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The Billion-Dollar Body Parts Industry: Medical Research alongside Greed and Corruption
Published: August 09, 2006 in Knowledge@Wharton
The Billion-Dollar Body Parts Industry: Medical Research Alongside Greed and Corruption [pdf]
As the cultured host of PBS' long-running "Masterpiece Theater," Alistair Cooke was an emblem of American taste and refinement. Since his death in 2004, Cooke has also become emblematic of a macabre and little-known market: America's distinctly shady traffic in human remains. Unbeknownst to his family, Cooke's bones were cut out before he was cremated and sold for $7,000 to two companies that prepare human tissue for transplant. Cooke's fate was ghoulish in the extreme -- but what is even more disturbing is that it was not at all unusual.
Body parts are big business in the United States. Tissue, organs, tendons, bones, joints, limbs, hands, feet, torsos and heads culled from the dead are the cornerstones of the lucrative and important business of -advancing scientific knowledge and improving medical technique. Body parts are a billion-dollar industry; they underwrite both cutting-edge research and everyday medical procedures. Major corporations such as Johnson & Johnson, Bristol-Myers Squibb, and Medtronic rely on human remains to guide them in developing medical equipment. Researchers rely on them to hone surgical techniques and even to create cosmetics. Doctors use them to replace heart valves, to treat burn victims, to replace bone, even to plump up lips and eliminate wrinkles.
Few people think to ask where the material that sustains this enormous industry comes from. But journalist Annie Cheney is a timely exception. In Body Brokers: Inside America's Underground Trade in Human Remains (Broadway), Cheney chronicles her quest to find out how human remains are procured, processed, marketed and used. What she discovers is a complicated tale of booming business and lack of oversight; of limited supply and endless demand; of unscrupulous brokers and the earnest donors, scientists and doctors they exploit; of unspeakable violations of the dead enabling marvelous scientific advancements.
The government regulates the procurement of organs and transplantable tissue, but it does not regulate human remains used for research and education. According to the 1968 Uniform Anatomical Gift Act, Cheney notes, it is illegal to buy and sell the dead. But according to this same law, it's legal to recuperate costs involved in securing, transporting, storing and processing cadavers. "Costs," Cheney notes, is an enormously expansive, exploitable term. It can and does mean whatever suppliers and brokers want it to mean.
In practice, the loophole in the Uniform Anatomical Gift Act means that bones, tissue, organs, joints, limbs, heads, and even entire torsos are hot commodities in a marketplace where the demands of researchers, product developers, and doctors far exceed the supply. Heads currently sell for upwards of $900, legs for close to $1,000, hands and feet and arms for several hundred dollars apiece. Fully dismembered and eviscerated, a human corpse can generate close to $10,000 on the open market. For the "body brokers" who supply materials to corporations, research centers, tissue banks and other clients, the profit motive is strong, the oversight is nonexistent and corruption is rampant.
Mutilation and Embezzlement
Cheney tracks two distinct forms of malfeasance in the human remains market.
The first is the illegal procurement and sale of parts taken from individuals who never consented to be donors. Noting that only 10% of states inspect crematoria or require crematorium workers to be certified, Cheney tells the story of a California crematorium owner who made hundreds of thousands of dollars illicitly dismembering corpses meant for cremation and selling the parts to the highest corporate bidders (he is now serving time for mutilation of human remains and embezzlement). The assistants who help pathologists with autopsies and manage morgues are also well positioned to sell off parts when no one is looking -- and, too often, they have done just that. So have undertakers.
The second, more complicated, form of malfeasance involves the trade in the bodies of people who have donated themselves to science. Donors and their families expect that they will land in the anatomy labs of medical schools, and that, in being dissected, they will help train the next generation of physicians. Most do go this route. But not all. Medical schools across the country have been implicated in the underground traffic in human remains, selling bodies and parts to brokers who then re-sell the goods to independent buyers. Along the way, these corpses make a lot of money for the suppliers, brokers and vendors who handle them. Needless to say, donors' families are neither informed of that profit nor invited to share in it.
