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Biotech / Medical : Biotech Valuation -- Ignore unavailable to you. Want to Upgrade?

To: Michael Young who wrote (8026)	3/13/2003 11:19:37 PM
From: tuck	Respond to of 52153

>>WASHINGTON -- After drugs get early approval to be sold in the U.S., pharmaceutical companies have little incentive to finish required research on them, a federal panel of cancer experts said Thursday. Further, doctors and patients are confused by the government's early approval of drugs that treat life-threatening conditions, these experts said, and wrongly think that drugs that get early approval are better treatments. In it's first such meeting, the Food and Drug Administration (News - Websites) called in makers of eight drugs for a two-day update on studies the companies agreed to complete as a condition of this early approval. Companies that presented at the conference included Ligand Pharmaceuticals Inc. (NasdaqNM:LGND - News) , MedImmune , Wyeth , Pharmacia , Schering-Plough Corp. (NYSE:SGP - News) , and Johnson & Johnson . Companies that win so-called accelerated approval do so by showing the drug is reasonably likely to work in a seriously sick, underserved group of patients. This conditional approval is supposed to be followed by full approval once studies confirm the drug's benefit. However, the FDA and drug makers have recently come under fire because some drugs on the market as long as seven years haven't completed the required research. The FDA has the authority to remove drugs from the market if companies don't meet these obligations, however, the agency has yet to do this. Panelist Dr. Silvana Martino, head of medical oncology at the breast cancer unit at the John Wayne Cancer Institute in Santa Monica, said companies are less motivated to finish studies if the drug is already earning the drug maker money. "It's an inherent problem," Mr. Martino said. "I'm personally very unhappy," said Dr. Richard Pazdur, who directs the FDA's cancer drugs division. Companies are making a profit, Pazdur said, which places responsibility of finishing the studies on the drug makers. Mr. Pazdur mentioned SkyePharma PLC DepoCyte, which is approved for certain, hard-to-treat brain tumors. "We have a drug here approved in 1999. Getting started with a confirmatory trial in 2003 points out some real problems." SkyePharma said it hadn't shirked its responsibilities, but echoed the comments of many drug companies that treat rare conditions, telling the panel it struggled to enroll enough patients in its studies. Mr. Pazdur said companies need to come to the FDA with a long-term plan early in the process instead of waiting until after a drug wins accelerated approval to begin the next phase of testing. Also, the FDA may need to rewrite the way it describes accelerated approval on drug labels so doctors understand it means more information on the drug is needed. The FDA began the accelerated approval process in 1992, as a way to lower the requirements drug makers had to meet to get medicines on the market for treating illnesses which aren't adequately addressed. Instead of waiting years or decades to prove a drug actually saves lives or completely cures a disease, the FDA allows drug makers to test for other signs that the drug should be effective. For example, several cancer medicines have been approved based on their ability to shrink tumors after drug makers promised to complete studies proving they extend patient's lives. Panelist Dr. Otis Brawley, associate director for cancer control at the Winship Cancer Institute at the Emory University School of Medicine in Atlanta said using the term accelerated approval implies that the FDA approved it quickly, so it must have been a slam dunk. "Instead it means the data are very tenuous," Mr. Brawley said. Better names, he said, would be "provisional, conditional or my personal favorite, premature approval." Dr. Robert Temple, chief of one FDA's drug centers, said the agency wants to improve the overall process. "We still believe in the idea of accelerated approval," Mr. Temple said. "We just want it work properly. It isn't only the companies that have screwed up." << Cheers, Tuck