Pharmageddon. David Healy

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СКАЧАТЬ like Worcester had been called repeatedly to homes to try to save the lives of children being literally garroted by membranes from the diphtherium bacteria forming deeper and deeper down in their windpipe. They would cut open the child's throat and pass in a tube and hope no membranes formed even lower down, though all too often this failed. Distinguishing diphtheria from other bacteria led to the synthesis of diphtheria antitoxin in 1894. As the membranes from the illness faded in response to an injection of the antitoxin, so also the nightmare of diphtheria began to fade away in areas where the antitoxin was available.²⁰ Successes like this heralded a future of pharmaceutical magic bullets.

      Discovering a new dye or drug in Germany of the late nineteenth century did not give a company sole rights to that product. If another company could demonstrate that it was able to produce the compound by a different process than that specified by the original company, the second company was entitled to manufacture its version of summer blue, say, or acetylsalicylic acid. When acetanilide, one of the drugs derived from dyes, was shown to be antipyretic (fever reducing), for example, well over ten companies found different ways to produce it. No company could easily make a blockbuster drug in these circumstances. Faced with this scenario, in 1886, another German company, Kalle, borrowing a practice from the proprietary industry, trademarked the name of their version of acetanilide—Antefebrin. Sales boomed. Other companies took note, and Bayer followed by registering Aspirin and Heroin in 1898, names with far more resonance to this day than acetylsalicylic acid or diacetylmorphine. The basis for both of these painkillers had first been created close to fifty years earlier, so Aspirin and Heroin were new social rather than pharmaceutical creations.²¹

      The first brands had got a foothold within medicine, and the medical profession began to make an uneasy accommodation to this changed reality. Medical students were taught to refer to the generic names of drugs—diacetylmorphine rather than Heroin. For almost a century this denial of brands worked passably well, but to continue to pretend that doctors today typically still prescribe generic drugs rather than brands passes beyond denial into fantasy.

      This denial was helped by the fact that the focus in promoting the new magic bullets from diphtheria antitoxin to Heroin was directed toward doctors rather than the public at large, and toward conquering the scourge of disease rather than capitalizing on the discontents of everyday life. Sales of these new compounds were promoted by visits from company representatives to doctors and ads in medical journals, rather than the hoopla customary to the proprietary medicines' industry. There was minimal effort to subvert medical judgment, in part perhaps because until the 1940s there was relatively little to sell.

      Then, in 1937, prontosil red, a dye produced by the pharmaceutical conglomerate IG Farben, gave rise to the sulfa antibiotics, which had as great an impact on lethal conditions like bacterial endocarditis, an infection of the lining of the heart, as diphtheria antitoxin had on diphtheria forty years earlier. Other antibiotics followed in the 1940s and from the sulfa nucleus came a host of other drugs, including diuretics to remove excess body fluid in heart failure, antihypertensives to lower blood pressure, and oral hypoglycemics to lower blood sugars. In the 1950s, dyes such as methylene blue and summer blue led to the antipsychotics and antidepressants.

      These new drugs all came branded by their manufacturers. These were brand names that spoke of medical diseases and or chemical contents rather than the old style panaceas whose promises were in inverse proportion to their efficacy. Thus just as Kalle had given doctors Antefebrin (antifever), Merck in the 1960s gave them Diuril (for diuresis), and Tryptizol (amitriptyline) as an antidepressant. Initially, as with brands such as Hoover and Mercedes, these new brands traded on quality. The brand stood for the fact that the drug was produced by a reputable company that was linked to previous breakthroughs and doctors could accordingly be confident about the pedigree of the product. This was an era of “magic bullets”—penicillin, the thiazide antihypertensives, and antipsychotics such as chlorpromazine—which would have marketed themselves, branded or not.

      Indeed, by the 1960s it seemed to many doctors as if medicine had faced down the destructive forces of marketing as the proprietary medicines industry withered away with the advent of these new magic bullets. Few drug company invaders in the 1950s and 1960s in dead of night appeared to crawl out of the Trojan horse that brands had introduced to the medical citadel. But the fatal breach had been effected. Changes to the patent laws in the 1960s, allied to the fact that these new drugs were available by prescription only, laid the basis for the emergence of blockbuster branding in the 1980s.

       PATENT MEDICINES

      Patents offer an exclusive right to produce a good or service. They are granted by a state, are even older than brands, and once provoked almost as much hostility within medicine as brands. Patenting drugs, and thereby restricting access to them either physically or by virtue of the increased price that comes with a monopoly, was for centuries regarded as incompatible with a vocation to alleviate disease. In the case of modern drugs, this period of monopoly lasts for twenty years.

      The first patent law was enacted in Venice 1474, and the idea then spread rapidly throughout Europe.²² In Britain, after widespread complaints about abusive patent monopolies being granted by the Crown for long-existing technologies, the law was tightened in 1624 to limit grants of monopolies to “the sole working or making of any manner of new manufactures within this realm, to the true and first inventor and inventors of such manufactures.”²³

      Being the exclusive patent holder of a good or service meant that you could produce it at a higher price than was possible in a competitive market. This, it was hoped, might lure innovative producers to Britain, and their activities would in turn stimulate commerce and improve national revenues.²⁴ However, in return for this benefit the producer had to show plans to create something novel that plausibly brought some benefit to the wider community.

      In Britain, patents went hand in hand with the enclosure of common lands in the sixteenth century, and critics of patenting since have referred to the anticommons effect of the practice. Because science hinges on common access to all data, many scientists and free market advocates have been hostile to patenting. But the deepest hostility to patents throughout the nineteenth and twentieth centuries came from within medicine. Neither the doctors who treated patients nor the pharmacists who dispensed remedies a doctor ordered regarded the remedies they gave as industrial or commercial products or their own activities as either industrial or commercial.

      In France, the Revolution led to promulgation of a new law in 1791 that permitted drugs to be patented.²⁵ Chemists and trade associations on the one hand argued at the time for the rights of inventors to be recognized. But French physicians and pharmacists argued against patents; their vocation, they said, was to treat the sick, not to make a profit. Furthermore, patents, they predicted, would lead to an increase in the price of medicines, which would be detrimental to public health.²⁶ In 1844, the French National Assembly reversed the 1791 law and removed medicines from the domain of patentable products.

      German law did not permit drugs to be patented, but it did allow companies to defend their product by taking out a patent on the process used to make the compound. Another company could get around the monopoly that these patents created, if they could find another way to make a compound. In some cases, as with acetanilide, this was easy, and it was this that led Kalle and Bayer to trademark their new compounds, which gave them exclusive use of the brand name they chose for their product.

      American law, in contrast, allowed patents to be taken out on drugs, even though some of the fathers of the Republic were hostile to patents. Benjamin Franklin refused to take out a patent on a stove he invented while Jefferson, referring scornfully to England's willingness to let anything be patented, refused to patent a hemp-brake he invented, stating that “nations which refused monopolies of invention are as fruitful as England in new and useful devices.” In this spirit, the nation's patent office was initially stringent in its review of applications for drug patents. In 1922, for example, Lilly attempted but failed to СКАЧАТЬ