THE FAUCI FILES, 3( 42): Fauci's Low CD4 = AIDS Hoax Unravels (Shaw's Theorem)

W. Fred Shaw fredshaw at primenet.com
Wed Mar 15 17:42:39 EST 2000


THE FAUCI FILES, 3( 42): Fauci's Low CD4 = AIDS Hoax Unravels  
(Shaw's Theorem)

March 15, 2000

Another key Fauci pharmaceutical-promoting anti-retroviral therapy 
(ART) Hoax unravels: the CD4+ T-cell count.

For the past 2 decades the prevailing HIV/AIDS treatment marker
has been tied to these superstitions:

  1. Low CD4 counts (under 200) presume an AIDS definition 
     (as adopted for the CDC AIDS case definition in 1993
      when it was changed to include healthy asymptomatics with
      less than 200 CD4s for the purpose of prescribing ART).

  2. The CD4+ T-cell marker alone is a valid measure of treatment
     success and immune competence.
 
  3. The CD4+ T-cell marker correlates directly with risk of
     pathogenic opportunistic infections.

While these CD4 "surrogate marker" myths couldn't be further from 
the truth, it is important to keep in mind that they arose from
the same statistical misinterpretations that would equally assert 
that blonde hair is caused by blue eyes.

Low CD4 counts are found in a wide variety of illnesses and
acute diseases.

There is NO evidence that CD4 counts predict ANY disease, rather, these
cell counts simply decline in the presence of a wide variety of
illnesses no different than the observation that blue eyes and blonde 
hair are also often found together.

Shaw's Theorem
What has been missing from consideration over the past two decades
of misdirected Fauci HIV pharmaceutical research is contradicted
by Shaw's Theorem: the increased probability that cell count
fluctuations are predictable and normal under conditions of various 
disease stresses and that this response of the body may have 
evolved for protective and survival reasons over the past 
few million years.

Gee, I wonder why nobody else has ever thought of that in terms
of the CD4 count?

W. Fred Shaw, Editor
THE FAUCI FILES
--------------------

Let's take a close look at the Editor's Correspondence published
in this week's  "Archives of Internal Medicine, March 13, 2000, 
Vol. 160 No. 5, Pages 715-716), which deals with a study of
53 HIV-negative patients, 55% of whom had less than 500 CD4 
T-cells and six (11%) of the 53 patients were found to have 
LESS THAN 100 CD4 T-cells, yet NONE suffered a single AIDS-defining
illness!

Here are the key quotes for this HIV-NEGATIVE population:

   "Nine patients (17%) had counts lower than 0.200 X 10^9/L, 
    and 29 (55%) had counts lower than 0.500 X 10^9/L."

     "Diagnosis            No. of Patients* 
 
     Infection                   21 
     Gastrointestinal bleeding   13 
     End-stage liver disease     13 
     Respiratory failure         13 
     Renal failure                9 
     Drug overdose                7 
     Cardiovascular disease       6 
     Acute hepatic failure        5 
     Cerebrovascular accident     5 
     Hypotension                  5 
     Pancreatis                   4 
     Trauma                       4 
     Diabetic ketoacidosis        1 
     Hypoglycemia                 1 
     Guillain-Barre syndrome      1 
     Status epilepticus           1 
     *Some patients had more than one admission diagnosis 

   "While significant alterations in T-lymphocyte profiles have been 
    observed with a variety of general infections, (5, 6) including 
    acute pneumonia (7) and tuberculosis, (8) as well as in acute 
    pancreatitis, (9, 10) to our knowledge no studies have examined 
    the impact of acute, severe illness on the CD4+ cell count, CD4 
    percentage, and CD4-CD8 ratio."

   "Although this study involved a relatively small number of patients, 
    several important observations can be made: more than half of the 
    study subjects had absolute CD4+ cell counts on entry that were 
    below the normal range, and in 9 (17%) they were below 0.200 X 
    10^9/L. The lowest CD4+ cell count was 0.037 X 10^9/L. These data 
    are in agreement with a study by Fantin et al,7 in which 17.6% of 
    HIV-negative patients with acute pneumonia had CD4+ cell counts 
    below 0.200 X 10^9/L."

   "CD4+ cell counts should not be relied on for a presumptive diagnosis
    of HIV in lieu of consent for serologic testing."

   "Finally, a larger study of CD4+ cell counts in critically ill 
    individuals might better define the prognostic value of a low 
    result."



http://archinte.ama-assn.org/issues/v160n5/full/ilt0313-6.html#rc1r2

Archives of Internal Medicine, March 13, 2000, Vol. 160 No. 5, Pages 
715-716.

Editor's Correspondence

The Effect of Acute Severe Illness on CD4+ Lymphocyte Counts in 
Nonimmunocompromised Patients ?

