This is the short form letter for use by those unfamiliar 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 longer form may be more useful and comfortable. 

On your letterhead

Date Written

Dr. Mark McClellen, 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. McClellen:

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."

It is my understanding that many of these diabetics may suffer Hypoglycemia Unawareness, a life threatening condition to them and those around them if they are compelled to change to synthetic insulins or porcine insulins to manage their diabetes. You, Lilly and Novo seem to support this notion given 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 in about 1995 or 1996 when these warnings were changed to bold face type.

I understand that the loss or reduction of such early warning symptoms may cause seizures, unconsciousness and death or injury to the diabetic and to those around him or her.

The American Hospital Formulary Service "Drug Information '86 Listings" under 68:20:08 AntiDiabetic Agents at page 1564 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," which seems to support this notion.

Recent ADA publications 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.

I can understand FDA’s bona fides concerns about the quality of insulins imported to the US. 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 beef insulin meets the "need" test. I believe that your agency is aware of a company or companies ready and able to supply the market for beef insulin if the FDA can find a way to expedite their approval(s).

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]

Cc:
Dr. James E. Mulvihill, DMD, 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. Barbara Kohn, 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