Scientists tell how to streamline drug research

The current model of drug development is inefficient, redundant and costly, according to a report by the Assn. of American Medical Colleges and the federal Food and Drug Administration.

The topic is such a hot one that research groups and think tanks have requested at least 4,000 copies of the August report that was the result of a January conference where researchers gathered to talk about how to rid drug research of the secrecy that's hindering new developments.

David Korn, MD, senior vice president of the AAMC's division of biomedical and health sciences research hopes that the large number of requests is a sign that drug companies, universities and government groups are prepared to make the fundamental changes outlined in the report.

"The current drug development methodology yields a very small return for an awful amount of work," Dr. Korn said. He cited data from Pfizer estimating that it takes 15 years and $881 million to screen 11 million compounds to get one new drug approved by the FDA.

Dr. Korn said researchers were eager to eliminate repeating each others' mistakes, but the framework to do that requires a fundamental change in an industry that keeps data secret and restricts sharing information with intellectual property claims.

To begin to ease restrictions, researchers recommended creating collaborative systems to share research, such as toxicology data, which is considered "pre-competitive," or part of the building blocks of development far from the final product stage.

With such data, Dr. Korn said researchers would be able to recognize early signs of organ toxicity, keeping them from wasting time and money pursuing dead ends.

They also recommended that the industry develop mechanisms to facilitate learning from failures, such as a consortium to analyze failed clinical trials.

In addition, researchers favored designing new regulatory incentive policies for small-market drugs and creating agreements that allowed them to share information now restricted as intellectual property or proprietary.

"Everyone agrees we need a better system that's quicker and much less expensive," Dr. Korn said. "If we could succeed in starting this process, it would be a wonderful achievement. The first step is always very difficult, but it's not rocket science."