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IDDT Canada

Media News

‘Like night and day’ - Return to pork insulin invigorates diabetic

Winnipeg Sun

March 12, 2001

Diabetic Don Cunningham is convinced the insulin he has been taking for the past eight years has been slowly killing him. The 57-year old’s suspicions were raised last month after a story in the Winnipeg Sun revealed some Type 1 diabetics – formerly taking insulin made from animal sources – were reporting adverse reactions to a new insulin made from human cells.

Cunningham, a resident of Traverse Bay, Man., was experiencing the same reactions, including fatigue, loss of feeling in his fingers and paralysis in his right arm. His eyesight also steadily declined from 1992, [error, should read 1996] when he switched to the human insulin until he eventually went blind four years ago.

Cunningham suffered a mini-stroke in 1994 and was hospitalized for a second stroke two years later.

"My life deteriorated since 1992," he told The Sun yesterday in a phone interview from his home. "There’s times I wanted to commit suicide". But after his wife Jean read him the article last month, Cunningham considered switching back to the pork insulin. Despite his doctor’s disapproval, Cunningham finally made the switch Thursday. Yesterday, Cunningham said he’s a new man: "Within four days, I’m like a million bucks," he boasted. "I can’t believe the results. It’s like night and day."

Cunningham said the feeling has dramatically returned to his right arms and his fingers. He’s also experiencing increased energy, improved blood pressure, more frequent bowel movements and no more back pain. "I’m pretty happy with myself right now," he added. "If it wasn’t for the story in The Sun, I wouldn’t be what I am today.And now Cunningham wants to warn other diabetics. "Don’t always take your doctors advice. Get a second opinion," he advised. "I should never have changed. I had to suffer all these months and all the years."

Cunningham was diagnosed with diabetes in 1980. Winnipeg resident Bernadette Brunka, who used the animal insulin mix for 45 years without any problems, said after she began using Humulin, a genetically engineered insulin identical to insulin produce by the human pancreas, she, too, experienced a variety of medical problems.

But Colin Reeve, a pharmacist and certified diabetes educator, said these cases may be rare. Reeve said his experience suggests diabetics would do better on genetically engineered human-based insulin. "(But) different people have different bodies," he added. "Therefore, they will take differently to different medications."

If this succeeds it could help people in the US import cheaper insulin from Canada!

Woman denied funds for life-saving drugs

The Ottawa Citizen

Maria Cook

February 13^th 2000

Ontario refuses to pay for insulin woman requires from Britain

A Nepean woman with diabetes is caught in a set of circumstances beyond her control that prevent her from getting the insulin she needs to keep her healthy and alive. Liliane Nixon, 44, relies on beef-pork insulin, which was discontinued in November 1998 by drug maker Eli Lilly Canada. Synthetic insulin has become the norm but she cannot tolerate it. While Mrs. Nixon is allowed to import beef insulin from England, she can’t afford it, and the Ontario drug benefit program will not pay for it. "We went to Mars and back" to get the Ministry of Health to fund it, said Bill Grant, spokesman for Ottawa West-Nepean MPP Garry Guzzo. No success.

It seems like a simple problem, but there are no bending of the rules in this unusual case.

Mrs. Nixon, who is on a disability pension, gets her drugs covered by the provincial drug benefit program. But the program only covers drugs that are licensed for sale in Canada and therefore have met Canadian standards. The company in England, CP Pharmaceuticals, has not yet applied to sell in Canada because the market is too small. "We owe it to those who are part of the plan to use drugs that are deemed safe by Health Canada," said Dan Strasbourg, a Health Ministry spokesman.

The cost—about $1,800 for a year’s supply—may not be an insurmountable problem for many people. But for Mrs. Nixon, whose household budget is $1,800 a month for a family of five, finding an extra $150 a month for insulin is next to impossible. Her husband, Doug, lost his job at a car dealership two years ago when her illness worsened and he booked off too often to look after her. He is now trying to start a small business.

"My God, this person has been through so much," said Mrs. Nixon’s endocrinologist, Dr. Jan Braaten, of the Ottawa Hospital, Civic campus. "Everything in life has been taken away from her and the government says, ‘Forget it. We won’t help you.’ Why can’t the government be generous? She deserves some help. She doesn’t want to die." Mrs. Nixon has enough animal insulin to last until the end of June. "It’s very depressing," she says. "By next summer, I won’t be around without my insulin. Without it, I can’t live more than three or four days."

Mrs. Nixon has suffered many complications since being diagnosed with insulin-dependent diabetes at age 10. She has had three toes and part of her right foot amputated, had a kidney transplant and lost most of the vision in one eye. She has heart problems and uses a wheelchair. Scouts Canada last year gave her the Award of Fortitude, their highest citation for adults, for volunteer work in the face of great adversity.

Mrs. Nixon’s problem is being played out against a background of debate over synthetic insulins and the diminishing availability of animal insulin. A U.S.-based Web site called compassionateuse.com is devoted to this issue. When synthetic insulin was launched in 1983, it was hailed as a dramatic improvement in diabetes care. Made with human DNA, the biosynthetics are the first insulins that are structurally the same as the kind the body produces and do not trigger the allergic reactions that animal insulins sometimes cause. "In properly conducted clinical studies there has not been shown anybody who can’t use human insulin," says Dr. Loren Grossman, associate vice-president of clinical research for Eli Lilly Canada in Toronto.

