THE GLOBE AND MAIL THURSDAY,
violated Contamination problems danger of infection reported at Connaught
A cardiac stimulant, Epinephrine, produced under conditions
unacceptable to federal health inspectors is still being sold by Connaught
Supplies came from inventory built up before the publicly
financed Canada Development Corp. subsidiary stopped production of a
number of drugs last summer after repeated complaints from federal
Inspectors in February last year found Connaught
had done nothing about infractions of health regulations reported more
than a year earlier and that, in fact, the situation had become worse.
In June, Ottawa's Advisory Board
Manufacturing was demanding "significant improvements" in the
quality of Connaught's operations.
And in September,
Dr. John Furesz, director of the bureau of biologics in Ottawa's
health protection branch, inspected some parts of the Connaught
operation. He found a number of problems.
Among the most serious were the "grossly
inadequate" quarters for control testing of Sabin polio vaccine.
"As a result, occasionally control
testing of more than one type of live vaccine is being done at the same
time. No proper separation of tissue cultures was seen, giving rise to
danger of cross-contamination.
"Danger also exists of
laboratory-acquired infection of the workers employed there," he
And yet, Donald McCaskill, Connaught
president, had told The Globe and Mail in a December interview that
the September inspection had found nothing seriously wrong.
Recently, after releasing the inspection report, he said in
defence of his earlier statement, "It's a
clean bill certainly in that he didn't take the licence away, eh?"
Mr. McCaskill also had said the drugs taken out of production
last summer were dropped because they weren't worth the money needed to
bring production up to federal standards.
Later, through a press relations firm, he said the action was
taken because the drugs in question were low-volume items and Connaught
had just a small share of the market and its staff could be better used on
In three interviews in three weeks, Mr. McCaskill had denied
that any federal officials ever expressed severe criticism of any
Connaught facilities or practices.
But. two weeks ago, he released the often critical
September inspection report. And confronted with copies of 1974 letters
from H.A. Showalter, drug boardchairman, he conceded that, among other
things, Connaught’s vital blood plasma fractioning plant had failed to
meet Government standards.He says he believes that it would pass
inspection now. Last February he was told in a memorandum from one
of his vice-presidents, S.R. McInnes, that $300,000
was needed immediately to renovate and expand the plant to comply with regulations.
Mr. McInnes said the building probably "would
be closed if it were subjected to an inspection."
He said the work was needed "to reduce
severe and costly contamination problems."
Though he didn’t say so, it was costly not only
to Connaught, which had become a profit-oriented operation since its CDC
takeover, but also to Canada’s superior blood transfusion service.
The Canadian Red Cross, its voluntary donor program envied around the
world, wants to avoid the controversy but its officials don’t like what
has been happening.
The Red Cross ships all out-dated blood (whole
blood lasts three weeks) to Canada’s only fractionation lab at
Connaught where, it is broken down into a variety of life-saving
The Red Cross buys some of these back for
low-cost distribution to hospitals, which increasingly require
blood fractions, often safer than whole blood transfusions. And
fractionating makes one donation do the work of five or more.
Mr. McInne’s memo about contamination problems lends support to what
some are saying outside of Connaught - that
as much as 50 per cent of the whole blood it receives never gets all the
way through the fractionation production line because of contamination.
Though they are backed by what international journals have lauded as
one of the finest blood services in the world, Canadian
hospitals have bought from private firms in the United States, and at
higher prices because Connaught cannot keep up with the demand.
However, a scientific review of operations last fall by
Dr. Margaret Pittman, a prominent semi-retired U.S. biologist, said of
the plasma operation the "the limited factor in
production volume is source material ..." but that Connaught
was planning new products and increased in efficiency.
Mr. McCaskill had received another and much more critical assessment of
the plasma operation from Dr.
Andrew Moriarity, vice-president of Connlab Holdings Ltd., CDC’s
health services division and owner of Connaught. Dr. Moriarity had
put his assessment in memo form in the same month that his colleague, Mr.
McInnes had called for the $300,000 for improvements.
Went to Ottawa
Dr. Moriarity said any proposal to expand the
existing plant would be a waste of money. Complete reconstruction, he
said, was required.
