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“The only thing necessary for these diseases to the triumph is for good people and governments to do nothing.”



London Sunday Times on Bayer drug trials

Mike Palmedo
Wed, 24 Jan 2001 13:32:41 -0500


Drug firm put patients at risk in hospital trials 

ONE of the world's largest drug companies placed hundreds of patients at
risk of potentially fatal infections by failing to disclose crucial
safety information to six hospitals at the start of a nationwide drug

Up to 650 people underwent surgery in Britain in the experiment
organised by Bayer, the German pharmaceutical giant, despite the company
having conducted studies which showed its drug reacted badly with
others, seriously impairing its ability to kill bacteria. 

This prior research, obtained by The Sunday Times, was not revealed at
the start of the study to the hospitals involved. 

The trial, whose flaw has never been revealed to the patients or their
families, resulted in nearly half of those operated on at one test
centre in Southampton developing a variety of potentially
life-threatening infections. 

At least one patient died during this part of the trial. Another
developed an infection so serious that his relatives were initially told
he would not survive. 

Infection and mortality rates at the five other trial centres - which
included the Queen Elizabeth hospital in Birmingham, St James University
hospital in Leeds and York district hospital - have never been revealed
on grounds of "confidentiality" by either Bayer or the Medicines Control
Agency (MCA), the government body that monitors clinical trials. 

"We have only just become aware of this information and have opened an
inquiry to determine the facts as a matter of urgency," said Mike Porte,
medical director of York Health Services NHS Trust, last week. 

"If anyone were to deny our ethics committee information, we would
regard that as a matter of the utmost seriousness." 

Concern about the trial was revealed by Stephen Karran, a retired
consultant surgeon from Southampton. 

He says he decided to contact the press after making a string of
complaints that have come to nothing. 

"Despite pointing out the flaw in the study at the earliest possible
stage, the trial went ahead unaltered across the country," said Karran
last week. "I believe patients have suffered and that full and
independent investigation is required." 

James Legg, a former soldier and gardener, was one of those entered into
the trial at Southampton. Rose, his widow, and Margaret Down, his
daughter, recall rushing to his bedside 36 hours after the operation,
having been told by his doctors that he had developed a post-operative
chest infection and was unlikely to survive. 

"We were told he had developed an infection but nobody has ever
mentioned that there was a problem with the trial," said Rose last week. 

Legg survived the infection but died of cancer three months later. "To
think the chest infection could have been avoided makes me so angry,"
said Rose Legg last week. "It sapped his strength and without it he may
have lived longer." 

Bayer commissioned research as early as 1989 which showed that its
antibiotic ciprofloxacin (sold as Ciproxin) reacted badly with a variety
of opiate-based sedatives or "pre-meds" commonly given to patients ahead
of surgery. 

The researchers, including Karran, conducted laboratory experiments
which showed the drug was not properly absorbed by such patients. This,
they reported to Bayer, would increase the risk of them developing
infections after surgery. 

However, by 1993 Ciproxin, already in use as a general antibiotic, had a
licence in one limited branch of surgery and Bayer was eager to win
others. Because the drug was available in a cheap tablet form, it had an
advantage over rivals, most of which have to be injected. "It is
possible that in the future the choice of antibiotic will be governed by
cost," reported one of its publications in 1993. In the same year Bayer
won clearance for a large-scale human trial of Ciproxin in surgery. 

Last week Bayer confirmed that it knew of the absorption problems
associated with Ciproxin before the study began. It also confirmed that
the study's protocol did not take account of the problem and that it was
changed at an unspecified point during the study. 

Bayer declined to reveal overall numbers for post-operative infections
and fatalities, on the grounds that the data remained confidential. It
did claim, however, that infection rates were "similar" among those
patients who received Ciproxin and those in the control group who
received a proven alternative. 

"The study was approved by the competent regulatory authority and all
local ethics committees prior to initiation," said a spokesman.