Healthy Skepticism Library item: 1950

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

Saul S.
Drug Makers to Police Consumer Campaigns
New York Times 2005 Aug 3
http://www.nytimes.com/2005/08/03/business/media/03adco.html

Keywords:
DTCA direct consumer advertising

Notes:

Ralph Faggotter’s Comments: Another article on self-regulation by the pharmaceutical industry of Direct to Consumer Advertising (DTCA) in the USA. I have read a number of these newspaper reports over the last few weeks, and the tone of the articles is becoming progressively more sceptical. Manipulating someone into buying a useless kitchen gadget is one thing, but manipulating them into taking a pill which they don’t need and which might harm their health is more serious and for this reason DTCA is banned everywhere except the USA and NZL.

Full text:

Matt Slocum/Associated Press
Billy Tauzin, left, of the drug trade group announced the plan on Tuesday.
http://www.nytimes.com/2005/08/03/business/media/03adco.html
By STEPHANIE SAUL

Published: August 3, 2005

SUPER BOWL ads promoting drugs for erectile dysfunction are remnants of the past, if the pharmaceutical industry truly follows its own new guidelines. Also extinct might be 15-second television ads that give little more than a drug’s name, without explaining its benefits or risks.

The industry’s main trade group yesterday announced details of a voluntary plan to restrict consumer drug advertising. The guidelines were developed to fend off stricter government regulation, as well as improve the industry’s public relations, which have been at all-time lows recently.

Although the industry’s critics said self-policing was insufficient, the trade group, the Pharmaceutical Research and Manufacturers of America, said it would open its own advertising accountability office. The office’s job will be to field complaints from the public and forward them to companies for action. At the end of the year, the association known as PhRMA (pronounced FARM-ah) will appoint an independent panel to review the process and issue a report.

Advertising industry executives said yesterday that it was too soon to say how the changes might affect the ad spending of drug makers. Advertising drugs to consumers has grown into a $4 billion industry since 1997, when the Food and Drug Administration relaxed restrictions on such ads.

But in the last year the ads have become the subject of criticism from Capitol Hill, doctors and consumers who say they seem only to promote the benefits of drugs without fully explaining the risks.

Critics, for example, say advertising led to the broad use of the painkillers known as cox-2 inhibitors by patients who would have done just as well with more traditional painkillers. The cox-2 drugs, including Vioxx, were later blamed by some for causing heart problems.

One of the drug industry’s harshest Senate critics, Charles E. Grassley, Republican of Iowa, yesterday called for regulators to step in. “It doesn’t make sense to rely on drug companies to police themselves,” Mr. Grassley said in a statement. “The Food and Drug Administration needs to stop dragging its feet and start exercising its authority to closely monitor the marketing of pharmaceuticals.”

The F.D.A. has said it plans to publish a notice in the Federal Register calling for a public hearing on drug advertising – the first step toward what could be a formal process for setting new regulations.

But the act of holding a hearing, probably in the winter or next spring, would not necessarily mean that the F.D.A. would draft new rules.

Dr. Scott Gottlieb, the top deputy F.D.A. commissioner, said yesterday that the agency viewed the industry’s voluntary guidelines as a positive development. “I think the industry itself, issuing principles like it did today, is an important step,” he said. “Clearly, they’re expressing a willingness to try to police themselves.”

More skeptical was Dr. Sidney Wolfe, who runs the Public Citizen’s Health Research Group, a consumer-rights organization. “PhRMA’s latest campaign of industry self-regulation via the guidelines announced today is both dangerous and, like previous industry efforts, doomed to failure, since selling drugs will always trump obeying the law,” he said in a statement, He called on the F.D.A. to more closely monitor drug advertising.

For ad agencies, the most significant new industry guideline may be the end of the 15-second televised “reminder” ads, which are normally used for well-known products. “Nexium, the Purple Pill,” for example, might be enough to remind patients and doctors who have used Nexium that the product is still around.

Dr. Gottlieb of the F.D.A. said such ads could serve a useful purpose, encouraging competition by reminding people about the full range of products available. But the F.D.A. has at times raised questions about some ads – like the reminder featuring a man with horns and touting Viagra. The F.D.A. argued that the image of horns pushed the ad beyond a mere reminder.

Because reminder ads have been allowed to omit risk information about the drugs as long as they do not mention any benefits, another concern has been that the ads do not provide consumers with the full range of information.

Andrew Schirmer of McCann HumanCare, a New York advertising company that handles large pharmaceutical accounts, said the new rules would virtually eliminate use of the 15-second spot by pharmaceutical companies, because 15-seconds did not give enough time to both promote a drug and list all its risks.

“It’s going to affect the overall marketing mix,” said Mr. Schirmer, predicting that the industry might look more toward magazine and newspaper advertising as a replacement for reminder ads. Mr. Schirmer declined, though, to estimate how the new program would ultimately affect spending.

Among other aspects of the code is an agreement that all ads will be submitted to the F.D.A. before they are used, to allow a review. That is frequently done already.

The guidelines, announced in a news conference yesterday in Dallas, also call for the industry to take time to inform doctors of new drugs before starting an ad campaign. But the measure stops short of establishing a specific time period for that. Senator Bill Frist, the majority leader, who had asked for a moratorium on advertising new drugs for two years, said yesterday that he applauded the industry’s plan but that he wished it had gone farther.

Bristol-Myers Squibb has announced it would embrace a one-year moratorium on advertising new drugs. But Billy Tauzin, the chief executive of PhRMA, said some drugs required shorter educational periods than others. “If a company needs six months to fully educate physicians, they’ll take six months,” he said. “If it requires a year to fully educate physicians, they’ll take a year.”