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Alabama federal judge: Time to end nationwide litigation against Pfizer anti-smoking drug Chantix
on October 06, 2014
By Kent Faulk
FLORENCE, Alabama – All of the nearly 2,900lawsuits claiming pharmaceutical giant Pfizer Inc.’s smoking cessation drug Chantix triggered suicidal thoughts and other psychological problems in patients have been settled – for about $300 million – so the nationwide litigation should now be dismissed, a federal judge in Alabama ruled Monday.
Despite the end to those lawsuits, Pfizer next week will continue its fight with the U.S. Food and Drug Administration for a less severe warning label for Chantix.
U.S. District Court Judge Inge Johnson on Monday held the final status conference in the litigation at the federal courthouse in Florence. Johnson had been appointed by United States Judicial Panel on Multidistrict Litigation in late 2009 to preside over all the Chantix cases being filed in the United States.
Johnson, in her order issued today, stated that she has now dismissed all the claims that were settled and she recommends the MDL panel terminate the litigation. If any future lawsuits are filed, Johnson writes, she would “welcome the transfer of any such action to this court for further proceedings, given the court’s experience with these claims.”
The judge noted the size of the 5-year litigation in her order. She wrote that with the assistance of counsel for both sides, “the court oversaw extensive discovery, including the production of over 22 million pages of documents, dozens of depositions, and voluminous written discovery.”
Johnson also stated she coordinated the litigation with related cases in New York state court “to reduce costs and duplication of discovery and to promote the consistent determination of similar issues among these proceedings. ”
“The court adjudicated a number of dispositive motions, including Daubert motions with respect to whether the use of Chantix can cause serious neuropsychiatric events and whether the current Chantix label is adequate as a matter of law,” the judge ruled.
Several bellwether – or test – cases were selected for trials before Johnson. But none of the trials happened before Pfizer reached a settlement that ultimately covered all the cases.
According to a Pfizer financial report, as of April 2013 the company had settled, or entered into definitive agreements or agreements-in- principle to settle, virtually all of the known Chantix claims in the U.S., including actions pending in the MDL and in state courts. The settlements at that time included charges to the company’s ledger sheet of $288 million in 2012 and another $11 million in the first quarter of 2013.
Kristian Rasmussen, a partner with the Birmingham law firm of Cory, Watson, Crowder, & DeGaris and a lead attorney on the Plaintiffs Steering Committee for the litigation, said Judge Johnson deserves most of the credit. “It is remarkable for a judge presiding over a case of this magnitude to have managed it to a satisfactory conclusion for both sides in such a short amount of time,” he said.
The first hearing was in January 2010 and Monday was the final hearing. Rasmussen said that, “unfortunately many multidistrict litigations drag on much longer than this.”
While the lawsuits are now in the rear view mirror for Pfizer, the company is fighting to get the U.S. Food and Drug Administration to ease up on the “black box” warning on Chantix – a label added in 2009 to warn of potential serious side effects.
The Wall Street Journal recently reported that the FDA in September updated the black box warning on Chantix to include information about some new studies that show the drug’s psychological effects, including suicide, isn’t as bad as once thought.
Next week – Oct. 16 – Pfizer officials go before a joint meeting of the FDA’sPsychopharmacologic Drugs Advisory committee and its Drug Safety and Risk Management Advisory committee to present its studies in the hopes of getting the black box warning removed altogether.
Lack of label warnings on Chantix was a key issue in the lawsuits. The black box warning was added in 2009.
“I cannot comment on any of Pfizer’s actions regarding Chantix,” Rasmussen said. “I do believe that it would be a mistake if the FDA takes action that minimizes the current warning in the drug label. However, I would defer to the experts and evidence.”
According to a statement issued by Pfizer on Monday afternoon, the new scientific evidence being presented next week “includes our analyses of the placebo controlled Chantix clinical trials conducted by Pfizer, and published or publicly available independently conducted large observational studies comparing Chantix to other smoking cessation medications.”
“The recent label update and the upcoming Advisory Committee meeting both serve as a step forward in the process of accurately communicating the clinical and observational data in the label in relation to the post-marketing reports of serious NPS(Novel Psychoactive Substance) events that are reflected in the Boxed Warning, which was added to the Chantix label in 2009,” according to the company.
Pfizer states that each year in the U.S., 480,000 people die from smoking and that the health benefits of smoking cessation are “substantial and immediate.”
“Chantix is a highly effective aid to smoking cessation treatment that has been shown to help adults quit smoking and increase their chances of staying abstinent for as long as one year compared to placebo,” according to the Pfizer statement.
More than 10 million smokers in the U.S. have been prescribed Chantix, according to the Pfizer statement.

