Originally created 06/14/06

Body parts business has few regulations



Don't worry, the doctor told Brian Lykins' parents, as he prepared to use cartilage from a cadaver to fix their son's knee.

A million people a year have operations that use tissue from donated dead bodies. The nation's largest tissue bank had supplied this cartilage. It was disinfected and perfectly safe, he assured them.

But it wasn't.

Four days after this routine, elective surgery, Lykins - a healthy, 23-year-old student from Minnesota - died of a raging infection.

He died because the cartilage came from a corpse that had sat unrefrigerated for 19 hours - a corpse that had been rejected by two other tissue banks. The cartilage hadn't been adequately treated to kill bacteria. The Georgia-based tissue bank, CryoLife Inc., knew that the donor had the germ and released the tissue anyway.

None of this broke a single federal rule.

And it could happen again today - likely is still happening today - because of shoddy practices by some in the billion-dollar body parts business and the lack of government regulation.

The industry is in the news because a New Jersey company is accused of scavenging corpses without families' permission and then selling those parts to tissue processors. But apart from this scandal, thousands more Americans each day are put at risk in more insidious ways by legitimate tissue suppliers.

A three-month investigation by The Associated Press found problems ranging from inadequate testing for potentially deadly germs to lack of a system for tracking tissues as they travel from donor to recipient.

At every step - from funeral homes, where the journey often begins, to hospitals and doctors' offices, where it ends with patients receiving the eyes, bones, skin and other parts of the dead - poor oversight invites abuse and creates danger.

It's worth noting that most tissue transplants involve reputable companies and do a lot of good. Olympic skiers, people who have lost eyesight and children born with bad hearts are among the millions who have benefited. But when things go wrong, the consequences are horrific.

Ken Alesescu died May 14 in his San Luis Obispo, Calif., home, victim of a fungus-infested heart valve.

Alan Minvielle, of Santa Cruz, Calif., lost a job and almost lost a leg to gangrene from a bad tendon.

Bonny Gonyer in Chippewa Falls, Wis., has pain and walks with a limp because of tainted tissue.

"It angers me when I read these stories," Pam Alesescu, the heart valve recipient's widow, said in an interview shortly before he died. "My kids are losing their dad, and I am losing my husband."

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'WE CONTINUE TO BE AT RISK'

The federal agency responsible for tissue safety, the Food and Drug Administration, is well aware of the problems. Its own report in 2001, 10 months before Lykins died, estimated that 519 cases of serious heart inflammation and 207 deaths occurred each year from fungus-contaminated heart valves alone.

Yet, many experts believe the rules it enacted last year as a long-promised overhaul fall short of providing the level of oversight needed. Each year, another germ is found to spread through tissue. Each year, the FDA inspects a smaller percentage of tissue businesses and doesn't even know how many there are.

When it does inspect, public health isn't always protected. In 2003, an FDA inspector saw that Biomedical Tissue Services - the now-notorious New Jersey company - wasn't documenting what it did with tissue unsuitable for transplant. The FDA let the matter drop after the company sent a letter saying it had fixed the problem. For two more years, thousands of people received tissue.

"I'm not surprised that a BTS (situation) occurred. And there will be others," said Areta Kupchyk, a former FDA lawyer who drafted rules that ultimately were adopted in watered-down form. "We continue to be at risk."

Here are some of the ways:

-A trade group, the American Association of Tissue Banks, requires accredited members to follow high standards, but without the FDA doing the same, hospitals and doctors can buy from unaccredited suppliers that offer tissue quicker or cheaper.

-Tissue isn't tested as thoroughly as blood is for infectious diseases. The tissue bank association bans use of tissue from donors with certain germs that can't be fully purged, but the FDA relies on catchall language saying tissue firms should not knowingly supply contaminated products.

-The FDA sets no age or health limits for donors; its rules do not prevent use of tissue from a 95-year-old cancer victim, as the New Jersey company did with "Masterpiece Theatre" host Alistair Cooke, for instance. The FDA also does not limit how long after death tissue can be taken.

-Funeral homes don't have to report deaths to organ procurement groups, leaving them outside a regulatory system and able to cut side deals to supply body parts.

-No unified system exists to track tissue, making it tough to know who got what when problems arise.

-Doctors often know little about the origins of tissue they use. Some hospitals buy it like surgical gloves and other supplies - based on price and availability. Patients are not always told they are receiving tissue from a cadaver or offered alternative treatments.

