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India & HIV

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In 2008, GAP client Dr. Kunal Saha came forward with evidence that World Bank funds had been used for years to purchase defective test kits designed to detect the presence of HIV/AIDS in blood samples. The kits, which had been procured by the Indian government and distributed to hospitals and blood banks across the country, frequently gave ‘false negative’ readings. As a consequence, HIV-contaminated blood would appear to be ‘clean’ and suitable for distribution.

After Dr. Saha reported these findings to the investigative unit at the World Bank, he faced a coordinated attempt to defame him and undermine his efforts to safeguard the Indian public.

Background

The Department of Institutional Integrity (INT) at the World Bank is charged with investigating corruption inside the institution. In 1999, the Bank approved $191 million in financing for India’s Second National HIV/AIDS Control Project. The project represented an intensive government effort to curb the rapid spread of the disease.

Dr. Saha is a recognized expert in the field of HIV/AIDS research, with over 20 years of research and clinical experience. When working as an associate professor at Columbus Children’s Hospital in Ohio, he was asked to serve as an investigator on a six-member World Bank team, hired by INT to examine HIV/AIDS-testing in India.

During March and April 2007, Saha and two other doctors examined documents and visited hospitals in India to assess the controls for corruption in the World Bank project. During the inquiry, Dr. Saha found clear evidence of the widespread use of faulty HIV/AID test kits. Data show that when blood samples known to be HIV-positive were tested with kits purchased from Monozyme, Ltd., they often produced ‘false negative’ results. The ‘false negatives’ are the most dangerous possible outcome, as it allows HIV-tainted blood to be donated for use in transfusions. In Dr. Saha’s words:

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 (NACO).

Specifically, Dr. Saha found that NACO, the government agency in charge of the program, had received multiple complaints about the test kits beginning in October 2004, but failed to take action. 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. Saha’s evidence, 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.

Dr. Saha notified INT of the immediate danger to public health, and pressed NACO further for action. When no steps were taken by either department, Dr. Saha took his concerns directly to then-World Bank President Paul Wolfowitz in 2007. He then went public with his disclosures to the Indian press.

The World Bank

Instead of investigating Saha’s claims further, a World Bank official simply dismissed the allegations, stating in the Indian Press:

(Saha’s) findings are personal opinions which the researcher has reached independently, and do not reflect the views of the World Bank.

The same article 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 – Saha’s disclosures 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 another report on the matter – potentially exposing additional transfusion recipients to HIV.

Prior to speaking out in the Indian press, Dr. Saha had sought from the Bank to be released from the confidentiality agreement he had signed regarding the INT investigation, in order to publicize the emergency. In August 2007, Dr. Saha presented his evidence in a face-to-face meeting with Bank officials. In response to this presentation, the Senior Institutional Integrity Officer wrote him on August 23, 2007:

We found the meeting both instructive and helpful. We recognize the need to follow up quickly on the issues you have raised and to that end would like to use your information in discussion with persons outside the Bank. [Emphasis added]

The follow-up, however, became a cover-up.

Cover-Up Using the CDC

GAP helped Dr. Saha raise his concerns through the Washington Post in a major story that was released in September 2007. In this story, Dr. Kees Kostermans, the Bank’s lead public-health specialist in South Asia, stated that the Bank had no “specific evidence” that HIV had been transmitted in India because of faulty diagnostic kits.

“Specific evidence” that a defective diagnostic kit may have transmitted a virus like HIV requires an analysis of both hospital/blood bank data, and the medical records of the patients in the follow up clinics – precisely the investigative procedure that the Bank should have started immediately but did not. In other words, as Dr. Saha pointed out, the Bank had no evidence because no one had looked for it.

In December 2007, as more articles began to appear in the Indian press focusing on the widespread use of defective HIV test kits, the Bank and Indian government solicited a misleading statement from a laboratory testing expert at the US Center for Disease Control (CDC) vouching for the kits’ accuracy. NACO, working directly with the Bank, stated to the Indian press:

The documents cited by Dr. Saha have been reviewed by Dr. Robert Martin, associate Director, Coordinating Centre for Health and Information Services, Centres for Disease Control and Prevention, USA who is also of the view that there is no evidence of use of poor quality HIV test kits in India and his allegations have no basis.

Dr. Martin did not consult Dr. Saha at any time before making this statement. The CDC (through its General Counsel) declined to identify to GAP, in the days after this statement was made, the evidence that Dr. Martin purportedly reviewed. The Bank presented Martin as an independent expert, but documents later showed that he was closely affiliated with NACO. Publicly, Dr. Martin stated that Dr. Saha did not have sufficient evidence to evaluate the kits.