But a small number of diabetics insist they do poorly on synthetic insulin or suffer potentially deadly side effects, the most serious of which is dangerous loss of the ability to recognize they are about to lose consciousness. Mrs. Nixon said she tried synthetic insulin nine years ago but went into cardiac arrest while using it. Dr. Braaten said it is possible the synthetic insulin caused the disastrous reaction, although it can’t be proved.

"A retrial of converting Mrs. Nixon to human insulin is unacceptable," Dr. Braaten wrote the drug program branch last October. (Eli Lilly still produces a pure pork insulin, but Mrs. Nixon says it does not work for her.) Dr. Braaten said he has about 15 patients who have had problems with synthetic insulin. "They complain about not being able to feel their blood sugar. They feel confused, faint without warning, have low energy and muscle pain." But Eli Lilly’s Dr. Grossman said reports of dangerous side effects are anecdotal and have not been proven.

Dr. Andrew Farquhar, a family doctor in Kelowna, B.C., does not accept this. "Lack of evidence is not proof that the phenomenon does not exist." Dr. Farquhar, a diabetic, tried synthetic insulin in the 1980’s but quit after he suffered low blood sugar one night and could barely get up for help. It raised the spectre of "dead in bed syndrome" in which a diabetic fails to experience low blood sugar symptoms, falls into a coma and dies from a seizure or heart failure. "I was scared," he said.

Janis Booth, 47, a diabetic who lives in the Toronto area, tried synthetic insulin from 1993 to 1999. "I went from a healthy, active person to a semi-invalid." She is negotiating with her insurance company to pay for beef insulin from England. If it’s not covered, she will pay for it herself. "I have no choice."

Meanwhile, a Victoria, B.C., woman is setting up a Canadian chapter of the Insulin Dependent Diabetes Trust, a lobby group of animal insulin users that began in the U.K. Carol Baker hopes to attract members and begin to lobby provincial drug programs for coverage. "It is a hardship issue," she said. "We’ve been left out in the cold." Ms. Baker can be reached at: iddt_cda@yahoo.com or 604-608-3103.

Of the 1.5 million diabetics in Canada, about 10 per cent, or 150,000 are insulin dependent.

Of those, up to three per cent, or about 4,500 are still using animal insulins. Injected daily, insulin replaces a hormone usually produced by the pancreas for people whose bodies do not manufacture it naturally.

TAKING THIS ISSUE TO THE MEDIA WORKED FOR THE NIXON FAMILY

The Ottawa Citizen reported on February 23 that the Ontario Ministry of Health has finally agreed to pay for life-saving insulin for a Nepean woman with diabetes, in a case her MPP calls a "debacle." Four days after Liliane Nixon's story appeared in the Citizen, her endocrinologist, Dr Jan Braaten of the Ottawa Hospital, received a notice of approval for payment of the insulin from the drug programs branch of the ministry. "The situation has been resolved," said ministry of health spokesman Dan Strasbourg. "It was an extraordinarily unusual case. It was reviewed and a decision was made by the ministry."

Marketplace CBC Television

13 February 2001

[Webposted]

Health problems linked to synthetic insulin

A British Columbia woman is set to launch a lawsuit against the makers of a genetically engineered insulin, saying the drug put her in a coma.

Colleen Fuller says she will also name Health Canada in the suit, claiming the department has a duty to provide alternative treatments.

The genetically engineered or synthetic insulin is called Humalin. It is gradually replacing animal insulin, which is being phased out.

Health Canada confirms that since 1998, it has received 121 reports of problems related to synthetic insulin use including:

· Comas

· Seizures

· Convulsions

· Hypoglycaemia or low blood sugar

In the United States, the FDA says it has received thousands of similar reports.

One of the makers points out that the vast majhority of diabetics have no problem with the drug. Dr Loren Grossman of Eli Lilly says "Clinical studies have shown that when people switch from animal to human insulin, with proper medical assistance, they can make the switch safely.

Only one animal insulin is available in Canada, and its hard to find. Fuller says that's outrageous, and the government has an obligation to provide animal insulin. But Ian MacKay of Health Canada says companies can't be forced to keep making a product. "We simply don't have the authority to force a manufacturer to continue marketing something that they have chosen to withdraw from the market for their own corporate reasons," he says.

The manufacturers say Humulin is cheapere to make in the long run, and is closer to the insulin actually produced by the human body.

Marketplace CBC Canada

13 February 2001

Imagine you've become dependent on a drug that saves your life. All of a sudden, you can't get it anymore. Your body won't adjust to the new, "improved" alternative. That's the case for thousands of diabetics around the world who say a genetically-engineered insulin is causing them serious health problems.

A group of Canadian diabetics is about to launch a class-action crusade for choice.

Insulin was discovered by Frederick Banting and Charles Best at the University of Toronto 80 years ago. It was one of Canada's proudest moments in research history. Now, animal based insulin is on the endangered list.

Only one pharmaceutical company in Canada sells an animal-based insulin. It has phased out its most popular animal insulins and it wants people to switch to its newer, genetically engineered product. The company says the newer insulin is better and it's safe for everyone. But some diabetics say they can't tolerate it and they want the right to choose.

Adverse reactions

Among those diabetics demanding the right to choose is Colleen Fuller of Vancouver. She's been a diabetic since she was sixteen years old. She used animal insulin, made from the pancreas of cows, for 27 years. Fuller says the insulin worked well. Six years ago, Fuller's doctor suggested she try the newer, synthetic insulin, called humulin. "The first night that he put me on humulin, I went into a coma," Fuller recalls. "That happened about four more times over the next month and a half. It was very...awful."

