Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Thanks to Cartoon Characters, We Know How Belsomra Works, But It Doesn't Work Well

Thanks to Cartoon Characters, We Know How Belsomra Works, But It Doesn't Work Well | Pharmaguy's Insights Into Drug Industry News |

One evening in the late summer of 2015, Lisa Schwartz was watching television at her Vermont home when an ad for a sleeping pill called Belsomra appeared on the screen. Schwartz, a longtime professor at Dartmouth Medical College, usually muted commercials, but she watched this one closely: a 90-second spot featuring a young woman and two slightly cute, slightly creepy fuzzy animals in the shape of the words “sleep” and “wake.”


Schwartz had a reason to be curious about this particular ad. Two years earlier, she had been a member of the advisory panel that reviewed Belsomra for the U.S. Food and Drug Administration—and the process had not gone well for the manufacturer, Merck. The company saw its new drug as a major innovation, emphasizing that the medication acted on an entirely different mechanism within the brain than the previous generation of insomnia medicines like Ambien and Lunesta. During the drug’s development, Merck had suggested that it could treat insomnia more effectively and produce fewer side effects than existing medications. In 2012, one Merck scientist described the science underlying Belsomra as a “sea change.”


But when Schwartz and her colleagues scrutinized data from the company’s own large-scale clinical trials, what they found was a lot less impressive. People taking Belsomra fell asleep, on average, only six minutes sooner than people taking a placebo and stayed asleep for a mere 16 minutes longer. 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.”


So when Schwartz saw the Belsomra ad, she was struck by how smoothly it sidestepped the drug’s limitations. A soothing voiceover hypes the science, giving a sophisticated explanation of how Belsomra targets a neurotransmitter called orexin to turn down the brain’s “wake messages.” “Only Belsomra works this way,” the voice continues. The ad ends with the young woman curling up with the “sleep” animal and falling into a peaceful slumber. “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,” Schwartz said. “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.”


The first marketing efforts for Belsomra appeared not long after the FDA had approved the medication, in the summer of 2015. Anyone who saw them might not have realized what was being sold, since many didn’t mention Belsomra—or any sleep drug—at all. There was a website,, which focused on sleep science, and a related Twitter feed, which now has more than 60,000 followers. Merck also worked with the nonprofit National Sleep Foundation to develop, a site where people with insomnia talk about their experiences. And there was an iPhone app called SleepGuru, which allowed users to monitor their sleep activity. For pharmaceutical companies, the great advantage of such “unbranded” advertising is that, since the ads don’t make claims about specific drugs, they aren’t legally required to talk about side effects, either.


Like the fuzzy animal commercial, the unbranded campaign for Belsomra told a compelling story about new developments in the field of sleep research. Older insomnia drugs try to induce sleep by making the brain more receptive to chemical signals that make people drowsy. Over the last two decades, scientists have developed an understanding of a separate set of chemical signals that make people alert. The WhySoAwake site gives a cartoonish version of this story, and a link on one page takes visitors to the Belsomra site, which explains that it is the only drug that acts to quiet the wake signals.


In Merck’s last quarterly earnings call for 2015, Adam Schechter, the president for global human health, linked the drug’s sales success directly to these marketing efforts. “With regard to Belsomra, I think we started off with a really good launch and we had nice growth,” he said. “It then flattened a little bit. We ran direct-to-consumer advertising and we saw an increase again in … volume.”


I asked Dominick Frosch, a senior scientist at the Palo Alto Medical Foundation Research Institute who has published widely on how patients make decisions, to review the Belsomra television spot with the fuzzy animals. “The ad promotes a very clear story as to what causes insomnia … that somehow insomnia is a problem of your neurotransmitters,” Frosch said. “They are giving you a very one-sided explanation of what causes insomnia, and of course into that cause fits this particular drug.”


“We all want consumers … to be highly engaged in their health care, and certain advertisements can do that. But it can also lead to a lot of overtreatment,” said David Grande, an assistant professor of medicine at the University of Pennsylvania who has written extensively on drug advertising, “It’s not as if we live in an imaginary world where messages in advertising are being driven by what’s important, rather than what makes more money.”


After Belsomra hit the market, Consumer Reports asked Schwartz to create a label for it. Her version presents the data on the drug in an even-handed way, noting that its ability to aid sleep is “modest” at the highest approved doses. “Short track record means that new, unexpected side effects are possible,” it explains. “Since this drug has a different way of acting than other insomnia drugs, the experience with it is particularly limited.” The label gives brief details on alternative remedies for insomnia, like cutting down on caffeine. Finally, it lists Belsomra’s known side effects. Not included on the list but probably warranted: skepticism.

Pharma Guys insight:

Related: "FDA Approved Untested Dosage of Belsomra, Says Consumer Reports Expert"; and "Big Pharma's Animated Ads & Mascots To Get FDA Scrutiny"; 

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"One-Click Rule" Also Won't Work for Print Sales Aids Says FDA. Baaa!

"One-Click Rule" Also Won't Work for Print Sales Aids Says FDA. Baaa! | Pharmaguy's Insights Into Drug Industry News |

According to a report by Alexander Gaffney in Regulatory Focus, FDA's Office of Prescription Drug Promotion (OPDP) issued an "unusual" warning letter to New Jersey-based Sciecure Pharma.

The letter took issue with the company's sales material promoting Doral (quazepam), a drug approved by FDA for the treatment of insomnia. 

The letter (find it here) cited several problems, including Omission of Risk Information, Unsubstantiated Superiority Claims, Omission of Material Facts, and Failure to Submit Under Form FDA-2253.

None of these is that "unusual" for problems cited in so-called "Notice of Violation" (NOV) letters. For example, 43% of such letters cite omission of risk information, and another 43% cite overstated efficacy, unsubstantiated superiority claims, and broaden indication (for more on that, read "Do TV DTC Ads Overstate Rx Drug Risks?").

Under "Unsubstantiated Superiority Claims" the FDA humorously refers to the "Image of a single white sheep among a group of four black sheep" on the sales aid cover (see image). More on the agency that designed this sales aid later.

It wasn't the sheep reference that made this letter "unusual" in Alex's eyes. So what did Alex find so unusual about the Doral letter?

Pharma Guys insight:

Remember "The Girl from Google"? A classic!

Joel Finkle's curator insight, November 25, 2014 10:39 AM

Entertaining article on Advertising regulations from FDA, and an attempted hijacking of online ad rules for print materials (it didn't fly).