As recent legislation shows, drug companies and their direct-to-consumer marketing campaigns need diligent monitoring -- especially when it looks like they need it the least.

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 (not a decade if the campaign began in 2004) 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.

Around this time, the commercials themselves also began to shift. The shock of those first DTC ads had since grown cliché. SNL skits and comedy writers regularly parodied their disclaimers and ad execs needed fresher ways to promote their products. One of the more effective methods the drug industry developed was animation, and soon it was everywhere. Bees started selling allergy medicine, water balloons suffered bladder control and balls couldn't bounce because of their depression. When those active people did sleep, they were aided by glowing butterflies and talking beavers. The human body, usually played by actors or represented by artery diagrams, also became more imaginative: a fun house of germs and a play yard of leaking pipes.

There are many reasons for this Disney-like shift in imagery. Cartoon mascots have long been an effective marketing tool. Their lack of gender and racial characteristics give them a wider appeal. Stylistic graphics tend to be more memorable than the acted-out ads, and consumers, perhaps jaded by all those perfect people, are often just more responsive to animated ads. Also, considering the anatomy involved, cartoon mucus and monster toe fungus can be a cute way to straddle the ick factor. They're currently making a sitcom out of the Geico cavemen. It would not be much of a reach if 'Meet the Mucinex's' were next.

But whether intentional on the pharmaceutical industry's part or not, the ads also serve a larger purpose of softening their drug's image. It's hard to imagine an anthropomorphized ball suffering kidney problems. A pastel butterfly wouldn't hurt a fly. Bambi's friends are also especially effective at obfuscating the drugs' side effects.

Professor Ruth Day, director of the Medical Cognition Laboratory at Duke studied how Flonase's British bee floats placidly during most of the ad. When it comes to the risks portion of the anti-allergen, however, his wings flap distractingly fast. Combine this with 10 years of DTC-perfected risk disclosures -- using a different, more monotone narrator (especially in celebrity endorsements), longer vocabulary (while most drug ads use 6th grade vocab, the side-effects usually use 9th) and accompanied by positive imagery (think lots of recreational activity) -- and the cartoon drug's side effects can be awfully hard to hear.

The tactics of self-regulating, using animation and downplaying side effects are, in themselves, hard to rail against. Pharmaceutical companies are following the letter of the law. When the FDA has sent out unenforceable "notices of violation" to the more over-stated and deceptive ads, the drug makers have been quick to respond. Plus, it could be argued, this is not a conspiracy campaign, just good selling. Consumers ultimately bear responsibility for finding out if the medication is "right for them."

There are, however, larger repercussions to consider. The fact is that while public opinion polls rank the drug companies as one of least trusted industries, nurses and pharmacists routinely place as the top two most honest and ethical professions. As skeptical as the public may be of the pharmaceutical industry, we believe in the power of their medicine. DTC ads and drug company PR take advantage of this faith in a way we consumers need to be more alert to.

Consider for a second the shows these ads are sandwiched between: ER, House, CSI, Grey's Anatomy. As our drug ads grow more infantile, our medical dramas are increasingly graphic. We see the blood. We're in the operation rooms. We're in the bodies. In some ways, illness and anatomy have never been so demystified in media.

At the same time, however, the magic surrounding medicine is as great as ever. Most of these shows are a medical who-dunnit. House and his assistants track symptoms to come up with a cause. Grey's interns take breaks from flirting to figure out a mysterious disease. Occasionally a medicine won't work but it's almost always because the hero-doctor misdiagnosed the problem, and by the end of the hour, the real cause is found and the magic pill is administered. These hyper-real shows tap deep into our culture of medical trust and encourage our wonder-drug optimism. The pharmaceutical ads aired beside them benefit by association.

And this is why the questions of responsible advertising and well-articulated risks are so important. Many drugs are great. They are life-saving. But others are not. Many are marginal improvements on cheaper medicines, often with greater risks that disclaimers make easy to tune out. Many are dubious re-dressings for older medications whose patents are running out. This is why the Institute of Medicine came back with such stronger language in 2006, calling for a two-year moratorium on new drug ads and a stronger FDA. This is why the pharmaceutical industry's efforts to avoid DTC regulation require such diligent monitoring -- especially when it looks like they need it the least.

Which brings us back to the recent drug bill. An interesting ad came out just before the senate took up FDA reforms. And, on its surface, it seemed to address all that is wrong with most DTC ads. The ad was for Celebrex, and it debuted during a Pfizer-sponsored edition of World News Tonight. Celebrex, an arthritis reliever and relative of the vilified Vioxx, had been taken off the airwaves in 2004 and the new ad was its long (in more ways than one) awaited return.

Rather than the traditional 30-second spot, the new Celebrex ad runs a full two and a half minutes. Where most companies bookend their commercials with the drug's healing properties, the Celebrex starts on a very cautious note and repeats risks throughout the entirety of the ad. Side effects are not only stated in relatively clear language, phrases related to stomach ulcers and kidney problems are written in text on the screen. Twice, it goes so far as saying side effects "can cause death." And while, yes, the ad's protagonist follows all the DTC clichés (he paints, bikes, fishes, plays with his dog and dances with his wife), the graphics -- white lines of script on a blue background -- actually seem to convey the disclaimers rather distracting from them. The closing slogan nails the message home: "Understand the Risks; See the Benefits."

It's unclear whether the timing of the ad -- released just prior to the senate bill -- was planned or mere coincidence. But one thing is certain: Viewed in light of the Institute of Medicine's recommendations, Pfizer seems to be advertising self-regulation as much as it is its medication. "Let's dive deeper," the narrator tells us at one well-executed point. Just under the ambient soundtrack, you can hear the ad patting itself on its back. The watchdog group Public Citizen has garnered some negative press for Celebrex by accusing the ad of overstating its similarities to less dangerous medications like ibuprofen. But judging by the ad's frequent airplay and, some would say, the recent weakened Senate bill, the ad is a drug industry success.

Realistically, the Senate bill owes more to PhRMA's massive lobbying efforts than to a clever drug ad, but that doesn't mean we should dismiss the power of the ads themselves. Direct-to-consumer advertising is exploding on-line, an area the FDA regulations haven't begun to truly address, and DTC television spending is not declining as some analysts once predicted. Since on-air DTC advertisements are the most visible part of the Big Pharma's campaign, the way drug companies manipulate these ads to sway public opinion is of particular importance. Right now, consumers are relatively skeptical. This is good. Considering our trust in medicine and the way pharmaceutical advertising takes advantage of it, it's up to us to take their cartoons seriously.

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.