Chantix Plaintiffs Expert Seeks Pfizer Documents
September 16, 2014
Amaris Elliott-Engel, The National Law Journal
A plaintiffs expert in the multidistrict litigation over the Chantix antismoking drug has moved to unseal court records in the advance of a U.S. Food and Drug Administration meeting next month to consider whether warnings about suicide risk are warranted.
Dr. Joseph Glenmullen, an expert causation witness for the plaintiffs, and Thomas Moore, a drug-safety researcher who also was a consulting expert in the Chantix litigation, called for the unsealing of thousands of Pfizer Inc. internal documents.
Both wrote about how smoking cessation treatments like Chantix were associated with a higher incidence of depression, suicide and violence toward other people.
They “want to ensure the public debate about the psychiatric side effects of Chantix includes a balanced scientific record, which was examined in depth in the Chantix litigation,” court papers said. The FDA meeting is slated for Oct. 16.
New data the FDA will consider during its meeting next month is partially sourced to Dr. Robert Gibbons, Pfizer’s expert witness in the litigation, according to Glenmullen and Moore.
They have specifically requested that documents in support of the plaintiffs’ claim for punitive damages be unsealed. They argue that the documents were sealed because they were stamped confidential by Pfizer, not because the documents contain trade secrets, personal information or any other type of information that should be legitimately kept out of the public record.
“Documents revealed in litigation often times provide the only mean by which the playing field can be leveled between the pharmaceutical industry with its huge financial incentive to minimize risks and the public’s interest in their health and safety,” the two scientists’ counsel, Eric Hoaglund of McCallum Hoaglund Cook & Irby in Vestavia Hills, Ala., wrote. “These documents do no public good sitting in a company’s or court’s archives.”
Moore also said that Pfizer subpoenaed him for documents related to his research, personal communications and publications about the risks of using Chantix. He said Pfizer did so to “harass and intimidate him because of the independent drug safety research he conducts. The use and potential abuse of nonparty subpoenas in pharmaceutical litigation is also an important public policy issue separate from but part of the overall objective to provide the public with a fair and balanced record of the risks and benefits of Chantix.”
The multidistrict litigation is pending in Alabama federal court. There have been 3,000 cases in the MDL, but it was down to a single case of Aug. 15, according to court statistics.
Amaris Elliott-Engel is a contributor to
New FDA label bolsters safety case for Chantix
September 24, 2014
WASHINGTON (AP) — New government-approved labeling on Pfizer’s drug Chantix suggests that the anti-smoking medication may not carry the risks of suicidal behavior that first earned it the Food and Drug Administration’s strongest warning more than five years ago.
The FDA updated the drug’s label Monday to include data from a number of recent studies that found little to no evidence of psychiatric problems or suicidal tendencies in patients taking the twice-a-day tablet.
The new labeling represents a victory for Pfizer Inc., which requested the update. Company executives say they will now ask the FDA to completely remove the drug’s so-called “black box” label — the strongest type — which warns prescribers of links to hostility, agitation, depression and suicidal behavior.
“Based on all this new information, a boxed warning is not supported,” said Pfizer senior vice president, Steve Romano, in an interview with The Associated Press. “The bottom line is that the label needs to reflect the most current understanding of the product’s benefits and risks.”
The FDA is convening a panel of its outside experts next month to review the latest data on Chantix’s safety — prompted by Pfizer’s request to update the label. The meeting comes more than a year after New York-based Pfizer paid $275 million last year to settle some 2,000 lawsuits alleging Chantix caused various psychiatric problems, injuries and suicides.
The FDA originally added the boxed warning about suicide in 2009, after receiving dozens of reports of suicide and hundreds of reports of suicidal behavior among patients taking the smoking-cessation drug.
At that time, the FDA also required Pfizer to conduct additional studies to determine the extent of the drug’s psychiatric side effects.
The new drug labeling includes results of five Pfizer studies enrolling nearly 2,000 patients which showed no increase in suicidal tendencies based on a medical questionnaire. The FDA also updated the label with results from four large independent studies of between 10,000 and 30,000 Chantix users. Those studies found no difference in self-injury, hospitalization and other serious adverse events between people taking Chantix and those using other quit-smoking aids, including nicotine patches and the medication bupropion.
There were several limitations to these larger studies. First, they only recorded problems that resulted in hospitalization, meaning many issues likely went unreported. Additionally, the studies were conducted after news of Chantix’s side effects had been widely reported, which means doctors may have steered patients with a history of psychiatric issues toward the alternate therapies.
The new FDA label isn’t all positive. It also contains new information about risks of seizure and interactions with alcohol among Chantix patients.
Pfizer’s drug works by binding to the same spots in the brain that are activated by nicotine when people smoke. The drug, known chemically as varenicline, blocks nicotine from binding to those spots and prevents the release of “feel-good” brain chemicals that make smoking so addictive.
The FDA first began investigating potential side effects with Chantix in 2007, the year after it hit the market.
The drug’s labeling tells patients to stop taking Chantix immediately if they experience agitation, depressed mood, suicidal thinking and other behavioral changes. Doctors are advised to weigh the drug’s risks against its potential benefit of helping patients quit smoking.
Chantix had global sales of $648 million last year. That was down about 26 percent from the drug’s peak sales of $883 million in 2007.
Pfizer shares rose 28 cents to $30.34 in midday trading. It shares had slipped almost 2 percent through Tuesday’s close since the start of the year.

Smoking-cessation drug linked to violence
Tragic experience with Chantix…

Critics see conflict of interest as Obama admin advises doctors on prescriptions
By Patrick Howley
Running the Business of Science
Science is seldom thought of as a business, but as the foundation for everything that exists in this world, it’s arguably the single most important business of all.

Report: Anti-smoking drug lawsuits cost Pfizer Inc. more than $273 million
March 08, 2013
By Ursula Zerilli –
KALAMAZOO, MI – Pfizer Inc. has entered settlement agreements in 80 percent of the 2,700 lawsuits alleging the company’s smoking cessation drug, Chantix, caused suicide and injury.
Reuters reports the agreements cost the company about $273 million in 2012 and the company is setting aside $15 million to resolve remaining claims in the United States in 2013.
Chantix was first released in 2006. The company was flooded with lawsuits relating to psychological side effects by 2008. Chantix’s packaging has included warnings of reports of suicidal thoughts since 2006, according to court papers. The notice was updated in 2007 and 2008, and a black box warning added in 2009. Plaintiffs argue Pfizer should have acted sooner.
In a study released in Oct. 2012, Pfizer said Chantix met its goals in a new trial showing it was safe and effective for use with patients diagnosed with depression. Days later, the company settled its first case, brought by the widow of a Minnesota man who committed suicide in 2007.
Ernest Cory, one of the lead plaintiffs’ lawyers, told Reuters a private resolution was reached with Pfizer on behalf of 254 clients in 28 states.
Pfizer, the world’s largest drugmaker, is one of Kalamazoo’s largest employers.

Study: Quitting Smoking With Chantix May Increase Risk of Heart Attack
July 4, 2011
By Alice Park
A popular drug prescribed to help people quit smoking may pose a significantly increased risk of heart attack in users, a new study finds. The results may further complicate doctors’ and patients’ decisions to use the drug, Chantix, which has been associated with various safety concerns since its approval in 2006.
The new paper, an analysis of data from 14 previous studies involving Chantix (varenicline), found that smokers and smokeless tobacco users taking the drug experienced a 72% increased risk of a serious heart event within a year.
“The magnitude of the risk did surprise us,” says Sonal Singh, a professor of medicine at Johns Hopkins University School of Medicine and one of the study’s co-authors.
Shortly before the July 4 release of the paper by the Canadian Medical Association Journal (CMAJ), the U.S. Food and Drug Administration (FDA) issued a safety announcement warning users that Chantix, while helping smokers quit for as long as a year, was associated with a “small, increased risk of certain cardiovascular adverse events in patients who have heart disease.”
That announcement was based on the findings of a randomized trial of 700 smokers with diagnosed cardiovascular disease who took either Chantix or placebo for three months. The data have prompted the FDA to include a warning on the drug’s label.
The CMAJ analysis included the study on which the FDA based its safety announcement. But most of the other participants included in the CMAJ study were healthy and did not have heart problems and still showed a similar spike in cardiac events.
The results may pose a quandary for many smokers who attempt to give up cigarettes each year — about half of the 46 million current smokers in the U.S. — as well as the doctors who advise them. Should people try to quit smoking with Chantix, or will using the drug increase their risk of heart disease just as much as, or even more than, smoking itself?
This is not the first time that harmful side effects have been associated with Chantix. According to the Institute for Safe Medication Practices (ISMP), a nonprofit organization that educates the public about drug safety, numerous reports of adverse effects from Chantix have been reported to the FDA since the drug was approved five years ago. In the final months of 2007, for instance, varenicline accounted for more occurrences of serious injury than any other drug, according to the FDA’s adverse events reports. These side effects included irregular heartbeat, seizures and blackout, as well as more serious psychiatric effects including aggression and suicide.
In 2008, when the ISMP published a compilation of its findings on Chantix’s potential harms, the drug’s psychiatric risks caught the attention of the FDA. The agency immediately ordered pilots with the Federal Aviation Administration to stop taking the drug; soon after, the Federal Motor Carrier Safety Administration, which oversees the trucking and bus industry, issued a similar ban for its commercial drivers. The Department of Defense followed suit and prohibited certain weapons and aircraft personnel from using the smoking cessation drug as well.
In 2009 the FDA gave the drug its most restrictive black box warning because of “serious neuropsychiatric events” including suicidal behavior.
The FDA says that it wasn’t aware of any potential heart risks until 2010, when Pfizer, which manufactures Chantix, conducted a study of the drug in heart patients to see whether it was as effective at reducing tobacco use in high-risk smokers as in those without heart trouble. When the company provided its results to the FDA, agency officials paid particular attention to any indication of heart problems. “We did a careful assessment of endpoints, exactly because it was a population of patients with known heart disease,” says Sandra Kweder, deputy director of the Office of New Drugs at the FDA. “That was where we saw the first signal that was particularly concerning, and led us to issue the safety communication.”
The agency acknowledges, however, that there may have been hints of heart issues in the original data that Pfizer submitted to win approval for Chantix in 2006. “When the application came in, we did notice a difference in cardiovascular events [between varenicline users and control subjects] just based on rough counts,” says Curtis Rosebraugh, director of the Office of Drug Evaluation II at the FDA. “What we typically do when we see an imbalance is assign viewers to look at the individual patient data to make sure things were coded correctly. We did that, and one reviewer said the imbalance was not as big as what the original data showed, and the other reviewer said that the difference actually favored Chantix. When we see things like that, that’s not a clear signal to us. That’s why things [such as a warning] weren’t put on the label.”
Singh takes issue with that decision, noting that if Pfizer and the FDA had noted the potential heart risks earlier, proper studies might have been done to investigate whether some people were more likely to develop heart problems than others on Chantix, potentially sparing many patients further harm. “What’s missing here is that this information was present with Pfizer in 2006,” says Singh. “Why wasn’t that presented on the original label? Why wasn’t this information given then? Why wasn’t I as a provider given that information in 2006? That’s what I’m mad about.”
Pfizer maintains that the drug is safe, and notes limitations in Singh’s analysis, including the small absolute number of heart events associated with Chantix. “The actual difference in cardiovascular event rates seen in the Singh analysis was less than one quarter of one percent (i.e., 1.06% with varenicline versus 0.82% with placebo),” Dr. Gail Cawkwell, vice president of medical affairs at Pfizer said in a statement. “The health benefits of quitting smoking are immediate and substantial.”
That’s something about which everyone can agree. The question is, how does the risk of continuing to smoke stack up against the risk of heart problems with varenicline? The currently available data aren’t sufficient to answer that question, so the FDA is asking the company to conduct its own study of all existing data on varenicline and heart issues among users.
In the meantime, some experts are turning to other smoking cessation options to help their patients quit. “Try the nicotine patch, try bupropion, try everything you can, and if you really can’t quit, and if you don’t have a lot of heart disease risk, then try varenicline,” says Dr. Steven Nissen, department chair of cardiovascular medicine at the Cleveland Clinic. “But I have to be careful in also telling people that I can’t tell you with absolute certainty that it’s safe.”
Quitting cigarettes, however, is always safer than continuing to smoke. It’s just a matter of weighing the risks of the way you decide to kick the habit.

