FDA rebukes top processor of human tissue

FDA rebukes top processor of human tissue

May 13, 2001 Orange County Register by Ronald Campbell
RTI is urged, but not ordered, to halt its practice of mixing parts from cadavers during processing.

Federal regulators have urged the nation's largest human-tissue processor to stop mixing parts from cadavers because it may be unsafe.

In a harshly worded letter, the Food and Drug Administration told Alachua, Fla.- based Regeneration Technologies Inc. that processing tissue from several cadavers in the same machinery "may expose individuals to unwarranted risks." But the FDA stopped short of ordering RTI to scrap its "BioCleanse" technology, something the agency could have done if it believed the method threatened public health.

"That's a decision that's with them (RTI)," said the FDA's Steven A. Masiello, who co-signed the May 3 letter to RTI.

RTI Chief Executive James Grooms said in a written statement that the company is "completely confident" in BioCleanse. Spokeswoman Nancy Walsh said Friday that the company will continue to use the technology pending a meeting with FDA officials next week.

While the tissue from different donors doesn't physically touch, it is processed by the same machinery at RTI, raising the potential for cross- contamination, according to critics. For scientific purposes, the tissue is considered mixed, or pooled.

RTI's stock fell 15 percent Thursday after the company reported the FDA warning, and an additional 2.5 percent Friday, closing at $11.

An Orange County Register investigation last July disclosed the potential safety issues surrounding the pooling of human tissue. The FDA inspected RTI three weeks later.

"The information that was collected during the inspection was fairly extensive," Masiello said, explaining the 10-month gap between the inspection and the FDA letter.

RTI buys donated cadaver tissue from tissue banks in Orange County and nationwide, turning it into products for orthopedic, urological and cardiovascular surgery. In the three years since its spinoff from the nonprofit University of Florida Tissue Bank, RTI has nearly quadrupled its sales to $120.9 million and eclipsed the longtime industry leader, New Jersey-based Osteotech.

BioCleanse has been a key to RTI's rapid growth. When it went public last August, RTI boasted that BioCleanse could sterilize tissue from as many as 100 cadavers at a time, reducing costs while increasing the acceptable age range of donors and nearly eliminating the risk of contamination. But the FDA said RTI has failed to prove that BioCleanse really does eliminate diseases.

The FDA is particularly worried that Creutzfeldt-Jakob disease, the human version of mad-cow disease, could spread through BioCleanse from a single cadaver to dozens of patients.

"We believe it prudent to discontinue immediately its use for processing of tissue," the FDA said.

No other major tissue processor mixes parts from donors.

The American Association of Tissue Banks has barred its members from pooling tissue from several donors for more than a decade. It imposed the ban after Japanese researchers tied pooled tissue to 40 deaths from Creutzfeldt- Jakob Disease.

RTI is not a member of the trade group.

A proposed FDA rule, issued Jan. 8, would bar pooling tissue from several donors.

AATB opposes pooling not only because of the potential for contamination but also because it would be hard to track down donors and recipients if someone contracted a disease from an implant.

"You may have 300 pieces of tissue, and then you'll have to find 300 different people," said AATB Executive Director Jeanne Mowe.

"If the donors are mixed together, it makes it that much more difficult to find those people."

Doug Wilson of Virginia- based LifeNet, one of the nation's largest nonprofit tissue banks, said RTI's procedures illustrate the influence of money on the industry.

"It is all in their literature," Wilson said.

"This is one of their stated procedures to save money."

Register staff writers William Heisel and Mark Katches contributed to this report.

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