A
grisly trade in human body parts leaves relatives grieving and some recipients
at risk of life-threatening disease.
On
February 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.
 |
| “Two ribs, two Achilles heels, two elbows, two eardrums, two
teeth, and so on’’ ... a relative holds a picture of Oleksandr Frolov, some of
whose body parts were found during a raid by Ukrainian authorities. |
The
seized documents suggested that the remains of dead Ukrainians were destined
for a factory in Germany belonging to the subsidiary of a US 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 US 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 fuelled
by powerful appetites for bottom-line profits and fresh human bodies.
’’I
was in shock’’ ... Kateryna Rahulina says she did not give permission for the
body of her mother Olha to be harvested.
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 “honours 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 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 US 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.
An
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 US 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 US Food and Drug Administration has documented at least 1352
infections in the US 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 US; the South Koreans to Mexico; the US 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 US. 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 US 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 $US80,000 to $US200,000
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 US, 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 US can get as much as $US10,000 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 learned
$US11.6 million in pre-tax profits on revenues of $US169 million.
Phillip
Guyett, who ran a tissue recovery business in several US states before he was
convicted of falsifying death records, said executives with companies that
bought tissues from him treated him to $US400 meals and swanky hotel stays.
They promised: “We can make you a rich man.” It got 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 colour of smoked salmon when it is professionally removed in
rectangular shapes from a cadaver. A good yield is about 5500 square
centimetres.
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 revolutionised what we can do in breast
reconstruction surgery”, explains Dr Ron Israeli, a New York plastic surgeon.
“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
orthopaedic 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 US companies that first
commercialised 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 is 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 organisations 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
Hoyer, 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
US-government funded study of the families of US tissue donors, published in
2010, indicates many may not understand the role that for-profit companies play
in the tissue donation system.
Seventy-three
per cent 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 US, 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. 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 sterilisation, 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 centralised 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 $US1000 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 1000 bodies that were dismembered was that of the famous BBC
broadcaster 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 US 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 US 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 US are required to
register with the FDA.
Yet
of the 340 foreign tissue establishments registered with the FDA, only about 7
per cent 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 per cent of active registered US 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 US 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 centres 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 per cent of its human-tissue needs.
Raw
tissue is shipped in from the US 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 US 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, orthopaedics and other areas. Ninety per
cent of the company's implants are made from human tissue, while 10 per cent
come from cows and pigs processed at its German facility.
RTI
requires its human body parts suppliers in the US 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 1000 tissues a month were being illegally recovered at a
forensic medical institute at Krivoy Rog and sent, via a third party, to
Tutogen.
Joseph
Duesel, 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 had 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 labelled its imports.
The company was obtaining Ukrainian tissue, shipping it to Tutogen in Germany,
then exporting it to the US as a product of Germany.
While
the company agreed to change its policies, there is some indication that it may
have continued labelling 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 labelled
"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 ICI.
“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.
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