OT Not quite Robin Cook's Coma ...
Matthew Kruk
SPIEGEL ONLINE
08/28/2009 08:02 PM
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Inside a Creepy Global Body Parts Business
By Martina Keller and Markus Grill
The German company Tutogen's business in body parts is as secretive as
it is lucrative. It extracts bones from corpses in Ukraine to
manufacture medical products, as part of a global market worth billions
that is centered in the United States.
Anatoly Korzhak, a pensioner and former engineer, died in Kiev on August
5, 2004. His body was picked up at 2 a.m. and taken to the forensic
medicine institute in the Ukrainian capital. That same night, Korzhak's
daughter, Lena Krat, received a telephone call and was asked to come to
the institute immediately in the morning, where she was told she would
receive further information.
It was the first time Krat was confronted with the death of a close
relative. "I was so upset that I couldn't think clearly," she recalls.
When she arrived at the institute in the morning, a man there said
something to her about skin transplants. He was an employee of a
Ukrainian company that works hand-in-hand with forensic medicine
experts. She said to the man: "Leave me alone. I don't understand what
you're talking about, and I don't want to listen to you."
But the employee was persistent and eventually gave her a form to sign.
He told her that if she consented to skin removal, she would be helping
pediatric burn victims who needed transplants. Krat signed the form. "It
was as if I had been hypnotized," she says.
But now Krat, a mother of two young girls, has learned from SPIEGEL that
the Ukrainian company in question sends the body parts to a German
company, Tutogen Medical GmbH, which in turn apparently supplies large
numbers of such parts to the American tissue market.
In addition to strips of skin, tendons, bones and cartilage are removed
from the bodies. "This shocks me," says Krat. "If I had known that so
much is cut out, I would never have given my consent."
A Lucrative Industry
The incident in the Ukrainian capital is part of the secretive daily
routine of a little-known but highly lucrative branch of the medical
industry, in which companies use corpses to make medical spare parts. In
doing so, they reuse almost everything the human body has to offer:
bones, cartilage, tendons, muscle fascia, skin, corneas, pericardial
sacs and heart valves. In the jargon of the profession, all of this is
referred to as tissue.
Bones and tendons, the parts that interest Tutogen the most, are
subjected to complex processing. The company degreases and cleans bones,
cuts, saws or mills them into the desired shapes, then sterilizes,
packages and sells the finished product in more than 40 countries around
the world. With a prescription, it is even possible to order Tutogen's
products through online pharmacies.
The market for tissue products is still small in Germany. When it comes
to bones, for example, experts estimate that only about 30,000
transplants a year are used in hospitals nationwide, mainly for use in
bone reconstruction for hip surgery and in spinal column surgery.
It's a completely different story in the United States. According to the
American Academy of Orthopedic Surgeons, more than a million bone parts
are used in transplants every year. In no other country is it possible
to make so much money with body parts. If a body were disassembled into
its individual parts, then processed and sold, the total proceeds could
amount to $250,000 (?176,000). For a single corpse! The US tissue
industry generates total revenues of about $1 billion a year, says
journalist Martina Keller, a co-author of this article and the author of
the German book, "Cannibalized: The Human Corpse as a Resource."
Legal and Ethical Questions
This raises the question of just how legal the process of obtaining raw
materials is. And are bone products made from corpses even medically
necessary? According to Klaus-Peter G�nther, president of the German
Society of Orthopedics and Orthopedic Surgery, they are often "not the
first choice" in operations. "For us, the gold standard is still tissue
taken directly from the patient in question."
Alternatives are only an option, says G�nther, when the material from
the patient's body is insufficient. Those alternatives include animal
bones and artificial replacement parts made of ceramic material, for
example -- or human donor bones.
Many hospitals collect and reuse bone fragments removed from patients
who have received artificial hips. "For this reason," says G�nther, "we
have not had to resort to dead donors so far."
In the United States, doctors have far fewer qualms about using body
parts from corpses than their German counterparts -- in such areas as
spinal surgery, sports injuries and cosmetic surgery. For instance,
doctors used pulverized skin particles to enhance lips and smooth out
wrinkles.
