BY CHARLES C. MANN AND MARK L. PLUMMER
ON A RECENT MONDAY EVENING DAN RATHER FINished summarizing the day’s outpouring of horror and tragedy and was replaced in viewers’ eyes by a man of journalistic aspect standing before a newspaper printing press. “I’ve been writing a lot of stories about aspirin lately,” the man said in a confident voice. “But if you think you’ve heard all about it, think again.”He flourished a newspaper with a story headlined “A BETTER ASPIRIN FORMULA.” Then came a graph. A white line indicating the Pain Relief Level of regular-strength aspirin crawled along the bottom. Then, rising majestically above it, came the yellow line of Anacin. “Anacin,” an announcer said, while teletypes clattered in the background. “A better aspirin formula.”
From a cursory viewing one would not learn that Anacin’s “aspirin formula" is simply aspirin plus caffeine— about as much caffeine in each tablet as is in a third of a cup of coffee. Or that the Food and Drug Administration has for ten years refused to confirm that caffeine enhances the power of aspirin, which suggests that the “aspirin formula” is in effect just aspirin. Or that the difference in Pain Relief Level may simply reflect the fact that each Anacin has 23 percent more aspirin than a regular-strength aspirin tablet. Or that similar claims for its products have given Anacin’s manufacturer, the large and secretive American Home Products Corporation, of New York City, a history of trouble over claims of false advertising that is unsurpassed, as ad people might say, for length and complexity.
Since its invention, by a Minneapolis pharmacist in 1916, Anacin has made millions upon millions upon millions of dollars by the simple but ingenious practice of pretending that it is made not of aspirin but of something else—say, “the pain reliever doctors recommend most.” Now, the illusion that Anacin is substantially different from other aspirin products can be fostered only through the use of what Mark Twain called “stretchers"—stories which, while not being untrue, do not tell the whole truth. American Home has over the years paid for more than half a billion dollars’ worth of advertising, much of it falling in the category of stretchers. The sum seems enormous until one considers the profit to be made from relieving pain.
Headaches are not subject to fashion. Year after year people stock their medicine cabinets with headache remedies, and year after year companies tell stretchers to get their brands in those medicine cabinets. Last year Americans bought $2.1 billion worth of non-prescription pain relievers. This is fully a quarter of the over-the-counter drug market, and more than the total for shampoos, deodorants, toothpastes, or any other single category of health and beauty products. (The sales of prescription drugs last year amounted to $16.5 billion, a total divided among many types of drugs other than pain relievers.)
Americans take more than 80 million aspirin tablets a day, and that figure doesn’t include the other two non-prescription pain relievers: acetaminophen, of which Tylenol is the most popular brand in this country, and ibuprofen, of which Advil and Nuprin are the most popular brands. All three are known as analgesics. The price of an analgesic tablet is roughly ten times the cost of its active ingredients, which leaves a hefty margin for packaging, distribution, advertising, and, of course, profit.
For the overwhelming majority of buyers, these many fine products are identical in terms of treating headaches. “They all make your basic headache go away equally well,”Stanley Wallenstein, an analgesics researcher at the Memorial Sloan-Kettering Cancer Center, recently told us. “It’s like putting in a tack—a tack hammer and a sledgehammer do the same thing.”The lessons of Econ 101 predict that companies faced with this situation will seek a competitive advantage by lowering their prices until a giant jar of aspirin sells for less than a Bic pen. But the lessons of Econ 101 alone are wrong in this case. Not until Econ 102 do they talk about marketing.
Because few companies have run successful advertising campaigns whose theme is that their products are exactly the same as their competitors’, the makers of analgesics have long sought differences, and have sometimes found them in the most unlikely places. And because firms that run unduly creative advertising put their competition at a disadvantage, the analgesic companies tend to sue and be sued over their claims—a situation that brings us back to Anacin and American Home Products.
A remarkably prosperous enterprise, American Home was run for decades by a man named William F. Laporte, who has cut a wide swath through the world of consumerproducts marketing. Laporte joined American Home in 1938 and became the president of the company in 1960, running it with legendary frugality until 1981, when he retired to the board, from which he is said still to exert considerable authority. During Laporte’s years at the helm, according to various published reports, American Home’s corporate fleet consisted of one used bus; Laporte personally authorized all non-budget expenditures over $500; and the executive restrooms were equipped with narrowwidth toilet paper that saved the firm many pennies. Another hallmark of Laporte’s tenure was the firm’s endless legal difficulties. As it happens, 1960, the year of Laporte’s ascension to the presidency, was the last year one bunch of lawyers or another was not investigating Anacin for or charging it with false advertising.
The following year the Federal Trade Commission brought charges of false advertising against American Home, Sterling Drug (which makes Bayer), Bristol-Myers (which makes Bufferin and Excedrin), and Plough (a smaller player, which makes St. Joseph’s aspirin), all of which claimed to make aspirin that was somehow better than other aspirin. One lump of aspirin being chemically identical to any other lump, the FTC thought that such claims must be untrue. The aspirin companies fought, and the FTC withdrew the complaints—only to try again, with more complaints. And again, with more. And again. The FTC and some of the parties were still sending reams of photocopied documents to the Supreme Court well into the 1980s, when the first replacements for the first lawyers had long since been replaced and few indeed could recall exactly why and how the first complaints had been brought.
But even as the FTC cases contributed to the growth in Xerox’s stock, the focus of attention switched to another American Home battle, this one a decade-long series of suits involving Johnson & Johnson, the makers of Tylenol, in which each company accused the other of deceiving the public through false advertising. One of the suits is so grandiose in scale that it has been split into three separate subsuits, merely one of which involved an attempt by Johnson & Johnson to collect $1.1 billion from American Home for its allegedly pernicious actions—such actions, of course, being mainly the sale and advertising of Anacin in ways that made Johnson & Johnson unhappy.
We were amazed by the records of these multiple battles when we stumbled across them a while ago. Indeed, we came to realize that the tale of the analgesic wars provides a pocket history of advertising in America, a case study in government regulation which should be dispiriting to those who believe in its efficiency, and a picture of entrepreneurial drive that should give pause to those who want to see more of it. When we called American Home to elicit Laporte’s reaction to our enthusiasm, the switchboard operator said she would put us right through. A man with a growly voice picked up the phone.
GROWLY VOICE: Yeah?
ASPIRIN REPORTERS: (startled) Mr. Laporte? Hello, we’re doing a story for—
G.V.: I don’t talk to press-titutes.
A.R.: (slow on uptake) Huh? Prostitutes?
G.V.: Press-titutes! Get it? Press-titutes! [Click.]
The Empire Built of Headaches
TO COPE WITH THEIR headaches our ancestors tried a variety of remedies, ranging from mudpacks to the ministrations of a spiritually inclined person who chanted and threw colored dust on the fire. Even in the eighteenth century treatment remained primitive. If you were unlucky, your splitting headache might be treated by the application of a leech to lessen the “pressure" on your brain. One folk remedy, however, did work: the bark of the white willow tree, Salix alba. Since Hippocrates people have been championing the virtues of chewing willow bark, the most widely noted such incident having occurred in 1763, when one Edward Stone, a clergyman in Chipping-Norton, Oxfordshire, reported that he had persuaded fifty feverish people to take some powdered willow bark in water, tea, or beer, to what is now called antipyretic effect—their fevers went away. The pace of scientific research being more leisurely then than now, some six decades passed before chemists managed to isolate the active ingredient. It became clear that willow bark is chockablock with salicin, which is not far, chemically speaking, from salicylic acid, which in turn is closely related to acetylsalicylic acid, CH3COOC6H4COOH, also known as the pain reliever doctors recommend most.