Humulin is a genetically engineered insulin manufactured by Eli Lilly and Company. Thousands of people are switching to it because Lilly has stopped making the two most popular animals insulins - one made from cow pancreas and the other made from cow and pig pancreases. Lilly says it was a business decision. The company asserts that genetically engineered insulin is popular and more closely resembles insulin made by the human pancreas. Another company, Novo Nordisk, pulled all of its animal insulins six years ago.

In Vancouver, Kathy Ferguson is also demanding that animal insulins remain on the market. Her son, Chris, was on animal insulin as a child. After he switched to humulin, he started having problems. "I'd get him up to go to school and he would start his breakfast and insulin," Ferguson told Marketplace. "I start work at 8:30, so I'd leave, and I'd come home and he wouldn't know what happened all day. So he wouldn't really know if he'd gone to school that day or not." Besides memory loss, Chris began having seizures and blackouts. Ten days after his seventeenth birthday, he died during the night. "He was halfway off the bed, from his waist down," Ferguson remembers. "He was at the opposite end of the bed that he normally sleeps. So are you going to tell me that he wasn't maybe awake? And didn't know something was happening?"

The autopsy report says Chris died of natural causes. The official cause of death was cardiac arrest, the result of seizures caused by his diabetes. Ferguson wonders if her son's insulin played a role. "They say it's a natural death. Well, at 17, it's not a natural death, I don't think."

Incidents not isolated

Ferguson and Colleen Fuller are not the only ones who say there must be a choice of insulins available. Marketplace has obtained several adverse drug reaction reports from Health Canada. The reports were filed by doctors and patients across the country.

Since 1998, 121 people on humulin, or its faster-acting version humulog, have experienced problems including comas, seizures, convulsions and hypoglycaemia (a sudden drop in blood sugar levels).

South of the border, the U.S. Food and Drug Administration has been flooded with similar reports. Between September 1999 and September 2000, the agency received more than 700 reports from patients and doctors who believe that humulin and humulog have caused disorientation, sent people to hospital, and have been linked to dozens of deaths. "I started to do my own research about the insulin and what I discovered is that there were thousands of people, not just a few, but thousands of people …who were having problems with human insulin," Fuller told Marketplace.

Health Canada would not speak on camera with Marketplace about the adverse drug reaction reports. But a spokesperson said the reports are purely anecdotal and not scientific. They are no cause for concern.

Looking for help

In desperation, Colleen Fuller turned to the Canadian Diabetes Assocation. The CDA's Martin MacInally says his organization tried to get Eli Lilly and its competitor, Novo Nordisk not to discontinue their popular animal insulins. "We definitely asked them to reconsider their decision," MacInally told Marketplace, "but the companies…said 'This is final. This is what we're doing. "

But Fuller is not convinced the CDA has done enough. She points to a survey published four years ago. The Association asked its members if they were having trouble switching from animal to genetically engineered insulins. Forty-three per cent of respondents said they were. "This would suggest the CDA should follow up and find out what's going on with their members,"

Fuller says. The British Diabetes Association heard from its members, too. It received 3,000 letters from diabetics who said they would lose warning signs of dangerously low sugar levels. Some believed they would have died had they not been rescued as they lay unconscious. The BDA never published a commissioned report because it considered it "too alarmist."

On its packaging, Eli Lilly warns that "a few patients" who switched to humulin found their "early warning symptoms" of hypoglycemic reactions were "less pronounced" than they were with animal-source insulin. But the company denies its synthetic insulins are the cause of illness or death. "There is no evidence from the clinical studies that there is a correlation, or a cause and effect relationship between human insulin and these symptoms that you're referring to," Eli Lilly's Dr. Grossman told Marketplace.

Problems documented

Research published in prestigious medical journals like The Lancet and the British Medical Journal has cited problems like people losing crucial warning symptoms when they switch to synthetic insulins.

Dr. Arthur Teuscher is a Swiss endocrinologist and one of the first physicians in the world to prescribe the newer, synthetic insulins. But he changed his mind after seeing how one of his patients reacted. "He had an abrupt, sudden, hypoglycemia," Teuscher said. "He was rushed to the university department and after three days...he was dead." Teuscher believes sudden deaths occur because some people on synthetic insulins lose typical warning signs like sweating and trembling as their blood sugars plunge.

Dr. John Hunt is an endocrinologist who has treated dozens of patients struggling on humulin. He does not understand how pharmaceutical companies could deny that some people are having problems. "To say somebody doesn't exist, when they're having major problems...they know the solution, and the solution is being removed from them. I think this is immoral." Synthetic insulin works well for the vast majority of diabetics. But those who can not adjust aren't just frustrated that no one appears to be listening. They are angry.

Lawsuit in the works

Colleen Fuller has organized a group of people who are about to launch the first class action lawsuit of its kind in Canada. They're working out the complicated details of the lawsuit and are hoping others will join their fight as they take on pharmaceutical giants Eli Lilly and Novo Nordisk.

"I think that they need to take responsibility for their product and the impact that it's had on people," Fuller said.

The lawsuit will also target Health Canada. Fuller says if the drug companies won't provide choice in insulin, the government has to figure out a way to make it possible.

