Early data in e-cigarette study may raise safety concerns – nytimes.com
A laboratory study presented early this year reported that the nicotine laced vapor generated by an electronic cigarette promoted the development of cancer in certain types of human cells much in the same way that tobacco smoke does.
Researchers involved in the little noticed study emphasized that their findings were preliminary and that the study did not involve people but specially treated human lung cells. Many researchers have expressed the belief that e cigarettes pose a far lower cancer risk than conventional cigarettes because they do not burn tobacco, a major source of carcinogens.
However, the findings, which were presented in January at a meeting of lung cancer researchers, may attract the interest of federal officials who are considering how to regulate e cigarettes. In a report to investors sent Tuesday, David J. Adelman, an industry analyst at Morgan Stanley, said the report, while preliminary, could result in legitimate questions from public health officials.
The study involved scientists from Boston University, the University of Texas Southwestern Medical Center in Dallas and the University of California, Los Angeles and was funded by the National Institutes of Health.
The Food and Drug Administration, which has oversight over tobacco, is expected to soon issue rules laying out a framework under which e cigarettes will be regulated. Hundreds of e cigarette brands are on the market, some of them made by major companies and others made by mom and pop shops.
In the study, researchers modified human lung cells to have specific genetic mutations that are associated with an increased risk for cancer. They then grew the cells in a liquid medium exposed for four hours to the vapor generated by an e cigarette. Similarly treated cells were grown in a medium exposed to tobacco smoke.
The scientists reported that the cells exposed to e cigarette vapor, like those exposed to tobacco smoke, exhibited changes associated with cancer.
Dr. Steven M. Dubinett, a professor at U.C.L.A. who led the study, emphasized in a telephone interview that the study s findings were preliminary and did not establish a link between e cigarettes and cancer. He added that the findings did underscore, however, how little is known about long term effects of e cigarette use or the specific effects of ingredients within the devices.
There is a lot that we don t know about e cigarettes, and one concern is that some of the substances within e cigarettes could contribute to negative health effects, Dr. Dubinett said.
He added that it was not clear which ingredient or ingredients in the e cigarette tested were responsible for causing the cellular changes.
Dr. Neal L. Benowitz, a leading nicotine researcher at the University of California, San Francisco, said it was hard to apply the findings of test tube studies to people.
Isolated cell systems may respond differently than organs in a person, he said.
While e cigarette vapor damaged human lung cells that were not modified to have the cancer related mutations, it did not produce reactions in them associated with cancer, researchers reported. Such mutations, however, are found in some people who are smokers or who have stopped smoking.
Dr. Dubinett added that researchers were collecting additional data before submitting the findings to a medical journal for publication.
Clinical trials involving users of e cigarettes are underway to determine what, if any, genetic changes occur in the tissue lining their lungs. Those studies are expected to continue for another year, Dr. Dubinett said.
Producers of e cigarettes, including some major cigarette makers, are also conducting clinical trials in an effort to quantify their products health risks, particularly in contrast to those of conventional cigarettes.
Asked for a response, David M. Sylvia, a spokesman for the tobacco company Altria, parent company of Philip Morris USA, said in a statement Given that only an abstract of the study has been released, which contains limited information, we are unable to comment on the study s findings.
R. J. Reynolds did not respond to a request for comment, and a spokesman for Njoy, an e cigarette company, said officials were not available Tuesday to comment.
England to introduce plain packaging for cigarettes
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Standardised plain packaging for cigarettes is to be introduced in England, following a comprehensive review of the evidence which found unbranded packs could cut the number of children starting to smoke.
Public health minister Jane Ellison told the House of Commons that she would introduce draft regulations swiftly “so it is crystal clear what is intended” although there will be a short consultation.
Sir Cyril Chantler, who was asked to look at the potential benefits, particularly to children, of plain packaging after the government postponed a decision last summer, made “a compelling case that if standardised packaging were introduced, it would be very likely to have a positive impact on public health,” Ellison said.
The government’s decision to delay last year provoked a political storm, because of revelations that a lobbying company owned by David Cameron’s election adviser, Lynton Crosby, had helped the tobacco industry fight the introduction of plain packaging in Australia.
The Chantler review found that standardised packaging which in Australia involves the entire packet being taken up by graphic health warnings is likely to contribute to a modest but important reduction in smoking, including a drop in the number of children who start.
“There is very strong evidence that exposure to tobacco advertising and promotion increases the likelihood of children taking up smoking,” says the report.
“Industry documents show that tobacco packaging has for decades been designed, in the light of market research, with regard to what appeals to target groups. Branded cigarettes are ‘badge’ products, frequently on display, which therefore act as a ‘silent salesman’.
“Tobacco packages appear to be especially important as a means of communicating brand imagery in countries like Australia and the UK which have comprehensive bans on advertising and promotion. It is notable that Japan Tobacco International responded to the decision to introduce tobacco plain packaging in Australia by attempting to sue the Australian government for taking possession of its mobile ‘billboard’.”
Chantler, who was once himself a smoker and found it hard to quit, said that “given the suffering that smoking causes, and the fact that most people start when they are children, even a small effect is very important”.
More than 600 children aged 11 to 15 start to smoke every day more than 200,000 a year. If that number could be cut even by 2%, said the review, 4,000 fewer would take up the habit.
“It is now for government to make its decision on whether or not to go ahead,” said Chantler. “I recognise that there is a democratic process to go through, but for my own view I hope they do introduce it, and I hope they do it quickly.”
The chief medical officer, Dame Sally Davies, supported plans to introduce plain packs within England’s devolved health administration. “This review only reinforces my beliefs of the public health gains to be achieved from standardised packaging,” she said.
Public health campaigners were delighted by the findings . “The Chantler review has backed a significant step towards a healthier future for the UK’s children,” said Harpal Kumar, Cancer Research UK’s chief executive. “We’re very pleased the government will now move forward and lay out draft regulations on standardised packs. This should happen as quickly as possible.
“Every day hundreds of children are lured into smoking an addiction that kills and causes at least 14 different types of cancer. Children find the brightly coloured and slick designs of today’s packs appealing.”
Professor John Wass, academic vice president of the Royal College of Physicians, said it was delighted by the news, although he added “It is disappointing that we will have to wait for the results of yet another consultation, but we hope this will be swift and not impede the introduction of regulations in this parliament. We are one step further towards a tobacco free UK.”
The tobacco industry contested the Chantler report’s findings. Daniel Torras, managing director of Japan Tobacco International UK, said “Nothing has changed since last summer when the prime minister said ‘There isn’t yet sufficient evidence for it and there is considerable legal uncertainty about it.’ The Chantler report explicitly references the ‘limitations’ of the evidence presented by a small group of tobacco control lobbyists.”