Carlsbad, Calif., – November 27, 2012 – Spinal Elements, a spine technology company, today introduced their “Pledge to be a Hero” program. This announcement follows the introduction of the company’s Hero™ Allograft last month at the North American Spine Society (NASS) meeting. Spinal Elements chose to name its first allograft tissue product “Hero” to honor those whose donation made the tissue donation possible. Although many companies earn significant profits from the sale of allograft, Spinal Elements, a for-profit company based in Carlsbad, Calif., has chosen to donate all profits from the sale of Hero Allograft to charities benefiting children with life-threatening medical conditions.
The “Pledge to Be a Hero” program offers surgeons and hospitals the opportunity to pledge to use only allograft tissue from companies that do not profit from the transfer of that tissue whenever clinically feasible. The company will help raise awareness of the given surgeon’s or hospital’s participation by offering to work with local media outlets to inform each participant’s community about their involvement in the program.
Leading neurosurgeon Dr. Carl Lauryssen of Los Angeles, the first neurosurgeon to inject stem cells into a human spinal cord, was also the first surgeon to take the “Pledge to Be a Hero.” He stated, “I’m proud to participate in this program. With all else being equal in terms of safety and efficacy, I would rather support something that goes to a good cause while paying respect to the donor that made the allograft possible.” Dr. Lauryssen began using Hero this month.
Hero consists of various configurations of human allograft tissue including demineralized bone matrix (DBM) in paste or putty form, compressible cancellous blocks and strips, and structural grafts. These types of grafts are typically used in fusion procedures. For more information, please visit www.spinalelements.com/hero.
About Carl Lauryssen, M.D.
Dr. Lauryssen is a world-renowned, board-certified neurosurgeon practicing in Beverly Hills, CA since 2003. He is currently the Director of Research and Education at Olympia Medical Center in Beverly Hills. Prior to that, Dr. Lauryssen was on the faculty at the Washington University School of Medicine for 7 years, where he directed the advanced neurosurgical spine program at Barnes-Jewish Hospital. In addition, Dr. Lauryssen was the first neurosurgeon to inject stem cells into a human spinal cord, as part of an FDA trial. (http://towerorthopaedics.com/lauryssenfull)
About Spinal Elements
Spinal Elements, headquartered in Carlsbad, CA, is a spine technology company for spine surgeons who demand innovative, extremely high quality surgical solutions. From the company’s early work which helped make PEEK commonplace throughout the spine industry to our recent advancements in controlled delivery, stand-alone technology, and titanium coated PEEK, Spinal Elements has built a reputation for being trustworthy, innovative and different. The company is focused on the development and marketing of progressive spinal treatment options and markets a complete portfolio of advanced spinal implant technologies across the globe. For more information, please visit www.spinalelements.com.
HUGE thank you to Bryant Jordan of Military.com! The Pentagon has ‘enhanced’ their biologics requirements thanks to Bryant’s reporting! Read his story. ”Congress and the Defense Department have begun investigations into the purchase of biologic medicines and implants after learning that military and veterans hospitals bought products from a company whose supplier was convicted of illegally harvesting human tissue from cadavers.
Defense Department officials have also ordered the services to set up a new system to better oversee and track the biologics – medical products made from bone, skin, arteries and tendons. Doctors use biologics in a wide range of procedures to include surgeries and treatments for burns…”
An investigation is underway following the seizure in Ukraine of a minibus containing packaged human tissue bound for Germany.
Biologics are medical products manufactured from tissue such as bone, skin, arteries and ligaments harvested from cadavers. They are used in a wide range of procedures, from treating psoriasis and back pain to burns, knee and spinal surgery to dental implants.
The minibus was bound for Tutogen Medical GmbH, a processing facility owned by RTI Biologics of Alachua, Fla. A review of federal contracts shows RTI has supplied biologics to Department of Veterans Affairs and Defense Department hospitals around the world. See the whole article… http://www.military.com/daily-news/2012/08/23/tissue-seizure-raises-specter-of-tainted-medicine.html
I’ve had many people ask me recently why I’m being so vocal against the tissue industry. I assure you – it is not because I want to see the industry shut down. It is quite the opposite – I want to see the industry flourish to help even more people.
