01 July 2010

8-Year-Old Burn Victim Receives Treatment after FDA Denies Him

Atlanta Journal-Constitution

After being denied a medical procedure by the U.S. Food and Drug Administration, 8-year-old burn victim Alfred Real is getting treatment for his wounds, which cover 80 percent of his body.

Alfred had a biopsy Thursday morning which allowed doctors to take a sample of his skin and grow it in a lab. Alfred’s skin will be used to cover his back and upper thighs, Real said.

The FDA gave final approval Monday for the Shriners Hospital for Children and the University of Cincinnati to proceed with the treatment after the university accepted full responsibility for the procedure, including any issues that may arise.

Alfred Real suffered severe burn wounds when he and a friend were playing with gasoline and a grill lighter outside Alfred’s home near Stone Mountain on June 7.

Alfred was originally denied the skin graft treatment, called “cultured skin,” after a third-party audit was performed on the procedure. The audit indicated that the trial gave inaccurate data and questioned if doctors were informing patients of potential dangers. This has been a real concern for Detroit burn center.

The treatment has been used in Shriners Hospital for 20 years through a clinical trial with the university, but in the past five years, it has been offered through the Cincinnati location.

Although it is unclear how many children are or have been adversely affected by the procedure -- the FDA indicated they can’t give medical information to the public and Shriners declined to comment -- Jonathan Sackner-Bernstein, associate director for post market operations at the FDA, stressed that children are the agency’s top concern.

“You have to understand that our motivations were to figure out what the best thing was for that boy,” Sackner -Bernstein told the AJC on Tuesday.

Alfred’s father, Zac Real, told the AJC on Thursday that the hospital will update him this weekend on how the procedure is doing.

Asked what would happen if the procedure didn’t go well, Real said, “We have to continue doing what we’re doing now, which means it will take longer and there is a greater risk for infection,” he said.

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