- - Monday, May 28, 2012

Tobacco kills more than 1,200 Americans each day. Soon that death toll could rise sharply to include thousands of animals who could be used to test new “light” tobacco products. As a toxicologist, I am deeply concerned about the public health consequences of new language in a draft guidance document from the Food and Drug Administration that recommends tobacco companies prove their health claims about modified- and low-risk tobacco products by testing them on animals.

The devastating health consequences of cigarettes are well-documented. Nearly 47 million U.S. adults smoke cigarettes, according to the federal Centers for Disease Control and Prevention. More than 8 million have a serious illness caused by smoking. About 88 million nonsmoking Americans are exposed to secondhand smoke. Decades of human epidemiology studies implicate tobacco use in heart disease, stroke, cancer, respiratory diseases, sudden infant death syndrome and other deadly conditions. And there is an economic burden: We spend more than $96 billion a year in medical costs.

There is no evidence that light cigarettes are any less harmful. In fact, the National Cancer Institute asserts that they are no safer than regular cigarettes, and itsreport “Risks Associated With Smoking Cigarettes With Low Tar Machine-Measured Yields of Tar and Nicotine,” says: “[T]here is no convincing evidence that changes in cigarette design … have resulted in an important decrease in the disease burden caused by cigarette use.”

The scientific community knows that the use of light cigarettes by smokers in the United States has not prevented the ongoing increase in lung cancer among older smokers.

Two years ago, Congress passed a law that would prevent the labeling of tobacco products as “light” or “mild” unless a tobacco company can prove that its product significantly reduces the risk of tobacco-related disease to tobacco users and benefits the health of the population as a whole. The FDA, charged by the law to regulate tobacco products, has now offered the draft guidance that includes the use of animal tests.

The Institute of Medicine’s recent report “Scientific Standards for Studies on Modified Risk Tobacco Products” says “it is not possible to make laboratory animals use tobacco products the way humans do, and there are inherent interspecies differences that prevent meaningful extrapolation of human effects.” In fact, tobacco-inhalation experiments conducted on animals a half-century ago strongly indicated that tobacco did not cause lung cancer. But human population research clearly proves the tobacco-cancer connection.

What’s more, the self-addiction studies that FDA recommends be performed on animals, such as “place preference,” “drug discrimination” and “self-administration” studies, are not only cruel, but tenuously linked to human behavior. Human population studies, clinical intervention trials and cellular studies should remain the foundation of tobacco research.

The bottom line is, tobacco - light or not - poses serious risks to the user’s health and to the health of others. Wasting countless more animal lives to prove the safety of an inherently harmful product, especially when such tests in the past have been misleading, would be grossly counterproductive for human health.

Bingxuan Wang is a research fellow of toxicology and regulatory testing with the nonprofit Physicians Committee for Responsible Medicine.