In response to the proposed removal of animal insulin from the market in the next few years, the Bellagio Group, an international professional group sponsored by the Rockefeller Foundation in New York, gathered in Bellagio Italy on April 8 to discuss what actions should be taken. The result is this document which they have issued to the World Health Organization and other public health agencies worldwide. The report is a set of guidelines for the use and value of animal insulin.

Prof. Arthur Teuscher, MD (Switzerland), Dr. Pier Luigi Barbero, MD (Italy), Nina Bollhalder Sureskumaran (Switzerland), Jenny First, FBCO (UK), Dr. Matthew Klin, MB.BS/DRCOG (UK), Scott King, Editor-In-Chief (USA), Dr. Kristian Midthjell. MD (Norway), Dr. Deo Mtasiwa, MD/PhD (Tanzania), and Prof. Malina Petkova, MD (Bulgaria)

The welfare of people with diabetes depends on their active participation in their care. To achieve this, the patient must have information about benefits, risks and alternatives concerning his treatment. The patient must also have the appropriate facilities available to make a free choice regarding what type of insulin to use.

New research has made possible an overall understanding concerning differences in warning symptoms of hypoglycemia when using genetically produced human insulin and natural animal insulin.

The debate on these differences has continued since the introduction of treatment with human insulin and, unfortunately, very often the patients' experiences have been classed as "only anecdotal" and of little value.

Evidence supporting these experiences demonstrates neurophysiological differences during hypoglycemia in human and animal insulins.

Research has already demonstrated that human insulin has no clinical advantage for patients and that it has a faster absorption and consequently a shorter duration of action, so accounting for the greater fluctuations in blood-glucose levels. However, it has been the general view that because of its exact similarity to endogenous insulin, human insulin should be the insulin of choice for all.

With this in mind, we have put forth these five points:

I. that this latest information be relayed to those living with type I diabetes. This will enable those experiencing impaired or reduced warning symptoms of hypoglycemia or diminished feelings of well-being and safety, to re-examine their choice of human or animal insulin. This choice will then be based on both scientific evidence and the reported experiences of patients.

II. that this information be reported to government health departments, WHO, IDF, Diabetes Associations, physicians and all diabetes health care professionals worldwide.

III. that when insulin is needed, animal insulin should be considered as first choice treatment for all those where hypoglycemia may be of special concern. This may include the following:

1. children
2. the elderly
3. those reporting severe and/or frequent hypoglycemia
4. those with severe cardiovascular disease or long-term complications
5. those who do not have access to frequent blood-glucose monitoring, e.g., in developing countries.

IV. (i) that animal insulin remain available in all countries which presently have that facility.

(ii) that animal insulin is re-introduced into countries in which it is no longer available through the normal prescribing mechanism.

(iii) that animal insulin for insulin pens become available again to provide equal choice for patients and physicians.

V. that in future, greater recognition be given to the value of patient experiences in relation to adverse drug reactions.