1 Federal drug regulators, concerned over British reports that diabetics have died after shifting from animal to human-based insulin, say they are considering a study to see if similar deaths have occurred here.
2 The United Kingdom reports came from Dr. Patrick Toseland, head of clinical chemistry at Guy's Hospital in London.
3 In a telephone interview Friday, Dr. Toseland said the number of sudden, unexplained deaths of diabetics he had seen this year was 17 compared with just two in 1985.
4 At least six of the deaths occurred among relatively young diabetics who had switched from animal to human insulin within the past year, he said.
5 Dr. Solomon Sobel, director of metabolism and endrocrine drug products for the U.S. Food and Drug Administration, said FDA officials have discussed Dr. Toseland's findings 'fairly intensively.' While there have been no reports of similar sudden unexplained deaths among diabetics in the U.S., Dr. Sobel said the FDA plans to examine Dr. Toseland's evidence and is considering its own study here.
6 Dr. Toseland, a toxicologist, said he was preparing an article for a British forensic medical journal raising the possibility that the deaths may have occurred after human insulin blunted critical warning signs indicating hypoglycemia, or low blood sugar, which can kill diabetics.
7 The usual warning signs of hypoglycemia include sweating, anxiety and cramps.
8 With proper warning, diabetics can easily raise their blood sugar to safe levels by eating sugar or sugary food. 'The anecdotal data certainly shows that some of the people were not aware of the rapid onset of hypoglycemia,' Dr. Toseland said.
9 At the U.S. National Institutes of Health, Dr. Robert E. Silverman, chief of the diabetes program branch, said no evidence of unexpected deaths from hypoglycemia had shown up in a study of 1,500 diabetics that has been under way at NIH for five years.
10 However, he said officials conducting the study hadn't been looking for signs of problems related to hypoglycemia unawareness. 'We are now monitoring for it much more closely,' he said.
11 'We do know there are slight differences in the way human and animal insulins drive down blood sugar,' Dr. Sobel said.
12 The human-based drug starts the blood sugar dropping sooner and drives it down faster, he said. 'But we don't believe there is enough of a difference to be clinically significant,' Dr. Sobel said.
13 Reports of Dr. Toseland's findings in the British press have triggered widespread concern among diabetics there.
14 Both the British Diabetic Association and the Committee on Safety in Medicines -- Britain's equivalent of the U.S. FDA -- recently issued statements noting the lack of hard scientific evidence to support Dr. Toseland's findings.
15 On Friday, the American Diabetes Association issued a similar statement urging the six million U.S. diabetics not to overreact to the British report.
16 'A loss of the warning symptoms of hypoglycemia is a complex problem that is very unlikely to be due simply to the type of insulin used,' the American association said.
17 The FDA already requires drug manufacturers to include warnings with insulin products that symptoms of hypoglycemia are less pronounced with human insulin than with animal-based products.
18 Eli Lilly & Co., the Indianapolis-based drug manufacturer, dominates the U.S. human insulin market with its product known as Humulin.
19 Lilly is building plants to make the insulin in Indianapolis and Fagershein, France.
20 In its latest annual report, Lilly said Humulin sales have shown 'excellent growth.'
21 Lilly officials said they had seen reports of hypoglycemic unawareness among some patients making the shift from animal to human insulin, but didn't know if the problem had caused any deaths.
22 Dr. Leigh Thompson, a Lilly group vice president, said the company's clinical trials of both its animal and human-based insulins indicated no difference in the level of hypoglycemia between users of either product.
23 Dr. Toseland said most of the British diabetics who died had been taking a human-based insulin made by Novo/Nordisk, a Danish manufacturer.
24 None of the diabetics were using Lilly's insulin.

In a telephone interview Friday , Dr . Toseland said the number of sudden , unexplained deaths of diabetics he had seen this year was 17 compared with just two in 1985 .
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