Healthy Skepticism Library item: 3019
Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.
Publication type: news
Barrett A.
Pfizer's Search for an Answer on Celebrex
Business Week online 2005 Dec 13
http://yahoo.businessweek.com/bwdaily/dnflash/dec2005/nf20051213_7961.htm
Keywords:
Pfizer Celebrex cardiotoxicity
Notes:
Ralph Faggotter’s Comments:
Pfizer wil be doing a large new study on Celebrex-
“The study should answer a big question: Were the cardiovascular problems seen with the withdrawn painkiller Vioxx unique to that drug or a common problem for all so-called Cox-2 inhibitors? “
But in reality this study will not answer that question since-
“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.”
If all the patients ae going to be on aspirin, this may well counter-act the pro-thrombotic tendencies of COX-2 inhibitors, so any increased risk of heart attacks which Celebrex might cause will not show up in this study. Furthermore, because all the patients will also be on Prilosec (to help protect the stomach lining) the adverse effects of Celebrex and the other NSAIDS being assessed will not show up either.
So what will this study actually prove?
Well it looks like a public relations exercise rather than an attempt to discover the truth about Celebrex.
It’s like trying to find out if a new car is safe in crashes by driving it into a pile of feathers at 5 miles-an-hour.
This Business Week article fails to make an important ditinction between ‘cardiovascular risk’ which includes thrombotic events and ‘cardiovascular toxicity’ which it could be argued refers to direct toxic effects on the heart and does not include thrombotic events.
This study may well provide information about the latter but not the former.
If the media generally fails to note this distinction, they could well fall into the trap of thinking that this study will provide definitive answers to the question of whether Celebrex increases the risk of heart attack or stroke compared with other arthritis drugs.
If the study shows no greater cardiotoxicity than other NSAIDS, this could then easily be mis-interpreted by the press as indicating that Celebrex, when taken on its own, does not pose an increased risk of heart attack compared to other NSAIDS.
Is this Pfizer’s hope?
If so, this hope is already being realized as the article ends with-
“ But when the data are finally in, a major medical question may finally be answered. “
Full text: NEWS ANALYSIS
By Amy Barrett
Pfizer’s Search for an Answer on Celebrex
The pharmaceutical giant will fund a multiyear, $100 million study to finally find out if the painkiller is safe
Pfizer (PFE ) 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.
