Withdrawn painkiller may be linked to hundreds of deaths

[Guest guest]

Well, looky who wrote this!!! Surprised he didn't find an opportunity to

blame Andy Wakefield for this too!

http://www.timesonline.co.uk/article/0,,8122-1482338,00.html

February 13, 2005

Withdrawn painkiller may be linked to hundreds of deaths

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Vioxx, which was withdrawn from sale over safety fears last September.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 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 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, , 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.