Healthy Skepticism Library item: 1947

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

Koenig D.
Update 4: New Drug Ad Guidelines Unlikely to Satisfy
Associated Press 2005 Aug 2
http://www.forbes.com/feeds/ap/2005/08/02/ap2168975.html

Notes:

Ralph Faggotter’s Comments : If your industry’s bad behaviour is being scrutinised by government, get the heat off by developing a ‘Code of Conduct’ or a set of ‘guidelines’ which enable your industry to continue along it’s merry way, without fear of sanction, while creating the illusion that you are actually going to clean up your industry’s behaviour. The current American DTCA guidelines appear ot be designed to serve this purpose.

Full text:

Associated Press
Update 4: New Drug Ad Guidelines Unlikely to Satisfy
08.02.2005, 08:28 PM

The pharmaceutical industry unveiled new guidelines Tuesday for the consumer marketing of medicines, including pledges to educate doctors before beginning consumer campaigns and more clearly outline the risks involved in taking prescription drugs.

“By adopting these principles, our member companies stand firmly behind the belief that direct-to-consumer advertising can and should increase awareness about diseases so that people know more about symptoms,” Billy Tauzin, president and CEO of the Pharmaceutical Research and Manufacturers of America, said at a news conference in Dallas.

The promise to put off consumer advertising while doctors learn about drugs is the most important of the 15 principles, Tauzin said. However, he said mandating a specific time restriction as many critics sought didn’t make sense, noting it could hold back information ads on lifesaving drugs. For example, he said there is a cervical cancer prevention vaccine in development that holds promise.

“I would want my daughter to know about that right away,” said Tauzin, who referred several times to his own experience as a cancer patient.

Critics responded that the voluntary code is toothless, and that many of its principles – such as presenting information that is accurate and not misleading – are already required by law. The industry will not sanction any company that violates the guidelines.

“They (the guidelines) are designed as a desperate attempt to fend off real regulation of drug ads,” said Dr. Sidney Wolfe, the director of Public Citizen’s Health Research Group.

If the industry was sincere about ending misleading advertising it would use its considerable clout to work with Congress to insure the Food and Drug Administration has adequate resources to police the industry’s current campaigns, said Rob Schneider, director of Consumers Union’s prescription drug reform effort.

Noting the agency doesn’t have the resources to do its job, Wolf said the number of letters the FDA has sent drug companies about misleading ads has dropped 85 percent since 1998, to just 24 last year.

Pharmaceutical ads have been under an intense spotlight since Merck & Co. removed its pain reliever Vioxx from the market last year after a study found it doubled patients risk of heart attacks and strokes. Vioxx was heavily marketed, and doctors say the ads pushed many patients who really didn’t require the pricey drug to take it, potentially exposing them to dangerous side effects.

Drug advertising has been exploding. Last year, the industry spent $4.02 billion on advertising, up 23 percent from 2003 and 62 percent from 2000, according to the consulting firm IMS Health.

Now backlash mounts. Last month, U.S. Senate Majority Leader Bill Frist, R-Tenn., called for a two-year moratorium on advertising new drugs, saying commercials drive up health care costs. In a statement, Frist said he welcomed the guidelines but still wishes they included a moratorium on new drugs ads.

Thirty-five percent of American adults favor a mandatory ban on consumer ads for new drugs for a limited time, according to a survey conducted by Harris Interactive for the Wall Street Journal Online’s Health Industry Edition.

Only 18 percent of consumers believe pharmaceutical ads can be trusted “most of the time,” according to a study released Friday by the Kaiser Family Foundation. That’s down by almost half since 1997, when one-third of people surveyed said you could trust ads most of the time.

There have been changes. Two months ago, Bristol-Myers Squibb Co. pledged not to advertise any of its new drugs to consumers for a year. Meanwhile, a commercial for Ortho Evra, a birth control pill made by a unit of Johnson & Johnson, features an unusually frank discussion between a woman and her doctor about potential side effects.

The new guidelines are part of an industry campaign to improve an image devastated by product recalls, allegations that drug makers hid clinical trial results and high prices. Earlier this year, the industry launched a campaign to make it easier for uninsured or underinsured people to find programs to help them afford medicines.

An office would be established to help ensure adherence to the code and after a year an independent panel would review the guideline’s effectiveness. The guidelines take effect in January.

Tauzin promised consumers would notice a change or else the code would “get tougher.” But he maintained that federal regulation was not the appropriate way to foster industry change.

“We are adding requirements the FDA and the government would have trouble with because of First Amendment rights,” Tauzin said.

Some of the guidelines exceed federal regulations. For example, the code says companies should submit their ads to the FDA for review before they are run.

The code also stops the practice of running ads which promote the name of the product without saying what it does. Currently, if a company doesn’t say what the drug does, it doesn’t have to include the risks.

The guidelines also say ads should be targeted to avoid audiences that are not age-appropriate, and designed to present a balanced view of a medicine’s benefits and risks.

AP Business Writer Dave Koenig in Dallas contributed to this report.