A dietary supplement containing an ingredient linked to the death of an Illinois teenager was never tested for safety, the head of the New Jersey company told a congressional investigating committee.
Robert Occhifinto, president of NVE Pharmaceuticals in Newton, testified yesterday the company had not used medical professionals in the formulation of supplements containing the controversial herb ephedra. He also acknowledged serving sentences for two criminal offenses once for money laundering and another time for his dealings involving the illegal drug hashish.
NVE, meanwhile, is under investigation by the Food and Drug Administration for adding a prescription male potency substance to an over-the-counter dietary supplement, he said.
The executive appeared under oath before a House Energy and Commerce subcommittee investigating health risks associated with ephedra. The insights into the operations of the Sussex County company and its president come amid increasing scrutiny of the largely unregulated world of dietary supplements.
The subcommittee heard a defense of ephedra products from the founder of Cytodyne Technologies of Manasquan, now known as Nutraquest, and from executives of Metabolife International of California. Three former Metabolife officials refused to testify, invoking their Fifth Amendment right against self-incrimination.
Derived from the Chinese herb Ma Huang, ephedra is an adrenaline-like stimulant that affects the heart and central nervous system. Supplements containing ephedra have been marketed as weight-loss aids, energy boosters and sports performance enhancers claims some experts question.
The FDA has warned ephedra- based products pose “significant and unreasonable” health risks, including heart attacks, strokes and death, and the agency is examining ways to impose new restrictions on the supplements.
An ephedra-based diet pill made by Cytodyne was named by officials as a factor in the death of a Baltimore Orioles pitcher in February. The state of New Jersey has sued Cytodyne for making false claims regarding the supplement and a successor that does not contain ephedra. Cytodyne said yesterday the death of Steve Bechler had nothing to do with ephedra.
In 1994 Congress largely deregulated the dietary supplement industry, making it difficult for the FDA to pull products off the market. A number of companies have been charged with making misleading claims and dozens of personal injury lawsuits have been filed against supplement makers.
One of those lawsuits was filed by the parents of Sean Riggins, a 16-year-old high school athlete from Lincoln, Ill., who died of a heart attack while using Yellow Jacket, an ephedra supplement made by NVE Pharmaceuticals.
The company denies responsibility for the teen’s death and is contesting the lawsuit. But Riggins’ father, Kevin Riggins, told the House panel yesterday that ephedra products “are a poison that killed my son.”
“The majority of companies in my opinion are illegitimate companies no more than drug pushers, because they are marketing a deadly substance and they don’t care.”
Occhifinto, in his prepared testimony, said: “I strongly believe in the safety and effectiveness of NVE’s products. The overwhelming scientific evidence is that ephedra is safe and effective when used as directed.”
The New Jersey executive also maintained the safety record of ephedra is “comparable and in some cases better than that of many over-the-counter pharmaceutical products.”
But in a questionnaire he filled out for the subcommittee, Occhifinto was asked whether his company conducted studies on any NVE product including more than 80 containing ephedra. He answered “no.”
Occhifinto, a high school graduate, was asked during the hearing whether he ever hired a medical professional or pharmacologist to formulate his products. He said he had not. Even though he lacks education or training, he said he was responsible for deciding the composition of scores of dietary supplements.
Rep. James Greenwood (R-Pa.), chairman of the subcommittee, expressed outrage at the testimony. He noted that after Riggins died and NVE pulled one ephedra product off the market, Occhifinto “changed the formulation of the product by increasing the amount of ephedrine and changing the name, without consulting any scientific or health experts.”