We are scared of the dark because of all the stories we’ve heard throughout our lives about all the evil lurking in the shadows. We are afraid of the woods because of all the tales we’ve been told of the horrible monsters waiting just beyond the trees. Despite this, at some point in our lives, we will have to sit in the dark and we will have to walk through the woods.
What if we could shine a light in that darkness? With no shadows to hide in, the evil would be gone. What if we could see behind the trees in the woods? We would know which monsters are waiting and how to prepare for them. We would no longer fear the dark and we would stroll through the woods without a care. In fact, we might even do it more, knowing there are no dangers to be found.
It is the same with tissue donation.
Right now, the industry is operating in the dark shadows. Nobody knows what really goes on, so far too many people choose not to donate. Those that do choose to donate do so without looking behind the trees in the woods, blindly trusting in what happens next. What if we could shine a light into that darkness and eliminate the monsters behind those trees? We could see what really happens…and the incredible good that can come of tissue donation. By doing this, we can actually increase donation.
By giving families the OPTION to learn as many details about the procedures as they’d like, we’d be giving them the power to truly decide what happens. By giving families the OPTION to choose for-profit or not-for-profit, we’d be giving them the ability to choose if someone makes money from their loved one’s gifts. By giving families the OPTION to choose the final use of the donated tissue, we’d be giving them the ability to choose the final use of their loved one’s tissues.
Will some families choose to hear all the details? Yes. Will some families choose to go the not-for-profit route? Yes. Will some families choose to only have the tissues used for life saving (and not cosmetic) uses? Yes. Will other families choose differently? Absolutely. But – we will be giving them the CHOICE.
THAT is what is missing from the industry today. It is not for you or me to decide whether there should be profits or not. It is not for you or me to decide what families need to know. It is not for you or me to decide whether tissues should be used in cosmetic surgery or life saving surgery. It should be up to the FAMILIES.
That, ladies and gentlemen, is why I’m speaking out against the industry, shining a light into the shadows, and calling out what is behind the trees. I am fully aware…painfully aware…that my actions my cause some not to donate. But I am also fully confident that if enough of us speak up, we CAN change the industry and, in the long run, increase donation far beyond what it is today.
This is, by far, the most common question I’m asked about why I’m speaking out against the current state of the tissue industry. The answer is simple:
1) Honesty/Full Disclosure. Families must be given the opportunity to learn more about the specific procedures that may be done. Instead of a simple ‘do you consent for the procurement of skin’ the families need to be told ‘There are a few different possibilities for how your loved one’s skin may be procured. Would you like to learn more about the different possibilities or would you prefer to consent or decline consent without learning more about the specifics? If the families choose to learn the specifics, the procedures must be explained in a way the family can understand.
2) Choice – Medical vs. Cosmetic. Families need to be given the opportunity to choose between donating tissues for medical need and cosmetic purposes.
3) Choice – For-Profit or Not-For-Profit. Families must have the ability to choose whether their loved one’s tissues are processed and sold by a for-profit processor or are processed by not-for-profit processor.
4) Tracking. Every piece of tissue bought, sold, or used must be given a bar code that can be used to track the tissue back to the processor and donor. That way, if there are safety concerns, the recipients of the tissue can be located and contacted. It is absolutely absurd that these things can’t be tracked! We can find out who bought infant car seats that are recalled but we have no way of tracking human tissues for transplant.
To Consent or Not: Stewards of the “Gift” Read more: To Consent or Not: Stewards of the “Gift” | The Daily Czech Rep. http://www.thedaily.cz/to-consent-or-not-stewards-of-the-gift/#ixzz212fiGUus
To Consent or Not: Stewards of the “Gift”
This, the third part in a series of reports from The Daily.cz entitled Skin and Bone: the Shadowy Trade in Human Body Parts of the International Consortium of Investigative Journalists, looks at the vague issue of consent in some countries and what it means in reality. Consent is not required in the Czech Republic, as the system is Opt-out, meaning everyone is a potential donor.
Stewards of the “Gift”
By Kate Willson
The International Consortium of Investigative Journalists*
Mandi Eisenbeis stood over her dad. It was a Thursday in May 2011 when she said her private good-byes at a funeral parlor in Lodi, Calif. George “Randy” Eisenbeis had died young, felled at age 57 by a methamphetamine overdose.
