Anti-smoking vaccines: set to ignite underdeveloped prescription market

25th January 2008

Although many smokers are keen to kick their habit, will power by itself is often not sufficient and smoking cessation aids are often needed. The prescription nicotine dependence market is set to grow strongly at a compound annual growth rate of 16% to reach $4.6 billion by 2016, driven by two promising pipeline nicotine vaccines and Pfizer's popular nicotine receptor agonist Chantix.

Although the dangers of tobacco use have been recognized for over half a century, and in an increasing number of countries have resulted in the banning of smoking in enclosed spaces, nicotine dependence continues to represent a serious public health problem. Indeed, smoking is a major contributor to illnesses such as lung cancer, emphysema, heart disease and stroke, and is one of the world's leading causes of preventable death.

Datamonitor estimates that nicotine dependence affects almost 116 million individuals across the seven major markets (7MM) - France, Germany, Italy, Japan, Spain, UK and US - in 2007. Despite the currently high prevalence of nicotine dependence, evidence suggests that only a small proportion of individuals actively seek help from their primary care physician (PCP).

Currently limited range of prescription treatments

A plausible reason for the low presentation rate to PCPs is that until recently, there was not an efficacious prescription drug available to patients. At present, the nicotine dependence market consists of a wide range of over-the-counter (OTC) products, such as a multitude of nicotine replacement gums and patches, with sales exceeding $2 billion across the 7MM in 2006.

By comparison, the prescription nicotine dependence market is considerably under-developed, with just two marketed products: GlaxoSmithKline's Zyban (bupropion) and Chantix (varenicline), which garnered combined sales of $213 million across the six major markets (6MM) - France, Germany, Italy, Spain, UK and US - in 2006. There are currently no prescription nicotine dependence drugs available in Japan.

Although the convenient access of OTC products to smokers intending to quit but not willing to see a physician and the sheer size of this market represents considerable competition to prescription products, the success of Chantix demonstrates that an efficacious drug, combined with a strong direct to consumer advertising campaign in the US can lead to an increase in presentation to PCPs.

Since its August 2006 launch, Chantix has experienced a strong uptake, particularly in the US, with sales exceeding $87 million across the 6MM in 2006. However, the nicotine prescription market could be even bigger. According to the National Institute for Health and Clinical Excellence in the UK, it is estimated that about four million smokers a year attempt to quit but that only 3-6% of these succeed. Therefore, a drug which demonstrates a lower relapse rate than Chantix can expect to gain substantial revenue. In view of the size of the patient potential of nicotine dependence, the opportunity for a drug offering an improvement on current treatments is huge.

A key advantage to companies entering the nicotine dependence market is that compared to several other markets, achieving reimbursement for a new drug is unlikely to be difficult. Healthcare payers and governmental bodies (such as the UK's NICE), should be willing to approve such drugs owing to the long-term savings accrued from reducing the incidence of smoking-related illnesses.

Nicotine vaccines set to make substantial impact on market

Nicotine vaccines, which are designed to prevent nicotine from entering the brain, are the largest drug class in late-stage development for the treatment of nicotine dependence. Datamonitor predicts the launch of two nicotine vaccines in 2010 and 2012 respectively: Nabi Biopharmaceuticals' NicVAX and Novartis's NIC-002.

The novel mechanism of action of NicVAX is expected to generate strong interest among physicians and Datamonitor forecasts the drug to garner 7MM combined sales of $706 million by 2016. Despite the second-to-market status of NIC-002, it is predicted that the compound's strong efficacy, combined with Novartis' strong sales and marketing experience will lead to a strong uptake, achieving sales of $1.3 billion in 2016. Despite yielding promising clinical trial results, neither of the nicotine vaccines is likely to be able to reduce an individual's craving for nicotine. Therefore, in theory, use of a nicotine vaccine in conjunction with an anti-craving drug has the potential to bolster long-term quit rates.

The injectable formulations of the vaccines and the need to take time off work in order to be administered the vaccine by a healthcare professional may deter some from using NIC-002 and NicVAX. However, opinion leaders interviewed by Datamonitor were unanimously optimistic about the potential of vaccines in the treatment of nicotine dependence and reported that there would be a sufficiently strong uptake among patients with a strong motivation to quit smoking.

The utility of vaccines in nicotine dependence lies in their convenient dosing regimen and long-term irreversibility which has the potential to improve patient compliance and reduce relapse rates, a key obstacle in the successful treatment of nicotine dependence. Due to these advantages, Datamonitor believes nicotine vaccines will become important players in the nicotine dependence market in the future, potentially allowing millions of smokers to kick the habit and playing a key role in the market growing strongly to reach $4.6 billion across the 7MM by 2016.
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Is Stop-Smoking Drug A Suicide Risk?
Dec. 26, 2007
WASHINGTON
FDA Gives New Scrutiny To Pfizer’s Chantix After Some Patients Claim Suicidal Thoughts
(CBS) Thirty-three-year-old Amy Garza has smoked since she was 16, trying time and time again to quit.
“I've tried the losenges, I've tried just about anything and everything you can think of,” she said.
She thought she had found a wonder drug this fall: Chantix, the new anti-smoking pill prescribed by her doctor.
Then, Garza said she tried to kill herself, CBS News correspondent Thalia Assuras reports. Garza has a large scar on one wrist to prove it.
“It was like a psychotic breakdown that came out of nowhere,” Garza said.
Garza, who says she’s never been under psychiatric care, blames Chantix, made by Pfizer.
“You really think it was because of this drug?” Assuras asked.
“I do,” Garza said.
Garza isn’t the only one. The FDA is investigating about 100 cases of smokers who had suicidal thoughts after taking Chantix.
It went on the market in 2006. It's the only stop-smoking product that blocks the nicotine receptors in the brain, preventing the buzz that comes from smoking and diminishing withdrawal symptoms. But nicotine withdrawal itself can change behavior. So is Chantix to blame for thoughts of suicide?
“I can tell you there's no scientific evidence establishing a causal relationship between Chantix and these reported events,” said Dr. Ponni Subbiah, vice president of Pfizer’s medical affairs.
Among the four million Americans prescribed the drug, there are big fans. Take David Bowers, a 30-year smoker who went on Chantix after developing Coronary Artery Disease.
“For me, I thought it was a miracle drug,” he said.
Clinical studies show that a year after taking the drug, 23 percent were not smoking. On Zyban, the only other prescription pill available, only 15 percent succeeded.
For now the FDA says the benefits of quitting cigarettes far outweigh the possible risks of taking Chantix. But the agency is still warning that anyone who uses Chantix should be closely monitored.
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No-smoke pill Champix on sale despite death link
December 31, 2007
Annalise Walliker
Article from: Herald Sun
ANTI-SMOKING "wonder drug" Champix will hit shelves in Australia tomorrow, even after being linked to more than 62 deaths and thousands of cases of suicidal thoughts and depression in the US and Britain.
The revolutionary pill, which blocks nicotine receptors in the brain, has support from the Therapeutic Goods Administration and anti-smoking groups, even though side effects have appeared in thousands of patients over the past year.
The TGA has ordered manufacturer Pfizer Australia to comply with a range of measures including direct warnings on consumer information and sending letters to doctors warning of the risk of suicide and depression in patients, a spokeswoman said.
The UK Government's medicine watchdog, the Medicines and Healthcare products Regulatory Agency, had received 1335 reports of patents suffering serious side effects, including seven deaths -- one of which was a suicide -- by December 18.
The drug, launched in the UK about a year ago, was also linked to 748 cases of psychiatric problems including suicidal thoughts and depression, 819 gastrointestinal disorders and 70 heart disorders.
The US Food and Drug Administration began investigating the drug, called Chantix in the US, in November after it reported 55 cases of suicide and 199 cases of suicidal thoughts in just one week.
The drug is available in 26 countries and will be available on the Pharmaceutical Benefits Scheme from tomorrow.
Pfizer Australia was unavailable for comment yesterday but has maintained there is no evidence Champix has dangerous side effects after they did not emerge in clinical trials.
Patient information on Pfizer Australia's website admits "a few people have reported . . . depression and thoughts of self-harming or of harming others" while taking the drug.
Pfizer had insisted the symptoms were not caused by the drug, but more likely withdrawal symptoms.
"It is not known whether these mood changes are related to Champix but it is known that mood changes can be due to the effects of stopping smoking," it read.
The TGA ordered the Australian patient information brochure to be amended at the beginning of December to include the post-approval reports of depression, mood changes, suicidal thoughts and suicide in users.
The National Prescribing Service will also issue a warning on Champix in its next bulletin, timed to coincide with the pill's release.
The TGA will continue to closely monitor the situation, the spokeswoman said.
The positives of quitting smoking far outweighed any negatives from rare side effects, Action on Smoking Health Australia CEO Anne Jones said. "The real risk is leaving people to continuing to smoke, which kills 16,000 Australians a year," she said.
"People at risk of suicidal tendencies and depression should not be given this drug.
"But as it needs to be prescribed by a GP those who do fall into that category can be given another smoking cessation tool."
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Shutting down deep brain region may help addicts: study
Thu Oct 25, 2007
CHICAGO (AFP) - An animal study released Thursday bolsters the notion that drug cravings can be "switched off" by shutting down a key part of the brain, a finding that could have implications for treating addicts.
The insular cortex, or insula, is a region deep within the brain that filters information about the body's physiological states and needs.
Researchers have previously shown that damage to the insula can dramatically extinguish a smoker's need for nicotine.
A study earlier this year found that 12 of 19 habitual smokers had effortlessly given up the weed after sustaining injuries, such as a stroke, to the small island in the cerebral cortex.
At the time, investigators were not sure whether the finding had wider implications and whether disruptions to the insula could ease the grip of other addictions, such as those to alcohol, over-eating or drugs.
But in experiments on rats, Chilean researchers have shown that temporarily "silencing" the insula suppresses cravings in drug-addicted rats and insulates them from the unpleasant side effects of medication, according to the study published in Science.
For the first experiment, the investigators gave a group of rats that were addicted to amphetamine a shot of anesthetic to numb the insula for 20 minutes.
The rats were caged in an experimental set-up composed of a darkened chamber and an adjoining bright white chamber which the rodents had been trained to associate with amphetamines.
The intervention had a pronounced impact on their behaviour, changing their preference from the white chamber to the darkened chamber -- which is a more natural setting for rats.
When the blocking was reversed, the rats once again demonstrated their desire for the drug, returning to the white chamber.
In a second experiment, the researchers injected rats with lithium, a medication used to treat mood disorders that often causes an upset tummy by way of a side effect.
The rats quickly laid on their stomachs -- showing signs of malaise. When the researchers numbed the insula prior to giving the rats the medication, they did not show any signs of discomfort and appeared to behave normally.
"This showed us that the insular cortex not only informs the rest of the brain about craving, but also gastrointestinal discomfort and that this information about bodily states may guide behaviour," said Fernando Torrealba, a neuroscientist at the Pontifical Catholic University of Chile in Santiago.
Taken together, his study in rats and the earlier one on smoking provide powerful evidence that the insula "underlies the conscious sense of craving," making it a good target for drugs designed to help addicts break the habit, he said.
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Anti-smoking pill shows promise in curbing drinking
July 9, 2007

