Press Articles

Businessweek, "Merck Could Use a Few Pep Pills"

         Merck & Co. has a history of going its own way in the drug industry. It was the first big drugmaker to buy a pharmacy- benefits management business, now called Merck-Medco, back in 1994. It has pushed aggressively into risky new research fields, conducting one of the biggest projects to find an HIV vaccine. And while big rivals such as Pfizer Inc. and Bristol-Myers Squibb Co. have tried to keep their new-drug pipelines flowing by pulling off major mergers or striking expensive development deals with smaller outfits, Merck Chairman and CEO Raymond V. Gilmartin has relied largely on the company's vaunted research labs.
         Wall Street, however, is now questioning that independent streak as Merck enters a critical period. Patents on several of its blockbuster drugs have been expiring, exposing them to competition from cheap, generic knockoffs. At the same time, the company's pipeline looks alarmingly thin. Merck had counted on its second-biggest product, arthritis drug Vioxx, to help it through this rough patch, but now its fast growth is stalling.
          Part of a new class of painkillers called Cox-2 inhibitors, Vioxx was launched in 1999 on the heels of a similar drug, Celebrex, now owned by Pharmacia. Both drugs were immediate hits. Then, last year, a study by Merck showed how easy Vioxx was on stomachs, the drug's main selling point, but also indicated that patients taking Vioxx were more prone to heart attacks than patients taking an older, rival, drug. Merck believes that Vioxx doesn't cause heart problems -- that instead the older drug may actually help protect the heart -- but a study to prove that point has not been done yet. So in September the Food & Drug Administration warned the company that its marketing must acknowledge that it is unclear whether Vioxx poses a cardiac risk.

Consumer Reports on Health, "The COX-2 controversy. Are newer arthritis drugs safer?"

          The newest class of arthritis drugs, called COX-2 inhibitors, is supposedly easier on the stomach than standard medications, such as nonsteroidal anti-inflammatory drugs (NSAIDs). That notion has made them by far the best-selling prescription pain relievers. But only one of two large, recent clinical trials clearly supported that idea - and that same trial raised the possibility that the COX-2 drugs may increase the risk of heart attack and stroke.
          The new, multicenter studies each involved some 8,000 patients, lasted six and nine months, respectively, and compared a COX-2 inhibitor - either celecoxib (Celebrex) or rofecoxib (Vioxx) - with one or more traditional NSAIDs. The celecoxib study found a trend toward fewer gastrointestinal complications from the COX-2 drug during the first six months. But that difference was statistically significant only for a secondary measure, not the main one. Data for one year, not yet published, showed less reduction in risk.
          The rofecoxib study did find significantly fewer gastrointestinal problems from the COX-2 drug. However, it also found that users of the drug had more heart attacks than the traditional NSAID users. The study could not determine whether that difference occurred because the COX-2 drug increases heart-attack risk (in theory by facilitating blood clots) or because the older NSAID reduces that risk (by inhibiting blood clots).
          A recent study in the Journal of the American Medical Association tried to clarify that question by comparing heart-attack rates in both COX-2 groups with the combined rate in the placebo groups of other studies. The risk was significantly higher for both celecoxib and rofecoxib. However, our consultants say that comparing heart-attack rates in different studies of different patient populations is too imprecise to shed much light on the heart-hazard question.