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"Many of today's youth who smoke cigarettes will become addicted to nicotine. But that's not all. Underage smokers are much more likely than non-smokers to use alcohol and other drugs. For example, underage smokers in South Carolina are:

• three times more likely to drink alcohol;
• seven times more likely to smoke marijuana;
• 15 times more likely to use cocaine; and
• 41 times more likely to use hallucinogens. "

SC DAODAS - http://www.scprevents.org...e/readroom/clearing.html

A vaccine against smoking

By Eran Shifferman

February 11, 2004, Haaretz News

A number of antidotes to nicotine, currently undergoing clinical trials, are designed to stimulate the body's immune system to create antibodies. These bind with nicotine molecules, forming a compound too large to traverse the blood-brain passage. The result is that the pleasurable effect of smoking is neutralized and the addiction to  nicotine prevented. The compound later breaks down into harmless components and is excreted from the body.

Three companies have produced vaccines. The Swiss firm Cytos has developed Nicotine-Qbeta. The Xenova Group in the U.K. is testing TA-NIC, in which the active ingredient is a kind of "tagging" procedure using a nicotine derivative and an endotoxin from the cholera virus. The American firm Nabi Biopharmaceuticals has developed NicVAX with an endotoxin from a different virus.

Binding with a protein stimulates the immune system to produce antibodies to nicotine, which would not have occurred had the nicotine molecules been able to move freely in the bloodstream. All the vaccines are administered by injection.

In preliminary trials, in which rats were injected with NicVAX, a 65 percent reduction in the nicotine entering the brain was observed. The San Diego-based Scripps Research Institute (TSRI) has announced that it is developing a second-generation nicotine vaccine designed to solve a problem that has vexed researchers: the nicotine molecule is flexible enough to produce structural changes, making it difficult for antibodies to bind with it. In the new version, the nicotine derivative has been engineered for stability. TSRI researchers claim that the second-generation vaccine produces a far broader immune reaction than its predecessor.

Reservations have been voiced within the medical community regarding the success of the vaccines. Some researchers wonder about nicotine addicts increasing the number of cigarettes they smoke to the point where the antibodies are unable to cope with the quantity of nicotine taken in.

In any event, the focus of the clinical trials at this stage is on the safety of the vaccine rather than on its efficacy and its ability to prevent addiction.

An additional problem is a question of ethics: the guidelines for the trials forbid giving nicotine to someone who has already been weaned off it.

Some of the biopharmaceutical companies are simultaneously working on a vaccine against cocaine. If their experiments succeed, it will provoke a social-ethical debate about the authority of society and of parents and teachers in controlling undesirable patterns of social behavior in advance. It is unlikely that anyone will object to a vaccine against cocaine, but the debate over nicotine will be interesting to watch.

© Copyright 2004 Haaretz. All rights reserved

http://www.haaretz.com/hasen/spages/392865.html

As stated in above articles, yesterday Nabi asserted to the world that "a Phase II clinical trial showed that 33 percent of 68 smokers inoculated with the company's NicVax vaccine were able to quit, as opposed to 9 percent who took a placebo." "The company did not say how long the smokers remained smoke-free. Nabi said it will release full Phase II clinical trial results at various scientific meetings in 2005."

Nabi's press release intentionally omits some rather critical info:

• How long they quit - a week, a month, three months, six months?
• How quitting was defined - continuous nicotine cessation, point prevalence or some new creative definition?
• What behavioral interventions, counseling and/or support were used (if any), that had their own proven effectiveness and for which NicVax should not be allowed to claim credit?
• What are the results of the study's blinding assessment?
• What happened to the 66% who relapsed with the vaccine still inside them - has their daily smoking actually increased?

What's most frightening is that we knew from the Phase I study that one-third of the nicotine smoked was not binding with the vaccine which we are told would have made the new molecule too large to pass through the blood brain barrier. In other words, we knew that a relapsed smoker would need to smoke roughly three times their old nicotine intake in order to have sufficient nicotine present in the brain to satisfy their old level of tolerance.

As for blinding, we just learned that a $1.4 billion dollar NRT industry has likely been built entirely upon junk science in that the studies were not blind as claimed (see - http://whyquit.com/pr/051904.html). If true, why would a psychoactive chemical (nicotine) not also be psychoactive in vaccine studies?

What are the odds that a substantial percentage of those assigned to receive the placebo in the NicVax studies remained blind to the fact that within 8 to 10 seconds of that first puff, a big big "aaahhh" sensation still arrived? Think about it. If they had joined the study in hopes of receiving this new miracle cure then what are the odds that they would have remained in the study once their expectations were dashed?

It's a bit different from realizing that they were not experiencing their dopamine/adrenaline high, as in the NRT studies, but the drug is still psychoactive and researchers in both study areas must come to terms that relying upon frustrated expectations to produce victories is not science but more closely akin to outright fraud. Frankly, I'm beginning to believe that it may be impossible to use a placebo study format when dealing with any psychoactive chemical.