Study Links Smoking Drug to Cardiovascular Problems
July 4, 2011
Chantix, the best-selling prescription drug for smoking cessation, was linked to an increased risk of a heart attack, stroke or other serious cardiovascular event for smokers without a history of heart disease compared with smokers who did not use the drug, according to a Canadian medical journal report released on? Monday.
The finding added to previous warnings about the pill’s connection to psychiatric problems and cardiovascular risks for people with a history of heart disease.
It posed a new challenge to a product that has been prescribed to 13 million people and had $755 million in sales last year.
Officials of Pfizer, the manufacturer of Chantix, and the Food and Drug Administration responded that they had been planning to conduct a joint analysis of clinical trials on whether Chantix posed heart risks, due next year.
“This would have raised a red flag for us if the flag hadn’t already been flying,” Dr. Celia Winchell, a team leader with the agency’s Center for Drug Evaluation and Research, said in an interview.
Pfizer, in a statement, said the analysis in the Canadian Medical Association Journal was based on too few heart or cardiovascular events to draw conclusions about the risks. The company said Chantix brought “immediate and substantial” health benefits to smokers who quit.
The senior author of the new report, Dr. Curt D. Furberg, a Wake Forest medical professor, said there were better ways to quit and called for removal of the drug from the market.
“It piles up,” he said. “I don’t see how the F.D.A. can leave Chantix on the market.”
The lead author, Dr. Sonal Singh, assistant professor of medicine at Johns Hopkins University, said the agency and Pfizer had failed to pursue signs of cardiovascular risk since Chantix was approved in 2006.
“The F.D.A. should have already put it on their warning label,” Dr. Singh said. “The risk is substantial, the risk is present in smokers without heart disease, and Pfizer knew about this for five years.”
Last month, the agency issued a safety notice about cardiovascular risk from Chantix use by people with a history of cardiovascular disease, based on a study of 700 people.
The new report is broader, analyzing 14 randomized clinical trials involving 8,200 patients, excluding those with cardiovascular disease so that it gives a better picture of which heart problems the drug could cause in otherwise healthy people trying to quit smoking.
The new study, known as a meta-analysis, compiled data from 14 random, blinded, placebo-controlled clinical trials that tracked cardiovascular outcomes. It found 52 out of 4,908 people taking Chantix had serious cardiovascular events, a rate of 1.06 percent, compared with 27 out of 3,308 people taking a placebo, a rate of 0.82 percent. While the absolute difference is only 0.24 percent, the weighted, relative difference is 72 percent.
“We have known for many years that Chantix is one of the most harmful prescription drugs on the U.S. market, based on the number of serious adverse effects reported to the F.D.A.,” Dr. Furberg said in a statement. “It causes loss of consciousness, visual disturbances, suicides, violence, depression and worsening of diabetes. To this list we now can add serious cardiovascular events.”
Dr. Furberg, who once directed clinical trials for the government and writes widely about drug safety, has been paid as an expert witness in cases against Pfizer. Dr. Singh and two other researchers said they had no conflicts of interest.
When combining studies of smokers with and without pre-existing disease, the study found that doctors could expect to get one extra cardiac event associated with Chantix for every 28 smokers they treated with the drug. The researchers also estimated one additional person would quit for every 10 treated with Chantix.
The benefit of Chantix was emphasized in a separate commentary in the journal by Dr. J. Taylor Hays of the Mayo Clinic in Rochester, Minn. He described the meta-analysis as “timely and important” but said it lacked overall size and standardization. Dr. Hays, who has been paid by Pfizer to study Chantix, said the benefits of quitting smoking outweighed the risks of the drug.
Chantix is selling well overseas. In Japan, for instance, some pharmacies ran out for a while recently, even as the drug failed to meet expectations in the United States because of health warnings and bad publicity.

Top Ten Legal Drugs Linked to Violence
January 12, 2011
When people consider the connections between drugs and violence, what typically comes to mind are illegal drugs like crack cocaine. However, certain medications — most notably, some antidepressants like Prozac — have also been linked to increase risk for violent, even homicidal behavior.
A new study from the Institute for Safe Medication Practices published in the journal PloS One and based on data from the FDA’s Adverse Event Reporting System has identified 31 drugs that are disproportionately linked with reports of violent behavior towards others. (More on New Hope For An Anti-Cocaine Vaccine)
Please note that this does not necessarily mean that these drugs cause violent behavior. For example, in the case of opioid pain medications like Oxycontin, people with a prior history of violent behavior may seek? drugs in order to sustain an addiction, which they support via predatory crime. In the case of antipsychotics, the drugs may be given in an attempt to reduce violence by people suffering from schizophrenia and other psychotic disorders — so the drugs here might not be causing violence, but could be linked with it because they’re used to try to stop it.
Nonetheless, when one particular drug in a class of nonaddictive drugs used to treat the same problem stands out, that suggests caution: unless the drug is being used to treat radically different groups of people, that drug may actually be the problem. Researchers calculated a ratio of risk for each drug compared to the others in the database, adjusting for various relevant factors that could create misleading comparisons.? Here are the top ten offenders:
10. Desvenlafaxine (Pristiq) An antidepressant which affects both serotonin and noradrenaline, this drug is 7.9 times more likely to be associated with violence than other drugs.
9. Venlafaxine (Effexor) A drug related to Pristiq in the same class of antidepressants, both are also used to treat anxiety disorders. Effexor is 8.3 times more likely than other drugs to be related to violent behavior. (More on Adderall May Not Make You Smarter, But It Makes You Think You Are)
8. Fluvoxamine (Luvox) An antidepressant that affects serotonin (SSRI), Luvox is 8.4 times more likely than other medications to be linked with violence
7. Triazolam (Halcion) A benzodiazepine which can be addictive, used to treat insomnia. Halcion is 8.7 times more likely to be linked with violence than other drugs, according to the study.
6) Atomoxetine (Strattera) Used to treat attention-deficit hyperactivity disorder (ADHD), Strattera affects the neurotransmitter noradrenaline and is 9 times more likely to be linked with violence compared to the average medication.
5) Mefoquine (Lariam) A treatment for malaria, Lariam has long been linked with reports of bizarre behavior. It is 9.5 times more likely to be linked with violence than other drugs.
4) Amphetamines: (Various) Amphetamines are used to treat ADHD and affect the brain’s dopamine and noradrenaline systems. They are 9.6 times more likely to be linked to violence, compared to other drugs.
3) Paroxetine (Paxil) An SSRI antidepressant, Paxil is also linked with more severe withdrawal symptoms and a greater risk of birth defects compared to other medications in that class. It is 10.3 times more likely to be linked with violence compared to other drugs. (More on Healthland’s Guide to Life 2011)
2) Fluoxetine (Prozac) The first well-known SSRI antidepressant, Prozac is 10.9 times more likely to be linked with violence in comparison with other medications.
1) Varenicline (Chantix) The anti-smoking medication Chantix affects the nicotinic acetylcholine receptor, which helps reduce craving for smoking. Unfortunately, it’s 18 times more likely to be linked with violence compared to other drugs — by comparison, that number for Xyban is 3.9 and just 1.9 for nicotine replacement. Because Chantix is slightly superior in terms of quit rates in comparison to other drugs, it shouldn’t necessarily be ruled out as an option for those trying to quit, however.

