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CHEST: Varenicline Helps Patients with COPD Quit Smoking 

Much as it aided the general population of smokers, varenicline (Chantix) helped patients with chronic obstructive pulmonary disease (COPD) quit too, a randomized trial showed.

From weeks nine to 12 of treatment, 42.3% of those taking varenicline remained abstinent, compared with 8.8% of those taking placebo (P<0.001), Donald Tashkin, MD, of the University of California Los Angeles, reported at the American College of Chest Physicians meeting here.

Also, a significantly greater number of patients taking varenicline remained abstinent from weeks nine through 52 (18.6% versus 5.6%, P<0.001), a secondary endpoint.

The magnitude of these benefits is similar to those observed in the pivotal trials of varenicline used in the FDA approval process, Tashkin said.

Action Points

* Explain to interested patients that varenicline is one of two smoking-cessation medications recommended as first-line treatment for helping patients quit.

* Explain that this study showed that patients with COPD who smoked derived the same benefits from varenicline -- with similar side effects -- as the general population of smokers.

* Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered preliminary until published in a peer-reviewed journal.

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NRT Smoking Cessation Aids in the US - Chantix Sales Declined by 30% in the US in 2008  

Research and Markets (http://www.researchandmarkets.com/research/dbf721/nrt_smoking_cessat) has announced the addition of the "NRT Smoking Cessation Aids in the US" report to their offering.

NRT smoking cessation value declined for the second year in a row in 2008, although the drop was less dramatic than that of 2007. Declines in 2007 were driven by the huge popularity of Chantix, an Rx remedy launched by Pfizer in 2006, and the growing strength of private label smoking cessation products, most notably private label NRT lozenges, which were approved in 2006. Private label products continued to hamper value growth in 2008, as consumers looking to quit smoking opted for cheaper alternatives. However, the impact of Chantix on the OTC NRT sector was negligible, as Chantix sales actually declined by 30% in the US in 2008.

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• U.S. backs vaccines for drug, nicotine addiction  

Convinced of the need for new and better treatments for addiction, the government is focusing its efforts on vaccine development as a new way to treat and possibly prevent addiction to a range of addictive substances.

"It's a perspective that is very different from what we've operated on in the past," Dr. Nora Volkow, director of the National Institute on Drug Abuse told reporters this week at the Society for Neuroscience meeting in Chicago.

Volkow said the agency intends to piggyback on the frenetic investment by drug companies in vaccine development, spurred by the need for new products and the runaway success of products like Merck's Gardasil vaccine to prevent the virus that causes cervical cancer.

"There is an enormous amount of research and development in vaccines for cancers and a wide variety of disorders," she said. "We can take advantage of those developments."

But first Volkow has to tempt drug companies to develop the vaccines by funding costly clinical trials.

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UPDATE 3-Cytos anti-smoking vaccine flops; shares drop 

Cytos Biotechnology's (CYTN.S) anti-smoking vaccine missed its main target in a mid-stage study, making it highly unlikely the product will reach the market and slamming the Swiss group's shares.

The Swiss start-up drug discovery group, which does not yet generate sales of its own products, will now probably miss out on a milestone payment by partner Novartis (NOVN.VX) and analysts said it would struggle to finance itself and pay debt.

"We see the company's prospects not only built on shaky scientific ground, as we have discussed it repeatedly over the past years, but also its financial foundation appears very fragile," said Olav Zilian, analyst at Swiss brokerage Helvea. . . .

Novartis bought the rights to the Cytos NIC002 anti-smoking vaccine in 2007 in a deal valued up to 600 million francs, including an upfront payment of 35 million francs, with further payments contingent on development milestones.

The vaccine aims to help smokers kick the habit by preventing nicotine from entering the brain, depriving them of the satisfaction many associate with smoking.

Novartis has now informed Cytos that the vaccine failed to show a statistically significant difference in continuous abstinence from smoking determined from weeks eight to 12 after start of treatment, compared with a placebo.

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• Stop-Smoking Vaccine in the Works  

The National Institute on Drug Abuse has given a $10 million grant to a Maryland company to help it in the final phases of research regarding a possible anti-nicotine vaccine.

Nabi Biopharmaceuticals of Rockville will launch a phase III study of a potential vaccine called NicVAX. The study, which could be the last step of research if the vaccine works, represents the most advanced investigation of a smoking-cessation vaccine.

The vaccine is designed to help people quit smoking and not relapse. According to a statement by institute director Dr. Nora D. Volkow, the vaccine has received "fast track" designation from the U.S. Food and Drug Administration and has survived a successful "proof-of-concept" study.

There's no guarantee that the study will prove that the vaccine works, nor is it clear whether it will get federal approval if it does. But researchers are hopeful.

The vaccine works by making the immune system kick into action when it detects nicotine. The idea is that antibodies will bond to nicotine molecules and prevent them from entering the brain, where they give smokers the high that they crave.

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Varenicline and suicidal behaviour: a cohort study based on data from the General Practice Research Database (Full Text) 

Main findings

We found no clear evidence of an increased risk of self harm associated with varenicline compared with other smoking cessation products, although the limited study power means we cannot rule out either a halving or a twofold increase in risk. Analysis of those patients prescribed varenicline suggested that they were likely to be at lower risk of self harm than those prescribed nicotine replacement products—they had lower levels of past psychiatric consultation and previous self harm.

