For-profit body-part, tissue-industry practices under increasing scrutiny

A News 12/Newsday probe into organ donations found that for-profit companies turned donated bones and tissue into a host of cosmetic products.

Every day across Long Island, body parts collected from the dead are used to help the living.

These parts have myriad uses -- skin grafts for cancer patients, ligaments for damaged knees, bones to strengthen spines and even dental implants.

They are part of a $1-billion for-profit worldwide trade in human body parts that advocates say improves patients' lives.


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Locally, North Shore-LIJ Health System -- New York State's biggest hospital group -- spent $3.7 million in 2012 for cadaver tissue used in surgery, obtained from vendors approved by the U.S. Food and Drug Administration.

This brave new world in medicine faces increasing scrutiny by government and health care critics, who express concerns about whether body parts are adequately regulated and obtained with proper donor consent. They also say a system should be put in place so that body parts can be tracked from donor to patient.

"People have no idea that their tissue can be donated to a for-profit company as well as a not-for-profit," says George Annas, a bioethics expert at the Boston University School of Public Health, about the current system.

Experts say this growing for-profit market in body parts differs markedly from the established not-for-profit organ donation system, which depends largely on local volunteer sources for hearts, lungs and kidneys. Instead, with an increasing number of uses for human tissue, a Newsday and News 12 Long Island investigation has found that moneymaking firms made bone, skin and tissue available to Long Island facilities, some taken from cadavers as far away as Ukraine, records show.

Though it is illegal to sell body parts in the United States, current law allows private companies to charge fees for the collection and processing of human tissue. This has opened the door for a new industry providing skin, bone and tissue to clinics for everything from sports medicine to cosmetic surgery.

"It is different -- there's no question -- from the organ donor network," says Kevin Dahill, president of the Nassau-Suffolk Hospital Council, which represents 24 hospitals. "We, the hospitals, have a lot more involvement with the not-for-profits."

Both organ and tissue distribution systems rely on cadavers provided as a "gift of life" by donors. Yet, an organ donor who checks off a box on a New York State driver's license application may not fully understand that his or her skin, bones and other tissue may end up with a firm that can collect as much as $100,000 in fees per cadaver for those parts.

"There is a huge opportunity for misconduct," says Harvard Business School associate professor Michel Anteby, whose 2010 study of the use of cadavers in New York hospitals also looked at this growing trade in human body parts. "It's difficult to control missteps, especially when a body gets cut into many parts, and the tracing and screening becomes very difficult."

 

Uncertain origin

Federal health officials worry that doctors and their patients don't always know the provenance of the parts, and how and where they were obtained. Although even retail store items commonly are given bar codes so they can be traced back to their source in case of problems, human body parts used every day by doctors have no such codes, they say.

Inside a North Shore-LIJ operating room in Manhasset last year, Dr. Nicholas Sgaglione implanted a cadaver ligament into patient John Cascone's right knee. Neither the doctor nor the patient knew where the ligament originated.

"It's not important to me who it came from," explained Cascone, 41, a real estate appraiser from East Northport, in an interview last year. "You trust your doctor and hope it will go successfully."

Both hospital and patient relied on one of several FDA-approved tissue vendors serving Long Island hospitals to ensure the ligament was obtained with the donor family's consent and tested and treated to avoid HIV, hepatitis and other possible infection.

"Donor tissue and donor availability has tripled in the past 10 years," says Sgaglione, North Shore-LIJ's chair of orthopedics. "However, there remains a need to be very careful and to scrutinize the practice of the tissue banks that are offering these products, because not all tissue banks are alike."

 

Dentist's crimes exposed

Long Island hospitals and patients learned about the dark side of the trade in human tissue when local authorities in Brooklyn exposed in 2005 a criminal enterprise by former dentist Michael Mastromarino.

His New Jersey recovery firm paid funeral homes in three states $1,000 for each cadaver, which were then cut up and distributed without any medical testing and without the consent of donors or their families, according to court papers. Some of the body parts from these cadavers were implanted into at least 70 Long Island patients, records show.

Former New York City undercover cop William Hale, of Ridge, received a letter from New York State health official after the Mastromarino case broke informing him that a bone transplanted into his neck in November 2003 at St. Charles Hospital in Port Jefferson had been stolen from a diseased body taken from a Brooklyn funeral home.

"I was shocked -- my heart skipped a beat -- I couldn't believe what I was hearing," recalls Hale, 45, who says he has not suffered any health problems from the transplant.

Some families whose loved ones' bodies were illegally harvested by Mastromarino sued RTI Biologics, a Florida for-profit tissue vendor, for allegedly not properly monitoring his activities. RTI has denied the charges in court papers. A scheduled Oct. 22 civil trial in Staten Island was postponed amid appeals of legal arguments.

In 2012, RTI and other tissue vendors settled lawsuits from the Mastromarino case brought by some patients, including Hale. Hospital officials say no sicknesses have been reported among the Long Islanders who received these parts.

RTI Biologics officials declined to be interviewed for this story. However, the company has said it follows all federal guidelines to ensure the health and safety of their products.

"I was devastated that this was done to my father," says Stacy Brooks of Farmingville, who learned that her 79-year-old father's remains -- which she thought had been cremated -- were actually cut up by Mastromarino's firm, according to court papers. "I know this was done without my father's permission. His will didn't say anything about allowing anyone to use his body parts."

Mastromarino is serving a 15-30 year sentence as a convicted body-snatcher and is now ill with cancer, a prison official said. In a jailhouse interview outside Buffalo last year, Mastromarino characterized himself as a middleman for top tissue vendors.

 

Reliance on vendors

Since the Mastromarino case, Long Island's biggest hospitals have continued to use both for-profit and not-for-profit vendors without any known health problems, officials said.

Stony Brook University Hospital and Nassau University Medical Center say they rely on tissue banks to follow proper procedures with donors.

"During the normal course of business, North Shore-LIJ does not get detailed donor and origin information for tissue," explained spokesman Terry Lynam. "The donor information is maintained by the vendor/tissue bank."

Chris Hendriks, spokeswoman for Catholic Health Services of Long Island, which runs several local hospitals, said "the vendors, not the hospitals, know where the tissue comes from."

U.S. Food and Drug Administration officials declined requests to be interviewed for this story. In a written response to questions, however, the agency said vendors who supply medical facilities with cadaver parts are responsible for following its health and safety regulations.

Overall, more than 1.5 million body parts are distributed in the United States each year, but government and industry experts say the chance for infection is remote. FDA records show 40 suspected fatalities linked to cadaver tissue from 2002 to May 2012 nationwide. During that same period, a computer analysis shows, the FDA received 1,352 reports of "adverse" infection or illness linked to cadaver transplants.

Tissue vendors like RTI say the current system, mostly overseen by the FDA, involves regular inspections and responds adequately when problems arise.

But in December 2011, the national Centers for Disease Control and Prevention warned of cracks in the existing safety system. Agency officials said poor traceability methods slowed their investigation that year of 43 bones and tissue samples -- taken from a dead Kentucky man infected with hepatitis C -- that were sent around the nation. Fifteen were implanted in other patients, including a child in Boston who received a heart patch made of tissue that later tested positive.

"Oftentimes, there's an awkward silence. They say: 'We don't know where it went,' " said Dr. Matthew Kuehnert, the CDC's director of Blood, Organ, and other Tissue Safety, last year.

 

Need to regulate better

As today's medical world finds more profitable uses for human tissue, the existing regulatory system must make sure donors are fully informed, says Laura Siminoff, chairwoman of the Department of Social and Behavioral Health at the School of Medicine at Virginia Commonwealth University and an expert on the industry.

"It's not the job of doctors to regulate tissue and they can't be expected to have this burden placed on them," said Siminoff. "I think we need to regulate this better as we do with organ donation." She said adequate "informed consent" surrounding the use of dead bodies is particularly important.

Currently, about 18 percent of New York adults have a red heart symbol on their state driver's license, which means they have agreed to be unpaid donors of lifesaving organs and tissues when they die. After checking with a state-run registry of donors -- or securing the permission of survivors -- hospitals can allow private vendors as well as FDA-approved not-for-profit groups to use needed body parts.

But Siminoff said donors and their families generally don't know that their "informed consent" also means body parts can be sold by for-profit vendors for purposes such as cosmetic surgery and as bone paste for dental repairs.

 

A worldwide issue

Concerns over tissue donations are not confined to the United States.

In February 2012, police in Ukraine discovered human skins and other cadaver parts in the back of a minibus. The official Security Service of Ukraine said families had been tricked with false information and consent "fraudulently obtained" before their loved ones' bodies were cut and body parts illegally removed, according to the agency's statement.

RTI Biologics and its subsidiary, Tutogen Medical, have acknowledged importing tissue from Ukraine and making it available to U.S. hospitals and clinics, FDA health records show. According to a 2008 New York State health inspection, the last one by the agency, Tutogen made tissue from Ukraine available to Long Island hospitals and others in the state gathered from seven Ukrainian recovery sites. It is not clear if any hospitals ever used such material, a state health department spokesman said.

In September, RTI said it "made a decision to voluntarily suspend import of tissues" with state-owned suppliers in Ukraine, where authorities have carried out multiple investigations over allegations of illegal tissue recovery.

Experts like Siminoff and Annas say tougher federal regulation is needed of this increasingly complex and global market in body parts.

In the wake of the Mastromarino case, Sen. Charles Schumer (D-N.Y.) proposed a "Safe Tissue Act," requiring better oversight of the industry. The bill failed to move ahead.

For his part, Cascone said he is grateful for his improved knee. "I'm happy to be walking around and being able to play sports with my kids," Cascone said.

Doctors have assured Hale he's no longer at risk of getting hepatitis C or any long-term problem, but he remains worried.

"It's there in the back of my mind, and I had to make peace with it," said Hale. "I don't know if anything will ever come of it. Nobody does. Nothing like this has ever happened before, so nobody can say."

The International Consortium of Investigative Journalists contributed to this story.

 

DONATION FACTS

According to state and medical experts:

-An estimated 18 percent of New Yorkers agree to be organ and tissue donors, granting legal consent for the recovery of organs, tissues and eyes for the purposes of transplantation and research at the time of death.
-By checking off a special box on a driver's license application, New Yorkers can agree to be donors, with their names then placed in a statewide registry. State Board of Elections and health departments have similar procedures. In confirming their consent with the state registry, potential donors can limit the terms and purpose for their donation.
-State health officials say a single donor of organs -- such as heart, liver, kidneys and others -- can save up to eight lives, while a tissue donor (bone, skin, heart valves, tendons, corneas) can improve 12 or more lives.
-Organ donation is primarily handled by not-for-profit agencies. But in recent years, tissue recovery has increasingly involved for-profit companies that pay for processing, transportation and other fees related to bone, skin and tissue ultimately provided to medical and dental clinics.

 

Sources: New York State Dept. of Health, New York State Dept. of Motor Vehicles, U.S. Food and Drug Administration, The Lancet

Related information:

Three-part NPR "All Things Considered"

NYS Department of Motor Vehicles: Organ and tissue donation

Four-part International Consortium of Investigation

NYS Health Department: Organ and tissue donations

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