'Safer' GM Tobacco Not So Safe / Tobacco giant funds 'bad gene' hunt (20/6/2004)

A new type of cigarette made from tobacco genetically engineered to contain less cancer-causing substances than conventional brands, may not be doing much to protect smokers, according to new research. [item1]

1.'Safer' [GM] Tobacco Products Not as Safe as They Seem
2.Philip Morris Betting on Genetic Breakthroughs from Tobacco Plant Research
3.Scripps Research Institute's association with Philip Morris
4.Tobacco giant funds 'bad gene' hunt

1.'Safer' Tobacco Products Not as Safe as They Seem
Reuters Health
by Alison McCook
Jun 2, 2004

NEW YORK (Reuters Health) - A new type of cigarette that contains less cancer-causing substances than conventional brands may not be doing much to protect smokers, according to new research released Tuesday. [Journal of the National Cancer Institute, June 2, 2004]

Although testing of the new OMNI cigarettes showed that they contain 50 percent less of a particular carcinogen, or substance that causes cancer, smokers who switched to the OMNI cigarette had only 20 percent less of the carcinogen in their bodies than they did while smoking conventional cigarettes.

This relatively small drop in carcinogen levels may not be enough to reduce a smoker's chance of developing cancer, study author Dr. Dorothy K. Hatsukami told Reuters Health. "Does that (20 percent difference) really translate to reduced cancer risk? We're not sure," she said.

She warned that smokers should not believe that by switching to a less carcinogenic brand, they are sidestepping the dangers of smoking.

If smokers think the new so-called "reduced-exposure" tobacco products are safe, "they'll maintain their smoking rather than make a concerted effort to quit," Hatsukami pointed out. "The best way to reduce your risk of disease is still quitting smoking," she added.

Tobacco naturally contains carcinogens, which are enhanced during the processing of tobacco leaves. In order to design safer tobacco products, companies are beginning to release cigarettes and snuff products that contain fewer carcinogens, created by adding protective chemicals, processing the tobacco differently, or using genetically engineering tobacco.

In the current study, Hatsukami and her colleagues at the University of Minnesota in Minneapolis tested the benefits of reduced exposure products by asking 54 smokeless tobacco users and 51 smokers to switch to either the newer brands or a nicotine patch for four weeks. Snuff users tried Swedish snus, while smokers switched to OMNI cigarettes.

Reporting in the Journal of the National Cancer Institute, the researchers found that smokers who switched to reduced-exposure products experienced a smaller decrease in the carcinogen NNK than was predicted by machine testing. Snuff users showed lower levels of carcinogens after switching to snus, but both snuff users and smokers experienced a smaller decrease in carcinogens than nicotine patch users.

In an interview, Hatsukami explained that people smoke in a different way than machines, and some smokers may have absorbed more carcinogens by taking more puffs per cigarette or inhaling more smoke than the machine predicted.

"Consumers really need to be wary when they see advertisements for reduced exposure products," she said.

2.Philip Morris Betting on Genetic Breakthroughs from Tobacco Plant Research
by Catherine Clabby
Jan 17, 2003 (The News & Observer - Knight Ridder/Tribune Business News via COMTEX)

When Philip Morris USA agreed to give N.C. State University scientists $17.6 million to map the genes in tobacco plants, the company bought access to any breakthroughs it finds useful.

The nation's largest cigarette maker will share licenses to any patents generated by the mapping study. Philip Morris also gets first dibs on negotiating exclusive licenses.

No one can guarantee that identifying genes will yield new, blockbuster tobacco products. But the cigarette industry clearly sees commercial promise in tobacco's genetic blueprint.

"This is one of the many tools in the toolbox that will get us where we want to go," Philip Morris spokeswoman Jennifer Golisch said.

One state cigarette maker already is diving in. Vector Tobacco, based outside Roxboro, is on the verge of launching a new brand of ultra-low nicotine smokes made with genetically altered leaf invented at NCSU in the 1990s.