Pfizer Lists Payments to Doctors. Health Care Reform Law Requires Big Pharma to List Payments by 2013
By Darren Gersh, Washington Bureau Chief?
Pfizer is not the first drug company to disclose payments to doctors, but it is the world’s largest drug company and today’s announcement was closely watched in Washington. You can check and see whether your doctor is on the list here.
Pfizer was forced to disclose under the terms of a Corporate Integrity Agreement it signed to settle an illegal marketing case with the federal government. You can find that agreement here.
So what have we learned? First, it’s hard to compare Pfizer and Lilly and Glaxo and Merck — the big companies that have disclosed so far. Each company discloses different categories of payments.
Pfizer, for example, discloses payments for clinical research — $15.3 million out of $35 million total. The other companies haven’t told us how much they spent on clinical trials.
But we do know more about speaking and consulting fees. That’s the most controversial of the payments. Pfizer paid $9.6 million for speaking and $7.5 million for consulting over six months. Here are Glaxo’s figures — $50.7 million in consulting and speaking fees for nine months of 2009. Merck paid out $9.4 million in speaking fees, but did not disclose information on consulting. Lilly paid out $62 million for advising, speaking and patient education. You can find Lilly’s disclosure here.
A good reference on this topic can be found here at the Pew Prescription Project.
It will be a lot easier for patients to find out what drug companies are paying their doctors in 2013. That’s when the Physician Payments Sunshine Act, a provision of the new health care law, kicks in requiring drug companies to post their payments on a public government website.

Pfizer payments list to health care professionals:

GA: Chantix, Anti-Smoking Drug Helped Cause Mayor Donald Walker’s Suicide. The GBI crime lab report says, “He was taking Chantix to stop smoking, which caused severe depression.”

