|Springfield State Journal Register
October 9, 2002
Parents urge ban on herbal stimulant
By DORI MEINERT
COPLEY NEWS SERVICE
WASHINGTON - Sean Riggins was a healthy, athletic 16-year-old who enjoyed football and wrestling at his high school in Lincoln.
He played hockey as a first-grader and acquired a shelf full of trophies from Tae Kwon Do competitions.
But on Sept. 2, Sean sat on the bench instead of joining his football team on the field. He complained of an upset stomach and headache. The next day, a doctor said he had bronchitis, gave him an antibiotic and sent him home. Within hours, he began having seizures and stopped breathing.
He died of what doctors said was a heart attack.
"How does a 16-year-old boy that active die of a heart attack?" his father, Kevin Riggins, recalls thinking even as he grieved.
"Sean didn't smoke. He was passionate against taking drugs," Riggins testified Tuesday at a Senate Government Affairs subcommittee hearing.
But an autopsy and subsequent interviews with his friends led the coroner to conclude that Sean died from taking Yellow Jackets, an unregulated dietary supplement containing the herbal stimulant ephedra as well as a kola nut extract containing caffeine. The combination causes a rapid heartbeat, an increase in blood pressure and a constricting of blood vessels.
Seated near two large photos of their only child, Kevin and Debbie Riggins urged the federal government to block sales of products containing ephedra.
They were alarmed to find out after Sean's death how many of his friends swallowed the pills they bought, three for $1.50, at the local convenience store or gas station. The teens took Yellow Jackets to improve their athletic performance, give them more energy, lose weight or get "a buzz."
Some just thought it was cool to feel their heart racing or see their hands shaking uncontrollably.
Sean and many other wrestling team members began taking the pills last winter.
"The problem with ephedra is that kids don't realize it's a drug," Kevin Riggins said. "I'm just afraid this could happen again."
It already has, said Sen. Dick Durbin, D-Ill., who chaired the hearing. U.S. Food and Drug Administration reports link ephedra to 81 deaths and 1,400 incidents of heart attack, high blood pressure and stroke, he said.
On Tuesday, an FDA official said the agency has requested a search warrant to inspect the New Jersey facilities of NVE Pharmaceuticals, which makes Yellow Jackets. In addition, the FDA on Monday banned imports of the product from a company in the Netherlands.
Lester Crawford, the FDA's deputy commissioner, said it was likely that the agency would attempt to ban the sale of the product - either because it was marketed as an alternative to street drugs or because of its composition.
"I am very doubtful as to whether there is a legitimate use of the product," Crawford said.
The difficulty is that a 1994 law passed by Congress exempted such "dietary supplements" from pre-market testing. It placed the burden on the federal government to prove such products are unsafe. In contrast, products classified as drugs go through vigorous pre-market testing with manufacturers forced to prove they are safe before they are placed on the market.
In July, Durbin had called on the FDA to ban sales of products containing ephedra, but received no response.
"How many more kids do we have to bury before we say enough is enough?" Durbin said.
Ronald Davis of the American Medical Association said the organization has recommended pulling products containing ephedra from the market. It's been banned by the National Collegiate Athletic Association.
NVE Pharmaceuticals declined an invitation to attend Tuesday's hearing, Durbin said.
But another manufacturer, Metabolife International Inc. of San Diego, said its products are safe when used by adults according to directions. The firm is now under investigation by the Justice Department for claiming it had received no reports of adverse health effects related to use of its product.
However, a joint House-Senate committee reviewed records undercutting that claim. Metabolife recently turned over records showing 2,000 telephone complaints from consumers of significant adverse reactions to its products, Durbin said. They included three deaths, 20 heart attacks, 24 strokes, 40 seizures and 465 incidents of chest pain, he said.
Currently, only a voluntary system for reporting such adverse effects from dietary supplements is in place.
Lanny Davis, an attorney representing the company, criticized the
committee's review for relying on what he described as "unsubstantiated" telephone reports.
Meanwhile, Sean's parents, along with Logan County Coroner Charles Fricke, say they are planning to talk about the dangers of such dietary supplements to young people in schools across central Illinois.
"It's going to help them and it's going to help us heal," said Kevin Riggins after Tuesday's hearing. "We're never going to get over this, but it will help us heal a little."
And, he and his wife want to warn other parents.
"Talk to your kids. Try and find out what's happening," he advised. "This stuff is deadly."