Should corpses be butchered to make cosmetic procedures possible? Ingrid
Schneider is decidedly opposed to the practice. For the past 15 years
the Hamburg political scientist, a former member of the Investigative
Commission on Law and Ethics in Modern Medicine in the German
parliament, has been involved in the subject of recycling body
substances. Schneider argues that the body is not a source of raw
materials that can be sold at will. Given such concerns, it is not
surprising that many people are deeply opposed to allowing the body of a
family member to be reused, even for medical purposes.
Even if it is unrealistic to expect that all commercialization of the
body could be ruled out in modern medicine, says Schneider, it is
important to set boundaries. For that reason, she insists that human
tissue ought to be used sparingly -- that is, only when such use is
medically necessary and clearly superior to other forms of treatment.
The conviction that the body is much more than an object has also shaped
the policies of the World Health Organization (WHO), the European
Parliament and the European Council, the EU's body representing the
leaders and ministers of the 27-member bloc. All of these bodies condemn
the practice of trading in human body parts to turn a profit.
In Germany, the country's organ transplant act regulates the removal of
tissue. Only those who have consented to organ and tissue harvesting are
considered as donors. If a person dies and is not already a donor, his
or her closest relatives can consent to donation. Paragraph 17 of the
transplant act explicitly states: "Trading in organs or tissue intended
for use in the medical treatment of others is prohibited." Physicians
who remove tissue can only be paid suitable compensation for their
efforts. The law calls for prison sentences of up to five years for
violation of the trading prohibition.
A Booming Tissue Market
Tutogen paid its Ukrainian partners a fixed price for each body part. In
January 2002, the company paid ?42.90 for a complete femur, ?42.90 for a
humerus and ?13.30 to ?16.40 for a pericardial sac, depending on its
size. Graduated prices were also arranged with the Ukrainians. Take, for
example, the removal of patellar tendons with bone segments, known as
"bond-tendon-bone," or BTB. When coroners supplied less than 40 BTBs
on-site, Tutogen paid ?14.30 apiece. For larger numbers of BTBs, the
price went up: to ?23 apiece for 40 or more BTBs and to ?26.10 for 60 or
more. For a coroner, who makes about ?200 ($287) a month in Ukraine,
such graduated prices must have been an incentive to remove as much body
material as possible.
Thousands of pages of internal memos, faxes, supply lists and documents
from the years 2000 to 2004, which SPIEGEL has obtained, suggest that
not only did Tutogen process the Ukrainian body parts itself, but it
also supplied the US tissue market.
Florida-based RTI Biologics, one of the US market leaders in the
industry, generated $147 million in sales in 2008. The company describes
itself as the "leading provider of sterile biological implants for
surgeries around the world."
To that end, RTI acquired Tutogen Medical, Inc., the American parent
company of the German company Tutogen Medical GmbH, last year. The
acquisition was good news for RTI shareholders, because of Tutogen's
large international donor network, says CEO Brian Hutchison. Put
differently, Tutogen is a company that knows the ins and outs of gaining
access to as many body parts as possible.
The body parts from Ukraine are shipped by air to Frankfurt or
Nuremberg. From there, they are taken to Tutogen headquarters in
Neunkirchen am Brand, a town of 8,000 people in northern Bavaria.
Tutogen's facilities in Neunkirchen, just a few kilometers north of
Nuremberg, comprise several low, warehouse-like buildings, where about
140 employees work. All in all, it is an inconspicuous place for
visitors who fly in regularly from Ukraine and the United States.
Company President Karl Koschatzky refused to respond to requests for an
interview, and the company declined to answer a list of questions sent
to its offices.
The Middleman
Tutogen uses a middleman to organize its deliveries from Ukraine. Dr.
Igor Aleshenko, a coroner by training, manages the company's
relationships with the various local forensic medicine institutes. He
has been working for Tutogen in Ukraine for about 10 years.
In that time, Aleshenko has become a wealthy man, and he now divides his
time between his two residences, one in Kiev and one in Moscow. In 2002,
Tutogen described Aleshenko as a "cost-intensive person." He too was
unavailable for an interview in Kiev, nor did he respond to written
questions.
In Ukraine, Aleshenko is far more than Tutogen's local contact. He is
the director of Bioimplant, a company that manages tissue removal.
Because of its close ties to the Ukrainian Health Ministry, Bioimplant
is practically immune to overly probing government inspections of bone
shipments crossing the border.