The CD4+ lymphocyte count is a crucial parameter for the assessment of 
the integrity of the immune system of patients infected with the human 
immunodeficiency virus (HIV). T-lymphocyte counts are not static, 
however, and may be affected by a number of variables, including 
circadian rhythm,1 smoking,2 pregnancy,3 and immunization.4 In addition,
a number of limited studies have suggested that infections and specific 
illnesses may also affect the CD4+ cell count1-4; thus, immune function 
evaluation of hospitalized HIV-positive patients is often deferred 
until recovery. There are no data addressing more broadly the effect 
of generalized severe illness on the lymphocyte profiles of 
non?HIV-infected patients. This prospective observational study was 
designed to evaluate lymphocyte subsets in an HIV-negative population 
that required intensive care unit admission during acute illness.

Patients, Materials, and Methods

The study was conducted in the Medical Intensive Care Unit (MICU) at the
Hospital of the University of Pennsylvania, Philadelphia, from February 
1996 through April 1997. All patients admitted between noon Sunday and 
noon Friday were evaluated consecutively, and all eligible patients were
asked to participate within 24 hours of admission. Informed consent was 
obtained from the patients or their parents or guardians, and the 
guidelines for human experimentation of the US Department of Health and 
Human Services, Washington, DC, and the guidelines of the Hospital of 
the University of Pennsylvania were followed in the conduct of the 
clinical research. Exclusion criteria included a known diagnosis of HIV 
or other primary immunosuppressing disease; nonemergent admission (eg, 
for scheduled catheterization); treatment with glucocorticosteroids, 
radiation therapy, or chemotherapy within the previous month; and 
refusal to be tested for HIV. Patients from whom informed consent was 
obtained had blood drawn for serologic testing for HIV, complete blood 
cell count, and lymphocyte profile via flow cytometry. A baseline 
history was taken to record the following: age, sex, date of hospital 
admission, medications on arrival to the MICU, and major admission 
diagnoses. Patients were observed through their stay in the MICU, and 
mortality outcomes were recorded. All statistical analyses were 
performed using STATA 5.0 software (STATA Corp, College Station, Tex). 
All P values are 2-sided.


Results

Three hundred fifty-three patients were screened for the study, and 144 
met the inclusion criteria. The majority of the exclusions were owing to
recent steroid or other immunosuppresive therapy or refusal to be tested
for HIV. Of these, 53 patients agreed to participate in the study and 
had evaluable data. Twenty-five (47%) of the 53 participants were men. 
The median age was 56 years (range, 17-98 years). Twenty-seven patients 
were transferred from another floor, whereas the remainder were admitted
from the emergency department or transferred from other facilities. The 
admission diagnoses are listed below.


Diagnosis            No. of Patients* 
 
Infection                   21 
Gastrointestinal bleeding   13 
End-stage liver disease     13 
Respiratory failure         13 
Renal failure                9 
Drug overdose                7 
Cardiovascular disease       6 
Acute hepatic failure        5 
Cerebrovascular accident     5 
Hypotension                  5 
Pancreatis                   4 
Trauma                       4 
Diabetic ketoacidosis        1 
Hypoglycemia                 1 
Guillain-Barre syndrome      1 
Status epilepticus           1 
 
*Some patients had more than one admission diagnosis 


All 53 patients were HIV negative. The median absolute CD4+ cell count 
at admission was 0.457 X 10^9/L (457/?L), and the mean CD4+ cell count 
was 0.510 X 10^9/L (normal range for our laboratory, 0.560-1.840 X 
10^9/L). Nine patients (17%) had counts lower than 0.200 X 10^9/L, and 
29 (55%) had counts lower than 0.500 X 10^9/L. The baseline median CD4 
percentage was 50% (range, 14%-84%; normal range, 32%-56%). Six (11%) of
those studied had percentages below the lower limit of normal. The 
initial median CD4-CD8 ratio was 2.2 (range, 0.2-9.7; normal range, 
0.9-3.4), and only 2 patients (4%) had abnormal ratios (test for trend: 
P=.06).


CD4 Cell             No. of        No. of patients 
Counts, X 10^9     Patients (%)    Who Died (%) 
 
 <0.100                5 (9)             3 (60) 
 0.100-0.199           4 (8)             2 (50) 
 0.200-0.499          20 (38)            5 (25) 
 >0.500               24 (45)            5 (21) 


Subset analyses were conducted on those who had low counts and those who
died. Of the 9 patients with initial absolute CD4+ counts lower than 
0.200 X 10^9/L, 5 (56%) died, compared with 10 deaths (23%) among the 44
subjects with a CD4+ cell count higher than 200 X 10^9/L. For the 
patients with an admission CD4+ cell count lower than 200 X 10^9/L, the 
relative risk of death was 2.4 (95% confidence interval, 1.1-5.3). The 
difference in CD4+ cell counts was statistically significant between the
expired and nonexpired groups (P=.05, Wilcoxon rank sum test). The 
median CD4+ cell count of the 15 study participants who died was 0.401 X
10^9/L. This was significantly lower than the mean CD4+ cell count of 
the 39 survivors (0.510 X 10^9/L; P=.05).