These two types of malfeasance blur together in what Cheney convincingly shows is a systemic problem of astonishing proportions. Michael Mastromarino, former CEO of New Jersey-based Biomedical Tissue Services Ltd., is a case in point. When Cheney interviewed him, he was both a major supplier of tissue to Regeneration Technologies, a Florida-based tissue processor that did a $75 million business in 2003, and a shady dealer in illicitly procured body parts. Right under the nose of the FDA, which had inspected his company and knew what his business was, Mastromarino was procuring tissue illegally, failing to process it appropriately and then selling it off for enormous profit. Indeed, as a police investigation revealed just last winter, Mastromarino was the very man who paid thousands for the bones of Alistair Cooke.
The Uniform Anatomical Gift Act of 1987 bans the sale of transplant tissue, and the FDA forbids the transplanting of cancerous tissue (Cooke's bones were riddled with cancer that had spread from his lungs). But this did not stop Mastromarino, who listed Cooke's cause of death as a heart attack in order to circumvent the one restriction while simply ignoring the other. Cooke's bone tissue was bought by Regeneration Technologies and the New Jersey-based Tutogen Medical Inc., where it was processed for transplant.
American medicine has always struggled to procure enough bodies for research and education. Since the late 18th century, when dissection became an essential component of medical training, the demand for cadavers has far exceeded the supply. Back then, the solution was grave robbing -- entrepreneurs could make a tidy profit digging up freshly interred corpses and delivering them, under cover of night, to medical men willing to pay handsomely for them.
Today, we aren't robbing graves, but we are violating corpses; we are failing to carry out donors' wishes, and we are putting patients at risk -- all because we have been disturbingly complacent about what actually happens to people's bodies after they die, and disturbingly ignorant about how greed leads pivotally positioned people to exploit the dead and endanger the living. A million Americans every year undergo procedures that use tissue or bone harvested from the dead. Describing how contaminated tissue transplants can injure, infect, and even kill, Cheney documents how the corrupt world of body brokering threatens the health of everyone who receives such transplants.
Body Brokers is a good read -- but it's also a wake-up call that every American ought to heed. The real success of Cheney's book will be measured not in sales -- though those have been brisk -- but in policy change that focuses on the people who deal in human remains, the companies that process tissue and parts for sale, the hospitals that do business with these companies, and the doctors and dentists who treat patients with products made from the flesh and bone of the dead.
From msnbc.msn.com
Few regulations on body-parts industry
Federal inspections decline while number of companies grows
updated 10:40 a.m. ET, Mon., June. 12, 2006
WASHINGTON - A piece of fruit coming into the United States is more likely to get government attention than a ligament or heart valve taken from a cadaver and destined for transplant.
While demand for donor tissue is booming, government inspections have fallen. In 2001, the Food and Drug Administration inspected 1 in 3 registered tissue companies; now it is 1 in 8. Over the same period, the tissue enforcement staff has shrunk from 252 to 227.
Meanwhile, the list of companies or individuals handling tissue has quintupled in that time frame from 406 to 2,030.
“Anytime you’ve got a growing industry with high profits to be made and the cops are not on the beat and they know it, it opens the door to mischief,” said William Hubbard, an FDA associate commissioner from 1991-2005.
The Bush Administration’s proposed budget for the FDA warns of dire consequences if it doesn’t get an extra $2.5 million and more inspectors: “Without this initiative, the American public risks an increase in preventable transmission of new and emerging infectious diseases.”
With limited resources, the FDA targets companies it views as most risky to patients’ health — those that are high-volume and less reputable. FDA spokeswoman Julie Zawisza called it “the smartest way to do inspections.”
But the agency didn’t jump on the signs it saw at Biomedical Tissue Services in 2003. An inspector found problems with the way the New Jersey company kept records on how it disposed of “unsuitable” tissue. After BTS’ chief promised the problems had been fixed, the FDA said it would verify that “during our next inspection.”
