Friday, April 25, 2008
Smoke and Mirrors
BY ADRIANE FUGH-BERMAN AND DOUGLAS MELNICK

The latest entry in disease-mongering (an art form in pharmaceutical marketing) is tobacco dependence. Products approved for helping smokers quit are now being groomed for a new role as permanent substitutes for smoking, on the grounds, apparently, that the drugs kill fewer people than the cigarettes.

A recent commentary in the Annals of Internal Medicine argues that tobacco dependence should be considered a medical disease, like asthma or diabetes. No, really, there’s a table that compares tobacco use to diabetes. Shared characteristics apparently include the fact that each “Causes multiple diseases/complications.” For each, patients have “Increased odds of achieving treatment goals with medications,” and therefore “Optimal treatment combines behavioral component with medications.”

The most important section of this article is the conflict of interest statement. The two authors who have advanced degrees are on the speaker’s bureau of Pfizer and are consultants to Pfizer, Novartis, GlaxoSmithKline, and Celtic Pharma. Pfizer makes varenecline (marketed under the brand name Chantix) and Nicotrol, a nicotine nasal spray. GSK makes Nicorette gum, Commit nicotine lozenges, Nicoderm nicotine patches, and Zyban (buproprion, which GSK also sells as an antidepressant under the name Wellbutrin). Novartis makes Thrive, a nicotine chewing gum (“thrive,” which means to prosper or flourish, seems a rather peculiar association for a delivery system for an addictive drug.) And Celtic Pharma is developing TA-NIC, a nicotine vaccine.

It is almost as if these companies had made a joint decision to cast smoking as a chronic disease in order to reposition their products as long-term maintenance medications, like methadone. Smoking cessation is painted as a goal unachievable without pharmacologic assistance. Nicotine, the addictive component in both cigarettes and nicotine replacement products, is portrayed as harmless in medicinal form, as is buproprion (which can cause seizures) and varenecline (which has been linked to psychiatric disturbances, including suicidal ideation and suicides).

This new model proposes that patients who cannot quit tobacco on their own – or after using the smoking cessation product according to how it was tested, approved, and labeled – be placed on continuous treatment. The article contains a case study of a woman who returned to smoking after her insurance company refused to continue paying for nicotine inhalers after two years. The pressure-the-payer objective of the article could not be clearer: “Although long-term use is considered off-label, patients should be encouraged to remain smoke-free, and if extended courses of pharmacotherapy will assist them, treatment should be continued, encouraged, and reimbursed.”

Reclassifying a dangerous habit as a chronic disease so that insurance companies will pay for nicotine replacement drugs to be taken off-label forever would transfer the financial burden for the patients’ nicotine fix from the patients to their insurance companies. Alternatively, patients could take expensive cessation drugs without the nicotine, but with known serious adverse effects, for the rest of their lives.

The corporate message for smokers appears to be: You can’t kick your habit without medication. You can’t even kick your habit with medication. But maybe you can substitute medication for smoking, and maybe lifetime medication will be less dangerous than lifetime smoking.

Or maybe not. After all, information on the long-term effects of the medications-formerly-known-as-smoking-cessation-aids is limited. Drugs are approved based on a risk-benefit ratio for the condition they are meant to treat. To subject countless patients to the unknown risks of medications prescribed outside their approved labeling, or beyond the treatment durations for which they have been approved, is to conduct a large, uncontrolled, and unconscionable experiment.

In truth, half of those who have smoked more than 100 cigarettes in their life cured their so-called disease by quitting permanently. The most popular method for quitting was “cold turkey,” without pharmaceutical smoking cessation aids. There is evidence that longer-term use of these drugs (beyond the duration found in their product labels) is not more effective for smoking cessation. But then smoking cessation, the approved use for these drugs, no longer seems to be the goal; it’s now the permanent substitution of pills and patches for cigarettes.

Quitting smoking certainly benefits individuals and decreases burdens on the health care system. Smoking cessation aids can be helpful for treating nicotine addiction. However, the long-term use of expensive drugs that have not been tested for this use exposes people to unknown risks. Casting smoking as a “disease” disempowers those who want to quit; willpower may conquer a habit or addiction, but a disease calls for doctors and drugs. The positioning of nicotine dependence as a chronic condition requiring lifetime use of medication can only damage public health.

Douglas Melnick is a preventive medicine physician in North Hollywood, California.

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