The Alchemy of Flow Cytometry
source:
http://www.omsj.org/corruption/the-a...flow-cytometry
PRODUCT RECALLS
Since 2004, the FDA has issued
66 recalls of flow cytometry products, devices, components and computer software.
Examples:
COMPANY: BD Biosciences
PRODUCT: FACSDiva Software
REASON: When data file containing one or no fluorescence (SIC) parameters is exported, the software will automatically apply compensation to this file and all subsequently exported files.
UNITS: 1074, US and worldwide distribution
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COMPANY: Quantimetrix Synovialscopics
PRODUCT: Synovial Fluid Control
REASON: This recall was initiated due to efficacy concerns with the stabilized erythrocytes, leukocytes and lymphocytes contained in this product group
UNITS: 24,937 Nationwide distribution
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COMPANY: Cytosol Opthalmics
PRODUCT: ShellGell Sodium Hyaluronate 0.8mL syringe, 12 mg/ml.
REASON: Product sterility may be compromised due to incomplete heat seals in the cannula pouches that are included with the viscoelastic syringe.
UNITS: 3,720 California and North Carolina
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COMPANY: Beckman Coulter, Inc.
PRODUCT: Cyto-Stat/Coulter Cone B6-RD
REASON: Diminished expression on B-cell population when drawn in EDTA tubes, which may lead to inaccurate interpretation of phenotype results
UNITS: 1053 Nationwide and Canada
The FDA has issued numerous warning letters to
PointCare Technologies, a leading developer and producer of flow cytometry products. In its latest warning letter dated
14 June 2011, the FDA cited PointCare’s repeated and unresolved problems with their testing equipment, reagents and manufacturing facilities:
“…two of these three lots failed the specifications for osmolality and optical density (OD)… devices are adulterated… their manufacture, packing, storage, or installation are not in conformity with the Current Good Manufacturing Practice (CGMP) requirements… did not perform adequate stability studies after changing the packaging of CD4NOW Gold Reagent to determine an accurate shelf-life for the product… functional performance of the gold pack was not acceptable… failed to provide scientific justification for performing gold functional testing on only one vial per lot… Failure to establish, maintain, and implement a corrective and preventative action procedure… due to an AC charging cable/adapter bursting into flames while service personnel charged the unit… Failure to have quality audits conducted by an individual that does not have direct responsibility over the matters being audited…” (emphasis added)
THE MARKETING OF JUNK SCIENCE
Of the 66 aforementioned recalls and warning letters, FDA complaints were issued for failures that typically result in low CD4 counts. For agencies that need low counts to claim high HIV infection rates e.g. revenues (and for clinicians who accept
kickbacks and
bribes from companies like Bristol-Myers Squibb [BMS] and Gilead Sciences), flow cytometry helps clinicians justify the unnecessary delivery of
toxic HAART therapies to healthy patients.
Flow cytometry is especially helpful in places
like Africa, where mining companies routinely dump toxins and heavy metals into waterways.
One company is
Kilembe Mines Limited, which is
trying to sell an operation that has polluted the environment and water supplies of southwestern Uganda
since 1956. Because foreign investors are reluctant to assume liability that comes with the purchase of toxic waste dumps, clinics and medical devices that blame pollution-caused ailments on HIV offer significant advantages to prospective investors.
According to
this report, the Uganda Catholic Medical Bureau (
UCMB) has distributed drugs in this area for
30 years.
In an effort to “scale up access to antiretroviral therapy…”
UCMB advised that “treatment procedures and the monitoring of clients are
simplified so that lower cadres of health workers can be trained to carry out some of the simpler functions… (of HIV testing, diagnosis and treatment).”
Gloria Kakuru of the Baylor University’s International Pediatric AIDS Initiative (
BIPAI) explains how
PointCare Now helps these “clinicians” diagnose HIV in the area surrounding the
Kilembe mines – claiming that the device is superior because it justifies earlier initiation of HAART medication in
adults and
children:
These inflated misdiagnoses are then used by agencies like UNAIDS, the World Health Organization (WHO) and drug companies like
Bristol-Myers Squibb (BMS), GlaxoSmithKline, Merck (and others) to push deadly HIV drugs – usually at
taxpayer expense.
Although labs continue to use PointCare Now and its CD4 Gold reagents, the recent FDA warning letters do not appear on the
PointCare website or in any of these marketing materials – nor is there any evidence that PointCare, clinical laboratories or advertisers made any attempt to contact patients who are misdiagnosed by the faulty equipment and protocols, poisoned by HAART medications or criminally convicted for having sex.
RELIABILITY
Dr. Marion Joppe describes “
The Research Process” this way:
“The extent to which results are consistent over time and an accurate representation of the total population under study is referred to as reliability. In other words, if the results of a study can be reproduced under a similar methodology, then the research instrument is considered to be reliable.”
Theoretically, reliable tests should deliver the same results no matter how many times it is applied to random members of the same target groups.
Because of the failure to conduct population studies that would have helped researchers understand CD4+ variability with age, sex, race, time of day or health status; along with the lack of standardization, the reliability of the HIV test results of the absolute CD4+ T cell value by flow cytometry is, at best, wholly unreliable.
While caution must be exercised in the interpretation of unreliable results, this has not been emphasized by the CDC. White blood cell counts can vary substantially from day to day and may account for shifts of as much as 50 to 150 in normal adults, although the degree of this change may be less in individuals with lower CD4 counts. Also substantial variability exists from laboratory to laboratory; those that do not perform cell count procedures frequently – or do not have quality assurance programs – can be expected to produce inaccurate test results. Compounding this problem, an extended delay of more than 48 hours between the time of sampling and actual specimen processing will result in inaccurate values. Therefore, if a laboratory does not perform the test on a daily basis, or if, for example, blood is drawn on Friday and processed on Monday, the test results may be inaccurate. Another common source of inaccuracy is
refrigeration of the blood sample.
Because caution conflicts with their ongoing social marketing campaigns, the CDC ignores the known science of CD4+T cell subsets, the Th1/Th2 dual strategy of the immune system, the function of nitric oxide in cell mediated immunity and the possibility for reversal of this immune imbalance with inexpensive nutracuticals, antioxidants and detoxification.
During the two years of its involvement in
HIV-related criminal cases and its review of medical and laboratory records, OMSJ has found no evidence that US laboratory facilities exercise caution in the use of flow cytometry equipment or have met any of the CDC’s recommended standards. Instead, laboratories shroud their operations in secrecy, which is only exposed when laboratories like Quest Diagnostics pay
$241 million in fines for fraud and kickbacks or
$302 million for illegally marketing misbranded diagnostic equipment.
Given these findings, there is no credible evidence that HIV is responsible for the decrease in CD4+T cells in acquired immune deficiency or that a decrease in CD4+T cells is a unique finding in people who are HIV+: Nor is there any credible evidence that the current usage of flow cytometry technology is justified as a diagnostic therapeutic tool in the current HIV/AIDS paradigm. Unfortunately, it is unlikely that clinicians will abandon these voodoo technologies anytime soon.
Dr. Nancy Banks is a graduate of Hunter College and Harvard Medical School. She practiced general obstetrics and gynecology for 25 years and is an expert in the testing, diagnosis, and treatment of sexually-transmitted diseases. She is the author of the award-winning book AIDS, Opium, Diamonds & Empire (2010).
Clark Baker is OMSJ’s Principal Investigator.
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