Nevertheless, controlling for these factors in multivariable models did not alter our conclusions.Wefound no evidence that varenicline increased the incidence of suicidal thoughts. However, associations with suicidal thoughts should be treated with caution as they are under-recorded in the General Practice Research Database (GPRD). Varenicline was associated with a reduced risk of treated depression, as indexed by initiation of antidepressant therapy. . . .

Conclusion

We found no clear evidence of an increased risk of self harm, suicidal thoughts, or depression in people prescribed varenicline compared with those prescribed other smoking cessation products. In view of increasing concerns about the possible increased risk of suicide associated with these drugs and their increasing popularity, further investigation of their effect on suicide risk is required in other databases and through secondary analysis of all adverse event reporting in relevant clinical trials. Any such risk must be balanced against the likely long term health benefits of smoking cessation and the robust evidence of the effectiveness of varenicline as an aid to smoking cessation.

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Varenicline and suicidal behaviour: a cohort study based on data from the General Practice Research Database  

Conclusion Although a twofold increased risk of self harm with varenicline cannot be ruled out, these findings provide some reassurance concerning its association with suicidal behaviour.

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Smoking cessation drug not linked to an increased risk of self harm or depression 

There is no strong evidence that the popular smoking cessation drug varenicline increases the risk of self harm or depression compared to other cessation products, according to new research published on bmj.com today.

Varenicline is a recently introduced smoking cessation product of proven effectiveness, but there have been concerns that it may increase the risk of suicidal behaviour and suicide. Despite warnings about the possible increased risks issued by regulatory authorities worldwide, varenicline continues to be used widely.

To provide more evidence, a team of researchers from the University of Bristol and the UK's Medicines and Healthcare products Regulatory Agency (MHRA) compared the risk of self harm among people taking varenicline with the risk of self harm associated with other smoking cessation products bupropion and nicotine replacement therapy (patch, inhaler, gum, tablet or lozenge).

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No Link Between Suicide and Stop-Smoking Drugs 

Action Points

* Explain to interested patients that varenicline (Chantix) and bupropion (Zyban) were associated with an increased risk of self-harm compared with nicotine replacement products.

* Note, however, that the confidence intervals were wide and straddled 1.00, leaving the researchers to conclude there was "no clear evidence" of a relationship between the drugs and suicide.

Contrary to information that led the FDA and other regulatory agencies to release warnings about varenicline (Chantix), a new study has found "no clear evidence" of a relationship between the risk of suicide and the smoking-cessation drug.

Both varenicline and bupropion (Zyban), another drug used in smoking cessation programs, were associated with a 12% and 17% increased risk, respectively, of self-harm compared with people who used a nicotine replacement product, but the confidence intervals were wide and straddled 1.00, David Gunnell, PhD, of the University of Bristol in the U.K., and colleagues reported online in British Medical Journal.

The limited study power "means we cannot rule out either a halving or a twofold increase in risk," the researchers said.

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Smoking cessation drug's link to depression countered 

A newer smoking cessation drug is not linked to an increased risk of self-harm or depression, a British study suggests.

Health Canada and the U.S. Food and Drug Administration have warned that people taking varenicline — sold in Canada as Champix and in the U.S. as Chantix — have experienced unusual feelings of agitation, depressed mood, hostility, changes in behaviour or impulsive or disturbing thoughts, such as ideas of self-harm or of harming others. . . .

Champix has been approved since April 2007. Of the 818 complaints about Champix Health Canada had received complaints on its adverse reaction database, 520 involved psychiatric problems, CBC News reported in February.

From January to November 2008, nearly 1.1 million Champix prescriptions were dispensed from Canadian retail pharmacies, according to IMS Health Canada, which tracks the pharmaceutical industry.

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• Study Counters Warnings on Quit-Smoking Drug  

The smoking cessation drug varenicline (Chantix) does not increase the risk for self-harm or depression, according to a new British study.

In July, the U.S. Food and Drug Administration mandated that the drug carry a "black-box warning" on its packaging, indicating that people who use it face increased risk for "serious neuropsychiatric symptoms," including changes in behavior, hostility, agitation, depressed mood, suicidal thoughts and behavior and attempted suicide.

In the new study, British researchers analyzed database information on 80,660 men and women, ages 18 to 95, who were prescribed a smoking cessation product between September 2006 and May 2008. Prescriptions were for varenicline, the antidepressant bupropion (Zyban) or nicotine replacement products, such as a patch, inhaler, gum, tablet or lozenge. People were followed through the period of the prescription and for three months after the date of their last prescription.

No clear evidence emerged that varenicline or bupropion increased the risk for self-harm, suicidal thoughts or depression, the study reported.

However, the researchers added that "the limited power of the study means we cannot rule out either a halving or a twofold increased risk."

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• So you've tried, and tried, and tried, AND TRIED to quit  

Somehow, this time - maybe it was the nicotine-replacement patch, maybe the counseling - Collins resisted the call of the cigarette. But there is no denying: The stranglehold nicotine places on smokers can sometimes prove insurmountable.