Yes, thirty-three (33%) percent is a solid recovery rate but only when put in an honest and comparable context. I am light years away from having the recovery understanding of Joel in helping educate and a group of quitters yet I have yet to do a quit smoking clinic where at least 50% of participants were not still nicotine-free at two weeks. Although it has been some time science we've done an evaluation here at Freedom, our last two evals produced 38 and 39% six month continuous nicotine cessation rates for new members posting to the group at least once.

We are not limited to just analyzing the active NicVax group (those receiving the vaccome either, as we know that roughly 10% of the placebo group should have successfully quit smoking for months if they had quit entirely on their own without any products, procedures or programs (see http://whyquit.com/whyquit/A_OTCPatch.html ). If the 9% in the Nabi study was for a period shorter than 6 months, or if counseling or group support was used as part of the study (both of which produce effectiveness in their own right) then it would seem to suggest that the placebo group may have sustained some degree of expectations defeat.

The NicVax study press releases have generally been less than forthright, omitting substantial detail that would have allowed smokers to better evaluate the vaccine's merits, if any. It is my guess that a creative definition of quitting is being employed. Why? Well, the very foundation of a vaccine is that it inoculates the user against risks posed by a known harm. If a smoker now believes that they can smoke nicotine but that the nicotine will not enter their brain then shouldn't we expect some precentage to try and test or challenge the vaccine now and then?

If so, wow do we come up with a quitting definition that will allow them to do so yet also allow the researchers to proclaim to the world that they quit? In NRT studies many researchers employed a quitting definition called "point prevalence" which only asked if the quitter had quit smoking during a particular time period, almost always the "point" in time -- and a stated number of days preceding -- when they were scheduled to have their next appointment at the study center for a quitting evaluation, an event which many studies paid participants financial compensation.

As you know, the NRT studies actually invented their own creative definition of quitting. No longer was continuing to be hooked on nicotine a concern as up to 7% of gum users still dependent upon the gum at six month were declared to have successfully quit. Now that science was able to extract nicotine from the tobacco plant and put it into new and creative delivery devices, for the very first time quitting smoking no longer required the addict to quit nicotine too.

What is troubling about past vaccine press releases is that they vastly over-inflated expectations. We each know that thousands of junkie minds are searching for a way to rationalize continued smoking. Those who attempt to convince them that a cure is just a few years away may actually be contributing to helping cost thousands their health and quality of life or, worse yet, life itself.

Overall the vaccine researchers have been extremely irresponsible by not telling nicotine addicts not to wait on "possibilities" but to quit now and quit today. I get mad at myself for even thinking such thoughts but with certain stories I was left with a deep hurt upon feeling that they almost wanted smokers to delay cessation.

After ten days to two weeks nicotine dependency recovery is almost entirely psychological. Pharmacology continues to all but ignore this reality. It would be fantastic if we could safely inoculate the world's children against nicotine addiction but don't hold your breath as it is not happening here.

Still only one rule for me as well as you, no nicotine just one day at a time ... Never Take Another Puff! John (Gold x5)

April 30, 2008

An anti-nicotine vaccine will be tested on 400 people in the Nordic countries over the next year aimed at helping smokers kick the habit, the Karolinska Institute in Sweden said on Monday.

"A Swedish vaccine against nicotine will be tested on 400 people in three Nordic countries," the institute said in a statement.

Lena Wikingsson, head of Independent Pharmaceutica, which is running the experiment, told Swedish daily Svenska Dagbladet that people taking part in the study -- heavy smokers who would like to quit -- would be given counselling before they stop smoking and would be given a drug to help them quit.

They will then receive one injection a month for four months. Half of the participants will be given the vaccine and the other half a placebo.

They will be followed for a year to see whether they begin to smoke again, Wikingsson said.

The vaccine, called Niccine, has been developed over the course of 10 years by Swedish researchers at the Karolinska Institute, under the guidance of professor Torgny Svensson who founded Independent Pharmaceutica.

Niccine is supposed to help the immune system build antibodies against nicotine.

If a person who has taken the vaccine smokes a cigarette, the antibodies jump into action, latching onto the incoming nicotine and preventing it from reaching the reward system in the brain -- thereby stopping the smoker from getting the "kick" that makes smoking addictive.

One problem in developing nicotine vaccines is that the immune system doesn't react to normal nicotine.

In order to activate the immune system, the nicotine in the vaccine needs to be latched onto a "carrier" or "host" that stimulates the immune system to create as many antibodies as possible.

For the vaccine to be successful, a large number of antibodies must be created, and the carrier component is therefore the key part of Niccine, Wikingsson said.

"There are several possible applications if the vaccine proves to be effective," Wikingsson told Svenska Dagbladet.