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To the defense of the fda!.

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Table 1. B7-CREG antigen distribution in whites and blacks with
seronegative rheumatoid arthritis (RA) and in control subjects
Group studied
Seronegative RA
Whites (n = 38)
Blacks (n = 22)
Whites (n = 242)
Blacks (n = 283)
Number (96)
with B7-CREG
17 (44.7)
5 (22.7)
11 1 (45.9)
89 (3 1.4)
to detect an association between B7-CREG antigens and
seronegative RA.
The explanation for the disparity between results
obtained by Wellborne et al and those obtained by our group
is not clear. Although comparable criteria for the diagnosis
of seronegative RA appear to have been utilized by both
groups, the possibility remains that inclusion of patients with
underlying seronegative spondylarthropathy could influence
the data. However, comparable studies of larger groups of
well-defined seronegative RA patients are clearly necessary
in order to exclude the possibility that Type 11 error due to
sample sizes might account for the observed differences.
Graciela S. Alarc6n, MD, MPH
Bruce 0. Barger, PhD
Ronald T. Acton, PhD
William J. Koopman, MD
University of Alnbania in Birminghani
Birmingham, A L
1. Ropes MW. Bennett GA, Cobb S , Jacox R, Jessar RA: 1958
revision of diagnostic criteria for rheumatoid arthritis. Bull
Rheum Dis 9:175-176, 1958
Doubloug JH, F@rre9, Kiss E , Thorsby E: HLA antigens and
rheumatoid arthritis: association between HLA-DRw4 positivity
and IgM rheumatoid factor production. Arthritis Rheum 23:309313: 1980
Alarcbn GS, Koopman WJ. Schrohenloher RE: Differential
patterns of in vitro IgM rheumatoid factor synthesis in seronegative and seropositive rheumatoid arthritis. Arthritis Rheum
25:150-155, 1982
Alarc6n GS, Koopman WJ, Acton RT, Barger BO: Seronegative
rheumatoid arthritis: a distinct imrnunogenetic disease? Arthritis
Rheum 25502-507, 1982
Burns T, Calin A: The hand radiograph as a diagnostic discnminant between seronegative and seropositive rheumatoid arthritis:
a controlled study (abstract). Arthritis Rheum 25:S124, 1982
Alarc6n GS, Barger BO, Koopman WJ, Acton RT: DR antigens:
distribution in blacks with rheumatoid arthritis. J Rheumatol (in
Wellborne FR, Tesar JT. Kunath AM. West SG, Ewe1 C, Welton
RC, Schwartz BD: Association of X antigen with seronegative
rheumatoid arthritis (abstract). Arthritis Rheum 26:S53. 1983
Alarcon GS. Acton RT, Koopman WJ, Barger BO: CREG
antigens differentially influence expression of extraarticular manifestations in whites and blacks with rheumatoid arthritis. Semin
Arthritis Rheum (in press)
To the defense of the FDA!
To the Editor:
Following the criticism of the Food and Drug Administration that began after the removal of Oraflex and, more
recently, Zomax from the market, I have waited in vain for
organizations like ours to come to the FDA’s defense. Such
action on our part would seem appropriate in view of the
marked attacks being leveled at that agency by people who
are in no way qualified to assess the problem.
I find myself in the unusual role of defending an
agency which I feel creates more than its share of problems
in the drug development area. However, as I understand it.
the FDA did its job “by the book” with both the abovementioned drugs. They haven’t deserved the criticism, and
organized medicine’s lack of support will simply push the
FDA back even more deeply into a shell.
Drugs, as we know them today, are not so specific in
their effects that we can expect only good results with no
possibility of adverse reactions. It appears we must get this
message out, not only to the lay public but to our colleagues
as well.
W. J . Blechman, MD, FACP
North Miami Beach, FL
Gout in Heberden’s nodes
To the Editor:
I read with great interest the report by Simkin et a1 on
gout in Heberden’s nodes (Simkin PA, Campbell PM, Larson EB: Gout in Heberden‘s nodes. Arthritis Rheum 26:9497, 1983). Since reading their report I have aspirated 2
Heberden’s nodes and, in both patients, examination by
polarizing microscopy revealed typical negatively birefringent crystals characteristic of gout.
The first patient, a 78-year-old woman with a history
of chronic alcoholism, was admitted to the hospital with
acute onset of painful swelling of the second and third fingers
and dorsal surface of the right hand. She was treated with
intravenous antibiotics for a presumed suppurative tenosynovitis. Three days later she was somewhat improved but was
complaining of a painful, swollen right ankle. Our rheumatology unit was contacted. Her medical history was remarkable
for a 10-year history of acute gouty arthritis which had
involved both great toes, ankles. and wrists. Serum uric acid
levels had ranged from 6.7 to 10.5 mg/dl (normal = 2-7
mg/dl). She had been treated with uricosuric drugs as well as
allopurinol, but compliance had been poor.
Examination revealed a red, warm, swollen, painful
right ankle and moderate diffuse swelling and tenderness of
the second and third fingers and dorsal surface of the right
hand. There was also a Heberden’s node or tophus on the
ulnar aspect of the second distal interphalangeal (DIP)joint.
After injection of 0.25 cc of lidocaine into this nodule, it was
aspirated and 2 drops of bloody fluid were obtained. The
right ankle was also aspirated; both samples contained
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