WhyQuit

WhyQuit reports that in surveys and scientific studies, more people were found to have successfully quit smoking long term using the cold turkey method than nicotine replacement therapies (NRT). NRT delivers smokeless nicotine to the user through chewing gum, lozenges, patches, and nasal sprays. NRT manufacturers typically tout their products as effective ways to ease nicotine withdrawal symptoms, which, in theory at least, should help smokers to quit. However, the vast majority of NRT users either resume smoking or become as addicted to expensive nicotine gum, patches, and lozenges.

Although no studies have compared cold turkey to Chantix, researchers have studied Chantix against NRT. While one study showed that Chantix appeared to be more effective than NicoDerm CQ in the short term, after a year, the success rate was statistically the same for both Chantix and NRT users. According to WhyQuit, the study forced Pfizer researchers to report that there were “no significant differences” between Chantix and NRT, but Pfizer’s ads do not mention the statistic.

If cold turkey is more effective than Chantix, and NRT is about the same, “why assume Chantix’s long list of serious use risks in exchange for little or no benefit?” WhyQuit asks.

The organization says that without support, “Chantix is probably worthless.” While counseling and support have proven their ability to drastically boost the chances of quitting permanently, Chantix has never been tested as a stand-alone smoking cessation aid. The drug is packaged with a support plan that includes a toll-free number and a web site to which consumers may turn for extra support. Pfizer hasn’t said what percent of Chantix users take advantage of the support program, but if the support seekers were subtracted from the total number of successful Chantix quitters, then the success rate would likely plummet.

Also, if Chantix were as helpful as Pfizer claims, then smoking rate in America ought to be descending. Since Chantix first appeared on the market, however, the adult smoking rate actually increased by one percent.

A third point of contention WhyQuit makes concerns the placebo studies that researchers conducted to gauge the effectiveness of Chantix. “Use of placebo controls in drug addiction studies is license to steal,” WhyQuit says, asserting that test subjects who experience severe withdrawal symptoms certainly know that they’ve been given a placebo rather than a drug that is supposed to mitigate those symptoms. Such studies allow Pfizer to exaggerate the efficacy of Chantix.

Fourthly, WhyQuit calls Pfizer out on its ads displaying people who claim, “I honestly love smoking,” saying that the ads mess with the drug-addicted brains of smokers. Pfizer adds appeal to Chantix by telling consumers that they may continue to smoke through the first week of treatment.

“It isn’t that we loved smoking but that we didn’t like what happened when we didn’t smoke,” WhyQuit claims.

“Drug addiction is about living a lie,” WhyQuit says. A dopamine reward pathway that convinces the addict that “nicotine use defines who they are, gives them their edge, helps them cope and that life without smoked nicotine would be horrible. Pfizer knows this and is now playing upon it.”

Finally, WhyQuit asserts that “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.” After 3 days of nicotine abstinence, physical withdrawal symptoms dissipate and the brain works to heal its receptors. Counseling and support help cold turkey quitters with the emotional and psychological aspects of quitting smoking.

SOURCE: Chantix Recall › Support group says Chantix ads conceal important information

Regular “light” cigarette brands contain 20 times the amount of nicotine as VLN cigarettes, a release by the manufacturer states. Even low nicotine cigarettes contain about 8 times more nicotine than a VLN cigarette.

Studies have shown that “Differences in nicotine content of cigarettes have significant implications for compensatory smoking, dependence, and efficacy in smoking cessation,” according to the manufacturer.

Research conducted so far indicates that VLN cigarettes may prove to be one of the most effective smoking cessation inventions yet. Although VLN cigarettes have yet to be tested in large clinical trials, they have been tested in a number of smaller, independent studies. In each of the studies, VLN cigarettes increased quit rates, whether they were used exclusively or in combination with nicotine replacement therapy (NRT), such as nicotine gum, lozenges, and patches.

A University of Minnesota trial suggested that using VLN cigarettes alone boosted smoking cessation success rates more than NRT.

43 percent of patients who used VLN cigarettes exclusively continued to be smoke-free after 4 weeks of continuous abstinence. The success rate for patients using NRT was just 28 percent.

A pair of studies conducted at Duke University, which set out to measure and compare the strength of nicotine cravings with the actual smoking habit, supported these findings.

The Duke studies found that the urge to light a cigarette is sometimes “more compelling than the physical need for a nicotine fix.”

In light of that finding, it’s no surprise that researchers found VLN cigarettes more effective in helping smokers to quit than NRT. VLN cigarettes gradually wean the body from nicotine as the user smokes. With NRT, the smoker stops smoking altogether but continues to feed the body nicotine, usually to “take the edge off” of smoking cravings. Very commonly, however, ex-smokers end up addicted to various forms of NRT even though they have successfully quit smoking.

