A tale of two drugs

The cases of thalidomide and Vioxx show what can happen when things go wrong

In the mid-1950s the drug thalidomide was used as an epilepsy treatment in Germany, despite a lack of supporting evidence. The drug had a sedative quality, and patients who received it reported a deep soothing sleep. By 1957, based on the drug’s ability to relieve nausea, it was being marketed as a treatment for morning sickness.

Although the effects on the mother were as expected, the drug proved fatal for many exposed to it in the womb. In the early 1960s, a British Medical Journal paper linked hundreds of cases of malformations in children whose mothers had taken thalidomide during the pregnancy.

In all, 8,000–12,000 babies were affected, only about 5,000 surviving beyond childhood. After thalidomide, the regulation of drug testing was tightened considerably and systems introduced to report adverse reactions.

Despite safety being much improved, the case of Vioxx illustrates that it is not infallible. Vioxx and related drugs were supposed to be good painkillers with fewer side-effects than existing drugs. It was launched in 1999, but almost immediately some researchers questioned whether it was really safe. In 2004, with global sales exceeding US$2.5bn (£1.2bn) a year, Merck withdrew the drug after a trial revealed a doubling of risk of heart attack and stroke.

It’s been estimated that Vioxx caused 88,000–139,000 heart attacks, 30–40 per cent of them fatal. Some critics accused the FDA, the USA’s drug-licensing body, of not doing enough to protect patients. Merck was accused of massaging data (which it denies). A settlement of nearly US$5bn (£2.5bn) has since been agreed for Vioxx lawsuits – without admitting liability.

About this resource

This resource was first published in ‘Drug Development’ in January 2008 and reviewed and updated in August 2014.

Topics:
Medicine, History
Issue:
Drug Development
Education levels:
16–19, Continuing professional development