WASHINGTON -- A single pill appears to hold promise in curbing the urges to both smoke and drink, according to researchers trying to help people overcome addiction by targeting a pleasure center in the brain.

A study published Monday suggests not just nicotine but alcohol also acts on the same locations in the brain.

The drug, called varenicline, already is sold to help smokers kick the habit. New but preliminary research suggests it could gain a second use in helping heavy drinkers quit, too.

Much further down the line, the tablets might be considered as a treatment for addictions to everything from gambling to painkillers, researchers said.

Several experts not involved in the study cautioned that there is no such thing as a magic cure-all for addiction and that varenicline and similar drugs may find more immediate use in treating diseases including Alzheimer's and Parkinson's.

Pfizer Inc. developed the drug specifically as a stop-smoking aid and has sold it in the United States since August under the brand name Chantix. Varenicline works by latching onto the same receptors in the brain that nicotine binds to when inhaled in cigarette smoke, an action that leads to the release of dopamine in the brain's pleasure centers. Taking the drug blocks any inhaled nicotine from reinforcing that effect.

A study published Monday suggests not just nicotine but alcohol also acts on the same locations in the brain. That means a drug like varenicline, which makes smoking less rewarding, could do the same for drinking. Preliminary work, done in rats, suggests that is the case.

"The biggest thrill is that this drug, which has already proved safe for people trying to stop smoking, is now a potential drug to fight alcohol dependence," said Selena Bartlett, a University of California, San Francisco neuroscientist who led the study. Details appear this week in the journal Proceedings of the National Academy of Sciences.

Pfizer provided the drug for the study, but was not otherwise involved in the research.

More often than not, smoking and drinking go together -- an observation pub-goers have made for hundreds of years. That a single drug could work to curb both addictions isn't a given -- nor is it surprising, said Christopher de Fiebre, an associate professor of pharmacology and neuroscience at the University of North Texas Health Science Center at Fort Worth.

"This is an extremely important paper and hopefully it will convince the major funding agencies that they need to examine the interactions between nicotine and alcohol to a greater extent than they have done to date," said de Fiebre, who was not connected with the study.

In fact, the University of California researchers, together with the National Institute on Alcohol Abuse and Alcoholism, are now planning the first studies in humans of the drug's effectiveness in curbing alcohol cravings and dependence, Bartlett said. That the drug is already Food and Drug Administration-approved should speed things along.

"This is a drug that people are actually using. That's not trivial -- not at all," said Mark Egli, co-leader of the medications development program at the NIAAA, part of the National Institutes of Health. "There is plenty of animal research that looks pretty cool but there is no way those drugs are ever going to be used by human beings."