By the end of the month, Vector is to introduce Quest, cigarettes with three increasingly lower nicotine levels, in seven northern states. Quest's very existence can be traced to a NCSU genetics lab.

In the 1980s, Mark Conkling, then a N.C. State plant geneticist, grew fascinated with a bunch of genes that seemed active only in the roots of tobacco. In time he focused on one gene: NiQPT1. It plays a key role in producing nicotine, a natural pesticide that normally moves from the plant's roots to its leaves.

In the 1990s, a N.C. State plant breeder approached Conkling about a small New York company's interest in breeding tobacco without nicotine. Traditional breeding would take years. Instead, Conkling's lab used an altered form of the gene to bio-engineer a new plant with nearly no nicotine. The small firm licensed the technology.

In time, Vector's parent company licensed the technique. Conkling went to work for Vector. And Quest went into development.

"Tobacco is easy to genetically modify," Conkling said. "It's one of the easiest plants to add genes to."

Philip Morris has said it wants to make less-dangerous cigarettes, possibly using genetic engineering. But, citing "business proprietary" reasons, the company won't discuss specific products it envisions from research at N.C. State or elsewhere, Golisch said.

H&R Block Financial Analyst Kelly Capaldi, who watches the tobacco industry, says all cigarette companies would be more likely to make products with genetically altered leaf if giant Philip Morris did. "If they ever released a product, you'd see copycats," she said.

Now vice president of genetics research at Vector Tobacco, Conkling said understanding all genes active in tobacco opens up new avenues for the industry.

Scientists know a lot about some of the scores of carcinogenic chemicals in tobacco smoke. With genetic re-engineering, they may be able to reduce their production, Conkling said.

Genetic tinkering could make tobacco plants more resistant to pests or easier to shred, Conkling said. Biotechnology gurus still believe genetically altered tobacco could be used to grow new products to open new markets to tobacco farmers. "There are a number of possibilities out there," he said.

Obstacles abound, too.

Some tobacco farmers have rejected farming bio-engineered tobacco, in part because European markets don't like those crops.

Early on, Vector executives said they saw Quest as a smoking-cessation aid. But Vector can't market Quest 1, 2 and 3 as such without FDA approval. Vector can't seek that approval until it has evidence the product is safe and effective.

Instead, Vector is pitching Quest as a product that can help smokers "step down" from nicotine. And it hopes the brand will be more successful than its first and not-yet successful venture: Omni.

Vector Tobacco is a sister company to Liggett Group, the former downtown Durham company that now makes mostly discount cigarettes in Mebane. The company was launched to use science to develop less risky cigarettes.

In 2001, Vector launched Omni, a cigarette advertised as a less-carcinogenic smoke due to some chemical adjustments and a newfangled filter. It hasn't sold well.

Vector Tobacco won't give out sales numbers. But it says its efforts to introduce and sell "potentially" reduced risk cigarettes lost

$20.2 million in the third quarter of 2002.

Still, Vector is moving on Quest.

"Quest offers smokers a new alternative and demonstrates the increasing role that technology has on the marketplace," said James Taylor, senior vice president of marketing for Liggett Vector brands.

Only time -- and sales numbers -- will tell.

3.Scripps has longstanding tobacco ties
By Stacey Singer, Palm Beach Post Staff Writer
Thursday, June 17, 2004

At a time when the nation's largest cigarette maker was under legal siege, Philip Morris sought out the president of The Scripps Research Institute for scientific advice.

From 1992 to 2002, Dr. Richard Lerner served as a paid consultant to Philip Morris, alongside another leading Scripps scientist, Nobel Laureate Dr. Gerald Edelman.

The two assessed research quality, the credentials of an outspoken Philip Morris scientist and other controversial matters, earning a total of $700,000 each for their work, according to Doug Bingham, Scripps' executive vice president and general counsel.

"They were initially engaged to give their opinion on the quality of the science being performed by Philip Morris and their associated companies worldwide," Bingham said this week.