'It's a crisis'
The next inspection came too late — after investigators found evidence the firm was shipping out thousands of unsuitable body parts with faked health records.“FDA used to have a presence so that people thought, 'We ought to follow the rules because you know they’ll be back,”’ said Hubbard. “Now they know we’re not likely to come the first time.”
U.S. Rep. Frank Pallone, D-N.J., has co-authored a bill to regulate tissue banks further. “I don’t think there’s much protection (for consumers) because there really isn’t much government involvement ... It’s a crisis.”
FDA says most tissue safe
FDA officials contend tissues are adequately safe, tested and free of disease because of new flexible rules that went into force a year ago. Zawisza said the agency can’t prevent “bad people” from breaking the law.
She and others point to the guidelines of the industry trade group, the American Association of Tissue Banks. But those guidelines are voluntary and the scandalized New Jersey company wasn’t a member of that group.
James Forsell, the president of the tissue bank association, says the organization tries to keep the industry clean “through peer pressure.”
“We don’t have the ability to force anybody to do it,” he said.
© 2007 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
MSNBC related stories
Flesh and Bone: Inside the body-parts business
Demand for body parts fuels trade
Few regulations on body-parts industry
Cadaver tissue poses growing risk to the living
Need a transplant? Be sure to take precautions
A look inside a tissue processing plant
FDA Cracks Down on Body Part Harvesters
Feds Boost Inspections of Human Tissue Harvesters After Scandals
The Associated Press
By SETH BORENSTEIN and MARILYNN MARCHIONE Associated Press Writers
WASHINGTON Jun 12, 2007 (AP)
A federal agency's review of the billion-dollar body parts industry calls for more inspections, but experts in the field say it ignores the problems that led to two recent scares involving human tissue destined for transplant.
An internal task force report Tuesday recommends the Food and Drug Administration require more extensive tracking of non-organ tissue such as tendons, bones and heart valves from the cadavers where they are retrieved to the patients where they are implanted.
The in-house review also advocated what is essentially the doubling of FDA inspections of companies that remove and handle body parts.
The FDA said it has already begun what one official called a "blitz" of inspections a total of 153 and no serious problems were uncovered. The booming body parts industry now has more than 2,000 companies registered, but the FDA has typically done less than 300 inspections a year.
On Tuesday, the agency's tissues chief, Dr. Celia Witten, pronounced the industry safe and said government oversight was working for the more than 1 million medical procedures involving non-organ body parts: "Today's report finds no significant industrywide problem in the recovery of human tissues."
But experts in the industry say those recommendations would not have prevented two recent well-publicized scandals over the safety of cadaver tissues that were transplanted. Thousands of Americans who had routine procedures like knee and back operations were urged to get tested for HIV and hepatitis last year because of concerns about the tissues they received.
The most egregious case involved charges that bones and other tissues were stolen from funeral home corpses, including that of "Masterpiece Theatre" host Alistair Cooke.
The FDA task force's recommendations wouldn't bar funeral homes from recovering body parts, don't require background checks and certification or immediate inspections of new companies that set up shop in the tissue business. They also wouldn't prevent fraud, critics said.
FDA Cracks Down on Body Part Harvesters
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Third Edition 2007 of The Nasty Side of Organ Transplanting is now available.
A Sixty Second View of Organ Transplanting
Heartbeat and blood pressure rise as the surgeon cuts into the supposedly dead organ donor, a similar reaction to a healthy person being attacked with a knife.
Some doctors recommend administering anesthetic, prior to harvesting, to prevent pain to supposedly "brain dead" donors despite the donor officially declared dead.
Organ donors get inferior treatment than organ keepers. This happens because treatment to preserve harvestable organs increases the injuries and may even kill the patient.
An organ recipient's body experiences the transplanted organ as a malignant invader to be killed. Doctors administer drugs to stop this rejection which then creates similar immune deficiency diseases to AIDS victims.
