Probe on human tissue exports. An international investigation into human-tissue exports is under way in South Africa.
The Interpol probe into the country’s multimillion-rand tissue industry – which turns donated bones, skin and tendons into end products began this week. It was a request requested by US health watchdog, the Food and Drug Administration (FDA).
A forensic investigator, authorised under the Human Tissues Act by the Department of Health, visited the only two tissue banks in South Africa and removed copies of documents, including donor registers and export permits.
His appointment was confirmed in a letter which he handed to tissue-bank officials signed by the Director-General of Health, Thami Mseleku.
investigate allegations of illegal exportation
The letter authorised him to investigate “allegations of illegal exportation and/or harvesting and/or transportation of human tissue for the purpose of business”.
He was joined by a senior investigator from the police Commercial Branch.
The probe will also cover allegations of the illegal harvesting of tissue without donor consent.
The National Tissue Bank (NTB), based at the University of Pretoria, and the Centre for Tissue Engineering (CTE), at the Tshwane University of Technology, sell a range of products crafted from human tissue to orthopaedic, plastic, maxillofacial and neurosurgeons and dentists.
Department of Health spokesman Solly Mabotha told the Sunday Times that South Africa was faced with a “frightening threat of illegal trafficking of organs and tissue”.
FDA special agent declined to comment on the probe
FDA special agent Rande Matteson, declined to comment on the probe, saying only that it was part of of an “ongoing investigation”.
This follows close on the heels of a major US tissue scandal last year which saw unscreened, diseased tissue stolen from bodies in funeral homes, sold to leading tissue banks and transplanted into American patients.
Class-action law suits are now under way, filed by hundreds of recipients infected with HIV, syphillis and hepatitis.
Both the NTB and CTE export tissue overseas through US distributor Global Orthopaedics, based in Florida, which has ties to a US tissue bank involved in the contamination drama.
Records show the two banks sent shipments in the last five years to Turkey, Spain, El Salvador, South Korea, Namibia, Germany and Switzerland.
Both banks this week said all their exports were above board.
company which harvests and processes heart valves
The export records reveal that the NTB, which does not procure heart valves, exported at least 120 valves to Germany. NTB said this week that its medical director, Dr Theo le Roux, had applied for export permits on behalf of Southern Cryoscience, a company which harvests and processes heart valves.
But the bank said on Friday that the practice would stop as it was uncomfortable with a private company dealing in human tissue.
An independent three-month Sunday Times investigation has established that:
- The tissue banks pay people at government mortuaries, funeral homes and eye banks to help them find donors;
- Funeral giant Doves this week pulled out of an arrangement with the CTE from which it had received payment for tip-offs about potential donors. In a memo to staff outlining strict new protocols, CEO Hannes Wilken banned staff from accepting money from tissue organisations or contacting families of the deceased regarding donations.
- For five years the lid was kept tightly on an export scandal involving a top South African orthopaedic surgeon, who is also a former tissue-bank official. He was involved in shipping cartons of South African tendons to Florida businessman Philip Heitlinger via South Korea in 2001. It is illegal to import South African tissue into the US.
- The relationship between the two tissue banks, which operate within a few kilometres of each other, is strained and because of this there is a battle over access to the SA’s small local donor base.
- The NTB, which processed 125 donated bodies last year, claims the advent of the CTE opening in 2002 has had a dramatic effect on its donor base.
But the CTE denies this. It refused to disclose how many bodies it processed last year, saying only that it had retrieved enough material to treat 15000 patients.
- The NTB has changed the arm that markets and distributes its donor products three times in the past four years; and
- The marketing and distribution partner of NTB and the CTE, Bone SA, has for four years been involved in a legal wrangle over patent rights for donor tissue products.
Medical scientist welcomes Interpol investigation
Medical scientist Dr Nicolaas Duneas, acting head of CTE, said he welcomed the Interpol investigation as his bank had nothing to hide.
He admitted his bank paid money to Doves and was very concerned that the arrangement with this “supplier” had stopped. “They will not do any work if they do not get reimbursed for time and effort.”
The CTE had an export policy which it openly disclosed freely to “anybody that wants to ask”.
NTB business manager Willem Boshoff said an investigator had visited his bank this week and customs officials had visited a few months ago “related to an Interpol inquiry”.
“We have not done anything wrong,” he said, but admitted there needed to be “proper control” from the government.
“I think we maybe should be more transparent, but I don’t think we are misleading the public,” he said.
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