RICHMOND, Va. -- At a Richmond, Va., research park that is home to several biotech companies, Philip Morris USA is building a $350 million research facility and preparing for regulation of tobacco by the Food & Drug Administration (FDA), according to The Wall Street Journal.
With Democrats in charge of Congress, the long-debated step appears more likely than ever, said the report. A Senate bill is expected to clear a key committee next month, and companion legislation has been introduced in the House. Both bills would give the FDA broad sway over [image-nocss] tobacco products, including the power to set product standards, which could include limiting certain ingredients in cigarettes.
The bills also offer a potentially lucrative opportunity, the Journal said. If a new kind of cigarette can be scientifically proven to significantly reduce harm to smokersand its availability would also benefit the health of the population as a wholethe cigarette's marketing claims may win approval from the FDA.
The legislation, which is backed by longtime tobacco-industry critics Representative Henry Waxman (D-Calif.) and Senator Edward Kennedy (D-Mass.), has won wide support from public-health advocates. But many warn that the FDA needs to be very careful about allowing any health-related marketing. We must be extremely wary of claims made by manufacturers, Kenneth Warner, dean of the University of Michigan School of Public Health, told the newspaper.
PM USA, which is working on many new products it hopes might qualify for FDA-approved health claims, acknowledges it must transform itself into a credible player in the expected scientific debates at the FDA. So the company is trying to emulate an industry already under the agency's purviewthe drug companies.
The company has a number of highly engineered products in the works, said the report, all of which are designed to possibly reduce tobacco's dangers. Among them: Marlboro Ultra Smooth, a cigarette with a high-technology carbon filter; Accord, which uses a holder to primarily heat, rather than burn, tobacco; and snus, a line of spit-free smokeless tobacco products.
So far, the products aren't selling well in test markets, PM USA confirmed for the Journal, possibly because they are not being pitched as having any health advantages. PM USA has not announced when, or if, any of them might be sold nationally.
Analysts told the paper that the effort is consuming about half of the estimated $200 million PM USA spends on research and development each year. Company scientists are conducting human studies, presenting results at research conferences and publishing findings in scientific journals such as the Journal of Clinical Pharmacology.
To staff its 450,000-sq.-ft. research center, its biggest investment in two decades, PM USA is trying to recruit dozens of physicians, biochemists and other scientists. And in the same way that pharmaceutical companies pay top researchers to lead drug studies and speak about their findings to regulators and other scientists, the tobacco maker is trying to forge relationships with outside experts who might support its research efforts.
The company faces big technical hurdles in its quest to develop an FDA-approved lower-risk cigarette. Scientists said there are not proven measures that would allow PM USA to verify that any new kind of tobacco product is less likely to cause cancer or heart disease.
A big problem for PM USA may be its reputation, the report said. For many years, tobacco companies denied the health risks of their products, funding research that ran counter to scientific opinion. They sold light cigarettes with implied health benefits when, under real-world conditions, the products were generally no safer than standard smokes. As a result, PM USA faces many deeply suspicious public-health experts. Many of them believe its efforts are at best, empty public-relations gestures and at worst, manipulative.
The industry has no credibility with the scientific community and the FDA, David Kessler, a former FDA commissioner whose efforts in the 1990s to regulate tobacco were struck down by the Supreme Court, told the paper. If there are to be reduced-risk tobacco standards, he said, the opinion leaders that are going to develop the science are not going to be the tobacco industry.
In the eyes of some analysts, PM USA's efforts are a gamble, said the report. Not only might the bills fail to become law, but it might be decades before cigarette makers are able to amass enough scientific data for reduced-risk products to pass muster with the FDA. The firm is making a sizeable and substantial investment, particularly versus the outlay of their peers, David Adelman, Morgan Stanley's tobacco analyst, told the paper. The risk, he added, is that if the company's newfangled products flop, time, energy and resources have been wasted.
Because of declining sales, PM USA said it has no choice but to pursue its high-risk strategy. We're doing this because we think it's in the interest of our business, John R. Nelson, president of operations and technology at PM USA, told the Journal.
In 2002, PM USA started an ambitious, yearlong examination of American smokers, the Total Exposure Study, to help answer questions about the effects of cigarettes. The study eventually involved 4,662 people at about 40 U.S. sites. Scientists gathered data about more than a dozen measures that might reveal the impact of exposure to cigarette smoke. Smokers had their blood checked for the presence of carbon monoxide and markers that signal heart risk, such as cholesterol and a protein that is a sign of inflammation. Urine was tested for chemicals that might be signs of cancer-causing substances. The data could eventually serve as a baseline, giving a picture of what measures best highlight the differences between a smoker's body and a nonsmoker's body, company officials said.
Many public-health researchers, while conceding that the research could prove useful, said they are wary of furthering the tobacco company's agenda, according to the report. They also fear the peddling of a safer cigarette could discourage smokers from quitting, ultimately the safest option.
Tobacco companies have a long and successful track record of subverting people in public health, David Burns, a professor at the University of California, San Diego, told the paper. He has testified against tobacco companies in court and said he refused an invitation from PM USA to apply for research grants. We have to be very careful that we maintain both objectivity and independence.
Nelson said the company is committed to trying to work with researchers who have opposed it. Some of our critics have a lot of constructive things to say, some are a little shrill, but we listen, and we talk, he told the paper.Members help make our journalism possible. Become a CSP member today and unlock exclusive benefits, including unlimited access to all of our content. Sign up here.