Veterans exposed to cadaver parts from contaminated lab

By Kathleen Miller, Bloomberg NewsBloomberg11:20 p.m. CST, January 24, 2014

WASHINGTON — The Department of Veterans Affairs ordered $241 million of cadaver tissue and other material derived from human and animal bodies in the last three years, some of it from vendors warned by federal regulators about contamination in their supply chain.

About $4.7 million of the VA purchases came from Alachua, Fla.-based RTI Surgical Inc. and the nonprofit Musculoskeletal Transplant Foundation, of Edison, N.J., according to data obtained by Bloomberg News under a Freedom of Information Act request.

The VA ordered human tissue from the two suppliers after they were warned by the FDA for safety deficiencies — RTI for contaminated products and processing facilities, and Musculoskeletal Transplant for distributing tissue from tainted donor bodies, according to federal contracting data compiled by Bloomberg.

http://www.chicagotribune.com/news/sns-wp-blm-news-bc-cadavers24-20140124,0,2117850.story

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When Organ Donation Relies on Facebook, Something Is Wrong

 

EMILE THERIEN
Special to The Globe and Mail
Published

That some Canadians are turning to social media in search of donors indicates the troubled state of organ donation in this country. The deceased donation rate in Canada, according to experts, is half that of those countries with the best rates, including Australia, the United States and Spain. The U.S. and Spain have 30 to 32 donors for every million people compared to 16 for every million people in Canada….

http://www.theglobeandmail.com/globe-debate/when-organ-donation-relies-on-facebook-something-is-wrong/article16252673/

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Law Enforcement Overrides Organ Donation Consent from Young Murder Victim’s Family

From WISC-TV in Madison, WI:
Family of Brayden Turnbill blocked from donation organs
Rock Co. coroner says block organ donation is rare
 
 
MADISON, Wis. – WISC-TV has learned the family of a 5-year-old alleged child abuse victim was blocked from donating his organs.

The Dane County District Attorney’s Office confirms they filed a restraining order in the matter.

Dane County Medical Examiner’s Director of Operations Barry Irmen said this is the first time in the state that this has happened, and that his office and the DA’s office got a judge to block the organ donation to preserve evidence.

Five-year-old Brayden Turnbill died on Oct. 24 at UW Hospital after being taken from his home with head and chest injuries that investigators say were from child abuse.

Turnbill’s family members said they consented to donating his organs, but Assistant District Attorney Tom Fallon confirms that the DA’s office stepped in, arguing to Judge Peter Anderson in a morning hearing on Oct. 24 that the body needed to remain completely intact to determine the cause and manner of death. Those court proceedings are sealed, but Anderson granted the restraining order and Turnbill had life support removed and died that evening.

Read more: http://www.channel3000.com/news/family-of-brayden-turnbill-blocked-from-donating-organs/-/1648/23057196/-/wcgm6k/-/index.html

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Woman declared ‘dead’ awakens just before doctors harvest her organs

Woman declared ‘dead’ awakens just before doctors harvest her organs

Imagine waking up to see operating room lights and doctors standing over you, armed with scalpels and other operating tools.

That’s exactly what happened to 41-year-old Colleen Burns, who had arrived at the emergency room at St. Joseph’s Hospital Health Center in Syracuse, N.Y., over a week earlier suffering from a drug overdose, Counsel and Heal reported.  Mistakenly believing Burns to be dead, doctors at the center were about to harvest the woman’s organs for transplant, before she opened her eyes.

Read more: http://www.foxnews.com/health/2013/07/09/woman-thought-to-be-dead-awakens-just-before-doctors-harvest-organs/?test=latestnews#ixzz2ZqIc2sTi

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Bidding for Bodies in Waukesha, WI (Fox 6 Milwaukee WI)

A huge thank you to Meghan Dwyer from Fox 6 in Milwaukee, WI for catching this and bringing it to the attention of the general public!

FOX6 Investigators: Bidding for bodies

MILWAUKEE (WITI) – In Wisconsin, when you sign up to be an organ donor, you are also signing up to donate your tissue. Tissue is everything that’s not a living organ, like skin, veins, heart valves, and tendons.

And while buying and selling human body parts is illegal in the United States, tissue banks and publicly traded companies are making a lot of money on human tissue.

Chris Truitt, who lives just outside of Madison, Wis., is an expert of sorts on the issue. His daughter, Alyssa, died when she was only 2 years-old. Truitt and his wife decided to donate her organs and her tissues.

Truitt says he was so moved by the process, he wanted to become part of it. He quit his job, and became what’s called a tissue procurement technician – someone who strips human bodies of tissue after they die.

“I just kinda woke up one day and decided you know what, I need to do this,” Truitt says.  He took a job at a tissue bank in Madison. Late at night he’d get the call that someone died. He’d rush to the scene. He did that for five years until something changed.
“We were eventually bought out by a for-profit company and through that transition of course we switched from doing what’s right by the donors, being stewards of the gift, to monitoring the bottom line,” Truitt says.

It’s what he calls the dark side of tissue donation. The more tissue you can salvage, the bigger the profits, even if that means essentially butchering a body. At one time, he says, he and his colleagues were competing. Whoever could strip the most skin off a body was rewarded.

“You know there’s a price tag on every piece of tissue a human has. You can put a price on a bone, you can price on a square inch of skin and it turned it to making sure we got all those pieces of bone, all that skin, maximizing the profits. I just couldn’t do it anymore,” Truitt says.

Tissue banks like the one Truitt worked for get tissue from a variety of sources like funeral homes, hospitals and morgues.
In February, Waukesha County did something did something nobody else had ever done in Southeast Wisconsin. The medical examiner asked tissue banks to compete for the exclusive right to recover tissue.  Truitt calls it “bidding for bodies.”

In the United States, the 1984 National Organ and Transplant Act prohibits buying and selling organs and tissues. But there’s a loophole. Agencies can recover the reasonable costs of collecting body parts.

In other words, tissue banks and tissue companies set prices for the tissue they collect and eventually sell. Morgues get “reimbursed” by tissue banks for the use of their facility. In Milwaukee County it’s a fixed cost. Tissue banks pay $7330 a month to use the morgue. In Sheboygan, it’s $750 every time a tissue bank uses the facility. The costs are supposed to be set ahead of time – not set per body.
“There are expenses for the supplies, there are expenses for shipping, so there has to be some way to reimburse the people doing the procedures,” Truitt says.

When Waukesha County put a tissue contract out for bid instead of setting a fixed cost for the use of the morgue, eyebrows raised.
An attorney for the Blood Center of Wisconsin wrote in a memo to the Waukesha County Board “the highest bidder approach is unlawful.” The Blood Center said it was illegal for the county to “profit from human tissue donations.” See the letter, here.
Notwithstanding that position, the Blood Center — who held a previous contract with the county for donor services — still put in a bid. The medical examiner said her costs were around $60,000 last year, so that’s where the minimum bid was set and that’s what the Blood Center bid. Another tissue bank, based in Madison called RTI Donor Services, bid $15,000 more. The contract went to the highest bidder, but the medical examiner insists it wasn’t about the money.

“It can’t be driven by money, my choice of tissue bank,” Dr. Lynda Biedrzycki explained to the Waukesha County Board’s finance committee. She implied that she wasn’t happy with her past working relationship with the Blood Center, and said she had little to do with the decision to bid out the contract. She told board members the purchasing department made that decision, to streamline billing.

The County’s Assistant Corporation Counsel, Erick Weidig, tried to justify putting the contract out for bid, by saying the extra $15,000 was merely reflective of what the state-of-the-art morgue was worth to RTI.

“We chose to use the bid process because we thought that process most fairly allowed the county to accurately recover what its costs would likely be,” Weidig explained.

Some board members say they never got the letter from the Blood Center. Those that did, however, overlooked the allegations of illegal bidding, saying they trusted advice of corporation counsel that the process was in fact legitimate.

When the full board got together only two board members voted no to the contract — not because they had a problem with the bid process — but because they say they had a problem with RTI Donor Service’s business practices.

Board Member Jennifer Grant, who voted no to the contract, said RTI isn’t an agency she’d want to work with. “I voted my conscience,” she says.

The winning bid meant an extra $15,000 to the county, but it means even more to the tissue bank. Truitt says a single body can be worth $80-100,000 in tissue. Hospitals will pay big bucks for implants and recipients will shell out for costly medical bills. According to their financial statements, even not-for-profit tissue banks are making millions of dollars a year.

“Profits can be very important in this industry, as with any medical industry. Profits are what drives research. Profits are what drives innovation. Profiteering takes it one step farther,” Truitt explains.

“You know to put it simply, profits are doing something for the greater good. Profiteering is turning those into your Lexus in your driveway or your beach house in Maui,” Truitt says.

The Waukesha County contract went to RTI Donor services, a not-for-profit tissue bank.  Truitt says much of the tissue it takes from bodies in Wisconsin is given to it’s for-profit arm, RTI Biologics, a publicly traded company that, according to financial reports, relies on tissue to make money. Last year RTI Biologics reported it made $85 million in gross profits. Financial reports show its CEO made more than $1.5 million.

Truitt admits some families and some donors may have no problem with that, especially because human tissue implants can greatly improve quality of life. But he says tissue donations are supposed to be respected gifts — not a vehicle for a total stranger to turn a profit.

The tissue industry doesn’t seem to want to talk about it. RTI refused an interview, only saying in a voicemail that it has been facilitating safe tissue in Wisconsin for 15 years.

The Blood Center of Wisconsin wouldn’t sit down with us, either.

The American Association of Tissue Banks asked us not to refer to tissue donations as an industry because it “sounds inhumane.” When we pointed out their own CEO calls it an industry another company executive told us “he’s new,” and refused to answer anymore of our questions.

“For many years it made me physically ill after I went down to the headquarters of the tissue company and saw all the nice cars sitting in the parking lot,” Truitt says. Those cars are there because of the money they made off of my daughter’s heart valves and that is just wrong.”

Wrong — but not black and white.

Truitt is no longer a tissue donor, but he doesn’t want to discourage people from donating. He just wants more oversight and more regulation of the tissue industry before he signs up again.

“If you asked the burn victim is it worth it – you got the skin your life was saved – they`ll tell you absolutely. If you ask the person that gets the heart valves, or the veins, or something else, was it worth it, they’ll say well you know it saved my life so yeah. If you ask the donor families? I don`t know anyone who would say profiteering is a good thing. It’s just, it’s not worth it.”

Truitt says attaching such big price tags to tissue incentivizes people to cut corners. For example, he says, people are more likely to illegally harvest tissue, and tissue banks are more likely to accept “dirty” tissue without making sure all paperwork accompanying the body is legitimate.

Wisconsin residents who want to opt out of donating their tissue can simply write “NO TISSUE” on the back of their driver’s licenses. If you are interested in donating your tissue to a specific tissue bank, you need to specify that in a will or other legal document.
If you’d like to sign up to be an organ or tissue donor, go to this website.

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Spinal Elements®, Inc. Announces Nationwide “Pledge to be a Hero” Program

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.

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US Military Changes Tissue Policy

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…”

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Tissue Seizure Raises Specter of Tainted Medicine

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

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Why Am I Speaking Out Against Tissue Donation?

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.

 

 

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