Toronto Star
February 7, 2002 Thursday  Ontario Edition
Insulin inquiry urged
Prithi Yelaja
Safety of synthetic product called into question
A group representing Canadian diabetics is calling for a public inquiry after uncovering reports of eight deaths and 465 adverse drug reactions linked to genetically engineered insulin.
The Society for Diabetic Rights held a news conference in Ottawa yesterday and demanded that Health Canada ensure greater access to an older form of insulin derived from pork and beef. There have been only nine reports of adverse reactions to pork insulin, and none to beef insulin.
The information on the deaths and adverse reactions was obtained under federal access to information law, said Colleen Fuller, the society's spokesperson.
"Over the last year, we?ve spoken to over 250 people across the country who have had serious problems with this type of insulin. The previous health minister, Allan Rock, swept our concerns completely under the rug."
A Health Canada spokesman said that synthetic insulin products are as safe and effective as insulin from animal sources.
"They have an excellent safety record with over 200,000 Canadians using them daily to manage their diabetes," said Andrew Swift.  "Assuming patients take injections twice per day, there are 400,000 doses of synthetic insulin administered each day or 146 million doses per year",, he added.
"The synthetic insulin includes a product warning that some patients have reported the early warning symptoms of hypoglycemia, which occurs when blood glucose levels fall below normal, were less pronounced than for animal insulin, Swift said. However, it's hard to pinpoint...whether it's the synthetic insulin that caused (these reactions) or some other factor."
In the United States, there have been 92 reported deaths and 4,000 adverse reactions reported by diabetics using synthetic insulin, which was introduced in 1982.
Although most diabetics can use it without a problem, the society says a significant minority experience serious reactions including hypoglycemia unawareness, convulsions, seizures and insulin shock.
"The effects of hypoglycemia and loss of warnings on the lives of some diabetics and their families can be enormous," said John Hunt, a former head of the Canadian Diabetes Association.
February 7, 2002
Synthetic insulin as safe as animal-based product, says Health Canada
OTTAWA (CP) -- Studies and clinical trials have repeatedly shown that synthetic insulin is as safe for diabetics as insulin derived from animals, says Health Canada.
The federal department responded Wednesday to concerns raised Tuesday by the Society for Diabetic Rights.
Health Canada has received 465 reports of adverse reactions -- including eight deaths -- linked to synthetic insulin, says the group representing diabetics. The serum is derived from human material and has been available since 1982.
Although most diabetics can use synthetic insulin without a problem, the society says a significant minority experience serious reactions including hypoglycemia unawareness, insulin shock and seizures.
Hypoglycemia unawareness desensitizes diabetics to low blood-sugar levels. It?s one of the most serious hazards of insulin therapy.
Citing data obtained under access to information law, the society called for a public inquiry. It says Health Canada has failed to adequately publicize the dangers of synthetic insulin.
But Andrew Swift, a spokesman for the department, says tests on synthetic or genetically engineered insulin have shown no significant jump in adverse reactions over animal-based insulins.
"In fact, synthetic insulin users avoid immune responses that can be triggered by the animal-based products", Swift said.
"Product literature warns patients that some may experience hypoglycemia unawareness, he added. It's a potential problem with all insulins, and it's difficult to tell if an adverse reaction is caused by the serum or the diabetes itself", Swift said.
Colleen Fuller, a spokeswoman for the society, wasn't satisfied. "Information collected by the group suggests there are about five times as many adverse reactions with synthetic than animal insulin", she said. "Health Canada doesn't know what's going on. I don't accept that they're going to say this is not alarming."
The society cites a case in which a 21-year-old woman, Kristine Spanks, suffered seizures and brain damage after switching to synthetic insulin.
Fuller is also concerned that animal-based insulin has been increasingly difficult to obtain, although it's still available. The society is pushing for more choice.
Health Minister Anne McLellan said she's aware of the concerns about synthetic insulin.
"I do want to reassure members of this House that in fact animal insulin continues to be available in this country," she told the House of Commons. "Both pork and beef insulin are offered through Health Canada's special access program", Swift said. About 200,000 Canadians use insulin at least twice a day.
Canadian Press
February 6, 2002
Eight deaths linked to synthetic insulin
By DENNIS BUECKERT -- Canadian Press
OTTAWA (CP) -- A group representing diabetics says Health Canada has received 465 reports of adverse reactions -- including eight deaths -- linked to genetically engineered insulin.
Colleen Fuller, a spokeswoman for the Society for Diabetic Rights, says the department has failed to deal with the issue and a public inquiry is needed. Fuller said the information on adverse reactions was obtained under federal access to information legislation but has not been publicized by Health Canada.
"We are talking to people who have been hospitalized in comas, they're having seizures," said Fuller in an interview. "Their doctors say there's no record of these types of problems and the reason they say that is because Health Canada is not issuing this information. Nobody knows about it."
Genetically engineered insulin, also referred to as synthetic insulin, was introduced in 1982.
No comment was available from Health Canada on Tuesday, but an official promised a response by Wednesday.
The Society for Diabetic Rights says insulin produced from animal sources has been increasingly difficult to obtain although it is still available.
