ARTHRITIS DRUG LINKED TO 10 DEATHS IN US

A PAINKILLER made by Monsanto, the genetically modified foods company,
has been linked to ten deaths and 11 cases of gastrointestinal
bleeding in its first three months on the US market, it emerged yesterday.

Celebrex was trumpeted as the first of a new generation of arthritis
medications. Its makers said it would spare sufferers side effects,
such as ulcers, associated with traditional drugs.

But according to reports handed to the US Food and Drug Administration
by the Wall Street Journal, five users have died after suffering from
gastrointestinal haemorrhages or ulcers. Two other deaths were
attributed to heart attacks, one to drug interaction and one to kidney
disorder. No cause was given for the tenth death.

More than two million people have taken Celebrex for osteoarthritis
and rheumatoid arthritis.

Earlier this month Switzerland became the first country in Europe to
approve Celebrex. As well as the United States, it is also approved
for marketing in Mexico, Brazil and Argentina.

Scarlett Lee Foster, a Monsanto spokeswoman, said yesterday that there
was no evidence that Celebrex caused the deaths or other health
problems in people taking the drug. It was launched after clinical
trials involving more than 13,000 patients and healthy volunteers in
more than 50 studies in 23 countries. "You can't draw any conclusions
from the adverse incident reports," she said.

The Journal did not specify the sources of the so-called adverse event
reports, which could come from health professionals, consumers or the
drug company itself.

Celebrex, manufactured by St Louis-based Monsanto's GD Searle
subsidiary, went on the market in January. It was touted by Monsanto
as an effective pain reliever much like ibuprofen, but was much less
likely to cause severe stomach problems. So far it has been a success,
with 2.5 million prescriptions filled in its first 13 weeks on the
market, compared with the record 2.7 million prescriptions of the
anti-impotency drug, Viagra, filled during its first three months.

Robert DeLap, director of an FDA office of drug evaluation, said more
research needed to be done before making a conclusion about Celebrex's
safety. "Do we think there's a signal that the product poses some
special risk? No, not at the moment," he said.

Steve Geis, Searle's vice-president for arthritis clinical research,
said he remained excited about Celebrex's performance. "We really feel
the drug is performing as expected. The safety profile is what we
would expect," he said.

Mr Geis declined to go into details about any cases of death linked to
the drug, but said that many patients taking Celebrex had other illnesses.

Anne Malo, 48, a Canadian who took part in one of the clinical trials,
said her life was transformed after she began taking the drug two years ago.

She had suffered from severe osteoarthritis for ten years and had
tried many drugs with "mediocre [pain] relief at best and, as is
common, gastrointestinal side effects".

Since taking the drug she had been able to jog between three and five
miles a day, swim and go skiing. She had also resumed performing as a
musician. "It is certainly not an understatement to say that Celebrex
gave me back my life," she said.