A watershed moment in the pharmaceutical industry came in 1997 when the FDA made a controversial decision to lift restrictions on direct-to-consumer advertising (DTCA) by drug companies.1 (The U.S. and New Zealand are the only countries that allow it.)2 Arthur Sackler had not lived to see it become a reality. He had found loopholes, mostly prepackaged promotional write-ups placed into the health sections of papers and magazines as if they were news. Sackler had also refined the art of running eye-catching, foldout inserts in national magazines that were likely to end up in the waiting rooms of physicians nationwide. That ad was intended for the doctor, he said when challenged once by a Senate panel. If the physician put the magazine into the patient waiting room, the inserts always had perforated edges, so the doctor could tear it from the magazine. Sackler knew, of course, that no physician could be bothered ripping out drug ads from Time, Newsweek, Family Circle, National Geographic, and Life.3
Until 1962, the Federal Trade Commission had power over drug ads.4 That year, the Kefauver Amendments passed to the FDA the jurisdiction over pharma advertising.5 Direct-to-consumer ads were not an issue to which the FDA paid attention. The concept seemed far-fetched and dangerous. Policymakers believed that consumers did not have the medical expertise to make informed decisions about prescription drugs. Ads would cause confusion and might persuade many to ask for a drug based simply on clever promotion. Only doctors, it was thought, were smart enough to evaluate and cut through overhyped advertisements. When some studies during the 1970s revealed that physicians were not much better than patients at making sense of pharmaceutical advertising, it oddly bolstered the case against allowing the industry to advertise to consumers.6
It took until 1969 for the FDA to issue its first comprehensive advertisement regulations. All prescription ads had to be a “true statement of information” that summarized a “fair balance” of the drug’s effectiveness versus risk.7 The FDA checked all ads, 90 percent of which were run in medical journals, to make certain they were not misleading or unbalanced.8 There was no mention of advertisements to the public.9 There were, however, a couple of small paragraphs that attracted little attention but became important years later. According to the 1969 regs, all ads by phone, radio, or television (there were no TV ads then for drugs) had to include the medication’s side effects “in the audio and visual parts of the presentation.” However, if the drug company could make an “adequate provision” to somehow pass along the side effect information separate from the ad, that was allowed. “Adequate provision” was not defined.10 The second part that seemed unimportant but later proved key were so-called “reminder advertisements,” in which a drug company did not have to mention side effects if it omitted the brand name or did not make claims about safety or efficacy.
Beginning in June 1970, the door to DTCA opened a little with efforts by consumer advocacy groups. The four-year-old National Welfare Rights Organization, an activist group dedicated to expanding government support for the poor, issued the first ever list of “patients’ rights.” Most of the twenty-six “rights” focused on privacy and confidentiality, nondiscrimination for medical services, and community representation on the governing boards of hospitals. Its core message was that patients should be fully informed about their diagnoses and treatment options.11 Two years later the American Hospital Association, representing most of the nation’s hospitals, relied on the language that came from the National Welfare group and adopted the first Patient Bill of Rights. That kicked off a wave of patients’ rights statutes at the state level.12
Several consumer groups, led by Ralph Nader’s Public Citizen and the Health Research Group, petitioned the FDA in 1975 and urged that the agency order that drug labels and inserts be included in all prescriptions dispensed to patients.13 Those package inserts, over which the FDA and drug firms often battled, were only included by pharma companies to pharmacists. Just as it was theoretically the obligation of a physician to know all the risks and benefits before writing a prescription, pharmacists were supposed to summarize verbally all the warning labels and inserts for the patient.
The same year that consumer groups asked the FDA for the right to the drug’s inserts, the nation had its first major “right to die” case. Twenty-one-year-old Karen Ann Quinlan had lapsed into a coma after mixing Valium, Quaaludes, and alcohol. The family sued after doctors refused to turn off her respirator at her father’s request. The often heated ensuing public debate was resolved when the New Jersey Supreme Court ruled for the family and the hospital removed the life support the following year. The debate over Quinlan fueled the growth of patients’ rights movements (she lived another ten years in a vegetative state).
