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KEYCODE BAYER #18

The Sunday Times, May 14, 2000

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 trial. 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.

By Paul Nuki, David Leppard, Gareth Walsh and Guy Dennis