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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.
In the Ukraine, for example, the security service believes that
bodies passing through a morgue in the Nikolaev district, the gritty
shipbuilding region located near the Black Sea, may have been feeding
the trade, leaving behind what investigators described as potentially
dozens of "human sock puppets" -- corpses stripped of their reusable
parts.
Industry officials argue that such alleged abuses are rare, and that the industry operates safely and responsibly.
For its part, RTI didn't respond to repeated requests for comment or
to a detailed list of questions provided a month before this
publication.
In public statements the company says it "honors the gift of tissue
donation by treating the tissue with respect, by finding new ways to use
the tissue to help patients and by helping as many patients as
possible from each donation."
'Our Misfortune'
Despite its growth, the tissue trade has largely escaped public
scrutiny. This is thanks in part to less-than-aggressive official
oversight -- and to popular appeal for the idea of allowing the dead to
help the living survive and thrive.
An eight-month, 11-country investigation by the International
Consortium of Investigative Journalists (ICIJ) has found, however, that
the tissue industry's good intentions sometimes are in conflict with
the rush to make money from the dead.
Inadequate safeguards are in place to ensure all tissue used by the
industry is obtained legally and ethically, ICIJ discovered from
hundreds of interviews and thousands of pages of public documents
obtained through records requests in six countries.
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.
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.
At the same time, critics say, the tissue-donation system can deepen
the pain of grieving families, keeping them in the dark or misleading
them about what will happen to the bodies of their loved ones.
Those left behind, like the parents of 19-year-old Ukrainian Sergei
Malish, who committed suicide in 2008, are left to cope with a grim
reality.
At Sergei's funeral, his parents discovered deep cuts on his wrists. Yet they knew he had hanged himself.
They later learned that his body parts had been recycled and shipped off as "anatomical material."
"They make money with our misfortune," Sergei's father said.
Awkward Silence
During the transformational journey tissue undergoes -- from dead
human to medical device -- some patients don't even know that they are
the final destination.
Doctors don't always tell them that the products used in their breast
reconstructions, penis implants and other procedures were reclaimed
from the recently departed.
Nor are authorities always aware of where tissues come from or where they go.
The lack of proper tracking means that by the time problems are
discovered some of the manufactured goods can't be found. When the
U.S. Centers for Disease Control and Prevention assists in the recall of products made from potentially tainted tissues, transplant doctors frequently aren't much help.
"Oftentimes there's an awkward silence. They say: 'We don't know
where it went,'" said Dr. Matthew Kuehnert, the CDC's director of blood
and biologics.
"We have barcodes for our [breakfast] cereals, but we don't have
barcodes for our human tissues," Kuehnert said. "Every patient who has
tissue implanted should know. It's so obvious. It should be a basic
patient right. It is not. That's ridiculous."
Since 2002 the U.S. Food and Drug Administration
has documented
at least 1,352 infections in the U.S. that followed human tissue
transplants, according to an ICIJ analysis of FDA data. These infections
were linked to the deaths of 40 people, the data shows.
One of the weaknesses of the tissue-monitoring system is the secrecy
and complexity that comes with the cross-border exchange of body parts.
The Slovaks export cadaver parts to the Germans; the Germans export
finished products to South Korea and the U.S.; the South Koreans to
Mexico; the U.S. to more than 30 countries.
Distributors of manufactured products can be found in the European
Union, China, Canada, Thailand, India, South Africa, Brazil, Australia
and New Zealand. Some are subsidiaries of multinational medical
corporations.
The international nature of the industry, critics claim, makes it
easy to move products from place to place without much scrutiny.
"If I buy something from Rwanda, then put a Belgian label on it, I
can import it into the U.S. When you enter into the official system,
everyone is so trusting," said Dr. Martin Zizi, professor of
neurophysiology at the Free University of Brussels.
Once a product is in the European Union, it can be shipped to the U.S. with few questions asked.
"They assume you've done the quality check," Zizi said. "We are more careful with fruit and vegetables than with body parts."
