Comments on: Pfizer’s Risky Legal Bet On Celebrex http://www.pharmalot.com/2007/10/pfizers-risky-legal-bet-on-celebrex/ News, Comment and Conversation Fri, 10 Feb 2012 20:01:37 +0000 http://wordpress.org/?v=2.6.2 By: John Machulis http://www.pharmalot.com/2007/10/pfizers-risky-legal-bet-on-celebrex/#comment-23624 John Machulis Sun, 28 Oct 2007 18:54:01 +0000 http://www.pharmalot.com/2007/10/pfizers-risky-legal-bet-on-celebrex/#comment-23624 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? 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?

]]> By: www.topcholesteroladvice.info » Pfizer’s Risky Legal Bet On Celebrex http://www.pharmalot.com/2007/10/pfizers-risky-legal-bet-on-celebrex/#comment-21666 www.topcholesteroladvice.info » Pfizer’s Risky Legal Bet On Celebrex Tue, 09 Oct 2007 12:04:41 +0000 http://www.pharmalot.com/2007/10/pfizers-risky-legal-bet-on-celebrex/#comment-21666 [...] 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 … [...] [...] 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 … [...]

]]> By: Hank http://www.pharmalot.com/2007/10/pfizers-risky-legal-bet-on-celebrex/#comment-21625 Hank Mon, 08 Oct 2007 20:23:11 +0000 http://www.pharmalot.com/2007/10/pfizers-risky-legal-bet-on-celebrex/#comment-21625 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. 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.

]]> By: Doug Bremner MD http://www.pharmalot.com/2007/10/pfizers-risky-legal-bet-on-celebrex/#comment-21588 Doug Bremner MD Mon, 08 Oct 2007 13:35:07 +0000 http://www.pharmalot.com/2007/10/pfizers-risky-legal-bet-on-celebrex/#comment-21588 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. 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.

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