As the Quinlan case had wound through the courts, the FDA held the first of three public hearings about “patient-packet inserts” (PPI). After three years of study, it issued a regulation requiring inserts in every dispensed prescription. Pharma companies expected that ruling since the public testimony and the questions and comments by FDA officials made it clear the government watchdog was in favor of “patients’ rights.” The Pharmaceutical Manufacturers Association immediately filed an administrative appeal and contended that the requirement was costly and an unfair burden since drug companies already provided that identical information to pharmacists. That prompted a one-year delay, until 1979, after which the FDA modified its regulation and limited it only to ten classes of prescription drugs.14
Ronald Reagan had only been president for four months when he appointed a new FDA director, Dr. Arthur Hayes Jr., in April 1981. Hayes took another look at the patients’ package insert rules. Drug firms opposed it. Besides the costs, they argued it was an unnecessary government interference. Physicians were also against it, contending it interfered with the “sanctity of the doctor-patient relationship.”15 Doctors wanted the discretion to decide which adverse effects to disclose, contending that as medical professionals they knew their patients best and that not all side effects were likely. (The FDA later determined that doctors reported only the most serious side effects, sometimes as few as one percent of what they observed.)
Hayes canceled the patients’ package insert program in 1982. The FDA replaced it with a pharma-recommended plan by which the companies voluntarily distributed all required information to patients.16 A British drug company, Boots, had a short run of TV spots in 1981 for its generic competitor to Upjohn’s Motrin. It was the first drug ad on American television. Merck entered the new marketing arena the following year, running a series of “are you aware of the pneumonia vaccine?” ads. Aftermarket research showed that only a small percentage of adults over sixty-five who should get the vaccine even knew about it.
FDA officials were split about television drug ads. One contingent thought that the more information the consumer had, the less likelihood they could be easily misled. Others countered that the 1969 rules had not seriously weighed the benefits and downsides of allowing drug companies to promote their products directly to consumers over TV. Twenty professional medical associations opposed direct television ads. In a poll taken by the AMA, 84 percent of physicians thought it was a bad idea.17
Commissioner Hayes leaned toward okaying DTCA. His only hesitation was whether adding oversight of direct-to-consumer ads to the long list of FDA responsibilities might be too much for the agency to handle. Its 1982 budget was $329 million, while prescription drug sales in America topped $15 billion annually. That did not include the approximately 300,000 heavily promoted over-the-counter products under FDA jurisdiction. A quarter of all FDA employees were in nondrug oversight such as cosmetics, food, medical devices, diagnostic products, and veterinary remedies.18 Ronald Reagan’s 1981 budget cuts had hit the FDA hard.19
Democrats had picked up twenty-six seats in the House in the 1980 election and had a solid majority. Michigan congressman John Dingell, chairman of the House Subcommittee on Oversight and Investigations, set public hearings to examine DTCA.20 Hayes ordered a moratorium on any direct-to-consumer advertising until the subcommittee issued recommendations.
When the hearings got under way, few seemed enthusiastic about DTCA. While there was no surprise that doctors overwhelmingly opposed it, what raised eyebrows were FDA-sponsored studies demonstrating most consumers wanted more drug data but did not think that drug advertisements were the best way to get it. Almost two thirds believed it would be difficult to near impossible to evaluate the risks of a drug in a thirty-second television spot.21 When asked if they felt confident to make an informed decision about whether to take a prescription medication, three quarters said no. Two thirds said they doubted they could tell whether a drug ad was misleading.22 The underlying loss of faith in the drug industry made many Americans skeptical about how pharma might package drugs in advertisements. In a 1966 poll, three quarters of Americans had a “great deal of confidence” in both medicine and pharmaceuticals. That had fallen by half as the DTCA hearings got underway (it bottomed out at less than a quarter of the public by 1990).23
Leading consumer groups, from the American Association for Retired Persons (AARP) to the Health Research Group, asked for a permanent ban on all direct drug advertising in print, radio, and television. Consumers, they contended, deserved more information about the medications they used, but not filtered through a Madison Avenue sales pitch. Spending money on consumer ads could raise drug prices, warned the AARP, and the public would be susceptible to thinking minor drug changes were important ones.
The pharmaceutical industry surprised the subcommittee. Its executives were unified in opposition. Schering’s senior vice president thought it “is not in the public interest”; Upjohn’s chairman said “it would be detrimental to the pharmaceutical industry and, more importantly, a potentially disruptive element in our medical delivery system”; Eli Lilly’s executive vice president said that “drugs embody a complex set of factors,” and direct advertising was “both unwise and inappropriate.”24 The only industry in favor, of course, was the advertising industry. Ad execs tried turning the “lack of sophistication” consensus about the public into a reason for DTCA. It would give the public much more exposure to drug information, they contended. The most creative argument pushed by Medicine Avenue was that a more informed consumer might even help spot diseases earlier.
Dingell’s committee took more than two years to complete its final report, “Prescription Drug Advertising to Consumers.” By the time it was published in September 1984, Arthur Hayes had been replaced at the FDA with a less industry-friendly commissioner, Dr. Frank Young, the dean of the University of Rochester’s medical school.
The subcommittee’s report concluded that “the perils of popularizing prescriptions” and “creating new consumer demand” would lead to “unnecessary prescriptions… and the use of potent drugs by those who do not need them.” Its bottom line was that “if the industry wants a better educated public” there were better ways than through product advertising.25 To most industry observers, that seemed the end of drug companies advertising directly to consumers.
In 1985, Commissioner Young startled just about everybody by lifting the moratorium on consumer ads. He thought it was only a symbolic change. Young directed that any ads to consumers had to meet the same legal requirement as when pharma advertised to physicians.26 Over time the “brief summary” of the drug’s label had become anything but brief. Young thought that made television ads impossible. Only in print might it be possible to include required warning information in a tiny font.
Over the next five years, only twenty-four drug products were pitched to consumers. Most, like Merck’s series to inform seniors about the pneumonia vaccine, concentrated on passing along information, not on a hard sell. Young had promised pharma he planned on taking another look at loosening the ad restrictions, so long as it seemed they were helpful for the public. Before he could do that, Young got tied up in a scandal at the FDA. Congress ordered the Department of Health and Human Services inspector general in 1988 to investigate reports of corruption in the generic approval process. It exposed a cabal of approval officers who accepted hundreds of thousands of dollars in gifts and cash in return for faster drug approvals. In some instances the generic makers had falsified the information to demonstrate they were the biological equivalents of the brand name. Others waited until their drugs were approved and then switched to cheaper coloring agents, fillers, and extenders. That altered their chemical stability of other drugs and made them less effective.27 The Justice Department eventually obtained convictions or guilty pleas from five FDA employees—three approval officers and two chemists—and twenty-four generic company executives, on multiple counts of fraud, racketeering, and obstruction of justice. The scandal prompted major changes in the generic review process, including uniform guidelines and a backup system intended to catch wayward approvals. It also cost Young his job.28
In November 1990, President George H. W. Bush picked David Kessler as the new FDA commissioner. He took charge in the wake of the generics corruption scandal. The FDA was in disarray and veteran employees demoralized. The agency was still coping with the aftershocks of the Reagan-era budget cuts and seemed adrift. Kessler, who had a medical degree from Harvard and law degree from the University of Chicago, was a relentless advocate that the FDA should proactively use its expansive powers to protect Americans from dangerous drugs and reckless pharmaceutical and food companies. He was persuasive, likable, and telegenic. Kessler’s frequent appearances on news programs made him for most Americans the face of a previously anonymous bureaucracy. His tenure was, as The New York Times described it, “tumultuous.”29
Kessler was inexhaustible in politicking on behalf of the FDA. And he seemed particularly energized when he was on the attack during a fight with Big Pharma or Big Tobacco. His critics thought he was a power-hungry self-aggrandizer whose naked ambition would be his undoing.30 However, all admitted he was smart. In the six years before his appointment as FDA commissioner, he taught at both New York’s Albert Einstein College of Medicine and Columbia Law School at the same time he ran a 431-bed teaching hospital.
He was in office five months when he showed how serious he was about getting tougher on the accuracy of food labels. Federal agents swooped into a Minnesota warehouse and seized two thousand cases of Procter & Gamble’s “Fresh Choice” orange juice because it “was misleading since it was made from concentrate.” Kessler told a food industry conference, “The time has come to end the din of mixed messages and partial truths on food labels in this country.”31
His FDA predecessors had always amicably resolved such labeling matters by correspondence. They never contemplated going after a $3 billion food and beverage company just to “make a point.” But for Kessler, that was the point—only by going after a giant like P&G would the rest of the industry pay attention.
The moratorium he supervised on silicone breast implants kicked off thousands of lawsuits that ultimately forced Dow Corning to file bankruptcy.I32 The following year he set the supplement and vitamin industry on fire by trying to regulate their products for safety and efficacy (Congress put an end to any possible meddling by the FDA by passing the Dietary Health and Education Act of 1994; it explicitly separated supplements from drugs and food additives). And he caused a furor when he tried extending the FDA’s jurisdiction to the promotion and labeling of tobacco.33
When it came to the question of direct-to-consumer drug ads, Kessler realized that his predecessors had kicked it down the road. He wanted to update the FDA’s 1969 ad rules. He instinctively tilted toward consumer protection and was skeptical that slickly packaged Madison Avenue ads could ever be genuinely informative. Kessler believed they were just another tool in pharma’s promotional arsenal to make Americans buy more medications.
He did not favor an outright ban without studying it more. Kessler was sensitive that patients wanted more transparent medical data. He did not want the FDA to appear out of step with the changing times by denying information to consumers. A couple of thousand patient advocacy groups, most of them disease-specific, lobbied Congress for everything from rights to privacy over medical records to increased research funding for diseases to easier-to-understand consent forms for surgery.34 And being a more informed patient was undoubtedly getting easier. America Online, Microsoft Network, and CompuServe were all fairly rudimentary online services when they got under way in the 1980s, but by the mid-1990s, surveys showed that consumers were searching for medical information online and visiting their doctors armed with a list of questions.35
Kessler increased the budget of the department that regulated drug advertising. In November 1994, any reform strategy he had envisioned was derailed. The Republicans swept to power in Congress. The new Speaker of the House, Newt Gingrich, attacked Kessler and the FDA and charged that it deliberately failed to approve good drugs and promising medical devices. That discouraged innovation, charged Gingrich, who called the FDA the “number 1 job killer.” As for Kessler, Gingrich called him “a bully and a thug.”36 Gingrich even floated a plan that would have privatized the drug approval process and taken it away from the FDA.
A growing number of pharmaceutical firms wanted to run more direct-to-consumer ads. They were frustrated by the 1969 rules that had not contemplated television. What had prevented TV ads was the requirement that companies pass along a substantial part of the drug’s warning label. They were so long that it would eat up most of the airtime. Pharma firms thought that fundamental limitation meant any campaign would be ineffective.
In 1996, Schering-Plough developed a groundbreaking television advertisement for Claritin, its just released prescription allergy medication. The thirty-second spot had attractive people skipping through a field of flowers. A man and woman talked over each other to an upbeat soundtrack: “Claritin. It’s time. It’s time. Don’t wait another minute for Claritin. Claritin, I’ll ask my doctor. It’s time to see your doctor. At last, a clear day is here. I want to know more about Claritin. Ask your doctor for a trial of Claritin and for free information and a $5 coupon toward a prescription for Claritin. Call 1-800-CLARITIN.”
Schering-Plough’s ad had everyone asking, “What is Claritin?” A poll by the New York Post showed most people thought it was an antidepressant since everyone seemed so happy. That spot received accolades from Madison Avenue. It also challenged the FDA. Would Kessler shut the door for all direct ads or would Schering’s spot force him to loosen the regulations?
