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B.C. women file lawsuit over Pfizer quit-smoking drug  

Three B.C. women are suing pharmaceutical giant Pfizer over a lucrative drug that is designed to help people quit smoking but which, the plaintiffs claim, causes suicidal tendencies as an unintended byproduct.

In a writ filed last month in B.C. Supreme Court, the plaintiffs claim Pfizer Inc. and its Canadian subsidiary put profits from Champix ahead of public safety, ignoring research that showed the drug was dangerous to some people and dragging its feet in warning B.C. doctors who prescribe it.

Vancouver lawyer David Klein is seeking to have the lawsuit certified as a class action.

"It's a scary drug," Klein said Thursday.

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• Three B.C.women file class action lawsuit over Pfizer quit-smoking drug 

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

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• B.C. residents sue maker of quit-smoking drug 

Three British Columbia residents are suing Pfizer, alleging the drug company's quit-smoking product Champix can cause serious psychiatric reactions.

Plaintiff Alicia Pickering, 34, said she was a normal, healthy woman until she started taking Champix to kick her smoking habit. Within days of starting the drug, the married mother of two experienced a dramatic change in personality and was consumed with thoughts of dying, she said.

"It literally felt like something had broken in my head," Pickering, of Sechelt, B.C., northwest of Vancouver, told CBC News. "Intense, severe depression overtook me. I would sit on the couch sobbing, not knowing why."

In a writ filed in B.C. Supreme Court, Pickering and two other B.C. residents claim Pfizer "negligently designed, tested, labelled, manufactured and marketed the drug to Canadians." According to the document, Pickering developed bipolar disorder after taking Champix.

The writ also claims the U.S. drug maker failed to warn customers of the adverse side-effects of the medication.

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• Reportlinker Adds World Smoking-Cessation Drug Market 2010-2025 

Our new report - World Smoking-Cessation Drug Market 2010-2025 - forecasts how the anti-smoking drug market will develop over the next 15 years. We predict that the launch of new smoking-cessation aids early this decade will answer some unmet needs currently limiting that pharma market segment. Besides extensive coverage of currently-marketed drugs, this report examines the most exciting products currently in development. We also include external opinions on the sector, gained thorough original unique surveys.

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Smoking Cessation - Charleston SC (Clinical Trial 7179) 

City: Mount Pleasant

State: SC

Zip Code: 29464

Study summary: Do you smoke? Volunteer for smoking cessation clinical research study.

This different approach to smoking cessation is evaluating the effectiveness and safety of an investigational vaccine vs. a placebo.

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Nicotine Vaccine Trials  

There may be new help on the way for smokers who want to kick the habit...The University of Minnesota is looking for volunteers to test an anti-nicotine vaccine.Dr. Dorothy Hatsukami of the University of Minnesota's Masonic Cancer Center says the vaccine basically makes nicotine less pleasurable. . . .

Dr. Hatsukami is looking for 50 people who smoke ten cigarettes or more a day to take part in a trial.If you're interested, call 612-626-5155.

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• A Statement From GlaxoSmithKline Consumer Healthcare on the Petition to FDA to Help People Quit Smoking  

mithKline (GSK) Consumer Healthcare, marketer of nicotine replacement therapy (NRT) products, including Nicorette®, NicoDerm® CQ® and Commit®, applauds two leading smoking cessation organizations for their efforts to improve the regulation of smoking cessation aids designed to help people quit smoking.

A citizen petition, filed jointly by the Association for the Treatment of Tobacco Use and Dependence (ATTUD) and the Society for Research on Nicotine and Tobacco (SRNT), urged the FDA to adopt a more flexible regulatory approach to expand access to and use of NRT products. These smoking cessation products have helped millions of people around the world quit smoking and, as a result, have significantly reduced their exposure to the risks of cancer and other smoking-related diseases.(1)

GSK Consumer Healthcare agrees that the packaging and labeling of these products should reflect the best available science to reduce barriers for smokers to access life-saving treatments. While the FDA is the final authority on the labeling of GSK's NRT products sold in the U.S., GSK is committed to continuing to work with medical and clinical experts, and the FDA, to assure that consumers have the best possible chance to quit smoking, and stands ready to assist in the effort.

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South Carolina Attorney Says Legal Options Still Available To Those Harmed By Chantix 

The anti-smoking patch Chantix continues to generate lawsuits from users who allege they have suffered serious harm from the drug. Federal lawsuits against Pfizer Inc., the manufacturer of Chantix, are moving forward, but that does not mean those who are not joined to existing litigation cannot seek justice if they have been harmed, says Columbia, S.C. lawyer Bert Louthian.

"Lawsuits against Chantix are in the litigation phase, but no one who believes they have been harmed by this product should feel like they have missed the boat," said Louthian, of the Louthian Law Firm in Columbia, S.C. "Anyone who has been harmed by this powerful drug is within their rights to seek justice through the courts." . . .

The Louthian Law Firm, P.A., of Columbia, South Carolina, has been obtaining fair compensation for personal injury victims since 1959. Anyone who has been harmed by this powerful drug is within their rights to seek justice through the courts.

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Ex-Smoker Talks About Chantix Side Effects 

All she wanted was to quit smoking, so she tried a widely advertised prescription drug that was supposed to help her. Instead, one suburban mom says something horrible happened. CBS 2's Anne State reports.

Tina Hurst is a suburban mother and a manager at a Fortune 500 company. Her life was great, but she had one dark secret.

"I was a closet smoker," Hurst said.

