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For Immediate release: February 6, 2002

Group calls for public enquiry into synthetic insulin

Diabetics from across Canada who depend on insulin say their health is threatened because Health Canada has failed to ensure they have access to a secure supply of animal insulin products. They want a public enquiry into the "conspiracy of silence" surrounding the adverse effects experienced by diabetics using synthetic insulin and the availability of animal insulin to those who need or prefer it.

While most diabetics are able to use genetically engineered (rDNA) insulin without incident, a significant minority experience serious adverse reactions including hypoglycemia unawareness, insulin shock, seizures and convulsions, allergic reactions, edema and memory loss.

"The effects of hypoglycaemia and loss of warnings on the lives of some diabetics and their families can be enormous," says Dr John Hunt, a BC-based endocrinologist who specializes in diabetes. "These effects are often totally ignored by many healthcare professionals and by Health Canada." Dr. Hunt is a former head of the Canadian Diabetes Association, past chair of the CDA's Clinical and Scientific Division and currently is Clinical Associate Professor in the Dept. of Medicine, University of British Columbia. He is one of only a handful of specialists who continue to prescribe animal insulin to patients who have problems with genetically engineered alternatives.

The two main insulin manufacturers, Novo Nordisk and Eli Lilly, introduced synthetic insulin to the European and North American markets in 1982. In 1995, Novo Nordisk withdrew all animal insulin from Canada, while Eli Lilly withdrew all beef insulin products in 1999. Lilly continues to sell pork insulin in Canada, but most physicians, pharmacists and health professionals are unaware of its availability.

Despite reassurances by the two companies that synthetic insulin (referred to as "human" by the manufacturers) is safe, reports of adverse reactions have continued to mount. The most common reports are hypoglycemia unawareness, a condition which robs diabetics of their ability to feel low blood sugars. Hypoglycemia is one of most serious risks associated with insulin therapy and can lead to insulin shock, inability to concentrate, confusion, among other problems. Other problems associated with synthetic insulin treatment include edema, serious weight loss, memory loss, skin rashes and allergic reactions.

"In the last year we have spoken to about 250 people who've had serious reactions to genetically engineered insulin," says Colleen Fuller, a spokesperson for The Society for Diabetic Rights, a group working for "insulin choice". "We don't know the exact number of diabetics in Canada who are unable to safely use synthetic insulin. But what we do know is that there has been a controversy about this product since it was released on the market in 1982 and no one at Health Canada seems interested in dealing with it."

The Society is calling for a public enquiry into the situation after learning that over 465 reports of adverse reactions had been filed with Health Canada, including 8 deaths, as of January 2001. These reports were linked to novolin, humulin and humalog insulins and obtained through a freedom-of-information request. In the case of humalog, 55 reports have been filed since it was released on the market in 1996. The same FOI request yielded nine ADR reports linked to pork insulin, and none that were linked to beef insulin.

"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," says Brenda Johnson of the Society. "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, they don't know that animal insulin is a safe and available alternative. They try to get these poor patients to "adjust". But it's like putting a square peg in a round hole "it doesn't fit."

The consequences for some diabetics can be traumatic. When Maureen Schug's 21-year old daughter, Kristine Spanks, switched to synthetic insulin she began experiencing severe and unexpected low blood sugars and blackouts. Two years ago she suffered severe brain damage after going into insulin shock. Schug wants a public enquiry to examine the link between synthetic insulin and Kristine's disastrous experiences.

"On January 27, 2000, Kristine was found in her bed by her younger sister," Ms Schug remembers. "She was in a coma and having seizures. She was rushed to hospital where they did all the tests over the next few days to try to figure out what happened. After several days they came to the conclusion that she'd had a low blood sugar, there was no other answer. It has been an up hill battle ever since. We were told the switch to synthetic insulin would be nothing, it wasn't supposed to be anything different. But it was."

Don and Sue Munro?s 24-year old daughter, Janna Munro, died on November 12, 2001. Mr. Munro says Janna was placed on synthetic insulin when she was initially diagnosed with diabetes at age 15. "Janna started experiencing seizures and blackouts three months after she was diagnosed," Mr Munro said. "She never felt her low blood sugars. They would come on suddenly and dramatically. Because of her seizures Janna was EKG'd, Cat-scanned and MRI'd up to her eyebrows, but no abnormal neurological disorders were uncovered. We were told by a number of endocrinologists that animal insulins were no longer available and would not work. Subsequently she died."