In the new study, researchers trained rats to drink alcohol and measured the effect of varenicline once the animals became the laboratory equivalent of heavy drinkers. They found the drug curbed their drinking. Even when stopped, the animals resumed drinking but didn't binge.

Just as varenicline doesn't work for all smokers, it's highly unlikely it would for all drinkers.

"Is this going to be a cure-all? No, not for smoking or alcoholism because both diseases are more complicated than a single target or single genetic issue," said Allan Collins, a professor of pharmacology at the University of Colorado who was not connected to the study.

Still, Collins, who's worked on the topic for decades, called the drug's potential use in treating alcoholism a "no-brainer." And Egli said it supports the emerging view that there is a common biological basis for addictions to both alcohol and tobacco.

As for Pfizer, the New York company has yet to decide whether to seek broader FDA approval for the drug, a spokesman said.

"Without having considerable more data on this it would be very difficult for us to say we might pursue it or not. It's almost a wait-and-see," said Pfizer's Stephen Lederer. E-mail to a friend
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Wooden Johnsons
May 2007, By Dave Hitt
The Robert Would Johnson foundation is an anti-pleasure organization devoted to increasing government interference in every aspect of your life, all in the name of health. On their web site they brag that they are "the nation's largest philanthropy devoted to improving health and health care." On NPR their slogan is "committed to helping Americans lead healthy lives and get the care they need." In reality they are a front group for the pharmaceutical industry, specifically for the giant Johnson & Johnson corporation.
Read more AND listen to the podcast

Pfizer Supports Complete Smoking Ban in Public Areas and Improved Access to Smoking Cessation Treatments across Europe
May 24 2007

Pfizer Inc (NYSE:PFE) (LSE:PFZ) welcomes the European Commission's Green Paper on smoke free environments(1), which was put for public consultation earlier this year. Today in Brussels, a week before World No Tobacco Day (May 31st), the world's leading life sciences company submitted its recommendations on the questions raised in the Commission's Paper. The Consultation will conclude on June 1st.

To effectively support millions of Europeans in their efforts to stop smoking, improve their health and prolong lives; to protect non-smokers from the damaging influence of passive smoke; and to prevent young people from taking up the habit, European decision-makers should endorse the following measures:

-- A total ban on smoking in public places as the most effective way to encourage quitting and discourage taking up smoking.

-- The introduction of binding EU legislation to implement such bans, as the most appropriate way to ensure compliance across the EU.

-- The implementation of supportive measures, such as awareness raising campaigns and increased access to cessation therapies, including funding of therapies, to maximise the impact of smoking bans.

The WHO-sponsored "World No Tobacco Day" also focuses on smoke-free environments this year. On its website, the World Health Organization states that the evidence demands immediate, decisive action to protect the health of all people. "100% smoke free is the only answer."(2) This is further supported by Article 8 of the Framework Convention on Tobacco Control (FCTC): Protection from exposure to tobacco smoke,(2 )which has been signed and ratified by the European Community.

Tobacco is the single largest cause of avoidable death in the European U nion accounting for over half a million deaths each year and over a million deaths in Europe as a whole(3). It is estimated that 15% of all deaths, 25% of all cancer deaths(3), and 16% of all deaths from cardiovascular diseases (CVD)(4 )in men in the U nion can be attributed to smoking.

Smoking, however, does not only kill, it costs money to EU citizens and governments: CVD alone is estimated to cost EU Member States EUR 463 million per day, mostly due to direct healthcare costs (62%) and productivity losses (21%)(4).

"There is a tremendous urgency for EU Member States to introduce a comprehensive and holistic set of policies aimed at protecting their citizens by reducing tobacco use and preventing tobacco related diseases in Europe", said MD Jack Watters, Pfizer's Vice President of International Medical Affairs. The urgency of these policies are recognized worldwide(5 )including the introduction of smoking bans as well as improved access to smoking cessation therapies for smokers motivated to quit.

In the field of smoking cessation, measures based on compromise are destined to fail. Pfizer welcomes the important process the Commission has set in motion by issuing this Green Paper. "The European U nion and Member States should now show the political courage to endorse the most comprehensive and all-inclusive policy options", said Watters. "Pfizer will strongly support every effort that leads to better health and disease prevention in Europe."

'Humans Aren't Rats,' Pfizer Expert Confides
 
February 27, 2007
Ed Silverman

The spat over nicotine therapy is getting still more interesting. Despite concerns that various gimmicks - prescription nicotine inhalers and sprays, to over-the-counter products, such as patches, lozenges and GlaxoSmithKline's Nicorette gum - are of questionable value, some public-health experts want to ease the warnings.

