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December 27, 2013

The Discrediting OTC Ads – Articles Include Potentially Misleading Claims

A recent study published in the Journal of General Internal Medicine found that as many as "six out of 10 pharmaceutical ads" contain "potentially misleading claims." The objective of the study was to compare claims in direct-to-consumer (DTC) television advertising with the FDA approved labeling in order to evaluate the frequency of false or misleading ads.

The United States is one of the only countries in the world that allows drug companies to directly advertised to patients or consumers through basically any medium—television, magazine, newspaper, etc. However, we recently reported that advertisements online and through social media have been a difficult and uncertain area for companies to advertise due to the lack of guidance and clarity from FDA on the issue.

To conduct the study, the authors analyzed a cross-section of TV ads for prescription and nonprescription drugs aired from 2008 through 2010 on ABC, CBS, NBC and CNN broadcasts. The researchers looked only at ads between 6:30 and 7:00 pm EST.

It should be noted that advertisements of any kind for nonprescription drugs (e.g., over-the-counter) are regulated by the Federal Trade Commission (FTC) not the FDA—however, FDA and FTC have a close working agreement to determine whether a nonprescription drug ad may be making an improper claim.

For each advertisement, the most-emphasized claim in each ad was identified based on claim iteration, mode of communication, duration and placement. This claim was then compared to evidence by trained coders, and categorized as being objectively true, potentially misleading, or false. Potentially misleading claims omitted important information, exaggerated information, made lifestyle associations, or expressed opinions. False claims were factually false or unsubstantiated.

Of the most emphasized claims in prescription (n = 84) and nonprescription (n  = 84) drug advertisements, 33 % were objectively true, 57 % were potentially misleading and 10 % were false. In prescription drug ads, there were more objectively true claims (43 %) and fewer false claims (2 %) than in nonprescription drug ads (23 % objectively true, 7 % false). There were similar numbers of potentially misleading claims in prescription (55 %) and nonprescription (61 %) drug ads.

The researchers said there were some limitations in the study method: the sample was drawn from a 30-minute period of the TV broadcast day on four major networks, and does not represent all ads on TV.  Also, they only analyzed what they determined as the most-emphasized claim in each advertisement and the coders need to interpret the meaning of claims to facilitate analysis, which did introduce subjectivity. For example, they categorized a Levitra ad as offering opinion, but no facts, when an actor said: "Levitra works for me. Maybe it can work for you." And a Prevacid ad offered "minimal facts" for boasting that "nothing works better" when superiority is not true.

The problem with this study is that it attempts to undermine the regulatory authority of FDA. All drug companies are required to submit any and all types of drug advertisements, especially TV commercials, to FDA prior to running such ads. Such advertisements are submitted to FDA with the drug application and are approved along with the drug if and when the product is approved.

While in the past, drug companies have run their TV ads without waiting for comments or a regulatory decision from FDA, the agency heavily regulates and monitors TV ads. In fact, we recently posted a summary of the various Warning and Untitled letters that FDA's Office of Prescription Drug Promotion (OPDP) sends to drug companies for improper advertising or promotion.

Consequently, because the authors selected commercials between 2008 and 2010, it is likely that some of the TV ads they selected were in fact ads that received regulatory letters from FDA that required the company to take down or change the commercial. However, FDA does not have the resources to handle every TV ad that comes across its desk and occasionally an ad may be broadcast that has improper information, and that is why FDA has the authority to issue a regulatory letter demanding a company correct such ads.

In addition, it is unclear exactly how the authors of this study determined an advertisement was "misleading." The authors noted that an ad would be "potentially misleading" if it

  • omitted important information,
  • exaggerated information,
  • made lifestyle associations, or
  • expressed opinions

What do the authors consider to be "important?" Is it the same type of importance as a patient would want to know or the FDA or both? What is an "exaggeration?" Why is a lifestyle association "misleading" when many diseases we see commercials for greatly affect lifestyles such as Crohn's disease, depression, skin diseases, and other illnesses? If you had trouble going to the bathroom frequently or were insecure about your physical appearance, wouldn't you want to know that a drug might help resolve those problems so you can actually leave your home with confidence?

Trained researchers and experts in health policy have their own biases and are well trained to identify information that the average patient and consumer would not identify as misleading. DTC ads are meant to educate patients about diseases, symptoms and possible conditions that may be untreated or undertreated.

No patient is convinced of the need for a drug or treatment from a DTC ad alone. Rather, DTC ads help patients—particularly with diseases that used to have stigma such as HIV or depression—discuss their problems with doctors when they might not have. More importantly, doctors also see these ads and are familiar with the influence they may have over patients and would not risk their practice, their license or the health of a patient solely from a DTC ad.

Ultimately, it is best for the FDA to determine what DTC ads are potentially misleading and for the agency to continue its oversight and enforcement through review. The use of this kind of potentially misleading research to scare patients away from DTC ads will only add to their confusion about complex and complicated diseases and illness when companies are simply trying to educate them to speak with their physician about choices and options.

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