Regulatory Focus™ > News Articles > Report: Human Tissue Donation Rules Lack 'Inadequate Safeguards'

Report: Human Tissue Donation Rules Lack 'Inadequate Safeguards'

Posted 18 July 2012 | By

An investigation into human tissue trafficking by The International Consortium of Investigative Journalists (ICIJ) has uncovered "inadequate safeguards" to protect consumers from poorly-sourced human tissue products.

"Despite concerns by doctors that the lightly regulated trade could allow diseased tissues to infect transplant recipients with hepatitis, HIV and other pathogens, authorities have done little to deal with the risks," ICIJ wrote. "In contrast to tightly-monitored systems for tracking intact organs such as hearts and lungs, authorities in the U.S. and many other countries have no way to accurately trace where recycled skin and other tissues come from and where they go."

The lack of traceability means even when problems are discovered-such as tissue product contaminated with HIV-it can be difficult, if not impossible, to recall the products or even know where a product has come from or gone to. "No centralized regional or global system assures products can be followed from donor to patient," ICIJ's report notes.

The problem is more than just an abstraction. A Freedom of Information Act (FOIA) request by ICIJ uncovered more than 1,300 tissue-related infections in the US known to the US Food and Drug Administration (FDA), with 40 cases resulting in the death of the patient.

The practices uncovered by ICIJ have affected more than just living patients, too. The profit motives of tissue traders has led to what one Ukrainian official dubbed "human sock puppets"-bodies illicitly stripped of their organs and returned to grieving and often unsuspecting families. The practice can be hard to detect as the evidence is quite literally buried or cremated.

Read more:

ICIJ - Human Corpses are Prize in Global Drive for Profits


NPR - Calculating The Value Of Human Tissue Donation

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