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Medical Post

VOLUME 38, NO. 11, March 19, 2002

Group charges side-effects from synthetic insulin not properly studied

By Louise Gagnon

OTTAWA - Members of the Society for Diabetic Rights are calling for a public inquiry into the relative unavailability of alternatives to synthetic insulin.
   The group also said adverse reactions to synthetic insulin seen in a minority of patients have not been monitored closely enough by Health Canada.
"We feel Health Canada has a responsibility to inform this community that animal insulin is a viable treatment option for people who choose to use," said Colleen Fuller, a diabetic and spokeswoman for the society.
   The group learned eight Canadians have died after taking synthetic insulin as of January 2001. Almost 500 people have had adverse reactions to synthetic insulin.
By comparison, they said only nine diabetics reported adverse reactions to pork insulin, and that none had adverse reactions to beef insulin.
Data from the U.S. show 92 reported deaths have been tied to use of synthetic insulin, and 4,000 adverse reactions have been reported owing to use of synthetic insulin. (Correction: There were 92 deaths and over 4,000 acverse reactions reported in ONE year.)
   Novo Nordisk, one of two manufacturers of animal insulin, withdrew its product in Canada in 1995. The other manufacturer, Eli Lilly, stopped the sale of beef insulin in 1999, but still makes pork insulin available in limited quantities.
   Health Canada's special access program makes beef insulin available.
   "There are about 200,000 insulin-dependent diabetics in Canada who typically take two injections of insulin per day, indicating human insulin is not a problem for most patients", said a departmental spokesman for Health Canada.
   "The clinical trials conducted show human, recombinant insulin is as safe and effective as insulin from animal sources" said Andrew Swift.
   A public inquiry is not likely, he said. "We don't deny some people do better on animal than synthetic insulin, but the majority of the 200,000 patients use it successfully each day."
   Patients have reported they cannot detect the early warning signs of hypoglycemia. These signs are less pronounced with synthetic insulin, compared to animal insulin.
   The synthetic insulin is absorbed in the body more rapidly, which is why patients miss the warning signs of hypoglycemia.
   "We acknowledge some people do not have the same comfort with human insulin as they do with animal insulin", said Swift. "It's hard to pinpoint the cause and effect directly to human insulin for all these drug reactions. The numbers are not necessarily due to animal or human insulin."
   Dr. John Hunt, an endocrinologist and former head of the Canadian Diabetes Association, said it's estimated 2% to 3% of patients do not tolerate synthetic insulin, but the range could be as great as 10% to 20% of patients. He noted younger physicians and pharmacists alike might be unaware of the existence of animal insulin as an alternative for their patients who do not do well with synthetic insulin.
   "Physicians have to respond to the needs of their patients if they experience adverse reactions to a therapy", said Dr. Hunt. "If the patients cannot detect that their blood sugars are low, this is dangerous. They would experience confusion and insulin shock. The consequences can be fatal."

Insulin Swiss Forum

Press release

March 9, 2002
Human insulin is not "human"
High level medical professionals, scientists, government officials and patients with diabetes met in the Swiss parliament buildings Friday to develop strategies to protect the future availability of natural animal insulin.

The meeting was prompted by concerns that the dominant insulin supplier in Switzerland is planning to withdraw all natural animal insulin from the European market in 2005. A number of studies indicate that a significant minority of diabetics experience severe adverse effects when using synthetic insulin.

Dr Philip Corfman, a former FDA medical reviewer, told the meeting that the Food and Drug Administration should not have approved the name of Humulin® because in his opinion it violates FDA regulations that prohibit product names that suggest drugs have exceptional characteristics.

"The name Humulin®", he said, "wrongly implies that this product is human. Humulin is not "human" and therefore the suggested characteristic in the name is misleading."

The meeting heard evidence that for some diabetics synthetic insulin is dangerous. Swiss scientists, medical professionals and diabetes patients discussed the nature and probable causes of the adverse reactions being reported to regulatory authorities. Colleen Fuller, the president of a Canadian group of diabetics, described the very similar challenges confronted in her country.

As in Canada, Swiss diabetics face the risk of sudden low blood sugar that may lead to black outs, inexplicable aggressive behaviour, and sudden death during the night. Patients who use natural insulin rarely experience these problems which have become common in most countries because of the increased use of synthetic insulin.

Swiss studies show that hypoglycemia is a leading cause of auto accidents, second only to alcohol consumption. This phenomenon has developed in parallel with the increasing use of synthetic insulin.

Another study described a syndrome appropriately called ?dead-in-bed syndrome? in which diabetics die unexpectedly during the night. The number of diabetics who have died or had severe health problems appears to be increasing as well.

One patient who was present, a Swiss radio journalist, read his moving account of how he survived severe hypoglycemia caused by synthetic insulin. This illustrated to representatives of Swissmedic and Swiss Health, a member of the Swiss parliament, and all participants that, as a matter of urgency, action must be taken to safeguard the future production of natural animal insulin in Switzerland for diabetics who need it. Patients must be encouraged to speak out about the differences between synthetic insulin and natural animal insulin and to demand the availability of both forms.

