Correspondence ____________ NONTUBERCULOUS MYCOBACTERIA AND ASSOCIATED DISEASES

To the Editor: The report by Wolinsky on non tuberculous mycobacterial was a fine analysis of the incidence of those bacteria and their diseases_ It contained a large chart with 41 references concerning the occurrence of the diseases in many areas of the United States and throughout the world, with special attention to the 2 most common types, Mycobacterium kansasii and Mycobacterium avium-intracellulare_ The only major area omitted in the United States was the west coast, notably California. This was unfortunate because comparative epidemiology requires contrasting data. The lack of data from California was my fault because I had them available but did not publish them. They had been collected from 1959 through 1971, especially from the Los Angeles area; they were reported at 7 different meetings

between 1963 and 1974; and they were compared with data from several other major areas in the United States. The classification used in the years after 1959 was that of Runyon. It was used, with slight changes, for comparison of area reports; it was modified slightly through the years; it was generally abandoned in the early 1970s so that the several groups could be catalogued with the larger number of acid-fast mycobacterial strains. The grouping is still useful, however, for comparison of the relative incidence of "atypicals" with other reports in the 1960s. The eventual Runyon grouping was as follows: TABLE 1 Mycobacteria

Group

M. kansasl/ (and marlnum)-photochrome M. scrofulaceum-scotochrome Battey bacillus (M. Intracellulare or avium complex)-non-chromogen M. fortuitum (and M. abscess us, called chelonel)-rapld grower

I II III IV

I

Wolinsky E. Am Rev Respir Dis 1979; 119:107-57. TABLE 2

INCIDENCE OF ATYPICAL MYCOBACTERIA IN LOS ANGELES COUNTY AND CALIFORNIA

Dates of Series

Cases (no.)

Barlow San Fernando Long Beach La Vlna

1959-1963 1959-1963 1959-1963 1959-1963

20 20

Los Angeles County

1959-1963

La Vlna La Vlna La Vlna La Vlna La Vlna

1963-1966 1966 1967 1967-1971 1963-1971

79 21 11 16 27 75

california Series

Total Cases (no.)

Group I (M. kans.)

(no.)

14 12 14 7

20 19

(%)

(no.)

(%)

70

2 5 6 11

30 25 30

60

70 37

47 4 9 10 11

19 82 62

34

45

28 11 2 2 9 24

81 62

52 57

60

40

Other Cases (no.) (%)

3

15 5

58

35

4

53 18 12

6

5 28

38

4 7

32

17

25 26 22

52 31

33

21

14

31

12

12

Los Angeles County

1959-1971

154

Olive View

1954-1961

108

Los Angeles County

1954-1971

262

143

54

86

33

33

13

1967

144

60

41

39

27

45

31

1968

264

104

39

83

31

77

29

408

164

40

122

30

122

30

670

307

47

208

31

153

22

california Dept. of Health California Dept. of Health California Dept. of Health Los Angeles County and California

M. kans.

154 108

Group II (M. av-Int.)

= Mycobacterium kansasli; M. av-Int. = Mycobacterium avlum-Intracellulare.

