(EMAILWIRE.COM, September 08, 2009 ) BOSTON – An article in this week's issue of the Journal of the American Medical Association (JAMA) reports that the Food and Drug Administration (FDA) has now acknowledged receiving 98 reports of suicides and 188 reports of suicide attempts that appear to be linked to use of Chantix, a prescription medication for smoking cessation. In addition, the FDA has received reports of patients taking the drug being involved in motor vehicle crashes.

At the same time, the FDA which has approved Chantix, seems focused on keeping electronic cigarettes, which have yet to be proven harmful, from the public.

A growing number of tobacco control experts and medical professionals are questioning the motives of the FDA. Dr. Michael Siegel, associate chairman and a professor in the Department of Community Health Sciences at the Boston University School of Public Health, wonders why the FDA is threatening to take electronic cigarettes off the market.

“If Chantix has been studied and has been found to have likely caused 98 deaths and an additional 188 attempted suicides and it is allowed to remain on the market because smoking cessation is such an important goal, then what is the point of removing e-cigarettes from the market while studying its potential adverse effects? Suppose e-cigarettes were to be found to have caused 100 deaths. Would that warrant taking it off the market, since it - like Chantix - is helping people to quit smoking?” Dr. Siegel asks in a statement released by the Center for Public Accountability in Tobacco Control.

According to the JAMA article: "Although varenicline’s label had already indicated potential psychiatric risks, the agency has continued to receive reports of attempted and completed suicide in varenicline-treated patients, including some who had no history of psychiatric problems. An FDA analysis, released earlier this year, of varenicline adverse event reports submitted to the agency between May 2006 and November 2007 documented 19 suicides and 18 reports of suicidal behaviors, including 15 suicide attempts... But at a press briefing in July, Rosebraugh said that based on crude counts the agency now has reports of 98 suicides and 188 suicide attempts."

The JAMA article also notes that the FDA is requiring Pfizer, the makers of Chantix, to conduct clinical studies to determine the incidence and severity of the adverse effects of Chantix: "To better understand the incidence of these adverse events and which patients may be at greatest risk, the FDA is requiring the manufacturers of both drugs to conduct additional randomized controlled trials. Unlike previous studies, these trials will include individuals with preexisting mental health conditions, who make up a disproportionate number of smokers."

Siegel notes that unlike Chantix - for which there were many immediate post-marketing reports of potential adverse effects -- e-cigarettes have been on the market for more than three years and there have yet to be any severe adverse effects reported.

“In other words, we know that people are dying from taking Chantix but we're going to allow it to remain on the market because it's helping people to quit smoking. We know that there is no evidence that anyone is dying from using electronic cigarettes, but we're going to take them off the market, even though they are helping people to quit smoking. That just doesn't make any sense,” Dr. Siegel said.

Another thing that troubles Dr. Siegel is why anti-smoking groups are calling for the removal of e-cigarettes from the market, “when we are not aware of any documented severe adverse effects, yet they are not calling for the removal of Chantix from the market even though we know this drug is probably killing people.”

One answer, he believes, is the heavy financial influence of the pharmaceutical industry. “So far, every anti-smoking group which has called for the removal of e-cigarettes from the market has been found to be financially tied to Big Pharma. The Campaign for Tobacco-Free Kids, American Cancer Society, American Heart Association, American Lung Association, and Action on Smoking and Health have all received funding of some sort from the pharmaceutical industry. None of these groups, however, disclosed their financial conflicts of interest when they called for a ban on electronic cigarettes.”

On September 2, Pfizer was fined $2.3 billion by Federal prosecutors for illegal drug promotion. Authorities called Pfizer a repeat offender, citing this was the fourth such settlement in the past ten years.

Dr. Siegel is concerned that the one constituency not being represented here is the public, which would want a reasonable alternative to products that are known to cause harm.

“I believe that not only are the actions of these groups inappropriate, unsupported by science, harmful to the public's health, and heavily biased due to financial relationships, but these actions are also unethical because it is unscrupulous to advocate for a public policy like this without revealing such an important and relevant financial conflict of interest,” Dr. Siegel said.

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Dr. Michael Siegel is associate chairman and a professor in the Department of Community Health Sciences at Boston University. He is a physician who completed his residency in Preventive Medicine at the UC Berkeley School of Public Health and trained in epidemiology for two years at the Centers for Disease Control and Prevention in Atlanta before coming to Boston. With more than 20 years of experience in tobacco control, primarily as a researcher, Dr. Siegel’s primary interest is in the area of tobacco control, focusing on secondhand smoke health effects, exposure, and policies, cigarette advertising and marketing practices and their effects on youths, and evaluation of tobacco control policies and their impact on youth and adult smoking behavior. His primary teaching is in the areas of mass communication, marketing, and public health advocacy. He is co-author of a book, entitled “Marketing Public Health: Strategies to Promote Social Change” and has been active in promoting smoke-free bar and restaurant policies throughout the country. Dr. Siegel has served as an expert witness in several major tobacco litigation cases. His research and writing on tobacco issues can be read at http://tobaccoanalysis.blogspot.com/.

Contact Information:
Center for Public Accountability in Toba
Michael Siegel
Tel: 617-638-4640
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