[Scripps Research Institute Access The Palm Beach Post's coverage of the biotech facility in Palm Beach County]

Edelman and Lerner, whose leadership at Scripps is responsible for the institute's expansion to Florida, declined to discuss their working relationship with Philip Morris. They referred questions to Bingham.

Scripps' relationship with the tobacco industry goes well beyond the past decade. But until now, it has gone largely unnoticed. Only recently have court documents detailing The Scripps Research Institute's association with Philip Morris been available to the public. They were made available under a 1998 master settlement agreement between cigarette manufacturers and the nation's attorneys general.

Besides the Philip Morris consultations, scientists at Scripps have received $2.2 million in grants from the Council for Tobacco Research and other tobacco industry sources since at least 1980, Bingham said.

Lerner himself relied on tobacco money to support his research in the 1970s as an assistant professor working with viruses linked to cancer. More recently, Lerner and Edelman helped persuade Philip Morris to dedicate $225 million to start an independent stand-alone research institute modeled on Scripps.

Science magazine, in 1996, called it "the largest single grant a tobacco company has ever offered for scientific research."

Such monetary contributions, as well as mounting tobacco litigation, have triggered a debate in the scientific community: Is it appropriate for scientists working to cure diseases to accept money from an industry that causes them?

Hostility toward tobacco

That's a question a growing number of universities and health centers have answered with a resounding no -- and one that Scripps likely will confront as it accepts a half-billion dollars in public money to expand its La Jolla, Calif., operation to Palm Beach County.

Scripps is moving to a county that was at the epicenter of landmark tobacco litigation. In 1997, Florida settled a lawsuit before Palm Beach County Circuit Judge Harold Cohen for $11 billion, the largest settlement ever reached with the tobacco industry at the time. It was increased to $12.7 billion the following year to match deals reached in other states.

And Florida courts continue to wrestle with multi-billion dollar tobacco lawsuits. The state Supreme Court now is considering a $145 billion verdict won in Miami-Dade County by thousands of Florida smokers in 2000. The 3rd District Court of Appeal tossed out the verdict last year, concluding the award came from a "runaway jury."

The jury ruled in part that the tobacco industry had misused science.

"The jury in Florida was asked to consider whether the Council for Tobacco Research was a legitimate funding source. And the answer was it was a fraud, it was deception," said Michael Cummings, a senior research scientist at the Roswell Park Cancer Institute in Buffalo, N.Y. "The jury learned that the council was formed by lawyers, not by scientists."

Cummings is overseeing the project to catalog court documents released as part of the 1998 master settlement agreement.

The Wall Street Journal, in a front-page article in 1993, called the Council for Tobacco Research the "longest-running misinformation campaign in U.S. business history," a creature of public relations firm Hill & Knowlton.

Because of that, the Harvard School of Public Health, Johns Hopkins School of Medicine and the University of California San Francisco took the position that tobacco money should not be touched, said Richard Daynard, a Northeastern University law school professor who chairs the Tobacco Products Liability Project, a public health advocacy group.

For decades, the tobacco companies used respected scientists' credibility to confuse the question of a smoking-cancer link, the risk of second-hand smoke and more, Daynard said.

"There is a bitter irony in leading scientists, whose careers are supposedly dedicated to preventing and curing disease, being intimately involved with the industry that kills over 400,000 Americans each year," Daynard said.

Bingham said there was no irony in Lerner's role -- that for the most part he was on a rescue mission to improve the quality of research conducted by Philip Morris.

"Richard was trying to help them get away from lawyer-driven science and get into science by scientists," Bingham said. "They had a lot of resources to do science and he thought if it was directed in the right way it would benefit science."

Bingham said Scripps has never taken a position on the ethics of accepting tobacco funds.

"Maybe we'll have that debate in the near future because of this," Bingham said. "These are deep philosophical questions. I don't know what the right answers to these questions are."