AMERICAN REVIEW OF RESPIRATORY DISEASE, VOLUME 120, 1979

1389

1390

CORRESPONDENCE

The first collection of data from California included 20 cases from each of 4 chest disease hospitals in Los Angeles County in 1963 for reports to the Pacific-Western Veterans Administration Conference, and a follow-up of the same series in 1966. The sources were the La Vina and Barlow sanatoria, and the San Fernando and Long Beach Veterans Administration chest disease hospitals (79 cases). Further reports on cases were collected in the next 6 yr at La Vina (75 cases); from a collection of cases at Olive View Hospital (108 cases); and from a 2-yr collection by the Tuberculosis Division of the California Department of Health (408 cases):for a total of 670 cases. According to the terminology and reporting practices in use at the time, the occurrence of the 2 major "atypical" groups, I and III, showed variation and even reversal in the early years in a few small series, although the culturing was done in good and mutual laboratories. The summaries of Los Angeles sources through the years, and the State of California collections showed approximately a 5-to-3 ratio of M. kansasii to M. avium~intracellulare. These findings match up with several U.S. series (Hobby, N.Y., 6:3; Lester, Denver, 6:4 and 5:5; Bates, Ark., 2:1). They differ notably from several southeastern series, with a predominance of Group I (Florida, 79 % Group III; Georgia, 90 % Group III; and Philadelphia, 75 % Group III), and from Chicago area reports (90 % Group I). Data were also collected on the age incidence in Califomia, the incidence in tuberculous hospital populations, the occurrence of mixed infections, the bacterial susceptibility of chemotherapy, the common and effective use of resective surgery, and the mortality, but these will not be reported here. The reasons for the difference in geographic incidence are still uncertain, although communicability seems to be excluded and a source in nature has not been demonstrated. Many adults in California are immigrants from other states and other countries. WILLIAM

H.

OATWAY, JR.

146 Monarch Bay South Laguna, Ca. 92677 (formerly Medical Director, La Vina Sanatarium and Hospital, Altadena, Ca.) August 30, 1979

THE FDA'S FINAL DECISION CONCERNING THE TUBERCULIN MULTIPLE PUNCTURE TEST

To the Editor: On July 10, 1979, the Federal Food and Drug Administration published its final rules and regula-

tionsl concerning the st:mdardization of multiple puncture tuberculin test devices (Tine,'" MonoVacc,® etc.) .The result has significant and probably adverse implications for all clinicians and public health workers using and/or intending to use these potentially valuable screening devices. A significant manufacturing defect first surfaced during the 2-yr deliberations of the Panel on Skin Test Antigens. 2 To understand the problem fully, one must know that the tuberculins used for skin testing are prepared from the liquid of a 6-to 8-wkold culture of tubercle bacilli growing on liquid media-simply: the liquid contains the metabolic waste products of bacilli growth, proteins from deteriorating bacilli, and components of the liquid media. This liquid is then sterilized, concentrated by evaporation, filtered to remove whole tubercle bacilli, and called-tuberculin. It has long been recognized that each new tuberculin can vary in potency, from minimally reactive to very reactive in humans. Obviously, the only way to ascertain the actual human reactivity (potency / sensitivity) of a new tuberculin is to inject it, in varying dilutions, into humans. The Panel on Skin Test Antigens, while reviewing the production procedures of multiple puncture tuberculin manufacturers, found that this important evaluation of tuberculin potency is not performed in humans, but rather is determined by testing varying dilutions of the new tuberculin on "at least" 4 guinea pigs. However, we have known since 1958 that a tuberculin may be reactive (potent/ sensitive) in guinea pigs and yet not be similarly reactive in humans.3 Based on this knowledge and addressing the tuberculins produced for use on multiple puncture devices, the FDA's Panel on Skin Test Antigens report of 1977 recommended: Since there is ample evidence in the literature that batches of tuberculin may vary widely in potency, it is necessary that each be tested for potency (sensitivity) in infected human beings. Since the test is to be used for screening purposes, then it is only necessary to test for sensitivity and not specificity. The Panel recommends sensitivity sufficient to elicit positive reactions in 100 per cent of at least 50 persons who are known to have had bacteriologically confirmed tuberculosis and who are tuberculin positive as demonstrated by a simultaneous Mantoux test with 5 TU of PPD.4

1 U.S. Food and Drug Administration. Federal Register July 10, 1979; 44:40285-90. 2 Sbarbaro JA. Am Rev Respir Dis 1978; 118:1-5. 3 Guld J, Bentzon MW, Beliker MH, Griep WA, Magnusson M, Wasler. Bull WHO 1958; 19:845-83. 4 U.S. Food and Drug Administration. Federal Register September 30,1977; 22:52674-723.

Nontuberculous mycobacteria and associated diseases.

Correspondence ____________ NONTUBERCULOUS MYCOBACTERIA AND ASSOCIATED DISEASES To the Editor: The report by Wolinsky on non tuberculous mycobacteria...
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