Less than two months later, however, when obliged to release its own Detailed Implementation Review in order to comply with U.S. legislation, the Bank was forced to acknowledge the validity of the claims made by Dr. Saha some seven months earlier – a direct contradiction of the CDC expert’s statements. The report’s revelations included:

  • Two years of test results provided by one hospital which showed that the Monozyme kits yielded an extremely high false negative rate.
  • Complaints from five Voluntary Counseling and Testing Centers to Municipal District AIDS Control Societies that Monzyme-supplied kits were producing invalid, false negative and/or discordant results.
  • Indicators of fraudulent and corrupt practices in the procurement of diagnostic test kits and blood bank equipment – particularly when conducted through decentralized procurement.

Specifically, the report stated:

“[S]ome of the test kits supplied by particular companies often performed poorly by producing erroneous or invalid results, potentially resulting in further spread of the disease or in the wastage of blood.”

In short, the World Bank’s own documentation showed that these kits had serious problems, but the data did not stop Bank officials from launching a smear campaign against Dr. Saha, whose allegations proved to be correct. In all likelihood, an unknown number of Indian citizens may have unnecessarily contracted HIV.

Despite the public release of the INT report in January 2008, the World Bank’s Kostermans still told the Washington Post in March 2008 that the HIV test kits were not faulty. At the same time the Bank issued a statement saying: “We take these indicators of fraud and corruption extremely seriously. Working with the Indian authorities, we will take action against those found responsible…” After 10 months’ delay from the initial time of Saha’s disclosure, the Bank did finally announce it would further investigate the problems with the kits – but only when coupling it with another false statement about the sanctity of the kits.

After this statement, GAP received a response to a Freedom of Information Act request related to this case, which produced private e-mails written by the CDC’s Dr. Martin expressing grave doubts about the procurement, validity and testing procedures at NACO. The private written statements contrasted directly with his public statements. When the emails surfaced, the World Bank began to distance itself from Dr. Martin. Ultimately two other experts were retained by the Bank, neither of whom had the correct expertise to evaluate medical equipment. Of the two, one also had a close affiliation with NACO and a conflict of interest; the other, John Parry, expressed his reservations about the reliability of NACO’s blood testing equipment, just as Dr. Martin had done privately and Dr. Saha had done publicly.

Aftermath

In March 2008, Dr. Saha filed a Special Leave Petition with the Supreme Court of India appealing a judgment and order of the Delhi High Court. Dr. Saha’s appeal argues that a decision taken by the lower court regarding resolution of allegations against NACO for disregard of public safety and for abuse of human rights does not go far enough to safeguard public health.

In response to GAP’s FOIA material, indicating a coordinated cover-up of the situation, the Delhi High Court ordered NACO to “ensure that they comply with the report by Professor John Parry and the observations made by him.” Dr. Saha’s lawsuit points out, however, that the court gave no specific orders to NACO concerning how and when it should comply with Parry’s numerous observations. Saha also argues that it is unrealistic to expect NACO to implement a fair investigation of its own actions in the matter of allegations concerning defective test kits made by hospitals, when NACO has already minimized, dismissed or ignored these allegations for as long as five years.

Dr. Saha notes in his suit that although NACO has admitted that the test kits used in some hospitals during the program were ‘invalid and produced inconsistent results,’ evidence indicates that neither NACO nor the World Bank has an interest in conducting an impartial review of the matter. Moreover, as Dr. Saha emphasizes in his suit, the court ordered NACO to address concerns raised by one expert (Mr. Parry), but not those identified by the others. Dr. Saha’s suit alleges that the lower court has left NACO excessive discretion in deciding on steps to address the issue and has unjustifiably exempted NACO’s decision-making in this matter from external oversight.

Dr. Saha now writes a blog about medical malpractice and negligence in India: People for Better Treatment. The Supreme Court of India handed down a landmark judgment on August 7, 2009, upholding the claim of medical negligence brought by Dr. Saha against four doctors and the Advanced Medicare Research Institute in Kolkata. The Court held the doctors and hospital guilty of negligent treatment, causing the death of Dr. Saha’s wife, Anuradha Saha, in 1998. In the Judgment, the Supreme Court also set out extensive new guidelines and regulations that physicians and hospitals must follow in treating patients.