A Pharmaceutical Cinderella

DRAPER, ROGER

Writers & Writing A PHARMACEUTICAL CINDERELLA BY ROGER DRAPER A Although aspirin has long been the most widely consumed of all drugs, until the 1960s it was the mere common drudge of the medical...

...as you can get," and the statement might well have been correct...
...But the firm was largely invisible to consumers, vending its powder to pharmacists and pharmaceuticals companies, who made it into pills...
...Nonetheless, the poorly financed academic studies described in the third and final part of The Aspirin Warshave revolutionized the pharmacology of ASA by investigating its ability to inhibit blood clotting, the cause of heart attacks and strokes...
...Bayer was nevertheless able to create an international pseudomonopoly by selling its product under the trademarked brand name Aspirin...
...In fact, the authors do not seem to be secure when their narrative carries them from the history of aspirin to general history...
...At the end of World War I, the U. S. government seized Bayer's American operations as enemy property and auctioned them off to Sterling Products, a patent-medicine outfit...
...Such a situation," write the authors, "virtually guarantees furious competition," though on the level of marketing, not of substantive product design —let alone price...
...up to World War II it depended on the technical assistance of German Bayer, now a branch of the I.G...
...Today, aspirin is the treatment of choice for the pre-eminent cause of death in Western countries: cardiovascular disease, particularly heart attacks and strokes...
...Hence, the studies that confirmed ASA's benefits in cardiovascular disease—no more than a pill every other day is sufficient to receive them, incidentally—also established a new methodology for confirming treatments...
...Aspirin, even in its most expensive packaging, is cheap...
...In this case, only very big tests can eliminate the impact of chance...
...Methodology was a more serious matter...
...By the spring of 1988, the authors write, this research seemed to have made ASA "so hot...
...That market is expected to grow at a rate of 15 per cent or more annually, whatever this might indicate about our national state of mind...
...This omission, and the authors' apparent lack of familiarity with German history, are the only significant weaknesses of an otherwise excellent book...
...Indeed, the company was much more interested in marketing than in manufacturing...
...Writers & Writing A PHARMACEUTICAL CINDERELLA BY ROGER DRAPER A Although aspirin has long been the most widely consumed of all drugs, until the 1960s it was the mere common drudge of the medical world, prescribed only for humble aches and pains...
...Like German Bayer long ago, Sterling's challengers took a known commodity, ASA, and concealed it in freshly minted names to build spurious monopolies...
...So far, no one has devised a better system...
...Like Sterling, they promoted it through advertisements, notably the famous Anacin television commercial that depicted the interior of a human head successively tormented by hammers, a tightly coiled spring and lightning...
...In Argentina, Sterling's subsidiaries spent enough on radio commercials in one eight-month period to broadcast 50 million of them...
...The authors make a serious error in their account of Sterling's German connections, writing that Farben's "directors were put in the dock at Nuremberg with Goebbels and Himmler," both of whom, of course, committed suicide in the spring of 1945...
...In 1886 a cetanilid, another coal-tar derivative employed in dye production, was found to have fever-reducing properties...
...Because none of the companies that produce either ASA or acetaminophen can profit exclusively from efforts to develop additional ways of using them, research is funded meanly, if at all...
...When the German doctors who discovered this informed the firm that had provided the acetanilid samples, the manufacturer realized it could never enjoy a straightforward monopoly on such an old and thus unpatentable substance...
...Aspirin is the modern descendant of a traditional folk remedy for fever and pain: willow bark...
...In the ad this was transformed into, "Bayer Aspirin brings relief that is as fast, as strong, and as gentle...
...None is very distinctive...
...Eventually, analgesics companies exploited the new legal regime in court challenges they themselves brought against one another's commercials...
...Should we really attempt to control closely the advertising of the big analgesics companies...
...The hammers were stilled as the announcer declared that Anacin "stops headaches...
...While the ASA makers were defending their statements in court, they were also attempting, unsuccessfully, to hold their share of the nonprescription pain-reliever market against two rivals: acetaminophen and ibuprofen...
...Nor was it true, as he further informed us, that Anacin "calms jittery nerves...
...Sterling mainly purchased the exclusive right to use the terms "Bayer" and "Aspirin" in the United States, for ASA's patent had expired in 1917...
...So the aspirin researchers compromised by using very big samples, but not following them up in great detail...
...Funds have not been the researchers' sole problem...
...The profits have been big: Name-brand ASA pills usually sell for 10 times their cost...
