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|Thank you, Colleen and Brenda for all your work on behalf of all diabetics around the world that cannot safely or effectively use the "human" insulins.
Congratulations on a job well done!
|Double click on the email globe to email us.||Double click on the email globe to email us.|
|Presentation to Standing Committee on Health: Feb. 03, 2003|
|Thank you for allowing us to appear before the Standing Committee on Health today. We represent The Society for Diabetic Rights, formed two years ago to work for a strategy to retain natural animal-sourced insulins in Canada. We have about 250 members from Newfoundland to British Columbia. We have more members than money - we all work as volunteers to inform physicians and people with diabetes about the problems we and many others experience with synthetic - or "human" - insulin. Our goal is to see a national strategy in Canada to ensure a secure, affordable and domestically-accessible source of natural animal insulin, both beef and pork.|
|We are asking the Standing Committee on Health to hold full public hearings on the experiences Canadian diabetics are having with synthetic insulin. The main questions we would like a public hearing to address are:|
|How many Canadian diabetics experience adverse reactions to synthetic insulin, including hypoglycaemia unawareness, severe and frequent hypoglycaemia, memory loss, skin rashes, weight loss, edema, anemia, arthralgia-arthritis-myalgia syndrome and other allergic reaction?
How accurate are product monographs?
What steps has Health Canada taken to increase awareness of the availability of pork insulin as a safe and viable treatment option, and a preferred treatment for those who experience adverse reactions to synthetic insulin?
How is Health Canada addressing the problems reported by diabetics using the Special Access Programme to obtain beef or pork insulin from the United Kingdom or Brazil, including the unfair burden imposed because of added costs?
What is the best national strategy to ensure that Canadian diabetics can obtain natural animal insulins - both beef and pork - readily in any pharmacy in the country on the same basis and at the same cost as synthetic insulins?
|In July 2002 we also asked the Standing Committee to investigate ways to raise awareness about synthetic insulin hypoglycaemia unawareness among physicians and within the diabetes community. We continue to see a great need to develop information for the public, diabetes educators, pharmacists and the medical community about these and other side effects associated with synthetic insulin. We believe Health Canada should encourage people with diabetes, physicians, pharmacists, diabetes educators and other health professionals to report suspected adverse reactions to insulin.|
|We also are concerned about the influence of insulin manufacturers on medical education, on Health Canada and on physicians and diabetes educators who advise patients about the most appropriate insulin treatment. In addition, we believe that physicians should have to disclose any conflict of interest to their patients when advising them about insulin treatment options. At the very least, those who publish insulin treatment guidelines should be required to list any potential conflicts of interest associated with the author.|
|These are the main points we raised in our letter to the Committee on July 2, 2002. In our presentation today we will address the reasons that support our request.|
|There is a wide schism between the claims about the advantages associated with synthetic insulin and the actual experiences reported by many diabetics both in Canada and worldwide.|
|When the first synthetic insulin was being tested, doctors involved in clinical trials for Eli Lilly said this new type of insulin would help reduce the incidence of long-term complications of diabetes by controlling blood glucose levels more effectively. But even the most ardent supporters of synthetic insulin said it should be used only on appropriate patients (those with allergies to natural animal insulins) and that transferring patients ?en masse? would be inappropriate.|
|In 1993 or 1994, Novo Nordisk succeeded in getting its new insulin product, Novolin, approved by Health Canada. A year later, it withdrew all of its animal insulin products from the Canadian market. At that time more than one-third of all diabetics ? roughly 45,000 people ? used animal insulin and, according to Eli Lilly, 95 percent of these used Connaught-Novo brands. Thus, Canadian diabetics were switched "en masse" to synthetic insulin between 1994 and 1995.|
|Canadian diabetes patients learned either from their pharmacist or their physician that Connaught-Novo's natural animal insulin was being withdrawn and that they would have to start using "human" insulin. Most were told by their doctors that "human" insulin was better than animal insulin because diabetics experienced fewer allergic reactions to it. "Human" insulin, doctors said, was safer, better and "identical" to the insulin naturally made inside the human body. Those diabetics who resisted switching were told that all animal insulin was being withdrawn from the market and they would have to roll with the times. Most diabetics were switched to Humulin, made by Eli Lilly. If they complained to their doctors that they were unable to achieve stable blood sugar levels, that they couldn't tell when their blood sugars were low, that they generally felt ill, they were simply told they would have to "persevere", that they had no choice.|
|Diabetics who contacted Health and Welfare Canada in the mid-1990s to complain about Novo Nordisk's decision and to report problems using "human" insulin were told to work more closely with their doctors. Doctors, the Health Protection Branch advised, should contact Novo Nordisk "to find solutions for patients having concerns or difficulties with the transfer from beef-pork insulins to human insulins". [Letter to Mrs. G. Mushet from the Health Protection Branch, June 26, 1995.]|
