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

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