Her doctor prescribed a drug called Chantix to help her quit. Seven million Americans have taken it.

Hurst says she took Chantix for two months and it worked great.

But when she stopped, "I totally went off the deep end," she said. . . .

Carol Southard is a smoking cessation specialist.

"I'm a huge advocate of Chantix and I've had a lot of success with it and very few problems," Southard said.

Southard says she has had more than 700 patients on Chantix.

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• The Global Research Neglect of Unassisted Smoking Cessation: Causes and Consequences 

Summary Points

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Research shows that two-thirds to three-quarters of ex-smokers stop unaided. In contrast, the increasing medicalisation of smoking cessation implies that cessation need be pharmacologically or professionally mediated.

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Most published papers of smoking cessation interventions are studies or reviews of assisted cessation; very few describe the cessation impact of policies or campaigns in which cessation is not assisted at the individual level.

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Many assisted cessation studies, but few if any unassisted cessation studies, are funded by pharmaceutical companies manufacturing cessation products.

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Health authorities should emphasise the positive message that the most successful method used by most ex-smokers is unassisted cessation.

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UW researchers testing smoking vaccine 

If pills, patches, sprays, inhalers, lozenges or gum haven't helped you stop smoking, maybe some shots can. A UW-Madison study of an experimental nicotine vaccine seeks 60 adult smokers to roll up their sleeves for six injections over six months.

The vaccine, called NicVAX, stimulates the immune system to produce antibodies that bind to nicotine in the bloodstream, according to its developer, Nabi Biopharmaceuticals, of Rockville, Md. That prevents nicotine from traveling to the brain and its pleasure centers, the company says. "We're removing the enjoyable part of smoking," said Doug Jorenby, a researcher at UW's Center for Tobacco Research and Intervention.

The center, which took part in a smaller study of the vaccine in 2006, is among 22 sites around the country planning to enroll 1,000 people in the new study.

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People’s Pharmacy: Chantix helped smoker quit  

Q. I know there is controversy over the stop-smoking drug called Chantix. I started smoking when I was 11 and just turned 60. Never in a million years did I ever think I would be able to quit smoking, nor did I want to.

My doctor told me firmly I should try to quit. The next year, he prescribed Chantix.

I filled the prescription, but in my mind I had no intention of quitting. The information with the pills said I did not have to stop smoking immediately; I could pick a stop date and start the meds and work up to that date.

I never picked a date because I didn't think it would work. . . .

It has been more than two years. I do not smoke anymore. That is a downright miracle! So when you report the side effects, keep my story in mind. Chantix can help some people quit without causing suicidal thoughts or other bad side effects. I am still in shock that it worked for me!

Bayer starts clinical Phase I study with personalized vaccine from tobacco plants  

The transfer into clinical development of a patient-specific vaccine represents a milestone for Bayer Innovation GmbH. Following approval of the Phase I study by the FDA (Food & Drug Administration) in the United States, the vaccine is now being tested in human subjects. This is the first time that proteins obtained from tobacco plants using magnICON® technology undergo clinical testing. The patient-specific vaccines produced in the pilot plant operated by the Bayer-subsidiary Icon Genetics in Halle, Germany, are intended for the treatment of non-Hodgkin's lymphoma (NHL), a type of cancer affecting lymphocytes. The objective of the therapy is to activate the patient's immune system, enabling the malignant cells to be targeted and destroyed by the body's own defense system.

"This personalized vaccine is being developed with the aim of keeping patients who have responded well to chemotherapy in complete remission," explains Dr. Detlef Wollweber, head of Bayer Innovation GmbH. "In other words, it should prevent a recurrence of the tumor. The initiation of this clinical trial also demonstrates that our magnICON® technology is suitable for manufacturing proteins for potential pharmaceutical applications."

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• UPDATE 1-Lawsuits claim harm from Pfizer quit-smoking drug 

Three personal injury lawsuits were filed against Pfizer Inc (PFE.N) on Thursday, claiming its smoking cessation drug Chantix caused attempted suicides and death.

The lawsuits, filed in New York State Supreme Court in Manhattan, claim that at the time the plaintiffs took Chantix, Pfizer did not tell doctors and patients about dangers it allegedly knew were related to the drug, including depression and thoughts of suicide.

Although Pfizer subsequently added warnings to its package insert, the law firm that filed all three lawsuits alleged the drug's label is still inadequate.

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POLITO: Five facts Chantix ads keep hidden 

1. Cold turkey quit smoking rates are likely superior to Chantix . . .

2. Without support Chantix is probably worthless. . . .

3. Placebo-controlled Chantix studies were not science-based. . . .

4. Pfizer's "I honestly loved smoking" marketing campaign toys with smokers. . . .

5. Full obedience to the "Law of Addiction" provides 100% odds of success. . . .

So long as no nicotine enters your bloodstream success is guaranteed. What Pfizer will never teach smokers is that cold turkey accounts for far more long-term success stories each year than all other quitting methods combined. Cold turkey does not mean quitting without counseling or support. It means ending nicotine use abruptly, without use of replacement nicotine or imitation substitutes. The body becomes nicotine-free and withdrawal peaks in intensity within 72 hours of ending all nicotine use. The brain works overtime to re-sensitize dopamine pathway receptors and down-regulate receptor counts. But just one puff of nicotine and up to 50% of nicotinic-type receptors will become occupied by nicotine. Although you make think you have gotten away with smoking, relapse is all but assured, as the brain will soon be begging for more.

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