As she looked at him lying in the coffin, she noticed his hands were oozing blood.
Eisenbeis didn’t know what had happened until later, when she learned the funeral director had sent a scathing complaint to the California Transplant Donor Network, the nonprofit organ and tissue bank that had stripped out George Eisenbeis’ usable parts.
“To say that this was simple a ‘hack job’ would be a compliment,” Lodi Funeral Home’s Michael Collins wrote in a letter accompanied by a series of graphic photos of a the torn-apart corpse. “I guess we should consider ourselves lucky that you left his head and his hands for viewing, and yes, that is his severed foot in the photo to the bottom left of the embalming table.”
In March the family sued the California organ bank, accusing it of fraud, mutilation of a corpse, and infliction of emotional distress.
According to call logs made of the consent process, the bank told Mandi Eisenbeis at least four times during the recorded consent process that the body would be properly put back together. She and the family couldn’t give informed consent, the lawsuit charges, because those promises were lies designed to manipulate them into giving their okay.
The California Transplant Donor Network is accredited by the industry gold standard — the American Association of Tissue Banks. According to its policies, tissue banks are required to reassemble a body out of respect for donors, their families and the professionals who handle bodies on their way to burial or cremation.
The tissue bank declined requests to comment for this story. In court filings the tissue bank has denied wrongdoing. In an earlier public statement the organization suggested that Randy Eisenbeis’ corpse had been in good condition when it sent it to the morgue for autopsy. “No matter how complex the reconstruction process may be, it is a standard to which we adhere consistently,” it said. “Unfortunately, we cannot speak to what may transpire once a donor’s body leaves our control.”
The medical examiner’s autopsy findings, however, reported that George Eisenbeis came to him naked and skinned, with his feet “separated from the ankles.”
What happened to George Eisenbeis may not be typical of how bodies are treated when they enter the tissue donation system. But as a worst-case scenario, his story provides a window onto a system that some say operates with inadequate regulatory scrutiny — and raises questions about how well the industry lives up to its own standards about the manner in which tissue banks obtain consent to take tissues from the recently departed.
Families often know little about what happens after they say, “Yes.” Ethics experts say many families in the U.S. and other countries assume that standard donor agreements apply only to hearts, lungs and internal organs. They don’t realize that in the brave new world of tissue harvesting, the dead’s bones, skin, tendons and heart valves can be cut out and used to create medical devices that can be sold for profit around the world.
Tissue from about 30,000 cadavers in the United States is cleaned and milled into medical devices each year and some is exported around the world. U.S. companies also obtain tissue from places including Slovakia, the Czech Republic and Latvia.
In many countries, the law allows tissue harvesting unless a donor opts out before death. In the United States, federal law requires that they get families’ approval. How they do that is up to states to decide — and many states have few requirements or guidelines. People are often unaware just what they are giving away when they agree to become a donor. And families often don’t know that when they okay donations to nonprofit organizations such as the California Transplant Donor Network, the tissue routinely goes to for-profit companies, feeding a billion-dollar industry that uses those tissues for everything from repairing a knee to plumping up a penis.
Without uniform federal standards, it is mostly left up to tissue banks to decide how much information to share with donor families. Few states require that companies tell families their loved ones’ tissue can be sold overseas, sent to a for-profit company or used in cosmetic procedures such as wrinkle-fillers and nose jobs.
“At Present the industry thrives because of public ignorance and indifference regarding the for-profit involvement” Robert Katz, a law professor from Indiana University wrote in 2006. “Most donors are either unaware of such involvement, or it does not trouble them enough to stop donating.”
In a 2010 study by researchers Laura Siminoff and Heather Traino, 70 percent of donor families said they’d object to a loved one’s tissue going to a for-profit business. Yet fewer than one in five said they’d been told that the harvested tissues could go to a for-profit company.
U.S. Sen. Chuck Schumer, a New York Democrat, introduced legislation in 2007 that would have established mandatory requirements for what banks had to tell donor families, as well as try to limit the profits companies can make from the donation. But the bill died after heavy lobbying by the industry, Schumer said.
Industry representatives have declined to answer questions for this story.
