Oh goody! A vaccine in the works to help people quit smoking!

[LCrawford67]

http://www.cnn.com/2009/HEALTH/11/09...ine/index.html

(CNN) -- When Katherine Frazier was a teenager in Silver Spring, Maryland, back in the '60s, smoking was the "in" thing to do. She thought it was glamorous. She thought it was cool. Her friends smoked, her parents smoked, and at the time, no one knew that smoking tobacco could kill you.

Fast-forward 40 years. Frazier, 57, still smokes, but she wants to quit. She knows that the longer she puffs, the higher her risk for developing certain health problems, including heart disease and certain cancers.

In her battle against the butt, Frazier has stuck on patches, chewed gum and even tried going cold turkey. Sometimes it worked, but never for long. "I am desperate to quit smoking for good," she said.

Soon, she might have another tool at her disposal.

The National Institute on Drug Abuse, a division of the National Institutes of Health, gave Nabi BioPharmaceuticals a $10 million grant to take its anti-nicotine vaccine, NicVAX, to Phase III clinical trials.

According to the National Institutes of Health, in Phase III trials, the treatment is "given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely." It's also the last step before the drug can go before the FDA for approval.

NicVAX is designed to stimulate the immune system to generate antibodies that latch on to nicotine in a smoker's body and actually prevent nicotine from ever entering the brain. The testing began last week.

"Nicotine addiction causes nearly a half-million deaths annually in the United States alone. Finding effective treatments that can help people stay off cigarettes has been a real challenge," NIH Director Dr. Francis Collins said. "This Phase III trial of a nicotine vaccine offers tremendous hope towards solving this immense public health problem."

Drug experts say nicotine is more difficult to kick than heroin. The American Cancer Society reports that of the 44 million smokers in the United States, 70 percent say they want to quit. About 40 percent do quit each year, but only 4 to 7 percent manage to give up smoking, without help, for good.

"We hope the Phase III trials will get stronger results so that a large percentage of our population can benefit from it," said Dr. Nora Volkow, director of the National Institute on Drug Abuse. "Ideally, we'd like to see 100 percent of those taking the vaccine stop smoking for good."

Volkow says that what makes NicVAX different from existing anti-smoking therapies is that it helps smokers quit permanently. Relapse is a significant challenge facing smokers, and relapse rates with currently available smoking cessation therapies can be as high as 90 percent in the first year after a smoker quits, Volkow says.

When a smoker inhales cigarette smoke, nicotine is absorbed through the lung tissue and into the bloodstream and carried through the body. Because nicotine is a small molecule, it easily crosses the blood-brain barrier and binds to receptors that release dopamine. The release of dopamine generates the pleasurable sensation known as a "smoker's high."

The whole process occurs very rapidly -- less than one minute after tobacco smoke is inhaled -- so the nicotine fix is quick, reinforcing the addiction.

The NicVAX vaccine prompts the immune system to create antibodies that bind to the nicotine molecules in the blood. The now-larger molecules are prevented by their size from crossing the blood-brain barrier. Trapped outside the brain, the bound nicotine can't reach the receptors that trigger the release of dopamine. No dopamine, no pleasure.

It's believed that a smoker's addiction to nicotine will diminish over time because, as the antibodies created by NicVAX continue to bind to the nicotine, the amount of nicotine reaching the brain will gradually decrease. This lack of feel-good reinforcement reduces the urge to continue smoking.

According to NicVAX maker Nabi, the results of prior trials have been promising, with few side effects. In the Phase II trials, Nabi reported that 30 percent to 35 percent of those given NicVAX were able to remain smoke-free over the long term, compared with only 10 percent of those receiving the placebo.

"In addition, those participants that continued to smoke but showed a high antibody response to NicVAX significantly reduced the number of cigarettes smoked over the full 12-month period from a baseline of 20 cigarettes per day to 10 cigarettes per day," Nabi reported.

The initial Phase III study for NicVAX will enroll approximately 1,000 patients. The primary reason for the study is to see what the abstinence rate is at 12 months: in other words, how many people are actually quitting for good? Study results are anticipated in the third quarter of 2011. According to Volkow, that's when "we can get the vaccine in front of the Food and Drug Administration for approval."

If you're interested in participating in a clinical trial, including NicVAX, click here

Frazier is thinking about joining the trial. But for now, she's relying on her own willpower to cut down on the number of cigarettes she smokes per day. Eventually, she knows she's gong to need some help.

"If I could quit, it would be a huge goal in getting my health in order. This could change my life," she said.

