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It sounds appealing: Take a pill to reduce inflammation and you might be able to prevent the damage caused by a brain injury such as a concussion. But it isn’t so easy, the Food and Drug Administration says.
The FDA has alerted consumers to what it calls possibly dangerous products being marketed to protect the brain. The latest target is Virginia-based Star Scientific — a supplement maker at the center of a series of scandals involving Virginia governor Bob McDonnell.
"We're very concerned that false assurances of faster recovery will convince athletes of all ages, coaches and even parents that someone suffering from a concussion is ready to resume activities before they are really ready," says Gary Coody, FDA's National Health Fraud Coordinator.
Concussions and TBIs have been in the news a lot lately — most recently, a report that baseball player Ryan Freel may have had brain damage that led to his suicide a year ago as well as reports that female athletes risk brain injuries that can cause problems that linger for years. There have also been concerns that TBIs may be fueling, in part, the military’s epidemic of suicide.
And there are also studies that suggest it might be possible to dial back the damage by preventing inflammation in the brain. FDA says no one’s been able to show their product actually does this, however.
Star Scientific has filed what’s called an investigational new drug application, or IND, claiming its studies have demonstrated a product called anatabine can actually help prevent damage from concussion and TBI.
“While anatabine has been authorized as an investigational new drug, it is also considered a new dietary ingredient, which is subject to premarket notification,” an FDA spokeswoman said. But Star Scientific didn’t have permission to start marketing this product yet.
Star Scientific is the third company to get a warning from the FDA. Last year, the agency warned two others, PruTect Rx, of Highlands Ranch, Colo., and Trinity Sports Group Inc., of Plano, Texas, and got them to change their marketing tactics.
"We first learned from the military about a product being marketed to treat TBI, obviously a concern with wounded veterans. We were taken aback that anyone would make a claim that a supplement could treat TBI, a hot-button issue," said Jason Humbert of FDA's Office of Regulatory Affairs.
"As we continue to work on this problem, we can't guarantee you won't see a claim about TBIs,” Coody added. “But we can promise you this: There is no dietary supplement that has been shown to prevent or treat them. If someone tells you otherwise, walk away."
Star Scientific, a company originally formed to find new uses for tobacco, says anatabine is found in cauliflower, eggplant, potatoes, and tomatoes. The company says anatabine isn’t made from tobacco, but it does not say what the product is made of, and a spokeswoman said she could not immediately answer that question.
The company’s CEO, Jonnie Williams, is close friends with the Virginia governor and his family and has given the family around $150,000 in gifts and loans. McDonnell, whose four-year as governor term ends Jan. 11, is under federal investigation for possible bribery charges relating to the gifts.