As the name indicates, salicylic acid is an acid—and, it happens, a fairly strong one. European users who bought bottles of it in the late nineteenth century had to wash it down with something else to avoid burning their mouths and throats, and once down the hatch the drug gave people the impression that their bellies were “crawling with ants.”By the standards of our era, salicylic acid was an unsatisfactory means of pain relief: it cured your headache, lowered your fever, and eased the aches of your arthritic fingers, but it also made you violently sick to your stomach.
Despite its unpleasant side effects, salicylic acid was sufficiently popular that in the 1890s a fertilizer, dye, and explosives firm, Friedrich Bayer & Company, assigned several researchers to look for a more palatable version of it. (This was not the American Bayer, which did not yet exist, but a German firm, pronounced By-er.) One of the Bayer researchers was a dye chemist named Felix Hoffmann, whose father, according to legend, was cruelly afflicted with rheumatism. The old man is said to have taken so much salicylic acid that he developed horrible ulcers; he begged young Felix to find him some relief. Hoffmann searched the literature and discovered that, years before, an Alsatian chemist had “acetylated" salicylic acid, which process rendered it much less acidic. After making up his own acetylsalicylic acid, he found that first he and then his father could take the stuff without harm.
Excited, young Hoffmann passed the discovery on to his supervisor, Heinrich Dreser, the head of Bayer’s industrial pharmacological laboratory, for further testing. Dreser had previously developed a substitute for morphine, the potent anesthetic, which was regarded as undesirable because it was addictive. Dreser called his new product Heroin. Heroin proved fabulously popular among doctors, many of whose patients came back for repeat doses, and pharmaceutical houses distributed thousands of free samples. Dreser studied acetylsalicylic acid and published his results in 1899, without so much as a word about Hoffmann. The drug was christened “aspirin.”
The simplest explanation for aspirin’s huge and immediate worldwide success is that it was one of the first patent medicines that worked and did not have a host of nasty side effects. Within a decade aspirin was being stocked by pharmacies from Moscow to Minneapolis, and the Bayer family had become rich beyond measure. Dreser received a royalty from Bayer for any new product that he developed. His royalty for aspirin grew so large that he was able to retire early. Hoffmann was apparently less fortunate. His contract with Bayer provided him with a royalty on any invention of his that was patented, but the failure of aspirin to win a patent in Germany seems to have blocked him from getting rich on it.
Bayer was part of the Dreibund, a big German chemical cartel. To stay competitive in the U.S. chemical market, most cartel members manufactured chemicals in German factories and staffed their small American offices with salespeople only—the type of salespeople who, as one history delicately puts it, “did not shrink from unscrupulous marketing methods.”In 1916 the Dreibund became part of the Interessengemeinschaft der deutschen Teerfarbenfabriken, an even bigger German chemical cartel then regarded in this country with the sort of warmth and approval that is today awarded to OPEC. The Bayer family had grandiose plans. With aspirin profits they built a factory complex in upstate New York, which sprawled over an astonishing seventy-five acres, the biggest such complex in the nation and the envy of rivals in the chemical industry including Herbert Dow and T. Coleman du Pont. In 1916 Bayer had sales of more than $6 million—a fortune for the time. It was the Empire Built of Headaches.
Bayer’s hold on the U.S. analgesic market was ended by the First World War. In 1917 Congress passed the Trading With the Enemy Act, which allowed the government to confiscate and auction enemy-owned property. (The proceeds were to be returned to the original owners after the war; unsurprisingly, payments were slow—extremely slow.) The transfer of Bayer’s ownership was supervised in December of 1918 by the newly appointed Alien-Property Custodian, A. Mitchell Palmer, who later became Attorney General and gained notoriety as the leader of the “Palmer raids,” which imprisoned some 3,000 hapless aliens and “subversives” (including Emma Goldman) during the Red Scare of 1919-1921. After lively bidding from half a dozen firms, the business was bought for $5.3 million by the Sterling Products Company, of Wheeling, West Virginia. A big patent-medicine outfit that was started in 1900 to sell a now-forgotten salve called Neuralgine throughout the West Virginia countryside, Sterling was willing to pay more for Bayer—the pronunciation was Americanized in this period to Bay-er—than such well-known firms as Du Pont and Paine, Webber. The price was a good one, for over the years Sterling, too, made a fortune from Bayer Aspirin, despite the expiration of the original U.S. patent on the drug in 1917 and the loss of the trademark “aspirin” in 1921.
In view of the money involved, Sterling was willing to face head-on the downside of the analgesic industry: bitter competition. By the 1930s more than a thousand brands of pure aspirin were being sold, together with an unknown number of compounds of aspirin and such other drugs as quinine and caffeine. One of the most prominent competitors was Anacin, which in the 1920s was bought from its creator by some people who knew about advertising. Sales increased in that decade almost a hundredfold as An-A-Cin (its sometime name) proclaimed itself a product that could be “administered to otherwise normal children for prompt relief.” Other, more fanciful claims attracted challenges from the American Dental Association and the Food and Drug Administration; Anacin survived them, and in 1930 was bought again, this time by American Home.
Created as a holding company for the makers of household, chemical, and pharmaceutical products, such as Hill’s Cascara Quinine and Petrolagar, an unguent of alleged medicinal properties, American Home was comfortable with the aggressive promotional style of Anacin. Indeed, the drug ran afoul of the Federal Trade Commission in 1944 for its familiar claim that Anacin was a special “combination of highly proven and active ingredients,” the implication being that Anacin was different from (and better than) aspirin. The FTC, however, dismissed the case on the curious grounds that the Anacin Company had been officially dissolved, even though its parent company, American Home, remained sufficiently intact that twenty years later the FTC would haul it into court on more or less the same charges. American Home should not be unfairly singled out, however; the FTC went after many aspirin companies, including Sterling Products, which advertised in the 1930s that “anyone can take Bayer” at any dose, for “it cannot possibly hurt you.” The company also alleged that aspirin could be used as a sleeping pill.
When Laporte became the president of American Home, the company adopted the lowest of low profiles. It never marketed products under its own name (Anacin, for instance, being sold by Whitehall Laboratories), had no public-relations staff, and even had the switchboard in its headquarters answer the phone with the telephone number rather than the name of the company.
The low profile did not extend to the company’s products. In I960 American Home spent more than twelve million pre-inflationary dollars to trumpet the marvels of Anacin.
ANNOUNCER:. . . Anacin has a combination of ingredients to relieve pain fast, calm jittery nerves fast, relax tension fast!
WOMAN: (sigh of complete relief) What relief!
ANNOUNCER: Anacin for fast, fast relief!
Anacin was by no means alone. That year its principal competitors, Bufferin, St. Joseph’s, and Bayer, spent more than $17 million on similar advertising. Bufferin, another aspirin product, claimed that it was “twice as fast as aspirin.” St. Joseph’s said that it was “faster than other leading pain relief tablets.” And Bayer insisted that it brought “fastest relief!” With so many mutually exclusive claims on television, it is a wonder that it took so long for any of the companies to get into serious trouble.
“WHAT IS TRUTH?” PILATE ASKED, AND PROVIDED grist for the mills of philosophers ever since. In our day few have wrestled harder with the devils of epistemology than the people charged with figuring out exactly when an advertisement is telling the truth. Advertisements persuade and sway, impress and influence, and every now and then they use, in the words of a judge on the Second Circuit Court of Appeals, statements “acknowledged to be literally true and grammatically correct [that] nevertheless [have] a tendency to mislead, confuse or deceive.” Consider, for example, a well-known commercial for Tylenol, the brand of acetaminophen made by Johnson & Johnson. The actress Susan Sullivan, of Falcon Crest, says, “Last year hospitals dispensed ten times as much Tylenol as the next four brands combined. If hospitals use Tylenol, shouldn’t you?” The claim is perfectly accurate, although the hospitals choose Tylenol not least because Johnson & Johnson supplies it to them so cheap that they are in effect paid to use it. It seems possible, however, that a viewer might gather that hospitals use Tylenol instead of the next four brands solely because it is more effective. Does that mean the advertisement is untruthful in some broader sense? If the answer is yes, this implies that truth is in the eyes and ears of the beholder. But are beholders skeptical or credulous? Is an ad false if it hoodwinks a blockhead but is transparent to brain surgeons and rocket scientists?