Ukrainians are kept somewhat in the dark when it comes to Bioimplant's
true business dealings. According to the company's Web site, its
"primary activity" is the "production of bio-implants" for use in
Ukrainian patients. But what does Bioimplant really do?
Kiev, on a summer's day in 2009. Anyone seeking to pay a visit to
Bioimplant's headquarters would be inclined to head to the company's
official address at Patrice Lumumba Street 4/6, an office building with
a number of tenants -- where Bioimplant doesn't even have its own
mailbox.
A guard and a doorman greet visitors and send them to the fourth floor,
where Bioimplant's offices are supposedly located. Room 305 is in a long
hallway of closed doors. There is not even a sign to identify the room
as being associated with Bioimplant. A young man in a pinstriped suit
opens the door. He says that he hasn't been working for Bioimplant for
very long, and that most of his work consists of photocopying.
According to the young man, the company leases three rooms in the office
complex, but Dr. Aleshenko is not in today. Tutogen brochures and
packets of sterilized corpse bones are stacked in the next room. Instead
of the expected production facility, the offices are nothing but a
distribution site.
Tutogen developed its business relationship with Aleshenko about 10
years ago. During a trip to Tutogen headquarters in the Bavarian
countryside in November 2001, Aleshenko met with Koschatzky at the
Bayerischer Hof Hotel in Erlangen, near Nuremberg. The minutes of the
meeting contain a list of "new pathologies" working for Tutogen in the
eastern Ukrainian cities of Dnipropetrovsk, Poltava and Zhytomyr.
Aleshenko had apparently brought along a wish list to the meeting, and
his German business partners were eager to comply. According to the
minutes, "TTG (Tutogen) agreed to provide 5,000 deutsche marks for
investment costs in Dnipropetrovsk (Ukraine). Dr. Aleshenko will send us
the necessary payment instructions."
Unkosher Discussions
Some of the issues discussed at the meeting were less than kosher. For
instance, the minutes state, "TTG is testing whether depilation of the
corpse prior to skin removal could alleviate the hair problem (perhaps
using the hot wax or cold wax method)."
A list of "pathologies currently providing (parts)," dated November
2001, already included abbreviations for 15 facilities in Ukraine. In
the 2000-2001 fiscal year alone, 1,152 bodies in Ukraine were used to
provide tissue for Tutogen.
But it still wasn't enough for the company, which needed more
cooperating institutions, more donors and more bone parts to supply a
booming tissue market.
According to an internal planning document dated June 17, 2002 (the file
is titled "Raw Tissue Requirements"), Tutogen needed the following parts
for the coming fiscal year:
* 2,920 shafts of the femur,
* 3,000 iliac crests,
* 1,190 patellar tendons,
* 3,750 kneecaps,
* 10,200 femoral muscle fascia (or fascia lata),
* 50 cranial bones,
* 70 Achilles tendons.
Aleshenko, who Tutogen apparently paid directly for the tissue parts, is
believed to have funneled part of the money to coroners in
Dnipropetrovsk, Kiev, Kharkiv and other Ukrainian cities. According to
an internal list of "paid incoming goods," Tutogen's Ukrainian partner
received roughly ?350,000 between January and August 2001.
The investment must have paid off. Online pharmacies charge between ?367
and ?854, depending on the size, for a Tutoplast Spongiosa Block (Bone
Substance). According to the price lists used at the time, the
Ukrainians received between ?23 and ?26.10 for the original body part,
again depending on the size. Even if Tutogen were paying twice as much
for the raw material today, it would still be a bargain.
Tissue and Organ Harvesting
Not surprisingly, Tutogen could afford to be generous to its Ukrainian
partners. That generosity included large quantities of equipment the
company routinely sent to its hardworking coroners.
According to the internal documents, in the 2000-2001 fiscal year
Tutogen shipped 6,000 scalpels, 2,600 pairs of sterile gloves, 500
surgical gowns, 15 hacksaw blades for autopsies and many other items to
Ukraine -- at a total cost of ?40,000 in "donor expenses without
tissue," as the Tutogen bookkeepers noted fastidiously. Tutogen paid its
Ukrainian partners roughly ?500,000 for the body parts during the same
period.
