We all see them every day, drug company ads for prescription drugs that are aimed at us as consumers.
For years, drug company advertising for prescription drugs was aimed directed at doctors, trying to get doctors to prescribe particular drugs to consumers. In the recent time, however, the drug companies have decided that going directly to the consumer is the way to go, with the idea that consumers then will ask their physicians for the particular drugs.
Is drug company advertising something that is safe to rely on? A recent episode suggests that caution is important.
Bayer Healthcare Pharmaceuticals, Inc. is a huge drug company. One of its products is YAZ, which, in the words of the Food & Drug Administration is “indicated for the prevention of pregnancy in women who elect to use an oral conceptive.” In other words, it is a birth control pill.
YAZ also is indicated for the treatment of symptoms of a condition called Premenstrual Dysphoric Disorder (PMDD), as well as for the treatment of acne in women at least 14 years old.
The Food & Drug Administration requires drug companies to disclose risks and other information about drugs. Bayer advertised YAZ as “Prevents Pregnancy, May Help Moderate Acne and PMDD.” Bayer did this through the most modern means, as sponsored links on the web. However, in doing so, it did not communicate any risk information about YAZ. The FDA was very concerned about this because YAZ has what is known as a boxed warning, and this information was not included.
The FDA concluded that Bayer provided an incomplete and misleading statement about YAZ when it suggested that YAZ was useful in a broader range of conditions for patients than had been demonstrated by supporting evidence.
Bayer settled claims brought by the Food & Drug Administration and 26 States that included requiring Bayer to conduct a national $20,000,000 corrective ad campaign for misleading consumers about the use of YAZ. In addition, Bayer agreed to submit future television ads promoting YAZ to federal regulators.
Why is all of this important? Because this reminds us that when we see drug ads we should be very skeptical of the claims and at least go back to the company’s website to get the full information about the drug before talking to our physician about it.