Such questions are by no means rhetorical; in a hermeneutic exercise worthy of Heidegger and Husserl, American Home Products decided that the Johnson & Johnson ad, though correct, was not true—and sued. At the same time, American Home was running a commercial for its product Anacin-3. The Anacin-3 commercial claimed that hospitals “recommend acetaminophen, the aspirin-free pain reliever in Anacin-3, more than any other pain reliever.”Here, too, the claim was accurate. In fact, it was the same claim that Johnson & Johnson made in its commercial, for the analgesic dispensed by hospitals is, of course, Tylenol. Does that mean that the American Home ad was not true? (Johnson & Johnson thought so; it countersued.) Does it also mean that if American Home Products had won its suit, the company should have been forced to yank its own ad off the air?
The FTC Steps In (And Around)
ESTABLISHED IN THE TRUST-BUSTING ATMOSPHERE of 1914, the Federal Trade Commission is charged with preventing “unfair or deceptive acts or practices in commerce,” which means, among other things, ensuring that America’s advertisers—such as the analgesic companies—do not deceive the public. (Originally the FTC was supposed to protect competition, not the consumer directly. This led to aberrations like FTC v. Raladam, in which the agency sued a firm that sold an obesity cure made of “desiccated thyroid” and other substances that would, the company claimed, safely melt away excess flesh. Although the medicine was bogus and even dangerous, the FTC lost the case, because every other obesity cure was quackery too, and thus there had been no harm to competition. The entire industry was allowed to continue blithely making false claims.) Throughout most of the agency’s history liberal critics have used words like “lax” and “slipshod” when describing its enforcement policies, and business executives have regularly decried the FTC as “oppressive.” All of these adjectives can be used to characterize the agency’s treatment of aspirin, which has ended up playing an astonishingly large role in the evolution of the FTC’s regulations concerning false advertising.
An FTC advertising case today begins when staff attorneys decide that an ad is false or misleading, which may happen in any number of ways. Famously, a lawyer in the Seattle bureau attempted to charge a parka company with fraud after spending a night in the mountains wearing his parka and concluding that the company’s claim that wearers could do just that without getting cold was false. The staff then presents the case to the five Commissioners of the FTC, who act as a grand jury. If the Commissioners decide the charges are well grounded, they vote to file a complaint. Most companies then give up and agree to a cease-and-desist order. But if the company decides to fight, the case then proceeds to an administrative law judge, another FTC employee, who listens to testimony, makes findings of fact, and ultimately hands down a decision. No matter what the judge’s decision, the losing party invariably appeals—to the Federal Trade Commission. A company can later appeal its case in federal court, but the courts routinely defer to the commission’s expertise in false-advertising matters, and the company rarely wins. If you find it peculiar that in America the same party should seem to serve as grand jury, prosecutor, judge, and appellate court, your surprise mirrors that of many businesses confronted with the FTC for the first time; you would probably not be reassured to learn that the FTC sometimes loses in its own court.
The crest of the first wave of analgesic cases occurred from 1934 to 1938, when the FTC issued complaints against no fewer than thirteen aspirin makers. To modern ears the ads have a certain familiarity. “Best’s Aspirin. . . the Aspirin your doctor prescribes.” “Lord’s Aspirin ... a speed hitherto unknown in the relief of pain.”The FTC fought with these people for years, and then, what with the Second World War, all but forgot about aspirin until the end of the Eisenhower Administration, although there was still some skirmishing over Anacin.
Even by the somnambulent standards of the Reagan era the FTC of the fifties was a poky place; the volumes of FTC Decisions remained slim, and the agency spent much of its resources checking up on fur and textile labels. One would never have guessed that the claims for analgesics being made on television had once been the object of rigorous government scrutiny. Hammers pounded in heads as Anacin provided the best pain relief, little as of aspirin and little bs of Bufferin chased one another through people’s stomachs as Bufferin provided the best pain relief, and nine out of ten doctors recommended Bayer, which also provided the best pain relief.
Eventually the irreconcilable claims of the aspirin manufacturers stirred the FTC to act. In I960 it commissioned two research physicians in Baltimore, Louis Lasagna and Thomas J. DeKornfeld, to evaluate the efficacy of five brands of aspirin: Anacin, Bayer, Bufferin, Excedrin, and St. Joseph’s. The doctors investigated, and concluded that there was no significant difference among these types of aspirin, although all had higher “pain-relief scores” than the placebos given to some test subjects. With this data in hand, the FTC brought its 1961 suit against American Home Products, Sterling Drug, Bristol-Myers, and Plough—and quickly discovered that the case was much messier than the lawyers had initially thought.
TYPICAL OF THE COMPANIES’ REACTIONS WAS THAT of Bristol-Myers, the New York-based conglomerate that Forbes once described as living on “headaches, hair, and BO.” Sued for its ad claims about Bufferin and Excedrin, the company responded to FTC subpoenas by inundating the understaffed agency with a stack of paper more than twenty-three feet tall, while its brilliant lawyer, Gilbert Weil, complained about the impossible burdens the government was imposing on it. Stunned, the FTC put the case against the four companies on “suspense" in June of 1962, and eventually withdrew it altogether before trial—one of the few times the agency had ever made such an about-face. When Lasagna and DeKornfeld published their work, that December, in the Journal of the American Medical Association, Weil demanded within ten days that the FTC make the two men available for what might be called preventive depositions, in order to grill them before their memories faded. The commission denied the motion, arguing that no grounds existed for the issuance of subpoenas, there being no active case.
To the chagrin of the FTC, Sterling Drug now capitalized on the Lasagna-DeKornfeld study by proclaiming across the land that a “government-supported medical team” had revealed in a “highly authoritative journal” that “Bayer Aspirin brings relief that is as fast, as strong, and as gentle to the stomach as you can get"—in other words, that Bayer was just as good as its competitors. The FTC was outraged. The study that it had hoped would be a weapon against analgesic ads was now being used in an analgesic ad. The commission sued Sterling—and lost. Judges at the district and appellate levels turned down the agency’s request for a preliminary injunction.
Humiliated by the collapse of its original complaint and the subsequent loss to Sterling in court, the commission’s lawyers switched to a different strategy. Besides attacking individual companies, the FTC can declare particular types of advertising to be “unfair or deceptive” and then sue any company that fails to heed the “trade regulation rule.” (If this sounds like an abridgement of free speech, that’s because it is; false statements in advertising, unlike false statements in journalism, are given little protection by the First Amendment. ) The advantage of such rules, in the eyes of the commission, is that companies can be fined immediately for their violations. Ordinarily a company is allowed “one bite of the apple”—that is, the first violation brings a cease-and-desist order but no fine. In July of 1967 the agency proposed to outlaw any advertisement that “represents that any analgesic effects resulting from the use of such product are faster, stronger, or longer lasting than those achieved by the use of a competitive product. . . .”
Bristol-Myers was the first to strike back. It attacked the constitutionality of the procedure for making trade-regulation rules, and then, after the FTC put into the record thirty-three scientific papers as evidence for its contention that the current crop of ads were bogus, Weil requested the power to subpoena the forty-four authors of the papers and “all matters relating to the contents of said articles,”the latter being defined generously enough to include practically everything each scientist had seen or heard since third grade. The company also requested all files produced by the FTC staff investigation. When the agency refused to turn them over, Bristol-Myers sued under the Freedom of Information Act—and won. Bristol-Myers’s victory came at the same time that the commission was rethinking its strategy yet again. It withdrew its proposed rule and declared its intent to scrutinize analgesic advertising on a company-by-company basis, putting everything back to square one.
