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 Philip Morris International Inc has hired more than 400 scientists
and technical staff at its research facility in Neuchatel,
Switzerland, including toxicologists, chemists, biologists,
biostatisticians and regulatory affairs experts.
Altria Group Inc, makers of Marlboro, has recruited dozens of
scientific and healthcare experts, as have independent e-cigarette
companies such as NJOY. They bring experience developing inhalation
devices and navigating the U.S. Food and Drug Administration,
valuable knowledge in the new world of electronic cigarettes.
They say they're 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 Neuchatel 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 U.S. 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."
SOPHISTICATED SCIENCE
PMI has poured more than $2 billion 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 doesn't 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.
Manuel Peitsch, a professor of bioinformatics at the University of
Basel and former senior official at Novartis AG and GlaxoSmithKline
Plc, helps lead a effort at PMI to analyze the constituents in
vapor, 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."
 RECRUITING STAFF
Tobacco executives say they have found willing recruits from the
pharmaceutical industry, thanks in part to a wave of mergers and
acquisitions that 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.
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 vapor company Pax Labs Inc, where she
mixes and tests potential liquid nicotine formulations.
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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. "I grew up in China where
there were far fewer smoke free areas," she said. "I am very
sensitive to smells and for a long time if people were smoking next
to me, I shut off half of my breath."
Dr. Joshua Rabinowitz, the interim chief executive of NJOY, said he
too was drawn the public health potential of e-cigarettes.
Rabinowitz co-founded Alexza Pharmaceuticals Inc, which makes an
inhaler that allows drugs to be quickly absorbed into the
bloodstream.
Some sought-after experts help companies comply with FDA regulations
and steer new products through the approval process.
Altria hired James Dillard to head its regulatory affairs division.
Dillard holds a degree in biomedical engineering from Tulane
University and spent 13 years at the FDA, eventually becoming
director of its cardiovascular and respiratory devices group. PMI
hired Bruce Clark in a similar role, as vice president of regulatory
and scientific affairs, a position he previously held at drugmaker
Apotex Inc.
Some healthcare recruits are willing to develop reduced risk tobacco
products but not for a company that also sells cigarettes.
"The whole set-up is schizophrenic," said Dr. Lars Erik Rutqvist, an
oncologist and former professor at Sweden's Karolinska Institute who
has been approached by big tobacco companies before. "I wouldn't
want to be part of that because they still make most of their money
from cigarettes."
Rutqvist works instead for Swedish Match AB, which sells smokeless
tobacco products known as snus. The company was the first to file a
modified risk application with the FDA for its snus products. A
panel of advisors to FDA recommended in April that the agency reject
the application.
 PAST SINS
The tobacco industry has recruited healthcare experts before, but
not on today's scale. Past veterans and many public health experts
question the motives behind the current recruiting. They fear
e-cigarettes will do nothing to benefit smokers and may instead
simply introduce a new generation to nicotine at a time traditional
cigarette smoking rates are falling.
"With each new generation of products there's a temptation to
believe they got it wrong before but they've got it right now," said
Matthew Myers, president of the Campaign for Tobacco-Free Kids."
Victor DeNoble, an experimental psychologist specializing in the
impact of drugs on the brain, joined Philip Morris in 1980 to create
a cigarette that caused fewer heart attacks, a challenge he found
exciting. But when his work showed that nicotine is addictive the
company closed down his lab and suppressed the research. A decade
later, DeNoble became the first whistleblower to testify against the
industry before Congress.
"The tobacco industry now says 'we made mistakes and we want to
correct them, and that's why we want you to join us,'" he said. "The
lure is still public health. But I'm older and wiser and I can't
trust an industry that has repeatedly broken its promises."
(Reporting by Toni Clarke in Washington. Editing by Michele
Gershberg, Sue Horton and John Pickering)
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