The Nasty Side of Organ Transplanting
Second Edition
Norm Barber
Chapter 9
Body Parts and Business
Body Parts and Products
Organ transplant interests complain that vital organ donations haven’t risen for the past ten years. This is true. Prospective customers aren’t shooting or knifing each other as in the good old days. Car seat belts and breath testing have dented the flow of brain-injured candidates. Better neurosurgery for stroke victims is reducing this other prime source of donors.
The Hidden Industry
But there is a hidden industry for which statistics aren’t publicly presented and the donation agencies feign surprise and anger when asked about it.
This is the market for completely dead donors whose hearts and everything else has stopped. They are called cardiac dead donors. They are really dead. Their vital organs aren’t always used, often due to deterioration during the dying process, but their bodies still provide raw material for surgical activities ranging from heart valve replacements to cosmetic surgery.
The American body parts processing industry is far more advanced than the Australian but demand for our cosmetic and surgical techniques is on par with the American. This means our industry is fed by imported parts and products harvested from dead Americans. Our medical industry, through demand for cadaver products, encourages Americans to aggressively harvest their own citizens’ bodies. In that way Australian users of imported body parts are also responsible for what Americans do.
Compulsory Harvest Requests
In 1998 Clinton Administration legislation forced United States hospitals that receive Medicare payments to pressure relatives of the deceased to sign voluntary harvesting consent forms. This increased cardiac dead harvesting in the United States 172% over five years to 20,000 bodies annually or three and a half times the number of vital organ donors.
Worth More Dead Than Alive
This isn’t a joke. The power of the American transplant industry to determine government legislation hinges on the fact that a single donor body can provide the raw material to generate products selling for US$220,000 wholesale.43 When adding surgical fitting costs it can reach one million dollars. If the donor also supplied vital organs the amount generated by one body is two million dollars. Most of us are worth much more dead than alive. The Gift of Life more resembles a market commodity and a factor motivating aggressive transplant coordinators to help meet market demand for dead bodies guarded by relatives who don’t want their next of kin to be harvested. There is a higher demand than supply and this creates a hungry market. This explains why transplant interests so aggressively lobby governments, manipulate public opinion and fund donor promotion registries.
Shortage of Skin for Burns but Plenty for Cosmetic Surgery
Harvested cadaver skin is used to cover holes left by tumours and make slings to support bladders of those with urinary incontinence thus alleviating the need for adult nappies. More skin comes from the obese and less from midgets and thin people. In the United States skin from one donor fetches $3600 if sold to hospitals to treat burns victims. Burns victims need layers of donated skin to protect the exposed and injured parts of their body from infections and to facilitate replacement of their own skin over the injured area.
Twenty thousand cardiac dead donors annually provide plentiful quantities of skin for medical purposes, but there is a continuous shortage. But in a free market society most of the donated skin is sold. Non-profit body harvesting Foundations receive the bodies for free then pass them on to cosmetic products companies for a token price. The processed skin for burns victims worth $3600 is transformed into cosmetic surgery products which eventually sell for $36,000 wholesale.45 This artificial shortage means that burns victims don’t get the cadaver skin. Instead their relatives undergo painful procedures with full anaesthetic where surgeons strip skin from their living bodies to be placed on their relatives’ injuries while donated skin, painlessly removed from dead bodies, goes for cosmetic surgery.
Thick Frankenstein Penis’
LifeCell Corporation, using donated cadaver skin, produces Alloderm, a plastic surgery product used to reconstruct eyelids for older women who want to look younger and sexier. Other uses include reducing or enlarging breast size and thickening penises.
Have you ever wondered how movie stars or aging TV newsreaders have so few wrinkles or the women have such big, red pouting lips? Collagenesis, Incorporated of Massachusetts, uses cadaver skin to make an injectable gel called Dermalogen. Cosmetic surgeons will, for $1000 a shot, inject Dermalogen into the women to puff up their skin to remove wrinkles and laugh lines or fatten their lips. The benefit of Dermalogen is that the body doesn’t break it down so repair jobs are less frequently needed. The drawback is with the permanency of injected cadaver skin. Ghastly mistakes are hard to fix.
