July 22, 2010

U.S. research in decline, Duke scientist argues

U.S. research in decline, Duke scientist argues

Robert Califf, M.D.

Robert Califf, M.D.

That was the question posed Monday by Robert Califf, M.D., at the 11th annual Visiting Scholars Day dinner, hosted by the Vanderbilt Office of Clinical and Translational Scientist Development.

Legal and regulatory constraints put the United States at a competitive disadvantage when it comes to conducting clinical trials of new drugs and treatments, argued Califf, vice chancellor for Clinical Research at Duke University. “We’re headed in the wrong direction,” he said.

Vanderbilt scientists attending the dinner at the University Club responded with their own question: Is U.S. science truly losing ground?

After all, many of the potential drugs that are being tested in India and China – because the trials are cheaper to do there – were discovered here.

And while the Indians and Chinese are investing heavily in genomic medicine, they are reluctant to share information with the rest of the world, said Ellen Wright Clayton, M.D., J.D., director of the Vanderbilt Center for Biomedical Ethics and Society.

Clinical trials “need to take place in the social context in which the health concern arises,” Clayton continued. “Exporting (them) is a non-sustainable strategy.”

Califf, who also directs the Duke Translational Medicine Institute, said he didn’t favor “off-shoring” clinical trials.

“What I’m in favor of is globalization so that every country does research in its own cultural context and you combine the data,” he said.

Unfortunately, the United States is perceived “as a declining empire because … we’re too expensive and we’re too complacent about what we’re doing,” he argued.

What’s needed, Califf said, is an “ingenious” system of national data networks that, by sharing electronic health information, could dramatically reduce the cost and accelerate the pace of clinical trials. “Then everybody will copy us,” he said.