Skin and Bone from The Center for Public Integrity

Medical journal issues warning about human tissue trade

2012-11-15T12:35:26-05:00

In its latest issue, the prestigious British medical journal The Lancet warns about the dangers of “profiteering” in the $1 billion international trade on human tissue and the lack of sufficient regulation worldwide – echoing the findings of an International Consortium of Investigative Journalists seriesearlier this year.

The November 10 issue of The Lancet – one of the world’s leading medical journals -- said that “profiteering threatens the altruism of tissue donation” and that doctors and health agencies in many nations have trouble tracing improperly-obtained bones, skin and tissue when problems occur.

The Lancet article highlighted case studies and major concerns contained in last July’s four-part ICIJ series, including the legal consequences of stolen tissue implanted in hundreds of patients because of convicted body-snatcher Michael Mastromarino, now in a New York prison.

The Lancet said the for-profit tissue industry “is not as tightly regulated as organ donation worldwide”. Voluntary donors -- and many families who allowed the use of loved ones’ bodies after death -- are not fully aware of the money-making uses of bones, tissue and skin for such things as cosmetic surgery and dental repairs, it said.

“When you introduce money into the process, then you increase the risk to quality and safety,” Imogen Swann, Director of Regulation at the United Kingdom’s Human Tissue Authority told the Lancet. “Donation should be about altruism.”

Read the full story.

IMPACT: RTI Biologics suspends import of human tissue from Ukraine

Ukraine — 2013-04-29T14:42:20-04:00

One of the biggest players in the global trade in human tissue has suspended its partnership with suppliers in Ukraine, where authorities have carried out multiple investigations over allegations of illegal tissue recovery.

RTI Biologics, a Florida-based manufacturer of medical implants made from skin, bone and other human parts, "made a decision to voluntarily suspend import of tissues from Ukrainian institutions," the company said in a statement Thursday.

Congressional staffers and the Pentagon announced this week they were reviewing contracts the government holds with RTI and its German subsidiary Tutogen Medical. The International Consortium of Investigative Journalists reported in July on RTI's relationship with morgues under investigation for allegedly forging documents or bullying families into signing donor consent forms.

"We comply with comprehensive regulations, both from U.S. regulatory authorities and those of other countries, that govern each and every activity performed by tissue banks," RTI said.

Ukrainian law, like U.S. law, requires donors or their loved ones give express consent before tissue can be recovered.

The trade in human parts is a billion-dollar industry that is growing and changing so rapidly, legislation has a hard time keeping pace. It is illegal in most countries to buy or sell human parts, but companies can charge fees for handling the tissue. RTI is a publicly-traded company that warns its stockholders, "the supply of human tissue has at times limited our growth, and may not be sufficient to meet our future needs."

RTI obtains tissue from more than 30 procurement agencies in the United States as well as in places such as Ukraine. The company supplies hospitals in more than 30 countries and in all fifty states. Records show the company has offered Ukrainian tissue to hospitals in New York.

German officials had planned a September inspection of 10 Ukrainian morgues that supply Tutogen, according to Ines Schantz, a spokeswoman for the Upper Bavarian government in Germany. But the company withdrew its licenses to import tissue from Ukraine into Germany on August 20.

The German government subsequently cancelled its plans to inspect the foreign tissue agencies. "After the removal of all the institutes from the import license, there was no legal basis any longer to perform the planned inspection," Schantz said.

She said German authorities continue to investigate human tissues already imported from the Ukraine.

ICIJ's eight-month investigation revealed that Tutogen, which was acquired by RTI in early 2008, has for years relied on its Ukrainian suppliers for a significant amount of human tissue in spite of concerns raised within the company more than a decade ago and a series of subsequent investigations.

Read the rest of the story.

IMPACT: Pentagon, Congress probe tissue contracts

2012-09-06T12:12:31-04:00

The Pentagon has announced a new program to better oversee human cadaver tissue used in Defense Department hospitals around the world and is investigating allegations that some tissue-based medical implants provided to service members may have been obtained improperly, military officials said Wednesday.

At the same time, Congressional investigators say they are looking into government contracts between the Department of Veterans Affairs and RTI Biologics, a Florida-based manufacturer of medical implants made from human bones, skin, ligaments and other tissues. RTI is one of the world's largest players in the billion-dollar human tissue industry — processing a quarter of all material recovered from cadavers in the United States.

The International Consortium of Investigative Journalists reported in July that RTI had obtained tissues from suppliers in the U.S. and the Ukraine that have been investigated for allegedly forging documents or bullying families into signing donor consent forms.

“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,” Defense spokeswoman Cynthia Smith said in a prepared statement.

Read the rest at ICIJ.org.

Traceability elusive in global trade of human parts

2012-07-19T13:05:40-04:00

The Kentucky man died in an off-road vehicle accident last year. His liver and kidneys helped save three dying patients in his home state. Musculoskeletal grafts taken from his heart, skin and bones were used in medical products used to improve the lives of 15 people around the country.

