The Body Brokers — Part 4: Gatekeepers

By Ronald Campbell,
William Heisel and Liz Kowalczyk
April 18, 2000


Scarce scrutiny

The Feds and industry say our tissue supply is safe, but inspections are rare, and statistics on tissue-linked illnesses don't exist.

Human-tissue transplants have caused AIDS, hepatitis and even rabies, but they're subject to less regulation than a kitchen toaster. The U.S. Food and Drug Administration supervises tissue banks but says it doesn't know how many exist. FDA and industry leaders say the nation's tissue supply is safe. But an Orange County Register investigation found gaping holes in the safety net:

No hard statistics back up industry and FDA safety claims. Regulators have focused on a handful of high-profile health threats but have not studied the long-term effects of tissue transplants. None of the federal government's primary health investigators -- the FDA, the Centers for Disease Control and the National Institutes of Health -- routinely tracks deaths or illnesses affecting tissue recipients. A cadaver suspected of carrying disease may be rejected by one tissue bank but accepted by another bank and its tissue sent out to patients.

There are so few inspectors that tissue banks can escape inspection for years, even if the most recent inspector found significant problems. California, one of four states that regulates tissue banks, has not inspected any in nearly two years.

Doctors and hospitals are not required to inform patients who received diseased transplants when tissue is recalled so that they can monitor their own health. "There isn't even a way for FDA to communicate with all tissue banks," said Margerie Moogk, program director of Pacific Northwest Tissue Bank in Spokane, Wash. "You just aren't used to thinking about there being that kind of gap in regulatory authority, particularly (for) something that's going into the operating room."

Congress considered regulating the industry 16 years ago. The nation's Lions Clubs, fearing that federal rules would hamper their eye banks, helped kill the proposal. It took a series of medical surprises to shock the federal government into action.

The first came in 1991, when Colorado health officials learned about a 77- year-old woman with HIV. They could find only one possible cause for her infection: She had received a new hip bone from a cadaver in 1985. The donor, a Virginia shooting victim, had tested negative for HIV when he died. Six years later, more-sophisticated tests conducted on frozen tissue samples showed he did have the virus. Six other recipients of his tissue tested positive for HIV, and two of them died of AIDS, before experts connected the cases to the tissue donor.

A second surprise came in 1993, when the FDA learned that a few tissue banks were distributing untested or poorly documented human tissue from Russia and Eastern Europe. That prompted an emergency FDA rule requiring that every donor be tested for HIV and for hepatitis B and C. Four years later, Japanese scientists nailed down a suspected link between transplants of dura mater, the outer lining of the brain, and Creutzfeldt-Jakob disease, a deadly neurological infection linked with mad-cow disease. The FDA followed up with a proposal for rigorous testing of dura donors.

Leaders of the tissue-bank industry say mandatory testing has virtually eliminated the threat of AIDS or hepatitis infection from tissue products. A leading expert on Creutzfeldt-Jakob Disease, Paul Brown of the National Institutes of Health, said that because of the new FDA guidelines, "I don't think we'll ever see another case of dura-mater CJD in this country."

The new guidelines came too late for Karen Bissell, who may have been the last American to contract Creutzfeldt-Jakob from a dura mater transplant. She received the transplant during brain surgery in 1992. "We at the time had no idea that they had used this patch," her mother, Eleanor Bissell, said. "We had no idea until we went into the hospital last September (1998)." Karen Bissell became ill in June 1998. The disease progressively stole her sight, her ability to walk and her consciousness. She died that September.

With these notable exceptions, human-tissue products have a superb safety record, industry leaders say. For example, dentists have been using powdered cadaver bone to treat severe gum disease for nearly 30 years. It is the most-common medical use of human tissue, used in 200,000 patients last year, according to industry estimates. "There's never been a single case of disease transfer," said Woodland Hills periodontist Robert Merin, president-elect of the California Society of Periodontists.

But Hessam Nowzari, director of advanced education in periodontology at the University of Southern California, argued that there is no proof for that assertion. If a patient developed kidney problems some years after gum surgery, he asked, would anyone think to link the two?

The FDA is focusing on the documented dangers of human tissue, not the theoretical ones. Its main weapons are surprise inspections of tissue banks and recalls of suspect tissue. Since 1993, it has conducted about 200 inspections and recalled more than 15,000 tissue products. "We're trying to develop a framework keyed to risk," said Bill Hubbard, the FDA's senior deputy commissioner for policy. "We didn't want to overregulate these products, but at the time (in 1993) they were fairly unregulated."

The FDA sets much-lower obstacles for human-tissue products than it does for more traditional medical products. The FDA requires years of testing for new drugs and artificial medical devices. Once they are approved for sale, their makers must tell the FDA when a patient is hurt.

But tissue bankers have argued, and the FDA has agreed, that products made from the human body don't merit such scrutiny. Unlike drugs, they don't alter the body's biochemistry. Unlike medical devices, they don't change the body's normal functions. So the FDA does not review the vast majority of products made from human skin and bones prior to sale. It does not know when a tissue product comes to market. It does not know when it harms a patient.

By comparison, even makers of consumer goods, such as toys and dishwashers, must tell a federal agency if they learn of a defect that could injure someone. In December, the U.S. Consumer Product Safety Commission fined Black & Decker Inc. $575,000 for failing to report that toasters had caused kitchen fires leading to eight injuries. Had the company been selling contaminated body parts instead of toasters, the government's authority would have been limited to ordering a recall -- if and when it discovered the problem.

