1
 Federal drug regulators,
5006
span

2
 concerned over British reports
5005
span

3
 that diabetics have died
5004
span

4
 after shifting from animal to human-based insulin,
3
circumstance

5
 say 
5002
attribution

6
they are considering a study 
5002
span

7
to see 
8
attribution

8
if similar deaths have occurred here.
5001
span

9
 The United Kingdom reports came from Dr. Patrick Toseland, head of clinical chemistry at Guy's Hospital in London.
5014
background

10
 In a telephone interview Friday, Dr. Toseland said 
5010
attribution

11
the number of sudden, unexplained deaths of diabetics
5009
span

12
 he had seen this year 
11
elaboration-object-attribute-e

13
was 17 
5008
span

14
compared with just two in 1985.
13
comparison

15
 At least six of the deaths occurred among relatively young diabetics
5012
span

16
 who had switched from animal to human insulin within the past year,
15
elaboration-object-attribute-e

17
 he said.
5012
attribution

18
 Dr. Solomon Sobel, director of metabolism and endrocrine drug products for the U.S. Food and Drug Administration, said 
19
attribution

19
FDA officials have discussed Dr. Toseland's findings fairly intensively.
5017
span

20
 While there have been no reports of similar sudden unexplained deaths among diabetics in the U.S.,
5019
concession

21
 Dr. Sobel said
5018
attribution

22
 the FDA plans to examine Dr. Toseland's evidence 
5018
List

23
and is considering its own study here.
5018
List

24
 Dr. Toseland, a toxicologist, said
5025
attribution

25
 he was preparing an article for a British forensic medical journal
5025
span

26
 raising the possibility
5024
span

27
 that the deaths may have occurred
5027
span

28
 after human insulin blunted critical warning signs
5022
span

29
 indicating hypoglycemia, or low blood sugar,
5021
span

30
 which can kill diabetics.
29
elaboration-object-attribute-e

31
 The usual warning signs of hypoglycemia include sweating, anxiety and cramps.
5028
background

32
 With proper warning, diabetics can easily raise their blood sugar to safe levels
5028
span

33
 by eating sugar or sugary food.
32
means

34
 The anecdotal data certainly shows
35
attribution

35
 that some of the people were not aware of the rapid onset of hypoglycemia,
5030
span

36
 Dr. Toseland said.
5030
attribution

37
 At the U.S. National Institutes of Health, Dr. Robert E. Silverman, chief of the diabetes program branch, said 
5037
attribution

38
no evidence of unexpected deaths from hypoglycemia had shown up in a study of 1,500 diabetics
5037
span

39
 that has been under way at NIH for five years.
38
elaboration-object-attribute-e

40
 However, he said
5041
attribution

41
 officials
5040
span

42
 conducting the study 
41
elaboration-object-attribute-e

43
hadn't been looking for signs of problems
5039
span

44
 related to hypoglycemia unawareness.
43
elaboration-object-attribute-e

45
 We are now monitoring for it much more closely,
5044
span

46
 he said.
45
attribution

47
 We do know
5046
attribution

48
 there are slight differences in the way
5046
span

49
 human and animal insulins drive down blood sugar,
48
elaboration-object-attribute-e

50
 Dr. Sobel said.
5047
attribution

51
 The human-based drug starts the blood sugar dropping sooner 
5049
List

52
and drives it down faster,
5049
List

53
 he said.
5049
attribution

54
 But we don't believe 
5052
attribution-n

55
there is enough of a difference 
56
consequence-n

56
to be clinically significant,
5052
span

57
 Dr. Sobel said.
5053
attribution

58
 Reports of Dr. Toseland's findings in the British press have triggered widespread concern among diabetics there.
5067
statement-response-n

59
 Both the British Diabetic Association and the Committee on Safety in Medicines
5060
span

60
 -- Britain's equivalent of the U.S. FDA -- 
59
elaboration-additional-e

61
recently issued statements
5059
span

62
 noting the lack of hard scientific evidence 
5058
span

63
to support Dr. Toseland's findings.
62
elaboration-object-attribute-e

64
 On Friday, the American Diabetes Association issued a similar statement
5063
span

65
 urging the six million U.S. diabetics not to overreact to the British report.
64
elaboration-object-attribute-e

66
 A loss of the warning symptoms of hypoglycemia is a complex problem 
5064
span

67
that is very unlikely to be due simply to the type of insulin used,
66
elaboration-object-attribute-e

