Sunday, October 10, 2004

Drug Giants Accused Of Pursuing Profit Over Safety

Drug Giants Accused Of Pursuing Profit Over Safety
By Jeremy Laurance
Health Editor
The Independent - UK

The multibillion-pound global pharmaceutical industry was accused yesterday of ignoring safety risks in pursuit of profits after the largest withdrawal of a prescription drug in history.
Doctors on both sides of the Atlantic said the removal from sale of Vioxx, a painkiller for arthritis, demonstrated the failure of the industry and drug regulators to protect people.
They warned of a public health emergency over other painkillers in the same class, known as Cox 2 inhibitors, which could also pose a risk. Articles in The Lancet and the New England Journal of Medicine said the companies making the painkillers knew of the potential risk for five years but failed to run the necessary trials to check whether the drugs posed a real danger.
On Tuesday the European drug safety agency announced an urgent safety review of all Cox 2 inhibitors, which have combined global sales of $10bn (£6bn). Vioxx, made by the US company Merck and Co, was launched in 1999 and was heavily promoted in 80 countries with annual sales of $2.5bn.
Eighty million people used it, including 400,000 in the UK. The increased risk emerged by chance during a trial of Vioxx in bowel cancer patients. It almost doubled the risk of heart attacks and stroke in people taking it for 18 months. But the New England Journal of Medicine said that studies since 1999 had repeatedly indicated a potential danger. Drug regulators made Merck include a warning in the drug package, but never ordered a definitive trial.
In the US, a report by the Food and Drug Administration leaked to the Wall Street Journal said Vioxx may have caused more than 27,000 heart attacks - possibly 7,000 of them fatal - in the time it had been on the market. The report's author, Professor Wayne Ray of Vanderbilt University, Tennessee, was quoted as saying: "I have been in this business for 20 years and this is the biggest drug-safety problem I have encountered."
Richard Horton, editor of The Lancet, said: "This is a public health emergency which raises grievous questions about the adequacy of our regulatory system. We need urgent disclosure of the data from the companies and the regulators with a view to possible immediate suspension of sales [of other Cox 2 inhibitors] should they indicate a similar adverse effect."
Eric Topol, chairman of the department of cardiovascular medicine at the Cleveland Clinic Foundation, said in an online article in the NEJM that Merck had spent more than $100m a year promoting Vioxx to consumers in the US. "Merck's commercial interest in refecoxib [Vioxx] sales exceeded its concern about the drug's potential cardiovascular toxicity," he said. "Considering the tens of millions of people who were taking refecoxib we are dealing with an enormous public health issue ... there may be tens of thousands of patients who have had major adverse events."
Dr Topol said the vast money in drug development and the dependence of doctors and drug regulators on the industry for research grants and funding put patients at risk. The antidepressant drugs known as SSRIs were banned for use on children last year and a review of use in adults is continuing in the UK. Crucial evidence about one of the drugs, Seroxat, made by the British-based multinational GlaxoSmithKline, was allegedly withheld by GSK.
Dr Horton added: "Drug regulators in the UK have displayed astonishing complacency. Any situation where a drug regulator is funded by the industry makes it impossible for that regulator to make unbiased decisions."
The withdrawal knocked 27 per cent off Merck's share price in a single day.