B.C. mom sues Pfizer after daughter’s suicide
April 4, 2010
By Louise Dickson and Richard Watts, Canwest News Service
22-year-old taking anti-smoking drug before she killed herself
VICTORIA — A Colwood woman has launched a class-action suit against the Pfizer drug company, claiming her 22-year-old daughter committed suicide after taking the prescription drug Champix to help her quit smoking.
Patricia Clow and two other B.C. women are suing Pfizer, alleging that the company failed to provide adequate warning to Canadians about the potential risk of serious injury and death related to Champix. The suit also claims Pfizer was negligent in its testing, design, labelling, manufacturing and marketing of the medication.
In June 2009, Heidi Megan Clow received a prescription for Champix. Four months later, in the early hours of Oct. 4, 2009, without showing any signs of depression, Heidi committed suicide by taking an overdose of painkillers.
“I would like to see it taken off the shelves,” said Patricia Clow. “And at the very least, I would like to educate people about the risks because I don’t think the drug company is doing a good enough job. I think the doctors are handing it out like candy.”
Heidi wanted to be as healthy as possible, said her mother. “She was changing everything in her life. She had lost weight and was working out every day, running downtown, reading all the packaging on everything she ate or drank. And quitting smoking was part of that.”
Clow insists her daughter wasn’t depressed on the evening of Oct. 3, the last time she saw her alive.
“I dropped her off at her friend’s house and she had a big smile on her face. And when she left his house, she made plans to see him the next day. She had tickets to a concert later in the week. So whatever made her do it, she just snapped like that.”
When Heidi didn’t show up for work on Monday, Oct. 5, Clow went to her apartment. She couldn’t get in — and is thankful for that now.
“I have an image of her smiling and walking away, looking beautiful, after I dropped her off. I was thinking to myself, ‘How did I get so lucky? She was the perfect daughter.’ “
Heidi had left her mother a note, telling her she loved her, telling her she was sorry. But her death was a shock to everyone who knew Heidi, Clow said. “Nobody saw it coming.”
Afterwards, Clow learned that Heidi had complained to a friend that the drug was “f—— her up,” but the friend thought this meant the drug was giving her an upset stomach.
Clow started looking at Champix websites and found information on links between the drug and the potential for depression and suicide, she said.
“I wonder if the Pfizer shareholders would give Champix to their children,” said Clow.
The class-action suit alleges that Pfizer failed to follow up on evidence that arose during clinical trials of the drug. One of the participants in a 2004 study committed suicide, says the claim. In a March 2005 study, there were multiple reports of adverse psychiatric effects among test subjects, including cases of acute psychosis.
In July 2009, the U.S. Food and Drug Administration required Pfizer to insert a “black box” warning into its labelling about the risk of suicide or psychiatric harm. Pfizer did not strengthen the warning on its Canadian label — which remains inadequate, the plaintiffs charge.
Pfizer said in a statement e-mailed to the Times Colonist that it is aware of the lawsuit and that it would be inappropriate to comment on specifics at this early stage.
But the company stated that all medications carry potential risks and patients should consult with their doctors to determine what’s right for them.
Pfizer noted the benefits of quitting smoking are immediate, and that Champix is a proven prescription aid that has helped many smokers quit. Since it was introduced in Canada in April 2007, about two million prescriptions for the drug have been written.
The company said it works closely with Health Canada to get information to patients, is vigilant in monitoring adverse effects and has extensive systems in place to collect, review and report findings.
“Pfizer acted responsibly and appropriately at all times in connection with the development, approval and marketing of Champix,” the company stated.
Likewise, Health Canada, also responding by e-mail, said it has posted warnings — as recently as Jan. 6, 2009 — suggesting patients and caregivers keep note of any unusual thoughts, especially those related to depression, aggression and self-harm.
Health Canada is working with Pfizer to update product information available for health professionals and patients using the drug. The federal department posted a notice stating that between April 2007 and November 2007, it received 107 reports of adverse reactions to Champix, 46 of which were psychiatric in nature — including 14 involving aggression, suicide or depression.
The agency also noted, however, that symptoms like depressed mood, insomnia, irritability, frustration, anger and anxiety are often reported while quitting smoking, with or without drug treatment.
Alicia Pickering of Sechelt is also part of the class-action suit, claiming she became deeply depressed and catatonic within days of taking Champix. Pickering took a leave of absence from work, thought of committing suicide and was ultimately hospitalized.
A third plaintiff, Nicole McIvor of Princeton, was prescribed Champix in December 2007 and became severely depressed. In May 2008, she tried to kill herself by smashing her car into an oncoming logging truck.
None of the allegations has been proven in court.
According to the statement of claim, Pfizer obtained regulatory approval to sell Champix in Canada under the Food and Drug Act in January 2007. The drug is supposed to work by inhibiting nicotine receptors in the brain. It acts as both “agents” and “antagonist” to decrease cravings and psychological rewards associated with smoking.

Three B.C.women file class action lawsuit over Pfizer quit-smoking drug
March 16, 2010
By TRACY SHERLOCK, Vancouver Sun
Three B.C. women have started a class-action lawsuit against Pfizer Inc. and its Canadian subsidiary, claiming that the smoking-cessation drug Champix causes depression and suicidal tendencies.
One of the women, Patricia Clow, from Victoria, is the mother of Heidi Clow, 22, who committed suicide on Oct. 4, 2009, while taking Champix, according to the writ of summons filed in the Supreme Court of British Columbia on Feb. 10, 2010.
The second plaintiff is Alicia Pickering, of Sechelt, who alleges in the writ that she became depressed and catatonic after taking Champix for just three weeks. She took a leave of absence from work, contemplated suicide and was ultimately hospitalized, all of which she attributes to the drug.
“If it saves even one soul from suffering the way I have, it’ll be worth it. I am outraged that this drug remains on the market,” Alicia said in a press release.
David Klein, one of two lawyers representing the class-action suit said in an interview that Pickering had no history of depression or any mental health problems.
“I can tell you that she was only on Champix for a few weeks. In fact, after just a few days she started to feel the effects. That’s a fairly typical response. It doesn’t take that long for people to be severely impacted,” Klein said.
Nicole McIvor, from Princeton, is the third plaintiff. She says that while on Champix she attempted suicide by trying to smash her car into an oncoming logging truck.
Champix is the brand name for the drug varenicline tartrate, and is sold in the United States under the brand name Chantix.
Pfizer Canada said in a statement that it stands behind Champix and that the drug that has helped many people quit smoking.
“Pfizer acted responsibly and appropriately at all times in connection with the development, approval, and marketing of Champix,” Pfizer Canada said. “The health and safety of Canadians is a priority for Pfizer, and we work closely with Health Canada to disseminate information about our products to patients and the medical community.”
According to Health Canada, the drug stimulates nicotine receptors in the brain like a weaker version of nicotine, while simultaneously preventing nicotine from binding. Sales of the drug started in Canada in April 2007, and within a year there had been 226 Canadian cases of neuropsychiatric adverse events reported to Health Canada, of a total of 708,534 prescriptions filled.
A warning was added to the drug cautioning family members to monitor people taking Champix for depression and suicidal behaviour. But for Klein, this warning does not go far enough.
“Champix was sold in Europe and the United States for about a year before it was put on sale in Canada, and in that year there were reports of psychiatric side effects and suicide, and yet the warnings are very mild on the Canadian product,” Klein said.
“The [U.S. Food and Drug Administration] required a stronger warning in the United States last year — what’s referred to as a black box warning — and Pfizer hasn’t put it on the Canadian label. The warnings on stronger in the United States, on the same product, by the same company.”
Klein hopes to either see Champix withdrawn from the market, or to have the warnings significantly strengthened on the drug.
Pfizer has not yet filed a statement of defence in the class action suit.

B.C. residents sue maker of quit-smoking drug
Last Updated: Thursday, March 11, 2010 | 4:24 PM ET Comments86 Recommend 33
Three British Columbia residents are suing Pfizer, alleging the drug company’s quit-smoking product Champix can cause serious psychiatric reactions.