They worry aloud that smokers are scared off. "A 17-year-old smoker of 25 cigarettes per day is doing the right thing to use nicotine gum," Jonathan Foulds, a tobacco researcher at University of Medicine and Dentistry of New Jersey, tells The Wall Street Journal (subscription required) in a fascinating look at the issue. "Why give him another hurdle to cross to get help?"

Recent studies of successful quitters suggest significant benefits of nicotine products seen in randomized clinical trials may not apply in real-world conditions. Critics say experts who favor nicotine meds are financially tied to manufacturers to see the limitations. And nicotine use by teens, pregnant women, heart-disease patients and smokers who haven't quit is controversial.

Meanwhile, studies in rats suggest the fetal brain may accumulate more nicotine from NRT than from smoking, says Theodore Slotkin, professor of pharmacology and cancer biology at Duke University who, conveniently, has a research grant from tobacco giant Philip Morris. He adds that nicotine in the fetal brain is associated with any number of neuro-behavorial problems.

Nancy Rigotti, a Massachusetts General Hospital tobacco researcher who is also a consultant to Pfizer, which makes a nicotine-replacement therapy, dismissed that concern, the Journal reports. "Humans aren't rats," she says knowingly.

Wait a second, now. Rats are used in pre-clinical work. But when a drugmaker wants to discuss or defend a medicine, doesn't it sometimes point to rodent results? Is it possible to want it both ways? Maybe Rigotti is wrong. Maybe some humans really are rats.
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More smokers going cold turkey

03/12/2007
BY KEN MILLSTONE, Columbia News Service, TwinCities.com-Pioneer Press
Sheri Odom started trying to quit smoking in her mid-20s. At least once a year, she would pick up a supply of nicotine patches or nicotine gum, throw out her cigarettes and steel herself to quit.

She would put up with the "slow torture" of the patch or gum regimen, gradually reducing the nicotine dosage. When she finished the treatment and stopped using the product, she would be cranky and irritable, and within three days, she would be smoking again.

So Odom, a special-education teacher in Springfield, Mo., changed tactics. She decided that those three days - the first three without any nicotine - were going to be bad no matter what. She joined a support group on the Internet, read about nicotine addiction and quit cold turkey in late 2004 while spending Christmas with her family. She figured they would understand if she were cranky.

With the patch, "You're putting off the inevitable that you have to go through anyway, which is the withdrawal from nicotine," said Odom, 40. "I think cold turkey, just from my experience, was the easiest. I just got it over with all at once."

Odom is part of a growing movement of cold turkey quitters who say nicotine patches, gums and lozenges merely draw out a quitter's withdrawal symptoms while feeding the addiction.

A leading advocate of cold turkey quitting is the Web site whyquit.com. The site encourages smokers to educate themselves thoroughly about nicotine addiction and then quit without first cutting down or using medication.

The site includes links to dozens of studies questioning the effectiveness of products like the patch and gum, collectively known as nicotine replacement therapy, or NRT.

An American Cancer Society report in 2003 found nearly 80 percent of ex-smokers said they quit cold turkey. Another study found 93 percent of over-the-counter NRT users relapse and begin smoking again within six months.

With nicotine replacement therapy, "the levels of long-term success are dismal," said Dr. Michael Siegel, a physician and professor at Boston University's School of Public Health. "More important, I think the role of nicotine replacement therapy as part of a national policy to address smoking cessation has been over emphasized. ... Quitting cold turkey has been the most effective way of quitting smoking."

OFFICIAL RECOMMENDATIONS

Quitters like Odom and researchers like Siegel may be shouting into the wind, however. Nicotine replacement therapy is recommended by virtually every government agency and major health organization trying to help people quit - from the Department of Health and Human Services to the American Cancer Society.

The Surgeon General's Web site states, "The most effective way to quit smoking is by using a combination of counseling and nicotine replacement therapy" or medicines like Zyban. The clinical practice guidelines established by the U.S. Public Health Service in 2000 say all eligible patients should use drug therapies.

Based on more than 110 clinical studies, nicotine replacement therapy roughly doubles a person's odds of quitting successfully, said Saul Shiffman, a professor of psychology at the University of Pittsburgh who has studied smoking cessation for 30 years.

"The bottom line is that it works," he said. "We just know that it works. It's a consistent finding, study after study."

Shiffman underscored that nicotine from the patch or gum is "not damaging in itself" and said using nicotine replacement products allows patients to focus on behavioral changes without enduring the worst side effects of nicotine withdrawal.

"Most people use the patch or gum for 10 to 12 weeks. Its real purpose is to get you through that period and launch you on the way to being an ex-smoker," Shiffman said, and if patients relapse later, the product isn't to blame. "It doesn't help everyone forever."