During their decade-long relationship with Philip Morris, Edelman and Lerner were asked to help the company in a variety of ways, documents show. The consultancy began in late 1992, when Charles Wall, then Philip Morris' general counsel, told the chief scientists at both Philip Morris and Kraft General Foods that he was retaining the men "to advise the company on scientific funding and various scientific projects."

In other memos, Wall discusses his interest in relying on Lerner and Edelman to help establish a new basic science institute that would grant first rights of refusal on discoveries to Philip Morris.

In a 2001 memo, Wall referred to Lerner as "a good friend of the company."

Cummings said that at the time Philip Morris was considering creation of an institute, the entire cigarette industry was growing interested in how the brain's neural receptors responded to the tobacco chemicals.

Twenty years earlier, Edelman had won the Nobel Prize for describing the chemical structure of antibodies. In intervening years, his research moved toward understanding the complexities of the brain. He founded the Neuroscience Institute at Rockefeller University in New York, and moved it to Scripps in La Jolla in 1992. Scripps, too, had significant expertise on brain biochemistry.

In early 1993, Lerner and Edelman began a worldwide tour of Philip Morris' laboratories, visiting facilities in Virginia, Germany and Switzerland. They toured greenhouses where genetically engineered tobacco grew and marveled at equipment that conducted complex smoke inhalation tests on rodents in Germany.

They spoke to scientists assessing the effects of cigarette smoke on lung cells.

At the end of their tour, they sent a letter to Wall concluding that while the science in Germany was excellent, the program in Virginia showed "a certain amount of bureaucratic stall."

"The machinery was state of the art and the technical understanding of the scientists was quite satisfactory. However, there was no evidence of the incisive use of this elegant machinery on important problems."

Board role recommended

Their findings culminated in a 1995 recommendation to Philip Morris' board to create an institute to study signal transduction, or the way that cells responded to protein stimuli and chemicals such as nicotine.

"In the early planning stages, a small board of four to five members, all of whom would be Philip Morris representatives such as Drs. Edelman, Lerner and current Philip Morris employees would be appropriate," the board documents recommend. "Later, an independent board should be named, including prominent individuals such as (former president) George Bush and leaders in the local community such as former FDA commissioner Charles Edwards."

The Molecular Science Institute came into being in 1996 as the Philip Morris Institute for Molecular Sciences. It occupied rented space on the grounds of Scripps Memorial Hospital in La Jolla, across the highway from the Scripps Institute. At the helm was famed molecular biologist Sydney Brenner. But soon after Science turned its microscope on the deal, Brenner left for the nearby Salk Institute. The Molecular Science Institute moved north to Berkeley, Calif., and severed ties with Scripps.

Philip Morris ceased its financial support four years ago, an institute official said.

"I think it had more to do with personalities than anything else," Bingham said. "That's all I really want to say."

Scientist fired

Philip Morris wanted more from Edelman and Lerner. In 1994, the seven CEOs of the nation's tobacco companies went before Congress and, in now-notorious testimony, took the position that neither nicotine nor cigarette smoking was addictive.

Soon after, Philip Morris asked Lerner and Edelman to review a paper for Congress justifying that position. It narrowly defined the term "addiction" to apply only to substances like heroin.

Believing the request was political in nature rather than scientific, "Richard didn't respond and their relationship continued," Bingham said.

There were other difficult jobs. In January 1993, a Philip Morris scientist named Ved Malik met with Lerner and Edelman, telling them about what he deemed to be illegitimately gained Ph.D.s among favored Philip Morris staff. In a subsequent letter, he spelled out a litany of potential problems from the company, from accusations that Chernobyl-tainted tobacco had been sold to warnings about heavy metals in tobacco.

Malik lost his job and his pension in a "downsizing." Lerner and Edelman, called in after Malik's termination, told Philip Morris he was "marginally competent," according to documents.

Bingham said he knew little about the issue, but understood that Malik was considered a disgruntled employee. Philip Morris, contacted Wednesday, said it needed time to prepare a response.

