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Doctor Presses Bank on HIV Tests
India Kits Defective, Specialist Claims

By Carrie Johnson
Washington Post Staff Writer
Friday, September 28, 2007

A doctor retained by the World Bank to examine a program to combat the spread of HIV in India has been warning officials for months that defective testing kits could be putting people at risk.

Kunal Saha, an AIDS specialist who visited India early this year at the behest of the bank, has pressed authorities to release a public report based on the inquiry. He also wants officials to ensure that the kits, which he says have produced false negative results, are removed from hospitals and blood banks. Saha said he has evidence that some of the questionable kits were in use as recently as April.

"If people are getting HIV because of defective test kits, it's horrendous, it's unthinkable," Saha said in a telephone interview.

The doctor, a self-described crusader who founded a patients rights group in India after his wife died because of medical mistakes nearly 10 years ago, furnished copies of letters and e-mail messages he sent top World Bank personnel, including former president Paul D. Wolfowitz, President Robert B. Zoellick and General Counsel Ana Palacio, in June and July asking them to take action. Bank officials told him they were finalizing a report, but Saha says the issue is urgent and he plans to take his case public today.

Kees Kostermans, the World Bank's lead public-health specialist in South Asia, said in an interview yesterday that a bank report on the issue is still a couple of months away from completion. But he said the bank had no specific evidence that HIV had been transmitted in India because of faulty diagnostic tests. Kostermans said the bank's partners at India's National AIDS Control Organization (NACO) have assured him that substandard test kits were no longer being purchased and that none remained in use.

"We have been looking into all of these matters very intensively," Kostermans said.

The bank did not purchase the allegedly flawed test kits directly. Instead, NACO dealt with state agencies and suppliers, Saha said.

Beatrice Edwards, who monitors World Bank operations for the Government Accountability Project in Washington and who is helping Saha, demanded stricter oversight and a rapid public accounting of the problems. "If there's any project in the portfolio that needs to be monitored and where the equipment needs to be safeguarded, this is it," Edwards said.

World health experts estimate that nearly 3 million people in India have HIV. In recent years, questions about the effectiveness of tests for HIV, hepatitis and other serious illnesses have spread across the country, along with reports of glitches in manufacturing and storage, financial corruption and fraud. Last year, Indian authorities filed charges against Monozyme India Ltd., which serves as an in-country distributor for some of the products Saha has criticized, in connection with flawed hepatitis screening tests, according to Indian press reports.

Saha, a professor at Ohio State University, traveled to India as a bank consultant as part of a team investigating possible problems with the $230 million AIDS control project the World Bank funded between 1999 and 2006. It was his first experience serving as a consultant to the bank, which approached him, Saha said.

Over five weeks in March and April, Saha and two India-based medical specialists visited hospitals and blood banks in major cities, collecting lab documents that he says suggest faulty testing kits wrongly assured people that they were not exposed to the virus. He cited 2004 and 2005 test results from two Indian hospitals in which blood samples that were known to be HIV-positive instead tested negative during a second, confirmatory test performed with defective kits.

The bank has not made public a draft report from the visit by Saha and the other two doctors. The draft warns of serious quality issues with HIV tests at blood banks and testing centers between 2003 and 2006, according to a copy of the April 26 e-mail.

This year, bank officials allocated $250 million more to a new anti-HIV program in association with NACO after deeming the previous program "satisfactory."

False positive results can lead blood banks to discard and waste otherwise useful blood. But false negative results carry more troublesome consequences: They can spread hepatitis or HIV to people who receive the tainted blood through transfusions. Saha said he found a document suggesting that questionable kits were available for use as late as April, despite public statements from Indian health workers and World Bank officials in the country that defective test kits had been removed from the shelves.

In an interview, the bank's Kostermans said he believed Saha was "mistaken" about the origin and make of the test kits he saw on the shelves in India earlier this year. The ones on the shelves, Kostermans said, posed no public health threat. "It is in nobody's interest to have poor-quality test kits," he said.

Saha took his concerns to the highest levels of the bank. He provided e-mail messages and letters reflecting that he had talked by phone with Wolfowitz shortly before the former Bush administration official left the bank this summer. Wolfowitz did not return a call or e-mails yesterday.

Saha spoke with reporters in India in July. Later he flew to Washington and spent at least two hours briefing mid-level staff members at the bank, including Kostermans, about his concerns Aug. 23. Another member of the three-physician team, Anil Gupta, declined to comment on the issues when reached by cellphone in India yesterday. Gupta cited a confidentiality agreement he signed with the bank when he became a consultant.

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