But soon after the transplants, the U.S. Centers for Disease Control and Prevention (CDC) learned the organ recipients had contracted hepatitis C. It turned out the Kentucky donor had a history of substance abuse and had served prison time. The tissue bank that recycled his remains, the CDC said, had screwed up the usual testing done to verify that tissues and organs were safe.

The CDC's Office of Blood, Organ, and Other Tissue Safety deployed a team of “shoe-leather epidemiologists” to track down the tissue before someone else got sick. Unlike hearts and other organs — or blood products that come with a unique barcode — there’s no easy way to track down tissue.

Instead the team found tissues one-by-one, calling hospitals and chasing down doctors. It took nearly a month to locate all the surgeons who had implanted tissue into 15 people. A child, later found to have hepatitis C, had received an infected heart vessel patch before the tissue recall began.

In some cases, inconsistent or non-existent recordkeeping prevents medical sleuths from ever finding potentially infected tissues. In one major case that played out in 2006, the U.S. Food and Drug Administration and five tissue companies moved to recall 25,000 tissues taken illegally from U.S. donors without proper consent or testing. Eight hundred of the tissues shipped overseas were never found.

The trade in human tissues is virtually untraceable at a global level. Poor accountability and inadequate safeguards have prompted concerns among medical experts that products made from bone, skin, tendon and other tissues taken from the dead could spread disease to the living — putting patients who receive tissue implants in dental surgery, breast reconstruction and other procedures at risk.

Little has been done to address this problem, despite U.S. government reports that have raised red flags for the past 15 years — and despite continuing concerns by the CDC and the World Health Organization.

Body brokers leave trail of questions, corruption

2012-07-19T13:06:42-04:00

In April 2003, Robert Ambrosino murdered his ex-fiancée — a 22-year-old aspiring actress — by shooting her in the face with a .45-caliber pistol. Then he turned the gun around and killed himself.

Soon after, Ambrosino’s corpse entered the United States’ vast tissue-donation system, his skin, bones and other body parts destined for use in the manufacture of cutting-edge medical products.

But before they entered the system, Michael Mastromarino, owner of a New Jersey-based tissue recovery firm, needed to solve a couple of problems. He didn’t want to have to report that Ambrosino had perished in a murder-suicide. And he didn’t want anyone to know that Ambrosino’s family hadn’t given permission for his body to be used for tissue donation.

Mastromarino solved both problems the same way: He lied.

Mastromarino was the leader of a now-infamous human tissue trafficking ring that fed an international trade in body parts. Along with tissues from Ambrosino’s corpse, he stole parts from grandmothers, electrical engineers, and factory workers, as well as from the remains of famed journalist Alistair Cooke.

The disgraced dental surgeon from Brooklyn supplied the raw material for products used for a host of surgical operations — from knee repair to plastic surgery and cosmetic implants. He was a ground-level player in an industry that makes its profits by harvesting human tissues mostly from the United States, but also from Slovakia, Estonia, Mexico, and other countries around the world. One of Mastromarino's top buyers was Florida-headquartered RTI Biologics, a processor of American, Canadian and Ukrainian body parts that trades among the high-tech companies on the NASDAQ stock exchange.

Years after Mastromarino was sent to prison and the publicity in his case quieted down, his story has been given new life by a lawsuit filed in a Staten Island courthouse. New York Supreme Court Judge Joseph J. Maltese has given the green light for RTI to stand trial Oct. 22 in a civil case that will delve into what the company knew — or should have known — about Mastromarino’s body snatching.

Human corpses are prize in global drive for profits

2013-04-29T14:42:17-04:00

On Feb. 24, Ukrainian authorities made an alarming discovery: bones and other human tissues crammed into coolers in a grimy white minibus.

Investigators grew even more intrigued when they found, amid the body parts, envelopes stuffed with cash and autopsy results written in English.

What the security service had disrupted was not the work of a serial killer but part of an international pipeline of ingredients for medical and dental products that are routinely implanted into people around the world.

The seized documents suggested that the remains of dead Ukrainians were destined for a factory in Germany belonging to the subsidiary of a U.S. medical products company, Florida-based RTI Biologics.

RTI is one of a growing industry of companies that make profits by turning mortal remains into everything from dental implants to bladder slings to wrinkle cures.

The industry has flourished even as its practices have roused concerns about how tissues are obtained and how well grieving families and transplant patients are informed about the realities and risks of the business.

In the U.S. alone, the biggest market and the biggest supplier, an estimated two million products derived from human tissue are sold each year, a figure that has doubled over the past decade.

It is an industry that promotes treatments and products that literally allow the blind to see (through cornea transplants) and the lame to walk (by recycling tendons and ligaments for use in knee repairs). It's also an industry fueled by powerful appetites for bottom-line profits and fresh human bodies.

Read this ICIJ investigation.