iz Moench thought it was obvious. During her job interview with Boots Pharmaceuticals in 1981, at its Shreveport, La., offices, the 23-year-old Moench asked company president John Bryer to describe the drug maker’s main customers.
“Doctors,” Bryer said.
Moench was surprised. “Why isn’t it the consumer?”
She got the job, and the rest is history. On May 19, 1983, Boots aired the first broadcast television commercial in the United States for a prescription drug, the pain reliever Rufen.
STAT has obtained a version of the ad and is posting part of it online for the first time.
Within 48 hours of the ad’s airing, the federal government told the company to take it down. And more than 30 years later, the fight over marketing prescription drugs directly to the public is still raging.
Now, the American Medical Association, the largest doctors group in the United States, wants to stop direct-to-consumer advertising for prescription drugs in the belief that the ads encourage patients to seek medicines unnecessarily. But the effort to have drug ads banned alongside tobacco ads will face plenty of obstacles, none bigger than the First Amendment. Perhaps the most unusual thing about this decades-long saga is that it’s an issue at all.
The United States is one of only two countries in the world to allow these ads. How did this little-noted example of American exceptionalism come to be?
It started with Boots.
The 1980s was an era of emerging consumer civil rights. People were taking greater charge of their health care decisions. Just two years earlier, in 1981, Merck debuted the first direct-to-consumer print advertisement, promoting its pneumonia vaccine. But Boots was the first to tap into the awesome potential of television broadcast advertising.
“It seemed so obvious that this was an industry that had missed its mark in engaging the people who were consuming their products,” Moench, now a senior vice president at BioClinica in Pennsylvania, said in an interview.
It wasn’t obvious to everyone. At the time, the FDA’s regulations for how drug makers could advertise their products hadn’t been updated since the 1960s.
“No one who was promulgating regulations in the late 1960s anticipated TV ads,” said Julie Donohue, a University of Pittsburgh health policy professor who is one of the top researchers of direct-to-consumer advertising. The drug companies had long focused their marketing instead on doctors, as Bryer had told Moench in her job interview.
Boots consulted Alan Kaplan, a Washington lawyer who had previously worked at the FDA, to test out the idea. Kaplan arranged for Moench and Boots executives to meet with three top FDA officials at the agency’s Bethesda, Md., headquarters a month before the ad went on the air.
“They were not prepared for the meeting nor could they rule on behalf of FDA,” Moench said. “I don’t think they could fathom the idea that there was an ability to go direct-to-consumer.”
Two FDA officials who attended the meeting told STAT they weren’t shocked by the idea of a drug company wanting to air a TV ad. But they acknowledged that they weren’t sure what to expect.
“Nobody knew what these ads were,” said Lou Morris, who helped oversee the agency’s drug promotion office. “We didn’t know what type of format they would take.”
The federal officials reiterated that the ad needed “fair balance,” the standard for an accurate assessment of a drug’s risks and benefits that governed other drug promotions. Moench’s takeaway was: Air the ad and then we’ll see.
So Boots did, and it quickly ran into trouble. Within two days, the FDA sent a cease-and-desist letter to the drug maker to stop airing the ad, Moench said. The agency asked for a few small revisions, Morris said, and then let the ad go back on the air — for a time.
On the guidance of the firm’s attorney, the ad never made any specific medical claims about its pain reliever. It simply told viewers that if they were taking ibuprofen — Motrin was the biggest brand name at the time — Rufen was available cheaper.
“You had to be a user of that drug to even know what the ad was talking about,” Moench said. “We trod very carefully.”
But, meanwhile, FDA officials had other drug companies knocking on their door, asking to air their own ads. Morris and Peter Rheinstein, another top FDA official at the time who was overseeing drug advertising, recalled one proposed ad for a diuretic that angered then-FDA commissioner Arthur Hayes.
The never-aired spot — dubbed “Dolores” — involved a firefighter making some suggestive comments, implying that the diuretic being advertised didn’t have the negative sexual side effects that some other similar drugs did.
Hayes “was pretty offended,” Rheinstein said. “It was that proposal, which was made in the commissioner’s office, that led to” the FDA issuing an official policy statement in September 1983, following an informal plea from Hayes earlier in the year, calling for a voluntary moratorium on direct-to-consumer ads until the agency could figure out what to do.