IN THE MIDDLE OF THESE PROCEEDINGS RALPH NADER and his associates issued their first critique of a regulatory agency. “They picked the biggest, fattest target they could find,”Robert Pitofsky, formerly at the FTC and now the dean of Georgetown University Law Center, told us recently. “They picked the FTC, which may actually have had the honor then of being the worst, slowest bureaucracy on Capitol Hill.” After Nader’s team described the FTC’s performance as “shockingly poor,”President Nixon appointed an American Bar Association committee to look at the agency; the ABA report, issued in September of 1969, said much the same thing, although in more diplomatic language.
Nixon rewarded the committee head, Miles Kirkpatrick, by making him chairman of the Federal Trade Commission, in 1970. Kirkpatrick in turn hired the committee counsel, Pitofsky, to be the head of the newly created Bureau of Consumer Protection. “The incentives for advertisers to lie then were very great,” Pitofsky said. “The government was doing practically nothing, effective selfregulation didn’t exist, and comparative advertising wasn’t allowed by the networks—the advertisements were a freefire zone. One oil company was claiming that if you used its gasoline your car would pull a locomotive up a hill. The airwaves were full of the most blatant lies.”
Kirkpatrick and Pitofsky hired a cadre of activist lawyers and told them to drag in some of the big boys. They did. America’s corporations were stunned by the fury of the new, demonic Federal Trade Commission. FTC lawyers worked day and night, and scores of lawyers found themselves having to defend advertisements their clients had run for years without regulatory flak. “We did dozens of these big cases,” Pitofsky said. “The last of that series was the analgesic cases. Obviously, we never dreamed what would happen with them.”
What happened is that the analgesic cases were shipwrecked on the reefs of epistemology. Until 1970 the agency had declared ads false when they were proved factually untrue. This definition was too small-minded for the new-model Federal Trade Commission. That year it sued Pfizer, a pharmaceutical company, over a commercial for Un-Burn, an ointment said to “anesthetize nerves” in sunburned skin, because Pfizer lacked adequate substantiation for the claims in that commercial. In other words, the commercial’s claim was deemed false not because it was untrue but because Pfizer had no evidence to support it. Bizarrely, the “Pfizer doctrine” implies that a company could be convicted for false advertising even if upon later investigation the commercial turns out to be true. Truth is no longer an absolute defense, as it is in libel cases, and the truth or falsity of an advertisement no longer depends solely on whether it is true or false.
If you think the Pfizer doctrine sounds vague, you’re not alone. The FTC lawyers who had looked to the decision in the Pfizer case for a precise definition of adequate substantiation were horrified when it was handed down and failed to provide any. The lawyers had argued for a straightforward definition of appropriate support for advertising claims: adequate, well-controlled scientific studies. The commission bought the argument that commercials had to have what it called “a reasonable basis” but rejected the definition provided by the FTC lawyers and failed to give one of its own.
David Bickart, the young lawyer Pitofsky charged with writing the aspirin complaints, thus had little to go on. Abandoning the reasonable-basis standard for the nonce, he decided to go after the analgesic makers on the ground that there was a “substantial question" in the scientific community about the correctness of their claims. By failing to disclose the scientific disagreement over the comparative effectiveness of various aspirin brands, he argued, aspirin ads were deceptive. By this logic they were just as deceptive as used-car sales pitches would be if they failed to disclose defective brakes or bad paint jobs. Going on this theory, the commission served American Home, Bristol-Myers, and Sterling Drug with similar complaints early in 1973.
Of the enormous number of commercials the FTC challenged, the one we liked best came from Bristol-Myers. Called “New Housing,” it shows a minor housing official about to tell an old couple that they are going to be kicked out of their condemned rental apartment in less than a week. Upset at the coming confrontation, the housing official gets a headache, the kind of headache that afflicts “sensitive people.” He pops two Bufferin. In moments he is calm and smiling. He is able to give the old folks the straight poop.
HOUSING OFFICIAL: That’s the way it is. So you’ll have to be out by Thursday.
OLD MAN: You know, our kids were born right here.
That’s their tough luck. Our man has gotten through this scene, thanks to Bufferin. The announcer says, “Bufferin. For sensitive people. It’s much better than plain aspirin.” (The claim in the last sentence is what irritated the FTC; there is no law against bad taste.)
AFTER MUCH SKIRMISHING, THE LAWYERS FOR ALL parties began pre-trial hearings before Administrative Law Judge William Jackson. It soon became obvious that the judge—“a relic from the fifties,” Bickart said to us—didn’t buy the “substantial question” approach. He seemed to delight in taunting the FTC lawyers about the vagueness of their new standard. In addition, Jackson slapped each of the three proceedings with an order protecting trade secrets which prevented any of the agency lawyers working on one case from talking to those working on the others. The order split the small office into three malfunctioning parts and brought work on the case to a standstill. Furious, Bickart and his subordinates decided to wait until Jackson’s retirement and hope for a more supportive jurist. “We played four-corners for eighteen months,” he recalled. “It was galling.”
In 1975 the case was assigned to Administrative Law Judge Montgomery K. Hyun, who quickly lifted Jackson’s protective order and allowed the FTC lawyers to proceed as planned, which didn’t get them very far. “Gil Weil, at Bristol-Myers, was the most litigious lawyer I ever met,” one FTC lawyer told us. “He was a master of the collateral suit.” With the FTC using a novel legal standard, Weil had a field day; some of the FTC legal staff members even worried that he would be able to get the case thrown out of court. “The odd thing,” a lawyer involved in the case said, “was that Bristol-Myers did more research than anybody else. They were fighting on procedural grounds, but they actually had some—but, the FTC thought, not enough— basis for their claims. Excedrin had one very well controlled clinical study that for years nobody could figure out how to crack.” Great was the glee of the agency staff when after great effort they discovered in Bristol-Myers’s files a big, expensive clinical study that, Judge Hyun concluded, could not “reject the hypothesis that aspirin is more potent than Excedrin. . . .” (our emphasis). Further, the study was, the judge wrote, “more precise and reliable" than the studies that supposedly provided substantiation for some of Bristol-Myers’s advertising.
“American Home,” the lawyer told us, “didn’t have a thing. They had a study comparing Anacin with Darvon, which supposedly was the grounds for their ad that Anacin was as strong as the ‘leading prescription pain reliever.’ It was ridiculous—they gave the drugs right out of the box. ‘Here’s some stupid Darvon. You think it’s as good as good old reliable Anacin? Ten bucks for your answer.’ Plus they gave people Anacin in capsule form and Darvon in pill form. Well, there’s a well-known placebo effect in that people think capsules are stronger than pills, and they constructed the whole study to take advantage of that. We killed it in ten minutes.
“And Sterling, which had a little bit of substantiation, was out there saying that nothing was better than Bayer aspirin, but it was also making Vanquish to compete with Excedrin and saying that Vanquish was better than aspirin.” One of the two claims had to be incorrect, and the FTC team thought that the company must be aware of it, “Incredibly, we lost,” the lawyer said. In theory, two companies with similar products can have substantiation for inconsistent claims about the relative merits of those products. The commission argued that to disallow a third firm, which sells two products, from making the same kind of claims with the same kind of substantiation would produce “an anomalous result.” And so Bayer won.
By 1977, when the first joint hearings on the analgesic cases took place, Michael Pertschuk had become the chief commissioner and the FTC had entered what people now call its radical phase. Pertschuk had been the staff director for the Senate Commerce Committee when most consumer-protection legislation had been passed. He pressed for sweeping changes in the conduct of American business, especially in the part of the economy that sold sugar-coated cereals and other sweets to kids.
The aspirin cases were lost in the hoopla. Hangovers from the Nixon Administration, they trudged through the Ford and Carter Administrations in a morass of hearings, motions, countermotions, filings, briefs, appeals, subpoenas, depositions, and lectures on medical evidence, until they finally came under the aegis of Reagan’s first chief commissioner, James C. Miller III, a celebrator of the free market who stood in relation to Pertschuk as matter stands to anti-matter. By that time successive waves of falseadvertising cases had led the FTC to clarify its “reasonable-basis” standard. The agency’s lawyers decided that maybe the analgesic cases should be tried under the Pfizer doctrine after all.
