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#drug-safety
2 articles
DES and the Cancer That Waited a Generation
Diethylstilbestrol — DES — was the kind of drug that seems, in hindsight, designed to teach a lesson about how medicine can fail. A cheap synthetic estrogen, first made in 1938 and never patented, it was prescribed from around 1940 onward to millions of pregnant women in the United States and elsewhere, marketed with the soothing promise that it would prevent miscarriage and make 'normal pregnancies more normal.' It did neither. As early as 1953, a careful controlled study showed that DES did nothing to prevent miscarriage — and yet doctors went on prescribing it to pregnant women for nearly two more decades. The true cost did not appear in the women who took it, or even in their pregnancies, but in the children those pregnancies produced. In 1971, doctors traced a sudden cluster of a rare vaginal cancer in young women — a cancer almost never seen in people that age — back to a single common factor: their mothers had taken DES while carrying them. It was the first time a drug had been shown to cause cancer not in the person who took it but in their child, years later, through the wall of the womb. The harm had waited a generation to appear. Behind it lay a tangle of failures — a drug sold without good evidence, kept on the market long after it was shown useless, and made by so many companies that, decades later, the women it injured often could not even prove whose pill their mothers had swallowed. This is the story of DES: what it was, why it was given, the delayed catastrophe it caused, and the lasting marks it left on medicine and the law.
Vioxx and the Painkiller That Broke Hearts
Vioxx was supposed to be a better painkiller. Approved in 1999 and marketed aggressively by the pharmaceutical giant Merck, it belonged to a new class of drugs — the COX-2 inhibitors — that promised the pain relief of traditional anti-inflammatories like ibuprofen and naproxen without their tendency to cause stomach ulcers and bleeding. It was a blockbuster almost instantly, prescribed to some eighty million people worldwide and earning Merck around two and a half billion dollars a year at its peak. But sitting inside the company's own clinical data was a signal it did not want to see: Vioxx increased the risk of heart attack and stroke. A large Merck study had pointed to it as early as 2000, and rather than confront the possibility that its blockbuster was dangerous, the company offered an alternative explanation, kept marketing the drug, and — according to documents later revealed in court — trained its sales force to dodge doctors' questions about heart safety. It was not until 2004, when a second trial produced cardiovascular results too clear to spin, that Merck withdrew Vioxx from the market. By then a scientist at the United States Food and Drug Administration had estimated that the drug may have caused tens of thousands of excess heart attacks and deaths. This is the story of Vioxx: a drug that worked as a painkiller and killed as a side effect, a company that saw the danger and looked past it, and a disaster that exposed how poorly the system guards against a medicine that turns out to be lethal after it is already in millions of bodies.
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