Health Canada's Ian MacKay says when the drug companies pulled their products, there was nothing Ottawa could do. "We simply just don't have the authority to force a manufacturer to continue marketing something that they have chosen to withdraw from the market for their own corporate reasons," MacKay told Marketplace. Fuller dismisses comments like that. "I'm so sick of hearing that, 'Oh, there's nothing we can do. There's nothing we can do.' There is something they can do. They can get off the pot and make sure this drug is available to people so that we're not subjected to these horrible experiences."

Diabetics can get animal insulins from other countries through a special access program run by Health Canada. But there is a lot of paperwork and patients have to pay for shipping and handling. On top of that, the insulins usually are not covered by provincial health plans. That can leave diabetics responsible for insulin bills of several thousands of dollars a year for a drug that keeps them alive. "If Health Canada were at all sensitive to their people, they would say if people really need it, let's make it easy for them rather than making it as difficult as we possibly can," according to Dr. John Hunt. Hunt has helped patients import insulins no longer on pharmacy shelves in this country. He says people who are able to get the animal-based insulins report fewer problems and can get back to normal.

Colleen Fuller knows her crusade will not be easy. Her battle for choice started when she stopped struggling with humulin and returned to the animal alternative. "It was a decision which said to me, 'You are going to be using this insulin - you are going to be involved in the fight of your life.' And that's what's happened."

CBC Marketplace Feedback

February 13, 2001 - Insulin

Canadian Diabetes Association objects to insulin story

The February 13, 2001, Marketplace segment, produced by Erica Johnson, which looked at the availability of insulin options in Canada for the treatment of people living with diabetes raised a number of issues that require a response. These include, the choice of medical treatments options, access to those treatments, transition from one type of insulin to another, misrepresentation of information and instigating fear and panic among hundreds of thousands of Canadians.

First of all, the segment raised an important point regarding the issue of choice and availability of prescribed treatment options. Insulin is a life sustaining necessity for hundreds of thousands of Canadians. The Canadian Diabetes Association strongly supports the principle that people who are dependant on a treatment option that has been approved for use in Canada by the federal government should continue to have access to that treatment or a viable alternative.

That being said, the segment that was presented on Marketplace did not adequately address the use of human insulin versus animal insulin for the treatment of diabetes. The show was extremely one-sided in its approach to the issue and in fact paid almost no regard for the 99.8 per cent of Canadians that are using human insulin to successfully manage the disease.

The alarmist way in which Marketplace represents certain health issues experienced by a few individuals who switched from animal insulin to human insulin was at best irresponsible.

As a person living with diabetes who successfully made the transition from animal insulin to human insulin, I am deeply concerned about the potential impact the Marketplace segment may have, and indeed already has had, on Canadians who are dependant on insulin to stay alive.

According to Eli Lilly, since the introduction of human insulin and fast-acting insulin analogues, the demand for animal insulin has declined significantly over the past decade. Their figures show that "today only 0.2 per cent of the Canadian insulin market is animal products." This figure represents about 400 people using animal insulin out of the approximately 220,000 insulin dependant Canadians.

As of today, the Canadian Diabetes Association has received numerous calls from people who have been successfully managing their diabetes with human insulin for years and who are now questioning their own personal safety and the safety of their loved ones. The Association strongly urges people who have questions to see their physician as soon as possible and to not make any decisions regarding a change in treatment options before having that discussion.

Transition from animal to human insulin is a worldwide trend and to the best of our knowledge the combination beef/pork insulin is no longer being manufactured anywhere in the world. Pork insulin is still available in Canada through Eli Lilly, and beef insulin is available in the United Kingdom through CP Pharmaceuticals Ltd. This fact, while provided to Marketplace was not made clear to your viewers. People do have a choice in regard to insulin treatment options. Eli Lilly has recently stated that the company does not intend to discontinue pork insulin production.

As part of its response when beef/pork insulin was first discontinued the Canadian Diabetes Association convened a subcommittee of its Clinical and Scientific Section to formulate a position statement on animal insulin. Dr. Robyn L. Houlden, FRCPC, Associate Professor, Division of Endocrinology, Queen's University was part of the group of diabetes specialists that compiled the position paper.

"The introduction of human insulin in the 1980's was accompanied by claims that in some patients the symptomatic awareness of hypoglycemia was altered on transfer to human insulin. A review of 39 clinical and 12 epidemiological studies provided no convincing scientific evidence to support a significant clinical difference in the frequency of or in the symptomatic response to hypoglycemia between animal and human insulin" said Dr. Houlden citing Diabetic Medicine 1994;11:925-934. Furthermore, according to the position paper compiled by Dr. Houlden and other diabetes experts "when transferring from animal to human insulin, the majority of people need minimal or no dosage adjustment. Human insulin is available in a broader range of formulations, including mixtures, and with more advanced pen delivery formulations. Since the arrival of human insulin, the problem of allergies, lipoatrophy and immunologic resistance to insulin have, for all practical purposes, been eliminated."

Experts recognize that for some people who have used animal insulin for some time, there is an adjustment period. Some individuals report adverse reactions. The Canadian Diabetes Association reinforces the importance of the transfer process being done under medical supervision. Should physicians require assistance in helping their patients through a transfer process, we have ensured that diabetes experts across Canada can be made available to offer assistance.

