Harold J. DeMonaco is one of our most prolific story reviewers and a frequent contributor to the HealthNewsReview.org blog. He was featured recently on our 10th Anniversary Podcast.
Jonathan Cohn deserves a round of applause for his recent Huffington Post story dissecting a television commercial for Belsomra, a prescription sleeping pill. The story, headlined “Drugs you don’t need for disorders you don’t have,” spotlights the critical perspective of experts such as Dr. Lisa Schwartz, a Dartmouth physician who served on the FDA advisory committee that evaluated Belsomra’s application for approval.
The 90 second commercial features a young woman and, as described in the Huffington Post article, “…two slightly creepy fuzzy animals in the shape of the words ‘sleep’ and ‘wake.’” What struck Dr. Schwartz was the way in which the commercial glossed over the drug’s very modest effects. According to Dr. Schwartz, “You have no idea watching that ad that we’re talking about falling asleep 6 minutes faster and staying that way an extra 16 minutes—and that’s at higher doses. We really don’t have a great idea of how well it works at the lower dose FDA actually recommends for people starting the medication.”
Billions at stake in sleeping pill market
Belsomra was approved by the Food and Drug Administration in August 2014. The approval process for the drug was complicated and it enters a sleep aid market in decline. Annual sales of drugs promoted for sleep are falling off primarily due to loss of patent protection. Annual sales are projected to slip from a high of $2.1 billion in 2013 to $1.4 billion in 2016. Analysts however predict a rebound in sales due in part to the introduction of Belsomra.
There is a good deal riding on this drug for Merck, and they’ve pinned their sales hopes on advertising. Merck is one of the top ten pharma companies using direct to consumer (DTC) advertising — spending $205 million annually with about $100 million in newspaper and magazine advertising. The industry as a whole spent $5.2 billion on advertising last year. That’s vital revenue for media companies who’ve seen overall advertising dollars slump over the past decade. So it’s perhaps not surprising that we don’t see too many of these companies’ news outlets rushing to scrutinize the claims made in DTC advertising.
U.S. is an outlier on DTC advertising
DTC advertising for prescription drugs is permitted in the United States and New Zealand but in no other country in the world. The Pharmaceutical Research and Manufacturers of America (PhRMA) have established guiding principles for such advertising that are theoretically in keeping with FDA guidelines on marketing and advertising. According to these principles, DTC advertising serves the public good by:
The guiding principles also emphasize the need to comply with Food and Drug Administration (FDA) regulations, which in general require that all DTC information:
Temporary paralysis, driving concerns among worrisome side effects
Quoting again from the Huffington Post story, “Some test subjects experienced worrying side effects, like next-day drowsiness and temporary paralysis upon waking. For a number of people, these effects were so severe that the researchers halted their driving tests, fearing someone would get into an accident. Because of these safety concerns, the FDA ended up approving the drug at a lower starting dosage than the company had requested—a dosage so low that a Merck scientist admitted it was ‘ineffective.’”
I believe this description is faithful to what was reported in the May 13, 2013 Peripheral and Central Nervous System Drugs Advisory Committee meeting. But you can read the transcript of that meeting and decide for yourself if this characterization is accurate.
Despite its lack of crucial details that would support patient decision-making about Belsomra, the ad, surprisingly enough, manages to uphold the aforementioned PhRMA principles. In fact, in my own mini-systematic review of how the spot addressed the PhRMA criteria for responsible advertising, I found that there was enough wiggle-room and vagueness to allow for “Satisfactory” ratings on most points. For example:
PhRMA principle #1: To be accurate and not misleading
My rating – Satisfactory: The ad basically makes no claims about efficacy, stresses the novel mechanism of action, and lists the host of potential side effects. The sleep-enhancing benefits are only implied by the on-screen activity and never directly stated. By the same token, the fact that Belsomra allowed subjects to fall asleep just 6 minutes sooner and for 15 minutes longer than those who received placebo is noticeably absent.
PhRMA principle #2: To make claims only when supported by substantial evidence
My rating – Satisfactory: There are no direct claims made other than a statement about the novel mechanism of action.
PhRMA principle #3: To reflect balance between risks and benefits
My rating – Satisfactory: A full 40 seconds of the ad are devoted to the side effects of Belsomra and warnings about its use. Benefits however are implied and never explicitly mentioned.
PhRMA principle #4: To be consistent with the FDA-approved labeling.
My rating – Satisfactory: The ad uses the word “insomnia” which is within the FDA-approved labeling. Although the ad never specifies that insomnia does not include an occasional inability to fall asleep or stay asleep, I’ll give the benefit of the doubt here.
My hat is off to the marketing and advertising folks who make these commercials. Being able to sell a product while dancing around the FDA and PhRMA requirements is a gift and an art form. Education and information, however, seem to have fallen by the wayside in the process. Dr. Schwartz has provided Consumer Reports with a Drug Fact Sheet about Belsomra that fills the need for accessible, accurate information about the drug. She and her husband, Dr. Steven Woloshin, have launched a company that hopes to create similar “drug facts boxes” for other medications. “The idea is to translate the gobbledygook that appears in prescription package inserts or those fine-print full-page magazine ads into language that average consumers can understand,” Cohn writes.
Thank you Jonathan Cohn and the Huffington Post for bringing us this important story. Wouldn’t it be great if others in the news media followed suit and looked more deeply into prescription drug advertising? I wouldn’t hold your breath waiting for those stories to be published, though. With a couple of billion dollars in advertising revenue at stake, there’s a strong incentive for the news media to keep hitting the snooze button on this issue.
Addendum: Huffington Post also hosts an “honest sleeping pill commercial” for fictional drug Lombestra that may or may not be considered a parody of Belsomra-type spots. WATCH: