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A Department of Justice press release dated September 17, 2008 said that the government will not oppose  a proposal by CEO Roundtable on Cancer that they develop the model contract language for clinical trials of potential new cancer treatments. The department found that the proposal would not be “anti-competetive.”  The press release described CEO Roundtable on Cancer as “a non-profit corporation.”

What the release did not say is that the “non-profit organization” CEO Roundtable is made up of heads of Big Pharma, a phrase that is often used to refer to companies with revenue in excess of $3 billion, and/or R&D expenditure in excess of $500 million.

Will Big Pharma’s control over what constitutes a clinical trial exclude non-pharmaceutical approaches, including the impact of nutrition and vitamins, to curing cancer?

WASHINGTON The Department of Justice announced today that it will not oppose a proposal by the CEO Roundtable on Cancer (CRC) to develop and publicize model contract language for clinical trials of potential new cancer treatments. The Department said the language is not likely to be anticompetitive and can be used to help increase efficiency in contract negotiations, potentially reducing costs and shortening the time needed to begin clinical trials.

The Department’s position was stated in a business review letter from Thomas O. Barnett, Assistant Attorney General for the Antitrust Division, to counsel for the CRC.

The CRC and the National Cancer Institute (NCI) will jointly lead the project to develop model language for clinical trials. The CRC is a non-profit organization whose goal is to make continuous progress toward the elimination of cancer as a personal disease and public-health problem. The NCI is the federal government’s principal agency for cancer research and training and is part of the U.S. National Institutes of Health.

The CRC requested a business review letter from the Division expressing its enforcement intentions regarding the CRC’s and NCI’s proposal to develop and publicize model clauses for use in clinical-trial agreements. Clinical-trial agreements typically involve three parties: a pharmaceutical or medical-device company known as a “sponsor”; a hospital, clinic, or university where the research is performed, known as the “research institution”; and the physician who is in charge of the trial, known as the “principal investigator.”

“Making the model language available to sponsors, research institutions, and principal investigators, as proposed by CRC, is not likely to reduce competition,” Barnett said in the letter. In the letter, Barnett explained that the “model language does not contain any provisions specifying prices or rates,” and that “[w]hether to use the language or any of its provisions will be left to the determination of each party acting independently.”

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