Although most diabetics can use synthetic insulin without a problem, the group says a significant minority experience serious reactions including hypoglycemia unawareness, insulin shock and seizures.
Hypoglycemia unawareness is a condition in which diabetics can?t feel their low blood sugars. It?s one of the most serious hazards of insulin therapy.
"The effects of hypoglycemia and loss of warnings on the lives of some diabetics and their families can be enormous," John Hunt, a former head of the Canadian Diabetes Association, said in a news release.
"These effects are often totally ignored by many health care professionals and by Health Canada," said Hunt, a B.C. endocrinologist who specializes in diabetes.
The society cites a case in which a 21-year-old woman, Kristine Spanks, suffered seizures and brain damage after switching to synthetic insulin. Her mother believes the synthetic insulin was to blame. The society is pressing for a broader choice of insulin products in Canada.
February 6, 2002
Diabetics Demand Insulin Safety Probe
Andre Picard
A group of diabetics and their physicians are calling for a public inquiry into the safety of insulin, saying that newer, genetically engineered products are sickening and perhaps even killing Canadians.
They are also demanding that Health Canada ensure that an old-fashioned form of insulin, derived from animals, be made more widely available.
"In the last year, I've spoken to about 250 people who've had serious reactions to genetically engineered insulin," said Colleen Fuller, a spokeswoman for the Society for Diabetic Rights.
In fact, using the access-to-information law, the new group has discovered that eight Canadians had died after taking synthetic insulin as of January, 2001. Another 465 people had adverse reactions. By comparison, only nine diabetics reported adverse reactions to pork insulin, and none to beef insulin.
In the United States, there have been 92 reported deaths, and 4,000 adverse reactions reported by diabetics using synthetic insulin.  (This report was for a 12 month period.)
"Most doctors and health professionals are unaware of the high number of reports linking serious adverse reactions to synthetic insulin because Health Canada maintains a veil of secrecy," said Brenda Johnson, another member of the society. She switched to pork insulin after lapsing into a coma while using synthetic insulin.
"When diabetics tell their doctors they're having problems, they're dismissed out of hand. Not only are doctors unaware that many other people are having the same problems, but they don't know that animal insulin is a safe and available alternative," she said.
Ms. Johnson said the group feels a public inquiry is justified because there has been an absence of monitoring of the drug's safety after it was approved by Health Canada. She said this is unacceptable, particularly given the fact that insulin was the first genetically engineered medication ever approved for use in humans.
The Society for Diabetic Rights will formally call for an inquiry at a press conference Wednesday on Parliament Hill.
There are about two million diabetics in Canada, about 220,000 of whom are insulin-dependent. Insulin replaces a hormone that is usually produced by the pancreas for people whose bodies do not manufacture it naturally; without insulin, diabetes is potentially fatal.
John Hunt, an endocrinologist and former head of the Canadian Diabetes Association, said that most diabetics can use genetically engineered insulin without incident, but a significant minority suffer from adverse reactions.
He said the most common problem is hypoglycemia unawareness, a condition in which diabetics lose their ability to feel that their blood sugars are low. This can lead to confusion, an inability to concentrate and insulin shock, in which a person can slip into a coma and die.
"The effects of hypoglycemia and loss of warnings on the lives of some diabetics and their families can be enormous," Dr. Hunt said. He continues to treat a number of his patients with animal insulin.
Synthetic insulin was introduced to Canada in 1982. In 1995, one of the two major insulin manufacturers, Novo Nordisk, withdrew all its animal insulin from Canada, leaving diabetics with no choice. Eli Lilly, the other major insulin maker, stopped selling beef insulin in 1999, and makes a limited amount of pork insulin available for import.
The manufacturers insist that the products are safe. Genetically engineered insulin is cheaper to produce, and drug makers say it is safer because there is no risk of patients contracting animal diseases. A study commissioned by the British Diabetics Association, however, found that about 10 per cent of users of synthetic insulin do not tolerate the drug well.
Maureen Schug blames synthetic insulin for the severe brain damage suffered by her 21-year-old daughter, Kristine Spanks. The young woman had been able to control her diabetes throughout her life but shortly after she was switched to synthetic insulin, she began experiencing severe and unexpected low blood sugar that caused her to black out.
On Jan. 27, 2000, she began having seizures and lapsed into a coma, a condition attributed to dangerously low levels of blood sugar. "We were told that the switch to synthetic insulin would be nothing," Ms. Schug said. "It wasn't supposed to be anything different, but it was."
Don and Sue Munro also blame synthetic insulin for the death of their 24-year-old daughter, Janna. She died on Nov. 12, 2001, at age 15.
Mr. Munro said that only three months after his daughter was diagnosed as a diabetic, she began experiencing severe seizures and blackouts, and then she died. He blames the synthetic insulin.
Mr. Munro is angry and demanding an inquiry because he was told by doctors that there was no alternative medication. "We were told by a number of endocrinologists that animal insulins were no longer available and would not work. Subsequently, she died."
On Tuesday, members of the group visited a number of MPs and senators, and some members of the Senate committee on health promised to look into the safety of synthetic insulin.
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