Chris Truitt, a former industry insider, is among the advocates who are working to reform the system and force companies and nonprofits involved in the process to do a better job of informing the grieving about what will happen to remains of family members who’ve died. Truitt is the author of a book, Dark Side of Tissue Donation, which exposes what he sees as abuses and profiteering within the donation system.
He began working in the industry after living through a family tragedy.
His daughter Alyssa was born with a condition that causes fluid to build in the brain. When Alyssa died at age 2, the Truitts donated her organs and tissues. It soothed the pain to know their daughter’s death had helped others in need. He and his wife began promoting donation.
“I felt it was basically my calling in life,” Truitt said. “I ended up doing what I could to find a position working in the field.”
Truitt signed on with nonprofit tissue bank Allograft Resources of Wisconsin. “My job was to go out and do the procedures. To recover bones, skin, veins, heart valves,” he explained. “We’d take the long bones out, we’d take skin out, take the veins out, take the heart valves out.”
The tools were mostly those found in any operating room — scalpels, retractors, scissors, and clamps. Sometimes, though, Truitt and other recovery technicians also used metal wedges and mallets to break through the bone.
Still, they prided themselves on being “stewards of the gift.” Donors, he said, were treated with respect. Once, an elderly woman whose husband had died thanked Truitt for his work. “She said that at his age in life, he and she both felt that they were completely useless, they had nothing left to give. But by being able to donate, it kind of showed that they still meant something, they were still worth something, they were still able to help somebody.”
But the bank’s record keeping was abysmal, making it impossible to track the tissue from donor to hospital buyer. In 2000 the U.S. Food and Drug Administration issued a warning letter — a serious and uncommon reproach. That’s when RTI Biologics — which had until then bought all the bank’s tissue — took over responsibility for its operations.
Once RTI got more involved in daily operations, Truitt said, training was upgraded. Experts came in to show him and his coworkers how to recover tissue in the most efficient manner. “I don’t think they made it any more professional,” he said. “I think they made it more industrial.”
The industrial part of processing and distributing tissue is so different from the soft nonprofit face that donor families are often shocked. “The for-profit trade in body parts is a legal gray area,” said Joshua Slocum, executive director of the Funeral Consumers Alliance. “This affects the confidence of the public and the whole donation process.”
Truitt has nothing against for-profit companies being involved in the industry. He just wants families to be fully informed when the dead’s remains are used to make commercial products. “What I’m saying is that I want that choice. I want to be able to know what that means. And I don’t think that’s what families are getting.”
That can be a challenge, given differences in disclosure laws among states as well as families’ vulnerability during the time of grieving.
Some families don’t want all the details, and it’s up to the organization seeking the tissue to judge how much to disclose, according to Christina Strong, a lawyer for organ and tissue banks and an expert on donation regulations.
Some families, Strong said, might say, “This is freaking abuse. Look, I’m giving OK. That’s it.” Others might say, “Yes, take it,” but they want an open casket funeral, which means that they need to be aware of the kinds of tissues to be taken and how that will affect the person’s appearance and clothing selection.
Most tissue donation center requests analyzed in the 2010 Study didn’t tell families that they could decide not to donate. And none told families they could change their minds after initially agreeing, according to the study published earlier this year in The Journal of Trauma, a medical journal.
Families often have even less information and fewer rights when it comes to harvesting tissue from the dead overseas. Express consent isn’t required, for example, when a company gets tissue from some former Soviet nations.
RTI’s trade-partner turned subsidiary Tutogen Medical has obtained tissue from the Czech Republic, Hungary and Latvia, where everyone is a donor unless they expressly opt out. The company also obtains tissue from Ukraine, where government morgues can recover tissue from the dead if they gain family consent.
Four of Tutogen’s Ukrainian suppliers have been investigated for allegedly taking tissue against the wishes of donors or their families. The first case was dismissed when prosecutors couldn’t prove the tissue hand been transplanted. The second was dismissed after the defendant died while a court deliberated his case. Two recent investigations are still pending.
The income that can be made from recovery to distribution is anywhere from $80,000 to $200,000 according to industry experts and court testimony. There is a cost involved in recovering, processing and distributing the tissue.
Overseas and in the U.S., some companies that profit from human tissue spend considerable resources cultivating sources of fresh bodies.