The first case to come before the commission, American Home, ended in 1981 with one of the last decisions written by Pertschuk, and it sent chills down the company’s spine. American Home’s order required it to reveal at last that Anacin’s active ingredient was aspirin whenever the firm made a claim about the product’s performance. By the time the other two cases were to be decided, Miller was firmly in charge, and the cases were in the hands of a man who often wore a tie adorned with small portraits of Adam Smith. The final orders imposed on Bristol-Myers and Sterling, in February of 1983, were considerably less onerous than the one given to American Home. American Home naturally sought to modify its order. It succeeded— three times. The last modification, in June of 1984, made its order equivalent to those given the other two companies. Twenty-three years after Lasagna and DeKornfeld, American Home had at great expense affirmed its basic right not to reveal its principal ingredient.
The companies were less than delighted by their victory. The war had been draining, and they had shuffled paper through the 1970s and 1980s with rising bitterness. “Here we were fighting this endless thing,” one former Sterling Drug lawyer told us. “And the whole business was getting increasingly removed from reality, because Tylenol suddenly started beating the pants off aspirin in the market, and nobody gave a hoot anymore about aspirin anyway.” The era of the really big lawsuits was just getting under way.
IN LATE 1976 WAYNE NELSON, THE PRESIDENT OF McNeil Consumer Products, the subsidiary of Johnson & Johnson that makes Tylenol, saw an Anacin commercial and became unsurpassingly annoyed.
SQUARE-JAWED SPOKESMAN: Your body knows the difference between these pain relievers [brandishes bottles of Tylenol and other acetaminophen products] and Adult Strength Anacin [brandishes Anacin]. For pain other than headache Anacin reduces the inflammation that often comes with pain. These [points to acetaminophen bottles] do not. . . . Anacin reduces that inflammation as Anacin relieves pain fast. These do not. Take Adult Strength Anacin.
The ordinary listener might have been struck by the near-incomprehensible syntax; one can read the sentence “For pain other than headache Anacin reduces the inflammation that often comes with pain” several times without causing it to discharge its precise informational content. But Wayne Nelson’s attention, and subsequently that of the federal judiciary, was drawn less to the content of the advertisement than to what it did not contain. “Anacin reduces that inflammation as Anacin relieves pain fast,”said American Home Products. “These [the acetaminophen products] do not.” Do not what? To Nelson, it sounded as if American Home Products was saying that Tylenol did not relieve pain fast. And that, Nelson said later, “was just plain false, and they knew it.” American Home Products, in Nelson’s considered opinion, would “say or do anything to get an extra buck.”
A silver-haired, strikingly handsome man. Nelson is often described by the term “marketing genius.” He began his adult life in journalism school but decided he’d rather do things himself than write about other people doing things, and went into business. He joined Johnson & Johnson in 1971, sixteen years after McNeil became the first American company to sell acetaminophen, under the name of Tylenol, and twelve years after Johnson & Johnson acquired McNeil. By that time acetaminophen, like aspirin, had a long and inglorious history. The analgesic properties of acetaminophen had been discovered in 1886, before the synthesis of aspirin, when an Alsatian pharmacist mistakenly filled a prescription for two doctors with acetanilide, a substance made by mixing vinegar and aniline. The two doctors noticed that their patients’ fevers went down. Three years later a German chemist named Karl Morner discovered that the body converts acetanilide to acetaminophen, which, we now know, is what actually made the fevers go down and headaches go away. Morner’s discovery was ignored, and pharmacists sold acetanilide mixtures as cure-alls, despite their occasional inducement of an unpleasant side effect—death. In the early years of this century acetanilide fought aspirin on store shelves under dozens of peculiar sobriquets: U-Re-Ka Headache Powders, Telephone Headache Tablets, Falck’s One-Minute Headache Cure, “Funny-how-quick” Headache and Neuralgia Cure (“Does Not Stupefy, But Braces One Up”), and The Infallible Headache Tablet, a mixture of acetanilide and caffeine that styled itself an “infallible cure” for something called “bighead.” One acetanilide brand, the whimsically named Harper’s CUFORHEDAKE BRANEFUDE, won the honor of being the subject of the first drug case brought under the 1906 Food and Drug Act. Word seems to have eventually got around that aspirin was easier on the system than acetanilide, and sales of acetanilide products dropped steadily.
There the matter remained until 1951, when scientists at McNeil Laboratories, a small prescriptiondrug outfit in Fort Washington, Pennsylvania, heard of acetaminophen, which by then had been synthesized and investigated by researchers in Europe. McNeil studied the drug, realized that it was much less likely to give children an upset stomach than aspirin was, and obtained FDA approval to market Children’s Tylenol Elixir in June of 1955. It was first sold in a small red plastic fire truck. (The names acetaminophen and Tylenol both come, tortuously, from the chemical name for the drug, N-acetyl-p-aminophenol.) Since Tylenol was McNeil’s only over-the-counter product, McNeil marketed it to adults like a prescription drug, telling doctors about its properties and asking them to recommend it to aspirin-sensitive patients. Doctors apparently did as they were asked, and annual sales of Tylenol slowly rose to $50 million by 1974. The following year the brand had acquired a more than 10 percent share of the analgesic market, despite having spent just $1.1 million on national advertising over the past decade, in addition to direct mailings to doctors. (In contrast, Anacin spent $226 million in the same period.) Then came Wayne Nelson.
NELSON WAS CALLED TO MCNEIL FROM JOHNSON & Johnson’s corporate headquarters after BristolMyers decided to go after Tylenol’s market share. Although Bristol-Myers already made the pain relievers Bufferin and Excedrin, which it described as the most effective in existence, it was eager to make another. In early 1975 Tylenol was selling at $2.85 for a hundred tablets, and Bristol-Myers decided to sell the same thing at a lower price. Because nobody had ever heard of acetaminophen, the company introduced its new product, Datril, by explaining to TV viewers in test markets in Albany, New York, and Peoria, Illinois, that it was the same as Tylenol but cost a dollar less. In both test markets Tylenol’s market share fell by half in eight months.
That June, Bristol-Myers launched Datril nationally, spending nearly a million a month on promotion for the next quarter. Nelson arrived at McNeil on July 1, and fought back the way anyone would have: he cut Tylenol’s price by a dollar and complained continually to the networks. After much huffing and puffing, Bristol-Myers was forced to use a different formula: “Datril can cost less than Tylenol. A lot less,” and then, after more complaints, “Depending on where you shop, Datril can cost less,” and finally, “Compare prices and save money.”
At the same time, Tylenol’s market share soared. People who had never heard of Tylenol now saw it featured in TV advertising. That some of them were watching advertising for an imitator didn’t stop them from trying the original. By the end of 1976, after Bristol-Myers had spent over $11 million on ads, Datril had two percent of the analgesic market but had helped to increase Tylenol’s share by more than a third.
Most of the increase was not for regular Tylenol but for the recently introduced Extra-Strength brand, which Nelson pushed because, he told us, “people thought that since Tylenol was easy on the stomach, it wasn’t as strong.” Magazine advertisements proclaimed, “You can’t buy a more potent pain reliever without a prescription.”
For most types of pain, the claim is factually correct. Nothing is more potent than the acetaminophen in ExtraStrength Tylenol, because all analgesics have the same potency at over-the-counter doses. There’s just more of the active ingredient: Extra-Strength Tylenol has half again more acetaminophen than regular Tylenol at half again the price per pill. The citizenry began taking two tablets of the new, bigger version of Tylenol rather than two tablets of the old, neatly restoring to McNeil much of the profit it had lost by cutting the price of regular Tylenol to match that of Datril. By the winter of 1976 Tylenol had overtaken Anacin as the nation’s leading analgesic and was well on its way to becoming the biggest-selling health and beauty product in the nation—most of the growth owing to advertising, and much of it owing to someone else’s advertising.