“We were really concerned about what would these ads look like,” Morris said. “Would it trivialize people’s view of what a prescription drug is? How much would they play on emotion as opposed to rational positive benefits?”
Ironically, at the time, Donohue said, after Hayes asked about their intentions, drug makers told Hayes that they weren’t that interested in ads for average people.
“Almost all of them said, ‘No, that would be a terrible idea,’” Donohue recalled. In a 1984 letter to then-Representative John Dingell of Michigan, who had inquired about direct-to-consumer advertising, an Eli Lilly executive said that it would be “both unwise and inappropriate.”
They reached a détente of sorts: The FDA said in 1985 that drug makers could air ads, but they also had to follow rigid rules for disclosing side effects and other information. That made the kind of ads we see today — specific health claims by specific drugs — implausible. It also meant Big Pharma wasn’t racing to put out a lot more TV ads.
But in the mid-’90s, Schering-Plough and others started poking another hole in the dam.
The company put a huge television campaign for Claritin on the air. It was cautious: The ads still never actually said what Claritin was for. One of the ads implored viewers, again and again, to see their doctor.
“It’s time,” said a sunny voice matching the sunny visuals.
The FDA had already started to reexamine its policies on television ads, but many experts credit the Claritin ad and others like it with forcing the agency to act.
The FDA decided in 1997 to relax its rules. In their TV spots, drug makers could now refer viewers to print ads, offer 1-800 numbers or websites, and urge people to talk to their doctor if they wanted that additional information that the FDA had previously required for TV ads, too, if they promoted particular drugs for particular conditions. That let drug makers air more detailed ads that made specific medical claims for specific drugs, the kind that now dominate airwaves.
“All of these changes together created a market situation where the industry wanted to move in this direction,” said Meredith Rosenthal, a health economist at Harvard University who has studied direct-to-consumer advertising, “and they basically pushed regulators to clarify these issues.”
The industry had won. Spending on all direct-to-consumer advertising ballooned from $360 million in 1995 to $1.3 billion in 1998. By 2006, it hit $5 billion, and most of that was on television commercials.
What all this has meant for health care is still a matter of debate. The drug industry points to research that shows consumer ads lead people to talk to their doctors and get treatments they need. But it’s also worth remembering that “lifestyle” drugs — erectile dysfunction being the quintessential example — are usually the kind of medicines promoted directly to the public.
“There’s always been a healthy skepticism,” Donohue said. “But so far, there isn’t strong evidence that (direct-to-consumer advertising) is having terrible effects on public health.”
There are some cautionary tales, however.
The anti-inflammatory drug Vioxx, which Merck put on the market in 1999, was famously promoted in a 60-second spot that featured figure skater Dorothy Hamill explaining how the drug had helped her overcome her osteoarthritis.
Five years later, Merck pulled the drug off shelves because of concerns about increased risk of heart attack or stroke. By that point, Vioxx was bringing in $2.5 billion in annual sales.
Congress was outraged. Hearings were held.
“These ads almost certainly encouraged the unnecessary use of these drugs,” Senator Ted Kennedy of Massachusetts told one panel. “Patients saw an ad, asked their doctor about them, and started taking them, even though another drug might have been just as effective. How many of these patients suffered a stroke or heart attack, or died because of it?”
In 2007, Kennedy worked with Wyoming Senator Mike Enzi, a Republican, to propose huge new restrictions on drug ads: The FDA would be allowed to prohibit advertising on drugs for two years.
But they ran into a big problem, the same one the American Medical Association will likely face as it tries to ban TV drug ads: the constitutional right to free speech.
For better or worse — some scholars argue worse — the modern-day Supreme Court considers commercial speech (i.e. advertising) to be highly protected by the First Amendment. It isn’t clear that, even if they were to convince the FDA or Congress to take action, opponents of direct-to-consumer advertising will be able to overcome that legal barrier.
More practically, those who were there at the beginning of mass-media drug advertising think that it’s too late to roll it back. It’s a part of the American landscape now.
“That ship has long sailed,” Moench said.