-Hospitals and doctors do not have to report tissue infections to health officials, and evidence suggests that many are missed. Lykins' infection was detected because it happened during the 2001 anthrax episode and doctors, suspecting that bioterrorism had killed him, investigated his death.

-The FDA requires no medical training to run a tissue bank or procure tissue.

-Consumers have few advocates. Big watchdog groups are not involved. Two congressmen recently proposed a bill but previous ones have gone nowhere.

And business is booming.

The number of tissues distributed for transplants rose from 350,000 in 1990 to 650,000 in 1999 and 1.3 million in 2003. A single donor can provide 100 products.

The number of companies also has grown, though it's a mystery how much. In 2001, the FDA estimated there were 114 eye banks, 110 "conventional" tissue banks, and hundreds of bone marrow banks, sperm banks, fertility clinics and other such firms.

Faulted by many for not even knowing the scope of an industry it is supposed to regulate, the FDA started requiring registration in 2001. Today, more than 2,000 companies and individuals are listed, but the FDA can't say how many separate businesses they represent.

What is clear, though, is that they vastly outgun the agency in resources. The FDA spends $5.4 million a year on tissue regulation - less than two days' revenue for the industry.

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SWIMMING IN CASH AND CLOUT

Federal law forbids buying and selling body parts but lets companies charge "reasonable fees" for procuring and supplying tissue, without limits on what is reasonable. A tendon that started out as a donation can wind up costing a recipient $1,000.

Tissue companies are awash in cash - even the nonprofits. The biggest is the Musculoskeletal Transplant Foundation Inc. of New Jersey. In 2004, it had $243 million in revenues and paid its chief executive $542,212 - more than the American Red Cross pays its chief to run an outfit 10 times larger.

Since 2000, top tissue businesses have spent more than $1 million lobbying Congress, including $490,000 in 2004 and 2005 as the government put finishing touches on the new FDA rules.

The FDA, on the other hand, lacks staff and money. Officials have asked for an additional $2.5 million and 10 people to better regulate tissue.

"Without this initiative, the American public risks an increase in preventable transmission of new and emerging infectious diseases," President Bush's 2007 budget request says.

Inspections of tissue businesses peaked at 285 in 2004. This year, the FDA expects about 250. Meanwhile, the number of registered companies rose from 1,325 two years ago to 2,030 now.

"I'm troubled at the fact that so much is happening so fast that neither FDA appropriations or staffing levels have kept up," said former FDA Commissioner Donald Kennedy, now editor-in-chief of the journal Science.

However, many gaps in oversight have nothing to do with resources, and stem instead from an FDA and Bush administration philosophy of not wanting to burden industry.

The FDA rules often state broad goals and let industry decide how to meet them. They say tissue should be tested for germs but do not specify the type or level of testing. Ditto for how tissue is disinfected. Some tissue, in fact, is not disinfected at all.

"We wish that we had more guidance from the FDA. We wish they would spell out what we need to do to make the products safe," said Carolyn Jacobs, microbiology chief at Bonfils Blood Center in Denver, a big testing lab.

An FDA quality and compliance official, Mary Malarkey, said she believes tissue is safe and that she would have no qualms about receiving it.

"I do actually have family members and friends who have," Malarkey said. "I take that very seriously."

The FDA's rules are clear enough on what companies need to do, she insists. For example, on procurement, "you have to recover each (tissue) in a way that does not cause contamination or cross-contamination," Malarkey said. "Yes, that is very broad. That is very flexible as to how someone would achieve that. But I will tell you we have used and will continue to use that" to sanction companies handling tissue improperly, she said.

The trade association's president, James Forsell, a tissue bank executive himself, said that most big companies are association members and that consumers are protected by his group's accreditation process even though "we do not have badges" and force of law, as federal officials do, when making inspections.

CryoLife was not accredited when Lykins and others got contaminated tissue, but is now.

If a non-member like BTS wants to falsify records or ignore proper procedures, "there is precious little that can be done," Forsell said.

But many see danger in allowing an industry group to police itself, especially since top tissue bank members run its board. Industry leaders say BTS is an extreme aberration, but it still exposed holes in the system that could be plugged to make tissue safer.

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CUTTING DEALS TO SUPPLY TISSUE

Blood is regulated by the FDA and supplied by the Red Cross and an association of independent blood banks. Organs are governed by a heavily regulated system run by the federal Health Resources and Services Administration.

But tissue banking is private enterprise, even though, like blood and organs, its products start out as donations.

A few years ago, some people working for organ procurement organizations were earning fees on the side for supplying tissue once organs had been removed. After news reports exposed the conflict, many organ groups severed ties with private tissue companies. Now the BTS scandal has revealed a new group able to cut side deals with tissue firms: funeral homes.

"If we simply required funeral homes to report deaths" to organ procurement groups as hospitals do, it would get them into a more regulated system, said Dr. Michael Bauer, a Denver blood center doctor who alerted officials to BTS' tissue practices.

U.S. Sen. Charles Schumer of New York proposed a bill to bar funeral homes from tissue deals but the National Funeral Directors Association successfully lobbied to kill that provision.

Little tissue procurement takes place in funeral homes, association president Bob Biggins contends, so "regulation isn't always the answer."

How and where tissues are procured is important because of the risk of infection. That depends not just on sterile conditions (one federal report said more than half of heart valves removed in open morgues were contaminated with germs) but also on who screens donors.

"Unlike blood donation, you're not talking to the donor," because the tissue donor is dead and can't answer questions about risks, like sex behavior and travel where certain diseases are common, said Dr. Matthew Kuehnert, a blood and tissue safety expert at the federal Centers for Disease Control and Prevention.

Some studies suggest that tissue donors are riskier. A Canadian study found a higher rate of hepatitis and HIV in cornea donors than is typically seen in blood donors. An American Medical Association report noted that an autopsy study of 94 donors who had satisfied all existing criteria for donation found potentially transmissible diseases in about 4 percent.

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FOOT-DRAGGING ON A SAFETY TEST

To rule out disease, the industry has long relied on tests that look for antibodies - substances the body produces in response to a germ. But these can take months to form, meaning that more recent infections can be missed. A newer method, nucleic acid testing, or NAT, finds genetic particles of the germs themselves immediately.

Blood centers started using it in 2001 to test for HIV and hepatitis, but the FDA did not require tissue banks to do the same. Instead, the agency insisted on extensive studies of tissue samples taken after death to validate that the tests were accurate in cadavers.

What this approach ignored is that in many cases, blood samples taken before a donor's death are available and can be tested to rule out infection. One such sample retrospectively proved that 40 people had received contaminated organs and tissue after an Oregon bank using the older antibody test missed hepatitis C in a donor in 2002.

"That hepatitis C case clearly made NAT testing the standard of care," and many tissue banks voluntarily started using it, Bauer said. A study found it would add less than $5 to a product's cost.

Bonny Gonyer would have gladly paid that to keep from getting contaminated tissue as she did in her 2001 knee operation.

"I'm now crippled," she said, an athletic woman no longer able to enjoy skiing or even playing in the yard with her children. "I can't kneel, I can't crawl. I can't bend my knee past a 90-degree angle."

Two NAT tests now are licensed for use on cadavers and the tissue bank association requires members to use them. The FDA still does not. Malarkey said she expects the agency will at some point in the future, and in the meantime has communicated "an expectation" that they be used.

Even when tissue starts out germ-free, germs can enter during processing. Tissue treatment is supposed to kill or disable germs, and involves radiation and chemicals. Bone can hold up to heavy processing, ligaments less, and cartilage very little without destroying its structure. Tissue Banks International, Forsell's company, became the first to use a system by the biotech firm Clearant that allows higher doses of radiation. Although it can't be used on heart valves or skin, 10 companies now use it to treat bone and spine tissue.

"The Clearant system is, in my mind, the best solution I see" for disinfecting tissue better, said Dr. Chris Larson, an orthopedic surgeon at Allina Medical System in Minneapolis who is doing an effectiveness study as a consultant for the company.

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DOCTORS UNAWARE OF RISKS

Doctors don't understand the risk of tissue they are using because "it comes in a nice package, it looks sterile," the CDC's Kuehnert said.

"Most physicians don't even know the questions to ask," said Dr. Ty Endean, a Tucson, Ariz., orthopedic surgeon who also consults for Clearant. "They order tissue and they leave it up to the surgical center at their hospital. And those people are just going on price."

Often, the people who order tissue for operations do not know how it was treated or even all the companies that handled it - just who sold it to them. When the BTS scandal broke, some hospitals did not even realize their tissue had come from an unaccredited supplier because they dealt only with a middleman.

Until last year, hospitals had no rules for tissue storage or record-keeping. The Joint Commission on Accreditation of Healthcare Organizations' new standards now cover most hospitals but less than one-fourth of outpatient surgery centers and almost no doctor offices.

