A Treatment For Smoking Hiding In Plain Site In Bulgaria

For many years Atlanta pharmaceutical executive Rick Stewart was unaware of a potential blockbuster drug to help people quit smoking. He was too busy working on another drug for a condition called Huntington's disease that failed its clinical trials. Actually, the drug turned out to be successful, but it didn't work in the six-month time frame required by the FDA, so the drug was rejected and Stewart was out of a job.

Stewart and colleague Anthony Stewart wondered what other misunderstood drugs might be out in the world, so they went on a hunt. Forming a company in the UK called Ricanto, a mashup of their first names, they defined their mission as pharmaceutical asset optimization. They resolved not just to hunt for new drugs but to find new value in old ones. “These drugs are uncared for or unwanted. They need tender loving care,” Stewart was quoted in the Washington Post. “And pharma, for whatever reason, can’t be bothered with them.”

In 2009, Stewart learned about laburnum trees.

A coworker told him about a stop-smoking product made in Bulgaria called Tabex. The medication contained a compound called cytisine, extracted from the seeds of laburnum trees, grow in giant orchards in Bulgaria. During World War II, soldiers tried chewing the seeds when their tobacco rations were unavailable. Some were able to quit.

It turned out there was a pharmacological foundation for the product. Cytisine blocks receptors in the brain that cause nicotine cravings. The product had been available as a herbal supplement since 1964, but it was only sold in Eastern and Central Europe.

There are only three alternatives for helping smokers quit in the United States. One is the prescription drug Chantix. Another is the antidepressant drug Zyban. There are also nicotine replacement gums, patches, and lozenges. None of these products works very well, and over one billion people worldwide are trying to quit.

Moreover, since 2008 Chantix and Zyban have come with FDA-required black box warnings, after both products were linked to risk of suicide. Pfizer, maker of Chantix, has had to pay out about $300,000,000 to settle 2,900 lawsuits. Sales of these products have plummeted.

Stewart noted that in the 5 million users of Tabex in Eastern Europe, there were no reports of suicidality. Neither were there reports of nausea, insomnia, and odd dreams, common with Chantix. Surely Stewart had a blockbuster on his hands, except that as an herbal supplement, it cannot be patented.

READ 10 Effects of Secondhand Smoke

Stewart reasoned that since it takes four years for laburnum plants to produce flowers and seed, he would at least have a head start in the competitive American market. He also had two favorable clinical trials and a favorable medical review:

• In 2011 findings were published in the New England Journal of Medicine showing cytisine was 3.4 times more likely than placebo to help people quit smoking and stay that way for one year. This is on par with Chantix.
• In 2012 scientists at the University of Sheffield in the UK published findings that cytisine (the plant chemical) is more economical and clinically superior to Chantix.
• And in 2015 another study, this one conducted by the New Zealand National Institute for Health Innovation and published in the prestigious New England Journal of Medicine, found that cytisine is superior to nicotine replacement gums and patches.

Stewart and his partners still face an uphill climb, but look for an American version of the cytisine product called Extab to be available in the United States in 2020 or 2021. An optimistic Stewart is making arrangements to plant 300,000 laburnum trees in the USA, a blooming forest that his competitors are sure to notice.