In addition to the issues already raised, the Marketplace segment also highlighted very select results of a survey that the Canadian Diabetes Association conducted in the Fall of 1996. The survey asked approximately 50,000 readers of Diabetes Dialogue, the Canadian Diabetes Association's consumer based magazine, how changing to a different type of insulin would affect them. A total of 134 people responded, out of which 25 per cent reported having used animal insulin - that works out to be 33 people. Of that number 43 per cent reported issues with the switch - that works out to be 14 people. The insinuation on the show that this number is much higher and that the Association should "find out what's going on with their members" is sheer misrepresentation of the results of the survey that were provided to Marketplace. In fact we do actively advocate on behalf of not only our members but all Canadians living with diabetes. In fact, priority issues that the Association is asked to pursue are access to newly emerging treatments and medical devices, access to quality health care and ensuring that neither treatment nor management supplies are cost prohibitive.

Marketplace proudly makes the boast that the show is designed with the protection and best interests of the Canadian consumer in mind. However, our February 13, 2001, segment on insulin did not meet your stated ideals. I hope that in the future if you present on diabetes, or other health issues of importance, you will approach the topic in a manner that does not potentially induce fear or panic in hundreds of thousands of Canadians that you purport to protect.

Sincerely,

John Bromley
National President
Canadian Diabetes Association

Marketplace responds:

Dear. Mr. Bromley,

Thank you for your letter received February 15th, 2001. We discussed your objections to the item at length with the CBC legal department and the senior editorial team at Marketplace. We are sorry you took objection to the item on insulin; however, we believe our story was accurate, balanced and fair.

It is certainly never our intention to instigate fear and panic amongst our community of viewers.

The story accurately and clearly stated the vast majority of people using human insulin find the product works well. The point of our report was to highlight the experiences of a small number of diabetics for whom genetically engineered insulin does not appear to work well.

We interviewed, and reported on both Eli Lilly and the Canadian Diabetes Association's views on the potential health affects of switching from animal to genetically engineered insulin.

We believe out item was fair in it's treatment of the issue, and based on viewer response, is serving a valuable public service by raising this issue for discussion.

To that end, we will be posting your letter along with this response to our website. Again, thank you for your comments about our insulin item.

Sincerely,

Julie Bristow
Executive Producer
Marketplace
CBC Television
Toronto

Eli Lilly's objections

I was both surprised and appalled at the recent segment on Marketplace regarding insulins. The public expects the media to provide Canadians with unbiased and useful information to help them make better decisions about their lives. This is even more crucial when the topic is healthcare. Instead, you chose to create hype and sensationalism with irresponsible and erroneous reporting.

Despite spending almost 30 minutes on the phone with Marketplace reporter Erica Johnson, the piece contained numerous errors and misinformation regarding the safety of human insulins. While the extent of error prevents me from responding to each and every one, I want to be certain to correct the more blatant inaccuracies featured in the broadcast.

1. Your segment needlessly raised questions and fears about the safety of human insulin. Human insulin is a safe and efficacious product, and offers clear advantages over animal source insulin. Human insulin does not cause the symptoms mentioned by those in the broadcast. It is the switch from animal to human insulin, without making adjustments that take into consideration the differences between the two types of insulin, that may lead to increased hypoglycemia and its consequences. These symptoms are not due to the human insulin itself. Anyone with diabetes who makes a change in therapy, be it from oral hypoglycemic agents to insulin, or changing insulins, is at risk of hypoglycemia, and needs to do so with the assistance of properly trained diabetes health care providers. Due to the importance of this point, I have provided a comprehensive explanation at the end of this letter (see #7)

2. Ms. Johnson referred to adverse drug reaction reports received by Health Canada and the FDA in the United States regarding human insulin and seizures, coma, hypoglycemia, and sudden death. However, Ms. Johnson failed to report that all of these events have also been reported with animal source insulin. It is well known that insulin from any source can cause hypoglycemia and its complications, so it is not surprising that these reports have been received. Ms. Johnson described hypoglycemia as "a sudden drop in blood sugar levels. The person is about to blackout." This is not correct, as most episodes of hypoglycemia do not include a blackout.

3. Ms. Johnson stated "thousands of people are switching to it [Humulin] because Lilly has stopped making the two most popular animal insulins." This is not the case. Thousands of people were switching to human insulin well before the decision was made to discontinue beef/pork insulin. It is because of this trend that Lilly decided to discontinue manufacturing beef/pork insulin. With the advent of human insulin, there is no longer the need for beef/pork insulin. In fact, of the estimated 217,400 Canadians using insulin, 0.2 per cent use animal insulin, with many of these prescriptions being filled for people's pets with diabetes. Also, as I clearly stated to Ms. Johnson in our interview on a number of occasions, Lilly is not discontinuing all animal source insulins. Lilly continues to offer purified pork insulin (Iletin II), and has no plans to discontinue it at this time.

4. Ms. Johnson referred to a number of published reports of "documented problems" with human insulin in the literature, and showed an article from the The Lancet (Lancet 1987;2(8555):382-5) by Teucher and Berger, describing three case histories of hypoglycemia in patients who switched from animal to human insulin. However, Ms. Johnson failed to report that, since then, a number of carefully designed randomized clinical trials have been published in equally reputable medical journals, such as Diabetes Care, Diabetic Medicine, and the British Medical Journal all demonstrating and concluding, that the incidence of hypoglycemia, severe hypoglycemic symptoms, or hypoglycemia unawareness was no different with human insulin compared with animal source insulin.

5. Ms. Johnson also reported on a survey of pharmacists across the country who claimed that they were under the impression that purified pork insulin (Iletin II) was no longer available. Obviously, I cannot comment on the impressions of others, but, as stated earlier, Iletin II remains readily available in Canada. A simple call to the pharmacists' wholesaler or to Eli Lilly Canada can arrange delivery of Iletin II. Eli Lilly Canada is not responsible for which products a pharmacy decides to stock. However, I suspect the low stock of this product reflects its low demand by people across Canada which, as previously mentioned, is 0.2 per cent of total insulin prescriptions in Canada

6. The brief interview clip with Mr. Martin McInally of the Canadian Diabetes Association (CDA), left the viewer with the impression that the CDA does not support the switch to human insulin. This is not correct. I invite readers to view the CDA website, (http://www.diabetes.ca/about_diabetes/animal_insulin.html) where it is clearly stated that "transition from animal to human insulin is a worldwide trend," and that "the majority of people transferring from animal to human insulin need minimal or no dosage adjustment." It also clearly states "the only animal insulin that is available in Canada at this time is pork insulin. Eli Lilly has recently stated that the company does not intend to discontinue pork insulin production." More information about the switch from animal to human insulin is available on the website.

7. Ms. Johnson, in her interview with Dr. John Hunt, asked how "pharmaceutical companies could deny that some people are having problems," and Dr. Hunt referred to this as "immoral." In reviewing the tape of my interview with Ms. Johnson, I never denied that some people were having problems. In fact, I clearly acknowledged that some people have had problems in switching from animal source insulin to human insulin. I offer the explanation and solution for these problems below.

The symptoms and other problems experienced by the individuals featured on the broadcast can be explained, not as a problem inherent with human insulin per se, but as follows:

With the administration of any foreign protein, the body can develop antibodies to that foreign protein. Animal source insulin, being foreign to the body, can induce an antibody response. In persons with diabetes, the anti-animal insulin antibodies can alter the time action profile of the administered insulin. In most cases, this results in a time-extension (prolongation) of the effect of the insulin, but can also result in an erratic release of the insulin from the antibodies. Other problems with the use of animal insulins include injection site reactions, allergic reactions, and dimpling or lumping of the fat below the skin (called lipodystrophy and lipohypertrophy).

Human insulin, made by recombinant DNA technology, is identical in structure and function to insulin produced naturally by the human pancreas, and is a clear advance over the use of animal insulins. However, with the switch from animal source insulin to human insulin, the antibody response will be altered. It has been clearly demonstrated that human source insulins produce a much weaker antibody response than animal source insulins, which would be expected, given that the human insulin is identical to naturally produced insulin and would therefore not be perceived by the body's immune system as a foreign protein.

In a small number of people, this change in antibody response can result in a substantial change to the time action profile of the human insulin compared with its animal source counterpart. In general, the time action profile of human insulins is shorter and has an earlier peak response compared to animal source insulins. So, human NPH insulin would have an earlier peak response and shorter duration of action compared with animal source NPH insulin, and human regular insulin would have an earlier peak response and shorter duration of action than animal source regular insulin. Thus, it is clear that in those individuals with a pronounced antibody response to their animal source insulin, a switch to human insulin would need to be accompanied by a change to the overall insulin regimen - doses, time of injection, number of injections throughout the day, etc.

Early after the introduction of human insulin, this phenomenon was not well characterized. Hence, some people who switched from animal insulin to human insulin had unexpected hypoglycemic reactions as a consequence of the altered time action profile of their new insulin. As well, this increase in hypoglycemia resulted in an increase in hypoglycemia unawareness, a decreased ability of the body to recognize hypoglycemia with the usual symptoms.

Hypoglycemia unawareness is not unique to human insulin, as it has been demonstrated with any increase in hypoglycemia from any cause. Over the years, diabetes specialists have become aware of this phenomenon and, when recommending a switch from animal to human insulin, recommend it be done in conjunction with an increase in glucose monitoring and a change in the insulin regimen to accommodate this change in time action profile. Without these considerations, it is clear that a simple switch to human insulin, without these other changes to the treatment regimen, could result in increased hypoglycemia, with hypoglycemia unawareness, which could increase the likelihood of complications of hypoglycemia: seizures and coma. These symptoms, as well as the others described by those in the broadcast, including sudden death, are not unique to human insulin. They have been clearly described with hypoglycemia occurring with animal source insulins as well. Furthermore, with more and more evidence confirming the need for improved glucose control to reduce the risk of the long term complications of diabetes, hypoglycemia remains an inherent risk with improved control. As more persons with diabetes strive for better glucose control, hypoglycemia may become more prevalent with almost any therapy, and needs to be anticipated and minimized with more intensified diabetes management. In fact, even though Ms Johnson included Humalog® with her report on human insulins, Humalog is an insulin analogue that has been clearly demonstrated to result in less hypoglycemia when incorporated into a proper diabetes treatment plan.

In the spirit of responsible journalism, I would ask that you post this letter unedited on your website to ensure that viewers are presented with the true facts.

Yours truly,

Loren D. Grossman, MD, FRCPC, FACP
Associate Vice President, Clinical Research
Eli Lilly Canada Inc.
Toronto

Marketplace's response

Dear Dr. Grossman,

Thank you for your letter to Marketplace received February 16, 2001. After careful discussion with the CBC legal department and the senior editorial team at Marketplace we believe our story is accurate, balanced and fair.

We accurately state human insulin works well for the vast majority of diabetics using the product. We fairly reported that your Eli Lilly is still selling pork insulin. And in terms of balance, we quoted Eli Lilly saying that the product was safe and efficacious.

It was the purpose of our piece to draw attention to the fact that a small number of people are experiencing problems with genetically engineered insulin. This small number of people are primarily concerned with making sure they have easy access to animal insulin as an alternative.