Subject: Re: B.C. residents sue maker of quit-smoking drug – (Yahoo) News – Mar 12/10
The usual approval time for any therapeutic product in U.S. and Canada is 3 years. Champix Plaintiffs and readers should be very angry to learn that Chantix/Champix received fast-track approval, by-passing the useless 3 year review process, which itself is usually conducted by the very industry wanting to sell and profit from the product.? Contradictorily, the very same authorities have been ordered by that same industry to ensure that Electronic Cigarettes, which are far safer than their products and would devastate their sales of their products, have been banned in Canada and half of the U.S., to never get approval.

Pfizer Canada accepts Prix Galien Canada 2009 Innovative Product Award for CHAMPIX
18. November 2009 07:34
Smoking cessation product honoured by Prix Galien, Canada’s most prestigious award for pharmaceutical research
Pfizer Canada accepted the Prix Galien Canada 2009 Innovative Product Award for CHAMPIX (varenicline tartrate), the first prescription treatment for smoking cessation in adults specifically designed to target nicotine addiction. The award was presented last night at a gala in Ottawa recognizing excellence in pharmaceutical research.
Judged by eight eminent specialists involved in the sphere of Canadian and Pharmaceutical research, the Prix Galien Innovative Product Award is presented to the company whose product has been deemed to have made the most significant overall contribution to patient care in Canada in terms of clinical efficacy, benefits and innovation.
“We are pleased to honour CHAMPIX with this year’s Prix Galien Innovative Product Award,” said Dr. Jacques Gagn?, President of the Prix Galien Canada. “The jury was impressed with the scientific approach to the development of this product, and considers CHAMPIX to be a truly innovative product that has shown favourable clinical efficacy and safety.”
In 2006 CHANTIX/CHAMPIX was approved by the FDA and EMEA, with Health Canada’s approval following in early 2007. CHAMPIX is the first product specifically designed for smoking cessation, and it is an innovative, targeted therapy with a novel and unique dual mechanism of action. Unlike other therapies, it is not a nicotine replacement therapy and does not deliver any nicotine to the body. In clinical trials CHAMPIX was found to be safe and well tolerated. The drug is an important treatment option that has helped many smokers who want to quit in Canada and around the world.
Discovered by Pfizer Inc, CHAMPIX was developed at Pfizer’s research facilities in Groton, Connecticut through a project that commenced in 1993. The original discovery team was seeking a smoking cessation treatment that could address the addictive properties of nicotine.
“Two factors make quitting smoking challenging and prevent smokers from achieving long term abstinence from nicotine: The presence of craving and withdrawal symptoms associated with quitting, and the reinforcing effects of nicotine,” said Brian O’Neill, Research Fellow, Pfizer Global Research and Development, who led one of the two chemistry labs involved in the development of CHAMPIX and accepted the award on behalf of Pfizer Canada Inc. “Based on the mechanism of nicotine addiction, we were able to develop a molecule that could specifically target the nicotinic receptors in the brain.”
In development, the team of scientists leveraged knowledge of naturally occurring plant compounds with clues from classical morphine chemistry, leading to the emergence of a new compound class. Once synthesized, CHAMPIX was studied in both a lab and clinical setting. CHAMPIX has a novel dual action that allows some stimulation of the receptor in the brain to reduce cravings experienced during nicotine withdrawal, as well as blocks nicotine from binding to the receptor thus blocking the positive reinforcement of nicotine if the patient smokes while on therapy. It is by addressing both of these issues in one medication that CHAMPIX supports the smoker throughout their quit process.
“This recognition is a testament to Pfizer’s dedication to research and develop innovative products to address the health and wellness of patients worldwide,” said Paul L?vesque, President of Pfizer Canada Inc. “Pfizer is proud to receive this award for CHAMPIX. We thank the Prix Galien for this great honour.”
Smoking involves a Nicotine Addiction
Nicotine addiction is a chronic, relapsing disorder that makes quitting smoking difficult, and involves both physical and psychological symptoms including withdrawal which can trigger a range of symptoms including craving, irritability, poor concentration and anxiety. Most smokers try to quit cold turkey, but according to the World Health Organization, less than five per cent of smokers trying to quit achieve lasting abstinence without help or support.
Almost five million people in Canada smoke, and each year tobacco kills 37,000 people, making it a major public health issue.
As with all medications, patients and their healthcare providers should discuss the risks of smoking, the health benefits of quitting smoking, and the product’s efficacy and safety profile. The most commonly observed adverse events associated with CHAMPIX were nausea, abnormal dreams, constipation, flatulence, and vomiting.

