World Bank Funding Use of Defective HIV-Testing Kits in India

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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 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 . " 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

National Office 1612 K Street, NW Suite #1100 � Washington, D.C. 20006

202.408.0034 � <www.whistleblower.org

Contact: Bea , International Director

Phone : 202.408.0034 ext 155, 202.841.1391

Email : beae@...

Dylan Blaylock, Communications Director, Government Accountability Project

202.408.0034 ext. 137; 202.236.3733 (cell)

1612 K. St, #1100 Washington, D.C. 20006

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