A Vaccine Against Narcotics?

[grandbaby]

From The Tyee:

http://thetyee.ca/News/2006/09/15/Vaccine/




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A Vaccine Against Narcotics

We're close to a controversial tool against addiction and overdose.

By Jeffrey Helm
Published: September 15, 2006


TheTyee.ca

Someday, along with jabs against mumps and measles, kids could get vaccinated against nicotine, cocaine and heroin.

Vaccines for cocaine and nicotine have already been tested in humans. Nicotine vaccines, in particular, are getting a lot of attention.

This summer a recruitment campaign got under way across the United States for clinical trials of NicVAX, a nicotine vaccine. Nabi Pharmaceuticals says it is developing NicVAX in order to help "billions worldwide who are addicted to smoking tobacco products or are at risk of becoming addicted."

But vaccines against a drug are different from normal vaccines against disease-causing viruses and bacteria. Normal vaccines prevent disease from taking hold. That is not the focus of drug vaccines like NicVAX.

"The target for [drug] vaccines right now is treatment or relapse prevention," says Dr. Paul Pentel from the University of Minnesota, one of the leading researchers in nicotine vaccine development. "It's simply way to early to know if vaccines would be appropriate for [addiction] prevention."

Even so, that won't prevent the off-label use of a product like NicVAX. Off-label use is when doctors prescribe a drug for something other than what it was originally meant for, and for some drugs, off-label use accounts for the bulk of their sales.

Whether the purpose is treatment or prevention, a vaccine made against a drug would soak up the drug and prevent it from working. Even if a smoker who was trying to quit slipped and lit up, the cigarette would just tar up their lungs a little more. No buzz, just stinky hot smoke. An effective nicotine vaccine would force you to quit cold turkey whether you wanted to or not. Which is both a strength and a potential problem of such treatments.


How an anti-drug vaccine works

Vaccines work by getting your body to produce antibodies, which are molecules designed to bind. They are tailor-made to latch onto and immobilize anything foreign that catches the attention of your immune system. Antibodies are also very specific. An antibody against a virus, like polio, won't work against anything else.

Normally the body does not make antibodies that target drugs because drug molecules are too small. They need to be small so that they can move easily from the blood to where they work in the brain.

In order for the immune system to make antibodies against a drug, a piece of the drug molecule is joined to a larger protein that the immune system will pay attention to. Then the body will start making antibodies that will grapple onto the drug.

With a standard immune response, other cells chew up bound antibodies, and whatever they are hanging onto. This does not happen with vaccines for drugs; the antibodies just stay latched to the drug molecules. But now the drug molecule is much bigger since it has an antibody stuck to it. So big, that the bound drug can't get into the brain to do any harm. Neither can it interact with anything else in the body.

A few party crashers help withdrawal

The intended use of NicVAX, and other drug vaccines in development, is to help people quit and stay clean.

In a small preliminary study, 40 per cent of smokers on NicVAX quit, as compared to a 9 per cent quit rate of those on a placebo (fake drug). "That differential was the largest differential of any smoking cessation product ever tested," Tom Rathjen, vice-president of investor relations for Nabi Biopharmaceuticals, told The Tyee.

Great results, even when some of the nicotine is getting to the brain.

Shutting out the drug completely from the brain was the initial idea, but the antibodies made from NicVAX let a little nicotine through -- which actually isn't so bad. The small amount of nicotine that gets through lessens withdrawal symptoms, and for reasons that are not entirely clear, the entry of unbound nicotine into the brain is also slowed. This slowing of nicotine entry also reduces its addictive strength.

"The reinforcing properties of nicotine are greatest in the first few seconds or minutes after a puff of a cigarette," Pentel told The Tyee. "If it's possible to slow the entry of nicotine into the brain, this could potentially reduce its subjective and its addictive effects."

But I don't like needles

Physicians have concerns with drug vaccines, like NicVAX, beyond possible allergic reactions that come with any vaccine. With a vaccine against a drug, whenever the drug is taken, bunches of antibody-drug formations fill the blood stream. When more than one antibody binds to a drug, the resulting clump, called an antigen-antibody complex, can cause problems.

Dr. David Marsh, who is the head of Addiction Services for Vancouver Coastal Health, expressed concern that drug vaccine studies have not always looked at antigen-antibody complex effects because they are difficult to study. "I'm not sure if the trials to date have addressed the potential risks of that, like glomerular nephritis (kidney problems), or other problems that antigen-antibody complexes are known to cause."

Although antigen-antibody complexes may still be a concern for other drug vaccines in development, for NicVAX it doesn't appear to be a problem. The antibodies produced with NicVAX bind nicotine one-to-one, so no antigen-antibody complexes would be formed that could damage the kidney.