While an FDA special committee considered that, Kessler surprised all of Washington by announcing his resignation in January 1997. He said it was for “family reasons.” That was true. His wife, Paulette, had implored him for months to quit. Watching him get “ripped to shreds for all the negative editorials, it gets wearing,” she told reporters.37
With Kessler gone, drug companies that had opposed direct-to-consumer ads suddenly lobbied the FDA to relax the regulations. Upjohn and Pfizer led the charge. The successful introduction of Rogaine for Upjohn and Viagra for Pfizer had changed their minds about the potential value of advertising to consumers. Several other pharma firms had well-known drugs—Tagamet, Zantac, and Pepcid—that were about to go off patent and then on sale over the counter.38
In the summer of 1997, the FDA made a landmark ruling. Instead of banning direct to consumer ads, the agency relaxed the guidelines and made it easier for television advertisements. There was no longer a requirement to explain the warning label. The ads would have to direct viewers to a toll-free number, a website, even a magazine ad.39 The pent-up demand in the pharmaceutical industry for TV advertising exploded. “Ask your doctor,” one of the lines from the breakthrough Claritin ads, became a widely used tagline in many of the new spots.
Veteran Madison Avenue ad men recall that the drug companies inundated their agencies with demands to get their products on TV. The FDA ruling, however, had caught the advertisers off guard. Even agencies such as Arthur Sackler’s McAdams or William Frohlich’s shop were not sure how to adapt their traditional print and direct mail campaigns to a quite different medium. Since buying ad time was so expensive, no company wanted to pay for agencies to learn on the job. Still, pharma was shelling out a lot of money to pitch its best products on TV. Just before Kessler left the FDA in 1997, there was about $35 million a year in DTCA ads. A year after the rule change, it was $1.17 billion, almost all in television campaigns.40 The evidence that the torrent of money had caught the ad industry unprepared is that in the first few years there were a lot of bad ads.41 There were talking stomachs, Abe Lincoln at a playground with beavers, Andrew Jackson praising a wonder ointment, even eerie animated characters that morphed into toenail fungus.
Consumer activists complained that the ads relied on celebrities and were heavy on imagery and light on information. In the battle over elevated cholesterol, for instance, Bristol-Myers used Kirk Douglas, Sylvester Stallone, and Angela Bassett for Pravachol, Merck relied on Atlanta Falcons head coach Dan Reeves for Zocor, and Pfizer picked Olympic figure skater Peggy Fleming for cholesterol-lowering Lipitor. Football great Joe Montana pitched Novartis’s Lotrel for hypertension against Jack Nicklaus for King’s Altace. Debbie Reynolds had the overactive bladder market to herself as the face of Pfizer’s Detrol.42 In the 2004 Super Bowl, two of the three erectile dysfunction drugs faced off against one another, one with ex–Chicago Bears coach Mike Ditka and the other featuring former senator Bob Dole.
Ad companies realized that sometimes celebrityhood gave the appearance of authority and expertise consumers wanted. Bayer’s sales of branded aspirin increased by 30 percent after it hired America’s most trusted family doctor: television’s Marcus Welby. Robert Young, who had played Welby for seven hit seasons, appeared in his white lab coat and gave the disclaimer, “I’m not a doctor, but I play one on TV.”
Schering-Plough signed Good Morning America’s co-host Joan Lunden, herself an allergy sufferer, for a $40 million Claritin campaign. She appeared in ads reading copy that made it appear as if she were simply the likable morning anchor presenting the news. Claritin’s sales soared 50 percent that first year, to $2.3 billion (it stayed over $2 billion annually until it lost its patent in 2002).43
Pfizer mastered the new medium for Lipitor, its cholesterol-lowering statin that became part of its product lineup after it bought Warner-Lambert in 2001 for $90 billion.44 Although Lipitor was late to the cholesterol-lowering drug market—Merck’s Mevacor and Zocor were billion-dollar drugs for almost a decade by then—Pfizer set aside a stunning $258 million for promotion and hired Robert Jarvik as its spokesman. Time called Jarvik a “national hero” when it put him on its 1982 cover after the first successful transplant into a patient of a self-contained artificial heart. The Lipitor ads portrayed Jarvik as the inventor of the artificial heart and as a busy medical practitioner who dispensed Lipitor to his patients. They ended with him disclosing that he used the drug himself. Lipitor was on its way to being the pharmaceutical industry’s most successful drug ever, with more than $15 billion in sales in a single year. The problem revealed in a later congressional investigation was that Jarvik, it turned out, had graduated from medical school but never got a license to practice. He was not a cardiologist and never prescribed the drug to anyone. He had taken it himself, but only briefly. And in some ads in which he was shown paddling a canoe, it was a body double. He was one of several medical engineers responsible for the artificial heart, not its inventor. By then, Pfizer had run the ads for five years.45
AstraZeneca decided it did not need to pay a celebrity or package someone as an authority. It used the capsule’s color to sell Prilosec, the market’s first proton-pump-inhibitor (PPI) to combat acid reflux. It became a megahit through a campaign that branded it only as “the little purple pill.”46 One of the most popular ads was a swarm of giant purple pills gently falling out of a brilliant blue sky, like a rain of candy from the heavens. The drug’s name was never mentioned. Prilosec was released in 1996. By 2000, AstraZeneca had spent $108 million in direct-to-consumer ads. Prilosec’s sales were $4.1 billion, the company’s biggest ever seller.
