Kunal
Saha, M.D., Ph.D.- helping
India |
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World Bank Funding Use of Defective HIV-Testing Kits
September 28, 2007
FOR IMMEDIATE RELEASE
Contact: Bea Edwards, International Director
Phone: 202.408.0034 ext 155, 202.841.1391
Email: beae@whistleblower.org
Contact: Dylan Blaylock, Communications Director
Phone: 202.408.0034 ext 137, 202.236.3733 (cell)
Email: dylanb@whistleblower.org
World Bank Funding Use of Defective
HIV-Testing Kits
‘False Negative’ Readings Prominent in Materials
used in India;
Corrective Steps not Taken Despite Expert’s Warnings
(Washington, D.C.) – A client of the Government Accountability
Project (GAP) has come forward with evidence that World Bank funds
have been used over a period of years to purchase defective HIV
test kits, which have been supplied by the Indian government to
hospitals and blood banks across the country. The kits, distributed
by Monozyme, Ltd., frequently give ‘false negative’
readings, meaning that HIV-contaminated blood will appear to be
‘clean’ and suitable for distribution.
The Department of Institutional Integrity (INT), the World Bank’s
anti-corruption unit, hired GAP’s client as a consultant to
review India’s Second National HIV/AIDS Control Project, financed
with $191 million in Bank funds. He found that although the National
AIDS Control Organization (NACO) at the Indian Ministry of Health
and Family Welfare had received multiple complaints about the HIV
test kits as long ago as October 2004, the agency had not acted
to withdraw the kits. When the media in India and Europe reported
widespread complaints about the accuracy of the Monozyme kits in
2006, a NACO spokesperson dismissed the allegations, saying that
the problem was confined to the state of West Bengal that year and
that NACO had addressed it.
GAP Client Dr. Kunal Saha, however, collected test data showing
that the Monozyme kits were still in use six months later, in April
2007, in Chhattisgarh, a state in central India.
Click
here to see the corresponding document: Blood sample data for HIV
contamination from JN Hospital, Chhattisgarh using Monozyme test
kits, April 2007.
Dr. Saha is a recognized expert in the field of HIV/AIDS research
with two decades of research and clinical experience. Currently
working as an associate professor at Columbus Children’s Hospital
in Ohio, he served as an investigator on a six-member World Bank
team that INT hired to examine HIV testing in India during March
and April 2007. After finding evidence that defective kits were
still in use, Dr. Saha notified INT of the immediate danger to public
health.
When no action resulted from either the Bank or NACO, Dr. Saha took
his concerns directly to then-World Bank President Paul Wolfowitz
in a letter dated June 11, 2007. He went public with his disclosures
to the Indian press in July.
“Analysis of the original test results showed beyond any reasonable
doubt that many hospitals/blood banks involved with HIV testing
were forced to use the sub-standard kits given by the National AIDS
Control Organization,” Dr. Saha told the Hindustan Times.
The Bank has been working on a review of health projects in India
for nearly one year but states that its report is still two months
away from completion. To date, however, neither a public notice
nor a recall of the defective test kits has occurred. When Dr. Saha
disclosed his observations to the Indian press in July, a World
Bank representative undercut his allegations for unknown reasons.
In a statement to the Hindustan Times of India in July 2007, a World
Bank official stated:
“(Saha’s) findings are personal opinions which the researcher
has reached independently, and do not reflect the views of the World
Bank.”
The same Hindustan Times July piece stated:
“The Bank has said it has no evidence so far of fraud involving
the kits.”
But the Bank did have evidence at that time, because of the disclosures
of Dr. Saha to his team leaders at INT. Further, the Bank chose
to postpone a decision on steps to address the issue of the defective
kits until the release of the delayed report. Again, referencing
the Hindustan Times article:
“The World Bank and the Government of India have been engaged
in a comprehensive review of Bank-financed health projects in India
to reduce the risk of fraud and corruption in the procurement of
pharmaceuticals and medical goods on which millions of lives depend.
Recent news reports about suspect HIV testing kits are part of this
detailed review.”
“The evidence shows that the World Bank and INT have treated
this public health emergency in India bureaucratically and evasively,”
said GAP International Program Director Bea Edwards. “News
reports in Europe a year ago revealed that Monozyme had distributed
more than 200,000 of these defective kits in the state of West Bengal
alone.”
In the Bank’s sole written response to Dr. Saha’s demand
that he be released from his confidentiality agreement related to
the INT investigation in order to publicize the emergency in India,
Ana Palacio, the Bank’s General Counsel, told him that the
problem had been addressed. It was clear from her message, however,
that she was confusing a criminal case brought against Monozyme,
Ltd. for defective distribution of Hepatitis B and C test kits with
ongoing issue of Monozyme’s distribution of the faulty HIV
kits.
The continued use of these kits is a public health disaster, condemning
many Indians to a life and death of AIDS. Action is needed immediately.
Evidence
Dr. Saha has produced documents from hospitals in India showing
that when blood samples known to be positive for HIV were tested
with kits distributed by Monozyme, Ltd. (Brand names: SD Bioline,
Biozyme), they produced ‘false negative’ results. The
‘false negatives’ are the most dangerous outcomes because
they allow HIV-tainted blood to be donated as ‘clean.’
Click
here to read the corresponding document: Correspondence from VCCTC
G.T. Hospital to Mumbai District AIDS Control Society, October 26,
2004.
Despite reports to the AIDS Control Society about the defective
kits, one year later this equipment was still in use, producing
false negatives in 50 percent of the tests conducted at the Department
of Microbiology, JJ Hospitals, also in Mumbai.
Click
here to read the corresponding document: Test data (October 13,
2005) shows that samples producing HIV positive results with a valid
test (ELISA) produced false negatives with Monzyme’s SD Bioline
kits.
Government Accountability Project
The Government Accountability Project is the nation’s leading
whistleblower protection organization. Through litigating whistleblower
cases, publicizing concerns and developing legal reforms, GAP’s
mission is to protect the public interest by promoting government
and corporate accountability. Founded in 1977, GAP is a non-profit,
non-partisan advocacy organization with offices in Washington, D.C.
and Seattle, WA.
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NRI,
Dr. Saha filed three cases against the doctors, who were responsible
for his wifes death
Kunal Saha, M.D., Ph.D.
Asst Professor
College of Medicine and Public Health
Pediatrics - Molecular Medicine
Children's Hospital Research
- Compensation claim of Rs.777 million
- Entire compensation amount would be donated for
promotion of health in India
- Supreme Court admits a Rs.1.43 billion compensation
claim by NRI Dr. Kunal - largest medical compensation
claim in Indian history
- Read More
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