Alloderm and Dermalogen compete with similar products such as one cultured from the bugs living in the puffy fluid of arthritis sufferers. The “stuff” is injected into a person’s (usually a woman) face to puff it up like arthritic fingers thus taking away the wrinkles. The puffy “stuff” is absorbed by the body and must be repeated at high expense every six to twelve months. Similarly, cowhides are made into a collagen and pumped into wrinkly faces. Another product made from botulism paralyses facial muscles to stop natural facial movements that cause wrinkles.
Ever admired the thighs of scantily clad move stars? Fascia Biosystems of Beverly Hills, California sell a trademark thigh tissue to cosmetic surgeons. Fascia lata is the connective tissue holding thigh muscles together. Fascia is transplanted from the corpse to the movie star which may explain those incredibly firm and tight bodies.
Football and sports heroes don’t miss out on the cannibal trade either. Ten of a corpse’s tendons bring $20,000 (the Achilles and patella come with bone still attached). Knee cartilage is worth $14,000. When an Australian Football League player breaks a tendon or wrecks a knee he is off to the morgue for spare parts. A humerus fetches $28,000. Need a varicose vein job? Saphenous and Femoral veins, used for varicose vein and blood vessel reconstruction, sell for $14,000. Corneas, the clear part of the eye that covers the colored part, fetch $2400 a pair. Heart valves are $7000 each from a heart costing Cryolife or other valve collectors less than $1000 from the non-profit Foundation, which they have usually set up as a front to obtain cheap or free corpses 47
Bones and the Ladies Powder Room
We may think the blood and bone people dealing in human body parts are from a Jeffrey Dahmer style murder trial, but it is technology and market demand that has created the impetus for this industry. The market is hungry so the body parts industry relentlessly pressures governments for increased access to corpses.
The human body has 206 separate bones most of which will fetch a reasonable price, but it is at the processed, ready-to-transplant stage where the profits are to be made.
Bones are deep-frozen or freeze dried at 92 degrees below zero Fahrenheit. This allows storage of five years and helps reduce rejection. The first stages of bone harvesting is so simple that some American doctors take cadavers home and remove the bones in their garages.Young donors with strong vibrant bones bring high prices while the porous bones of older woman are ground up for dental dust which gives a new twist to the term "ladies powder room". Harvesters want every human bone which indicates the challenge to morticians at open casket funerals and the delight of plastic medical pipe suppliers.
Dental Dust and Bone Putty
Small carpentry shops using only human bones grind out specially manufactured parts for hospital and dental surgeries. These include bone chips (looking like grated parmesan cheese), bone paste, screws made from bones, wedges, spears, blocks and a large range of custom made parts used to reconstruct, patch or replace the injuries suffered by living humans. Osteotech, Inc makes a bone putty costing US$853 for two teaspoons that is used to patch up small breaks. Larger cracks are mended using a chip and putty blend. Demineralised human bone is ground into "dental dust" and used to improve healing after tooth extractions, spinal fusions and minor surgery. The "dust" is made by removing the 70% mineral content from bone leaving 30% collagen and non-collagenous proteins.
A dentist uses it after grinding out rotting teeth and jawbone. Dental dust is sprayed onto the exposed healthy bone to increase the healing rate.
It is also used when transplanting bone material from a corpse to a living patient. It helps to fuse the two bones together. It also fuses worn vertebrae and other joint bones to stop movement and associated pain. Dental dust’s popularity hasn’t suffered despite a problem with it transferring HIV-AIDS. This problem has reportedly been solved.
