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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