Professionalism/Kunal Saha and the World Bank

Kunal Saha was a medical doctor retained by the World Bank to examine a program designed to combat the spread of HIV/AIDS in India. However, in May of 2007, Dr. Saha alleged that the kits, paid for by the World Bank and distributed by the National AIDS Control Organization (NACO), frequently produced false negatives and HIV contaminated blood was deemed clean and suitable for distribution.

Kunal Saha
Dr. Saha has initiated efforts to combat poor medical treatment in India and is a self-proclaimed crusader for patients. His involvement with the World Bank and HIV testing kits is only one example of his efforts to safeguard the Indian public. He also serves as an associate professor at Columbus Children's Hospital in Ohio. He consistently travels between Cleveland, OH and Calcutta to make his case against medical negligence. Dr. Saha founded an organization called People For Better Treatment following the decision of the Supreme Court of India on the medical negligence of doctors in Kolkata, India in the wrongful death of his wife, Anuradha. This organization provides legal support for victims of medical negligence as well as oversees the public health system in India. Dr. Saha fights for both of these causes as he has witnessed the unethical treatment of patients in India.

World Bank Project and Investigation
In 1999, the World Bank allocated $191 million to India for the Second National HIV/AIDS Control Project. The project was aimed at reducing the spread of HIV infection in India and strengthening India's capacity to respond to HIV epidemic on long term basis, specifically targeting high risk groups like female sex workers and injecting drug users, promoting awareness campaigns, and strengthening local hospital and clinic infrastructure. The Second National HIV/AIDS Control Project was administered by NACO, an agency within the Government of India’s Ministry of Health and Family Welfare. NACO delegates responsibilities to local agencies, State AIDS Control Societies, that purchase supplies such as HIV testing kits from independent suppliers. The selection of these partner organizations was supposed to be competitive and transparent to ensure their credibility, yet the evidence suggests corruption in the awarding of supplier contracts. Dr. Saha was asked by the Department of Institutional Integrity to serve as an investigator to examine the status of the Second National AIDS Control Project with respect to HIV/AIDS testing in India and to assess the controls for corruption.

Monozyme Ltd
Monozyme India Ltd. was founded on 7th July, 1989 and launched commercial operations on 15th May, 1991. It initially functioned as a private company but converted to a public Ltd. company in 1991. The company has been manufacturing and importing substitute diagnostic kits for the Indian market since the early 90s. In 2006, Monozyme allegedly used genuine blood-test kits as decoy to deceitfully obtain a government supply contract. In 2007, however, the Government of West Bengal claimed that the quality of medical kits supplied by Monozyme were standard. Ironically, the National AIDS Control Organization (NACO) had claimed the complaints about HIV testing kits were confined to West Bengal in 2006. Furthermore, in the Detailed Implementation Review (DIR) released by the World Bank in 2007, Monozyme was listed as an example of fraudulent and corrupt practices on local contracts. The review stated that the Mumbai District AIDS Control Society (MDACS) awarded the manufacturing contracts of HIV testing kits to Monozyme despite their non-compliant bid submission and fraudulent certificate of good manufracturing practice. MDACS also neglected another company’s offer of a lower-priced bid for the exact same product. Monozyme was involved in corruption and fraudulent acts, demonstrating the poor integrity of government organizations in India which greatly endangered the public health of India.

Timeline and Location of Faulty Kits
In late 2006, the Indian media reported that expired HIV testing kits were distributed in West Bengal. The media also reported that pregnancy testing kits and kits designed for other purposes were also distributed as tools to diagnose HIV. According to the Calcutta police, Monozyme was believed to have distributed nearly 200,000 kits to West Bengal hospitals and blood banks starting in April 2006. In addition, the World Bank confessed in their 2007 DIR that 43 facilities in Mumbai, the most populous city in India, had also received the Monozyme test kits, and the MDCAS also received complaints from five different voluntary counseling and testing centers since 2004.

Previous Complaints
The World Bank’s 2007 DIR revealed that physicians and professors had filed complaints about the Monozyme HIV testing kits as early as in 2004. One of the most common defects reported was that the control band of the testing kit failed to show. Faint testing results and high frequency of false negative results were also observed. In addition, NACO also received complaints about HIV testing kits supplied by Span Diagnostics back in 2002 and by Zhongshan in 2004. Even after these complaints and the media reports in late 2006, NACO and the World Bank did not take action. A NACO spokesperson claimed that the problem was confined in West Bengal that year and NACO had resolved the issue; however, the test data that Dr. Saha collected showed that Monozyme testing kits were still being used in central India six months after NACO’s previous claim. NACO and the World Bank’s negligence and failure in furthering the investigation of the defective HIV testing kits indicated poor ethical standards and lack of professionalism in these organizations.