Phillip Guyett, who worked as a ground-level body wrangler in California, North Carolina and Las Vegas before he was sent to prison for falsifying death records, said the demand for tissue grows more intense every year. One tissue buyer, Guyett said, summed up the all-out competition for corpses this way: “Whoever has the most bone wins.”
When RTI took over the Wisconsin tissue bank where Chris Truitt worked, he said employees were pushed to compete hard with other tissue banks for access to bodies — courting hospitals, funeral homes and morgues. “We would convince them when they came across a death to call us in for the tissue, rather than some other tissue bank,” Truitt said.
Once the tissue left the bank, it was sent to RTI, sterilized and milled into implants. “It is a medical device. It’s regulated as a medical device,” he said. “It’s no longer part of Uncle John. It’s product XYZ123.”
Skin from the Wisconsin bank was also sent to New Jersey-based LifeCell. Truitt says a representative of LifeCell initiated an award for the person who could recover the most tissue from a donor. He said the award was named the Golden Dermatome Award after the instrument designed to strip layers of skin off a donor’s back, thighs and arms.
LifeCell did not respond to questions about the award but said in a statement to ICIJ that the company “is committed to improving patients’ lives.”
“When they started giving out those rewards, it really sunk into me that instead of being stewards of the gift and treating each donor with the ultimate in respect, the company was actually looking at each donor as a profit machine, as nothing more than raw resources,” Truitt said. “And it was our job to take as much of those resources as we possibly could.”
He left the bank, disillusioned that any profits could be made from recycling human tissues from donors like his daughter. He even had his name removed from his state’s list of organ and tissues donors. But he hasn’t given up hope.
“Saving lives, making lives better. That’s what it should be all about,” Truitt said. “I talk with a lot of recipients. I talk with a lot of donor families. And we all feel the same thing. It’s too important a thing, too incredible a thing to just stop. We have to fix it instead.”
Mandi Eisenbeis hopes that her family’s lawsuit, filed this spring in San Joaquin County (Calif.) Superior Court against the California Transplant Donor Network, will spur that kind of reform among recovery banks.
The case is still in its early stages; the family’s lawyers hope lawmakers will notice the case and call for changes in how they obtain consent and treat donor bodies.
Eisenbeis said the condition of her father in the coffin — and the photos she saw afterward that showed the full picture of the mutilation — roused her to take her complaints to the bank.
Three times, she said, she sent copies of the funeral director’s letter and pictures to the tissue bank. Three times the bank said it never received the mail. Then, she said, it stopped picking up the phone at all.
It was only after getting the silent treatment, she said, that her family decided to file the lawsuit.
“I don’t want anyone to go through what I felt the day I saw those pictures,” she said. “For me, I just wanted things to change, and when I saw those pictures I knew that I had to do everything I could to get someone to stand up and listen to me.”
Contributors to this story: Vlad Lavrov, Martina Keller and Thomas Maier
* The International Consortium of Investigative Journalists is an independent global network of reporters who collaborate on cross-borders investigative stories. This story was co-reported by National Public Radio (USA).
All materials herein are copyright of TheDaily-LaVoce/ICIJ and may not be reproduced or redistributed without prior consent. To enquire about republication or localisation, please contact firstname.lastname@example.org.
While here in the US the tissue industry is largely unregulated, in Australia they appear to have the opposite problem. They are actually importing tissue from the US when it is available. Here’s a great article that talks about the plight of one recipient:
Donor shortage left fire survivor facing the fight of her life
- July 19, 2012
Julie Robotham, Linton Besser
IN THE long roll-call of people who saved Turia Pitt’s life last year are fellow athletes, surgeons, a helicopter pilot, and at least three unidentified Americans who were already dead.
The 24-year-old’s heroic evacuation out of the Kimberley in Western Australia in September, after a savage bushfire cut off her path in a 100-kilometre ultramarathon race and burnt her catastrophically, was only the start of a harrowing six-month journey to hospital discharge.
All the skills of Concord Hospital’s burns unit could not prevent infection taking hold in Miss Pitt’s wounded back and legs, and human skin – taken from cadavers and laid in strips over burns – represented her best chance of survival.
