Congress and the Defense Department have begun investigations into the purchase of biologic medicines and implants after learning that military and veterans hospitals bought products from a company whose supplier was convicted of illegally harvesting human tissue from cadavers.
Defense Department officials have also ordered the services to set up a new system to better oversee and track the biologics – medical products made from bone, skin, arteries and tendons. Doctors use biologics in a wide range of procedures to include surgeries and treatments for burns.
Military and Department of Veterans Affairs hospitals bought biologics from a company called RTI Biologics at a time that one of their suppliers, Biomedical Tissue Services, was convicted of harvesting tissue from illegally acquired cadavers. Military officials have started to review purchase orders to determine if, and when, it bought biologics from RTI, or its Germany-based subsidiary, Tutogen GmbH.
The International Consortium of Investigative Journalists completed a series on the world tissue trade in July highlighting questions over tissues potentially obtained by Tutogen in Ukraine.
The Pentagon says its new biologics tracking policy is intended to make sure any human tissue-made product passes legal and regulatory muster.
“We are currently in the process of determining if our Military Treatment Facilities – administered by the Army, Navy, and Air Force respectively – have conducted business with RTI or its subsidiary, Tutogen,” Pentagon spokeswoman Cynthia Smith said in a statement.
“We are also in the process of implementing a new policy – signed in late July – on human cell, tissue, and related product procurement, which would help prevent such occurrences within the U.S. military.”
Meanwhile, the House Committee on Veterans Affairs is also getting involved.
The committee has begun probing federal contracting records to see if RTI sold biologics to VA hospitals between 2004 and 2006. Committee officials are “looking at whether the VA used any contaminated materials and whether anyone was tracking it,” said a source who spoke on the condition of anonymity.
The VA has not responded to multiple requests for comment.
U.S. and German officials do not allege wrongdoing by RTI or Tutogen. In its only official response to the Ukraine incident in February, RTI issued a statement saying it “has a long history as a responsible steward of the gift of donation and delivering safe tissue implants for patients in need.”
“RTI fully complies with comprehensive regulations, both from U.S. regulatory authorities and those of other countries, that govern each and every activity performed by tissue banks,” said Wendy Crites Wacker, an RTI spokeswoman.
Service officials must establish tissue management programs to identify and oversee all policies, procedures and responsibilities related to acquiring, storing and tracking human tissue, according to the directive signed July 26 by the Assistant Secretary for Health Affairs Dr. Jonathan Woodson.
The new policy mandates recordkeeping that “ensures tissue traceability from the supplier to the patient and back to the manufacturer.” It also requires investigations of any adverse patient outcomes related to biologics and notification of adverse outcomes to suppliers of the materials and the U.S. Food and Drug Administration. Officials based the policy on FDA guidelines.
The Pentagon’s new policy may turn out to be the biggest single action taken to correct flaws and abuses in the tissue trade, said Chris Truitt, a former tissue recovery specialist who wrote the book, “The Dark Side of Tissue Donation.”
He describes a billion-dollar industry where “donated” bodies net companies tens of thousands of dollars in revenue. However, tracking those body parts is rare in the business. That is why Truitt is so hopeful about the progress the Pentagon’s policy could make.
“That’s absolutely incredible that they have chosen to take this up,” he said. “This is going to improve the safety of the product and it will improve the safety and security of the troops and veterans. It’s going to be challenging to get it all implemented, but it’s a huge, wonderful step.”