A direct-to-consumer (DTC) drug ad is raising some controversy over marketing of a medication that has long been surrounded with debate. Consumer Reports is questioning the ethics of a Chantix (varenicline) ad that, while never mentioning the drug by name, appears to be marketing the medication while seeming to be a public service announcement.

The commercial focuses on a Website dedicated to smoking cessation entitled MyTimeToQuit.com and presents information in a public service format, says Consumer Reports, pointing out that it is only at the end of the commercial that hints about the ad’s origin are discreetly revealed. The ad indicates, in the final moments, that it is sponsored by Pfizer, which is the maker of Chantix. Also, the MyTimeToQuit Website leads viewers to the Chantix Website.

Consumer Reports notes that the methods, while “sneaky,” are legal and point to a trend in which such DTC ads are leaning more toward so-called “help-seeking” ads. These ads, says Consumer Reports, do not mention the drug being marketed, but, rather, discuss the treatment for which the drug is approved, sending viewers to a Website or toll-free telephone number. The next step—the initial Website or toll-free number—provides more information that includes learning about a “prescription treatment option.” Consumer Reports noted that www.FibroCenter.com and www.PsoriasisConnect.com are both such types of pharmaceutical industry-sponsored Websites that lead consumers to information on prescription drugs.

This emerging type of advertising is effective when industry is looking to market a medication that has extensive or dangerous side effects because if the drug’s name is not mentioned, the advertiser is not mandated to disclose its side effects, according to the U.S. Food and Drug Administration (FDA), said Consumer Reports.

Chantix, a smoking cessation medication marketed by Pfizer, Inc., was approved by the FDA in 2006. Chantix side effects may include suicidal thoughts, depression, and even violent behavior. In September 2007, Chantix side effects were implicated in the bizarre death of a Dallas, Texas man, among other horrible stories.

A number of adverse event reports were made to the FDA following Chantix’s release to the market such as “serious neuropsychiatric symptoms,” including “changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide” said Consumer Reports. The reactions prompted a drug label update last year to include warnings about potential psychiatric side effects associated with Chantix use.

One of the problems with the release of Chantix is that Pfizer conducted studies on the medication, but did not include people with a history of depression, bipolar disorder, or serious mental illness, all of which include heavy smokers and for whom Chantix might pose serious risks. Some believe, said Consumer Reports, that because Chantix affects some brain processes and because some high-risk groups were not included in testing, the adverse events were not revealed until after the drug received FDA approval.

Consumer Reports warns that when approached with public service-like advertising, to determine from where it is sponsored and be aware that if the information is sponsored by the pharmaceutical industry, the goal of the information is to sell drugs. Also, be aware of options on such sites requesting information on personal stories, which require patient release and enable release of the entire story for marketing purposes.

This entry was posted on Thursday, February 19th, 2009 at 3:59 pm and is filed under Chantix, Legal News, Pharmaceuticals.