Tissue fraud generates patient anxieties

The FDA has shut down the tissue bank in question and recommends that recipients of human tissue from that source be tested for communicable diseases.

By Victoria Stagg Elliott — Posted March 27, 2006

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Stephen Pineda, MD, an orthopedic surgeon in Springfield, Ill., breathed a sigh of relief when he concluded that none of his patients received transplanted bone or tissue originating from Biomedical Tissue Services Ltd. But many physicians have not been so fortunate and are now trying to help their patients face the fallout.

The tissue bank was shut down by the Food and Drug Administration in February because of allegations that it took bone, skin and tendons from hundreds of cadavers without permission, possibly including that of former "Masterpiece Theatre" host Alistair Cooke. Cadavers also may have been too old or diseased to be considered appropriate donors under most circumstances, and tissues may have been contaminated during removal.

The company's owners have since been indicted, but the ripple effects of these activities are still being felt.

"Bone allograft is not a high-risk tissue, but this has created a new level of fear in the system," Dr. Pineda said.

He's had dozens of phone calls from those who received bone and tissue, some from years ago, asking if it came from this company and if they are at increased risk for an infectious disease. Spouses have called to find out their risk, too. He's even had patients refuse cadaver bone transplants, instead insisting on using their own bone even though this can result in more pain and longer hospitalization. Dr. Pineda's experiences are examples of the impact this scandal has had on physicians who do not have patients directly involved. For those who did, the situation is even trickier.

The Food and Drug Administration is urging them to test these patients for several infectious diseases and monitor them closely. It's unclear exactly how many patients this tally could include, but it could be thousands.

"The FDA strongly recommends that health care providers inform their patients who received tissue implants prepared from BTS donors that they may be at increased risk of communicable disease transmission and to offer them testing," read an FDA statement posted on MedWatch earlier this month.

No associated cases of infectious disease were confirmed at press time, and most agree that the actual risk to individual patients is small. Though the bone and tissue was obtained under suspect circumstances by a company not accredited by the American Assn. of Tissue Banks, it was then sold to five credible companies. It is believed that these companies processed the material correctly -- testing it for various pathogens as well as structural integrity.

"If there's one good piece of news in the whole tragic scenario, it's that the tissue was processed by accredited processors," said Bob Rigney, CEO of the American Assn. of Tissue Banks.

What seems to be the biggest issue for patients now is their peace of mind. Local newspapers and patient blogs have been full of fearful tales of sleepless nights and endless worry. There is also a general sense of repulsion because the tissue -- used to relieve a patient's suffering -- may not have come from a willing donor.

"Patients feel very betrayed," said Shelby Lassiter, RN, director of infection prevention and control with Wake Med Health and Hospitals in Raleigh, N.C. She has tracked down 30 tissue recipients.

Fears for the process's future

But while many physicians are struggling with the immediate concerns of patients, there are also worries about how this scandal will affect a patient's willingness to accept a cadaver bone or tissue graft and a physician's willingness to use it. There is also significant concern about how this incident will affect an individual's willingness to donate.

"The worst part of this would be if people were turned off from the transplant process and would not donate or do not get what they need done because of this," said Steven Malkin, MD, an internist from Arlington Heights, Ill., and president of the Chicago Medical Society.

Despite these anxieties, the FDA's stepped-up regulation of tissue banks has drawn praise. A 2001 report by the Health and Human Services Office of Inspector General found the industry was poorly policed. The FDA has since expanded inspections, created a database of all tissue banks and launched an Office of Cellular, Tissue and Gene Therapies. Biomedical Tissue Services Ltd. was the first tissue bank shut down under the agency's new comprehensive framework for human tissue products.

"It's not a broken system but one that's working," said Gary Friedlaender, MD, professor and chair of orthopedics and rehabilitation at the Yale University School of Medicine in New Haven, Conn.

Even with the new regulations, though, many experts say more controls are necessary to prevent this kind of thing from recurring. They point out that this bank may have been shut down by the FDA, but the malfeasance was not initially discovered by the agency. Also, the potential financial gain is so great that this case is unlikely to be the last time it happens or is discovered.

"The FDA, by and large, limits their oversight to one area of this whole process. There's no oversight from beginning to end," said Todd R. Olson, PhD, professor in the Dept. of Anatomy and Structural Biology and director of anatomical donations at Albert Einstein College of Medicine in New York. "Exorbitant profits can be made. Between the charitable acts of donors and the physicians who want to improve the health of the living is a commercial wasteland."

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Tracing tissues

In the wake of the shut-down of Biomedical Tissue Services Ltd, a tissue bank based in Fort Lee, N.J., the Food and Drug Administration recommends that physicians:

  • Inform patients who received tissues originating from this bank that, because donors were not properly screened, they might be at increased risk of communicable disease transmission.
  • Offer these patients tests for HIV, hepatitis B and C, and syphilis.
  • Communicate to patients that the risk of catching a disease from these tissues is low, although the extent of this risk is unknown.

Source: Food and Drug Administration

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External links

"Update of Information about BioMedical Tissue Services," Food and Drug Administration public health notification, March 2 (link)

"Safety of Tissues for Transplantation," American Medical Association Council on Scientific Affairs report, 2001 (link)

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