Facing Monday trial, Pfizer settles bellwether Chantix case October 18, 2012 | By Tracy Staton Pfizer ($PFE) settled its first lawsuit over Chantix's links to suicide, Alabama media reports. After failing to win a postponement earlier this week, the drugmaker made a deal with the plaintiff, a Minnesota woman whose husband killed himself while using the stop-smoking drug. The terms were undisclosed. It's the first of the Chantix bellwether suits, the leading edge of the litigation over the drug's psychiatric risks. Some 2,600 claims were filed nationwide linking Chantix with suicides, attempted suicides, and other serious psychiatric problems, but all those cases are now consolidated in an Alabama court. Pfizer had asked Judge Inge Johnson to put off the trial until January to give the company time to work in new data from a trial of Chantix in depressive patients. That data made its debut Tuesday. Johnson rejected Pfizer's motion; the settlement followed. Attorneys in the case had also asked the judge to compel Pfizer CEO Ian Read to take the stand. The next case up for litigation was filed by Billy G. Bedsole, Jr., an Alabama man who claims that Chantix triggered suicidal thoughts, erratic behavior, mood swings, anxiety and memory loss. He says he was hospitalized for psychiatric reasons after using the drug. Read more: Facing Monday trial, Pfizer settles bellwether Chantix case - FiercePharma http://www.fiercepharma.com/story/facing-monday-trial-pfizer-settles-bellwether-chantix-case/2012-10-18#ixzz29mSwdNk5 Subscribe: http://www.fiercepharma.com/signup?sourceform=Viral-Tynt-FiercePharma-FiercePharma Lets hope the heart attack cases go as smoothly !!!

Pfizer Fails to Bar Expert Witness Testimony in Chantix MDL Cases Lance Andrews | September 4th, 2012 | Posted in Recent Settlements Drug manufacturer Pfizer has had a motion dismissed in the pre-trial process for pending Chantix suicide lawsuits. Pfizer attempted to bar expert witness testimony for the plaintiffs, which was rejected by the federal judge on August 21, 2012. This means that these experts can testify about the psychological risks, such as depression and suicidal thoughts, that occur while individuals were taking smoking cessation drug Chantix. The Chantix settlement amounts demanded by each plaintiff are officially in excess of $75,000, though if the cases are successful, the amounts awarded are likely to be far greater. Chantix lawyer files case in California The lawsuit of Saul Frazier v. Pfizer was first filed in the Superior Court of Los Angeles County. At the request of Pfizer, the case was then transferred to the United States District Court in the Central District of California. On March 2012, the case was then transferred to the United States District Court for the Northern District of Alabama. This federal lawsuit is part of a multidistrict litigation (MDL), a group of consolidated lawsuits which will be presided over by Judge Inge P. Johnson. Chantix violence, other side effects spur lawsuits against Pfizer In 2006, the Food and Drug Administration (FDA) approved the drug Chantix (varenicline) for use in the United States. This prescription medication was meant to help people quit smoking by reducing the pleasurable effects in the brain that come from smoking. In 2009, the FDA issued a requirement that a black box warning be added to the Chantix drug label, which was intended to let people know about the risk of psychological problems. Some of these included increased hostility, depression, and thoughts of suicide. Thousands seek Chantix Settlement Amounts Drug manufacturer Pfizer currently faces approximately 2,600 lawsuits, which have been filed on behalf of those who have been severely injured due to psychological problems, including those who have committed suicide. In 2011, the FDA issued another warning of an increase in heart problems in people taking Chantix. According to a report published in the PLoS ONE medical journal in January 2011, researchers from the Cambridge Hospital and the Institute for Safe Medication Practices found that Chantix was linked to violence in over 400 reported cases. This research was conducted over a five-year period, and focused on adverse event reports submitted to the FDA through the year 2009. Researchers have stated that the primary cause of Chantix violence is an increase of dopamine to the brain instigated by the drug. In July 2011, the same researchers issued a report outlining the risk of aggressive and violent behavior of Chantix users, but indicated that these side effects quickly disappeared after discontinuing use of the drug.

