Toni Clarke
SCIENTISTS who have devoted years developing medicines to cure disease are now working for tobacco companies to make e-cigarettes.
Philip Morris International (PMI) has hired more than 400 scientists and technical staff at its research facility in Neuchâtel, Switzerland, including toxicologists, chemists, biologists, biostatisticians and regulatory affairs experts.
Altria Group, the makers of Marlboro, has recruited dozens of scientific and health-care experts, as have independent e-cigarette companies such as NJOY. They bring experience developing inhalation devices and navigating the US Food and Drug Administration (FDA), valuable knowledge in the new world of electronic cigarettes.
They say they are trying to improve public health.
“We were looking at drugs that make people very ill and maybe extend their life by 12 to 14 weeks,” said Gizelle Baker, a PMI biostatistician based in Neuchâtel who previously worked at the cancer drug developer Poniard Pharmaceuticals. “If you have a product that prevents cancer in the first place you can have a much bigger impact on public health.”
The goal is to improve the current generation of e-cigarettes and, where possible, provide evidence that they reduce the risk of disease.
Companies that succeed could have an advantage in a market that Bonnie Herzog, an analyst at Wells Fargo Securities, sees surpassing combustible cigarettes in the US within the next decade.
Products declared reduced risk by the FDA could be treated with a lighter regulatory hand.
“If tobacco companies can prove there is reduced risk, e-cigs are likely to remain less regulated and taxed than cigarettes,” said Philip Gorham, an analyst at Morningstar who views PMI as leading the way in the industry. “If they can’t, they will likely be subject to the same restrictions.”
PMI has poured more than $2 billion (R24bn) into developing and assessing reduced risk products. Next year it plans to apply for a modified risk claim with the FDA for its iQOS product, a tobacco stick that is heated just enough to produce an aerosol but does not combust. Burning tobacco produces most of its toxic chemicals.
The company is betting the presence of real tobacco may make it more satisfying to smokers than existing e-cigarettes. It is also developing next-generation e-cigarettes.
But proving a product reduces risk requires sophisticated science, and the FDA wants to see health benefits for both individual smokers and the population as a whole.
Effect on cells
Manuel Peitsch, a professor of bioinformatics at the University of Basel and former senior official at Novartis and GlaxoSmithKline, helps lead an effort at PMI to analyse the constituents in vapour, assess their effect on cells and model how likely the products are to cause disease.
The company is also conducting clinical trials in humans to assess whether the products reduce a person’s exposure to harmful constituents and, if so, whether that reduction corresponds to a lower risk of developing lung cancer, heart disease or chronic obstructive pulmonary disorder.
Tobacco companies have not historically had these skills in-house. But they are the life blood of the pharmaceutical industry and that is where tobacco companies are turning for talent.
“They have in essence been preparing for this for 20 years,” said Dr David Kessler, the former FDA commissioner who led the agency’s investigation into the tobacco industry in the 1990s. “They have understood for a long time that they are in the nicotine-delivery business.”
Tobacco executives say they have found willing recruits from the pharmaceutical industry, thanks in part to a wave of mergers and acquisitions that have left many researchers looking for work. The 2008 financial crisis led to tens of thousands of job cuts and rattled even those who retained their positions.
Not all companies have the resources to conduct the kind of clinical trials being run at PMI, but many are looking for medical device experts who can help make higher-quality products.
Liquid nicotine
Chenyue Xing is a chemical engineer who worked for MAP Pharmaceuticals and cancer drug company Genentech. Two years ago she joined the San Francisco-based vapour company Pax Labs, where she mixes and tests potential liquid nicotine formulations.
The work is similar to that at MAP, where she tested ingredients for use in the company’s inhaled drug devices. But she likes the entrepreneurial atmosphere at Pax and the idea of creating a smoke-free alternative to cigarettes.
Some sought-after experts help companies comply with FDA regulations and steer new products through the approval process.
Some health-care recruits are willing to develop reduced risk tobacco products, but not for a company that also sells cigarettes.
The tobacco industry has recruited health-care experts before, but not on today’s scale
. – Reuters