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Ten years after the FDA first approved pharmaceutical direct-to-consumer (DTC) advertising, the Senate has finally resolved to step up DTC regulation. Sponsored by the bi-partisan coalition of Edward Kennedy (D-Mass.) and Mike Enzi (R-Wyo.), the bill passed by a resounding 93-1. The House has a similar bill on its calendar and a full vote is expected in July.
Problem is, although the legislation has been touted as a victory over the big, bad drug companies, the success is actually Big Pharma's.
At first glance, drug company influence on the recent legislation can be hard to see. The bill raises fees on pharmaceutical patents to beef up FDA staff and speed review. It also gives the FDA power to fine companies for ads that fail to list risks in a "clear and conspicuous neutral manner."
However, compared to the recommendations made by the Institute of Medicine back in September, this bill replaces a steak knife with a spoon. The Senate bill ignores their suggested two-year moratorium on advertising new medication. It fails to require FDA approval before ads go on air and allows the FDA to assess fines only after the fact.
Even then, many critics doubt the fines will be much a deterrent. As Bill Vaughan, a policy analyst at Consumers Union, points out points out, "When a company can make more than a million dollars a day in drug sales, a $150,000 fine for running a misleading advertisement won't have much impact."
In fact, the bill is so soft that even Billy Tauzin, former Republican congressmen and current president of the powerful drug group, Pharmaceutical Research and Manufacturers of America (PhRMA), praised the bill, saying it "will no doubt make a good system even better."
Tauzin should be so congratulatory. In many ways, the bill is his success. When he took the reigns of PhRMA after the Vioxx debacle in 2004, he spearheaded an aggressive campaign to improve Big Pharma's image.
The campaign's formula: Lobby hard behind the scenes. Play very nice in public. And promise any changes that need to happen. We can regulate ourselves, thank you very much.
By the time the Democrats took Congress and made it clear they were gunning for stricter DTC regulation, Tauzin and his industry had several year's worth of marketing practice to perfect their defense.
The drug companies' effort to recast themselves as friends of the FDA and champions of patient rights is not in itself surprising. Nor is their PR campaign -- lobbying, playing friendly, self-regulating -- particularly novel.
But considering how this campaign affects public debate, and how images of their products influence our ideas about health and the promises of modern medicine, it's a campaign deserving scrutiny.
It all began 10 years ago with a preternaturally green field and blue sky. Details were vague: We were told to ask our doctor. But never fear, Claritin was here. And soon that drug was not alone. Our airwaves slowly filled with more commercials of cloudless skies and the people who enjoyed them -- happy people who swung on rope tires and performed slow motion somersaults. Over those first early years, the active people's afflictions gradually multiplied. They suffered hair loss and got herpes. The guy couldn't always perform up to par. Through it all though, the people seemed to genuinely like holding hands, and they aged really well. Their seven-day forecasts were never short of spectacular.
Those first few antinasal drop ads have since exploded into a $4.5 billio-a-year industry, encompassing almost every imaginable ailment: depression, arthritis, cholesterol, PMS, HPV, restless legs, irritable bowels, toenail fungus and what, as the ads told it, seems to be an insomnia epidemic.
As the popularity of these ads grew, so did the media debate about their ethical and medical implications. Op-ed columnists, doctors and consumer watch groups all weighed in, with many arguing that DTC ads exploit consumers by "selling sickness" and emphasizing drugs' benefits while downplaying their risks.
But it wasn't until six years later, when drug giant Merck withdrew Vioxx from the market, that the issue came to a head.
Determined to keep its customers -- and its ad spots -- the drug industry responded with a makeover. In the spring of 2005, PhRMA launched a 15-point guideline for reforming DTC advertising. Along with submitting ads to the FDA for review and "more directness," the guide called for an end to reminder ads: short spots that name a product but not its purpose or risks. Some critics pointed out that most of the bulleted points duplicated laws already on the books. Others noted that the rules were voluntary, vague and unenforceable. Republican Senate majority Bill Frist, who was pushing for a two-year moratorium at the time, limited his praise to "a good first step," but talk of a moratorium soon after stalled. PhRMA's token gesture ensured their ads were -- if only for profit's sake -- safe.
See more stories tagged with: advertising, marketing, direct-to-consumer, drug companies, big pharma
Alicia Rebensdorf is a freelance writer and author of the recently published, Chick Flick Road Kill: A Behind the Scenes Odyssey into Movie-Made America.
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