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May 2005 Reinventing Drug Development
by Nancy Evans America’s health care system is broken, drug development takes too long and costs too much, and the FDA needs major reform.Better prediction, not only of potential benefits of new drugs but also of potential harm, remains an unfulfilled promise of biotechnology, speakers from the industry said at the sixth annual Health Care and Biotech Symposium at the Business School in January. Using pharmacogenomics to identify biomarkers that have true predictive value would shorten development time. So would focusing more resources on larger Phase 1 trials to maximize the collection of biological information early on. The United States also needs a better system for reporting health problems with new drugs after they are approved, said Donald Kennedy, editor of the journal Science, a former commissioner of the Food and Drug Administration and president emeritus of Stanford. New drugs cost in the range of $1.2 billion each to develop. Philip Pizzo, dean of Stanford’s School of Medicine, asked biotech executives on a panel for an explanation. “The main reason drug development is expensive is that it’s so unproductive,” James Sabry, CEO of Cytokinetics, responded. “The chance of finding a drug is small. The chance of finding an innovative drug is smaller. We’re developing drugs like we did 10 or 20 years ago when outcomes were hard to predict,” Sabry said. The discussions, organized by the student Stanford Health Care Club, drew a diverse audience of more than 250, including students and alumni from the Stanford schools of business, medicine, and law. Focusing on smaller markets with unmet medical needs also can reduce costs, some say. “What it costs you to reach the key decision makers—those who treat cancer—is much less than trying to reach a broader general market,” explained William Ringo, CEO of Abgenix. “Oncology is an example of lower-than-blockbuster cost of reaching a market.” The panel also talked about price and the fact that U.S. investment in drug development subsidizes lower prices in countries such as Canada. “The little secret was that big pharma made pacts with other industrialized countries to not have them pay [for research and development] because sales to those countries get manufacturing up and increase profits,” explained Corey Goodman, CEO of Renovis. Thanks to public Internet access, that arrangement has unraveled, opening the need for discussions of R&D cost-sharing by those countries that can afford to pay more. Belated bad news about blockbuster drugs such as Vioxx and Celebrex rocked the U.S. FDA last year and eroded public trust in government and the pharmaceutical industry, speakers said. “We have no reliable system in the U.S. for detecting adverse drug reactions,” said keynote speaker Kennedy, who led the FDA in the 1970s. Busy doctors tend to underreport adverse drug reactions on a voluntary basis, and companies, required to report, are “doing reasonably well,” Kennedy said. “But at the end of the day … we just don’t know enough soon enough.” He cited systems in other countries such as England and New Zealand as “decisively better than ours.” The reporting or underreporting of results from clinical trials are another aspect of the bad news problem at the FDA. The International Consortium of Medical Journal Editors has announced that its members will no longer report the results of a clinical trial unless that trial is registered in a publicly accessible forum before enrollment begins. “The registry that everyone thinks is the right one is www.clinicaltrials.gov, which is maintained by the National Institutes of Health,” Kennedy said. This issue is being debated in Congress, he noted, and the pending legislation “looks tougher than the editors’ requirement, but nobody knows what the outcome will be.” |
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