Kathy Ferguson, whose son Chris died in 1996 unexpectedly in the night, says a public enquiry is urgently needed because many young diabetics are experiencing unnecessary trauma. "They told us this was "human" insulin," she says, "the purest and best kind of insulin you could take. But it didn't work for Chris. He had always had excellent control of his blood sugars. Several years after switching to this genetically engineered insulin, he died during a seizure in his sleep. I don't want any other families suffering the needless grief that we continue to go through."

The Society for Diabetic Rights (SDR) was set up last year to fight for a broader choice of animal insulin products for Canadian diabetics who cannot use the synthetic varieties distributed by pharma giants Eli Lilly and Novo Nordisk. The group has about 230 members from across the country.

For more information please contact:

Colleen Fuller : 604-255-6601

Fact Sheet

Public enquiry to look at:

* the inadequate or absolute absence of post-market monitoring of people's experiences with synthetic insulin by the government and the impact this has had on treatment of diabetics by physicians and health professionals;

*the lack of information available to physicians and patients about the hundreds of reports received through the ADR reporting system, and the experiences that have been reported outside of Canada;

*the ignorance in the medical community about all of the safe treatment options for insulin-dependent diabetics who experience problems with synthetic insulin, or who simply would prefer to use a non-synthetic form of insulin;

*the need for full disclosure of all clinical studies conducted on synthetic insulin, not just the ones used to support the manufacturers' applications for approval (and even these aren't always available);

*the use of confidentiality clauses to silence physicians participating in clinical studies of synthetic insulin (this is a sensitive issue in Canada);

*the lack of monitoring to ensure that insulin manufacturers are reporting consumer experiences, both those in Canada and internationally.

CBC TV

SHOW: MARKET PLACE ( 7:30 PM ET )

January 30, 2002, Wednesday

Update on diabetics locked in fight with insulin maker Eli-Lilly

ANCHORS: ERICA JOHNSON

ERICA JOHNSON: Hi, I'm Erica Johnson in Vancouver with an update on a story we brought you last year that generated a lot of viewer feedback. Our story about diabetics in Canada, locked in a bitter fight with drug manufacturer Eli Lilly. We've learned they're taking their fight to Parliament Hill.

UNIDENTIFIED WOMAN: Okay, let's go.

JOHNSON: Colleen Fuller is a diabetic. For most of her life she relied on a traditional form of insulin, the type derived from the pancreas of cows and pigs. Then, like thousands of diabetics, she followed doctors' orders and switched to a newer genetically engineered insulin called Humulin.

COLLEEN FULLER (Diabetic): The first night that he put me on humulin I went into a coma. My husband had to call 911 and that happened about four more times over the next month and a half. It was very awful.

JOHNSON: Fuller is worried the last remaining animal-based insulin on the market will soon disappear. She says most diabetics can tolerate the genetically engineered insulin, but some can't. After our story aired, "Marketplace" heard from close to one hundred viewers who said they, too, have had seizures on Humulin, blacked out, gone into comas. Some reported that loved ones had even died. Now, some two-hundred and fifty diabetics have banded together. They're calling for a public inquiry, say Health Canada has done nothing to tell diabetics or doctors about hundreds of adverse drug reaction reports linked to synthetic insulin.

FULLER: So when patients go to their doctors and say, I'm having this problem, the doctor says, well, that doesn't have anything to do with synthetic insulin when in fact there is mounting evidence that it is linked to synthetic insulin and Health Canada is doing nothing about that.

JOHNSON: Health Canada says studies show diabetics should be able to switch to the newer insulin. The manufacturer, Eli Lilly, says when properly taken, there's no problem. But Fuller hopes the new Health Minister will heed next week's call for a public inquiry.

CBC TV

SHOW: MARKET PLACE ( 8:00 PM ET )

February 27, 2001, Tuesday

INSULIN UPDATE

ANCHORS: JACQUIE PERRIN

JACQUIE PERRIN (Marketplace): And now an update on a story we brought you two weeks ago about insulin for diabetics.�� We reported a small number of diabetics say they can't tolerate a genetically engineered insulin; just one animal-source insulin remains available in Canada, and many diabetics say it's hard to find. Three days after our story aired, the manufacturer of that animal insulin, Eli Lilly, sent a letter to doctors and pharmacists across the country. The letter states that the company's pork insulin is still available. We called Eli Lilly and asked if our story prompted this letter. They told us the letter was just part of routine communications.

News Release

Brenda Johnson: 905-892-0803

Society for Diabetic Rights
Newletter # 2

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