Cover-Up
Dr. Saha presented his findings to the Department of Institutional Integrity at the World Bank, which had retained Dr. Saha. After the presentation, the Senior Institutional Integrity Officer had initially expressed concern over Dr. Saha's findings. The World Bank, instead of investigating Dr. Saha's claims, dismissed allegations in the press. Kees Kostermans, the World Bank's lead public health specialist in South Asia at the time, said in an interview that he believed Saha was "mistaken" and that there was no public health threat associated with the kits.

The World Bank and the Government of India solicited a statement from Dr. Robert Martin, Associate Director at the Centers for Disease Control (CDC) speaking to the kits' accuracy and therefore acceptance for use prior to transfusions. The Press Bureau of the Indian Government cited Dr. Martin’s statement indicating that there was no evidence of use of poor quality HIV test kits in India. However, less than two months after Dr. Martin’s claims, the World Bank issued a Detailed Implementation Report (DIR) in which the World Bank was forced to acknowledge the validity of Dr. Saha’s claims. The DIR also revealed key facts suggesting that the World Bank knew the prevalence of faulty HIV testing kits; one hospital had two years of test results showing that the Monozyme kits yielded an extremely high false negative rate, testing centers had logged complaints that the kits were producing invalid results, and other evidence indicated corrupt procurement practices with regards to test kits and blood bank equipment.

Moreover, in 2008, the Government Accountability Project obtained internal documents from the CDC showing that Dr. Martin expressed a number of concerns about the amount of data he was given to refute the Dr. Saha's claims. Dr. Martin was worried that he would give the impression that NACO was purchasing and validating the kits in an appropriate manner, referring to previous conversations he had with NACO on their issues with fraud. One week later, he issued statements to the contrary, criticizing Dr. Saha. These statements strongly suggested that Dr. Martin had been pressured to change his mind.

Spread of Disease
Since HIV is transmitted through various bodily fluids, the defective kits led to thousands of undiagnosed cases. People who received a false negative test result for the virus spread it to their sexual partners, children, and recipients of their blood (via transfusion), magnifying the original problem rather than reducing the incidence of the disease. In one instance, a 13 year old boy received an HIV and Hepatitis B infected blood transfusion while being treated for lung cancer in an Indian hospital; this instance inspired suo moto legal action by the National Human Rights Commission.

National Aids Control Project- Phase III
Dr. Saha discovered the defective kits while reviewing the World Bank’s Second National AIDS Control Project (NACP-II). The DIR of the NACP-II conducted by the World Bank Group identified the major sources of error leading to the distribution of HIV/AIDS test kits. The DIR revealed deficiencies in recording of financial data by NACO and the regional offices and Non-governmental Organizations (NGOs) that report to NACO, leaving room for bribes, corruption, and fraud. Many factors led to the distribution of invalid HIV/AIDS test kits including lapses in inventory management, and improper transportation and storage of the kits; suspiciously, only a very few number of companies won contracts to distribute kits relative to the number of companies bidding as well. Identification of these errors helped guide the World Bank in the implementation of its subsequent Third National AIDS Control Project (NACP-III), which set strengthening the infrastructure of treatment programs and management of information as two of its major goals.

Lawsuit
Dr. Saha's organization, People for Better Treatment, has filed a lawsuit against one manufacturer of the HIV testing kits Monozyme India Ltd. Similarly, People For Better Treatment has filed a Public Interest Litigation in Calcutta High Court against members of the West Bengal Health Ministry, as many children received HIV-infected blood transfusions in this area.

Dr. Saha also took his complaints to the Delhi High Court, where he filed a lawsuit against the National AIDS Control Organisation. . The Delhi High Court ordered NACO to ensure that they comply with the recommendations made by Professor John Parry in his review of the NACO program after Dr. Saha made his allegations. However, Dr. Saha argues that NACO cannot conduct a fair investigation of itself with a history of minimizing, dismissing, or ignoring the allegations waged against it. Thus, Dr. Saha has field a Special Leave Petition with the Supreme Court of India.

Conclusion
Dr. Saha performed his duty to the highest of his ability. In assessing the NACP-II program, he reported his findings to his superiors at the World Bank, and in doing so, expected them to remedy the situation. When the World Bank did not, he made the case public and found his superiors soliciting statements to protect the reputation of the World Bank and the Indian government. Dr. Saha's reputation was put on the line, but he acted as a true professional in coming forward when he believed there was wrongdoing.