While a Houston doctor thinks he has found the cure for cocaine addiction, bureaucratic red tape is hindering the vaccine's approval and building doubts for its future success.
"My hopes are pretty simple: number one, find some company in the U.S. that will actually make the vaccine," said Dr. Thomas R. Kosten of the Baylor College of Medicine. "I think the problem we have in America is that instead of the government regulating the pharmaceutical industry, the pharmaceutical industry regulates the government."
The cocaine vaccine consists of deactivated cholera toxin molecules bound to cocaine. Subjects receive the vaccine in five injections. The body produces antibodies against the cholera toxin and against the cocaine molecules. Vaccine recipients simultaneously build immunity to cholera and cocaine: a one-two punch procedure.
Twenty-two people volunteered in the early study at BCM and 115 in the placebo-controlled study. Twenty-five percent produced low antibody levels, 40 percent built strong immunities against cocaine and the remaining 35 percent developed resistance to low doses of the cocaine. The studies also show a 50 percent relapse rate in low-dose subjects and a five percent relapse rate in high-dose subjects.
Kosten said the experiments produced successful results, but finding a pharmaceutical company to manufacture the drug is still a problem.
FDA regulations yield a three-step approval process. The process requires human safety testing, effectiveness in an experimental setting and efficacy in larger sample sizes.
Unfortunately, the third phase also requires a pharmaceutical sponsor, which Kosten says he does not have.
"There's something wrong with the American pharmaceutical industry," Kosten said. "They seem to have no sense of public health being important, which is different in other countries."
Kosten said the idea originated when he was a graduate student at Rockefeller University 35 years ago, but did not implement the idea until 1995.
He also said the idea for a drug vaccine is not new as two separate groups began developing vaccines for heroin and morphine, but abandoned them in favor of other drugs like methadone, naltrexone and apomorphine.
While Kosten's studies show successful results, there are still concerns that the vaccine can be counterproductive.
The Washington Post quoted Kosten in January 2010, voicing these concerns.
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The vaccine, called TA-CD, shows promise but could also be dangerous; some of the addicts participating in a study of the vaccine started doing massive amounts of cocaine in hopes of overcoming its effects, according to Thomas R. Kosten.
The Post also cited concerns that the vaccine encourages addicts to consume more cocaine to reach the same satisfaction.
Kosten said there were no dangerous overdoses during the studies as the hazardous side effects come from the cocaine itself and the vaccine negates the effects of cocaine altogether.
Third-party cooperation is absent, but Kosten says he is trying to double the number of subjects in the next year.