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When human insulin first appeared on the market it was thought to be a "special" insulin and the beef/pork insulin that I had taken for years was termed "standard" insulin. A lot has changed since those days. What was once thought to be the standard is now in danger of being pulled from the market.
What Triggered "Essential or Expendable?"
We started researching this month's feature in May of this year after receiving a number of letters and phone calls from people with diabetes, their parents/partners and diabetes specialists. All were very unhappy to hear that Eli Lilly had plans to pull their insulin of choice from the market.
Most had heard of the plans to stop production of Iletin I (beef/pork) insulins in 1998 by calling Lilly's customer service line (800-545-5979). I then called our Eli Lilly press representative who repeated what these callers were hearing. When I asked how many people take this insulin, I was told "only 300,000 customers use this brand of insulin." I then confirmed this number with a contact at Lilly's competitor, Novo Nordisk. (A side note: Lilly and Novo Nordisk both make special insulins for the 30,000 insulin pump users in the United States.)
Later, after hearing of our plans to write a story on this topic, a Lilly executive telephoned and asked me not to publish the information I had been given by Lilly's press representative. He claimed that the information I had been given was "off the record."
He said they needed more time - another month for Lilly to ready its public announcement. He offered assurances that Lilly would work with us on the story. I agreed to wait.
Still Waiting for Lilly
Four months later and there has been no formal, public announcement, but callers still get the same information on the 800 line about the discontinuation of the beef/pork insulin. We decided to proceed with the story.
We tried repeatedly to get Lilly to give us its spin on what was happening and were very surprised when our calls were not returned. We finally faxed over questions to be sure they hadn't missed our phone calls somehow. Our questions: Why was this happening now? How many would be affected? Who made the decision? What suggestions did Lilly have as to which products to switch to?
The press representative then called and asked for an extra day to get answers. The next day the representative's superior called to say that the questions would not be answered because he was sure Lilly's statements would be misquoted.
Still More Questions
This left us with even more questions: Why is Lilly announcing their plans to callers, but not publicly? Is holding back this information some kind of business strategy? Does Lilly think it might lose customers to another manufacturer if an announcement is made too early?
Everyone we spoke with for this story suggested that money was the motivation for Lilly's action - Lilly will somehow make more profit by taking this action. Surprisingly, Lilly has increased their advertising budget from $1 million to $7 million per year to market synthetic human insulin to diabetics.
Length of Action
Synthetic human insulins are more aggressive, with a quicker onset and shorter duration of action. For a significant minority (maybe 15 percent of insulin users), these differences can result in profound changes in injection schedules. The Canadians Diabetes Association offers this: "Sometimes, switching to human insulin means increased injections. If patients are under control with beef/pork insulin and don't want more injections, that's another reason for staying with animal insulin." This is one of reasons why I think we should have the ability to choose which insulin works best for us.
A Significant Minority Do Better on Standard Animal Insulin
I believe that the people in Canada and Great Britain advocating for animal insulin availability are not just doing it to be a thorn in some insulin company's behind. They truly feel that they do better on this insulin. Success stories abound of hypoglycemia awareness returning along with a general sense of well-being when people return to animal insulin.
In addition, I have talked to many people with diabetes who are very brittle. One young man, currently being treated by a diabetes specialist, has repeated seizures from hypoglycemia. He was extremely frustrated, and his doctor usually said he must be doing something wrong.
I asked, "Have you ever considered trying animal insulin?" He had never heard of it and was unaware that many have found it to be a remedy for problems similar to those he described. He discussed switching insulins with his doctor, got the go ahead and his problems have largely subsided.
I attribute my good control to the use of beef/pork insulin for my basal. If this insulin is no longer available, people like me (approximately 300,000 of us) will have lost our ability to choose the therapy that works best for us in the manner we find most convenient.
When you look at the Canadian Diabetes Association's (CDA) and the British Diabetic Association's (BDA) statements on animal insulins (page 1) you see that both groups strongly state their dedication to keeping animal insulins available. As the CDA states, it is, "committed to advocating for the continuation of beef/pork insulins for those whose health, well-being or quality of life will be affected by the change."
I want to know who is going to advocate for those same people in the United States. This is of special concern to me because unlike Britain and Canada, we in the United States have no socialized medicine. Many here won't have a doctor who is able to coach them through the significant changes in lifestyle and dosing that accompany an insulin species transfer.
Who Could be Against Choice of Insulins?
As you will see in "Essential or Expendable," there are big differences of opinion in research and clinical circles as to the effects specific to insulin species. I think it's obvious that enough people favor the benefits of animal insulin to warrant its availability. Unfortunately, not everyone agrees with me.
If no one has yet provided evidence strong enough to unite the research and clinical communities in their opinions on the effects of insulin species, how then can I be sure I won't have a problem if forced to switch over to human insulins?
I think pulling Iletin I (beef/pork) insulin is the wrong decision.
0 comments - Oct 1, 1997
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