VOICES OF EXPERIENCE

Still, traffic to whyquit.com has grown steadily. John Polito, the site's founder, believes many of those visitors believe the studies and quitting advice on the site confirm their own experiences - that quitters who used NRT return to smoking.

"I ran from miracle cure to miracle cure," said Polito, 52, an attorney and cessation counselor in Charleston, S.C., who smoked three packs a day for 30 years. "I did the patch twice, the gum twice and hypnosis twice." The only thing that worked, he said, was going cold turkey.

Polito started the site in 1999 and a short time later joined forces with Joel Spitzer, who runs cold turkey quitting clinics in Chicago. The site and its sister message board, "Freedom from Tobacco," are free and take no outside financing. Polito and a small volunteer staff pay the sites' costs out-of-pocket.

Spitzer and Polito stress that withdrawal symptoms are at their worst during the three days it takes for nicotine to be completely flushed out of the body, and it's better to just get through that period than to wean away with patches and gums.

The site gives tips for enduring those three days and learning to modify behavior over the subsequent weeks and months.

One thing everyone agrees on is there is no easy way to quit.

"There is no silver bullet here. People need to understand that," said Dr. Lowell Dale, a physician at the Mayo Clinic's Nicotine Dependence Center and an NRT advocate. "We really encourage them to seek the help of a counselor."

Siegel agreed.

"Quitting smoking is probably one of the hardest things that many people will do in their entire lives," he said. "It takes a lot of motivation and a lot of willpower."
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How the drug industry uses non-profits to push its interests (Read)

October 12, 2006
Surrogates for Their Agenda

The article states:

...the pharmaceutical industry has mounted a sophisticated grassroots campaign to build support for its position on key issues that affect its bottom line. The industry has funded various groups to champion its positions, sponsored studies tilted to the industry and hired public relations firms to spearhead campaigns to soften up public opinion and government policies....

I've linked to this story in prior posts but I think it is important to make this story a post of its own. If you click on the title above you can read the entire story. And true enough it is a story that needs to be told, but at Clearing the Air the real story that The Center for Public Integrity is missing is HOW THE DRUG INDUSTRY USES NON-PROFITS TO PUSH ITS SMOKING BAN AGENDA....TO PROP UP PHARMACEUTICAL NICOTINE (smoking cessation) PRODUCT SALES.

Here are a sample of grants directly from Johnson & Johnson Company's political arm, the Robert Wood Johnson Foundation (RWJF), (see links above for Nicoderm rationale to implement smoking bans) so you can see the type of non-profits that the drug industry funds; and the activist goals and agenda:

Read
And when Clearing the Air informs lawmakers and you the general public, that the health "hazard" claims these activists' are making reqarding secondhand smoke are nothing more than exaggerations and lies; here are the facts and science we base that claim on: Read and Read.

Smoked out?
There's an easy, patented way to quit, for only $400. Ready to sign up? Well ...

September 9, 2006
By SCOTT BARANCIK, Times Staff Writer

Attention cigarette smokers: If your patch has petered out, your gum grown cold, and your luck with lasers and hypnotists run dry, a Tampa company says it has a $400 cure.

Welplex Inc.'s patented program - a couple of shots of FDA-approved medicine, two weeks of pills and a pamphlet on behavior modification - is a snap. Your addiction will end immediately, the company says, with few or no symptoms of withdrawal. More than half of its patients are still smoke-free a year after treatment.

"The patent encompasses the best that medical science has to offer for the treatment of nicotine addiction," says a page on Welplex's Web site, www.nosmoke2000.com. With an estimated 438,000 Americans dropping dead each year from cigarettes, it's a powerful marketing statement.

But critics are concerned:

- The drugs used by Welplex and its 10-state, 22-city chain of franchises are approved by the Food and Drug Administration - but not for treating nicotine addiction.

- Though Welplex says its anticholinergic drugs cure addiction and withdrawal symptoms instantaneously, the Surgeon General's 200-page "clinical practice guideline" for treating tobacco dependence never mentions them.

- Several experts have questioned the scientific rigor of the "clinical" study, conducted by the company itself, that serves as the basis for Welplex's purported success.

- Atlanta's Fox News staff recently contacted 21 local Welplex patients a few weeks after they received treatment. All but three had resumed smoking.

- Though Welplex says serious side effects are rare, a Georgia couple interviewed by Fox was so despondent during treatment that they decided to give away their business, children and cats - and live on canned green beans under a bridge. University of South Florida psychiatry professor Glenn Catalano coauthored a study about a 59-year-old patient who became psychotic after treatment and considered killing himself and his wife.

Norman Edelman, chief medical officer of the American Lung Association, was blunt in his assessment of Welprex's treatment protocol. "The public should not use medications, especially ones that are proven to have side effects, unless their efficacy and safety have been established," he said. "I'm saying this to physicians as well as the public."

