Far-Fetched FDA Claims

In the last year, the FDA has more than tripled the number of warnings about misleading ads that it sends to drug companies. In the 12-month period between August 2004 and 2005, the FDA sent 17 warnings; in the same period from August 2003 to 2004, five warnings were issued. I think we’re expected to pat the agency on the back for its tremendous efforts to increase enforcement of drug advertising laws.

In 2003, drug companies spent $3.2 billion on such ads. There were only five warnings issued from August 2003 to August 2004? Figures for 2004 expenditures have yet to be issued, but the trend indicates that the amount continued to rise. We’re supposed to believe that increasing the number of warnings by 12 made a difference?

The FDA division that regulates the ads is responsible for reviewing 30,000 to 40,000 ads each year, according to the Washington Post. Only 17 of these ads were out of line? I don’t think so. More significant, though, is that the FDA is almost powerless in enforcing drug advertising requirements. An article in the Seattle TimesSuddenly Sick series makes this pretty clear:

“The FDA has the task of making sure that drug companies do not make misleading claims in their ads, whether in medical journals or in mass-market Parade. But the regulatory agency, with part of its budget dependent on drug-company funding, has little firepower.

“When the FDA reviewed drug ads between 1997 and 1999, it found that more than half were inaccurate. It asked companies to change them, and in most cases they did.

“When companies refused and the FDA took them to court, the agency lost eight out of 10 court challenges on grounds of free speech.

“The FDA doesn’t have the authority to fine companies, either. The agency can go to court and ask a judge to fine them, but it has never done so, FDA spokeswoman Laura Alvey said last week.”

Unless major changes to the FDA’s authority accompany new legislation, tightening direct-to-consumer ad laws is a patch that will fail before it adheres.

What’s the motivation drug companies to clean up their acts? Even on the off chance that FDA cites a company, it’s after the first round of ads have already run, and the message is out to millions of people.

When I worked in communications for the government, a supreme spin master held the reins. He crafted messages that glorified our agency’s activities. No one believed the rhetoric because it wasn’t true. Neither he nor the FDA official who spoke today understand that to convince the public that you’re involved in spectacular activities requires engaging in spectacular activities.

News & Research, Society

Emotional Appeals Persuade Skeptics

Critical thinkers are still influenced by ads, a new study reports. Skepticism is an effective deterrent to the influence of factual ads, but not to emotional ads. Even with the skeptic views emotional appeals as manipulative, he or she is still likely to be won over with the use of emotion.

Otherwise critical consumers fall prey to snake oil sales when they are desperate for a cure. Emotional appeals are the ultimate persuasion tool for salespeople, and it’s scary to think that skepticism isn’t always an ally. Although the article doesn’t specifically address stories from traditional media, the same principles could apply. So now we also have to watch out for ads, articles or information that surreptitiously tug at our heartstrings.


Pfizer’s Drug Ad Plan

I’ve railed against Pfizer’s advertising before (see Education or Advertising? and Education & Advertising Revisited). The company announced yesterday that it will change the way it promotes drugs to the public. According to the New York Times, Pfizer said that by the end of the year, it will “provide more detail on risks, involve doctors at least six months before marketing begins and suggest alternative treatments in some cases.”

The Boston Globe explains Pfizer’s stated plans and criticisms in Pfizer Calls Halt to New Drug Ads. A two-sided account is available from the Kaiser Network. You can also learn about it through rose-colored glasses by reading Pfizer’s press release, which details the company’s strategy.

Kevin, MD comments, “I’ll believe it when I see it.” I’m still trying to give drug companies the benefit of the doubt. We’ll see.


Point-Counterpoint on DTC Drug Ads

An Atlanta Journal-Constitution editorial contends that voluntary restrictions on direct-to-consumer drug ads are unlikely to provoke much change. The editorial argues that the FDA should regulate drug ads and maybe even reinstate the pre-1997 ban.

The editorial was accompanied by a counterpoint article that supports drug ads for increasing public awareness of disease and treatments. PhRMA CEO and President Billy Tauzin maintains that the industry’s voluntary restrictions go above and beyond government requirements.

Funny how often point-counterpoint pieces don’t actually address the issues raised by the opposing side. And how choosing an author like the president and CEO of the organization that’s being criticized makes the first, and presumably “right,” argument even stronger. He should at least get a gold star for effort.

In any situation, I like to think that all parties will have a beneficial outcome (a win-win if you’d like). Trying a compromise instead of swinging wildly from one end of the continuum to the other is logical. Even though I think that drug companies aren’t necessarily evil, current DTC drug ads are. There may be a few exceptions, but I have yet to see them. If the new guidelines don’t inspire drastic changes, I’ll be marching for a ban on DTC ads too.