The FDA has proposed requiring banks to keep donor records for 10 years and show them to FDA inspectors. The proposal, awaiting approval by the federal Office of Management and Budget, would let the FDA trace tainted tissue to its source. But the proposal doesn't go far enough, a 1997 report from the congressional General Accounting Office says. "Without a requirement to report serious errors and accidents," the watchdog GAO wrote, "FDA is missing an opportunity to target facilities that may need additional oversight."

In its reply to the GAO, the FDA said it lacked the money and manpower to review error and accident reports. The tissue industry contends that strict oversight is unnecessary because its products are safe.


Tissue banks follow four steps to keep the nation's tissue supply disease- free:

  1. Screening cadavers by asking the family about the person's sexual habits and possible drug use.
  2. Testing the blood in donated bodies for, at a minimum, AIDS and hepatitis B and C. Some tissue banks test for other diseases.
  3. Sterilizing tissue, either chemically or by freezing.
  4. Handling the tissue in "clean rooms" to prevent transmission of disease from tissue-bank workers to the body parts.

These are informal standards, not required by law. In practice, these standards vary widely from bank to bank, allowing one bank to distribute tissue that another won't. For example, in 1994, Pacific Coast Tissue Bank in Los Angeles accepted a cadaver that another tissue bank rejected, according to an FDA inspection report. A Florida tissue bank rejected the donor, a cocaine user, because he was so fat that the bank feared it couldn't rule out the presence of needle tracks on his arms. Pacific Coast accepted the donor because the pathologist performing the autopsy couldn't find needle marks.

In April 1998 the New Jersey-based Musculoskeletal Transplant Foundation learned from another tissue bank that one of the foundation's cadavers had tested "repeatedly reactive" for the HIV p24 antigen -- an indication the body might have the AIDS virus. The donor had passed the two HIV tests that the foundation requires, so its medical director continued distributing bone sections and powdered bone from this donor. FDA inspectors discovered the situation during a routine inspection in June 1998 and demanded a recall. "We stated that a positive test result for HIV should not be ignored and appropriate action should be taken to retrieve these tissues" from the hospitals that bought them, the FDA inspectors wrote.

Seventeen patients received parts from the donor, said Joel Osborne, the foundation's quality-assurance director. The foundation did not notify the patients or their doctors, leaving that up to the hospitals that bought the tissue. The foundation refused to name the hospitals, and the FDA could not provide them. Osborne said the foundation is convinced the transplanted tissue poses no danger. The p24 test is "prone to false positive results with cadaver serum," he said. Notifying patients about the test result "could cause some very unnecessary worry, concern (and) mental anguish to patients," Osborne said. "The FDA seems to be blind to that."

FDA inspectors audit the donor records that every tissue bank is supposed to keep, looking for cadavers that failed disease tests. When they find a violation they can demand a recall. But the demand for skin, heart valves, tendons and other tissues is so high that they rarely stay in a tissue bank's freezer for more than a few months. By the time inspectors discover a problem, years may have passed. For example, the FDA inspected Los Angeles-based Doheny Eye and Tissue Transplant Bank in late 1997. It was the agency's first inspection of Doheny in three years, although a 1994 visit found "several significant deficiencies." This time they uncovered cadavers that tested positive or reactive for hepatitis B, hepatitis C, syphilis and HIV.

Under FDA prodding, Doheny issued a recall in December 1997 for products from seven donors distributed during the previous three years. Most of the tissue already had been implanted or destroyed. "We immediately modified our practices" because of the recall, said Toby Bernstein, a spokeswoman for Doheny's parent company, Tissue Banks International.

Two of the five distributors that received Doheny tissue refused to join in the recall, according to FDA records. One unidentified distributor said it sold Doheny tissue, knowing it could carry the hepatitis B virus, to an "implanting surgeon" who knew the tissue was questionable. It is not known if the surgeon implanted the tissue or if he or she told patients about the risk. The other distributor, Pacific Coast Tissue Bank in Los Angeles, said its own tests contradicted Doheny's tests, which had shown that two cadavers might carry the hepatitis B virus. Different tests for hepatitis B can produce conflicting results. The FDA argues that a positive or reactive result on any test should disqualify a donor.

At the time of the Doheny incident, FDA recalls were operating on shaky legal authority. New Jersey-based Biodynamics International, now Tutogen Medical Inc., won a 1995 court battle with the agency over its authority to retain or destroy tissue shipments. That defeat prompted the FDA to back away from a planned recall order against Metairie, La.-based Southern Transplant Service, which had distributed tissue from 21 unknown donors without medical records, according to an FDA report.

The FDA adopted a permanent rule in 1998 after public hearings and says it now has legal authority over the industry. The FDA is now attempting to "reinvent" its inspect-and-recall strategy. It has proposed requiring more tests of cadaver tissue and making tissue banks register their products.

Tissue bankers are wary of more FDA requirements. "I don't have a problem with their concern," said Doheny President Ron Smith. But "sometimes they go a little overboard. We have a system right now that has proved very safe."

The new FDA regulations won't change that system. The agency says it can't keep up with the industry's growth, so it plans to let trade groups, such as the American Association of Tissue Banks, do many inspections.

*Register staff writers Dena Bunis, Mark Katches and Susan Kelleher contributed to this report.
*Copyright 1999 The Orange County Register
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