Another concern, and potential benefit, would be the longevity of the treatment. Some traditional vaccines against disease can give you immunity for life -- immunity that you cannot reverse. A lifelong effect is much more economical than a regime of pills, but, as a general rule, non-reversible treatments make doctors nervous. If something goes wrong, you cannot stop the treatment.

Although NicVAX does last a long time, the effects are not lifelong, so the treatment should be reversible in time. Preliminary studies have shown that a treatment of NicVAX lasts for 12-18 months.

No more 'just say no'

The biggest controversy around drug vaccines is the possibility that the technology could be used to immunize people against drug use before they become addicted. Researchers say that it is much too early to even begin thinking about using vaccines for addiction prevention. But market forces being what they are, researchers don't have much say.

NicVAX is being fast-tracked for approval by the Food and Drug Administration (FDA) of the United States, and if everything goes well, it could be on the market by late 2008. Once NicVAX is on the shelves, there is nothing preventing doctors from prescribing it for the troubled child of parents worried that their offspring might pick up bad habits after school.

Nabi recognizes that this off-label use of NicVAX could occur and is careful not to make any rash judgements. "That [preventative use] obviously becomes a controversial issue with many people," says Rathjen. "It would not be something that we are going to be pursuing, at least initially."

But not all off-label use of NicVAX is as ethically questionable as childhood vaccinations. Less controversial would be vaccinating pregnant mothers to protect developing children from the negative effects of their mother's drug use.

Nabi is leaving their options open, but vaccinations in the interest of healthy babies aside, the debate on drug vaccines for addiction prevention might be closed before the ethical arguments even start. This is because drug vaccines don't provide absolute immunity. Especially for people who don't want to be immune.

The amount of antibodies that are produced in response to a vaccine are not limitless. Thus, if someone really wants to get high, they will just take more of the drug in order to overwhelm the antibodies in their system. But the amount of drug that would be needed to overwhelm the antibodies would be very high and dangerous to take, since it could very easily lead to an overdose. In the case of NicVAX, you'd have to smoke a whole lot of cigarettes. Rathjen told The Tyee that NicVAX "was effective in animals that were given the equivalent of 20 packs of cigarettes a day."

Previous research also shows that people and animals don't take more of a drug in an effort to overwhelm the antibodies. But it is unlikely that the animals knew they could overwhelm the antibodies with more drug, and people that sign up to test a drug vaccine probably have at least a small desire to quit.

"Vaccines [for addiction], like other medications, have to be used in appropriate populations," says Pentel. That population being people who want to stop using and abusing addictive drugs.

For overdoses, antibodies made to order

With vaccines it often takes time, and sometimes more than one injection, before there are enough antibodies in the body to get anything done. It takes around four injections of NicVAX over two months to get functional antibody levels. But in critical situations, like a drug overdose, you only have minutes, not months.

The body needs time to make antibodies, but antibodies can be pre-made and injected into the bloodstream, which would be a useful tool for doctors. "If somebody arrives at the emergency room with an overdose, you could infuse them with a packet of antibodies and soak up the drug," explains Dr. Marsh. Pre-made drug antibodies would also have less safety concerns than vaccines because they wouldn't stay in the body as long.

Where pre-made antibodies would be most beneficial is for other abused drugs besides nicotine. Currently there is vaccine and antibody research being done for cocaine, heroin/morphine, methamphetamine, and phencyclidine (PCP).

Jeffrey Helm, a former neuroscientist, is writing about science and addiction issues for The Tyee this summer.

Reputation Comments on this post:

interesting post

[N0ly]

damn. thats all i have to say

[Forthesevenlakes]

cant wait til these vaccines are MANDATORY for anyone wishing to work at a major corporation, government office, school, etc!

god bless progress...excuse me while i go puke.

[Riconoen {UGC}]

I'd kill myself if anyone gave me that.

[Demonslayer]

Originally Posted by Riconoen {UGC}

I'd kill myself if anyone gave me that.

I'd kill anyone who gave me that.

[Paracelsus]

now THIS is a very annoying part of the drugwar.

First, they locked dudes up for using drugs. Then they required drug tests before anyone gets a job, while talking about social rehabilitation of drug addicts (drug tests lead to criminality - if you cant get a job, how will you earn your living?).

And now this vaccine thing. The only thing I can say about that: I hope I'll die before they start coming to our schools and giving kids drug vaccines.
This is immoral and draconic.
SWIM remembers some illegal medicine that interferes with alcohol, that "doctors" give to alcoholics, without them knowing it, and this creates hypertension, rapid heart beat and such dangerous stuff (when the pacient uses alcohol). SWIM personally knows a former alcoholic whose wife put that stuff into his food and that way he couldnt consume alcohol anymore, because of those adverse effects. This would be ok but there were a couple of deaths reported of alcoholics who were given that stuff. SWIM bets that will happen with those drug vaccines.

