In a last-ditch attempt to stop Novartis new anti-smoking vaccine from getting to market, Big Tobacco has launched a series of legal interdicts through the US Supreme Court.

“This vaccine is a result of unproven and still untested biotechnology,” declares Reggie den Akker, spokesman for RJ Reynolds.

“The tobacco industry has spent decades researching the health effects of our products and we have done all we can to ensure the safety of our cigarettes. Can we say the same about the Franken-foods industry?”

Anti-GM lobby groups have been protesting outside the courthouse and confronting even larger crowds of anti-smoking groups.

Novartis new drug, developed by Cytos Biotechnology of Switzerland, prevents nicotine entering the brain and so depriving it of the stimulation that smoking provides. It has been in late-stage clinical trials since 2008. “We are in no doubt that the public wants this vaccine and we aim to release it on time,” said Hans Vermaak, of Cytos.

The markets clearly believe him. Novartis closed 17% up on the day, while the broad range of tobacco stocks has plunged more than 53% over the past month.

ANALYSIS >> SYNTHESIS: How this scenario came to be

Background
In 1962 the Royal College of Physicians produced a report entitled “Smoking and Health”. In 1964 the US Surgeon General, Luther Terry, announced that smoking causes lung cancer. The British report led to a Code of Advertising Standards in 1965 which banned TV advertising of tobacco products in Britain. The Americans instituted a similar ban in 1970. Thereafter package labeling warnings became common. By 2005 the World Health Organization had produced a global anti-smoking convention.

Yet smoking continues to be legal.

The simple truth is that governments, through repressive taxation on cigarettes (“sin taxes”), make more money than the cigarette companies themselves. Philip Morris, with only 12% of the world market, has revenues in excess of US$ 100 billion per annum. In China tobacco taxes make up 9% of government revenue. Worldwide taxes can be as high as 50% of the purchase price. Cigarette manufacturers and governments both profit from tobacco addiction.

Anything that threatens this cosy relationship is bound to make waves.

2007: The Science of Addiction
Peculiar partnerships between psychologists, economists and medical scientists start revealing the nature of addiction. At a conference on gambling and addiction in Cape Town in April, Professor Don Ross of the University of Cape Town, a neuro-economist, presents the findings from a study conducted with MIT, based in the US.

“The science of addiction is becoming better understood. Some addiction is purely chemical-based. We expect that commercial drugs to combat this type of addiction will come on to the market shortly. Once that happens we will be left only with those who are addicted due to societal pressure.”

According to Ross, the interaction of serotonin and dopamine is to blame. “Addicts – and it doesn’t matter of what type – find that they depress their serotonin levels and so flood their bodies with dopamine. Dopamine is the body’s own stimulant and you become ‘addicted’ to this. If we can stop the suppression of serotonin then we can stop this type of addiction.”

In late April Novartis, looking for exciting new drugs, signs an exclusive license agreement with Cytos who are in clinical dose trials of a new vaccine for nicotine.

“Nicotine is the principle addictive component of tobacco and acts after uptake via the lungs in the brain. Smoking cessation efforts of most smokers fail because a single slip (one cigarette) often delivers sufficient nicotine to the brain to reinstate the drug seeking behavior. Blocking nicotine from entering the brain by induction of nicotine-specific antibodies may thus be an effective mean to prevent such relapses,” says Cytos.

2009: A testing experience
Cytos’ trials started in 2003 when they entered Phase 1 testing. In September 2008 they complete their clinical study to assess the appropriate dosage for their drug. The Swiss Medical Council has been closely involved with the trial and is ready to license the drug for distribution.

Novartis excitedly begins testing the marketing for the product. Saatchi & Saatchi are retained as the advertising company and they produce a startling and award-winning series of commercials. “We were looking for something different. This is earth-shaking stuff,” says Hugh Latemor, media manager for the account.

Scientists flood talk-shows to discuss the radical nature of the medication. The hype is massive and, in the expectation that cigarette sales will decline – especially in the West – Philip Morris, RJ Reynolds and British American Tobacco (among others) stocks start to decline quite swiftly.

At a special meeting of the Tobacco Manufacturers Association, the industry lobby groups meet to discuss what they should do. The obvious is to do what they have always done; throw suspicion at the science.

“Say, isn’t this a biotech product?” asks one executive.

Within days their public relations companies have swung into gear and the message is clear: “tobacco is a natural product, but can you trust genetically modified drugs?”

2010: The defense of the indefensible
Novartis is having difficulty persuading the public about the health benefits of their product. “We were caught completely by surprise by the animosity of the public feeling against a pure GM drug,” says Hans Gordon, a marketing strategist at Novartis.

“So we went back to basics,” says Hugh Latemor at Saatchi & Saatchi.

Basics means presenting the case against tobacco. The “Wish you were here” campaign is startling and striking. To the haunting sounds of a song written by Amy Mann a child walks through a never ending graveyard, while faces of departed relatives and friends fade through the sky. The message is clear: “Accept the facts; smoking kills millions of people a year. More people die from smoking than from all other causes put together.”

“It is fitting,” says Professor John Malcomsohn at Oxford’s Marketing Department. “Cigarettes are a creation of marketing. They serve no real purpose and their popularity is entirely the result of brilliant associative marketing campaigns. Consider the Marlboro Man, or the aspirational values of Peter Stuyvesant commercials. It’s powerful stuff. Saatchi’s response is a remarkable counter to that.”

Anti-GM lobby groups are in a quandary – who should they support? Membership is divided and angry fights break out at rallies.

2011: Launching the end of addiction
With the April launch date only weeks away the Tobacco Manufacturers Association files a last-minute court interdict in the US state of Virginia, home to Big Tobacco.

“This vaccine is a result of unproven biotechnology,” declares Reggie den Akker, spokesman for RJ Reynolds. “The tobacco industry has spent decades researching the health effects of our products and we have done all we can to ensure the safety of our cigarettes. Can we say the same about the Franken-foods industry?”

Scientists queue up to debunk the bunk. “It is almost like the Scopes Monkey Trial in Tennessee,” says Dan Rather, advising CNN as the world’s media decamps to Virginia. “You remember that one? The State of Tennessee took John Scopes to court in 1925 for teaching evolution in schools. They won the case, but lost the war.”

Something similar seems to be happening. People may be full of doubts about the safety of GM medication but being stuck between GM – offering to cure a frightening addiction – and tobacco – killing millions through traumatic cancer every year – is proving to be mighty tricky.

The answer won’t be out for a month but markets seem to have made their choice already.

“Novartis up 17%; Philip Morris down 23%,” roars one newspaper headline. Now the courts must decide.