Harvard study concluding that cigarette makers have for years deliberately increased nicotine levels in cigarettes to make them more addictive led to renewed calls on Thursday for greater oversight of the industry by the US federal government.
"Given the harm that tobacco causes, it shouldn't be a game of cat-and-mouse to figure out what the industry is doing to cigarettes," said Josh Sharfstein, commissioner of health for the city of Baltimore, Maryland.
US Democratic Senator Edward Kennedy, who is now chairman of the Senate Health, Education, Labor and Pensions Committee, promised to reintroduce within weeks a bill that would allow the Food and Drug Administration to regulate cigarettes.
Kennedy said the Harvard study, which was released this week, "is dramatic new proof that Big Tobacco is addicted to addicting millions of young smokers."
Kennedy's bill passed the Senate in 2004 but failed in the House. With Democrats now in control of both houses, public health advocates said they had new hope that the legislation -- debated for more than a decade -- could pass.
Philip Morris, the nation's largest cigarette maker, released a statement on Wednesday taking issue with the Harvard study, but saying the company supported Kennedy's bill.
The company, which is owned by the Altria Group, said its own reports showed that nicotine yields for its top-selling Marlboro brand were the same last year as they were in 1997. Changes between those years, it said, "reflect that there are random variations in cigarette nicotine yields."
The Harvard researchers analyzed data only from 1997 through 2005, although they promised to include last year's figures in future analyses.
Gregory Connolly, a professor at the Harvard School of Public Health who was a leader of the study, said there was nothing random about the growth in nicotine yields, which occurred across all cigarette brands and makers.
"We know from our data that there are intentional design changes that result in more nicotine in smoke that increases the capacity for the cigarette to cause and maintain addiction," Connolly said.
Company representatives at Lorillard Tobacco, owned by Loews, and R.J. Reynolds Tobacco, owned by Reynolds American, did not offer a response.
Cigarette makers have for decades denounced scientific efforts to measure the byproducts and effects of cigarette smoking.
Best ways to measure
And for decades, experts have been arguing over the best ways to measure what's in cigarette smoke.
One common way has been to use machines to mimic smoking. For years, these tests were done at the US Federal Trade Commission.
In recent years, however, government regulators have asked cigarette makers to do these machine tests themselves. And beginning in 1997, Massachusetts regulations required cigarette makers to file an annual report with health regulators on the results of the tests.
In August, the Massachusetts Department of Public Health issued a study showing that according to the industry's own reports, the amount of nicotine that could be inhaled from cigarettes had increased an average of 10 percent from 1998 through 2004.
The report was immediately criticized by cigarette makers.
So Connolly and colleagues decided to undertake a far more sophisticated analysis of the underlying data provided by cigarette makers. The Harvard group found that nicotine yields from smoking had increased an average of 1.6 percent each year from 1998 through 2005, or about 11 percent altogether.
A sophisticated mathematical analysis of the data demonstrated that the increase could not be due to random variations, Connolly said.
In August, in a racketeering suit brought by the Justice Department against the tobacco industry, a federal judge found that tobacco companies had for decades "manipulated the use of nicotine so as to increase and perpetuate addiction."
In ordering strict new limitations on tobacco marketing, the judge, Gladys Kessler of the US District Court for the District of Columbia, also said that for decades, tobacco companies had "lied, misrepresented and deceived the American public."
Julie Brill, an assistant attorney general in Vermont, said she did not think the latest study would do anything to alter a deal reached in 1998 in which the tobacco industry agreed to pay states US$246 billion. The money was to settle lawsuits seeking to recover expenses related to the treatment of tobacco-related illnesses.
Brill said she was "disappointed but not surprised" by the Harvard study.
"It leads one to question how long this industry can continue to be as unregulated as it is," she said.
Richard Hurt, director of the Mayo Clinic's nicotine dependence program, said he had reviewed the Harvard analysis and found it credible. And Hurt said documents disclosed in litigation against the industry showed that cigarette makers closely controlled the nicotine content of their products.
"If anyone thinks that tobacco companies have changed for the better and are now reformed, I have some beachfront property in Nebraska I'd like to sell them," he said.
David Kessler, who as commissioner of the FDA during the Clinton administration sought to impose regulatory authority over cigarette makers, said cigarette makers had been manipulating nicotine levels for decades.
"Tobacco makers still have not answered some fundamental questions about why this is happening," said Kessler, who is now dean of the School of Medicine at the University of California, San Francisco.
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