|In 1989, The Economist noted that Humulin, Eli Lilly's synthetic brand insulin, was causing a "peculiar reaction" in diabetic patients. "But why, no one knows.", the article said. Three years later 400 diabetics in Great Britain came together to launch a class action lawsuit against Novo Nordisk and Eli Lilly, claiming harmful effects from using synthetic insulins. This attempt collapsed after two Novo Nordisk sponsored studies were published disputing the litigants' claims. Six years later, Suzan Kawulok, an American woman, launched a class action lawsuit against the two companies claiming she and others had been inadequately warned about severe side effects, up to and including death. We do not know the status of this lawsuit.|
|In 1995, the US Food and Drug Administration listed Humulin insulin as the 8th most reported drug for adverse reactions. MedWatch reported in early 2000 that over a period of two years, 1998-1999, inclusive, 4,000 adverse events were reported with synthetic insulins as a suspected primary or secondary agent. These events included 150 deaths, 144 automobile accidents and 1,400 hospitalizations. The most commonly reported adverse event involved hypo- and hyperglycaemia "drug ineffectiveness";.|
|Adverse event reporting has been widely recognized as an under-utilised tool in Canada's system of post market surveillance. Estimates vary, but the rate of reporting is between one percent and ten percent of actual experience. As of December 30, 2002 there were over 630 adverse reactions reported to the Marketed Health Products Directorate - up from approximately 450 in February 2002. These include 9 deaths.|
|Our society has received reports from all of our members and some of these have also been reported to the MHPD. We have received reports of 11 deaths. Two families in our group represent young women with severe and irreversible brain damage caused by night time hypoglycaemia and seizures. Many of our members are permanently disabled and unable to work because of their inability to avoid severe and frequent hypoglycaemia. One of our members represents a group of approximately 140 Ontario families with one or more children who have diabetes. He reports that approximately one-quarter of the children in these families are unable to identify an insulin reaction when it occurs. Many also report frequent and severe hypoglycaemia, blackouts, memory loss, lethargy and inability to focus or concentrate.|
|The most common complaints associated with synthetic insulin are loss of control over blood sugars, unexplained fluctuations, hypoglycaemia unawareness, increased severity and frequency of hypoglycaemia including blackouts and comas (insulin shock), inability to focus or concentrate, memory loss, myalgia or arthritis-type symptoms, edema, anemia, depression, severe and rapid weight loss, vomiting, diarrhoea, skin rashes.|
|The quality of life for diabetics trying to survive on synthetic insulin is low. Many report they are afraid to sleep at night because they don't believe they'll wake up in the morning. Those with young children report they must train their children to rescue them if they black out unexpectedly. Many who are grandparents report that their kids don't want to leave the grandchildren with them because of their frequent blackouts.|
|This is no way to live, and it is, in many - perhaps most - cases, unnecessary.|
|2. There is a wide schism between what the manufacturers claim and what the evidence suggests.|
|Letters from Eli Lilly and Novo Nordisk to our members state that antibodies are associated with animal insulin. Diabetics who reported that animal insulin lasted longer than synthetic brands were told they were likely producing antibodies to the animal-derived insulin they were using. These antibodies, according to Novo Nordisk, "can extend the duration of the insulin by binding the insulin in circulation". Customers were also informed that antibodies can cause problems at injection sites. According to Novo Nordisk "these reactions are seen with insulin usage but rarely or never when using human insulin". [Letter to Dr. Francine Goulet from Dr. Anders Bogg, Director of Medical Affairs, Novo Nordisk Canada, July 21, 1995.]|
|According to Eli Lilly, "Animal insulin is a foreign substance in the human body. It produces antibodies when used in humans, that is, the body recognizes it as a foreign protein. That is why human insulins were invented and brought to the market in Canada in 1983. Human insulin, known as Humulin, is identical to the insulin that is contained in the pancreas of people without diabetes". [Letter to Helga Kelnor from Mark Fleming, Manager, Lilly Diabetes Care, July 8, 1996]|
|One of our members who contacted Eli Lilly in 1999 to express concern about the withdrawal of beef-pork insulin products was told that some patients experienced problems "when transitioning from animal-derived to human insulin". A number of factors, she was told, are involved: "people taking animal insulin develop significant levels of antibodies against that insulin"[which] may attenuate and buffer the activity of injected insulin. When switching to human insulin, these antibodies significantly and rapidly decrease and may even disappear entirely". [Letter to Mrs. Marie Fitzgerald from Donna R. Loughbridge, RN, Medical Information Associate, Eli Lilly Canada, Inc., April 21, 1999]|
|In July 2002 The Cochrane Review published the results of a thorough review of randomised controlled trials of human versus animal insulin. Its review (Richter B, Neises G. 'Human' insulin versus animal insulin in people with diabetes mellitus (Cochrane Review). In: The Cochrane Library, Issue 3, 2002. Oxford: Update Software) found that ?At the time of introduction of human insulin, marketing strategies suggested that the lower immunogenicity of human insulin and the anticipated decline in antibody titres would offer a clinical advantage for insulin treated patients?. However, these claims were disputed as early as 1988. According to Richter and Neises, ?The studies on immunogenicity of human and animal insulin were difficult to compare because of the different assays for insulin antibodies. Overall, depending on the duration of follow-up, a decline in insulin antibodies was observed following transfer from animal to human insulin. This tended to level out in studies of six months and longer follow-up, rarely demonstrating significant differences at the end of the trial? [pp. 10-11]|