Story of Biased Chantix Study by Pfizer-Funded Author Gets Worse; Article Violates FDA Recommendations, Excludes Heart Attack and Stroke Events, and Doesn't Adequately Consider Low Power of Studies

Thursday, May 10, 2012

Monday, I discussed the results of a re-analysis of a previous study that showed an increased risk of adverse cardiovascular events among patients receiving Chantix. The new study concludes that Chantix is perfectly safe for use in patients in terms of cardiovascular risk. One of the authors of the new study is a recipient of grant funding from Pfizer, the manufacturer of Chantix, and therefore has a significant financial conflict of interest. I have previously argued that: "The bias present in the study has the appearance of being a result of this conflict of interest."

Today, I reveal several more dimensions of this story.

First, as Dr. Sonal Singh points out in his rapid response to the re-analysis, it appears that the authors excluded from their analysis several severe adverse cardiovascular events that have already been reported, including by the FDA itself. As Dr. Singh notes: "For example, in the largest clinical trial, the Rigotti study, the authors recorded 10 events in each treatment arm. In contrast, the updated FDA label, which contains warnings about an increase in cardiovascular risk associated with varenicline in patients with cardiovascular disease, notes several more treatment-emergent cardiovascular events during 30 days in varenicline than placebo [in this same study]: “These include treatment emergent events (on treatment or 30 days after treatment of angina pectoris (13 patients in varenicline arm vs 7 in placebo arm), and the serious cardiovascular events of non-fatal MI (4 vs 1) and nonfatal stroke (2 vs 0).”"

These exclusions presumably occurred because the authors did not count any adverse events that happened more than 30 days after discontinuation of the drug. However, the FDA-mandated clinical trial to assess the cardiovascular risks associated with Chantix required that follow-up of treated patients for adverse cardiovascular outcomes must continue out to at least one year. Thus, the study violates the FDA's recommendation that a one-year follow-up period is necessary. Apparently, the FDA is concerned that adverse effects of Chantix could occur well after discontinuation of the drug.

And well they should be. We all know about the severe cardiovascular adverse events associated with Vioxx use. Vioxx was in fact pulled from the market because of these effects. It is critical to note that these adverse cardiovascular effects of Vioxx persisted up to one year after discontinuation of the drug. How does it make any sound scientific sense, then, to exclude events occurring more than 30 days, but less than one year, after discontinuation of Pfizer.

This dimension of the story seems to make the apparent bias of the study even more striking.

Second, I do not believe that the article appropriately considers the lack of power in the clinical trials to detect a significant increase in a rare, serious adverse event such as heart attacks. These studies were powered to detect differences in smoking cessation between treatment arms, not to detect differences in rare adverse events. Pfizer itself notes that these clinical trials should not be used for conclusive evidence on whether the drug poses cardiovascular risks. Speaking about one clinical trial, Pfizer notes: "The study was powered for assessing efficacy (ie quit rates) but not for assessing differences in the occurrence of serious CV events between CHAMPIX and placebo. Therefore, the study was not large enough to allow conclusions regarding the difference in the incidence of CV events reported in the two arms."

In this light, it is difficult to understand how the paper could conclude not only that there was no statistically significant increase in risk, but also that there was no clinically significant increase. As I pointed out yesterday, even a 0.27% absolute increased risk would translate into thousands of adverse events because of the large number of patients being treated with the drug. And if the drug is not particularly effective in achieving smoking cessation, then the risk-benefit analysis could easily tip towards the risk side.

Even if one accepts the results of the article at face value, the upper end of the confidence interval for the risk difference was 0.63%. This means that because of the small sample sizes in the clinical trials, this meta-analysis cannot rule out an effect as large as a risk difference of 0.63%. With 1.8 million annual prescriptions for Chantix, however, this excess risk of 63 events per 10,000 treated patients would be quite significant. To conclude definitively that there is no clinically significant cardiovascular risk associated with Chantix based on the meta-analysis thus appears to be quite biased.

Finally, while the article does not provide details of the purpose for which the conflicted author is receiving funding from Pfizer, it turns out that this funding is for a clinical trial of Chantix among hospitalized smokers. In my opinion, this makes the conflict of interest even stronger.

Clearly, the verdict is not yet in and an investigator who has a conflict of interest by virtue of taking money from Pfizer for a clinical trial of Chantix should not draw a conclusion at this point in time, based on the existing under-powered clinical trials, that the drug has no clinically significant cardiovascular risks.