Piece of the Action
Inside the marketplace for human tissue, the opportunities for
profits are immense. A single, disease-free body can spin off cash flows
of $80,000 to $200,000 for the various non-profit and for-profit
players involved in recovering tissues and using them to manufacture
medical and dental products, according to documents and experts in the
field.
It's
illegal in the U.S.,
as in most other countries, to buy or sell human tissue. However, it's
permissible to pay service fees that ostensibly cover the costs of
finding, storing and processing human tissues.
Almost everyone gets a piece of the action.
Ground-level body wranglers in the U.S. can get as much as $10,000
for each corpse they secure through their contacts at hospitals,
mortuaries and morgues. Funeral homes can act as middlemen to identify
potential donors. Public hospitals can get paid for the use of
tissue-recovery rooms.
And medical products multinationals like RTI? They do well, too. Last
year RTI earned $11.6 million in pretax profits on revenues of $169
million.
Phillip Guyett, who ran a
tissue recovery business
in several U.S. states before he was convicted of falsifying death
records, said executives with companies that bought tissues from him
treated him to $400 meals and swanky hotel stays. They promised: "We can
make you a rich man." It got to the point, he said, that he began
looking at the dead "with dollar signs attached to their parts." Guyett
never worked directly for RTI.
Smoked Salmon
Human skin takes on the color of smoked salmon when it is
professionally removed in rectangular shapes from a cadaver. A good
yield is about six square feet.
After being mashed up to remove moisture, some is destined to protect
burn victims from life-threatening bacterial infections or, once
further refined, for breast reconstructions after cancer.
The use of human tissue "has really revolutionized what we can do in
breast reconstruction surgery," explains Dr. Ron Israeli, a plastic
surgeon in Great Neck, N.Y.
"Since we started using it in about 2005, it's really become a standard technique."
A significant number of recovered tissues are transformed into
products whose shelf names give little clue to their actual origin.
They are used in the dental and beauty industries, for everything from plumping up lips to smoothing out wrinkles.
Cadaver bone -- harvested from the dead and replaced with PVC piping
for burial -- is sculpted like pieces of hardwood into screws and
anchors for dozens of orthopedic and dental applications.
Or the bone is ground down and mixed with chemicals to form strong
surgical glues that are advertised as being better than the artificial
variety.
"At the basic level what we are doing to the body, it's a very
physical -- and I imagine some would say a very grotesque -- thing,"
said Chris Truitt, a former RTI employee in Wisconsin.
"We are pulling out arm bones. We are pulling out leg bones. We are
cutting the chest open to pull the heart out to get at the valves. We
are pulling veins out from the inside of skin."
Whole tendons, scrubbed cleaned and rendered safe for transplant, are used to return injured athletes to the field of play.
There's also a brisk trade in corneas, both within countries and internationally.
Because of the ban on selling the tissue itself, the U.S. companies
that first commercialized the trade adopted the same methods as the
blood collection business.
The for-profit companies set up non-profit offshoots to collect the
tissue -- in much the same way the Red Cross collects blood that's later
turned into products by commercial entities.
Nobody charges for the tissue itself, which under normal
circumstances is freely donated by the dead (via donor registries) or by
their families.
Rather, tissue banks and other organizations involved in the process
receive ill-defined "reasonable payments" to compensate them for
obtaining and handling the tissue.
"The common lingo is to talk about procurement from donors as
'harvesting,' and the subsequent transfers via the bone bank as 'buying'
and 'selling,'" wrote Klaus Høyer, from the University of Copenhagen's
Department of Public Health, who
talked to industry officials, donors and recipients for an article published in the journal BioSocieties.
"These expressions were used freely in interviews; however, I did not hear this terminology used in front of patients."
A U.S.-government funded study of the families of U.S. tissue donors,
published in 2010, indicates many may not understand the role that
for-profit companies play in the tissue donation system.
Seventy-three percent of families who took part in the study said it
was "not acceptable for donated tissue to be bought and sold, for any
purpose."