"Because of recent quality-control
problems with certain of our plasma products" he wrote in his
memorandum, "I have taken the opportunity to inspect the Connaught
"By almost any standard, this production
unit is inadequate. Areas for quarantine, processing, cleaning, storage,
etc., are inadequate and poorly segregated."
"Flooring is old and worn and complicates
any sanitation process, inadequate lighting and poor ventilation represent
health hazards for the workers."
"Crowding, exposed piping and peeling
paint are not consistent with the standard of quality expected of
Connaught. It is no wonder that contamination has been a recurring problem
with our plasma products."
He continued, "Certain improvements have
recently been made but these are obviously of a makeshift nature. How this
plant has passed inspection by the various regulatory agencies, I am at a
loss to understand."
Dr. Moriarity’s criticisms of Connaught operations extended to many
other aspects including
other production units and to management and its policies.
They finally got him fired and after a
wait of four months and word form colleagues that there had been no
improvement, he took his allegations to federal authorities.
Mr. McCaskill, who makes a blanket rejection of Dr. Moriarity’s
complaints, said in a written statement in The Globe and Mail that at the
time the plasma plant was inspected by
federal officials in January 1973, it met the regulations.
Many facilities were inspected at that time
although not, he said, Connaught’s insulin plant. It had not been
checked by the federal Health department since being built four years ago.
However, Mr. McCaskill’s reference to a 1973
plasma plant inspection was in error, according
to Rene Mercier, Ottawa Health Department spokesman.
Saying that he could not explain the neglect, Mr.
Mercier said the plant had not been inspected since March, 1969. After
Globe and Mail inquiries this month, an inspection was conducted. The only
other plasma-related inspection was early in 1971, when one facet of
plasma production - in another building was checked.
Theoretically a drug producer found violating regulations may be
suspended from doing business with governments, - Connaught’s biggest
customers - for 90 days, and must correct the violations to win
In January 1973, Connaught was found in breach of regulations governing
the sensitive areas of raw material and packaging tests and product
stability. Yet no punitive
action was taken.
And in February, 1974, there was another inspection.
In May, Mr Showalter, the drug board
chairman, wrote to Connaught chairman Dr. R.
J. Wilson saying there were violations not
only in the areas cited the year before, but also in the areas of finished
product tests and quality control.
In mid-June, Mr. Showalter wrote again, commenting on an
intervening letter from Connaught, expressing a continuing disappointment
and stating that the drug board "may be inclined to examine the next
report very critically, unless significant improvement is shown. I have
been requested to convey this to you in the clearest terms."
The next report -
as can be ascertained - was the one from Dr. Furesz last September and,
again, along with some "very good" notations, were references to
hazardous situations and violations of regulations.
Mr. McCaskill conceded that the
inspection did not include a look at the blood plant,
he did not know if it included other areas of concern raised by Mr.
Meanwhile, during the period of
Government disclosures of inadequacies and threats and repeated threats
that Connaught might be blacklisted, the very things the
regulations are aimed at preventing are said to have taken place, including
delivery of vaccines said to have been below proper potency.
Dr. A.B. Morrison, assistant deputy minister in
charge of the federal health protection branch, confirms
that investigations have been started into the allegations made by Dr.
He said he could not discuss the nature or scope of the
investigation because it
was conceivable some people would be charged under the Canadian Food and
Mr. McCaskill said in December
that the study by Dr. Pittman, a 71 year old
consultant on assignment for the World Health Organization, was
to be an investigation of the validity of the Moriarity charges.
Her 17 page preliminary report, he said,
gave Connaught "a complete bill of health."
However, he said, "compliance
with Government regulations was not a specific part of Dr. Pittmans terms
of reference," and he conceded,
after reluctantly releasing a copy of her report, the study was not as
thorough as he had first implied, nor was it directed to the specifics of
Dr. Moriarity’s allegation."
Dr Hilda MacMorise, head of Connaught’s human biologics, agreed that the report was somewhat superficial. And
Dr. Pittman herself referred in a section assessing scientific resources
to her "cursory observation."
But generally she spoke of products being good or excellent and said
quality control was satisfatory.
In her brief concluson, Dr. Pittman wrote:
Although going through an adjustment period, CLL is a viable
oranization with potential of its
mandate to manufacture products for national health care and for
"The production divisions are functioning relatively well. Some
improvements were suggested ... a
better understanding between financial management and scientists was