Drugs you don’t need for disorders you don’t have

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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.”

In the United States, commercials like these are simply part of the cultural wallpaper. But just because drug ads are ubiquitous here doesn’t mean they’re a normal way of informing consumers about their medical options. In fact, the U.S. is one of only two developed countries in the world that allow drug companies to advertise their products on television. (The other is New Zealand, which has a population of some 4.5 million people.) One study, from the Journal of General Internal Medicine, found that 57 percent of claims in drug ads were potentially misleading and another 10 percent were outright false.

For a variety of reasons, drug companies are now increasingly relying on direct marketing to American consumers. Last year, the pharmaceutical industry spent $5.2 billion on ads promoting specific drugs—an increase of 16 percent over the previous year. At a time when most other industries are spending less on television advertising, drug companies are spending more. They are also devising new forms of so-called direct-to-consumer outreach, like smartphone apps that consumers may not even realize are a form of marketing and that the FDA is still figuring out how to regulate. (The FDA recently asked Kim Kardashian to delete Twitter and Instagram posts touting a morning sickness pill she was taking, because she hadn’t explained its side effects.)

Concerns about direct advertisements of pharmaceutical products have become so acute that last November the American Medical Association called for an outright ban, saying that the practice was “fueling escalating drug prices.” Spending on prescription drugs already accounts for about one in every six dollars that go into medical care. Between 2013 and 2018, the government anticipates that the average annual increase in this spending will be about 7.3 percent—higher than the overall rate of health care inflation. One of the reasons for the increase is the massive sum that manufacturers pour into advertising.

Last year, for instance, Merck spent $96 million promoting Belsomra. The investment proved to be worth it. Analysts expect the drug to generate more than $300 million in sales this year and to overtake both Ambien and Lunesta as the top-selling insomnia medication sometime within the next decade.

Out Here, No One Can Hear You Scream
Up until the early 20th century, newspapers were full of ads making outlandish claims about potions and elixirs that were sometimes toxic and nearly always useless, such as Doctor Quenaudon’s Spring Cure, an “extract of green herbs for purifying the blood and the cure of all diseases arising from its impurity, also of all other chronic diseases.”

Over time, a series of federal laws, starting with the Pure Food and Drug Act of 1906, took these concoctions off the shelves and put their producers out of business, giving rise to the pharmaceutical industry as we know it. In 1938, the Federal Food, Drug and Cosmetic Act mandated that the most powerful drugs could only be purchased with a doctor’s prescription. After that, manufacturers focused their promotional efforts exclusively on physicians, running ads in professional journals, dispatching representatives to doctors’ offices, and wooing them with fancy dinners and junkets.

But the FDA, which eventually gained authority over both the manufacturing and marketing of drugs, had never actually prohibited mass advertising. In 1981, Merck broke new ground by running a text-heavy, black-and-white advertisement for a pneumococcal vaccine in Reader’s Digest. The following year, Arthur Hull Hayes Jr., the head of the agency, hinted in a speech that the FDA would be OK with such ads. Seizing the moment, Boots Pharmaceuticals created the first-ever television commercial to promote its version of prescription ibuprofen. That’s when the FDA got jittery. It asked the industry to observe a moratorium while the agency came up with some ground rules.

Under guidelines released in 1985, the FDA allowed drug companies to run ads that simply raise awareness of a disease without much restriction. But if a company wanted to describe what a drug was supposed to do, it was required to explain the risks. The ads that followed fell heavily into the first category, because companies saw no way to cram sufficient information about side effects into 30-second spots. The companies began pushing for fewer restrictions, and in 1995, they gained a powerful ally in new House Speaker Newt Gingrich, who started beating up on the FDA as a “job killer.” Under pressure from lobbyists and Capitol Hill, the FDA in 1997 produced new guidelines declaring that companies’ ads just had to devote roughly equal time to the risks and benefits of a drug.

One year later, spending on television drug ads had more than doubled, from $310 million to $664 million. A major early beneficiary was a new generation of antihistamines that did not make people drowsy. Thanks to the advertising push, first Claritin, then Zyrtec and Allegra became some of the most frequently prescribed medications in America.

These antihistamines represented a meaningful improvement for allergy suffers. The same could not be said for other drugs that manufacturers began promoting with multimillion-dollar campaigns. Take the case of Nexium, which is now infamous in the world of health care policy. Until the 1980s, doctors had treated acid reflux with over-the-counter pills, like Tums, that counteracted the effects of stomach acid. Then, in 1990, a drug went on the market that reduced the production of acid itself.

Prilosec would become a moneymaking monster, with sales reaching $6 billion a year. But AstraZeneca, the company that ended up marketing it, knew these profits would last only as long as the drug’s patent, which was set to expire in 2001. So it launched a desperate bid to find a replacement—an effort named “Project Shark Fin” because the graph of Prilosec’s expected revenues rose and fell like an inverted V. Eventually, researchers produced Nexium, which AstraZeneca promoted as a new, improved acid inhibitor.

Chemically speaking, however, Nexium was extremely similar to Prilosec. There was little evidence that it was better than Prilosec or new generic alternatives. In fact, public health experts argued that many people taking acid inhibitors didn’t need medications at all—they needed to change their diets. But the advertising blitz worked: Within two years of its release, Nexium had surpassed Prilosec in sales; by 2010, it had surpassed Lipitor, the anti-cholesterol drug, as the highest selling drug of all.

The best thing I heard experts say about Belsomra was that it was no worse than any of the other drugs out there.