The rules do not require hospitals to use accredited tissue banks or to report infections to health officials, although they must tell suppliers.

Kuehnert, of the CDC, wants a uniform system to trace tissue instantly from donor through processors to recipients.

"This is a daunting task, but it is doable," especially with new technology like the bar-code system blood banks recently adopted, he said.

It's doable if people want it, believes Steve Lykins, father of the Minnesota student who died.

"What the tissue companies did when Brian died was legal. The problem was, there were no laws out there to break," he said. "Any one of us could have opened a tissue bank in our garage. We could have hired the neighborhood kids who were interested in science to work for us."

Lykins and his wife, Leslie, made many trips to Washington, lobbying for change.

"We didn't want to be sitting around watching TV and hear of another case where someone had lost a son like we lost Brian and know that we didn't do anything about it. We worked very hard for quite a while to encourage the FDA to start regulating this industry," he said.

Now there are hundreds of pages of rules, but "we still have an uncontrolled industry on many different levels," said Don Keenan, an Atlanta lawyer who settled dozens of lawsuits on behalf of the Lykinses and other tissue victims. "We've seen case after case point out where those loopholes are. If anything, people have this false impression somebody's looking out for them."

People who have worked for the FDA are among those most adamant that more needs to be done to ensure tissue safety.

"When an industry feels like its feet are not held to the fire, it feels emboldened not to care," said William Hubbard, longtime FDA associate commissioner for policy and planning.

"The tissue industry was an example of a nascent industry that needed a firm regulatory hand," he said. "It never got a firm regulatory hand."

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Associated Press medical writer Marilynn Marchione reported from Milwaukee; science writer Seth Borenstein reported from Washington; contributing to this story were AP writer Adam Goldman in New York, biotechnology writer Paul Elias in San Francisco, medical writer Lindsey Tanner in Chicago and researcher Rhonda Shafner in New York.

Who to contact for quality-checking donor tissue industry

Here are some contacts for checking whether tissue banks and others who handle donated human tissue are in good standing:

-The American Association of Tissue Banks' Web site has a list of accredited tissue banks nationwide, including locations and phone numbers: www.aatb.org; for more information, e-mail aatbaatb.org or call 703-827-9582.

-The Association of Organ Procurement Organizations' Web site has a state-by-state list of organ and tissue procurement groups it accredits, including phone numbers: www.aopo.org. For more information, e-mail aopoaopo.org or call 703-556-4242.

-The Joint Commission on Accreditation of Healthcare Organizations, has detailed tissue-handling guidelines for hospitals and surgery centers it accredits. Call 630-792-5800 to check accreditation status or request a quality report; Web site at www.jointcommission.org.

-The Council of Better Business Bureaus' Web site has a locator list for local Better Business Bureaus, and has a "check an organization" page where consumers can plug in the name of businesses including funeral homes to check any complaints or regulatory action: www.bbb.org or call 703-276-0100.

Multitude of nasty bugs can come from donor tissue

Many viruses, bacteria and other germs have spread to people through transplants of tissue from cadavers or organs from live donors. It's not known whether cancer can be spread through this process. Here is a look at cases reported over the years:

Fungus - More than 500 heart valve transplants each year are believed to be contaminated with fungus, leading to an estimated 207 deaths a year.

Hepatitis C - Cases in 1992, 1995 and 2002. More than 40 people received contaminated organs or tissue after an Oregon tissue bank failed to detect the virus in a single donor in the 2002 outbreak. One likely died as a result.

Hepatitis B - 1954. One tissue transplant.

HIV - 1983 and 1992. Four tissue transplants.

Clostridium, "flesh-eating," and other types of bacteria - November 2001. A Minnesota man's death led to discovery of more than 60 other bacteria-contaminated transplants in 20 states, including some tissues infected with multiple types of bacteria.

Cytomegalovirus, or CMV - Cases have occurred involving donated skin.

West Nile virus - August 2002. Several organ recipients developed fever and altered mental status from virus-contaminated transplants.

Rabies - 2004. Three organ and one tissue recipient die after contaminated transplants.

Chagas Disease - April 2001. Three people caught this parasite, common in Latin America, from organ transplants from a common donor.

LCMV, a rodent virus - May 2005. Three people died after receiving contaminated organs. Others received tissue from the same donor. Three others died in December 2003 after receiving organs infected with LCMV.

Tuberculosis - 1953. One tissue transplant.

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Sources: Food and Drug Administration, Centers for Disease Control and Prevention, American Academy of Orthopedic Surgeons, various science journals.

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