Healthy Skepticism Library item: 13623

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Grogan K.
Drugmakers stand up to Congress criticism of DTC tactics
Pharma Times 2008 May 9
http://www.pharmatimes.com/WorldNews/article.aspx?id=13451&src=EWorldNews

Full text:

Pharmaceutical firms have been defending direct-to-consumer advertising at a US Congress hearing brought to discuss whether tougher restrictions are needed to stop “misleading and deceptive tactics” being used to promote certain drugs.

The tone of the hearing was set by Congressman Bart Stupak, chairman of the House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations, who held the hearing and highlighted three advertising campaigns campaigns that have been discontinued – Merck & Co/Schering-Plough’s Vytorin ((simvastatin/ezetimibe), Pfizer’s Lipitor (atorvastatin) and Johnson & Johnson’s Procrit (epoetin alfa).

Rep Stupak criticised Lipitor ads featuring the celebrity heart specialist Robert Jarvik, “an individual who has never held a licence to practice medicine” and a Procrit campaign which was approved to treat chemotherapy and dialysis-induced anaemia. However, “for seven years, it was marketed directly to consumers for the treatment of ‘cancer fatigue’ in order to improve the ‘quality of life’ for patients. “This was clearly an instance of off-label marketing”, he said, a practice that is prohibited by the US Food and Drug Administration, and “not only did the company advertise the drug, but the FDA did nothing to stop them”.

Rep Stupak added that Merck and S-P’s ads for Vytorin “peppered the airwaves” at a time when “the release of an important study examining Vytorin’s ability to stop cholesterol build-up was delayed and suppressed by the companies”. He added that “we now know that Vytorin has no effect on cholesterol build-up – however, this information came to us about two years too late”.

Both the Lipitor and Vytorin ads were voluntarily withdrawn shortly after the subcommittee began investigating DTC ads in January but Rep Stupak said that “American consumers should not have to rely on the oversight function of Congress to make sure drug companies tell the truth in their advertisement campaigns”. He added that the FDA’s Division of Drug Marketing, Advertising and Communications is responsible for regulating DTC ads but cannot impose fines except through an administrative hearing.

“Pharmaceutical companies should consider it a privilege to be allowed to air DTC ads in this country,” Rep Stupak added, and “with all privileges, there comes responsibility, and we should make sure that pharmaceutical companies conduct themselves responsibly”. If the three ads are indicative of typical DTC campaigns, “it appears that we need to enforce significant restrictions” to protect American consumers from manipulative commercials’, he concluded.

One of the witnesses at the hearing, Ruth Day, head of Duke University’s Medical Cognition Laboratory, claimed that drug companies use a variety of tactics to highlight a drug’s benefits and downplay risks. She cited an ad for S-P’s allergy drug Nasonex (mometasone furoate) featured a bumble bee that flew around as side effects were listed, but only hovered when benefits were discussed. “All of these wing flaps and wing flashes and sparkly things essentially divided the attention of the viewers”, leading to “decreased knowledge” of risks, she said.

However the drugmakers defended their ads, and Deepak Khanna, senior vice president and general manager of the Merck/S-P joint venture, noted that the Vytorin ‘Food and Family’ ads were reviewed by the FDA and backed by research. Kim Taylor, president of J&J’s Ortho Biotech unit, which makes Procrit, told the hearing that the company worked with the FDA to develop ads that were “true, responsible and substantiated by scientific studies.”

James Sage, a Pfizer senior director, spoke about the benefits of such ads, saying that DTC is necessary because it motivates patients to seek additional information, consult physicians “and follow treatment plans”. There was also support for the concept from Congressman John Shimkus a Republican who sits on the Energy and Commerce Committee.

He claimed it was too soon for further restrictions to be imposed by Congress, saying “we gave the FDA power to act [earlier this year] and we haven’t really given them time to really impose civil fines on false and misleading ads”. The FDA, which was not invited to the proceedings, will holds its own DTC meeting next week.