Reprint
Withdrawn painkiller linked to hundreds of deaths
The Sunday Times, February 13 2005
Brian Deer
DOCTORS have reported 103 deaths they suspect were due to the painkiller Vioxx, which was withdrawn from sale over safety fears last September.
The figures released by the drug safety agency also show there were 7,150 adverse reactions to the drug during its five years on sale in Britain.
Experts say, however, that under-reporting through the government’s “yellow card” system, could mean the true death figure may be as high as 2,000.
Vioxx was licensed in April 1999 with claims that it was safer than traditional painkillers, such as ibuprofen and diclofenac, for its main use in relieving arthritis. It was backed by a massive media campaign, often featuring middle-aged celebrities ice skating, and with a huge push to doctors through sales reps. In Britain about 10m prescriptions were written.
But evidence from studies sponsored by its manufacturer, Merck Inc, aimed at expanding the drug’s use into other medical conditions, found a dramatic rise in heart attacks and strokes, prompting its overnight withdrawal.
New Jersey-based Merck, one of the world’s biggest pharmaceutical groups, said its priority was patient safety.
According to Merck, about 400,000 mostly older people were taking Vioxx in Britain when the company voluntarily withdrew it worldwide. Some patients had been won to the product from other drugs, but many were new to taking regular painkillers. Prescriptions often provided a month’s supply and a typical patient used Vioxx for two years.
Calculations based on the yellow card reports suggest 2,000 patients may have died, a death rate of 1 in 400. The company disputed these figures this weekend, but the calculations support those of Dr David Graham, an official of the US government’s Food and Drug Administration (FDA), who became a whistleblower claiming that Vioxx was responsible for 140,000 heart disease cases and up to 56,000 American deaths.
This week the FDA is to hold crisis hearings in Washington over Vioxx and other drugs of its kind. “In a huge number of cases, the benefits of these new drugs just wasn’t worth the risk,” said Professor Andrew Herxheimer of the UK Cochrane Centre in Oxford, who is one of Britain’s drug safety experts. He believes only about 5% of problems are reported through the yellow card system.
Britain’s notification arrangements by the Medicines and Healthcare Products Regulatory Agency are considered among the best in the world, but research by Herxheimer and others reveals huge underestimates. One survey found that only 16% of doctors had ever sent a yellow card, while another found that 80% of the reports were filed by only 7% of doctors.
Numbers do little to reveal the human tragedy of premature deaths. “People say time is a great healer, but you never get over it,” said Maureen Watt, 64, of Bargoed, south Wales, whose husband, Alexander, died of a heart attack at the age of 58 while taking Vioxx. “In my heart I know that tablet killed him,” she said.
The Watt case has been taken up by lawyers hoping to add British clients to a tide of Vioxx litigation now sweeping America. But turning statistical links of harm into evidence that a drug was responsible for any particular death is fraught with difficulties.
Merck’s UK subsidiary said adverse reaction figures had to be compared with those for traditional painkillers, which caused about 2,000 deaths a year. “We withdrew the drug as soon as we recognised there was a problem,” said a spokeswoman.