[Demonslayer]

I wish they would invent a vaccine against stupidity.

This is just mind-control and I would violently oppose any government or corporation who tried to impose this on people. It is a crime against humanity. If they get it to work without fucking up peoples brains, then we are under a serious threat from Big Brother. He wants you to think like him and obey. This is in fact a vaccine against free thought.

[Alicia]

Swia agrees with demonslayer, on this one. she does not have a problem with people wanting to take it to free themselves from a difficult addiction they cant cope with. but to impose it on people is wrong whether they like it or not is wrong. Swia would also do a lot of damage if anyone went to inflict this on her.

[SPWIM]

It would be nice if they could use the technique to vaccinate against certain poisons.

[static_vodka_420]

Originally Posted by SPWIM

It would be nice if they could use the technique to vaccinate against certain poisons.

but of course thats not as impirtants as saving our youth from the evil of drugs

[Euphoric]

Can a drug cure an addict?

Researchers are working on a vaccine that could neuter the effects of narcotics like cocaine. Some experts warn this magic bullet could backfire
Dec 22, 2007 04:30 AM

A man is at a downtown loft party. He knows he shouldn't be there, but a friend convinced him it would be a good time, one not to miss.

The music, the short skirts and familiar faces set off an urge he has been fighting for six months. It's been that long since he last cut cocaine. And he swore to stay clean.

But tonight, the pull is too strong. In a bathroom, after a quick exchange, he gets his fix.

He waits a few minutes. Yet the euphoria does not come. The vaccine worked – it stopped the cocaine molecules swirling in his blood from reaching his brain – and the man, even after giving in to temptation, does not spiral back into addiction.

The man in this scenario does not exist. But in as few as five years, this experience could be very real for the hundreds of thousands of people in North America who struggle with cocaine addiction.

In an ever-widening search to treat addiction, scientists have homed in on vaccines as a way to help people kick their habits for good. They say the powerful technology holds promise as an innovative way to treat drugs of abuse, including cocaine, methamphetamine, and even nicotine.

Human trials for the nicotine and cocaine vaccines are already well under way and have yielded good results. The National Institute for Drug Abuse in the U.S. has put $15 million toward research.

The promise of a magic bullet, a quick fix that would tear people away from drug dependency, is enticing to researchers, clinicians and addicts alike. But even as the technology is being perfected in laboratories, experts doubt that a single type of treatment will be able to solve addiction, a complex puzzle that affects dozens of brain processes and arises from myriad environmental, economic and social situations.

Anti-addiction vaccines also come with a host of ethical dilemmas: Should parents be allowed to inoculate their children against cocaine and nicotine?

Should convicted drug offenders have to be vaccinated against their illegal habit before entering prison? Should a vaccine be forced upon people, whether a person with mental illness or a pregnant mother, to protect their health?

Despite these concerns, proponents say vaccines, if and when they are shown to be safe and effective, will hold an important niche in addiction treatment and therapy.

There needs to be a wide variety of options since people respond differently to different treatments, says Margaret Haney, an associate professor of clinical neuroscience at Columbia University who studies medications, including a vaccine, to treat cocaine dependence.

Right now, she says, there are not enough medications available to treat most types of drugs of abuse, particularly cocaine.

"A vaccine is not going to cure cocaine addiction," she says.

"But there is a subset of people who will benefit from this approach ... There is a great call out there among people who are dependent, and from their family members, for something to help."

Anti-addiction vaccines employ immunotherapy and work by setting the body's immune system against drug molecules floating in the blood.

Normally, cocaine and nicotine molecules are too small for the body to recognize and easily pass from the bloodstream into the brain, where they set off pleasure receptors and produce a high.

To create a vaccine, scientists pair drug molecules with proteins to increase their overall size.

This forces the body to recognize them and to start producing antibodies against them.

After several inoculations, a patient who tries to use drugs will have enough antibodies in their blood to fight the new drug molecules, which are then prevented from reaching the brain.

The antibodies are excreted with no lasting effects.

Since vaccines target drugs before they reach the brain, scientists predict patients should experience fewer side effects.

Most other medications used to treat addiction work by changing neural pathways in the brain that mediate the effects of a particular drug.

At Columbia, in 2003, Haney tested a cocaine vaccine on 10 people who had no plans to quit using the drug.

After a course of four vaccines injected over a 12-week period, half of the people produced sufficient levels of cocaine antibodies and reported a substantial decrease, up to a 70 per cent drop, in their dependence.

Haney says the results are exciting.

