Cocaine Vaccine a Bust

In the early days, mental health professionals who dealt with drug addiction hoped that sson a new vaccine would cure cocaine addiction. In 2000, a Phase I study at Yale used:
The vaccine, TA-CD, is designed to generate drug-specific antibodies, which bind to cocaine and prevent it from traveling to the brain from the bloodstream. This neutralizes its psychoactive effect.
Inclusio criteria for the study was 30 days of abstinence, a desire to stop using and willingness to seek treatment. The study authors mentioned that the vaccine did not reduce cravings for cocaine, but simply interfered with its effect to produce a high. What they are being injected with is actually succinylnorcocaine linked to recombinant cholera toxin B-subunit protein. This means that the cocaine molecule is attached to the cholera toxin protein in order to trick the body into making antibodies against the cocaine along with the protein.
To override the vaccine’s effects, it may be possible to take massive amounts of cocaine, but it is unlikely that addicts who are actively working to overcome their addiction would want to do that.
http://www.biopsychiatry.com/cocaine/vaccine.htm
From this last statement, one would gather that either these scientists were being overly optimistic or they really just didn’t understand how addiction works. In any case, they knew this outcome was possible, but they played it down.

2004: BBC Headline States “Cocaine Vaccine Stops Addiction”

The vaccine is created by attaching the cocaine to a large protein molecule which is used to stimulate the body’s immune system to produce antibodies that recognise the drug.
(…)
Trials carried out in the US showed almost half of those given the TA-CD vaccine, developed by Xenova, were able to stay off the drug for six months.

Yes, it turns out that half these people were able to stay of cocaine for 6 months- which means it didn’t work so well for the other half, and who knows what heppened after the 6 months were up and they were out of treatment. Nonetheless, the scientists remained optimistic and the drug company had the MSM touting the benefits of their new wonder-drug, as usual. Of note, no reference is given to the actual study so readers can look at the data for themselves.
http://news.bbc.co.uk/2/hi/health/3804741.stm
Fast forward to 2010: Washington Post reports “Testing of Cocaine Vaccine Shows It Does Not Fully Blunt Cravings For The Drug’
Well, as we saw from the earlier reports, it was never designed to blunt cravings. And you kow what happened? According to the article,
some of the addicts participating in a study of the vaccine started doing massive amounts of cocaine in hopes of overcoming its effects
That’s right, they just kept trying to get high even though it wasn’t working anymore. Now, that is not surprising, really, because that is what all addicts do once they get to a certain point, especially with cocaine, where tolerance develops very quickly and after te first hit off the crack pipe, you spend the rest of the night making yourself feel like crap hoping to catch the buzz you did with that first puff. The doctors at Yale mentioned that this could be a possibility back in 2000, but they forged ahead anyway and hoped for the best. The article goes on to elaborate that,
Nobody overdosed, but some of them had 10 times more cocaine coursing through their systems than researchers had encountered before, according to Kosten. He said some of the addicts reported to researchers that they had gone broke buying cocaine from multiple drug dealers, hoping to find a variety that would get them high.
That’s not what I would call a success, heh heh.
http://www.washingtonpost.com/wp-dyn/content/article/2010/01/04/AR2010010402752.html

An article on the blog Addiction Inbox, entitled “Cocaine Vaccine Hits Snag’ gave us more details:

Of 115 addicts involved in the study, only 38 % produced sufficient antibodies to dull the effects of cocaine, Rachel Saslow of the Washington Post reported. And among the high-antibodies group, only 53 % stayed free of cocaine 50 % of the time. “Immunization did not achieve complete abstinence from cocaine use,” said Thomas Kosten of Baylor college of Medicine, one of the authors of the paper.

Not everyone produced ‘adequate antibodies’, and when they did, the vaccine mad a mediocre success rate. Nonetheless, “NIDA director Nora Volkow characterized the work as “a promising step toward an effective medical treatment for cocaine addiction,” with the proviso that “larger follow-up studies confirm its safety and efficacy.”

When you hear ‘safety and efficacy’- watch out! it means they are going full steam with this. Confirm safety? How can it be confirmed when studies so far have shown that a significant amount of recipients increased their cocaine use, risked overdose, and went broke in the process? Confirm efficacy? When only 38% of people ‘responded’ to it, and among those only 53% stayed clean 50% of the time? That amounts to what- 19% of people who received it being able to abstain half the time? In other words, 81% of participants failed to stay clean, which is equivalent to the success rate for most regular rehab centers. Is that really a success rate for the vaccine or is it roughly how many cocaine addicts would stay clean 50% of the time with standard treatment anyway?
http://addiction-dirkh.blogspot.com/2010/01/cocaine-vaccine-hits-snag.html

Remeber that efficacy is n ot equivalent to effectiveness. Efficacy represents something you measure in the lab, such as antibodies. Effectiveness is how well the product succeeds in achieving the desired result in real life. For example, a flu vaccine that claims 90% efficacy, may translate to 35% effectiveness in terms of actually preventing you from catching the flu (and remember that, speaking of flu shots, only 5-15% of the population actually catches the flu in any given flu season, so 35% effectiveness means it has lowered your chance of getting sick by about 2-5%, but I digress…)

In a 2009 clinical trial on 109 methadone patients, 21 out of the 50% receiving the vaccine achieved purportedly adequate antibody levels. Of these, 45% had cocaine-free urine tests, vs 35% for the remaining 88 who eithe rreceived a placebo or did not develop high enough antibodies. That means that about 9/21 people in the high antibody group stayed off the coke for a few weeks. How anyone could create statistics and come to any kind of conclusions on the vaccine’s effectiveness when the sample size was so small is beyond me. I was taught in school that you can never talk about statistics unless you have a sample of at least 100 people. But this becomes an effective way for pharmaceutical companies to make data appear to work in their favor. For example, you take 200 people with lung cancer, give 50% chemo and 50% chemo +radiation, and if you have 10% 1-year survival in the chemo group and 11% in the chemo +radiationn group, you can claim that radiatio exteded survival by 10%. Really, this is a lot of nonsense. All you had was one extra person live a year, but it is enough for somebody to make a lot of money giving somebody some kind of additional useless treatment.

And so it seems to be with the cocaine vaccine. They overlook the obvious red flag that it doesn’t work for most people, works shabbily when it does, and even drives a sizeable number of recipients to increase their cocaine use to dangerous levels. But none of that would deter Big Pharma, whose priority is evidently profit, never mind at whose expense.

Here are a couple of the original studies:
http://archpsyc.ama-assn.org/cgi/content/abstract/66/10/1116

http://www.biologicalpsychiatryjournal.com/article/S0006-3223(09)01052-X/abstract