THIS, THEN, WAS THE REALM THAT WAYNE NELSON saw threatened by imprecise syntax. American Home Products had pulled out all the stops, spending almost $12 million in 1976 to spread the message that “Anacin stops inflammation as Anacin relieves pain fast.”
When a company sees stretchers from the competition, it has four main options. It can protest to the networks, each of which maintains a “standards” department to review the 25,000 commercials that it airs every year. It can complain to the National Advertising Division of the Council of Better Business Bureaus, a self-regulatory group created in 1971 by the advertising industry. (In its first nine years the NAD investigated American Home more than twenty-five times—more than any other company but one.) It can alert the Federal Trade Commission. Finally, it can sue its competitor under Section 43(a) of the Lanham Trademark Act of 1946, which says that “any person who shall . . . use in connection with any goods or services . . . any false description or representation, including words or other symbols tending falsely to describe or represent the same, . . . shall be liable to a civil action ... by any person who believes that he is or is likely to be damaged by the use of any such false description or representation.”
Aggrieved firms usually work their way up the ladder from letters to lawsuits, and this is just what McNeil did, writing to the networks in late December of 1976. In response, ABC forced American Home to change the statement to “Anacin relieves both pain and inflammation fast. These [the acetaminophen products] do nothing for inflammation.” CBS and NBC, however, let the original commercial stand. At the same time, Johnson & Johnson protested to the print media and filed a complaint with the National Advertising Division. True to its penchant for hanging tough, American Home saw and raised: On March 21, 1977, it sued Johnson & Johnson for complaining too loudly and too publicly. Saying that the charges hurt business, it demanded a declaratory judgment that its advertisements did not hurt Johnson & Johnson and requested the court to enjoin the other company from making further accusations. On April 6 Johnson & Johnson called and raised. It countersued under the Lanham Act, charging American Home with false advertising, and eventually, in May of 1978, it won.
American Home Products v. Johnson & Johnson began what one knowledgeable legal reporter has described as “one of the longest and most ridiculous corporate legal vendettas in recent American history.” Half a dozen Lanham Act suits between these two companies have been tried, and several more are in the wings. To distinguish among them, lawyers use Roman numerals: Anacin I, Tylenol II, and so on. Eleven years, dozens of market-research reports, hundreds of witnesses, and thousands of pages of transcript later, the parties are still battling in the fields of the Southern District Court of New York. The court files on the cases are so voluminous that staff members sometimes refuse point-blank to carry them to inquiring reporters. The federal judge involved in the latest series of battles, the long-suffering William C. Conner, has taken to wondering aloud if he is doomed to spend the rest of his days as “the czar of over-the-counter drug advertising,” forever adjudicating what one of his decisions has called “an endless war between two titans of the over-the-counter drug industry.” Even some of the lawyers seem a little embarrassed, although not enough to forgo their fees.
Impartial Medical Research
IN ANY DISCUSSION OF ADVERTISING FOR OVER-THEcounter drugs a certain question inevitably crops up: To avoid this dispute, why not commission a disinterested party to perform scientific experiments to establish exactly what these drugs can and cannot do, and then say that advertisers can’t make claims that have not been scientifically established? Why not, in short, put the question to the authority of impartial medical research?
Headache remedies are particularly difficult to evaluate, because most headaches have no known cause and go away on their own. There’s no “headache-ometer” that you can slap on a sufferer’s skull to see his pain fall from one level to another, and you can’t be sure whether or not the pain would have diminished anyway. People who want to test aspirin (or any other analgesic) on headaches have two unpalatable choices: collect a batch of headache-prone people, wait for them to get headaches, give out the aspirin, and ask if they get more relief from this product on this headache than they did with the last product on the last headache; or try a different kind of pain, like the aftermath of wisdom-tooth extraction, and hope, without much evidence, that relieving wisdom-tooth-extraction pain has something to do with relieving headache pain. As a result, a great fog of uncertainty surrounds the studies concerning brands of aspirin, and one can be found to support almost every point of view.
Nonetheless, the Pood and Drug Administration has been given the unenviable duty of finding out just what headache remedies do. Amendments made in 1962 to the Food, Drug, and Cosmetics Act charged the agency with investigating the effectiveness of all drugs, including analgesics. Panels of outside experts were to write monographs that would set down the properties of each over-thecounter drug and, by implication, what its makers could say about it.
Inundated with medical evidence supplied by companies, the agency proceeded slowly. Today, sixteen years after the panels were convened, perhaps one quarter of the monographs have been published and the others are moving through the agency at geological speed. The internal-analgesics panel, which evaluated over-the-counter pain relievers, in 1977 published a draft of its final monograph, which stated that aspirin and acetaminophen provided equivalent relief of headache and other minor pain. Analgesic-makers were given one year to present new evidence, after which the final monograph was to be published. Today, years after the internal-analgesics panel was disbanded, the data are still coming in, and the final monograph is but a gleam in regulatory eyes. Adding to the problem, FDA officials say, the present Administration has not encouraged the creation of more regulations on commerce. In the words of one FDA employee, the review of over-the-counter drugs as a whole is likely to be completed “sometime after the next return of Halley’s Comet.” Until then questions about analgesic advertising apparently will not be settled by recourse to impartial medical research.
The New Player: Ibuprofen
WHEN TYLENOL MADE INROADS ON ASPIRIN, THE aspirin manufacturers struck back. In 1977 W. Clark Wescoe, the chairman of Sterling, watched Bayer’s share of the analgesics market slip to a thirty-year low of 10 percent—10 percent for mighty Bayer!—and saw himself faced, like Churchill, with losing battles on many fronts.
The most obvious line of attack—to release its own acetaminophen, which it called Bayer Non-Aspirin Pain Reliever—failed. After decades of hearing that Bayer was pure aspirin, not part aspirin, Americans were befuddled to learn that Bayer was now not aspirin. American Home Products took a different tack. It, too, introduced an acetaminophen product, Anacin-3. Because few consumers knew that Anacin was mostly aspirin, American Home, unlike Bayer, didn’t have to worry about confusing people when it put out acetaminophen. But the company’s eventual strategy was to beat acetaminophen with something else: ibuprofen, an analgesic discovered in the early 1960s by Stuart Adams, a researcher at the English pharmaceutical company Boots, and marketed in Britain in 1969 as a prescription drug to relieve the pain of arthritis.
Ibuprofen belongs to the same biochemical class as aspirin—non-steroidal anti-inflammatory drugs—but it has a different chemical formula. Not different enough, however, to make it safe for many people who are sensitive to aspirin. Like aspirin, ibuprofen relieves headaches and has anti-inflammatory power. It may also be more effective for severe, non-headache pain. Boots licensed ibuprofen to Upjohn, which sold it in North America as a prescription drug with the name of Motrin beginning in 1974. By 1983, when Boots began talking about selling ibuprofen over the counter in this country, more than eight billion doses had been sold and ibuprofen was the fourth biggest seller, by volume, among prescription drugs. Unfortunately, Upjohn had blundered badly in its original agreement with Boots; it did not nail down exclusive over-the-counter rights to ibuprofen. In the spring of 1983 Boots sold a second set of rights to American Home Products. (Discussions between Boots and Johnson & Johnson never came to fruition.) Faced with the certainty that American Home would put ibuprofen on store shelves—and airwaves—across America, Upjohn was forced to jump into the fiercely competitive world of over-the-counter analgesics.
