015. We may ask the NIH to consider expanding the trials registry to include more information on the economics of clinical trials.

Here is a link to the Regulations.Gov docket for the proposed rule:

http://www.regulations.gov/#!documentDetail;D=NIH-2011-0003-0003 Continue Reading

UACT sends letter to Tufts President, Chairman of Trustees, asking questions about R&D cost study

On November 24, 2014. the Union for Affordable Cancer Treatment (UACT) sent a letter to Anthony P. Monaco, Office of the President, Tufts University, with copies to Michael Baenen, the Tufts Chief of Staff, and Peter Dolan, Chairman of the Board of Trustees for Tufts University, regarding the Tufts University press conference to announce an estimate of $2.6 billion as the R&D costs for new drugs. Continue Reading

The Winning Bet

Leading up to the release of Professor Joe DiMasi’s latest study of the cost of drug development, KEI offered $50 to the individual who could most accurately predict the new cost for drug R&D.

We received 26 guesses, ranging from $1.157 billion to $5 billion.

Joel Lexchin’s estimate ($2.47 billion) was the closest to DiMasi’s number ($2.558 billion). It was also the 5th largest estimate.

A complete list of submissions is below.

Name & Guess
Charles Clift – 1.157 billion
Nicole H – 1.2 billion
Ronald Rader – 1.55 billion
Wouter Deelder – 1.655 billion
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Former WTO Director-General, Pascal Lamy, mooted to chair Global Fund’s Equitable Access Initiative

On 14 March 2014, KEI published “Resurrecting the Ghost of Høsbjør Past: Global Fund seeks to establish global framework on tiered pricing enforced by WTO rules” in which we provided an analysis of the Global Fund’s plans to create a global framework for tiered pricing enforced by the rules of the World Trade Organization (WTO). Continue Reading

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WIPO patent committee (SCP21): Intervention of KEI on Patents and Health

The following intervention on patents and health was delivered by KEI during the 21st session on WIPO’s Standing Committee on the Law of Patents (SCP). Part 1 was delivered on 4 November 2014 during discussions of the Feasibility Study on the Disclosure of International Nonproprietary Names (INN) in Patent Applications and/or Patents. Part 2 was delivered on 5 November 2014 during general discussions on patents and health.

Statement of Knowledge Ecology International (KEI)

Item 7: Patents and health

Part 1

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