Drug industry swallows dose after dose of bad news
Pharmaceutical industry's outlook appears rocky
New York ? The pharmaceutical industry endured a disastrous 2004, and the aftermath will linger into the new year.
Regulators at the Food and Drug Administration already were expected to take a more cautious approach about new drug approvals in the wake of Merck & Co.’s withdrawal from the market of its pain reliever Vioxx because it doubled patients’ risk of heart attack and strokes. Pressure on the FDA increased at year’s end when Pfizer Inc. announced that a study of its pain drug Celebrex showed it had similar problems at high doses. The two products are in the same class of drugs, known as cox-2 inhibitors.
Questions still linger about whether Merck muzzled negative news about Vioxx in order to keep selling the drug. But the combination of problems with Vioxx and Celebrex is certain to raise more questions about the safety of the drugs sold in the United States.
Drug makers already are struggling with growing generic competition and lackluster prospects for new medicines now in the pipeline. Some analysts believe further industry consolidation is likely because expense reductions resulting from mergers may be the key to increasing earnings at a time when revenues are stagnating.
“This has been a tough year, largely of their (the drug companies) own making,” said Dr. Catherine DeAngelis, editor-in-chief of the Journal of the American Medical Assn. “Drug companies were not as honest and forthright as we expect them to be.”
Besides the debacles at Merck and Pfizer, Chiron Corp. got a black eye earlier this year when products from the British plant where it was to produce half the country’s flu vaccines were blocked by safety officials. The industry also was buffeted by revelations that drug companies had stifled negative clinical trial data from studies examining anti-depressant use in children.
Those woes came amid mounting anger over the price of prescription drugs and increasing demands for the legalization of importing cheap drugs from Canada and Europe. And not to be outdone, a federal official testified before Congress that the sale of five drugs approved by the FDA should be stopped or curtailed because they are unsafe.
Stocks shriveled and reputations sank as few positives emerged to balance the negatives. In late December, the Standard & Poor’s 500 Pharmaceutical Subindustry Index was down 10.7 percent for the year while the S&P 500 was up 7.4 percent.
Twenty-one new drugs were approved by the FDA through September, the last date available, including novel cancer treatments Avastin, made by Genentech Inc., and Erbitux, from ImClone Systems Inc. and Bristol-Myers Squibb Co. Merck and Schering-Plough Corp. also got a green light for Vytorin, a cholesterol-lowering agent with blockbuster potential. But beyond those, analysts were hard pressed to name new products that were either major medical advances or potentially huge money makers.
Carl Seiden, an analyst at UBS AG, said regulators may become more circumspect about approving any drug that was the third or fourth competitor in a class because it wasn’t filling a major void. And he predicted they wouldn’t OK any novel compound without vast safety data. Both will delay launches, depriving companies of revenues.

