Arizona Attorney General Wants Body Donation Programs Regulated

Published: Thursday, January 28, 2016 - 5:00am
Updated: Thursday, January 28, 2016 - 5:22pm
Audio icon Download mp3 (5.02 MB)
(Photo by Matthew Casey - KJZZ)
Science Care workers prepare cremated remains of people who donated their body to science.

The Arizona Attorney General thinks willed-body-donation programs create a public health issue that needs oversight, but a Phoenix-based company is worried that a proposed bill in the Arizona Legislature could lead to overregulation of a growing industry.

“When you start talking during the course of this investigation about severed heads being discovered or other body parts that were being collected by people, it really is gross,” Mark Brnovich said. “And I don’t know if there is a better word that would describe it.”

Brnovich was referring to his office’s probe of Biological Resource Center of Arizona (BRC). The state accused BRC of selling diseased body parts and providing them for uses for which donors did not consent.

Attorney General's Office records show BRC gave tissue contaminated with Hepatitis B or C to organizations in several states. They also show that a Tucson company waived tests for contagious diseases in order to get tissue more quickly. And a researcher at a Georgia facility was reportedly stuck with a needle while working on contaminated, unidentified tissue, but had been previously vaccinated.

BRC also provided cadavers to a company that then gave them to the U.S. Army Research Laboratory, documents show. That cost the Army about $950,000 because some of the donors did not consent to being used in a military project.

The Army unknowingly used some cadavers from BRC for the sometimes destructive process of developing a new crash-test dummy, records show. Once allegations against BRC surfaced, the Army quarantined other cadavers.   

BRC’s owner, Stephen Gore, pleaded guilty last year to operating an illegal enterprise. But that may only be the beginning as records show the case grew from a federal probe that started about 2,000 miles away in Detroit. Similar investigations are ongoing.

“We know that today there is really absolutely no regulation (of willed-body-donor programs)” Brnovich said. “There is no federal regulation. There is no state regulation.”

State Rep. Gina Cobb, a District 5 Republican, recently introduced House Bill 2307. In its current form, it would require body donation companies renew a state license every two years.

“We want to make sure that it is safe for the people that are donating their bodies,” Cobb said.

The Phoenix-based non-transplant tissue bank, Science Care, is in its 16th year, according to Melinda Ellsworth, vice president of donor services.  Science Care operates in four other states and may soon expand.

“Science Care is that link between the people who want to give back and the medical researchers and educators who need human tissue to make those advances happen,” Ellsworth said.

Science Care isn’t opposed to state regulation. But Ellsworth doubts it would be as tough as getting accredited through the American Association of Tissue Banks (AATB), which must be renewed every three years. Science Care has been AATB accredited for more than a decade.

“And the AATB can come in at any point that they have a concern — at any point — and do a deep physical audit,” Ellsworth said. “I don’t necessarily feel that additional regulation is required. We have laws on the books that protect the public. We have in our industry adopted the AATB as a standard of excellence. Nearly everyone is accredited. And I think that helps us to hold each other accountable and hold the public trust.”

Brnovich said he has no philosophical issue with people giving their bodies to science. But he wants the Legislature to mandate that certified medical professionals review donors’ medical records before giving tissue to researchers. He also wants regular physical inspections of body donation facilities and a system to track human tissue once it’s shipped.

“There was recently a Delta cargo flight where 15 human heads were being shipped,” Brnovich said. “No one knew about it and the only reason why it was discovered by customs is that blood was literally dripping from the boxes.”

If stakeholders agree to policies that protect the public and have all body donation companies follow uniform protocols, Cobb said there they may be no need for legislation.

“Hopefully we can correct some of that so that it’s not overregulation and it’s not another layer the state is putting on,” Cobb said.

If you like this story, Donate Now!