Medical expert backs Metabolife
herbal supplement ephedra are "unfounded". Dr Steven Karch claimed
that the health reports logged by Metabolife contain 'insubstantial
information'.
A medical expert has said that the recent calls to review the herbal supplement ephedra are "unfounded".
Last week supplement manufacturer Metabolife was asked by the US Food and Drug Administration to release health reports gathered by its consumer Healthline, following claims that it had not disclosed a large number of reports on its side-effects.
The company has since asked the National Institutes of Health to help establish a blue-ribbon commission to review all clinical trials on ephedra-caffeine combinations for weight loss and to confirm their safety. It would ask the commission to recommend additional studies to evaluate the safety and efficacy of ephedra supplements when taken in dosages recommended by the manufacturer.
However Dr Steven Karch, a cardiac pathologist and medical examiner, has released an analysis of Metabolife's health communications on ephedra (available from the Ephedra Education Council) and said that the rush to judgement on its safety was unnecessary.
"The assumption these new reports provide any scientific basis regarding the safety of Ephedra is unfounded," said Karch. "The data from the reports is absolutely inconclusive and provides no evidence that the use of Metabolife 356 is associated with any significant health risks."
According to Karch's analysis, the HealthLine logged approximately 12,685 pages of contact records from 1997 to September 2001 but only approximately 89 call reports alleged a significant side-effect. This represents less than 1 per cent of the total contact records made to the HealthLine, he said.
In his Analysis Karch said: "the only reasonable conclusions are that the data contained in these records is insufficient to demonstrate any pattern of significant side-effects resulting from the use of Metabolife's 356 product."
He added that the HealthLine records contain no data suggesting that the product, taken in recommended doses, poses any significant health or safety hazards and that safety assessments need to be based on controlled clinical trials, "not on the sort of insubstantial information contained in these contact records."
Karch's analysis is published by the Ephedra Education Council, a committee supported by industry bodies.