The US Food and Drug Administration (FDA) currently lists 20 facilities
in Ukraine that are authorized to supply body parts for the US market.
But no matter which of these facilities one clicks on in the FDA
database, all share the same contact information: the telephone number
of Tutogen Medical GmbH in northern Bavaria.
One of the facilities on the list is the forensic medicine institute in
Krivoy Rog, an industrial city in southeastern Ukraine, with a
population of about 700,000. According to the FDA database, the Krivoy
Rog site is authorized to supply bones, cartilage, fascia, ligaments,
pericardial sacs, sclera (the white of the eye), skin and tendons.
Tissue and Organ Harvesting
The whitewashed, Spartan structure housing the forensic medicine
institute is on the edge of the hospital grounds. Frosted glass
windowpanes behind latticed windows discourage prying eyes. Visitors
immediately notice the cloying odor of corpses upon entering the
building. The director of the institute is unavailable, even though his
car is parked on the hospital grounds. A doctor wearing a denim jacket
assumes the task of getting rid of anyone inquiring about the
institute's collaboration with the German company.
Instead, he tells the reporters to contact the district attorney's
office and points to a sign above the door, which reads: "No Admittance
without Authorization." Does that include Tutogen, the reporters ask?
"No, Tutogen is not unauthorized here," the man says, indicating that
the conversation is over.
The former director of the city's forensic medicine department, Vladimir
Bondarenko, is slightly more forthcoming. A retiree, he meets with
visitors at a street caf�. Tissue harvesting began at his department
about 10 years ago, says Bondarenko.
"It was illegal," he says. "The family members should have been told
about what was happening with the bodies," but they had no idea. "When
the deceased is lying in the coffin, the family members see nothing but
the face. What they don't see is that the bones of the legs or arms have
been removed."
The Ukrainian tissue transplant act includes a provision stating that
family members must consent to tissue donation if the deceased did not
already do so while still alive. However, there are indications that
this was often not the case. Ukrainian authorities in Krivoy Rog and
several other cities are conducting investigations into suspected
illegal tissue and organ harvesting.
The case of the deceased father of Kiev resident Lena Krat, for example,
was examined in connection with an investigation identified by the file
number 50-3793, begun on Jan. 4, 2005. The investigation included all
incidents that took place between May and September 2004. The names of
10 deceased persons are listed in the files. Their family members stated
that they "did not consent to the removal of anatomical material."
According to the court order authorizing the proceedings, "family
members were deceived, in that they were told that only a small part of
the deceased would be removed, such as a bone or tissue fragment. In
actual fact, almost all bones and tissue were removed. ... All of the
material is taken to Germany."
A Legal Twist
Despite the evidence, the Kiev district attorney's office closed the
proceedings in July 2005, "for lack of a statutory offense." Curiously,
the document states, as grounds for dropping the case, that the
Bioimplant employees had not violated the transplant act, because they
had not transplanted material from corpses, but had merely removed it so
that it could be processed into "bio-implants." As a result of this
legal twist, the recycling of corpses has been allowed to continue to
this day.
Kiev, the forensic medicine institute on Orangery Street: A long, brick
building, from which doctors wearing light-green aprons occasionally
emerge to smoke cigarettes outside the front door. Family members stand
next to the entrance, waiting for the release of their dead relatives.
There is a display of coffins and wreaths in front of a funeral parlor
across the street.
Vladimir Yurchenko is the director of the institute. He points to the
room where bodies are processed for Tutogen. It is on the ground floor
and sealed off to outsiders. Why? "Because that's what the US health
authorities require," says Yurchenko.
Kiev's senior forensic pathologist explains the process. Bioimplant
obtains the relatives' consent, and company employees also come to the
institute to harvest the body parts. Yurchenko's staff members assist in
the process, for which they receive additional compensation. Once bones
and other parts have been removed, wooden sticks are inserted into the
body so that it retains its shape until the funeral.
The harvested bones, tendons and pieces of cartilage are stored in
zinc-plated metal boxes in a refrigerated room in the basement. "The
tissue parts are brought up once every few weeks, when a truck comes and
takes them away," says Yurchenko. Karl Koschatzky, the secretive Tutogen
executive from Bavarian, also turns up occasionally.