68
 the American association said.
5064
attribution

69
 The FDA already requires drug manufacturers to include warnings with insulin products
5069
span

70
 that symptoms of hypoglycemia are less pronounced with human insulin than with animal-based products.
69
elaboration-object-attribute-e

71
 Eli Lilly & Co., the Indianapolis-based drug manufacturer, dominates the U.S. human insulin market with its product
5070
span

72
 known as Humulin.
71
elaboration-additional-e

73
 Lilly is building plants
5071
span

74
 to make the insulin
73
elaboration-object-attribute-e

75
 in Indianapolis and Fagershein, France.
5072
Same-Unit

76
 In its latest annual report, Lilly said 
77
attribution

77
Humulin sales have shown excellent growth.
5074
span

78
 Lilly officials said
5078
attribution

79
 they had seen reports of hypoglycemic unawareness among some patients
5077
span

80
 making the shift from animal to human insulin,
79
elaboration-object-attribute-e

81
 but didn't know 
82
attribution

82
if the problem had caused any deaths.
5076
span

83
 Dr. Leigh Thompson, a Lilly group vice president, said
84
attribution

84
 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.
5080
span

85
 Dr. Toseland said
5086
attribution

86
 most of the British diabetics
5085
span

87
 who died 
86
elaboration-object-attribute-e

88
had been taking a human-based insulin
5084
span

89
 made by Novo/Nordisk, a Danish manufacturer.
88
elaboration-object-attribute-e

90
 None of the diabetics were using Lilly's insulin.
5087
elaboration-additional

5001
span
6
purpose

5002
span
5003
span

5003
span
5007
Same-Unit

5004
span
2
elaboration-object-attribute-e

5005
span
1
elaboration-object-attribute-e

5006
span
5007
Same-Unit

5007
multinuc
5016
span

5008
span
5010
Same-Unit

5009
span
5010
Same-Unit

5010
multinuc
5011
span

5011
span
5014
span

5012
span
5013
span

5013
span
5011
elaboration-additional

5014
span
5015
span

5015
span
5007
elaboration-additional

5016
span
5036
span

5017
span
5035
span

5018
multinuc
5019
span

5019
span
5020
span

5020
span
5034
span

5021
span
28
elaboration-object-attribute-e

5022
span
27
consequence-n

5023
span



5024
span
25
elaboration-object-attribute-e

5025
span
5026
span

5026
span
5033
span

5027
span
26
elaboration-object-attribute-e

5028
span
5091
span

5029
span



5030
span
5031
span

5031
span
5032
span

5032
span
5026
elaboration-additional

5033
span
5020
elaboration-additional

5034
span
5017
elaboration-additional

5035
span
5016
elaboration-additional

5036
span
5057
span

5037
span
5038
span

5038
span
5042
antithesis

5039
span
5041
Same-Unit

5040
span
5041
Same-Unit

5041
multinuc
5042
span

5042
span
5043
span

5043
span
5044
result

5044
span
5045
span

5045
span
5056
span

5046
span
5047
span

5047
span
5048
span

5048
span
5051
span

5049
multinuc
5050
span

5050
span
5048
elaboration-general-specific

5051
span
5054
antithesis

5052
span
5053
span

5053
span
5054
span

5054
span
5055
span

5055
span
5045
elaboration-additional

5056
span
5036
elaboration-additional

5057
span
5068
span

5058
span
61
elaboration-object-attribute-e

5059
span
5061
Same-Unit

5060
span
5061
Same-Unit

5061
multinuc
5067
Comparison

5062
span



5063
span
5066
span

5064
span
5065
span

5065
span
5063
elaboration-additional

5066
span
5067
Comparison

5067
multinuc
5092
span

5068
span
5090
span

5069
span
5082
concession

5070
span
5073
span

5071
span
5072
Same-Unit

5072
multinuc
5070
elaboration-additional

5073
span
5075
span

5074
span
5073
elaboration-additional

5075
span
5081
background

5076
span
5078
span

5077
span
5076
circumstance

5078
span
5079
span

5079
span
5081
span

5080
span
5079
elaboration-additional

5081
span
5082
span

5082
span
5083
span

5083
span
5089
span

5084
span
5086
Same-Unit

5085
span
5086
Same-Unit

5086
multinuc
5087
span

5087
span
5088
span

5088
span
5083
elaboration-additional

5089
span
5068
elaboration-additional

5090
span



5091
span
5031
antithesis

5092
span
5057
elaboration-additional