|The claims human insulin did not produce antibodies, or that it produced fewer antibodies, are not supported by the studies reviewed by the Cochrane review. The association of rDNA insulin with the human insulin produced in the pancreas of non-diabetics is not accurate.|
|3. There is a schism between the information issued by Health Canada and both the adverse reports filed by Canadian diabetics and the conclusions of the Cochrane Review.|
|The Marketed Health Products Directorate has dismissed the concerns of many hundreds of Canadian diabetics who have reported their own experiences, or those of their children, spouses, siblings or parents. It is probably safe to say that the response of Health Canada and the MHPD (and the Therapeutic Products Directorate before April 2002) has discouraged many from reporting in the first place. Health Canada has described our dilemma as an issue of "choice" on the market, and advised us it cannot force a company to produce a product it doesn't want to produce. While we support choice of insulin, we feel our concerns are related to our health and not our options as consumers.|
|In May 2002, Health Canada issued a bulletin entitled "The Safety of Human Insulins". It stated that "human [sic] insulins have largely replaced animal insulins because they are more effective and have an excellent drug safety record, both in Canada and in other countries." The Cochrane reviewers found that, on the contrary, the evidence indicates synthetic insulin is not "more effective". Health Canada seems to be unaware of the reporting history associated with synthetic insulin products in the United States and Great Britain.|
|Health Canada's bulletin also states that "The major advantage of human insulins is that there are fewer anti-insulin antibodies formed than with animal insulins. This means a lower risk of adverse allergic reactions and a lower possibility the patient will need higher and higher doses of insulin."|
|Not only is this assertion is also contradicted in the Cochrane review, it is also contradicted by the experiences of our members. It is estimated that between one percent and three percent of diabetics who used animal insulin prior to the introduction of Humulin experienced allergic reactions. Estimates vary, but many suggest that a similar number, at least, are allergic to synthetic insulin.|
|Health Canada's bulletin claims that "Prior to human insulins being approved and marketed in Canada, a thorough review of their effectiveness was done. The results of clinical trials, some conducted in Canada, were studied and post-marketing experiences from other countries were examined. The conclusion was that the benefit-risk balance of human insulins was appropriate."|
|This is an alarming assertion. The Cochrane Review found that "most studies were of poor methodological quality" and that "None of the studies assessed diabetic complications, diabetes-related mortality or total mortality, health-related quality of life, costs or socio-economic effects". Diabetes-related complications include retinopathy, nephropathy, neuropathy and increased risk of cardiovascular disease. The reviewers concluded that "The story of the introduction of human insulin might be repeated by contemporary launching campaigns to introduce pharmaceutical and technological innovations that are not backed up by sufficient proof of their advantages and safety".|
|There is no evidence that synthetic "human" insulin is better or safer than animal insulin. There are few reliable studies that indicate what the experience of diabetes patients is with hypoglycaemia. The estimates of how many people experience adverse effects from using synthetic insulin vary from three percent among endocrinologists in Canada, to 20% by Diabetes UK, to 53% by Swiss endocrinologists. Recently the Swiss health minister, Dr. Thomas Zeltner (his proper title is Director, Federal Office for Public Health, Switzerland) wrote to outgoing director of the World Health Organisation, Dr. Gro Brundtland to ask her to address "what steps might have to be taken to ensure the future production of porcine insulin on a global level". Dr Zeltner estimated that at least 10 percent of diabetics required animal insulin to survive.|
|Low blood sugar is a side effect of insulin use. The confusion arises about whether severe and frequent hypoglycaemic events are an acceptable and necessary consequence of insulin treatment. We say no, it isn't, as long as animal insulin remains on the market.|
|Hypoglycaemia during the transition from animal to synthetic has been the focus of most of the clinical trials comparing synthetic and porcine insulins. This leaves a gap in information about those who never used animal insulin. More research is required to determine why some people see their weight drop to 75lbs. or 85lbs. for no reason, why we experience unexplained bouts of vomiting and persistent diarrhea. There is no question that the effects of human insulin on our quality of life and on diabetes-related complications and mortality have not received adequate attention.|
|Until these questions are answered Health Canada must respond to the reports of adverse reactions by patients who report to the MHPD and ensure we have access to animal insulin in Canada. We ask the Standing Committee on Health to support a public hearing to more fully understand the situation so that a strategy to ensure animal insulin is available at the local pharmacy is developed.|
|Thank you on behalf of our members for allowing us to address the Committee.|
|Colleen Fuller, President and Brenda Johnson, Vice President|
|Society for Diabetic Rights|
|Society for Diabetic Rights - Page 1|
|Society for Diabetic Rights - Page 2|