Few Protections
There is an inherent risk in transplanting human tissues. Among other
things, it has led to life-threatening bacterial infections, and the
spread of HIV, Hepatitis C and rabies in tissue recipients, according to
the CDC.
Modern blood and organ collection is bar-coded and strongly regulated
-- reforms prompted by high-profile disasters that had been caused by
the poor screening of donors. Products made from skin and other
tissues, however, have few specific laws of their own.
In the U.S., the agency that regulates the industry is the Food and
Drug Administration, the same agency that's charged with protecting the
nation's food supply, medicines and cosmetics.
The FDA, which declined repeated requests for on-record interviews,
has no authority over health care facilities that implant the material.
And the agency doesn't specifically track infections.
It does keep track of registered tissue banks, and sometimes conducts an inspection. It also has the power to shut them down.
The FDA largely relies on standards that are set by an industry body, the
American Association of Tissue Banks
(AATB). The association refused repeated requests over four months for
on-record interviews. It told ICIJ during a background interview last
week that the "vast majority" of banks recovering traditional tissues
such as skin and bone are accredited by the AATB. Yet an analysis of
AATB accredited banks and FDA registration data shows about one third of
tissue banks that recover traditional tissues such as skin and bone
are accredited by the AATB.
The association says the chance of contamination in patients is low.
Most products, the AATB says, undergo radiation and sterilization,
rendering them safer than, say, organs that are transplanted into
another human.
"Tissue is safe. It's incredibly safe," an AATB executive said.
There is little data, though, to back up the industry's claims.
Unlike with other biologics regulated by the FDA, agency officials
explain, firms that make medical products out of human tissues are
required to report only the most serious adverse events they discover.
That means that if problems do arise, there's no guarantee that
authorities are told.
And because doctors aren't required to tell patients they're getting
tissue from a cadaver, many patients may not associate any later
infection with the transplant.
On this point, the industry says it is able to track the products
from the donors to the doctors, using their own coding systems, and that
many hospitals have systems in place to track the tissues after
they're implanted.
But no centralized regional or global system assures products can be followed from donor to patient.
"Probably very few people get infected, but we really don't know
because we don't have surveillance and we don't have a system for
detecting adverse events," the CDC's Kuehnert said.
The FDA recalled more than 60,000 tissue-derived products between 1994 and mid-2007.
The most famous recall came in 2005. It involved a company called
Biomedical Tissue Services, which was run by a former dental surgeon, Michael Mastromarino.
Mastromarino got many of his raw materials from undertakers in New
York and Pennsylvania. He paid them up to $1,000 per body, court records
show.
His company stripped bodies of their bones, skin and other usable
parts, then returned them to their families. The families, ignorant of
what happened, buried or cremated the evidence.
One of more than 1,000 bodies that were dismembered was that of the
famous BBC broadcaster and Masterpiece Theatre host Alistair Cooke.
Products made from the stolen human remains were shipped to Canada,
Turkey, South Korea, Switzerland and Australia. More than 800 of those
products have never been located.
It later came out in court that some of the tissue donors had died
from cancer and that none had been tested for pathogens like HIV and
hepatitis.
Mastromarino falsified donor forms, lying about causes of death and
other details. He sold skin and other tissues to several U.S.
tissue-processing firms, including RTI.
"From day one, everything was forged; everything, because we could.
As long as the paperwork looked good, it was fine," said Mastromarino,
who is serving a 25-to-58-year prison sentence for conspiracy, theft and
abuse of a corpse.
Global Sheriff
Each country has its own set of regulations for the use of products
made from human tissue, often based on laws that were originally
intended to deal with blood or organs.
In practice, though, because the U.S. supplies an estimated
two-thirds of the world's human-tissue-product needs, the FDA has
effectively been left to act as sheriff for much of the planet.
Foreign tissue establishments that wish to export products to the U.S. are
required to register with the FDA.
