An investigation is underway following the seizure in Ukraine of a minibus containing packaged human tissue bound for Germany.
Biologics are medical products manufactured from tissue such as bone, skin, arteries and ligaments harvested from cadavers. They are used in a wide range of procedures, from treating psoriasis and back pain to burns, knee and spinal surgery to dental implants.
The minibus was bound for Tutogen Medical GmbH, a processing facility owned by RTI Biologics of Alachua, Fla. A review of federal contracts shows RTI has supplied biologics to Department of Veterans Affairs and Defense Department hospitals around the world.
A report published in July by the International Consortium of Investigative Journalists on the worldwide tissue trade included details on the Ukraine seizure, noting that some tissue found in the minibus was labeled “Tutogen: Made in Germany.” A false German label found on tissue coming in from Ukraine raised the specter of questionable tissue and caused concern among authorities. Connections to RTI and its contracts with VA and Defense Department hospitals raise further questions to be answered within the military community.
As with any medical product, a great deal of confidence is based on government regulation and control over its sourcing, process and manufacture. Tissues from a European Union country such as Germany are on nearly equal footing as tissues from the U.S.
There is no law against importing tissue from Ukraine, but previous investigations involving Ukraine tissue recovery resulted in the U.S. Food and Drug Administration directing RTI to label tissue originating from there, according to the July report.
The ICIJ noted in its July report how easily tissue may move across the world and the problems that causes.
“If I buy something from Rwanda then put a Belgian label on it, I can import it into the U.S.,” Dr. Martin Zizi, a professor of neurophysiology at the Free University of Brussels, told ICIJ. “When you enter into the official system, everyone is so trusting.”
RTI does have a history of connections to illegal and even infected tissue making its way into its operations, having relied on one New Jersey-based supplier whose record of illegally harvesting from cadavers landed him an 18-year jail sentence.
German officials have not claimed any wrongdoing by RTI or Tutogen.
RTI spokeswoman Wendy Crites Wacker said the company “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,” she said.
Officials from the Defense Department and VA did not respond when asked several times in recent weeks if they have concerns about biologics originating with tissue from Ukraine getting into the military and VA medical system.
Chris Truitt, who worked for RTI as a tissue recovery specialist, said the Pentagon and VA should be concerned.
“There are so many procurement agencies and processing labs [for tissue] and so far it has proven impossible to get people on the same page or system for tracking,” said Truitt, author of the 2009 book “The Dark Side of Tissue Donation.” “You can track down a box of cereal based on the bar code, but you can’t do that with tissue.”
Truitt got involved in tissue recovery after he and his wife donated the organs and tissue of their 2-year-old daughter, who died suddenly. The donation helped save the life of another young girl.
“The end-user never really knows where the product is coming from,” he said.
For a time, Truitt considered his work an important calling, but then concluded the overall system was an industry driven by profits. Tissue recovery is a roughly $1 billion-a-year business, according to IJIC, whose July series was titled “Skin and Bone: The Shadowy Trade in Human Body Parts.”
The ICIJ reported that a single body can generate revenues of more than $80,000. In the U.S., about 30,000 bodies are donated.
The VA and Defense Department buy biologics from many suppliers. Both agencies have bought from RTI since about 2004, to include a period when RTI and several other manufacturers found themselves connected to a grisly story of illegal and unsanitary organ and tissue recovery.
Michael Mastromarino of Biomedical Tissue Services in New Jersey paid undertakers for bodies that he then stripped of tissue and sold to medical companies, including RTI, which turned them into biologics.
In a number of cases, he peddled infected tissue. Prosecutors said at the time of Mastromarino’s conviction in 2008, thousands of patients may have had biologics made from contaminated tissue put into their bodies.
Mastromarino operated BTS from 2002 until the FDA shut him down in early 2006, during which time he sold tissue to several companies that did business with the Defense Department and VA, among them RTI.
RTI and Tutogen are named as defendants in a class action suit brought on behalf of patients against companies who bought tissue from BTS. Three other companies, LifeCell Corp. of New Jersey, Lost Mountain Tissue Bank of Georgia and Central Texas Regional Blood and Tissue Center, had also been named in the lawsuit but later were dropped as defendents. The five companies had to recall 25,000 products, the ICIJ reported.
According to a review of federal contracts, the DoD and VA purchased from all the companies except Tutogen during the period Mastromarino was found to operate illegally.
The Defense Department and the VA failed to respond to repeated questions about any investigations conducted on the biologics it purchased from the four companies during the time they were using tissue from BTS.
In Germany, a spokeswoman for Upper Bavaria’s inspectorate department in Munich said an unannounced inspection of Tutogen was conducted to check donor documentation and tissue imports from Ukraine following the February minibus seizure.
The government’s plan to conduct a third-party inspection of the Ukraine facilities has come up short since Tutogen has voluntarily surrendered its license to import tissue from Ukraine, Ines Schantz wrote in an Aug. 21 email.
She said the inspections could only be carried out if requested by the importing company, Tutogen. Since it no longer buys tissue from Ukraine, it canceled the inspection application.
“Investigations are ongoing concerning tissues already imported from the Ukraine,” she wrote.
This article originally reported that LifeCell Corp. of New Jersey, Lost Mountain Tissue Bank of Georgia and Central Texas Regional Blood and Tissue Center were still defendents in the lawsuit.