A blood bank physician at a major university and medical school reports that the community blood center allows allogeneic blood donations by insulin-dependent diabetics (even if the donor is on an insulin pump), so long as the donor appears in "good health" at the time of presentation. This policy is in direct conflict with the inquiring blood banker's institutional donor deferral guidelines. The inquiring member 'discovered' this conflict in policies when one of the first year medical students, who is an insulin-dependent diabetic, mentioned that often donates at the community blood center since their policy allows insulin-dependent diabetics to donate. Of note, the medical student takes recombinant (not bovine) insulin. The inquiring member is curious to know how widespread is the policy that allows insulin-dependent diabetics to donate allogeneic blood, and if these policies distinguish between bovine insulin (risk of vCJD?) and recombinant insulin.

(Editor's note: According to the medical director of the Southern California Region, American Red Cross policy states that so long as the prospective donor (autologous, directed, or allogeneic) is otherwise healthy and has not had a recent change in their insulin regimen, they can be eligible for donation, provided the donor has NOT been exposed to bovine-derived injectable products made in BSE-endemic countries. The FDA has recommended the following question or a similar question to be asked of potential donors: "Since 1980, have you knowingly obtained and been injected with a non-U.S. licensed drug product made from cattle, such as bovine (beef) insulin?" This question would apply to all allogeneic donors, whether diabetic or not. Finally, diseases associated with diabetes (atherosclerotic heart disease, renal disease, etc.) must be assessed, and the donor must meet acceptability requirements with those diseases in mind.")

Please share your policies regarding diabetic blood donors, including policies addressing bovine source insulin.

ADDENDUM Nov. 15, 2001

1. The following was submitted by a blood bank physician in Texas regarding donors taking insulin:

"Our community blood center in Texas allows donation by insulin-dependent diabetics IF:

• they have never used bovine insulin (see discussion below)
• they have no end-organ disease (we ask about peripheral neuropathy, renal disease, retinal disease)
• they have not had an episode of ketoacidosis in the last month.

Incidentally, when the FDA rules about deferring for bovine insulin first came out, I called the Eli Lilly Company (makers of bovine insulin in the U.S.) and asked them if they had ever used cattle from Britain as a source material for preparation of the insulin in the United States. After being transferred around a couple of times on the phone, a very authoritative-sounding woman (whose name I regret I do not have recorded) said that yes indeed they had used British cattle as the source of some past lots of U.S.-prepared bovine insulin. Therefore, our blood center will defer any donor with current or past bovine insulin use, no matter if they got it in the U.S. or another country."

ADDENDUM Nov. 16, 2001

2. A blood bank physician at a university medical center in The City by The Bay remarked "we accept donors with diabetes mellitus, both IDDM and NIDDM, if they are well controlled on stable doses of oral hypoglycemics or insulin, as long as they do not have diabetes-associated diseases (arteriosclerosis, CAD, renal failure - all lead to permanent deferrals). At Blood Centers of the Pacific, where I trained as a fellow, we also accepted donors with both IDDM and NIDDM diabetes who were well controlled. IDDM donors who had been treated with bovine insulin since 1980 are indefinitely deferred, except for donors who received Iletin I or II bovine insulin manufactured by Eli Lilly (who allegedly do not use cows at risk for BSE). If Lilly does use cows from Europe, as the first response indicates, this criterion may have to be reconsidered."

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Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator