DRUG LINKED TO DEATHS TO BE TESTED

Bayer says trials not the result of bad press

Bayer Canada will fund clinical trials of a blood product implicated
recently in the deaths of tens of thousands of people worldwide during 50
years of common usage.

The decision to undertake clinical trials of albumin was made independently
by the Canadian arm of the pharmaceutical giant, even though the drug
industry as a whole has declined to take a position on its alleged safety
risks, said Dr. Tim Shannon, vice-president of medical and scientific
affairs at Bayer Canada in Toronto.

A study published two weeks ago in the British Medical Journal reviewed 30
small clinical trials involving about 1,400 critically ill patients,
concluding that albumin was linked to six extra deaths for every 100 people
treated with it.

Shannon denied that the upcoming clinical trials, which will likely begin
this winter and involve five hospitals and hundreds of patients, most
suffering from burns, were prompted by the study conducted by the Cochrane
Injuries Group.

In Canada and elsewhere, the drug was exempted from clinical testing
because it was in common usage by the time modern drug laws were enacted.

Expected to cost Bayer at least $1 million, the trials are being designed
by an international group of critical care experts, Shannon said yesterday.

``The reason for undertaking the trial is to really understand how to best
use these products to maximize benefits to patients.''

But Doug Elliott, who represented the Canadian AIDS Society at the
three-year-long Commission of Inquiry into the Blood System headed by Mr.
Justice Horace Krever, was skeptical that Bayer's clinical trials were
unrelated to safety concerns raised by the study.

In the wake of the tainted blood tragedy of the 1980s and the many lawsuits
that have flowed from it, many implicating drug manufacturers, Bayer is
``very, very familiar with the sensitivity Canadians have to the safety of
the blood supply,'' Elliott said.

If Bayer took no action in the face of the study, ``and simply decided to
hope for the best, they would be opening themselves up to future
litigation, I'm quite certain,'' he said.

A Toronto resident, Marjorie Nightingale, 65, died in March after falling
seriously ill with colitis and being treated with albumin.

As with the tainted blood scandal, questions about the safety of albumin,
used to boost blood volume, ``make me wonder how vigilant some of the
people who we assume are watching these things really are,'' said her
husband, Peter Nightingale.

The theory of the way albumin does harm by leading to waterlogged tissues
and respiratory failure ``sounded very much to me like a part of what
happened to my wife,'' he said.

Although he was pleased that at least one drug company planned to put the
drug to the test, ``I just wish it had been tested long ago,'' the Toronto
resident said.

``You kind of trust the medical people to know what they're doing and
assume that if there are dangers, there will be warnings issued.''

Dr. Ian Roberts of the Institute of Child Health in London, the study's
principal author, contends that tens of thousands of critically ill
patients may have died as a result of being treated with albumin.

While Shannon admitted the study raised ``substantial uncertainty'' about
the safety of albumin, he said in an interview yesterday that the methods
used can't support a conclusion that the drug is responsible for killing
people.

Checked-by: (Joel W. Johnson)