Connecting over 25 millions NRIs worldwide
Most trusted Name in the NRI media
NRI PEOPLE- OUR NETWORK
 
NRI, US Dr. Kunal Saha

 

SD Bioline test kits, as used by NACO and procured with World Bank funds

Government Accountability Project
National Office
1612 K Street, NW Suite #1100 • Washington, D.C. 20006
202.408.0034 • www.whistleblower.org


January 13, 2009
John A. Roome, Operations Director
South Asia Region
The World Bank
1818 H St. NW
Washington, D.C. 20433

Dear Mr. Roome:

Dr. Kunal Saha forwarded to me your recent response to his concerns regarding SD Bioline test kits, as used by NACO and procured with World Bank funds. We noted with concern that the Bank now considers this matter resolved. Dr. Saha and GAP, however, have continuing concerns and questions about the blood testing equipment used as part of NACP2.

First, we note that you no longer reference Dr. Robert Martin’s conclusions about the issues raised by Dr. Saha regarding NACP2. We assume that Dr. Martin’s disengagement has occurred because the US Centers for Disease Control, where he is employed, has pointed out to the Bank and to GAP that its personnel have neither the expertise nor the mandate to evaluate the validity and reliability of any medical devices, and certainly not of the SD Bioline and Monozyme blood test kits used in India. As we informed you on June 18th, 2008, CDC Assistant Surgeon General and Rear Admiral Mitchell L.Cohen wrote us to say that the CDC is not the appropriate US agency to query about medical devices, such as blood testing equipment. In the United States, the Food and Drug Administration responds to these inquiries.

Further research shows that the same division of labor in public health matters obtains in both the UK and in Australia. Responsibility for evaluating and approving medical devices lies with the Medicines and Healthcare Products Regulatory Agency in the UK and with the Therapeutic Goods Administration in Australia. Rather than contacting these agencies – or other acknowledged experts in evaluating medical equipment – the Bank retained experts from the Health Protection Agency in the UK and from the National Serology Laboratory in Australia to evaluate blood testing equipment.

For reasons unknown, the World Bank has contracted three different experts in testing protocols to determine whether medical equipment is reliable.

Moreover, as Dr. Saha and GAP informed you in our meeting last summer, both Drs. Dax and Martin have conflicts of interest in this matter and neither of them can be in any way construed as ‘independent’ experts. Both Drs. Dax and Martin conducted workshops on HIV/AIDS testing protocols for the World Bank and NACO and their services were contracted for technical assistance in building up lab systems in India. Documentation we have obtained revealing Dr. Martin’s candid judgment of Dr. Saha’s allegations shows him to be under considerable pressure to vouch for NACO’s procurement procedures in November and December, 2007. Further, the documents show that Dr. Martin a) felt unqualified to respond to NACO on the matter of blood testing equipment; b) did not believe that he had enough data to make a judgment about the reliability of NACO’s equipment, and c) was reluctant to put anything in writing that might be used by NACO to justify its existing procurement procedures. In the past, Dr. Martin had also expressed serious concerns about the approach followed by NACO for validation of test kits and testing of blood, not only for HIV but also for other diseases like Dengue, Typhoid and Hepatitis. These documents show that the conflict of interest issue was of real consequence for Dr. Martin and was not simply an abstract possibility. The documents also show that the World Bank was instrumental in soliciting a judgment for NACO from Dr. Martin on the Indian blood test kits.

These documents will be material to a lawsuit in the United States.

We continue to question Dr. Dax’s judgment, given that her circumstances parallel those of Dr. Martin. She too had a conflict of interest and lacked the expertise to evaluate medical devices.

We cannot comment on the conclusions drawn by the British expert, except to note that he too lacks the institutional background needed to address the issue at hand.

Regards,

International Program Director
Government Accountability Project
1612 K St. NW
Washington, D.C. 20006
202-408-0034 ext. 155

 


Dr. Saha in Columbus, Ohio