American Home and Upjohn were in a race against time, because the patent on ibuprofen was set to expire in just two years. If either firm was to seize the over-thecounter market, it would have to placate the less than friendly FDA Arthritis Advisory Committee and win approval to sell the drug before Boots’s patents expired and the market was flooded with imitators. The stakes were huge: ibuprofen was expected to take 10 to 15 percent of the market within a year of its appearance. Each percentage point being equivalent to sales of $14 million a year, people stood to gain or lose a lot of money.
The members of the Arthritis Advisory Committee worried that people who couldn’t tolerate aspirin would be among those most likely to buy a new non-aspirin headache remedy. They also doubted that American Home, the purveyors of Anacin, would be likely to inform thousands of potential buyers that they should avoid ibuprofen. Nonetheless, on May 18, 1984, the FDA compromised, releasing ibuprofen for over-the-counter sale on the condition that Upjohn and American Home “voluntarily” give the FDA the right to monitor their advertising. Unfortunately, the FDA does not have the legal right to regulate advertising for over-the-counter drugs—that power is reserved to the FTC.
Six days after approval Johnson & Johnson spoke up for the FTC by suing the FDA. Piously disclaiming any desire to “interfere with the launch” of the product, the makers of Tylenol argued that the FDA’s action, if unchallenged, might open the door to sweeping, illegal regulation of the entire over-the-counter-drug industry. The judge threw the suit out of court in June of 1985.
While the suit was pending, American Home rushed its ibuprofen brand, Advil, to the shelves. At the last minute Upjohn contracted with Bristol-Myers to market what it called Nuprin, but the delay was fatal; advertising heavily, Advil seized the initiative, and Nuprin quickly became a hugely promoted also-ran—the Datril of the 1980s. Johnson & Johnson pressed its attack by inundating the nation’s doctors with mailings comparing a judicious selection of the side effects of Tylenol and ibuprofen, of course favoring Tylenol. These prompted American Home Products to sue Johnson & Johnson in June of 1985 for false advertising, initiating a new spasm of litigation that has yet to see its end. American Home was further exercised by a Tylenol ad that appeared in medical journals from July to October of 1985. It showed a lush, rosy-cheeked Red Delicious apple. Upon close inspection, however, the apple revealed a flaw: a wormhole surrounded by a dark, icky-looking region. The caption: “Aspirin and Ibuprofen—The Closer You Look . . . Up to 1/3 of newly diagnosed gastric ulcers may be related to aspirin therapy.” Although the ulcers were linked only to aspirin, the implication was that ibuprofen could be tarred with the same brush. (It should come as no surprise that the next year Johnson & Johnson began selling its own brand of ibuprofen, Mediprin.)
Johnson & Johnson countersued, citing a number of American Home advertisements for Anacin, Anacin-3, and Advil. For example, one medical-journal ad claimed that Advil “interacts” (which doctors take to mean interacts unsafely) with fewer drugs than acetaminophen does. Accompanying the claim was a footnote citation: “Data on file, Medical Department, Whitehall Laboratories.” Whitehall, as noted, is the subsidiary that makes American Home’s analgesics. Upon further investigation at the trial the “data on tile” turned out to consist mainly of a few pages in a textbook from Whitehall’s library. Unfortunately, as American Home’s own expert witness admitted, even these few bits of data failed to support the claim. The trial has come to be known as Tylenol I (except by the Johnson & Johnson lawyers, who prefer to call it “Advil I”).
AS ONE MIGHT IMAGINE, MUCH OF TYLENOL I FOCUSED on the safety of aspirin, acetaminophen, and ibuprofen—especially the safety of acetaminophen. Worries about acetaminophen center on its effects on the liver. Whereas aspirin overdose causes vomiting and ringing in the ears, acetaminophen overdose is often initially asymptomatic; the patient doesn’t feel bad until the harm has been done. Johnson & Johnson makes an effective and widely available antidote, Mucomyst, and many doctors believe that liver damage is reversible if the antidote is administered within eight to twenty-four hours. For reasons still unknown, children are extremely resistant to acetaminophen poisoning — much more so than adults— and the drug is amazingly safe for pediatric use.
In recent years some alcoholism centers have pulled acetaminophen from their shelves. Toby Litovitz, the chairwoman of the data-collection committee of the American Association of Poison Control Centers, told us, “In the last three to five years concern has focused around chronic alcoholics. There’s maybe fifteen million of them, they often have liver disease, and there’s been a great deal of controversy in the medical profession about the effects of acetaminophen on alcoholics.” The scenario that worries some doctors is that people will fall into the habit of drinking too much, waking up with a hangover, and downing a lot of Tylenol. Because doctors didn’t know until relatively recently of the harm that acetaminophen can do to the liver, nobody knows how much alcohol-related liver damage has been exacerbated by acetaminophen.
Analgesic overdoses are common, because analgesics are common: In 1987, according to Litovitz, 14,500 people were treated in hospitals for acetaminophen overdose, and 7,700 were treated for aspirin overdose. (The same year, aspirin caused thirty-five deaths and acetaminophen nineteen, mostly suicides.) Most reports of overdose concerned children, and the higher total for acetaminophen reflects its bigger share of the children’s analgesic market. Such overdose data, however, tell little about the relative safety of the drugs for long-term problems like gastric bleeding and liver toxicity. And there is considerably less data on ibuprofen, Litovitz said, “which is part of the reason why they’re arguing endlessly about its safety in court.”
As Tylenol I dragged on and Judge Conner became better acquainted with the history of the industry, he seemed to worry that he was never going to extricate himself from the clash of the analgesic titans. The Tylenol team and the Anacin and Advil team seemed ready to fight forever, a prospect that the judge described as “dispiriting.”
As the claims and counterclaims piled up, Conner trifurcated the trial into what might be called Tylenol I-a, I-b, and I-c. Tylenol I-a, the original dispute over advertising, went first; I-b and I-c, which dealt with issues that arose after the suit began, were to follow. The simplest explanation of the long, complex, rather sardonic opinion Conner issued for Tylenol I-a in February of 1987 is that both sides lost—their ads were declared false.
Tylenol I-b centered on Johnson & Johnson’s charge that all aspirin labels, including Anacin’s, should have carried warnings about Reye syndrome before 1986, when the FDA asked aspirin makers to add them. Reye syndrome is a rare, serious disease that children can develop if they take aspirin when they have flu or chicken pox. After the warning was put on, sales of children’s aspirin declined steadily; St. Joseph’s, one of the best-known producers, stopped making children’s aspirin last February. The switch from children’s aspirin was a windfall for Tylenol, but Johnson & Johnson nonetheless demanded $1.1 billion in damages from American Home in Tylenol I-b, because the windfall had not come earlier. The judge ultimately dismissed Johnson & Johnson’s suit, in part because that company, as a member of the Proprietary Association, an over-the-counter-drug manufacturers’ trade group, had vigorously argued from 1983 to 1985 against precisely the same warnings on the label that it later sued American Home for failing to add. Johnson & Johnson explained that its opposition had been “philosophical.”
The damages claim was thrown out with Tylenol I-b, but the floodgates were open. Tylenol I-c concerns damages for Tylenol I-a, and both sides say that they won’t back away from the hundreds-of-millions-of-dollars standard of Tylenol I-b. Both sides have not yet informed the court of the exact sums they will seek. Conner’s troubles will by no means end with Tylenol I-c. Eight weeks after his final decision on Tylenol I-a, Johnson & Johnson again sued American Home under the Lanham Act, this time for claiming that Advil, “like Tylenol,” does not upset the stomach, thus creating Tylenol II. When the overworked Judge Conner granted Tylenol’s request for an injunction last December, American Home appealed, losing in May. Meanwhile, the two adversaries embroiled themselves in another Lanham Act suit, Tylenol III, which will be tried when the other suits are out of the way, or after the firms finish adding zeros to their damage figures, or maybe after the next return of Halley’s Comet.