[scotia21]

OH MY GOSH !!!

[fiddaman]

Triffic. What next - a vaccine for non-smokers?

[luc]

This is just SICK. $$$ and more $$$...

[Lucy]

God Help us. I heard last week that new 'brain drugs' may soon be available for weight control. With so many overweight, including the ever-increasing numbers of people on SSRIs, that will be an incredible new source of $$$ for the drug companies.

[luc]

Originally Posted by Lucy

God Help us. I heard last week that new 'brain drugs' may soon be available for weight control. With so many overweight, including the ever-increasing numbers of people on SSRIs, that will be an incredible new source of $$$ for the drug companies.

Hey, Lucy. When I read this my jaw dropped...

[carolyn]

I'll take the vastly unpopular opinion and think that, with proper testing, this might be a good thing. Smoking has massive and immediate health repercussions and giving people more tools to quit could be OK.

[luc]

Originally Posted by carolyn

I'll take the vastly unpopular opinion and think that, with proper testing, this might be a good thing. Smoking has massive and immediate health repercussions and giving people more tools to quit could be OK.

Hey, Caroline. "Proper testing"-here lies the rub. The Big Pharma will use all their manipulative machinery to ensure the good results of their new "quick fix".

If they pulled it off with SSRIs and many others, they might do the same here...

[Lucy]

I think I heard about the weight control drugs on public radio. One proposed drug was wellbutrin or something similar, another was a combination of naltrexone plus something else - can't recall other details. At another time in my life, I might have thought of weight control drugs as good news. Now I think 'There will be many victims who fall for this'.

[carolyn]

Originally Posted by luc

Hey, Caroline. "Proper testing"-here lies the rub. The Big Pharma will use all their manipulative machinery to ensure the good results of their new "quick fix".

If they pulled it off with SSRIs and many others, they might do the same here...

true enough.

[luc]

Originally Posted by Lucy

I think I heard about the weight control drugs on public radio. One proposed drug was wellbutrin or something similar, another was a combination of naltrexone plus something else - can't recall other details. At another time in my life, I might have thought of weight control drugs as good news. Now I think 'There will be many victims who fall for this'.

You know, Lucy, the SSRIs withdrawal is an unimaginable hell. But there's one thing that is paradoxically good about that. Having gone (and still on the ride) through all this, and knowing what it's all about, I'll never let my children and my family go anywhere near it. It, in a way, was the most potent vaccination (its side-effects are only good ones)*. When I hear about all this "quick fixes", I'm EXTREMELY cautious, because 95% of such short-cuts are...short-cuts.

*Though, it was VERY painful itself...

[scotia21]

If you don't change the underlying behaviors that make a person want a cigarette, a donut, a drink, etc. - then you can take pills and shots all day long but they won't really work. People know what makes us fat, yet we still sit on our couches in front of the tv scarfing down McDonald's food. Taking a pill isn't going to change that.

Addiction is addiction is addiction - it doesn't matter what form it comes in. You don't solve it with a pill. You solve it by learning coping skills so that you don't turn to the cigarette, the whiskey, or the food to make you feel better. Plus - with any med there is the chance of addiction and you might just be trading one h*ll for another.

[LCrawford67]

I quit smoking almost 11 years ago. Scotia is absolutely right...there were things I had to change to aid with my success.

I came home every night and had a Pepsi and a cig. Had to stop that altogether and what ended up happening, to boot, is I stopped drinking soda and started drinking water. Bonus!

Years ago, and I'm talking 20+, the Lung Association use to say, the best way to stop smoking, was to simply quit. The great American Smoke Out was one day dedicated to folks going cold turkey, for one day, to prove to themselves they could do it. Notice how you never hear of that anymore?

[luc]

Originally Posted by scotia21

If you don't change the underlying behaviors that make a person want a cigarette, a donut, a drink, etc. - then you can take pills and shots all day long but they won't really work. People know what makes us fat, yet we still sit on our couches in front of the tv scarfing down McDonald's food. Taking a pill isn't going to change that.

Addiction is addiction is addiction - it doesn't matter what form it comes in. You don't solve it with a pill. You solve it by learning coping skills so that you don't turn to the cigarette, the whiskey, or the food to make you feel better. Plus - with any med there is the chance of addiction and you might just be trading one h*ll for another.

I was just about to write the very same, Scotia. It's sad, but they prey on the people's naive belief that all their problems/addictions will miraculously go away at a finger snap. Life would be so easy, like in a fairy-tale; "Got problem? We'll fix it right away". Too bad that SSRIs were prescribed to people who already suffered immensely and they trusted the doctors so much...

