Last Updated: 03/15/04 06:40 PM

With the GREAT FOX and CBC work, this is the long form letter for use by those familiar with the facts of the beef and beef-pork insulins that so many of us depend on for our lives. For other writers the much shorter form may be more useful and comfortable

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On your letterhead

Date Written

Dr. Jane Henney, Commissioner
The United States Food and Drug Administration
Center for Drug Evaluation and Research
5600 Fishers Lane
Rockville, MD 20852

300,000 US Diabetics Use and Need Beef Insulin

Dear Dr. Henney:

I am writing you with a deep sense of concern for insulin using diabetics. It is my understanding that the FDA has decided that, although Iletin® I (85% beef, 15% pork) insulin production was terminated by Eli Lilly & Co. sometime in October of 1998, there is no need for beef insulin in the US. There are at least 300,000 US diabetics along with thousands of US cats and dogs for all of whom "Beef" (Iletin® I) insulin is currently in use and/or has been strongly recommended over "Human" or "Pork."

I find the FDA's position very difficult to comprehend or accept given:

1. The warnings in all "human" insulins sold in the US, warnings first raised with FDA approval by Lilly in 1982 that, "A few patients who experienced hypoglycemic reactions after being transferred to Humulin have reported that these early warning symptoms were less pronounced than they were with animal-source insulins." This language was apparently added to all Novo human insulins in about 1990 with FDA approval and was further amplified with FDA approval prior to 1995 when these warnings were changed to bold face type. The loss or reduction of such warning symptoms may cause seizures, unconsciousness and death or injury to the diabetic and to those around him.

2. The strong warning in Jan 1986 by The American Hospital Formulary Service "Drug Information '86 Listings" under 68:20:08 Anti-diabetic Agents at page 1564 which admonishes, "Pork Insulins ... Cautions: ... hypoglycemic reactions have also been reported in patients who were transferred from beef to pork insulin or from mixed beef or from beef to mixed beef/pork preparations."

3. The recent large price increases in Lilly Iletin® II purified monocomponent Pork insulins at the retail level. I am told that Lilly admits fewer patients use this form of insulin than currently use the Iletin® I beef-pork mixture, and that Lilly also terminated the production of pure beef insulins as primary insulin products in Mexico along with this US termination.

4. The absence of scientific evidence of any clinical benefit to the use of "Human" insulin in human, canine or feline diabetics.

5. The numerous scientific studies which have shown better diabetic outcomes for many using animal insulins.

6. The lack of adequate warning regarding the termination of Iletin® I insulins to the many US diabetics stabilized on beef based insulins.

7.  Recent ADA publications which show as much as a 6 hour earlier "peak" activity in Human insulins and more than a 16 hour shorter duration of some Human insulins when compared to unspecified "animal" insulins. As shown in the following recently released table from the American Diabetes Association:

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Certainly, no one would wish any producer of any product to be forced to produce it against their will. I can understand FDA’s bona fides concerns about the quality of insulins imported to the US. Beyond that, I can also understand how the FDA may be reluctant to approve imports on a "freedom of choice" basis rather than based on a true "need."

I believe, however, that the list above coupled with the fact that many pharmacies around the US are already reporting no beef based insulins available (and some are reporting no pork based insulins from Lilly) meets the "need" test. This may be a surprise and shock to both Lilly and the diabetics who need beef if ONLY due to item 7 above and that this constitutes a "need" as defined in FDA regulations. I believe that your agency is aware of a company or companies ready, willing and able to supply the enormous market for beef insulin if your agency can find a way to expedite their approval(s).

Given the near monopoly held by Lilly and Novo for insulin in the US, it may be a stretch, but I believe that failure to expedite import approval of long proven products such as Beef insulins might be interpreted as "restraint of trade."

Accordingly, I respectfully request your assistance in assuring adequate supplies of beef insulin for US diabetics by every reasonable means at your disposal.

Respectfully,

[Sign your name]

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Cc:
President & CEO
The Juvenile Diabetes Foundation International
120 Wall St
New York, NY 10005-4001

Surgeon General
Office of the US Surgeon General
US Dept. of Health & Human Svcs.
Hubert H. Humphrey Bldg., Rm. 716G
200 Independence Ave. SW
Washington, DC 20201

Secretary of Health and Human Services
US Dept. of Health & Human Svcs.
Hubert H. Humphrey Bldg., Rm. 716G
200 Independence Ave. SW
Washington, DC 20201

Mrs. George W. Bush, First Lady
White House
1600 Pennsylvania Avenue
Washington, DC 20500-0003

Representative George R. Nethercutt, Co-Chair House Diabetes Caucus
United State House of Representatives
1527 Longworth Building
Washington, DC 20515

Representative Dianna DeGette, Co-Chair House Diabetes Caucus
United State House of Representatives
1527 Longworth Building
Washington, DC 20515

Mr. John H. Graham, IV, Chief Executive Officer
The American Diabetes Association
1660 Duke St.
Alexandria, VA 22314

Dr. Donna Malloy, Senior Staff Veterinarian
United States Department of Agriculture
Animal and Plant Health InspectionService
Veterinary Services
National Center for Import and Export Production Programs
4700 River Road, Unit 40, 3B81
Riverdale, MD 20737-1231

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