- 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.
-
- ©2004 Independent Digital (UK) Ltd. All rights
reserved
-
- http://news.independent.co.uk/
- uk/health_medical/story.jsp?story=569936
|