Welplex's founder and owner, Clearwater resident Paul J. Hudson, declined to be interviewed. Tampa physician Steven Schweinshaupt, who offers Welplex's treatment locally, did not return a call Friday. But Rick Fee, a Tampa lawyer who is representing Welplex in an unrelated intellectual property lawsuit, says Hudson is a convenient target for competitors who resent the patent he received in 2000.

"The U.S. Patent and Trademark Office doesn't hand out patents willy-nilly," Fee said. "People don't get patents on snake oil."

Two documents provided by Fee, including a seven-page report on the rationale for treating nicotine addiction with anticholinergic drugs and a 14-page protocol for administering Welplex's treatment, were authored by a medical toxicologist. Welplex's Web site says the company is planning a "double-blind, placebo-controlled clinical study" on its effectiveness, but its Phoenix franchisee's Web site says it's unlikely to seek FDA approval because of the substantial costs involved.

Welplex's Web site and the outgoing message on its local voice mail describe a procedure that cures smokers both rapidly and inexpensively.

The three-step process begins with a 11/2-hour visit to the local franchisee's clinic. There, the patient fills out a medical questionnaire, watches a video describing the procedure and its effects, and receives an EKG test, a lung-function test and a brief physical exam. Once cleared, the patient is injected with a trio of drugs that are supposed to block signals from the brain's nicotine receptors.

Before leaving, the patient receives (Step 2) a self-help manual on the psychological aspects of addiction and (Step 3) a two-week prescription for anticholinergic pills, which Welplex says will shield patients from the final stages of withdrawal.

"The brain actually enjoys the experience," Welplex's local recorded message says. "Patients will notice about 5 to 7 minutes after treatment that their urges and cravings are gone!"

Hudson, the company's 53-year-old founder, did not invent the trio of drugs or the concept of behavior modification. His patented idea was to combine the initial injections, low-level pills and behavior modification in one program.

Competition for smokers - an estimated 70 percent of the country's 44-million adult puffers want to quit, according to the Centers for Disease Control and Prevention - is stiff. This week, Welplex filed suit against a California company for allegedly ripping off its program. It filed a similar suit earlier this year against an Indiana company that later agreed to drop its allegedly infringing Web site.

Times staff researcher Angie Drobnic Holan contributed to this report. Scott Barancik can be reached at barancik@sptimes.com or (727) 893-8751.
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Doctors Want to Prescribe Drugs Against Smoking, Survey Says

Sept. 5, 2006
Steven Bodzin

Doctors around the world wanted more effective medicine to help smokers quit smoking and wanted the habit classified as a medical condition, a survey found.

Large majorities -- 81 percent -- considered smoking to be a chronic medical condition and wanted more effective drugs, the survey found. There were big differences between countries in how likely doctors were to talk with patients about tobacco use, with 68 percent of North American doctors having such conversations compared with only 14 percent in Japan and Korea.

The study of 2,836 physicians from 16 countries, conducted by Harris Interactive, was sponsored by Pfizer Inc., maker of anti-smoking medicine Chantix, the drugmaker said in a statement distributed yesterday by Canada NewsWire.

Doctors in Canada and the U.S. were the most likely to prescribe drugs to help people quit, with 57 percent doing so, compared with 29 percent globally and 21 percent in Europe, the survey found.

The findings were presented yesterday at the World Congress of Cardiology/European Society of Cardiology meeting in Barcelona, Spain, Pfizer said in the statement.
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From: Mark Wernimont [mailto: cleanairquality@gmail.com]
Sent: Thursday, July 06, 2006 9:06 AM
To: ENFORCEMENT
Cc: attorney general; attorney.general@state.co.us
Subject: Potential violation

I have a concern about the upcoming acquisition of Pfizer by Johnson and Johnson Company.

It does appear to have serious monopolistic overtones. Not the least of which will affect the smoking cessation marketplace.

J & J owns ALZA which manufactures Nicoderm & Nicoderm CQ.....Pfizer's new drug Chantix is due out later this month. Which puts nearly all of the smoking cessation drugs on the market into the hands of one giant corporation Johnson & Johnson.

This sale should not go thru.

Mark Wernimont
Watertown, MN.
Global Air Filtration Systems Inc.
www.clean-air-quality.com

---------- Forwarded message ----------
From: SEC Help help@sec.gov>
Date: Jul 7, 2006 12:14 PM
Subject: SEC Response - File HO1162687
To: "Wernimont, Mark" cleanairquality@gmail.com>

Dear Mr. Wernimont:

Thank you for contacting the SEC.

