Pharmageddon. David Healy

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      2

       Medicine and the Marketers

      When she became pregnant in 2004, 38-year-old Gina Fromm did a range of things that few women would have done in the early 1960s— she took cold rather than hot showers in case she might harm her baby, stopped eating yogurt and incinerated chicken because of the risk of bacterial infection, from listeria to salmonella. She balked at taking prenatal vitamins, though she had been taking Paxil following a fleeting episode of anxiety. She continued to take it through her pregnancy; she had found stopping difficult and her doctor reassured her it posed no risk to her baby. On February 2, 2005, her son was born with congenital heart defects.¹

      In the decades following the passage of Senator Kefauver’s bill, women were far less likely to smoke, drink alcohol or coffee, or take painkillers while pregnant. Nevertheless, Paxil and other SSRI antidepressants, among the direct successors of thalidomide, were on their way to becoming the most commonly prescribed drugs in pregnancy— especially in the United States. In 2006, forty-four years after the 1962 amendments to the Food and Drugs Act, the first legal actions were filed for birth defects induced by SSRI antidepressants, resulting in verdicts against GlaxoSmithKline and huge settlements, but this made little dent on the prescribing of SSRIs in pregnancy, which continued to mount.

      Nothing about the 1962 amendments obviously predicted the replays of drug-induced birth defects we now have. Medications continued to be available on a prescription-only basis. With the 1962 amendments to the Food and Drugs Act, companies were to be restricted to selling medications for real diseases rather than for trivial indications like halitosis or fleeting anxiety states. Furthermore, from 1962 onward, companies had to demonstrate by means of controlled trials that their remedies did in fact work.

      There can be few better symbols of Pharmageddon than prescription only drugs becoming among the most consumed drugs in pregnancy in the face of strengthening warnings that they cause birth defects. The answers to how this could happen lie in great part in how the pharmaceutical companies have managed to capitalize on the very protections put in place by Senator Kefauver in his 1962 bill and in the reforms that defeated him. Prescription-only status has made doctors the targets of a marketing exercise that is far more sophisticated than placing even billions of pages of advertisements in medical journals and bribing doctors to use drugs. As outlined in chapter 1, the patent status of drugs has given companies an incentive to chase blockbuster profits—doing so regardless of patient welfare. Controlled trials have given the companies a means to persuade doctors that snake oil works so well that withholding it in pregnancy would be unethical, and also a means to make problems consequent on treatment vanish. But all of these hinge on the fact that these drugs are available by prescription only.

       WHAT THE DOCTOR ORDERED

      When Alfred Worcester or Richard Cabot wrote a prescription for a remedy at the dawn of the twentieth century, they were following a centuries-old tradition of asking an apothecary to take certain ingredients and mix them according to a formula (Rx = Recipe). If there was more than one ingredient in the mix, each should have a particular purpose. If the remedy worked, patients were able to take the prescription back to the pharmacy on numerous occasions asking for refills for themselves without further endorsement from the doctor. Alternatively, having once obtained something by prescription that worked, they could revisit the pharmacist and ask for the same medicines again, for family members. A prescription from a doctor was only one means by which people could access the drugs they believed they needed.

      Because in Cabot’s day all medicines, including opiates, bromides, barbiturates, chloral hydrate (used for sedation), antiseptics, remedies for the gut, urinary system, and heart and respiratory system were available without recourse to a doctor, the threshold for visiting a doctor was far higher than it is today. Until the middle years of the twentieth century, there was no one being treated for latent diabetes, latent hypertension, or raised lipids. Aside from a few wealthy people engaged in psychoanalysis, no one had contact with the mental health system other than those relatively few who had psychoses and were committed to asylums.

      When the US Congress passed the 1906 Food and Drugs Act, it contained no prescription requirement, only a requirement that medicine manufacturers state the contents of the product on the label. The pharmaceutical industry lobbied hard against the act, but once it was in place many enterprising manufacturers found ways of working the new situation to their advantage, for instance, by labeling their product “as approved by the Chemical Bureau.”²

      There were no implications here for traditional medical practice. But another regulatory step taken soon thereafter had profound implications. The nineteenth century saw a growing concern about opiate and cocaine abuse, as well as alcoholism. These problems had been of little concern to medicine. Drug addiction, like alcoholism, was considered a social problem, except where the affected people became patients by virtue of cirrhosis or psychosis. After a variety of social approaches to treating the problems of addiction floundered, in 1914 the US Congress passed the Harrison Narcotics Act, which introduced prescription-only status for opiates and cocaine.³ The problem of addiction would be managed, or so it was thought, by making these drugs legally available only through a medical practitioner.

      After СКАЧАТЬ