Health Care Professional Calls to Save Insulin
Health Care Professional Calls to Save Insulin
I read your October 1997 Diabetes Health article entitled "Essential or Expendable..." and your editorial ("I want my Iletin I") with interest because the discontinuation of Iletin I insulin directly affects me, my family and many other patients and providers within our health care system. Ben Eastman's article addressed both sides of the controversy which surrounds the removal of Iletin I from the market.
At first I hesitated to speak out because I have been a health care professional for 26 years and a loyal consumer of Eli Lilly products for 41 years. Throughout this time I've had tremendous respect for its products and its service to our health care system. However, I don't agree with its decision to remove this essential treatment option from patients who really need it to manage their diabetes.
After reading your article, I placed a few calls. First, I phoned Eli Lilly. No one at Lilly could/would explain all the factors involved in the decision to discontinue Iletin I (beef/pork) insulin. I was told that most corporate decisions are made by committee but was not given the name of this committee or names of its members.
It was confirmed that the manufacture of Iletin I insulin is scheduled to stop in April 1998. Each employee I spoke with told me the decision has been very controversial. A medical information specialist said the company couldn't justify the costs incurred in producing the insulin with the decreasing demand for it. She also stated that there was no definitive way to calculate the number of individuals who currently use Iletin I insulin, or the reason(s) they choose this type of insulin over other types of insulin.
As a health care professional since 1971, I can understand why the demand for Iletin I products decreased. For quite some time, physicians and patients have been told that Eli Lilly planned to stop the production of its beef/pork insulin. Knowing this, I would be tempted to not advise patients to even try the Iletin I insulin (despite personal knowledge that these products can be the most effective pharmacologic therapy available for certain individuals). This is because I know they won't be able to continue with this therapy after the supply is exhausted. Many other diabetes care professionals have stated they thought and acted in the same manner.
I quickly realize that calling Lilly was probably not effective since it had already made its decision. It appeared as if the decision to stop producing this product was more economic than research-based. However, I was informed that Lilly conducted prospective studies on over 530 individuals using Humulin insulin.
The findings, reported in 1988, contended that "there was no significant differences" between the use of human and animal insulins in most of the individuals Lilly studied. Lilly did not appear to consider the size and composition of the population who can best manage their diabetes using Iletin I insulin products. There may also be an unstudied number of Humulin patients who could be better managed on Iletin I insulin.
This doesn't mean that research can't be done or statistics can't be collected that would justify the need to continue production of Iletin I insulin in the United States. My husband and I concluded that the only effective way to thoroughly investigate public concerns surrounding the controversy is to collect data via organized professional channels so that the greatest number of Iletin I consumers can be reached. The channels can be either quantitative, clinical research or qualitative (i.e. submitting professional and consumer reports to the FDA MedWatch program: 800-332-1088).
Because time is an issue with the April 1998 deadline approaching, I would certainly advise calling MedWatch so the FDA will be aware that a great number of patients may be affected by this situation.
As I have reported to the MedWatch staff, my personal health and safety depends on this particular type of insulin. I have severe, insulin-dependent diabetes-mellitus. Using the beef/pork insulin allows me to feel physical symptoms as my blood glucose level changes. As you know, this is critically important when the blood sugars drop because it enables me to treat symptoms to avoid losing consciousness.
In 1987, under the advice of my physician, I tried human insulin. Several times I experienced no warning symptoms before passing out. I tried the Purified Pork Insulin, only to find out that I was allergic to it.
Finally, my physician advised me to return to Iletin I (beef/pork) insulin. Once again I was able, and am still able, to experience warning symptoms whenever my blood sugars drop to dangerous levels.
In 1996, again with my endocrinologist's assistance, I tried to refine my blood glucose management with Lispro. I found that so long as I mix the Lispro with an animal insulin (NPH Iletin I), I experience symptoms as my blood glucose level changes. However, when I took the Lispro alone at dinner, I felt no physical symptoms as my blood glucose level dropped dangerously low. I routinely checked my blood glucose two hours after dinner to find it sometimes dropped as low as 26-36 mg/dl without any symptoms.
My physician advised me to substitute Regular Iletin I for the Lispro. Since doing this I felt, and continue to feel, physical symptoms that correspond to the changes in my blood glucose level. My diabetes management is optimal. Recent tests revealed that my A1c is 5.7% and that I do not have severe, long-term diabetes complication, even after having IDDM for 41 years.
Indeed, I have no choice but to use the beef/pork insulin to maintain my health. As you are aware, many other individuals have had experiences similar to mine. To date, Eli Lilly is the only company which produces the Iletin I (beef/pork) insulin in this country. What I learned from the Lilly Corporation is that this is a major reason for controversy in its decision to discontinue the production of Iletin I product.
The medical information specialist at Lilly heard my personal history and professional concerns about the discontinuation of Iletin I. She repeatedly advised me to have my endocrinologist telephone either Dr. Holcombe or Dr. Bastry of Lilly's U.S. Medical Operations staff, to seek advice on counseling me about dosage adjustments when switching to Humulin.