Yet of the 340 foreign tissue establishments registered with the FDA,
only about 7 percent have an inspection record in the FDA database, an
ICIJ analysis shows. The FDA has never shut one down due to concern
over illicit activities.
The data also shows that about 35 percent of active registered U.S. tissue banks have no inspection record in the FDA database.
"When the FDA registers you, all you have to do is fill out a form
and wait for an inspection," said Dr. Duke Kasprisin, the medical
director for seven U.S. tissue banks. "For the first year or two you can
function without having anyone look at you."
This is backed by the data, which show the typical tissue bank operates for nearly two years before its first FDA inspection.
"The problem is there is no oversight. The FDA, all they require is
that you have a registration," said Craig Allred, an attorney previously
involved in litigation against the industry. "Nobody is watching what
is going on." The FDA and industry players "all point the finger at
each other."
Yet in South Korea, for example, the booming plastic surgery market uses FDA oversight as a selling point.
In downtown Seoul, the country's capital,
Tiara Plastic Surgery explains that human tissue products "are FDA-approved" and are therefore safe.
Some medical centers advertise "FDA-approved AlloDerm" -- a skin graft made from donated American cadavers -- for
nose enhancement.
Le Do-han, the official in charge of human tissue for the South
Korean FDA, said the country imports 90 percent of its human-tissue
needs.
Raw tissue is shipped in from the U.S. and Germany. This tissue, once
processed, is often re-exported to Mexico as manufactured goods.
Despite the complicated movements back and forth, Le Do-han acknowledges that proper tracking hasn't been put in place.
"It is like putting tags on beef, but I don't even know if that is
possible for human tissues because there are so many coming in."
Teaming Up
In its U.S. Securities and Exchange Commission filings, publicly
traded RTI provides a glimpse of the company's size and global reach.
In 2011, the company manufactured 500,000 to 600,000 implants and
launched 19 new kinds of implants in sports medicine, orthopedics and
other areas. Ninety percent of the company's implants are made from
human tissue, while 10 percent come from cows and pigs processed at its
German facility.
RTI requires its human body parts suppliers in the U.S. and other
nations to follow FDA regulations, but the company acknowledges there
are no guarantees.
In
2011 securities filings,
RTI said there "can be no assurances" that "our tissue suppliers will
comply with such regulations intended to prevent communicable disease
transmission" or "even if such compliance is achieved, that our implants
have not been or will not be associated with transmission of disease."
Like many of today's for-profit tissue companies that were once
non-profits, RTI broke away from the non-profit University of Florida
Tissue Bank in 1998.
Internal company files from Tutogen, a Germany medical products
company, show that RTI teamed up with Tutogen as early as September 1999
to help both companies meet their growing needs for raw material by
obtaining human tissue from Eastern Europe.
The companies both obtained tissue from the Czech Republic. Tutogen
separately obtained tissues from Estonia, Hungary, Russia, Latvia,
Ukraine, and later Slovakia, documents show.
In 2002, allegations surfaced in the Czech media that the local
supplier to RTI and Tutogen was obtaining some tissues there improperly.
Though there is no suggestion that Tutogen or RTI or its employees did
anything improper.
In March 2003, police in Latvia
investigated
whether Tutogen's local supplier had removed tissue from about 400
bodies at a state forensic medical institute without proper consent.
Wood and fabrics, replacing muscle and bone, were put into the
deceased to make it look like they were untouched before burial, local
media reported.
Police eventually charged three employees of the supplier, but later
dismissed the charges when a court ruled that no consent from donors'
families was necessary. Again, there was no suggestion Tutogen acted
improperly.
In 2005, Ukrainian police launched the first of a series of
investigations into the activities of Tutogen's suppliers in that
country. The
initial investigation did not lead to criminal charges.
The relationship between Tutogen and RTI, meanwhile, became even
closer in late 2007, when they announced a merger between the two
companies. Tutogen became a subsidiary of RTI in early 2008.
Officials at RTI declined to answer questions from ICIJ about whether
it knew about police investigations of Tutogen's suppliers.