Comment

While significant alterations in T-lymphocyte profiles have been 
observed with a variety of general infections,5, 6 including acute 
pneumonia7 and tuberculosis,8 as well as in acute pancreatitis,9, 10 to 
our knowledge no studies have examined the impact of acute, severe 
illness on the CD4+ cell count, CD4 percentage, and CD4-CD8 ratio. We 
chose to study an MICU population since an MICU is one of the settings 
in which clinicians use CD4+ cell counts as a surrogate for HIV testing 
and may make clinically important decisions based on the results. The 
heterogeneous admission diagnoses of our patients clearly reflect a 
"real-life" experience in that HIV-infected patients can present with 
any of these diagnoses. Although this study involved a relatively small 
number of patients, several important observations can be made: more 
than half of the study subjects had absolute CD4+ cell counts on entry 
that were below the normal range, and in 9 (17%) they were below 0.200 X
10^9/L. The lowest CD4+ cell count was 0.037 X 10^9/L. These data are in
agreement with a study by Fantin et al,7 in which 17.6% of HIV-negative 
patients with acute pneumonia had CD4+ cell counts below 0.200 X 10^9/L.
Furthermore, there was a trend toward lower CD4+ cell counts in the 
patients who died. A CD4+ cell count lower than 0.200 X 10^9/L was a 
predictor of death with a relative risk of 2.4; the highest CD4+ cell 
count among those who died was 0.610 X 10^9/L, and the median was 0.401 
X 10^9/L. The sample size was too small to determine if this was an 
independent predictor. It is very important to note that despite the 
sometimes markedly low absolute CD4+ cell counts, the CD4 percentages 
and the CD4-CD8 ratios were preserved in most subjects. Thus, the low 
CD4+ cell counts were a reflection of a panlymphopenia, perhaps 
reflecting the level of stress and endogenous glucocorticoid production.

It is common practice to defer immune status evaluation of HIV-infected 
patients until after recovery from hospitalization to avoid taking 
misleadingly low values. Our investigation both supports that concept 
and suggests the need for further definition of the impact of acute 
illness on lymphocyte profiles in the HIV-infected population. The data 
should also serve as a strong reminder that using the CD4+ cell count as
a surrogate for HIV testing has a risk of markedly overestimating the 
diagnosis of HIV. Therefore, CD4+ cell counts should not be relied on 
for a presumptive diagnosis of HIV in lieu of consent for serologic 
testing. Finally, a larger study of CD4+ cell counts in critically ill 
individuals might better define the prognostic value of a low result.

?
Jenifer Aldrich, MD
Robert Gross, MD
Mary Adler, MD
Kathy King, MD
Rob Roy MacGregor, MD
Stephen J. Gluckman, MD
Philadelphia, Pa

?
1. Laurence J. T-cell subsets in health, infectious disease, and 
idiopathic CD4+ T lymphocytopenia. Ann Intern Med. 1993;119:55-62. 

2. Tollerud DJ, Clark JW, Brown LM, et al. The effects of cigarette 
smoking on T-cell subsets. Am Rev Respir Dis. 1989;139:1446-1451. 

3. Miotti PG, Liomba G, Dallabetta GA, Hoover DR, Chiphangwi JD, Saah 
AJ. T lymphocyte subsets during and after pregnancy: analysis in human 
immunodeficiency virus type 1-infected and -uninfected Malawian mothers.
J Infect Dis. 1992;165:1116-1119. 

4. Eibl MM, Mannhaler JW, Zlabinger G. Abnormal T-lymphocyte 
subpopulations in healthy subjects after tetanus booster immunization. N
Engl J Med. 1984;310:198-199.  

5. Williams RC, Koster FT, Kilpatrick KA. Alterations in lymphocyte cell
surface markers during various infections. Am J Med. 1983;75:807-816. 

6. Blumberg RS, Schooley RT. Lymphocyte markers and infectious diseases.
Semin Hematol. 1985;22:81-114. 

7. Fantin B, Joly V, Elbim C, et al. Lymphocyte subset counts during the
course of community-acquired pneumonia: evolution according to age, 
human immunodeficiency virus status, and etiologic microorganisms. Clin 
Infect Dis. 1996;22:1096-1098.

8. Beck JW, Potts RC, Kardjito T, Grange JM. T4 lymphopenia in patients 
with active pulmonary tuberculosis. Clin Exp Immunol. 1985;60:49-54. 

9. Curley PJ, McMahon MJ, Lancaster F, et al. Reduction in circulating 
levels of CD4 positive lymphocytes in acute pancreatitis: relationship 
to endotoxin, interleukin 6 and disease severity. Br J Surg. 
1983;80:1312-1315. 

10. Pezzilli R, Billi P, Beltrandi E, et al. Circulating lymphocyte 
subsets in human acute pancreatitis. Pancreas. 1995;11:95-100.






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