The SEC does not approve or disapprove acquisitions, including mergers, takeovers or other transactions. Rather, the federal securities laws are intended to provide the investing public with full and fair disclosure of material information on which to base informed investment or voting decisions. In certain circumstances the SEC may review the disclosures made by the companies and ask them to address any concerns that the SEC staff has.

Sincerely,

RINELL RANDOLPH JR
U.S. Securities and Exchange Commission
100 F St, NE
Washington, DC 20549-0213
(202)551-6321

Press Release
DrugMax Changes Name to Familymeds Group (Nasdaq: FMRX)

July 10, 2006

Company's Core Familymeds Brand Continues to Expand and Demonstrate Strong Momentum

FARMINGTON, Conn., July 10 /PRNewswire-FirstCall/ -- DrugMax, Inc. (Nasdaq: DMAX - News) today announced its name change to Familymeds Group, Inc., the recognized brand name of the Company's core pharmacy business. In conjunction with the name change, effective today, the Company will begin trading under its new Nasdaq stock symbol "FMRX". The company's corporate website can be found at http://www.familymedsgroup.com.

Ed Mercadante, R.Ph., Chairman and Chief Executive Officer of Familymeds commented, "The Familymeds name best reflects the strategic direction of our business. Our hospitals, patients, and doctors all know us by our existing Familymeds brand. We feel that changing our corporate name to the same name that our customers know us by strengthens our overall brand identity. Our current shareholders understand the value of the Familymeds brand and overwhelmingly support consistency with our customers and the investment community. Furthermore, the name change will reduce our costs associated with maintaining both names."

The inherent value in the Familymeds name is derived from almost a decade of brand strength and familiarity by hospitals, doctors and patients within the Company's markets served. The Familymeds platform includes all of our Familymeds and Arrow Pharmacies, Worksite Pharmacies(SM), and Valley Medical Supply operations.

Mercadante continued, "Our sales performance during the first half of 2006 shows that our growth strategy for our core pharmacy operations is gaining traction. We look forward to continuing to produce solid financial and operating results that will drive value to our shareholders."

An amendment to the Company's Certificate of Incorporation to change the name of the Company to Familymeds Group, Inc. was approved at the Company's annual meeting of stockholders held June 23, 2006.

About Familymeds Group, Inc. (DrugMax, Inc.)

Familymeds Group, Inc. is a pharmacy and medical specialty product provider formed by the merger on November 12, 2004 of DrugMax, Inc. and Familymeds Group, Inc. Familymeds works closely with doctors, patients, managed care providers, medical centers and employers to improve patient outcomes while delivering low cost and effective healthcare solutions. The Company is focused on building an integrated specialty drug platform through its pharmacy and specialty pharmaceutical operations. Familymeds operates 85 locations, including 7 franchised locations, in 14 states under the Familymeds Pharmacy and Arrow Pharmacy & Nutrition Center brand names. The Company also operates Worksite Pharmacy(SM), which provides solutions for major employer groups, as well as specialty pharmaceutical distribution directly to physicians and other healthcare providers. The Familymeds platform is designed to provide services for the treatment of acute and complex health diseases including chronic medical conditions such as cancer, diabetes and pain management. The Company often serves defined population groups on an exclusive, closed panel basis to maintain costs and improve patient outcomes. Familymeds offers a comprehensive selection of brand name and generic pharmaceuticals, non-prescription healthcare-related products, and diagnostic supplies to its patients, physicians, clinics, long-term care and assisted living centers. More information can be found at http://www.familymedsgroup.com. The Company's online product offering can be found at http://www.familymeds.com.

Safe Harbor Provisions

Certain oral statements made by management from time to time and certain statements contained in press releases and periodic reports issued by Familymeds Group, Inc., including those contained herein, that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements involve risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Forward-looking statements are statements regarding the intent, belief or current expectations, estimates or projections of Familymeds, its directors or its officers about Familymeds and the industry in which it operates. Although Familymeds believes that its expectations are based on reasonable assumptions, it can give no assurance that the anticipated results will occur. When used in this report, the words "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates," and similar expressions are generally intended to identify forward-looking statements. Important factors that could cause the actual results to differ materially from those in the forward- looking statements include, among other items, management's ability to successfully implement its business and growth strategies, including its ability to acquire other businesses, open new Worksite locations, and improve sales and profitability. Further information relating to factors that could cause actual results to differ from those anticipated is included under the heading Risk Factors in the Company's Form 10-K for the year ended December 31, 2005, and its Form 10-Q for the quarter ended April 1, 2006, filed with the U.S. Securities and Exchange Commission. Familymeds disclaims any intention or obligation to update or revise forward-looking statements, whether as a result of new information, future events or otherwise.
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