SAN DIEGO: Metabolife International, maker of the controversial diet supplement Metabolife 356, has been forced to step up its crisis communications due to a US Justice Department criminal investigation that came to light August 15. The government is seeking to determine whether the San Diego-based company lied concerning consumer complaints about the diet pill.
Metabolife 356 contains ephedra, a stimulant widely used for weight loss.
Consumer group Public Citizen claims ephedra has caused deaths, which the company denies.
On August 15, after Public Citizen urged the US Food and Drug Administration (FDA) to encourage an investigation, Metabolife put out five press releases and statements on the matter, including a seven-page letter president David Brown sent to the Department of Health and Human Services (HHS).
A major accusation against Metabolife is that in April 1998, Michael Ellis, then president of the company, stated in a letter to the FDA that "Metabolife has never received one notice from a consumer that any serious health event has occurred because of the ingestion of Metabolife 356."
Yet in its August 15 letter to HHS, the company admitted it has had 13,000 complaints, of which about 80 mentioned serious injury or death.
Metabolife attorney Lanny J. Davis said that Ellis was taking the position that an adverse-event report must mean the incident was caused by Metabolife and their was no such evidence in these situations.
Sidney Wolfe, director of the Public Citizen Health Research Group, called this "preposterous, and added, "For him to say they never got a report where in his view the problem was caused by Metabolife is ridiculous."
Metabolife also submitted to HHS its records of consumer contacts about the supplement, records the FDA has long sought.
Davis, a partner in DC powerhouse law firm Patton Boggs, said the company planned to release the records three weeks earlier. It had even been working with The Wall Street Journal on a piece, but was delayed in finishing the analysis of the reports, he said. "Then Public Citizen put out its release to preempt what we were doing."
In 2000, Davis, a former Clinton White House counsel, set up Patton Boggs' legal crisis management group to integrate legal and media approaches in litigation and other crises.
As for Metabolife, he said, "Our PR strategy is that it's science versus junk science. I use those phrases with every reporter I talk to. Private Citizen's evidence is anecdotal. We have ten years' worth of clinical studies."
Wolfe, a medical doctor, was critical of Davis' efforts: "To put someone up like this to manage a crisis is interesting but no one can expect him to know anything about the science. And that's the issue. Is this dangerous or not?"