Be Still, My Beating Heart
ONCE A MONEY MACHINE, ASPIRIN HAD BECOME AN advertiser’s nightmare: an enormously powerful and effective drug that had no aura of glamour or magic; a complex, sophisticated chemical that was associated with the era of black-and-white television sets and non-radial tires. Doctors had for many years known that aspirin could have benefits for the heart, but the drug began a serious comeback only last January, when The New England Journal of Medicine released a preliminary study showing that taking an aspirin every other day significantly reduces one’s chance of a first heart attack. The press gave the study wide coverage.
Doctors viewed this news as a mixed blessing. One family practitioner, Sam Slonim, told us, “I worry that some people might start taking an aspirin a day and go back to their steak, eggs, and cigarettes. No study has shown that taking aspirin is a substitute for attention to the controllable risk factors for heart disease—cholesterol, smoking, and high blood pressure.”
Doctors’ worries were exacerbated by the reaction of the aspirin manufacturers, who regarded the study as a savior from the plague of acetaminophen and ibuprofen. “If people are going to have aspirin in their medicine cabinets for a heart attack, they’ll probably use it for headaches,” one Johnson & Johnson representative privately conceded. Within a month a small aspirin brand, Ascriptin, began an advertising campaign based on the study. Bayer and Bufferin, for their part, developed plastic “calendar packs” that would help people remember to take their aspirin.
These campaigns were faithful to the traditions of analgesic marketing. The advertisements failed to mention, for instance, that aspirin did not lower the overall death rate of subjects in the study. (The rate was in any case extremely low, because the study sample consisted of extraordinarily healthy doctors.) Nor did they say that some of the lives spared from heart attack were offset by lives lost to hemorrhagic stroke—that is, blood vessels bursting in the brain. This result fed suspicions that aspirin might increase the likelihood of such strokes. (According to the FDA, people with high blood pressure should be especially wary of regular use of aspirin.) The commercials did not mention that a smaller but longer-term study in England found that aspirin had no such effect on heart attacks, an omission that might be regarded as misleading. According to Gerald Weissmann, a professor of medicine at New York University Medical Center, these ads might also be regarded as misleading because they do not specify dosage and so imply that people need a sizable amount of aspirin for the effect to occur, if it really does occur. “You could almost lick a baby aspirin every other morning,” Weissmann told us recently. “That’s a little exaggerated, but not much. You certainly don’t need a Maximum Strength Anacin every day, or more, which is what they’ll try to sell you.”
Aspirin, Weissmann said, has three modes of action. In high, prescription doses it relieves inflammation. In moderate, over-the-counter doses it stops headaches. In minute doses it may help certain people avoid certain types of heart attack. “That’s pretty simple,” he said. “It’s troublesome when the drug companies obscure the message.”
Although the FDA is not permitted to regulate advertising for over-the-counter drugs, it can pull a product from the shelves if the product’s maker encourages customers to use it in ways not covered by the labeling—a threat that frightened manufacturers refer to as the FDA “squeeze play.” Learning of the new aspirin ads, the FDA Commissioner, Frank E. Young, summoned aspirin manufacturers to a meeting on March 2. There Young explained that aspirin ads about preventing first heart attacks would be considered an act of “misbranding” subject to regulatory action. The firms agreed to “voluntary” restraint on their advertising until the final study was completed.
The FTC, of course, was annoyed. Any bureaucracy is jealous of its privileges, and here the FDA had shut down an advertising campaign, thus encouraging a monopoly on health information by the medical profession, preventing information from reaching consumers, and stepping on FTC toes. “Worse,” one FTC economist said, “the FDA wanted this study never to be advertised at all—they thought people would not be able to understand it.”
Although the aspirin companies acquiesced to the FDA, they had obvious reasons to be unhappy—or, at least, all but one did. That one was American Home Products, for which the moratorium provided some breathing room while management pondered crucial decisions. Although the firm, as is its wont, refused all comment, people who follow the industry had a good time hooting about Anacin’s identity crisis. Having spent a half century boasting of its special formula and secret ingredients, and having wriggled out of an FTC order that would have forced it to reveal that its primary ingredient was aspirin, Anacin was now in danger of becoming a victim of fashion. If aspirin was repositioned as a high-tech heart-attack preventive, would Anacin be forced to come out of the closet? “Watch the box,” David Dobbins, one of Johnson & Johnson’s lawyers, told us. “Pretty soon you’ll see the word aspirin in legible type.” So far the type size is still small, but the word aspirin does come up in commercials for Anacin.
DOBBINS’S PREDICTION PROMPTS REFLECTION. IF American Home ever decided that it was in the company’s interest for consumers to know that Anacin was just aspirin and caffeine, the information could be spread with incredible rapidity by one of the most efficient means of communication known to humanity: advertising. Advertising can disseminate information in a wonderfully quick and efficient way—look at Johnson & Johnson’s ads in the wake of the Tylenol poisoning incidents, which probably stopped people from buying its own product (for a time) faster than any government action could have. Furthermore, the drug companies whose activities we have chronicled are responsible for many of the significant advances in medicine which have made millions of people’s lives better. Research into new drugs in the Western nations is carried out almost exclusively by private industry. American Home, Bristol-Myers, and Johnson & Johnson are consistently among the top ten or so spenders on drug research in the world. (Exact international ranking in such matters is difficult, because currency values change quickly, and because different companies draw different borders between research into drugs and research into cosmetics.) American Home, for example, was one of the first producers of penicillin, and developed Inderal, an important cardiac drug; Bristol-Myers is a leader in anti-cancer treatments; Johnson & Johnson has for decades spurred advances in vital hospital supplies, such as sterile bandages and surgical gloves. Sterling Drug—the only company of the four that did not try to prevent us from speaking to any of its employees—is conducting a series of expensive tests to determine the possibility of engaging entire communities in preventive health programs. In the Eastern bloc, drug research is carried out, of course, by the state, and the Eastern bloc has introduced very few significant new drugs. It also has very little trouble with false advertising. Perhaps this farrago is a necessary consequence of the way we do things here.
But that may change. The activist FTC of the 1970s, the niggling criticism by the networks, the barrage of Lanham Act suits—all have pushed the over-the-counter-drug companies, however grudgingly, in the general direction of telling something like the whole truth, although often in incomprehensible language. Fewer stretchers reach the airwaves these days, although we are fond of a long-running set of ads in which more doctors say they would prefer to take Bayer to a desert island than Tylenol, ExtraStrength Tylenol, or some other brand. Until a “new” survey appeared recently, the combined Tylenol vote was higher than the Bayer vote, as the chart that flashed briefly on the screen made clear.
The good old days of aspirin advertising have been left in the dust of ever-multiplying legal restrictions, and the fun is going out of stretcher-seeking. How can you not miss the clanging sledgehammers in the head, little as and bs chasing one another around someone’s stomach, strong medicines helping sensitive people evict elderly couples? Most of the new ads feature bland, careful, legalistic people making bland, careful, legalistic claims. Has there ever been a more insipid statement than Tylenol’s perpetual cry that the drug does not “irritate your stomach, the way aspirin or even ibuprofen can”? The way aspirin can—even ibuprofen—each and every hedge word the product of a lawsuit. Housing Official, where are you?
Still, every now and then we see something that makes us wonder if the old swashbuckling spirit of William Laporte might live on in the corporate heart of Anacin’s makers. Those actors dressed like reporters keep popping up on Anacin commercials to ask if we’ve heard the news about aspirin. As the Advertising Age columnist Bob Garfield has pointed out, the “news” about aspirin must refer to the heart-attack study, unless someone just discovered that acetylsalicylic acid can prevent cancer. But the commercials talk about pain relief, and it’s hardly news that Anacin’s makers would like people to believe that Anacin treats headaches better than plain aspirin does. The inattentive viewer might even get the notion that Anacin somehow does a better job than aspirin of heart-attack prevention. But such bold examples of the art of the stretcher are increasingly rare. Alas, analgesic ads have become much duller since they’ve been forced to flirt with full disclosure.