[luc]

Originally Posted by LCrawford67

The great American Smoke Out was one day dedicated to folks going cold turkey, for one day, to prove to themselves they could do it. Notice how you never hear of that anymore?

Precisely! There's no market for it, and no profits involved.

[fiddaman]

I bet there is no government health warning on the vaccine as there is on packets of cigarettes [at least there is in the UK]

I'm a smoker, it's one vice that I am not very proud of. I always tell myself that what I am doing is wrong, always tell myself that one day I will quit... thing is, I always put that day off.

It should be a breeze compared to quitting Paxil eh?

[LCrawford67]

Originally Posted by fiddaman

It should be a breeze compared to quitting Paxil eh?

I'd quit smoking a thousand times over one Paxil w/d.

[scotia21]

I am an overeater and it's the same principle. I know that I shouldn't eat things when I am not hungry but I find myself doing it anyway. It's an addiction like anything else. I have to change the behaviors that lead me to plopping my fat ace on the couch and eating a whole bag of potato chips.

[Lilly]

I totally agree with what scotia wrote too, but have to add, this sounds quite a bit like Chantix and how it worked on the brain to help people quit smoking.

Sales for it have dropped dramatically since all the side effects of it have been coming out and I am suspicious about this vaccine and see no good coming of it.

Lilly

[nickels]

Originally Posted by scotia21

If you don't change the underlying behaviors that make a person want a cigarette, a donut, a drink, etc. - then you can take pills and shots all day long but they won't really work. People know what makes us fat, yet we still sit on our couches in front of the tv scarfing down McDonald's food. Taking a pill isn't going to change that.

Addiction is addiction is addiction - it doesn't matter what form it comes in. You don't solve it with a pill. You solve it by learning coping skills so that you don't turn to the cigarette, the whiskey, or the food to make you feel better. Plus - with any med there is the chance of addiction and you might just be trading one h*ll for another.

BINGO!

This is a load of crap. While I think its important to find better ways to help people quit smoking...I wouldn't trust this vaccine after reading how its supposed to work.

A lot of people are addicted to the nicotine, sure, but just as many smokers are addicted to the habit of having something in their mouth/hands or for the routine of smoking or b/c they "think" it relaxes them. What will this vax do for these aspects of addiction?

[luc]

Originally Posted by nickels

BINGO!

This is a load of crap. While I think its important to find better ways to help people quit smoking...I wouldn't trust this vaccine after reading how its supposed to work.

A lot of people are addicted to the nicotine, sure, but just as many smokers are addicted to the habit of having something in their mouth/hands or for the routine of smoking or b/c they "think" it relaxes them. What will this vax do for these aspects of addiction?

QFT. I was a smoker (up to one packet of cs a day). I quit when I went c/t with Paxil. Smoking was not so much of a physical addiction, but psychological one (this whole ritual of lighting a cigarette, puffing, etc.)

[Lucy]

Originally Posted by luc

You know, Lucy, the SSRIs withdrawal is an unimaginable hell. But there's one thing that is paradoxically good about that. Having gone (and still on the ride) through all this, and knowing what it's all about, I'll never let my children and my family go anywhere near it. It, in a way, was the most potent vaccination (its side-effects are only good ones)*. When I hear about all this "quick fixes", I'm EXTREMELY cautious, because 95% of such short-cuts are...short-cuts.

*Though, it was VERY painful itself...

Yes, our suffering has given us a very painful education about the dangers of pharmaceutical drugs, and that education may benefit our families - if they will listen to us - that's one good thing that I can say about this.

[scotia21]

You don't cure a chemical addiction with another potentially addictive chemical. Period. End of story. When will people realize this?

[jule1]

I'm speechless. I think you're on to something scotia!

[LCrawford67]

We live in a society of "instant gratification." We want everything done NOW and we want it done for us. We blame pharma, doctors, etc. for creating these things and handing them out, but we have to take responsibility too. It's supply and demand.

Many of us, myself included, had an issue, wanted it fixed, and willingly took that little pill, which fixed everything. We don't want to actually have to "work" to get results.

Instead of diet and exercise, pills and bariatric surgery. Instead of quitting smoking, patches, gums, pills and now, this. And you know what? People will be clammoring for it, because it'll do the job for them. Doesn't matter what's potentially in the vaccine, or what it may do in regards to side effects. And, as long as drug companies have this kind of market, they'll continue rolling out this kind of crap.