One of the concerns with a cocaine vaccine is that once inoculated against a cocaine high, determined users will seek other drugs. But Haney's subjects did not do that.

"On the outside, they were using less cocaine. They just stopped. None of them switched to another drug of abuse."

A 2005 Yale University clinical trial of 18 cocaine addicts in early treatment found that cocaine antibodies persisted in the blood six months after inoculation, and subjects reported the usual euphoric effect of cocaine had diminished.

Clinical trials of nicotine vaccines have also met with success and experts say one of these vaccines will likely hit the market in as little as three years.

A 2005 clinical trial out of the University of Minnesota looked at NicVAX, a vaccine produced by Nabi Biopharmaceuticals based in Boca Raton, Fla. It found 38 per cent of smokers who received a higher dose of the vaccine quit smoking for one month, compared with 9 per cent of the placebo group.

"This is proof of principle that this (vaccine) can help people quit smoking," says study author Dorothy Hatsukami, the Forster family professor in cancer prevention at the University of Minnesota.

She sees the vaccine as a tool to help determined quitters from relapsing.

"Nothing is going to be a miracle cure," she says.

"Cigarette smoking is about more than just the drug itself. It includes a lot of things, the social environment, the pleasure sensory of smoking, using it to deal with stress. There are a lot of factors associated with smoking that people still need to deal with ... It (quitting) will still be a struggle, but it's always good to have something to help with the struggle."

Scientists who are working on anti-addiction vaccines see both the promise and the challenges that lay ahead.

Before the nicotine or cocaine vaccines can get to market, scientists have to figure out how to make them more effective, says Paul Pentel, professor of medicine and pharmacology at the University of Minnesota and a pioneer in the field.

It is clear, he says, from the three nicotine and one cocaine clinical trials that the more antibodies a person can produce, the better their chance of not using the drug. The clinical trials have also shown that not everybody who gets the vaccine will produce enough antibodies. Scientists don't yet exactly know why this happens.

"It needs to be improved to be generally useful and to get the most out of it," says Pentel.

Experts also say the mounting excitement over anti-addiction vaccines has to be tempered. Many people think of vaccines as a cure-all. And in most cases that is true; a shot against, say, measles, will prevent the disease from striking.

But anti-addiction vaccines work more like medication, says Pentel. People will likely need multiple doses over many months or years. Vaccines won't curb cravings or deal with the underlying reasons for addiction. And, in their current form, they certainly will not stop people from seeking drugs in the first place.

Haney at Columbia is adamant that people are not vaccinated against their will.

"If parents want to vaccinate their kids, I feel very strongly that that will be a disaster," she says. "The only appropriate use is for somebody who is very motivated to quit."

Tony George, a professor and chair in addiction psychiatry at the University of Toronto, says anti-addiction vaccines will be used in treatment programs once they are proven to be safe and effective. Clinicians are always looking to have more tools to help clients stay clean for good.

"This will be a bonus to our armoury," he says. "It just increases our repertoire and our chances of success."

A recovering addict cautions

Cheryl Peever, left, has been clean and sober for more than 16 years. Her substance abuse problem started in her teens and quickly spiralled into periods of bingeing on alcohol and drugs.

In her late 20s, things got worse. She started to drink and use every day and even began to deal.

"I had no personality, no soul, no moral compass at that point," she says. "I was nothing more than a vessel you poured drugs into."

Peever said there came a moment when she realized she needed treatment. And, after some difficulties negotiating the system, she found her way into a 12-step program and pulled herself out of addiction.

Looking back on her struggle to get clean, Peever, who is now manager of the women's mental health program at Toronto's Centre for Addiction and Mental Health, is not sure whether she would have trusted a drug, even if it was a vaccine, to help her kick the cocaine habit.

In her mind, she says, it would be too dangerous to substitute one drug for another.

"I think it can't be used as a stand-alone treatment," she says. "There's a lot of recreating soul and personality that goes into recovery. It's not just stopping behaviours."

After a short pause, Peever reconsiders and says it could be useful as one part of a treatment plan. She points out that an anti-cocaine vaccine won't stop all of the behavioural and environmental triggers, from the stuffed-up feeling in the nose during a cold to watching a movie character taking drugs, that coax someone into using again.

She appreciates that scientists – and even addicts – would like to have a quick fix, but says researchers often do not understand what it's like to live with addiction.

"There are a lot of systemic issues that keep addiction alive," she says.

"Extreme poverty, mental illness, lack of adequate housing and childcare, these all keep it (addiction) going and prevent people from moving on and getting treatment. A vaccine developed in a laboratory isn't addressing these issues. It's a nice little piece of the puzzle, but it's only one piece."

http://www.thestar.com/article/287513