Another smoking cessation approach, of course, is to use pharmaceutical therapies such as Chantix or Zyban (also known as Wellbutrin). One problem, however, is that these drugs don’t adequately address the habitual side of smoking. They may mitigate the effects of nicotine withdrawal, but after the quit date, the patient is left to cope with the sudden absence of a psychological “crutch.”

More importantly, however, is the safety factor. Because they already smoke, people who use VLN cigarettes do not introduce any new chemicals or other compounds to their bodies, thereby exposing themselves to a range of dangerous and occasionally deadly side effects.

Chantix has been linked to several side effects ranging from mild to severe and including:

• difficulty breathing
• swelling of the face, lips, tongue, or throat
• fever
• sore throat
• headache
• blistering, peeling skin rash
• nausea, vomiting
• stomach pain
• indigestion
• weakness
• fatigue
• increased appetite
• unpleasant taste in mouth
• headache
• sleeping problems
• vivid and unusual dreams
• mood or behavior changes
• agitation, hostility, depression
• suicidal thoughts

SOURCE: Chantix Recall › “very low nicotine” cigarettes may become sound alternative to Chantix

Chantix

“If Chantix has been studied and has been found to have likely caused 98 deaths and an additional 188 attempted suicides and it is allowed to remain on the market because smoking cessation is such an important goal, then what is the point of removing e-cigarettes from the market while studying its potential adverse effects?” Dr. Siegel asked in his blog.

“Suppose e-cigarettes were to be found to have caused 100 deaths. Would that warrant taking it off the market, since it — like Chantix — is helping people to quit smoking?” he asked further.

“… unlike Chantix – for which there were many immediate post-marketing reports of potential adverse effects, e-cigarettes have been on the market for more than 3 years and there have yet to be any severe adverse effects reported,” Dr. Siegel said.

“In other words, we know that people are dying from taking Chantix but we’re going to allow it to remain on the market because it’s helping people to quit smoking. We know that there is no evidence that anyone is dying from using electronic cigarettes, but we’re going to take them off the market, even though they are helping people to quit smoking. That just doesn’t make any sense,” Dr. Siegel said.

Dr. Siegel also blames the pharmaceutical industry’s massive power to influence opinion, whether it’s a position taken by a consumer group, an erroneous statement made by a nonprofit organization, or the public opinion in general.

He notes that some anti-smoking groups are calling on the FDA to withdraw e-cigarettes from the market despite a lack of evidence suggesting they are harmful, yet the same groups do not advocate for the removal of Chantix, even though the drug tops the FDA’s list of most dangerous drugs.

“So far, every anti-smoking group which has called for the removal of e-cigarettes from the market has been found to be financially tied to Big Pharma. The Campaign for Tobacco-Free Kids, American Cancer Society, American Heart Association, American Lung Association, and Action on Smoking and Health have all received funding of some sort from the pharmaceutical industry,” Dr. Siegel said.

SOURCE: Chantix Recall › FDA favors Chantix over e-cigarettes. Why?

Carter, who played keyboard and guitar for Edie Brickell & The New Bohemians, was shot and killed by his girlfriend’s neighbor in the predawn hours of September 3, 2007. According to Ryann Rathbone, Albrecht’s girlfriend at the time, the two had spent the evening at a Dallas bar before going back to Rathbone’s home, where they both took their Chantix doses. Shortly afterward, Albrecht began speaking incoherently and acting violently, hitting Rathbone several times.

Rathbone ran out of the house and Albrecht pursued her. She then ran back into the house, closed the door, and locked Albrecht outside, whereupon he began pounding on the door and yelling. He then entered the neighbor’s backyard and began beating on his back door and shouting. Alarmed by the commotion, the neighbor fired what he said he intended to be a warning shot through the front door. The bullet hit Albrecht in the head, killing him instantly.

Both Rathbone and Albrecht’s family and acquaintances said that his behavior on that fatal night was uncharacteristic. Rathbone says that Albrecht’s behavior became increasingly erratic once he started taking Chantix. Autopsy results showed that Albrecht’s blood alcohol level was more than twice the legal driving limit in Texas, yet those who knew him say that his behavior on September 3 was abnormal, even after drinking heavily.

Chantix first became available by prescription in 2006. Awareness of the drug’s potential to cause negative neuropsychiatric events was not well documented at the time of Albrecht’s death. Just a couple of weeks after the deadly incident, a CBS affiliate in Dallas ran a story about Albrecht’s strange behavior called Chantix: Miracle Drug or Dangerous Problem? Two months later, the Food and Drug Adminstration issued an early communication about an ongoing safety review of Chantix, alerting the public that Chantix may be linked to changes in behavior, agitation, depressed mood, suicidal thoughts and actions, and other side effects.