Action on Champix and Other Cessation Medications
13th October 2009.
Champix is one of the many cessation treatments available on the market (and on prescription), differing from most because it doesn’t contain nicotine.
Not long after the article in the main story appeared, the press threw out a story to the effect that Champix was not harmful. An example is published in the MedLexicon News.? A classic case of bad headline writing, the article is headed ‘No link between smoking cessation drug and increased risk of self harm or depression’. Embedded in the article we read,
??? Although they found no strong evidence of an increased risk of self harm related to varenicline, the authors caution ‘the limited power of the study means we cannot rule out either a halving or a twofold increased risk’.
So much for no link. Even the EPG drug information page on Champix gives the information:
??? Post-marketing cases of myocardial infarction, depression and suicidal ideation have been reported in patients taking varenicline. There have also been reports of hypersensitivity reactions, such as angioedema and facial swelling.
That’s alright then – there is a link between Champix and other kinds of harm though we don’t know that it is conclusive. Note also the ban on aviation personnel taking Champix, implemented last year.
Our main story is the work of a hypnotherapist, Chris Holmes. He notes how nearly two years after a safety warning had been issued about suicidal thoughts and behaviour connected with Champix, no warning has appeared on the site for Action on Smoking and Health – an organisation supposedly set up with the health of smokers in mind.
He also notes how the treatments recommended by ASH are exclusively drug based. Even after former Director Deborah Arnott had been forced to apologise to Easyway, because she denied they had a 53 per cent success rate, ASH did not do the decent thing and recommend the Allen Carr method (or hypnotherapy), both of which boast far better results than drug therapy without adverse side effects. It is hard to escape the conclusion that ASH is ‘simply a shop window for drug companies POSING as a public health charity’. It is telling that the page for non-NHS treatments is empty.
Last week. the Department of Health issued a series of press releases honouring heroes in the ‘smoking cessation profession’ from different areas in the north west of England. I was under the impression that such awards were usually given for voluntary work but those nominated do appear to be on the public payroll for their activities.
The expression ‘smoking cessation profession’ suggests that careers are based on trying to stop people smoking – how strange! … so many people employed to fight the use of a legal drug that nobody has any intention to outlaw, but they do want to control it. Even more astonishing that, like ASH, the NHS appears to promote only drug remedies to smoking, rather than hypnosis or the Easy Way method – although they do supply books, and counselling support. There is reason to doubt, however, that ‘you are four times more likely to quit with NRT’, as Chris discovered earlier this year.
It is hard to escape the conclusion that drug manufacturers have their interests well and truly tied up with tobacco control – it is imperative that politicians realise that the smoking cessation treatments that are being offered to smokers are not the ones that produce the best success rates, but those that further the interests of tobacco control. In the words of Allen Carr in his open letter to Tony Blair:
??? Your government, aided by the medical establishment, the NHS, ASH and QUIT, under the powerful influence of the pharmaceutical industry, is pouring hundreds of millions of pounds of taxpayers’ money each year into the pockets of the pharmaceutical companies which are, in effect, competing with the tobacco industry to supply the nicotine addicted market and perpetuate nicotine addiction.
This is hard enough for those of us at large in the community: it is even worse for those not at liberty, like people in psychiatric care, whose smoking facilities are being closed to them.

Champix Kills: But Don’t Tell The Smokers!
September, 2009
By Chris Holmes
The Real Threat to Doctors, Pharmacists and the Medical Profession
To learn the truth about Champix, all you have to do is Google “Champix suicides” and read it for yourself.
But why should smokers have to do that? Most smokers assume that their doctor or their pharmacist would warn them of any serious risks that their patient might be running if they take Champix. Some do: in fact, we have heard anecdotally of one or two doctors who have refused to prescribe it. However, these are the exceptions.
Reading around the blogs which are dealing with the Champix controversy it becomes frighteningly clear that most smokers are left completely in the dark by doctors and pharmacists about the serious side effects of Champix, and only warned about the minor ones. The fact that this negligence is leading to injuries and deaths must surely be actionable. We are talking about a medication that is currently under investigation by the FDA for serious and dangerous side-effects. It has been very clearly implicated in many suicide attempts and a considerable number of deaths. Many other people have had other horrible reactions that have left them hospitalised, terrified and emotionally damaged, and also Champix has wrecked relationships and families.
Your doctor and your pharmacist may decide, though, that they’d better not tell you that in case you decide not to take the damn stuff.
One recent contributor to this blog, Kath (see Champix 4: Enough Already. Comment No.98) – was particularly angry about that point, once I had explained that she was not alone. She said:
“Chris thank you for taking the time to respond to me. As I read your reply what really stuck out is that when I had a weird episode of behavior at 4 weeks, I would have known where it was coming from if I knew that Champix has side effects. If my doctor had warned me to watch for behavioral changes I would have been off this drug much sooner, before it made me into a blubbering mess. That is what bothers me the most.
I was having a conversation with a friend today about how even the doctor makes money when he writes a script. That is really effed up. How can my doctor have a financial benefit to prescribing a drug? What the hell kind of world are we living in? How can we expect to get proper health care when the gp’s make money for giving us life-threatening drugs?”
How indeed. And this is the real threat to the future of the medical profession. It is obvious why Champix is getting the whitewash treatment, and it all comes down to money. Doctors are treated to free trips, lavish treatment at ‘conferences’ and all kinds of incentives to promote medications which can all be summed up in one simple word: Corrupt.
How stupid are you, all you medical professionals who are just sitting on your hands and pretending it is okay to keep taking the incentives and keep your mouths shut about killer drugs like Champix? You keep pretending nicotine replacement is a real medication even though you know it doesn’t work at all, you keep prescribing Prozac and Seroxat even though we all know now that they didn’t perform any better than placebos in the trials… Your professional credibility is rotting away even as I type this, and the stench of your corruption is making even the most conservative of patients wince. If you continue down this road there will BE no medical profession, it will all become Medico-Pharmaceutical Inc.
Think I’m exaggerating? Then have a look at this report by one of the few exceptions, a blog edited by practising Canadian pharmacists called Canada Pharmacy News. The story points out that The Canadian Lung Association fails to mention any serious side effects associated with Champix. This is a very serious omission, but it is no different from what most doctors are doing. The blog also informs us that The Canadian Lung Association received funding in the form of a grant from… Pfizer Canada, the Canadian arm of the global drug giant Pfizer, who make Champix. Only a few days ago, the Justice Department in the USA announced that Pfizer had been ordered to pay a record settlement of 2.3 billion dollars for “fraudulent marketing”. Nothing to do with Champix, that one, by the way. But this is (link).
The credibility of pharmacists and doctors was originally based on hard science, but it has all been hijacked by the medico-mafia of the drug companies and their well-placed friends in the medical authorities, the medication approval bodies, academia and the press. Once you’ve lost that credibility in the minds of the public, Doc, you will never get it back.

Read More:? Chantix Page 2

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