She found it difficult to accept the fact that I am allergic to Lilly's Purified Pork products, despite a therapeutic trial on this insulin with a physician's guidance. This person also suggested that I might be experiencing hypoglycemic unawareness due to long-term, tight blood glucose control. I reiterated to her that my particular "hypoglycemic unawareness" is not relative to tight blood glucose control since I've only experienced it when I have used human insulin.
When the beef/pork insulin is in my system, physical symptoms clearly accompany changes in my blood glucose level. I take issue with the fact that this customer service representative did not accept what I said to her. Lilly didn't listen to what I said. For this reason, I would firmly advise the following approach.
Any patients (or diabetes care professionals who work with patients) affected by Lilly's decision should call the MedWatch program at (800) 332-1088 and report their concerns about the withdrawal of this vital product.
The MedWatch staff told me it only takes a couple of clearly documented reports to initiate an FDA investigation into such concerns. The more consumers who report such concern, the more effective this effort will be.
As a diabetes care professional, I work with my patients to find the most effective means to maintain their blood sugar levels as close to normal as possible - while decreasing the incidence and severity of their hypoglycemic episodes. As you know, this is done to help individuals avoid or delay costly complications from their life-long diabetes condition. Successful diabetes management therapy truly improves the quality of life for the patient, his/her family and our entire society.
Thank you so much for your time and consideration.
Cheryl D. Smith, RN, MSN, ADA
Health Care Delivery and Public Health Council Member
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I have had type 1 diabetes for 36 years now, and I keep plugging on. I am now 65-years-old.
We have called Lilly about its discontinuation of Iletin I insulin next year. I would think they made a lot of money on it over the years, but I guess that's not enough.
Please tell all your readers to call and petition for the continuation of Iletin I. In my opinion, 300,000 Iletin I users are too many to ignore.
Mary Jo Wilton
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I was very interested in the article on animal insulin because it described not only my feelings but also my problem.
I have been an insulin dependent diabetic for 33 years. On my first insulin, Lente, I developed lipoatrophy in my abdomen and thighs. We thought it was due to the preservative.
After switching to NPH, I was found to be allergic to pork insulin. After going to beef NPH, I did well for 20 years.
When I went into intensive therapy I was placed on UltraLente (animal) and Regular (human). I did very well until the supply ended. I believe I received the last two bottles of Nova animal UltraLente.
Since using Humulin UltraLente I have not done too well and Lispro does not seem to be the answer.
If certain companies are required to produce rarely used medications, why not animal insulin? Maybe this should be included in the new diabetic legislation in Congress. If it is a problem of profit, change the price of animal insulin and designate one company to produce it.
I hope there is success in bringing animal insulin back.
Troy G. Rollins, MD
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Walk in My Shoes, Mr. Legislator
I have been following your articles about proposed legislation for funding of diabetes research, education and reimbursement of supplies for several months. I think the new Medicare reimbursements are a step in the right direction. I have a suggestion which might help convince any state or national legislator of the importance of these expenditures.
How about sending a one-week meal plan, exercise regimen and schedule for finger sticks (with a BG monitor) to whomever in the government you wish to address. Challenge that person to follow the routine for one week, then go in and talk with him or her. The official would certainly have "walked a mile in another person's shoes," and might have a new appreciation for the problems that people with diabetes have.
I do hope the moneys being poured into research result in a cure for diabetes. I'd like to be put out of a job.
Evelyn Geisler, RPh, CDE
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Public Display of Support
Responding by e-mail, Dan Lieberman voices his support for the woman asked to leave a restaurant because she injected herself at the table. Dan and his wife feel that the only way to draw attention to diabetes is to encourage "open" treatment of the disease. In other words, "the squeaky wheel gets the grease."
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Internet Chats Up Rising BGs Over Flu Shot
I had a flu shot and noticed that my blood glucose was higher than expected. No problem, a little extra insulin brought it right down. Has anyone else had this reaction?
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I got both my flu and pneumonia shots last Friday. I was just getting over a cold, though, so perhaps my BGs should be thrown out of the curve. Colds always tend to depress my BGs instead of making them rise. Maybe I should stay sick for good BGs!
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I got both shots last week also, and I had little soreness but more with the flu shot. I am taking chlorpheniramine for allergies and I think that prevented most side effects.
This is the first year I have taken the shots. Since switching to Humalog, I have not gotten sick once and I used to get colds all the time. I want to keep this up!
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Hi, I'm Leesa I have been a type 2 diabetic for about five years. My BGs go up after the flu shot, too. It goes up when I'm sick so it makes sense that the shot, which gives you a mild case, would raise it too.
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I am on micronase, not insulin and yes, my glucose was all over the place for about four to five days after the flu shot.
I had both the flu shot and pneumonia vaccine on the same day. It was the first time by BGs went above 350, which scared me.