from pharmaceutical companies advertising in its journals.
Kefauver's bill (S. 1552) was rewritten by his congressional opponents to make it more company friendly and in this form it seemed to have good prospects of passage. But then reports began to surface from Germany of the effects of a drug called thalidomide. Thalidomide was a sleeping pill sold over the counter in Germany and about to be marketed in the United States by Merrell Pharmaceuticals, when it was linked to a new and disturbing problem—babies of mothers who had taken the drug were born limbless or with useless flippers (phocomelia) where limbs should have been. The makers, Chemie-Grunenthal, fought the linkage to their drug and only removed thalidomide from the German market under pressure. Almost a year after the first reports, Merrell were mailing samples of the compound to American doctors, even though it had still not been licensed in the United States.
These events transformed the political imperative. Kefauver's bill was resurrected and rushed through both House and Senate, resulting in the 1962 amendments to the Food and Drugs Act. This mandated proper animal testing of drugs for toxicity before launch, and gave the FDA control over advertising. The new bill contained three further provisions whose far-reaching ramifications will be explored in chapters 2 and 3— it maintained prescription-only status for all new drugs, it required that companies demonstrate their drugs worked for a specified condition (where before they only had to prove safety), and it required companies to use controlled studies to demonstrate drug benefits. Kefauver's bill, however, was stripped of its provisions to change patent law, despite support from the Chief Patent Officer. And because the patent law wasn't changed, the 1962 amendments had no effect on Kefauver's primary target—control of the prices of drugs.
While it failed in its primary objective, the stripped-down bill was passed to wide acclaim. Kefauver, flanked by the junior senator from
Tennessee, Albert Gore, Sr., had been given the honor of speaking to it on the Senate floor. The disturbing changes in the climate of medicine would be stopped or even reversed, he hoped. Kennedy and Kefauver basked in the glow of success. Frances Kelsey, a staffer at the FDA, whose bureaucratic delay in reviewing and handling the license application for thalidomide undoubtedly restricted the number of American children exposed to the drug in utero, received a President's Award for Distinguished Federal Civilian Service. The reforms to the FDA were copied by other regulatory agencies worldwide. When it came to drugs, the management of pregnancy became the one area of medicine that most closely conformed to Pinel's hopes for all of medicine—that doctors in knowing when not to prescribe would demonstrate the highest medical art. Many still think this to be the case, but today's reality is quite different.
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