We believe our item is serving a valuable public service by drawing this to the audience's attention. We appreciate you taking the time to write. In an attempt to further the discussion on this issue and to deal directly with your concerns we will post your letter along with this response on our website.

Sincerely,

Julie Bristow
Executive Producer
Marketplace
CBC Television
Toronto

More Insulin letters

I have been a type 1 diabetic for 30 years (I am 65 years old). I had maintained a "relatively" controlled life with a regime of beef & pork insulin until I was FORCED to move to synthetic insulins. Since then it has been pure hell trying to maintain a "controlled" lifestyle which allows me to work and live without fear of sudden, and without warning, hypoglycaemic reactions.

The most frustating and damming aspect of this is the total ambivalence and denial of the manufacturer (in my case Novo Nordisk) to my problem and to some extent the ignorance of the medical profession. I realise that most type 1 diabetics have been able to adapt to these new insulins but that 10 to 20% of type 1 diabetics are very "brittle" (my understanding is that the immune system is involved by blocking the hormone until it suddenly releases causing a sudden onset of diabetic reaction).

Regardless of my simple and perhaps misguided view as to the cause, as indicated on your program of Feb 13 many of us are having great difficulty.

Al Strong

An interesting story, this, but one filled with major gaps in information.

As a Type 1 insulin dependant diabetic of some 30 years duration, I was frustrated constantly by the jumps in logic and the lack of explanation of what the problems may be here.

First off, not a single word stating that each and every one of the "side effects" of human insulin happen to anyone, with varying degrees, who has a severe hypoglycemic reaction.

Secondly, no mention was made of the antibodies that build up in the human body to animal insulin, and the subsequent need to increase doses over the years to maintain the same effect.

Third, no mention of the standard advice that some doctors (not all, and there's a story there) gave to patients making the switch, namely, drop your insulin doses by a third, and adjust up.

Before you ask to see my Eli Lilly hall pass, I will mention that my switch to human insulin was dangerous and dramatic, and put me in situations where my life was in real peril. The fact that this was entirely due to my physician's lack of warning or knowledge was the culprit, not the insulin itself.

The rise in reportable incidents from physicians might also have something to do with the relatively recent phenomenon of "intensive diabetes management", where those of us with diabetes are now urged to keep our blood sugar level within normal ranges as often as possible, through more frequent injections and frequent blood glucose monitoring.

When you strive to keep sugars normal, lows occur much more frequently…Since my switch to human insulin, my incidence of severe lows has increased dramatically. So too, has the quality of my diabetes conrol, as evidenced by hemoglobin A1c readings (3 month average blood sugar level test) which are very close to normal. Not perfect, but much better than before, under animal insulins and loose control.

So, is Eli Lilly's position defensible? Not really. To state that there are no patients who can't tolerate any drug is foolish. There were a small number of diabetics who had allergic reactions to the animal insulins, so it goes to figure that there would be a similar problem with the new variety. But your program, which fell well short of Marketplace's normal standard of accuracy, was fear-mongering, plain and simple. It was, in fact, just bad reporting, and every bit as indefensible as Lilly's stand.

Mark Nesbitt

I have been a diabetic for over 49 years. For the most of that time I was on NPH and regular Insulin. Four years ago I was given no choice but to switch to humulin R and humulin N insulin. From then on HELL has broken loose.

I used to take insulin only in the morning. Now I have to take it twice a day. Before I had much more control and could trust my feelingws when my blood sugar was low from either insulin. Now…my blood sugar soars and dips and I can't tell by my feelings — IT IS FRIGHTENING TO MY WIFE AND I.

Since Humulin she has had to call 911 a number of times…I feel like I'm sitting on a time bomb. I wrote a long letter to the CDA, and got a sympathetic reply. My druggist, too, has tried but the bottom line is YOU CAN'T BUCK BIG BUSINESS. It's so frustrating when the solution is so handy but nobody will offer it.

Those capable of offering me hope don't seem to care. I thank the CBC for trying.

Rev. A. Fred Archibald

Excellent report on current insulins available. The issue of biosynthetics insulins was well covered and very clear. There was no hesitation to describe the issues involved and the response from Eli Lilly, the Canadian Diabetes Association and Health Canada.

As a health care professional, I will be more cautious in describing insulin actions to persons with diabetes and will be more aware of the possibility that insulins have different lengths of actions in different people. From my experience I would say that this issue affects far more individuals than is presently known.

Anna Brundage

I am 52 years old and I have been an insulin dependent diabetic since diagnosis in 1985. I was surprised and shocked at the misleading nature of your report on insulin. Not once was the cornerstone of modern diabetes control - blood glucose self testing and intensive insulin therapy mentioned.

I am very familiar with both types of insulin mentioned. I participated in a clinical trial of the Novo human insulin and I currently use the Lilly product. I test my blood 3 to 5 times daily and adjust my insulinaccordingly. Indeed. my signs of low blood sugar did change, however, by testing my blood I easily recognised the change and acted accordingly. It is a fact that with either insulin type these signals change over time.

None of your subjects mention blood glucose testing. If a diabetic is taking any new medication or changing an insulin dose or type and not testing - it is an invitation to serious problems and in no way is a surprise. Not mentioning the important relationship between testing and insulin dosage is simply irresponsible and unforgivable.

