Healthy Skepticism Library item: 18390

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Publication type: news

Russell J
Drug makers told: Give risks equal billing
The Indianapolis Star 2010 July 9
http://www.indystar.com/article/20100709/BUSINESS03/7090329/Drug-makers-told-Give-risks-equal-play

Full text:

A woman is on the couch, grabbing her knee, wincing in pain.

“Are you paying the price of fibromyalgia pain? Cymbalta can help,” reads the headline in Eli Lilly and Co.‘s print ad, followed by 14 sentences touting the drug’s benefits for fibromyalgia, a chronic condition marked by widespread pain. Take Cymbalta once a day, the ad says, and “you may begin to function better and feel better.”

What about possible side effects? You would have to look on the next page to find them, in much smaller type: nausea, dry mouth, constipation, agitation, sleepiness and increased likelihood of suicidal thinking.

Not good enough, the Food and Drug Administration said in a warning letter to the Indianapolis drug maker earlier this year. The risk information “is not likely to draw readers’ attention” and gives a “misleading presentation.” The letter demanded that Lilly stop running the ads and make the risk information more prominent.

Increasingly, the FDA wants drug makers to give equal billing to possible risks of taking drugs, not just rattling them off in the last few seconds of a TV commercial or burying them deep in print.

Last year, the agency sent 41 warning letters to drug makers taking issue with their ads, twice the number from a year earlier, according to Bloomberg News. The ads covered a broad range of drugs that promoted treatments for diseases such as AIDS and lesser maladies such as foot fungus.

And now drug ads are coming under the microscope again. The FDA is preparing to issue new rules that would require drug makers to state possible side effects “in a clear, conspicuous and neutral manner.”

Among the guidelines:

The ads would have to use language “readily understood by consumers.”

Text would have to be easily readable — not in tiny type or in images that quickly vanish from the TV screen.

The audio information would have to be clear in terms of volume, articulation and pacing.

No graphics, images, text or sound could distract from the message.

“What the regulators want to do is tighten up the rules so drug makers know in advance what they can and can’t do, and that there are penalties if you cross the line,” said Les Funtleyder, a drug industry analyst at Miller Tabak & Co. in New York.

Many consumer groups, doctors and insurers have long criticized the drug ads for downplaying possible side effects. Some have pushed for a ban or moratorium on drug advertising. They say many of the ads are high on emotion and low on information about the drugs and their side effects, while a few ads are informative and fair.

The new rules would not ban drug ads, but would spell out how drug makers must present possible risks. Currently, not all drug makers do an adequate job of that, some observers say.

“It’s all over the map and has been for years,” said Steve Findlay, a senior health-policy analyst at Consumers Union, publisher of Consumer Reports. “Some companies have bent over backward to mention all the side effects and risk information very clearly. Others have chosen to ignore it as much as possible.”

Some drug companies have drawn sharp rebukes from the FDA for downplaying risks. Allergan, for example, touted a new eyelash-thickening drug, Latisse, using actress Brooke Shields. But the FDA said the ads omitted or minimized side effects, including a bacterial infection that could lead to blindness.

In another promotion, retired basketball superstar Earvin “Magic” Johnson touted the AIDS drug Kaletra, made by Abbott Laboratories, in a DVD testimonial. But the FDA dashed off a reprimand to Abbott, saying the promotion didn’t discuss serious risks, such as pancreatitis and new-onset diabetes.

“Specifically, the first 11 1/2 minutes of the promotional DVD are devoted to an engaging and lively discussion with Magic Johnson presented in an interview format. . . . In contrast, the presentation of serious risks associated with Kaletra is relegated to the end of (the) DVD after the interview is over, where it is unlikely to draw the viewer’s attention,” the FDA letter said.

Every year, drug companies, including Lilly, spend lavishly to advertise drugs. Last year, the industry spent $4.5 billion on direct-to-consumer ads, up about 2 percent from 2008, according to Nielsen Co. The ads took the form of TV commercials, newspaper and magazine ads, consumer handouts and Internet sites.

Last year, Lilly was the third-largest drug advertiser, spending about $350 million, chiefly to promote Cymbalta (an antidepressant also approved for fibromyalgia, general anxiety and diabetic pain) and Cialis for erectile dysfunction. That’s a huge leap for Lilly. Five years ago, the company wasn’t even in the Top 10.

But even as the companies spend millions to promote their drugs, a lot of patients remain confused, many doctors say. Only 40 percent of doctors thought patients understood the risks of a drug after seeing a drug advertisement, according to the American Journal of Medicine. Almost half of physicians polled feel some pressure to prescribe drugs as a result of consumer advertising, according to Medical Marketing & Media, an industry publication.

And some consumers already feel overwhelmed by lengthy drug risk disclosures. About 41 percent of people ignore the information on TV commercials, while half ignore the disclosures in print ads, according to a study last year by Opinion Research Corp. of Princeton, N.J.

The drug industry says the new rules could lead to longer ads to spell out all of the risks in detail. Lilly, in a letter to the FDA, said it generally supports the new standards, but added that “too much information can make it difficult for the audience to comprehend.”

It also took issue with a requirement that the ads spell out the frequency of certain risks, saying some people might not understand — “particularly in lower health literacy populations or populations who are challenged with numeracy.”

Still, the FDA’s push that drug makers not underplay side effects could already be working, even before the rules are adopted. Some drug makers already have begun expanding the risk information. Commercials for Pfizer’s stop-smoking drug Chantix now include more than a minute of safety warnings, compared with 14 seconds before, according to FiercePharma, an industry blog. Bristol-Myers Squibb now uses half of its air time on blood thinner Plavix to talk about side effects, twice as much time as before.

Additional Facts
Where the ads are seen

» The biggest outlets by dollar amount were network television ($1.6 billion), cable TV ($861 million), syndicated TV ($254 million), newspapers ($162 million) and radio ($46 million).

What doctors and patients think

» Almost half of physicians feel some pressure to prescribe as a result of consumer advertising.

» 60 percent of patients think ads directed at them do not provide enough information about risks.

» 60 percent of physicians think patients have little or no understanding from these ads about the possible risks and negative effects.

» 72 percent of physicians think patients have little or no understanding from the ads about who should not use the products.

Sources: Food and Drug Administration, Nielsen Co., Medical Marketing & Media

$4.5 billion
Amount drug companies spent on consumer advertising in 2009, up about 2 percent from 2008.

The big spenders
» $1.1 billion Pfizer.
» $371 million AstraZeneca.
» $350 million Eli Lilly and Co.
» $345 million Merck.
Sources: Nielsen Co., Medical Marketing & Media