'A Source of Raw Materials'
According to Yurchenko, about 8,000 corpses a year are delivered to the
forensic medicine department. Of that number, more than 5,000 are
potential bone donors, but family members only consent to harvesting
from about 150 bodies. If the two facilities in the capital already
provide parts from about 150 bodies each, as Yurchenko says, and if a
total of 20 facilities in Ukraine are registered with the FDA -- and,
therefore, are collaborating with Tutogen -- it can be assumed that the
German company obtains its body parts from large numbers of Ukrainian
corpses. "All we are for the rich countries is a source of raw
materials," says Yurchenko.
In May 2004, Tutogen signed a five-year contract with Bioimplant, which
describes the process as follows: The Ukrainians transfer harvested
tissue to Tutogen in Germany to have it processed into products. But
this processing is costly. How does the Ukrainian company pay for the
expensive processing? The answer is deceptively simple: with the bones,
from Ukrainian corpses, that have been processed into products in
Germany. This is the currency accepted by both parties to the
arrangement.
What the agreement does not state is that the Germans were not producing
products for Bioimplant, but were ordering substantial amounts of raw
material from the Ukrainians every month.
At times, much larger numbers of body parts from Ukraine and other
countries were arriving in Neunkirchen than Tutogen could even process.
A document titled "Inventory, Raw Material Storage 1," dated March 2000,
reveals the scope of this excess material. According to this inventory
document, Tutogen warehouses already contained 688 patellar tendons,
1,831 kneecaps, 1,848 fibula, 2,114 fascia and 1,196 foot bones, or a
total of more than 20,000 body parts.
In June 2002, Tutogen employees wrote the following comments in the
minutes of a meeting: "Warehouse problems. More tissue than necessary
continues to be delivered. Solutions are needed to address this
problem."
The company documents also include references to the kinds of solutions
Tutogen had in mind. According to an internal memo dated April 2002, a
Ms. R. noted "that there is no longer any storage capacity in the deep
freezers. Efforts must be stepped up to ship tissue to the USA."
According to a document dated June 2002, which lists the "Raw Tissue
Requirements for USA Needs," the US partners required the following
monthly supply:
* 119 iliac crests,
* 667 pieces of fascia lata,
* 267 kneecaps,
* 243 shafts of the femur.
Did Tutogen Break the Law?
Apparently, the deliveries to the United States were not only sent to
the parent company in Florida, Tutogen Medical Inc., which could have
been explained as a way of shifting the problem within the company, but
also to RTI, the company's US competitor at the time.
In a table detailing a shipment from Lugansk in Ukraine, delivered on
Dec. 7, 2001, a sum of ?62,000 is quoted, but the recipient is
identified as "TM/RTI."
If Tutogen was indeed shipping unprocessed tissue to the United States,
this could constitute an act of engaging in illegal tissue trade,
provided a profit was generated as a result.
In a memo dated April 4, 2002, a Tutogen employee issued the following
cautionary statement: "We should avoid shipping unprocessed raw material
to TMUS (Tutogen USA), so as not to create the impression of engaging in
the tissue trade."
The German Institute for Cell and Tissue Replacement, another major bone
producer, categorically rejects such practices. Director Hans-Joachim
M�nig insists that "obtaining raw tissue from one country and passing it
on to third parties is against the law. In our view, this constitutes
the crime of trading in tissue."
To date, its collaboration with Aleshenko and the Kiev Health Ministry
has worked exceedingly well for Tutogen. All investigations against
Tutogen's Ukrainian partners in Krivoy Rog, Kiev and Dnipropetrovsk have
been suspended.
But that could change. Last year, the public prosecutor's office in
Krivoy Rog launched a new investigation.
Once again, forensic medicine employees, as the public prosecutor's
office states in response to SPIEGEL's inquiry, are suspected of "having
used coercion and fraud to obtain the consent of family members for the
removal of tissue and other anatomical material for purposes of
transplantation." Seventeen family members of the deceased have already
testified.
On Jan. 9, 2009, the district attorney's office submitted the case to
the relevant district court, where the case is still underway.
Lena Krat, the Kiev woman who was persuaded to release her father's body
for tissue harvesting in 2004, would be pleased to see those responsible
finally brought to justice. "Those people are truly guilty," she says,
"and I am outraged that these terrible things are still taking place."
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