Biotechnology Newswatch

February 18, 2002

Diabetics demand animal insulin, citing bad reactions to human form

By Michael Smith

A group of Canadian diabetics is calling for a public inquiry after learning of reports that eight people have died and 465 have suffered adverse reactions to synthetic human insulin since the hormone was introduced in 1982.

The Society for Diabetic Rights is also demanding that Health Canada ensure greater access to insulin from animal sources, but officials of the health department said synthetic insulin is at least as safe as the animal-derived hormones.

The information on the deaths and adverse reactions was obtained from Health Canada under the Canadian government?s access to information laws, according to society spokesperson Colleen Fuller.

"Over the last year, we've spoken to 250 people across the country who have had serious problems with this type of insulin,' Fuller said. She said the former health minister, Allan Rock, 'swept our concerns completely under the rug."

(Rock was replaced in the health ministry in late January in a cabinet shuffle unrelated to this issue.) Fuller said there are about five times as many adverse reactions to synthetic insulin as there are to the animal-derived hormone.

Health Canada spokesman Andrew Swift said the synthetic insulin, produced by a genetically engineered bacterial construct, is as safe and effective as other forms, and users may even avoid some immune responses triggered by the animal-derived hormone.

Synthetic insulin has "an excellent safety record, with over 200,000 Canadians using (the hormone) daily to manage their diabetes," Swift said. He said, assuming the hormone is used twice daily, Canadians inject about 146 million doses a year.

The drug was introduced in 1982; in the U.S. there have been 92 reported deaths and about 4,000 reported adverse events since then.

Although most diabetics can use the synthetic insulin without problems, a significant minority can have serious reactions, the society said, including hypoglycemia unawareness, convulsions, seizures and insulin shock.

Endocrinologist John Hunt, a former head of the Canadian Diabetes Association, said the most significant problem is hypoglycemia unawareness, in which diabetics lose their ability to sense when their blood sugars are low.

"The effect of hypoglycemia and loss of warnings on the lives of some diabetics can be enormous," Hunt said. He added that he continues to treat some of his patients with animal insulin.

Diabetic Brenda Johnson, a member of the society, said she switched to porkinsulin after lapsing into a coma while using the synthetic hormone.

"Most doctors and health professionals are unaware of the high number of reports linking serious adverse events to synthetic insulin," Johnson said. She blamed the lack of awareness on "a veil of secrecy" maintained by Health Canada.

URL: http://www.platts.com

The St. Catharines Standard

Tuesday, February 12, 2002

BRENDA JOHNSON'S INSULIN CRUSADE

Diabetic Ridgeville Woman Who Can?t Tolerate Synthetic Insulin Product Preaches Merits of Pig Insulin

By Bill Currie

When Brenda Johnson switched from her injections of animal-based insulin to a synthetic form, she experienced severe changes in her diabetic condition.

Johnson had seizures and became unable to detect when her blood-sugar level was dropping, a serious problem that can lead to blackouts.

She feared being alone in case she was in a situation where she needed assistance.

The 51-year-old Ridgeville woman said a television show saved her life a year ago.

Johnson is one of a minority of diabetics who say they cannot tolerate synthetic insulin.

But she didn?t know that a pork-based insulin was still being produced and was available in Canada until a CBC Marketplace segment aired on Feb. 13 last year.

Two months later, she had switched back to the animal insulin and her symptoms disappeared.

She has been on a crusade ever since to inform people about the availability of the sometimes hard-to-find product and to ensure that drug companies keep producing it.

People don?t even know that pork (insulin) exists," Johnson said, "it's one of the best-kept secrets around."

Last week, Johnson, who has suffered from the condition for 32 years was one of a group representing diabetics who petitioned the federal government in Ottawa for a public inquiry. The Society for Diabetic Rights wants to know why Health Canada didn?t properly address 465 cases of adverse reactions to synthetic insulin, including eight deaths.

Society members feel let down by the government, the Canadian Diabetes Association and Eli Lilly, one of the suppliers of synthetic and animal-based insulin.

Health Canada maintains that studies and clinical trials have repeatedly shown synthetic insulin is as safe as the type derived from animals.

Eli Lilly said synthetic insulin doesn?t cause the symptoms mentioned in the Marketplace report - insulin shock, hypoglycemic unawareness and seizures.

The serum has been available in Canada since 1982.

Johnson said she first tried to switch from the animal insulin to synthetic in the late 1980s. She switched back to pork a few years later, until she was told by her pharmacist that pork insulin was no longer available.

She was forced to go back on synthetic insulin in the late 1990s.

"My life was just a mess," she said. "I've had seizures. In the year 2000 I was in intensive care twice. It got to the point where I was afraid to go to bed at night because I was sure I wasn't going to wake u in the morning."

Eli Lilly said it?s the switch from animal to synthetic insulin that may lead to complications and adverse reactions if changes to the treatment and monitoring regimen are not made.

But Johnson doesn't believe it. She maintains her problems were caused by the genetically engineered insulin itself.

"I was on the animal insulin for over 20 years, never had a problem," she said.

Diabetic Group calls for Insulin Alternative