I am certainly not a poster boy for outstanding diabetes control. It is an endless, exhausting battle with only a drop of blood and a needle to help. Human insulin has made my life better, my control more precise and I am grateful for it. I am equally grateful for the tiny machine that measures my blood sugar in 15 seconds and tells me where I am. I'd be dead without them both.

Craig Strickland

As a diabetic who has spent the last year in and out of insulin shock, I want to thank you for presenting this story to the country. At last people are starting to realize that I was not doing something deliberately to cause my going in and out of insulin shock. Even the Doctors in this community have not believed that one minute you can have a normal blood sugar reading and with half an hour be unconscious.

My hope and the hope of all diabetics is that we live long enough to see a cure for this disease and I believe that this story will help some of us see that that day come.

Vicki Yakemishin

For Price Break on Drugs, Congress Looks to Canada By ROBERT PEAR

New York Times

September 9, 2001

WASHINGTON, Sept. 8 - Congress is taking steps to allow imports of prescription drugs from Canada, in the hope of giving American consumers access to lower-priced medicines. The Food and Drug Administration and drug companies oppose the legislation, but many lawmakers said they know of no serious safety hazards with Canadian imports.

"It would be very hard for anyone to make a credible case that there is a risk in importing drugs from Canada," said Senator Byron L Dorgan, Democrat of North Dakota, who is leading efforts to relax restrictions on such imports.

A law adopted last year allowed pharmacists, drug wholesalers and distributors to import low-priced prescription drugs from 26 countries including Canada, Japan, Israel and members of the European Union. But the law gave broad discretion to the secretary of health and human services. The Bush administration and the Clinton administration both refused to issue rules to carry out the law. They said they could not certify that the import plan would be safe and would save money for consumers. In an interview, Mr. Dorgan said, "We are narrowing the bill this year to focus on imports from Canada as a first step."

The broader proposal was included in a spending bill approved last year by votes of 86 to 8 in the Senate and 340 to 175 in the House. A measure dealing just with Canada could pass even more easily, Mr. Dorgan and other lawmakers said. In July, by a vote of 324 to 101, the House approved a bill that would make it easier for people to import low-cost prescription drugs for their own use. Mr. Dorgan plans to offer his proposal on the Senate floor this month.

Proposals to allow drug imports appeared unexpectedly on the House floor last year without much study or analysis by the committees that usually handle health care legislation. The idea has attracted serious attention in recent weeks as the federal budget surplus has shrunk, making it more difficult for Congress to add drug benefits to Medicare, the federal health program for the elderly and the disabled. Senators James M. Jeffords, independent of Vermont, and Debbie Stabenow, Democrat of Michigan, are working closely with Mr. Dorgan to push legislation through the Senate. Drug costs were one of the top issues in Ms. Stabenow's campaign last year. She organized bus trips to Canada for Michigan voters who wanted to buy prescription drugs at the lower prices available there. Prescription drugs are subject to price controls in Canada, as in many industrial countries. The bill Mr. Dorgan and his colleagues are drafting, like the one enacted last year, says that imported drugs must comply with all the safety and labeling requirements that apply to drugs made and distributed in the United States. Each batch of imported drugs would have to be tested for purity, to make sure it was not adulterated or misbranded.

Stephen L. Giroux of Middleport, N.Y., a pharmacist who owns three drugstores about 40 miles from the Canadian border, said, "I would be totally confident and comfortable buying products from Canadian suppliers." At a Senate hearing this week, William K. Hubbard, senior associate commissioner of the Food and Drug Administration, said he "would have a relatively high degree of confidence" in drugs purchased in Canada. But he said that large-scale imports from Canada would pose immense challenges to the F.D.A.

Drug manufacturers and distributors said they now had virtually complete control over the custody of prescription drugs, from the factory floor to the retail pharmacy. But after drugs leave the United States, they said, they could not be sure of the conditions under which the drugs are stored and handled. Canada has a sophisticated system for regulating drugs. But Mr. Hubbard said he could not give assurances about the safety of products imported from Canada because he did not know how the drug distribution system worked there. "Once a drug goes into the Canadian market, it's outside F.D.A. jurisdiction," Mr. Hubbard said, adding that "all sorts of malevolent things" could happen to drugs there. Senator Dorgan said he considers the drug-import bill a tool to "put pressure on drug companies to lower their prices."

Congressional aides who have visited Canada and studied the pharmaceutical market there said it was unrealistic to think that the United States could solve its problems by giving United States consumers access to the Canadian market. Canada has a population of 31 million, compared with the United States' population of 285 million.

Alan Sager, a professor at the Boston University School of Public Health, said drug makers could try too thwart Mr. Dorgan's bill by limiting the supply of drugs available in Canada for export to the United States.

Drug companies would, in effect, be competing with themselves if they sold large amounts of drugs in Canada, only to see the products shipped to the United States for sale here at discount prices. Mary R. Grealy, president of the Health Care Leadership Council, a coalition of chief executives from large health care companies, said Canada could become "a trans-shipment point" for counterfeit drugs being sent to the United States from third-world countries. "You don't know where drugs in Canada came from," she said. "They could have been made or stored in third-world countries with no regulation at all."

Federal law says that a prescription drug made in the United States and exported may not be imported to the United States except by the manufacturer. The law, adopted in 1988, sought to end a "gray market" for drugs that were counterfeit, adulterated or too old to be used safely.

The 1988 law, drafted by Representative John D. Dingell, Democrat of Michigan, was widely seen as a consumer protection measure. Congressional investigators had documented many cases in which counterfeit drugs, including birth control pills, had been imported.

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