Business Links to Non-profit Foundations and Government Enterprises
One might wonder where business, donation agencies and hospitals merge in this creeping neo-cannibalism. Government hospitals are often reluctant players. Most doctors and nurses are dedicated to the Hippocratic ideal not to harm patients yet the act of cutting out a healthy (and it must be healthy) beating heart from an injured patient isn’t exactly First Aid. Some wish organ harvesting had never been developed.
The organ procurement businesses have infiltrated their influence into medical establishments and may be pressuring next of kin within three or four hours of the patient being diagnosed brain dead – or even before this point. This is usually before the rest of their family have reached the hospital or even been told of the injury. The patient can even be harvested before some nearby relatives learn of the illness or injury.
Hospital staff may avoid skin and bone harvesting and a team from the euphemistically entitled Tissue Bank will arrive to dismantle the corpse. American Tissue Banks operate like the non-profit Musculoskeletal Foundation. It is the largest body procurer in the U.S.A. theoretically operating as a benevolent society but actually a front organisation specifically set-up in 1987 by Osteotech, Incorporated, to obtain bodies free of charge, then transfer them for a tiny price to Osteotech, who begin the process of turning each body into $220,000 worth of products. Virtually every American body procuring Benevolent Foundation is a secret agent for a private company.48 The Musculoskeletal Transplant Foundation of the U.S.A. produces a catalogue listing 650 body parts products.
Australians use more subterfuge and hide their body parts businesses within government science and educational institutions, but the relationships are the same. One section of the institution acts as a non-profit organisation that lures in the donated corpses then passes them to a business ally, which is another section of the institution. The Donor Tissue Bank of Victoria discreetly operates as a business within Monash University and the South Australian Tissue Bank operates under cover of the Institute of Medical and Veterinary Science in Adelaide. The New South Wales Bone Bank hides out at St George Hospital in Kogarah. Another Australian characteristic is that body parts are often removed under the guise of medical post-mortems unlike in the United States where relatives are directly approached to donate the body for parts and materials.
The common feature of both types of organisations in the United States and Australia is that participants at every level profit financially, except donors and heirs.
The intractiveness of our predicament is that we have a medical industry on which over 500 surgical procedures depend on human body parts and products. National governments fund a medical industry that depends on the consumption of its injured, dying and dead humans. While this method of medicine remains funded by taxes and government protection our wellbeing will remain dependent on a form of cannibalism that we euphemistically call “body parts recycling” or the “gift of life”.
The Nasty Side of Organ Transplanting Third Edition 2007
Free E-copy
Copyright and Acknowledgments
An Invented Death
Donors May Need Anaesthetic
Apnoea "Brain Death" Test May Kill The Patient
Organ Rejection
Battle for the Body
Aggressive Hospital Harvest Teams
Harvest Time
The Nurse's Tale
Types of Donors
Donation after Cardiac Death
Futile transplants and flexible survival statistics
Body Parts and Business
Body Parts and Business
Coercion, Live Donation and Slippery Ethics
Deception by Organ Donor Agencies
Australian Transplant Legislation
Avoiding Harvest Time
Societal Consensus and the
Slippery Slope
Terminology and Gender Donor Rates
Getting A Transplant
Religion, Culture and Harvesting
The Politics of Suppressed
Death Statistics
A Short History of Human
and Xeno Transplants
Trusting Your Hospital
Organ Selling, Organ Theft
Sociological Implications
Appendix One
Appendix Two
End NotesStripped for Parts by Jennifer Kahan
Leading Neurologist Changes Mind About "Brain Death"
Sober, Precise Language from Dr David W Evans
The Heart-Stopping Truth About Organ Donation by Steve SalernoOther Good Stuff
Earl Appleby's Brain Death Site
Organ Retainer Cards
Links
Remove Your Name from the Donor Register
Quote of the Week Archive Newest (July 2006 to present)
Quote of the Week Archive - a rich source of links to opinions critical of organ transplanting (May 2003 to July 2006)
Older Quote of Week Archive (April 2002 to April 2003)
Real Myths of Organ Donation
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