SOURCE: Chantix Recall › Family of musician killed in Chantix rage sues Pfizer

The Food and Drug Administration

The new boxed warning on Chantix labeling will read: “Serious neuropsychiatric events, including, but not limited to depression, suicidal ideation, suicide attempt and completed suicide have been reported in patients taking Chantix.”

Revised warnings state that neuropsychiatric symptoms and suicidality have been found in patients using Chantix. The post-marketing reports include changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, hostility, agitation, anxiety and panic, as well as suicidal ideation, suicide attempt, and completed suicide.”

The warnings state that patients should stop taking Chantix immediately if they experience any of the adverse neuropsychiatric symptoms or exhibit changes in thinking and acting that aren’t characteristic of the patient.

The new Chantix warnings also caution that “there have been post-marketing reports of traffic accidents, near-miss incidents in traffic, or other accidental injuries in patients taking Chantix.

The new warnings also advise that “resolution of symptoms after discontinuation of Chantix was reported,” but that the symptoms persisted in some cases.

Warnings for Wellbutrin and Zyban are to carry warnings similar to those for Chantix. “Patients should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide.”

SOURCE: Chantix Recall › FDA approves stronger, expanded warnings on Chantix labeling

“People who are taking Chantix or Zyban and experience any serious and unusual changes in mood or behavior or who feel like hurting themselves or someone else should stop taking the medicine and call their health care professional right away,” The FDA warns in its latest announcement.

The FDA also urges friends and family members to be observant of those using the medications, watching for behavioral changes in particular. The FDA said observers noticing such changes should “tell the person their concerns and recommend that he or she stop taking the drug and call a health care professional right away.”

Health officials are reluctant to withdraw smoking cessation drugs from the market even if the drugs prove to be dangerous for many people because smoking is the leading cause of preventable death in the U.S. Instead of an outright ban, they recommend taking the drugs with extreme caution.

In addition to boxed warnings on product labeling, the FDA will also require all adverse risks to be described in the drugs’ Medication Guides. The same regulations will also apply to generic versions of Zyban.

According to the FDA, analyses of both Chantix and Zyban users revealed disturbing patterns, noting that while many people stopped experiencing adverse affects once they discontinued the medication, others “continued to have symptoms after stopping the medication. Also, in a few cases, the problems began after the medication was stopped.”

The FDA also said it will require the drug manufacturers to conduct new clinical trials to determine how frequently serious neuropsychiatric symptoms occur in patients undergoing various smoking cessation therapies. To help discern whether the drugs cause the symptoms or merely exacerbate them, the trials will include patients with and without psychiatric disorders.

Chantix is manufactured by New York-based Pfizer Inc. Zyban is manufactured by GlaxoSmithKline, Brentford, Middlesex, United Kingdom.

Sources: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm170100.htm

http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm169988.htm

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm170090.htm

SOURCE: Chantix Recall › FDA now requiring stronger warnings on Chantix labels

Such a finding would steer attention away from the host of negative side effects that Chantix is known to have. Moodiness, erratic or unpredictable behavior, depression, blackouts, memory loss, confusion, and suicidal thoughts and actions are some of the psychiatric side effects reported by many Chantix users. Non-psychiatric reactions such as sleeplessness and nausea are just as prevalent.

Soon after news of Chantix’s dark side emerged, the drug seemed to enter a tailspin. Pfizer yanked its commercials from the airwaves, numbers from the Institute of Safe Medicine Practices and the FDA revealed it to be one of the most dangerous drugs on the market, and sales and revenues plummeted.

Now that sales have steadied, the time is right for Pfizer to give its lackluster blockbuster a boost. According to CNN, “a study that demonstrates Chantix helps prevent heart attacks could mitigate the safety issues and revive sales, though there is the risk that a negative result would further damage sales.”

According to the CNN report, the study would examine whether Chantix reduces “the risk of subsequent heart attacks in smokers who have already had one.”

However, people who stop smoking, whether they use Chantix or some other smoking-cessation aid, will have already reduced their risk of heart attack simply by quitting smoking, so such studies would seem redundant.

But there you have it. If suicidal tendencies were considered a positive benefit of Chantix, you can bet Pfizer would be spending millions on finding more about that link.

According to the CNN report, Pfizer will decide whether to fund such a study by the end of the year.

SOURCE: Chantix Recall › Pfizer might fund study of Chantix and reduced risk of heart attack