Ask Jerry Remy, the Red Sox TV analyst who acknowledged last month that, despite enduring lung cancer, he still falls prey to the occasional impulse to smoke.

Ask Barack Obama . . .

The failure to quit, research has shown, has nothing to do with weakness of will. Nicotine, the primary addictive agent in tobacco, steals into the brain, setting on fire circuitry that regulates our sense of pleasure. At the same time, cigarettes acquire a sort of social permanence in smokers' lives - a way to start the day, to end a meal, to celebrate good times, to muddle through bad times.

So specialists who treat smokers now emphasize a double-barreled approach that combines counseling and medication, including patches, gum, and other nicotine substitutes along with drugs designed to thwart nicotine's addictive effects. There's even a nicotine vaccine being tested that would prevent the substance from reaching the brain.

Still, it's estimated that while roughly 70 percent of smokers want to quit, fewer than 10 percent succeed each year. . . .

Her first major attempt to quit was in 2000, when she went to group counseling at Mass. General. "I'd go there and I'd talk. And I'd leave immediately and have a cigarette.'' She tried again and again to stop smoking for good. Finally, last year, she decided, "This is ridiculous.'' She again sought counseling and wore the most potent nicotine patch available.

Her last drag on a cigarette, she said, was last October.

"No one can tell you to quit smoking. No one can make you feel like a social miscreant to make you quit smoking,'' said Collins, who lives in Belmont. "You have to summon it up from inside. You really, really do.''

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LETTER: Time for a new approach to help smokers give up 

I RECENTLY completed a masters degree at Keele University in which I looked into smokers who say they wish to quit yet cannot.

It relates to my work as a hypno-psychotherapist, but I have never actively sought out smokers to treat because there appeared to be plenty of free help available to them.

I think the NHS is doomed to a high degree of failure and is acting irresponsibly by offering nicotine gum and patches and pharmaceutical preparations to help people quit. . . .

Suggestions clients will find quitting impossible without the NHS's help will feed into the unconscious and make it almost impossible to give up.

It is bizarre that, in testing drugs, the medical profession takes stringent precautions to eliminate the effects of the "mind" when testing drug potency.

In admitting, therefore, that the "mind" can even override the effects of drugs, why not use it to help smokers quit, instead of relying entirely on pharmaceutical preparations, some of which can be dangerous, especially if misused?

What we need now is a new approach to smoking cessation, not government directives that their method is the only method to help smokers to quit.

We need properly-trained people to help smokers to stop.

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• CHAPMAN: Pfizer’s campaign to drug as many smokers as possible  

Pharmaceutical giant Pfizer is in the middle of a major campaign to convince Australian smokers that they should not try to quit without taking anti-smoking medication.

The company sells over-the-counter nicotine replacement therapy (NRT) and prescription drug varenicline (brand name Champix). A Pfizer brochure "what makes you think you can quit this time?" and website stress that "only 3-5% of people who try to outsmart cigarettes without treatment succeed", that "a serious quit attempt needs a plan" and that most smokers "require help from a health-care professional".

Each of these claims is highly contestable. Pfizer and other pharmaceutical companies see cold turkey as the enemy of their efforts to medicate as many smokers as possible. Smoking cessation has become increasingly pathologised to the point that public awareness of its natural history has become heavily distorted.

For years, cold turkey has been denigrated as a hopeless strategy and ignored in public campaigns. But ask 1000 ex-smokers how they stopped and you get a very different answer. As occurs with personal efforts to stop problem drinking, gambling and narcotics use, population studies consistently have shown that a large majority of smokers who permanently succeed in quitting do not use any form of assistance. . . .

Pfizer’s claim that "most require help" is not only nonsense, but contrasts with a reference it cites in its own brochure, which states "about one-third of smokers now use a medication when they try to stop", meaning that two-thirds don’t. Its claim that smokers need a plan is also highly debatable. A recent study (Nicotine Tob Res 2009;11(7):827-32) of unplanned cessation found that unplanned cessation attempts were twice as successful as planned attempts and significantly, that most unplanned quit attempters do not use any assistance.

The emphasis about the futility of people trying to stop smoking unaided acts to exclude popular understanding of what is the most common story of cessation: doing it without professional or therapeutic help. When citizens have common, ordinary and self-limiting ailments, traits and behaviours constantly redefined as needing treatment, avoidable iatrogenic consequences and burgeoning health-care expenditure can follow. But the steady erosion of human agency and self-belief as people lose confidence in their ability to recover or change unhealthy practices is perhaps of greater concern.

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E-Cigarette helps curb smoking better than Chantix 

The FDA has acknowledged near 300 reports of suicide and attempted suicide that are linked to the smoking cessation drug Chantix. If you want to curb your smoking habit, you have a choice: Mind-altering drugs or a safe alternative: The electronic cigarette. . . .

A growing number of tobacco scientists are questioning the FDA’s motives to try and ban electronic cigarettes. Dr. Michael Siegel notes that "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 three years and there have yet to be any severe adverse effects reported."

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