Will Big Pharma Get to Drop Its Side Effect Warnings from TV Ads?

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You’ve likely heard the side effect warnings in direct-to-consumer drug ads. They’re read quickly at 2X speed like something out of the Chipmunks movies. They need to be there to warn us, but we rarely pay attention to them until they happen to us. Now big pharma is lobbying to kill even that small bit of reality. Let me explain.

What Are the Current FDA Requirements for Prescription-Drug TV Advertising?

To grasp the newest study, it’s important to understand what the FDA’s current rules are for prescription-drug TV advertising. There are three general requirements: the commercial must list the name of the drug, both the generic and brand name, must include an FDA-approved use of the drug, and must reveal “important risks” associated with the drug.

In addition, more specific requirements are that the “important risks” be spoken and that information be provided on the ad to direct consumers to a full list of risks (via a website, phone number, your doctor, the drug’s prescription inserts, etc.). The FDA focus is that both the risks and the benefits be provided in a “balanced fashion.”

One of the problems with these guidelines currently is that it leaves too much room for big pharma to cherry-pick those “important risks” it wishes to include. Now, instead of tightening up these rules, the FDA seems to be considering loosening them, by limiting the side-effect warnings in TV advertising even more. Why?

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New Study Finds the Best Way to Communicate Risks Is to Not Advertise Them?

The recent study, conducted by the FDA, consisted of 500 participants with depression, high cholesterol, or insomnia. The objective was to determine if limiting the risks listed audibly in TV prescription-drug ads would allow the participants, or viewers, to better understand and retain the information presented. Each participant viewed a version of a drug ad for his or her specific condition (Abilify for depression, Crestor for high cholesterol, and Lunesta for insomnia). There were multiple versions of each ad, and each version contained either an unedited list of risks or an abbreviated list of risks. Some ads disclosed that not all risks were included; some did not.

Participants then completed a survey that measured retention, their perception of the benefits and risks provided, and their reaction to the disclosure statement revealing that not all risks were included. Better retention of the risks was found in each of the three groups shown the abbreviated list of risks. Two of the abbreviated-list groups, depression and insomnia, had more focus on the drug benefits as they were better able to recall these than their counterparts in the full-list groups.

The conclusion? The FDA researchers suggested that an effective solution for communicating risks might be to include a disclosure statement in the ad explaining that not all of the risks are listed. Yes, you read that right! In other words, the best way for us to communicate the risks may be to not list them in the ad (since you either aren’t listening, won’t remember them, or won’t understand them anyway) and to also tell you we aren’t listing them in the ad. The FDA guideline does suggest that drug manufacturers provide website addresses in their ads, so if you want the full list of risks, perhaps you can track it down yourself by browsing the website.

Keep in mind that the U.S. is one of only two developed countries in the world (New Zealand being the other) that allows direct-to-consumer (DTC) marketing of prescription drugs, and now it seems we want to dim the risks in TV ads so we can shine a brighter light on the benefits.

A Better Solution?

A concern with this study is, of course, that pharma’s control over the FDA has been well documented. So are the study results biased? No way to tell. However, there is another way to solve the issue that would work, but pharma would never allow it.

Take an NSAID drug, like Celebrex, for example. You could easily have half of the commercial focus on the benefits and half or even one-quarter focus on the risks. So scenes of happy middle-aged and elderly people riding bikes and frolicking after popping their Celebrex would then be followed by people having sudden-death heart attacks and GI bleeds, the two biggest side effects.

The upshot? Hmmm…On one hand, I get the concept that listing lots of risks may cause us to tune out. On the other hand, in my personal opinion, as a physician who gets to prescribe drugs, patients only ever concentrate on the happy smiling faces in these ads. Hence, if you really want to clean up direct-to-consumer drug advertising, a surefire way is to show actors who also experience side effects. While that will never happen in Pharmerica, it needs to happen!

 

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Chris Centeno, MD is a specialist in regenerative medicine and the new field of Interventional Orthopedics. Centeno pioneered orthopedic stem cell procedures in 2005 and is responsible for a large amount of the published research on stem cell use for orthopedic applications. View Profile

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