There’s a well-established body of research showing that advertising plays a critical role in a drug’s popularity. In one of the most famous studies of direct-to-consumer advertising, a team of researchers from Canada and the U.S. studied consumer behavior in two demographically similar cities: Sacramento and Vancouver. The U.S. consumers, deluged with ads for prescription drugs, were more than twice as likely to ask for a drug they’d heard about as the consumers in Canada, which doesn’t allow such ads. In another study, researchers trained actors to seek medical help for symptoms that resembled depression at different levels of severity. The good news was that most people with symptoms warranting medication received drugs. The bad news was that most people without symptoms warranting medication also received drugs. Just over half of that latter group came away from their physician’s office with a prescription for a drug they’d asked about after seeing an ad on TV.

Companies like Merck point out that their ads always instruct patients to consult a physician. And it’s true that doctors aren’t supposed to prescribe medication unless they think it makes sense clinically. But as multiple studies have shown, doctors often give patients the particular brand-name drugs they ask for, even when a cheaper generic version is available.

Pharmaceutical companies are eager to exploit this fact, because promoting drugs to doctors has become harder than it used to be. In 2002, the federal government prohibited pharmaceutical companies from providing financial incentives or other “tangible benefits” to physicians who prescribe their drugs. In the last few years, it has begun prosecuting apparent violations through anti-kickback statutes. “In the old days, pharmaceutical representatives were always taking docs out to dinners, bringing them Cuban cigars, taking them to Yankee games in the box seats,” said Stephen Hoelper, a veteran drug marketing executive and vice president for sales and marketing at MediSolutions. The Centers for Medicare & Medicaid Services “doesn’t like that and says that if you induce a physician to prescribe a product, then you are potentially making health care more expensive.”

Meanwhile, the employers and insurers who pay most of America’s medical bills have been looking for ways to discourage excessive prescribing in an attempt to rein in costs. Most private insurance plans have formularies, or lists of approved drugs, managed by special companies called “pharmaceutical benefit managers.” These firms negotiate with drugmakers over prices and divide medications into tiers, forcing patients to pay more out of their own pockets for certain expensive drugs. Brand-name sleeping pills frequently end up in the tiers requiring higher co-pays, which means the pharmaceutical companies must work even harder to convince consumers that the drugs are worthwhile.

Finally, during the past decade, drug companies have simply had fewer genuine game-changing drugs coming onto the market. With the exception of occasional breakthroughs for diseases like hepatitis C, it is becoming harder and harder to find drugs that offer clear-cut clinical advantages over existing treatments. Between 2003 and 2011, the success rate for clinical trials fell, the time from trial to approval rose, and the ratio of approved drugs to trial drugs declined. These are all signs that the drug pipeline is drying up. Innovation could pick up again, but in the meantime, drug companies have been spending much of their time pushing drugs of questionable clinical advantage, or persuading viewers to seek medication for “a disease that may be hard to distinguish from normal behavior in most cases,” according to Aaron Kesselheim, an associate professor at Harvard Medical School who focuses on the drug industry. In his field, the tactic is known as “disease mongering.” And to critics of consumer drug advertising, Belsomra is a perfect example of these practices at work.

Out Here, No One Can Hear You Scream
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, WhySoAwake.com, 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 BeyondTired.org, 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.”

Merck’s Belsomra commercial.
The insights about separate sleep and wake mechanisms represent real scientific advances, as Ian Parker documented in a 2013 account of Belsomra’s development for The New Yorker. Someday, the discovery might even lead to major advances in treatment. But those advances have not yet been made. All of the sleep medicine experts I interviewed emphasized that therapy and behavioral changes remain the best treatments for insomnia. Like most other sleep drugs, Belsomra provides only mild relief. “Clinically meaningless” is the way one sleep expert, Gregg Jacobs from the University of Massachusetts Medical School, described Belsomra’s effects. “Almost none of the patients I see are taking Belsomra because it does not work,” Jacobs said. The best thing I heard experts say about Belsomra was that it was no worse than any of the other drugs out there.

In response, a Merck spokesperson pointed out that in one of its trials, Belsomra patients slept half an hour longer than people taking the placebo. However, the sample for that trial was just 62 people. Larger, more predictive trials found that Belsomra had much weaker effects.

In a January 2016 report, the nonprofit Institute for Safe Medication Practices analyzed more than 1,000 consumer complaints that the FDA had received about Belsomra between February and July 2015—a number the institute described as “substantial.” A large number came from patients who complained that the drug was ineffective. Others reported that they had experienced side effects including sleep paralysis and next-day drowsiness. There were also reports of suicidal thoughts and attempts, two of which were successful. Merck correctly points out that the side effects correspond to the ones the company included on the warning label. There is also no way to definitively prove a link between these particular complaints and the drug, particularly when it comes to the suicides. Still, in its report the institute noted that the trials of Belsomra had not tested the drug’s effect on people taking antipsychotics or antidepressants, even though insomnia is a “key symptom” of depression and anxiety. It concluded, “The preapproval trials of [Belsomra] had so many limitations that it was challenging to draw any valid conclusions about what might happen when a new kind of hypnotic is marketed to a patient population measured in tens of millions.”

Out Here, No One Can Hear You Scream
When drug companies defend their use of advertising, they often argue that it performs a valuable public service. A much-aired commercial might prompt patients to discuss conditions they never knew they had, the logic goes, or reduce the stigma around certain diseases. If you see ads for depression or irritable bowel syndrome every night while eating dinner, you might feel less embarrassed asking your doctor about it. Critics of direct-to-consumer advertising acknowledge these benefits.

But when the people raising awareness about a condition are the same people selling a drug to treat it, some rather obvious problems arise. Ads rarely provide the kind of context consumers need to make good decisions about their health—about how often a drug actually works or whether an alternative treatment might be better. 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.”

Policymakers in Europe and Australia have decisively rejected proposals that allow American-style drug advertising.

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