Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

Biotech / Medical : Pharma News Only (pfe,mrk,wla, sgp, ahp, bmy, lly) -- Ignore unavailable to you. Want to Upgrade?

To: Anthony Wong who wrote (1164)	12/2/1998 1:25:00 PM
From: Anthony Wong	Read Replies (1) \| Respond to of 1722

Monsanto Co. Reiterated 'Buy' at DLJ Bloomberg News December 2, 1998, 9:20 a.m. ET Princeton, New Jersey, Dec. 2 (Bloomberg Data) -- Monsanto Co. (MTC US) was reiterated ''buy'' by analyst William R. Young at Donaldson Lufkin & Jenrette Securities Corp. The 12-month target price is $52.00 per share. -- Andrew Bekoff in Princeton, New Jersey, (609)279-3652

To: Anthony Wong who wrote (1164)	12/2/1998 1:36:00 PM
From: Anthony Wong	Respond to of 1722

U.S. FDA Officers Say 27 Drugs Shouldn't Be on Market, Watchdog Group Says Bloomberg News December 2, 1998, 11:03 a.m. ET FDA Officers Say 27 Drugs Shouldn't Be on Market, Report Finds Washington, Dec. 2 (Bloomberg) - U.S. Food and Drug Administration medical officers in a survey identified 27 drugs they thought should not have won agency approval in the last three years -- according to the watchdog group Public Citizen. Nineteen of 53 officers who replied to the Public Citizen survey identified the 27 drugs and said they had in at least some instances raised concerns about their safety, according to the consumer group's report. The report comes as FDA critics charge the agency's accelerated review of drugs has led to an increase in recalls for safety reasons. Public Citizen did not name any of the 27 drugs and was not specific about the concerns the medical officers raised. Many of the officers, who are the FDA scientists responsible for closely reviewing an application and making approval recommendations, said the agency is clearing more drugs in less time and said that they felt more pressure to recommend approvals than three years ago. ''Our findings are shocking by any yardstick,'' said Sidney Wolfe, director of Public Citizen's Health Research Group and a co-author of the study. ''Subtle and not so subtle pressure is being brought to bear on FDA physicians who dare to question a drug's safety.'' Public Citizen's Health Research Group, in recent years a frequent critic of the FDA for moving too fast to approve drugs, queried a total of 172 agency medical officers for its study. Of that group, 53 replied to the survey, a roughly 31 percent response rate. The survey promised total anonymity to officers who chose to respond. Eight of the replying officers who filled out surveys said in a total of 14 instances over the past three years, they had been instructed not to present their own opinion or data during an advisory panel hearing called to review particular application, the report said. Most Recalls in History The Public Citizen report follows the most drug recalls in FDA history. The withdrawal of American Home Products Corp.'s Duract pain reliever in June marked the sixth withdrawal of a drug due to safety concerns in 12 months, after only 10 such recalls between 1980 and 1996. During that 12-month period, American Home also pulled its fenfluramine diet drug and Redux, a diet drug it sold for Interneuron Pharmaceuticals Inc. Meanwhile, Roche Holding AG pulled its Posicor blood pressure drug and Hoechst AG replaced its Seldane allergy drug with its next generation Allegra version -- following worries about dangerous interactions between Seldane and other drugs. And in August 1997, Novartis AG pulled its Ex- Lax off the shelves after the U.S. government proposed banning its key ingredient on safety concerns. Pressure on FDA The spate of recalls put pressure on the FDA as critics said the agency was moving too fast to approve drugs and not screening them carefully enough. In recent years, the agency has nearly doubled the number of drugs it approved each year. Between 1996 and 1997 the agency approved the largest number of drugs -- 92 -- ever in a two-year period. Still, Congress has told the FDA that if anything, it should speed up its approval rate. And FDA officials and supporters say the agency's standards haven't suffered as a result of faster approvals, which have come mainly as the agency has hired more reviewers with funds garnered by fees from companies. Many side effects are so rare that they don't emerge in clinical trials, no matter how thorough they are, FDA supporters say. In addition, the growing number of new drugs available means that unforeseen drug interactions are more likely, they say. Public Citizen in the past has often criticized the FDA and drugmakers. In August, the group petitioned the FDA to convene an expert advisory panel to review the safety of Viagra after the drug was used by patients who later died. While the FDA has updated warnings on the drug's label, the agency hasn't found any direct link between the impotence pill and the deaths. It also hasn't moved to convene an advisory panel to review the drug. Also in August, an FDA medical officer took the unusual step of publicly criticizing the way the FDA and drug companies handle the design of studies of new diabetes drugs, prompting a letter of support from Public Citizen. The reviewer, Robert Misbin, pointed at the time to Warner-Lambert's Rezulin study as one example. --Kristin Jensen and Kristin Reed in the Washington newsroom