CHANTIX ( varenicline tartrate )

1. CHANTIX(varenicline tartrate ) ROBERT A. SCHWARTZ Executive Vice President Managing Attorney - Houston Attorney in Charge of Mass Tort and Commercial Litigation Bailey & Galyen 18333 Egret Bay Blvd., Suite 120 Houston, Texas 77058 (281) 335-7744  Main phone (866) 715-1529 Toll free  (281) 335-5871 Fax web site:  http://www.pinjury.com e-mail:    bschwartz@galyen.com Licensed in Texas and Missouri CONFIDENTIAL ATTORNEY WORK PRODUCT

2. THE SMOKING PROBLEM According to the Centers for Disease Control and Prevention (CDC), an estimated 45 million adults in the United States smoke cigarettes, and more than 8 million of them have at least one serious illness caused by smoking.

3. PFIZER FOUND THE CURE FOR TOBACCO SMOKING ADDICTIONS • PFIZER’s new prescription quit smoking pill: • CHANTIX (U.S.) • CHAMPIX (Europe and other nations)

4. APPROVED TREATMENT • Approved course of Chantix treatment:12 weeks • For the first three days, patients take 0.5 milligram (mg) once a day, • followed by 0.5 mg twice a day for the next four days, and • then 1 mg twice a day for the remainder of the treatment period. Patients who successfully quit smoking during Chantix treatment may continue with an additional 12 weeks of treatment that further increases the likelihood of long- term smoking cessation.

5. The FDA Approves New Drug for Smoking Cessation In May 2006, the Food and Drug Administration approved Chantix (varenicline tartrate) tablets to help cigarette smokers ages 18 and older stop smoking. The drug received a priority review because of its significant potential benefit to public health. Chantix was reviewed in six months rather than the regular review time of 10 months, says Curt Rosebraugh, M.D., M.P.H., deputy director of the FDA's Office of Drug Evaluation II. "Chantix underwent priority review," Rosebraugh says, "because at the time the application was filed, a preliminary review of the efficacy studies indicated that smokers treated with Chantix may have a superior rate of smoking cessation compared to Zyban (bupropion), another currently approved product for smoking cessation." Chantix acts at sites in the brain affected by nicotine and may help those who wish to give up smoking in two ways: by providing some nicotine effects to ease the withdrawal symptoms and by blocking the effects of nicotine from cigarettes if they resume smoking. Rosebraugh says, "If someone slips up, they would probably not have the reinforcement that they would normally get from smoking a cigarette." FDA Consumer MagazineJuly-August 2006

6. QUESTION:IS IT SAFE AND EFFECTIVE? PFIZER SAYS: • The effectiveness of Chantix in smoking cessation was demonstrated in six clinical trials, which included a total of 3,659 chronic cigarette smokers who were treated with varenicline. Five of the six studies were randomized, controlled clinical trials in which Chantix was shown to be superior to placebo in helping people quit smoking. These smokers had previously averaged 21 cigarettes a day for about 25 years. • In two of the five placebo-controlled studies, Chantix-treated patients were also more successful in giving up smoking than patients treated with Zyban. "Both studies had very similar results with approximately 44 percent of people taking Chantix having stopped smoking at the end of 12 weeks, compared with 17 percent of people who were taking placebo and 30 percent of people taking bupropion," Curt Rosebraugh, M.D., M.P.H., deputy director of the FDA's Office of Drug Evaluation II says. "Researchers followed study participants in both studies for a year and found that approximately 22 percent of people taking Chantix, 16 percent of people taking bupropion, and 10 percent of people taking placebo were still smoke-free at the end of the year.

7. THE REAL STORYON PFIZER’S STUDIES • A closer look at three comparable studies using 1mg of Chantix twice daily published in July and August 2006: • Gonzales • 21.9%* of Chantix users were still not smoking at one year. • Oncken • 22.4%* Chantix users were still not smoking at one year. • Jorenby • 23%* Chantix users were still not smoking at one year. • That's an averageone-year rate of 22% still not smoking after a year,or, a relapse rate of 78%. A 78% RELAPSE RATE DOES NOT SUPPORT EFFICACY. *these rates were achieved under highly artificial clinic study conditions.

8. SIDE AFFECTS AND ADVERSE REACTIONS • Pfizer's patient information insert lists only five "common" side effects: nausea, followed by changes in dreaming, constipation, gas, and vomiting. • Pfizer’s separate insert for doctors lists* different adverse reactions: suicidal thoughts, aggression, and neurological and psychiatric disorders. • In Europe, where the drug is known as Champix, the United Kingdom’s Commission on Human Medicines (similar to the FDA) lists Champix on its new drugs under intensive surveillance and discussed a potential signal of a risk of "suicidal thoughts and behaviors" associated with this pill. *in 1-millimeter size print smaller than used in this note

9. PFIZER’S CHANTIX WEBPAGE FOR DOCTORS • PSYCHIATRIC DISORDERS • Frequent: Anxiety, Depression, Emotional disorder, Irritability, Restlessness. • Infrequent:Aggression, Agitation, Disorientation,Dissociation, Libido decreased, Mood swings, Thinking abnormal. • Rare: Bradyphrenia, Euphoric mood, Hallucination, Psychotic disorder, Suicidal ideation

10. PFIZER’S CHANTIX WEBPAGE FOR CONSUMERS Side Effects and Safety • What are the possible side effects of CHANTIX? • The most common side effects of CHANTIX include: • Nausea, sleep disturbance (trouble sleeping, changes in dreaming) constipation, gas, vomiting. • Tell your doctor about side effects that bother you or that do not go away. • These are not all the side effects of CHANTIX. Ask your doctor or pharmacist for more information.

11. IS IT OR ISN’T IT SAFE? • Pfizer says YES: • Chantix is safe and • There is no causal association between Chantix and violence. • Getting it’s safety information from Pfizer, the FDA says YES: • Chantix is safe and effective when used according to the product's label. • September, 2007, Washington D.C. political watchdog group Public Citizen put Chantix on its worst pill list.

12. CONCLUSION CHANTIX IS NEITHER SAFE OR EFFECTIVE