Today, at 63, Malik said he was broken by the experience and appalled by Lerner's and Edelman's involvement with the tobacco industry.

"I had hoped that these men were men of character," Malik said. "I trusted them, but they disappointed me."

4.Tobacco giant funds 'bad gene' hunt
Secret memos show BAT has spent millions on studies playing down cigarette link to cancer
Jamie Doward, social affairs editor
Sunday May 30, 2004
The Observer

Secret documents reveal Britain's largest tobacco company has gone to great lengths to produce scientific evidence clouding the link between smoking and lung cancer.

According to newly unearthed internal company papers, BAT has spent millions of pounds funding university research to back the controversial theory of 'genetic predisposition', which argues that some people are more susceptible to lung cancer than others because they have 'bad genes'.

The tobacco industry is keen to advance the theory because it implies that only around one in 10 smokers - those with 'bad genes' - are at a 'heightened risk' from smoking and need to quit.

In recent years a number of scientists have used the theory to raise the possibility that people will soon be able to take a genetic test to see if they are more likely to suffer from lung cancer.

But most scientists scorn the theory. They point to several studies which found no significant link between someone's genetic make-up and lung cancer. They also say the tobacco lobby's research ignores other diseases such as emphysema.

Now it has emerged that, in an attempt to provide itself with more ammunition to advance the theory, BAT - whose brands include Benson & Hedges, John Player and Rothmans - has been bankrolling research into 'genetic predisposition' at several British universities.

According to the environmental campaign group Gene Watch, which obtained scores of internal memos from the firm, research into 'bad genes' was by far the largest area of university funding by BAT between 1990 and 1995.

In conjunction with the anti-smoking group Ash, Gene Watch is preparing to publish a list of UK scientists who have received BAT funding but not declared it in their research papers, something which opens them up to the accusation that they failed to declare a conflict of interest.

'Geneticists who take tobacco money are dancing with the devil,' said Helen Wallace, spokeswoman for Gene Watch. 'The public has been misled for decades by scientists who think they've found the gene for lung cancer. All smokers are at risk of early death or serious disease.'

The group obtained the documents after trawling BAT's huge depository in Guildford, Surrey. After a series of court cases the company was forced to open the depository to the public. But it has been accused of making papers difficult to find by not indexing them or by blanking out dates.

Academics at the London School of Hygiene and Tropical Medicine are attempting to post a copy of every document on a website with an index, a move that would give the anti-tobacco lobby a powerful weapon in future court cases.

Already the academics have found evidence that some of the documents have been tampered with. They point to one disclosing BAT's marketing strategy to 'illiterate low-income 16-year-olds in the Middle East' which has been crudely changed to '18-year-olds' in places.

A spokeswoman for BAT said: 'We have a policy that we don't comment on documents unearthed in Guildford. There are over six million documents in the depository and they can be taken out of context.' She declined to comment on BAT's funding of research into 'bad genes'.

However, a memo submitted by BAT to a parliamentary health select committee in 2000 revealed that its scientific research group had spent £6.6 million funding a range of studies including 'genetic predisposition to disease'.

In recent years the idea of a 'testing kit' which would allow smokers to work out whether they had 'bad genes' has captured the attention of politicians and the public.

A memo from PR firm Burson-Marsteller to its client, tobacco giant Philip Morris, written in 1996, suggests the test would allow 'the non-susceptible population to smoke with a clear conscience'. Last September, Professor Zvi Livneh, of Israel's Weizmann Institute of Science, made headlines when he said he was three years away from developing such a test. His research suggested some smokers are 10 times as likely as others to get the disease.

However, according to documents seen last night by The Observer, Livneh received more than $500,000 between 1985 and 1991 from the Council For Tobacco Research, the tobacco lobby's research arm.

Livneh could not be contacted for comment last night. It is unclear if he declared the grants in his research paper submitted to the Journal of the National Cancer Institute.

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