Pfizer’s Risky Legal Bet On Celebrex
4 CommentsBy Ed Silverman // October 8th, 2007 // 8:19 am
There will be a hearing in federal court in San Francisco tomorrow to determine whether Celebrex can increase the risk of serious cardiovascuar events - otherwise known as heart attacks and strokes - and under what circumstances.
US District Court Judge Charles Breyer will have to sift through expert reports, depositions and testimony before ultimately deciding whether there’s reliable scientific evidence to suggest Celebrex presents a serious cardiovascular risk. The event, which is known as a Daubert hearing in legal circles, is part of the Multi-District Litigation concerning Pfizer’s Celebrex, as well as Bextra, a newer Cox-2 painkiller that was pulled from the market two years ago due to…cardiovascular concerns.
However, the hearing is only for Celebrex and appears to be an interesting gambit. Keep in mind that there already exists medical literature, such as an article from the American Heart Association’s Circulation journal, suggesting Celebrex poses cardiovascular risk. According to the motion, Pfizer is trying to exclude testimony by several expert witnesses for plaintiffs who claim they were harmed by the Pfizer painkiller. Likewise, the plaintiffs’ lawyers are trying to bar Pfizer expert witnesses. (This is the Pfizer motion)*.
Of course, should Breyer decide otherwise, Pfizer can proclaim that Celebrex - which, of course, is still on the market - is safe enough. And suddenly, that big chunk of litigation will look smaller and, perhaps, worth settling. On the other hand, should Breyer determine there is, indeed, a serious cardiovascular risk, his ruling may resonate beyond the courtroom, dampening enthusiasm for the painkiller just as Pfizer accelerates an FDA-approved effort to advertise Celebrex once again.
Such a ruling wouldn’t affect Celebrex’s availability; that’s a decision the FDA would have to make. But a decision against Pfizer could easily provide Cox-2 critics with still more ammunition to marginalize the drug.
When we first got wind earlier this year that a Daubert hearing was in the works, a Pfizer spokesman downplayed the implications and wrote: “If the court rules in Pfizer’s favor, Pfizer believes it will streamline the Celebrex litigation. If, however, the court does not rule in Pfizer’s favor, it merely means that certain types of claims may be resolved by juries on a case-by-case basis.â€
* - We’re having trouble loading the plaintiff’s motion. As soon as we can overcome the problem, we will do so. Thanks for your patience.
Doug Bremner MD
Reading their motion to exclude the plaintiff’s experts reminds me
of Aristophanes description of Athenian Socratics, that they can take any argument and turn it around
on its head. Their arguments that mechanisms by which COX-2 inhibitors increase
clotting are just a speculation, or that a 2 fold increase in risk doesn’t matter,
are patently absurd. In fact there is good evidence in the literature that
Celebrex increases cardiovascular risk. The CLASS study of 2000 looked at one year of treatment,
but only the results found after six months were published. Based on data released to the FDA,
it was later discovered that in the second six months there was an increase in heart attack risk with Celebrex.
The editor of the journal, Catherine DeAngelis, MD, was understandably perturbed when told about
this after the fact, as she expressed in an editorial in her journal.
APC, published in 2005, a cancer prevention trial, randomized 2035
patients to two doses of celecoxib or placebo. Patients on celecoxib showed a 2.3 fold
increased risk of stroke, heart attack or heart failure with 400 mg of Celebrex a day,
and a 3.4 fold increase with 800 mg of Celebrex a day. There was also a 3-fold
increase in death from heart disease or stroke at the highest dose. This study showed
that there is a dose response effect, i.e. the higher the dose the greater the risk.
Another cancer prevention trial published in 2006 was
PreSAP. In this study 1561 patients who had an adenoma removed
from their colon and were at high risk of recurrence were assigned celecoxib or
placebo for three years. There was a significant reduction in recurrence of polyps
at three years in the celecoxib group versus placebo (34% v 49%). There were 30%
more cardiovascular events with celecoxib, an increase that was not statistically significant.
However there was a significant doubling of cardiovascular
events in patients on celecoxib who were not taking aspirin.
And these drugs are not better than NSAIDs at treating arthritis
pain. Who wants to double their risk of having a heart attack? Not me.
Hank
Where does the big Cleveland Clinic study figure in here, I wonder? I guess the assumption is that there is already enough data one way or other for present purposes.
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[...] Ed Silverman wrote a fantastic post today on “Pfizer’s Risky Legal Bet On Celebrex”Here’s ONLY a quick extractKeep in mind that there already exists medical literature, such as an article from the American Heart Association’s Circulation journal, suggesting Celebrex poses cardiovascular risk. According to the motion, Pfizer is trying to exclude … [...]
John Machulis
I had previously heard that the Daubert hearing was to begin on August 9th 2007. Was the initial hearing date delayed or is the Oct. 9th 2007 hearing a continuation? Did Judge Bryer give any indication as to when he would make a ruling?