But the only facility that harvests and processes the temporary grafts had none in its bank – the result of policies that reduce its capacity to stockpile disinfected and frozen skin, leaving the nation dangerously dependent on imports.
”They wrapped me in plastic but that didn’t work. I was shocked that we didn’t have [donated skin] in Australia,” Miss Pitt said this week at her mother’s home in Ulladulla.
Her story has surfaced as part of a Heraldinvestigation into the global trade in human body parts by public and private institutions.
Miss Pitt was fortunate; the US bank had skin available, though its arrival was delayed several days while doctors organised customs and health clearances and a courier flight.
The Californian bank has turned down two of four previous Australian requests – during its own bushfire crisis, and when stored skin did not have family consent for export.
The head of the Victorian tissue bank, Stefan Poniatowski, said human skin had oxygen-conducting and infection-fighting properties unmatched by artificial substitutes, but it had to be changed frequently, meaning three or four donors were needed to treat one severely burnt patient. ”What Australia really needs is a national contingency reserve of skin. Australia needs to become self-sufficient.”
Of 20 to 30 requests a year, he said, ”a third of the time we won’t be able to facilitate the request”.
Mr Poniatowski said new privacy rules around deaths examined by the Victorian coroner – which provide the bulk of skin donations – made it more difficult to obtain medical histories, ruling out potential donors. As well, he said, legislation allowed tissue banks only to recoup strictly defined costs, affecting their ability to pay on-call retrieval technicians.
Federal government figures show there were 66 skin donors in 2011, 19 of whom also gave organs. Australia’s precarious skin supply reflects a wider malaise in tissue donation – of skin, bones, heart valves, tendons and corneas – as the government focuses on high-profile kidney, lung and heart transplantation programs, say people working in the sector.
Robert Herkes, NSW medical director of the Australian Organ and Tissue Authority, said the sector, run by state governments and charities, was ”tiny … and all funded by cost recovery”, severely limiting its capacity to pay for even essential capital items such as new freezers.
A report by the authority acknowledged there was ”a limited and irregular supply available to treat burns victims outside of Victoria”.
It said a newly licensed Queensland skin bank would treat patients in that state and ”may also be able to establish a stored supply of cadaveric skin … in the event of a serious disaster.”
Miss Pitt said: ”After what happened to me a lot of friends and family who weren’t donors changed that [on their driver's licence record]. I was already a donor but I didn’t tick the box for skin. I think maybe if people knew what it was used for and how it saves lives they’d be more willing to donate it.”
19 July 2012 , 10:11 AM by Elliott Dunn
First up on today’s show, Angela spoke with Chris Truitt from Wisconsin in the United States. He gave us an insider’s view into the business of organ and tissue donation in the US, just as a shortfall of donations in Australia is making local headlines.
Chris’ story of why he went to work for a tissue bank is a moving one.. and his reasons for leaving the business may unsettle you.
You can listen to Angela’s interview with Chris Truitt below. Angela started by asking Chris to explain the difference between organ donation and tissue donation.
Thank you to Joe Shapiro of NPR for a great piece on the problems with the tissue industry! Joe approaches the story in a ‘common sense’ mode, talking about the good that the industry does as well as the abuses that plague it. I had the privilege of being a part of the story. Check it out on the NPR site: Calculating the Value of Human Tissue Donation, Little Regulation Poses Problems Tracking Tissue, and Am I A Tissue Donor Too?
Told from the perspective of an industry insider and donor father, The Dark Side of Tissue Donation provides a unique, emotional, and disturbing perspective on tissue donation. Chris shares what the tissue banks don’t want you know; information that has for too long been too taboo to speak of, but information that every donor family must know before the choice to donate is made. You’ll learn what it’s like to be a donor father procuring tissues from other donors. You’ll find out what it takes to make it through a day in the life of a procurement technician. You’ll also be exposed to information that only those within the industry have been allowed to know; what really goes on behind the closed doors of operating rooms and corporate board rooms. Profiteering, a body’s worth, industry abuses, informed consent, organs and tissues for illegal immigrants, minorities and donation – nothing is too controversial and Chris covers it all. Get ready to find out what really happens in The Dark Side of Tissue Donation.
Just head to The Dark Side of Tissue Donation to order your eBook or paperback today.
eBook: $1.99 Paperback: $9.99