) is taking a big gamble in its bid to revive the beleaguered painkiller Celebrex. On Dec. 13, Dr. Steven E. Nissen at the Cleveland Clinic announced that Pfizer was funding a massive, 20,000-patient study to finally answer questions about the possible cardiovascular risk posed by the blockbuster drug (see BW, 12/19/05, "Big Pharma's Favorite Gadfly"). The study, being run independently by the clinic, will compare three drugs: Celebrex (the Cox-2 drug from Pfizer), ibuprofen (sold under the brand name Motrin), and naproxen, sold under brand names such as Alleve. It will cost more than $100 million.
"We know many Americans take these drugs, and we've never systematically looked at the issue of cardiovascular toxicity," says Dr. Elizabeth G. Nabel, director of the National Heart, Lung & Blood Institute of the National Institutes of Health. The NHLBI will have a member on the committee monitoring the trial.
SPREADING SUSPICION. The study should answer a big question: Were the cardiovascular problems seen with the withdrawn painkiller Vioxx unique to that drug or a common problem for all so-called Cox-2 inhibitors? Merck (MRK
) pulled Vioxx from the market in the fall of 2004 after a study confirmed it was linked to a higher risk of cardiovascular problems, including heart attacks (see BW Online, 12/13/05, "Merck's Plan for Relief").
Celebrex fell under similar suspicion in December, 2004, when one Pfizer's studies showed a possible link to increased cardiovascular risk at higher doses. Those fears have hammered the drug's sales. This year Celebrex is expected to bring in just $1.7 billion in revenue, according to SG Cowen analyst Stephen M. Scala, vs. $3.3 billion in 2004 (see BW Online, 4/5/05, "Pfizer's Savings Rx Is a Partial Cure").
The study should provide a wealth of information to individuals wrestling with how to treat their arthritis. The trial will focus on people with heart disease or at high risk for it. All patients will be given low-dose aspirin, which is a typical treatment for people with heart problems, as well as the drug Prilosec, to reduce stomach acid.
"DEFINITIVE ANSWER." Nissen says giving those treatments across all the study groups will ensure a level playing field. "When this is done we will know: Is the problem with the Cox-2 drugs a class effect or not? And we'll know what is the safest regimen for the heart and for the stomach." Adds Nissen: "I think we'll get a definitive answer."
The trial has been a long time in coming. Back in October, 2004, Pfizer first said it planned to do a trial to examine Celebrex' cardiovascular safety. It declined to explain why the trial has taken so long to develop. And certainly it's a risky study for Pfizer. It could find that Celebrex does pose a cardiovascular risk, and that would doom the product.
Recently, a number of drugmakers have funded studies in an effort to bolster their drugs, only to find the trials backfired. Case in point: Bristol Myers Squibb (BMY
) funded a study that compared its cholesterol-lowering drug Pravachol to Pfizer's Lipitor, only to find Lipitor appeared to be more effective.
"OVERPRICED"? But even if Pfizer's gamble pays off, some on Wall Street warn that Celebrex may never regain its lost luster. SG Cowen's Scala says if the cardiovascular worries about it are determined to be unfounded, sales may stop declining. But he doesn't expect Celebrex to ever approach the $3 billion-plus it generated at its peak. Cox-2 drugs "are overpriced products that don't add a lot of value," compared to cheaper options, Scala argues.
Despite that pessimism, Pfizer has been promising Wall Street that Celebrex will again become a growth franchise. But for now the drugmaker doesn't seem to be pushing its Celebrex marketing machine into high gear.
Pharmaceutical market research firm ImpactRx surveys 2,000 primary-care doctors to get a handle on how pharmaceutical companies are promoting their products. The firm's survey found a year ago that one-third of doctors were getting visits every month from Pfizer sales reps to promote Celebrex. More recently that has fallen to about 25%.
Pfizer sales reps won't have data from the Cleveland Clinic study anytime soon. The trial will take about 18 months to sign up participants. And patients will be followed for an average of two years. But when the data are finally in, a major medical question may finally be answered.
Barrett is BusinessWeek's Philadelphia bureau chief