Pharmageddon. David Healy

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СКАЧАТЬ Where almost no one had bipolar disorder, osteoporosis, or female sexual dysfunction two decades ago, these new conditions are now global epidemics.

      Claims like these are cheap. If it were so simple to capture the institution of medicine just by coming up with fancy names for drugs, drug classes, and diseases, the proprietary medicines industry of the nineteenth century would never have died out. But driven by a real desire to care for the most vulnerable in society and a commitment to science, medicine eliminated these imitations of medical remedies for a century, with the exception of some holdovers from the former era such as Listerine and Clearasil. Good medicines clearly pushed out bad ones, in large part because they were based on good science. And good science continues—we now have astonishing developments in genetics and in medical imaging, so the argument presented here needs to pull back the curtains on the tricks of the pharmaceutical trade and show not only how modern marketing has closed in on the holy grail of fooling all of the people all of the time, but also why there has been so little resistance among doctors.

      A great deal of the marketers' sleight-of-hand has involved a manipulation of the appearances of science. There is the early twentieth-century science that produced the sulfa drugs and other antibiotics such as penicillin that let the dying rise from their deathbeds. Science like this cuts across marketing. The results were so dramatic that the drugs in effect sold themselves. But the best-selling drugs today aren't like this. They come wrapped in numbers that appear to come from science but that have been fashioned by marketers to indicate abnormalities of lipids, blood pressure, blood sugar, mood, bone density, and respiratory flow, as well as penile stiffness and clitoral sensitivity that their company's drugs just happen to treat.

      But science on its own, however artfully presented, would not have produced the comprehensive shift toward lifestyle drugs we have seen in recent decades or permitted pharmaceutical companies to penetrate the inner sanctums of medicine and transform it from a profession deeply hostile to marketing into a marketer's dream. There has been more involved. We have dealt with one structural element—the change in patent laws. We will now move on to two others—the emergence of prescription-only status for new drugs and the turn to controlled trials in the evaluation of drugs.

       CLIMATE CHANGE

      In retrospect the twenty-five years stretching from 1937 when the sulfa drugs were first introduced to 1962 when the US Food and Drugs Act was revised to tighten up regulations governing pharmaceuticals seems like a golden age. There were more novel agents introduced during this period than at any time before or since—the first antibiotics, antihypertensives, antipsychotics, and antidepressants, and the first oral antidiabetic drug. The period had not started well, however. Soon after sulfanilamide was introduced in 1937, a pharmacist in Oklahoma, unaware of the risk of ethylene glycol, sold sulfanilamide made up in this solvent, leading to over a hundred deaths.⁴² In response, in 1938, American politicians stepped in to regulate commerce in medicines, through the Food, Drugs and Cosmetics Act. In 1962, American politicians stepped in again to regulate the industry with consequences that will follow us through to the end of the book.

      Up to the late 1950s, prior to the passage of the 1962 amendments, in a history all but forgotten, the American Medical Association (AMA) had laboratories where they conducted their own testing of new drugs. They vetted any advertisements run in their journal, the Journal of the American Medical Association (JAMA), for accuracy and only permitted those that earned their Seal of Approval. They regularly ran assessments of new treatments that were not beholden to the pharmaceutical industry. They were known for their support of generic formulations of drugs in preference to branded drugs. But in the 1950s these curbs on promotion stopped. The Seal of Approval scheme was watered down as the AMA sought further advertising revenue from pharmaceutical and other companies to fight Democratic plans to introduce a bill for Medicaid in Congress. With the new advertising, their revenues doubled.

      In the 1950s there emerged a new set of discontents with the practices of the pharmaceutical industry and the prices these companies were charging for their drugs. The discontents were brought to public focus by the Democratic senator from Tennessee, Estes Kefauver. Kefauver's interest was stimulated when members of his staff found that several versions of the same antibiotic, marketed by different companies, had identical prices, and that the prices being charged were of the order of a 1000 percent of the price of manufacture. As they explored the issues, Kefauver's staff found compelling evidence that companies were secretly engaging in cartel practices to maintain the price of medicines and corrupting doctors with backdoor payments to prescribe on-patent and more expensive drugs. There seemed to be, as Kefauver put it, “an upside down competition where prices continue to go up even when production remains low or declines.”⁴³ As the chair of the Senate antitrust and monopoly subcommittee he had the mandate to investigate what might be behind the apparent price-rigging.

      Another concern of Kefauver's was the advertising for drugs. There was the sheer volume. As Walter Griffith of Parke Davis told Kefauver, “the ethical pharmaceutical industry of this country” had turned out “3,790,908,000 pages of paid journal advertising” and “741,213,700 direct mail impressions.”⁴⁴ But of greater concern was that the ads were commonly misleading and in many cases downright fallacious. Kefauver's staff unearthed one ad for an antibiotic which displayed two chest X-rays, giving the impression of clinical improvement when the X-rays in fact came from two different patients neither of whom had had the antibiotic featured. As Dale Console, a former medical director at the Squibb pharmaceutical company later put it at Kefauver's Senate hearings, “If an automobile does not have a motor, no amount of advertising can make it appear to have one. On the other hand, with a little luck, proper timing, and a good promotion program, a bag of asafetida with a unique chemical side chain can be made to look like a wonder drug.”⁴⁵

      Yet other concerns lay in drug company practices of withholding safety data on drugs, their lack of testing of new drugs on animals prior to marketing to humans and, more problematically, the fact that the regulators had no procedures in place to ensure a drug worked. The 1938 Food, Drugs and Cosmetics Act solely required companies to demonstrate safety in a number of patients without even basic toxicology testing in animals. As Kefauver's staff noted, if a drug didn't work for a condition for which it was marketed or worked less well than an already available product, then it was inherently unsafe. These discontents led in 1959 to the establishment of the Kefauver-Harris Senate hearings on pharmaceutical practices.⁴⁶

      Kefauver's main target was the patent system, which he thought was primarily responsible for the artificially high prices American patients uniquely faced. At the hearings, he elicited some revealing testimony from Frederick Meyers, a University of California professor of pharmacology who admitted that “most of the program [in drug research] has come from European and British researchers.” The purpose of much of the work done by American drug firms was, according to Meyers, “partly to exploit and market” these foreign products but “mostly to modify the original drug just enough to get a patentable derivative.”⁴⁷ Was this a good idea? Kefauver's staff produced figures to show that out of 77 countries surveyed, 28 allowed product patents and in these countries the prices of drugs ranged from 18 to 255 times higher than in the nonpatent countries, with both American-made and European- made drugs costing far less in Europe than in the United States.

      But as Kefauver found, “These drug fellows pay for a lobby that makes the steel boys look like popcorn vendors…anyone who dares seek the truth will be accused of being a persecutor.”⁴⁸ Up for reelection in 1960, he found himself branded a “socialist hell-bent on ruining healthcare.” He was reelected comfortably, but when it came to his bill, despite having been the 1956 Democratic vice-presidential candidate, Kefauver had no support from the Kennedy administration, who were at the time trying to get Medicaid through Congress and did not want to antagonize the pharmaceutical industry. He also had no support from the American Medical Association, even for something as basic as a requirement that companies prove their drugs work before they are let on the market. The AMA was gearing up to fight Medicaid and was dependent on the increasing СКАЧАТЬ