Two Ribs
In 2008 Ukrainian police launched a
new investigation,
looking into allegations that more than 1,000 tissues a month were
being illegally recovered at a forensic medical institute at Krivoy Rog
and sent, via a third party, to Tutogen. Joseph Düsel, the Chief
Prosecutor in Bamberg, said in 2009 that "what the company is doing is
approved by the administrative authority by which it is also monitored.
We do not currently see any reason to initiate investigation
proceedings."
Nataliya Grishenko, the judge prosecuting the case, revealed during
subsequent court proceedings that many relatives claimed they'd been
tricked into signing consent forms or that their signatures had been
forged.
However, the main suspect in the case -- a Ukrainian doctor -- died
before the court could deliver a verdict. The case died with him.
Tutogen "operates under very strict regulations from German and
Ukrainian authorities as well as other European and American regulatory
authorities," the company said in a statement while the case was still
pending. "They have been inspected regularly by all of these
authorities over their many years of operation, and Tutogen remains in
good standing with all of them."
Seventeen of Tutogen's Ukrainian suppliers have undergone an FDA
inspection. The inspections are announced, according to protocol, six to
eight weeks in advance.
Only one -- BioImplant in Kiev -- received negative feedback. Among
the findings of the 2009 inspection: not all morgues could rely on hot running water and some sanitation procedures were not followed.
FDA inspectors also identified deficiencies with RTI's Ukrainian imports when it visited the company's facilities in Florida.
RTI had English translations, but not original autopsy reports, from its Ukrainian donors, FDA inspectors found during a
2010 audit.
Those were often the only medical documents the company used to
determine whether the donor was healthy, inspectors noted in their
report.
The company told inspectors it was illegal under Ukrainian law to
copy the report. But following the inspection it began maintaining the
original Russian-language document along with its English translation.
In 2010 and 2011, FDA
inspectors asked
RTI to change how it labeled its imports. The company was obtaining
Ukrainian tissue, shipping it to Tutogen in Germany, then exporting it
to the U.S. as a product of Germany.
While the company agreed to change its policies, there is some
indication that it may have continued labeling some Ukrainian tissue as
German.
This past February police launched a raid as officials at a regional
forensic bureau in Nikolaev Oblast were loading harvested human tissues
into the back of a white minibus. Police footage of the seizure shows
tissue labeled "Tutogen. Made in Germany."
In this case, the security service said forensic officials had
tricked relatives of the dead patients into agreeing to what they
thought was a small amount of tissue harvesting by playing on their pain
and grief.
Seized documents --
blood tests, an
autopsy report and labels written in English and obtained by ICIJ -- suggested the remains were on their way to Tutogen.
Some of the tissue fragments found on the bus came from 35-year-old Oleksandr Frolov, who had died from an epileptic seizure.
"On the way to the cemetery, when we were in the hearse, one of his
feet -- we noticed that one of the shoes slipped off his foot, which
seemed to be hanging loose," his mother, Lubov Frolova, told ICIJ.
"When my daughter-in-law touched it, she said that his foot was empty."
Later, the police showed her a list of what had been taken from her son's body.
"Two ribs, two Achilles heels, two elbows, two eardrums, two teeth,
and so on. I couldn't read it till the end, as I felt sick. I couldn't
read it," she said.
"I heard that [the tissues] were shipped to Germany to be used for
the plastic surgeries and also for donation. I have nothing against
donation, but it should be done according to the law."
Kateryna Rahulina, whose 52-year-old mother, Olha Dynnyk, died in
September 2011, was shown documents by investigating police. The
documents purported to give her approval for tissue to be taken from her
mother's body.
"I was in shock," Rahulina said. She never signed the papers, she
said, and it was clear to her that someone had forged her approval.
The forensic bureau in Nikolaev Oblast, where the alleged incidents
happened, was, until recently, one of 20 Ukrainian tissue banks
registered by the FDA.
On the FDA's website the phone number for each of the tissue banks is the same.
It is Tutogen's phone number in Germany.