Safety Alerts for Human Medical Products Chantix (varenicline): Label Change - Risk of Certain Cardiovascular Adverse Events

Safety Alerts for Human Medical Products Chantix (varenicline): Label Change - Risk of Certain Cardiovascular Adverse Events

http://open.salon.com/blog/xylocopa/2011/05/29/chantix_is_suicide_an_expected_eventChantix was approved by the FDA on the basis of five studies, all funded by Pfizer and published in July and August of 2006. The designers of these studies seem to have pulled out all the stops in their efforts to stack the deck in Pfizer’s favor.

As many as one-third of prospective study participants were turned away for conditions including but not limited to a history of cancer, cardiovascular disease, chronic obstructive pulmonary disease, a history of alcohol or drug abuse, major depression, panic disorder, bipolar disorder, systolic blood pressure greater than 150 or diastolic pressure greater than 95, a body mass index of less than 15 or higher than 38, weight less than 45kg, those with "clinically significant abnormalities in the screening laboratory values…” The list goes on and on. 

Chantix Heart Problems Difficult to Prove

Chantix Heart Problems Difficult to Prove

Stop-Smoking PIll Chantix May Cause Heart Attack, FDA Warns « CBS Sacramento

Stop-Smoking PIll Chantix May Cause Heart Attack, FDA Warns « CBS Sacramento

FDA Issues New Warning Label for Chantix

FDA Issues New Warning Label for Chantix

More Health Risks Associated with Chantix Drug

More Health Risks Associated with Chantix Drug

http://www.huffingtonpost.com/2011/07/05/chantix-heart-attack-risk_n_890359.html

It all started the end of March 2011. I went to my dr. and told him I wanted to stop smoking . It was unhealthy , it was expensive , and I was just tired of the mess..lol. My dr. gladly gave me a prescription of Chantix. I put off getting the prescription filled. I am a chronic procrastinator , and honestly very unmotivated about the fact that I hopefully would not be smoking any more. Finally in may 2011 I said to myself ..."ok its time". I went and got the Chantix prescription filled. I started taking  the Chantix a day later. I thought hmmm I dont know all the hype about this medication is, I feel fine. I did get a bit of nausea  right after I took it , but honestly . I did not feel angry or suicidal or anything. I felt normal. Within 10 days ,bam... I put the cigs down and could have cared less if I ever picked them up again.

 Early June 2011 still not smoking. I was however out of breath a whole lot of the time. I thought to myself ,for goodness sake I could feel better if I smoked . I was still determined by then to stay and ex smoker. Mind you I was still popping the Chantix 2 times a day as required. I went to the dr. about my breathing . The dr. scheduled me for a stress echo cardiogram. I took the test and my heart seemed to be ok. The people giving me the echo said you get out of breath WAY too fast , but still nothing wrong with my heart. The dr. then scheduled me for a pulmonary test . You know the one you blow in the tube until your lungs are gonna explode. No sign of any lung problems, like COPD , or Chronic bronchitis.  All those  tests  came back normal. I did blood work.40 years old ,  Great cholesterol levels, every thing came back great. I was healthy as a horse ( my dr's exact words). I finally just gave up, and contributed my shortness of breath to being an ex smoker ,  and not the most athletic person in the world. I stopped the Chantix at the beginning of July, when the prescription ran out.


November 2011 . My partner and I had road out to get something to eat. I told him wow dinner really gave me heartburn. I got back home. I took some antacids. By this time my shirt , and pants were soaking wet and I was very light headed. I felt like I was up side down. I told my partner " I think we need to go to the hospital". At that moment the burning in my chest was unbearable.  I get to the ER asap. I walk in and the dr's do an EKG and see I AM HAVING A HEART ATTACK.. I was rushed up stairs and put into surgery and a stent was placed in my back heart artery. A clot had formed. A few days went by and I got out of the hospital. My cardiologist specifically told me . He was baffled by the fact I had an unexplained heart attack. He said it happens but not often. HE then asked me if I had taken any drugs. I laughed at him and said" no  I never have done illegal drugs". He said no" I mean prescription drugs." I said "yes Chantix to quit smoking , but that was months ago." My cardiologist's said" Im not saying that Chantix caused this for sure  , but that's a dangerous drug and I would not recommend ANYONE taking it".

January of 2012 I started researching Chantix heart attacks. I got a lawyer and still waiting to see what happens. Im not out to get rich , but I will never be the same. I will be on pills for the rest of my life, my heart will be damaged some what forever , and I will question the confidence I had in my body pre- heart attack. I have no scientific proof this drug did this to me , but I feel it in my gut. I am still not smoking , but was it worth it. Id like to hear any and everyone's experience.