...It is safe and effective...
...In the 1960s the Federal Trade Commission (FTC), the overseer of drug advertising, began a 20-year campaign to attack these unfounded claims and omissions...
...Overeager grocers were ordering ASA-based products at half again their previous rate...
...McNeil Laboratories, the leading marketer of acetaminophen, must therefore promote its undistinctive product through the now-venerable merchandising expedient of selling a name, Tylenol—for a decade the leading brand of analgesics in the United States...
...Hoping to establish a pseudomonopoly, it resorted to the novel device of selling its acetanilid under a brand name...
...Meanwhile, the aspirin companies will continue their furious, basically phony, not terribly harmful competition...
...Salicylic acid, its active component, was synthesized in 1838 and came to be used not only as a drug but also in the making of dyes...
...As the authors note, he learned about ASA"not so much in the laboratory as in the library'': It had been discovered four decades earlier...
...Although never sold as an analgesic before the early 1950s, acetaminophen had been synthesized in 1878...
...If everyone receiving a certain drug in an experiment survives some otherwise fatal threat, the outcome probably is not a matter of chance, even if the sample is fairly small...
...Farben cartel...
...Mann and Plummer tell their story in three parts...
...Finally, the commercial concealed the fact that Anacin is mainly ASA...
...Yet consumer sales failed to rise in 1988, andaspirin's-share of the $2.7 billion U.S...
...McNeil Laboratories, Tylenol's manufacturer, sued American Home for asserting that Anacin reduces inflammation more effectively than Tylenol does...
...Acetaminophen, Tylenol's active ingredient, is less likely to upset stomachs yet can provoke asymptomatic liver problems that sometimes cause significant damage before becoming apparent...
...At the end of the century a Bayer chemist looking for a less harmful form of salicylic acid, which had serious side effects, found a new way of using it to synthesize ASA...
...The intensified regulation generated many absurdities...
...This was quite true, but he then said that the product "relieves tension," which was not...
...that the unthinkable happened: Anacin admitted it was made of aspirin...
...A Federal judge, though, decided the claim had not been adequately proved and prohibited it...
...At one point, the FTC denied Sterling's right to advertise the conclusions of a study the commission itself had ordered, showing that none of five leading brands of ASA, including Bayer, provided greater pain relief than the others...
...I would argue that we can surely permit its consumers, like the consumers of religious and political opinions whose consequences are very often vastly more dangerous, to judge the competing arguments for themselves...
...It demanded as well a more careful monitoring of subjects than was practical or affordable in projects enrolling many thousands of people...
...During the "aspirin wars" recounted in the second part of the book, however, it was defeated by Anacin and Bufferin, whose respective manufacturers (American Home Products and Bristol-Myers) applied Sterling's own techniques more thoroughly...
...Perhaps a fairy godmother looks after the destinies of pharmaceutical Cinderellas, for two decades of research have transformed the little white pill into "a kind of miracle drug," Charles C. Mann and Mark L. Plummer tell us in The Aspirin Wars: Money, Medicine, and 100 Years of Rampant Competition (Knopf, 420 pp., $25...
...In 1945 Sterling was the dominant dispenser of aspirin in the Western Hemisphere...
...What Mann and Plummer believe about the underlying logic of the intensified regulation of the 1960s and '70s never becomes clear...
...over-the-counter analgesics market has remained flat at 42 per cent...
...American Home was right...
...Having lost its monopoly, Sterling attempted to capture the bulk of the market by using massive consumer advertising to give its product—once again —a false air of uniqueness...
...The first describes the emergence of acetylsalicylic acid (ASA), as the stuff is known to chemists, and the business it created...
...Unfortunately, the experimental results obtained from every treatment for cardiovascular disease are much less clear-cut...
...That meant Bayer could patent ASA in just two countries—Britain and, disgracefully, the United States...
...Received medical wisdom had insisted on large percentage differences between the placebo and test groups, not merely large absolute numbers in both categories...
...The courts soon ruled that "aspirin" could not be used as a trademark...
...In 1860 a chemist devised an industrial process for manufacturing salicylic acid out of phenol, a dye industry material derived from coal tar...
...like aspirin, it has long been unpatentable...
...Since Germany's dye business was overcrowded, other companies, including one founded by Friedrich Bayer, attempted to make drugs with coal tar...
...The basic pattern of the over-the-counter analgesics market, a reliance on marketing devices to distinguish identical products, emerged even before the coming of aspirin...

Vol. 75 • January 1992 • No. 1


 
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