Crude animal studies should cede to in vitro methods

The tobacco industry and regulatory authorities should support more-relevant and less-costly in vitro toxicology testing methods over unreliable animal testing, according to a review of research advances published this week in the comment pages of the peer-reviewed scientific journal Alternatives to Laboratory Animals.

The article by researchers with People for the Ethical Treatment of Animals (PETA) and the Physicians Committee for Responsible Medicine (PCRM) comes as the US Food and Drug Administration’s Tobacco Products Scientific Advisory Committee prepares to evaluate the US’ first application to market a group of tobacco products with reduced risk claims. The products will be evaluated on April 9 and 10 at the FDA’s White Oak campus in Silver Spring, Maryland.

PETA and PCRM examined more than 50 technologically advanced tobacco toxicology studies that had been reported since 2009, when the last comprehensive review of such methods was conducted. In the 2009 review, non-animal methods were deemed not to be quantitatively reliable enough to allow ‘valid comparisons of substantially different tobacco products’.

But things have moved on and the PETA and PCRM researchers found that the 2009 observations ‘no longer accurately describe the study of tobacco product toxicology in vitro’.

‘Since 2009, when the Tobacco Control Act became law, the field of tobacco toxicology has shifted toward the use of predictive methods based on human cell culture and away from poisoning animals,’ said PETA researcher and author Joseph Manuppello. For example, scientists could now expose reconstituted human bronchial tissue to whole smoke and measure perturbations in toxicity pathways.

PETA is concerned about the use of animals in tests supporting marketing applications. ‘The US Family Smoking Prevention and Tobacco Control Act gives the FDA authority to regulate the marketing of tobacco products,’ PETA said in a press note. ‘The FDA lists animal studies among those that it recommends for assessing the toxicity of tobacco products. PETA is concerned that large numbers of animals may be used in studies to support tobacco product marketing applications.

‘Because of this concern, last December, PETA and PCRM participated in a workshop with representatives from the FDA, industry, and academia, as well as other NGOs, to discuss modern and humane in vitro models available to replace crude and inaccurate animal tests for evaluating the role of tobacco exposure in causing lung disease, specifically chronic obstructive pulmonary disease (COPD).

‘Workshop participants agreed that guidance from the FDA, specifically on in vitro test methods, would likely reduce animal testing conducted in support of tobacco product applications.’

A report from the workshop was presented on March 23 at a Society of Toxicology ancillary meeting in San Diego, California.