What did AstraZeneca do when Prilosec’s patent expired the following year? It sold Prilosec over the counter and rolled out Nexium as its prescription replacement. The FDA had approved Nexium although it was essentially Prilosec. The only chemical alteration was it did not have one of Prilosec’s less important mirror-image isomers. The drugs worked almost identically and clinical tests repeatedly demonstrated that the equivalent dose of each had the same efficacy.47 The only visible difference to the public was that Nexium was a brighter shade of purple than its predecessor.48
AstraZeneca knew, however, that there was an important difference between the two pills. Nexium, at $4 each, cost 600 percent more than the over-the-counter Prilosec.49 Its $200 million ad campaign worked. Consumers moved to Nexium. It became a billion-dollar drug faster than any other medication in the ulcer and acid-reducer class. Nexium stayed on top of that drug category for a decade, puzzling many industry analysts who thought it was “ripe for price competition” since there were so many inexpensive rival generics.50 Consumer groups filed dozens of lawsuits against AstraZeneca, claiming its advertising was false since it marketed essentially the same drug under a different name and color shade. AstraZeneca prevailed on all cases, although it took a decade. The company’s defense rested on the FDA approval of Nexium as a stand-alone drug.51
Who was vetting drug ads for their accuracy? No one, it turned out. The pushback against direct-to-consumer promotion reached a crescendo in 2004 when Merck pulled the ads for Vioxx, its hit painkiller (figure skater Dorothy Hamill, an arthritis sufferer, was the drug’s face on TV). The nonsteroidal anti-inflammatory COX-2 inhibitor was at the center of a scandal about how the company had ignored warnings that its drug increased the risk for heart attacks and strokes. Its aggressive marketing of Vioxx for treating menstrual cramps, osteoarthritis, and muscle pain had turned it into a $2-billion-a-year pill since its 1999 release.52 Merck yanked it from the market just days before the FDA issued a mandatory recall. Vioxx broke Merck’s perfect record of never having had a drug recalled.II53
The Vioxx scandal prompted a concerted pushback against consumer drug ads. Bristol-Myers announced they would voluntarily withhold any direct-to-consumer ads for its new products. David Kessler, now the dean of the Yale School of Medicine, directed his words to the executives who had done their best to undermine him when he was at the FDA: “Your companies likely will face lawsuits eventually about the claims they make for their products in television commercials. One day in a courtroom, I assure you, one of you is going to have your DTC ads played.”54
There were calls from consumer groups that another moratorium be put on all direct drug ads. The FDA considered a one- to two-year freeze while it conducted hearings. Instead, in only two months, the agency bowed to industry pressure. The FDA issued only some minor revisions to its guidelines. The one it touted was that it had protected America’s children by ordering that erectile dysfunction medications only be advertised between 10 p.m. and 6 a.m.55 Activists dismissed that as inconsequential and predicted the FDA’s surrender would reinvigorate pharma’s appetite for TV ads. Not even the consumer activists could have imagined that in a few years there would be $200 million annually in cringe-worthy ads for incontinence and overactive bladders.56
I. Three independent government reviews later concluded that there was no link between silicone breast implants and any autoimmune illness. The moratorium was lifted after sixteen years.
II. As the Vioxx scandal worsened—faked results in some of the clinical trials and senior executives who buried alarming reports about adverse effects—Merck faced hundreds of class action lawsuits. It ultimately settled most of them in 2007 for $4.85 billion, and then paid another $950 million in 2011.