Another drug marketing campaign has federal regulators concerned about misleading advertisements. GlaxoSmithKline’s prostate drug, Avodart’s, TV ads utilize a space theme that has been criticized by the U.S. Food and Drug Administration (FDA), reports the Star Tribune.

Avodart is prescribed to treat symptoms of enlarged prostate, such as frequent urination. The Glaxo ads feature a man working on a model of the solar system, who must stop painting to “make frequent trips to the bathroom,” said the Star Tribune. A colleague then suggests Avodart, saying that “other medicines, they don’t treat the cause, because they don’t shrink the prostate.”

FDA regulators, reports the Star Tribune, said that the ad’s claim is bogus and in a letter to Glaxo’s U.S. officials, the agency wrote that Merck and Company Inc.’s drug, Proscar, reduces the size of the prostate, and “has a similar indication,” stating that, “Nothing in the labeling for Avodart suggests any specific advantage.” The letter was dated last week, posted online Friday, and must be responded to by March 4, according to the Star Tribune.

The agency has also criticized other elements of the ad. For instance, a man holding a model of a planet, which is then replaced with a much smaller planet model, ostensibly to mimic how Avodart can shrink the prostate, said the Star Tribune. According to the FDA, the ad’s visuals are an exaggeration of the drug’s effects, which reduce the prostate by about 25 percent, but after two years, noted the Star Tribune. “The planet shrinking in size represents a reduction in prostate volume that is much greater than the reduction actually achieved with Avodart,” said the FDA.

Direct-to-consumer (DTC) drug ads have been the subject of much scrutiny lately with Chantix making the news most recently. Last month, Consumer Reports questioned 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 in question focused on a Website dedicated to smoking cessation entitled MyTimeToQuit.com and presented information in a public service format, said 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.

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.

Also, recently, as part of a settlement with 27 states, Bayer will be changing the way in which it advertises Yaz, one of its birth control medications, reported BizJournal in an earlier report. This is in addition to a settlement in 2007 with Bayer that responded to cholesterol medication Baycol, said BizJournal. Baycol was pulled from the American market over safety concerns in 2001.

Late last year, the FDA sent Bayer a warning letter over two Yaz televisions ads that misled consumers into believing that Yaz could help relieve symptoms associated with pre-menstrual Syndrome (PMS) and could also help in the treatment of specific types of acne. The FDA has never approved Yaz for either of these medical issues, said BizJournal, which noted that Yaz is FDA-approved for some acne types only. Bayer has been mandated to implement a $20 million dollar advertising campaign to “remedy” the misinformation it promoted and must also submit all subsequent television advertisements to the FDA for pre-approval; comply with the FDA on TV and print advertisement suggestions; and “clearly and conspicuously” disclose for what the FDA has approved when discussing—in its print ads—those symptoms Yaz can treat, said BizJournal.

This entry was posted on Tuesday, March 3rd, 2009 at 12:37 pm and is filed under Pharmaceuticals.