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Prescription drug ads always feature absurdly long lists of side effects at the end. Why? And does anyone vet these ads to make sure they're accurate?



Prescription drug ads on television can be grimly amusing. Just consider the commercial for the prescription sleep aid Lunesta: a soothing voice tells you the drug might deliver you to "the land of restful sleep"... or, alternatively, that you might end up driving your car in a foggy sleep, feel suicidal, or experience an allergic reaction that leads to fatal throat swelling.

These kinds of ads are only found in two countries: America and New Zealand. In the rest of the world, drug companies can peddle their drugs to doctors or raise awareness about diseases their products are meant to address through unbranded campaigns. But only America and New Zealand allow pharmaceutical companies to market prescription drugs directly to potential patients.

Now, the reason the ads are so absurdly structured — and a frequent target of parody — has to do with how they're regulated. In the United States, companies need to warn people of all the potential risks of their drug, and advertise only the indication for which the drug has been approved by the Food and Drug Administration. (Some drugs have multiple potential uses, but only one or two have been specifically sanctioned by the FDA. The unapproved uses are called "off-label" and can't be advertised.) That's why you see commercials extolling a drug's potential benefits — and then slamming you with a laundry list of side effects.

Ever since these ads hit the mainstream media in the 1990s, this odd format has dismayed researchers who study risk communication — in part because, for all the regulation, these ads leave out a lot of important info.

Drug companies are not required to tell patients how well their drugs actually work or really give any context all. Companies don't have to say how many people will actually benefit from the drug, or how many might be harmed. They also don't need to mention cost, or whether there's a cheaper generic version of the drug, or whether improved diet and exercise could help a person's condition more than their medication.

This means drug companies have no incentive to spell out the fact that their new insomnia pill will probably only grant you 15 minutes more sleep a night, while delivering a 70 percent chance that you’ll be drowsy to the point of potentially crashing your car the next day.

"These ads are out there for a reason, which is try to sell the drug," said Harvard's Aaron Kesselheim, "and as a result, there have been a lot of instances where they tend to overstate positive components and understate or present negative ones in ways that aren’t necessarily as strident as they could be."

Researchers have also found that very few direct-to-consumer drug ads give hard data on a drug's benefits; most opt instead for vague statements that too often oversell. And because the probability of side effects isn't communicated, that overwhelming list can be difficult to make sense of — like a pilot warning you that his flight might take you to your dream holiday in Paris or crash and burn, without any mention of the absolute risk of each fate.

What's more, really unbalanced drug ads can hit the airwaves or the internet before anyone does anything about them. The FDA does not typically vet ads before they're published (unless a company asks for advice). It only has the authority to send warning letters to companies it believes violate the law and mislead consumers, asking for the ads to be stopped right away. That's why Kim Kardashian was able to advertise a morning sickness drug on her social media pages without mentioning the drug's many potential side effects — but then followed up with a corrective ad after the FDA issued a warning letter.

Now, of course, the marketing isn’t all bad. "Their stated purpose is to help people know what their options are, and there's some evidence they do inform some people," said Steven Woloshin, a Dartmouth College physician-researcher who recently launched the Informulary, a resource for evidence-based facts about popular medicines. "The downside is that the information comes from manufacturers, so there's a strong financial conflict of interest."

"Even that kind of disease awareness has been taken to the extreme," said Kesselheim, "where some companies have been accused of disease-mongering — creating a disease by their advertising." He continued: "Direct-to-consumer ads are weighted in favor of brand-name drugs and high-cost drugs, and for some conditions, older and less-expensive and generic drugs are just as good. Those aren’t being advertised, and that can sway people's opinions about which drug they want. What people request is a substantial contributor to what physicians end up prescribing."

Drug ads could soon change — both for the better and for the worse

The FDA recently issued new draft guidance for improving risk communication in direct-to-consumer drug ads. Among the recommendations, companies would be required to deliver information about their products in plain language, and they wouldn't need to mention every side effect of a drug, only the "most serious and the most common" ones.

This could be great for patient comprehension — spelling an end to that laundry list of side effects — unless it means Big Pharma uses that leeway to mislead people. One researcher writing in the New England Journal of Medicine pointed out that selectively reporting risks "raises difficult questions about which risks to exclude, and it's worrisome when discretion is given to marketers who have an interest in downplaying overall risks."

The situation could also get worse for another reason: Two drug companies recently sued the FDA over their rule that they're not allowed to advertise "off-label uses," claiming that it violates their First Amendment right to free speech. If drug companies win the right to market drugs for unapproved uses, it might have massive implications for public safety. "These cases are very concerning," said Kesselheim. "We'll see a flood of advertising drugs for conditions for which the evidence supporting their utility would not meet FDA standards but will be loudly promoted as showing that the drug works and is effective for this condition."

In the already bewildering world of pharmaceutical advertising, it'll be even more difficult to know what's true.

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