WASHINGTON, Aug. 15 (UPI) -- A consumer group said Thursday it has uncovered a letter indicating the federal government is considering a criminal investigation into false statements Metabolife President Michael Ellis made about the safety of the dietary supplement ephedra, which is contained in the company's product.
The Department of Justice sent a letter to the Food and Drug Administration last month stating Ellis may have lied and committed a federal crime when he stated in a 1998 letter to the agency that his company was not aware of any health problems associated with the use of Metabolife 356, Public Citizen's Health Research Group charged in a letter to Health and Human Services Secretary Tommy Thompson.
Public Citizen is asking Thompson to urge FDA to permit the Department of Justice's request to launch an investigation into Ellis and Metabolife, Sidney Wolfe, director of the Health Research Group, told United Press International.
Specifically, Public Citizen said Ellis stated in the 1998 letter his company "has never received one notice from a consumer that any serious adverse health event has occurred because of the ingestion of Metabolife 356 (a best-selling, ephedra-containing diet product)."
Ellis' statements may be a crime, the Justice Department letter continued, because the company had received numerous reports of adverse effects due to their product, which are reflected in sealed documents in two separate court cases against the company,
"It's obvious that Ellis is lying," Wolfe said, noting the sealed documents contain "a lot of reports of serious reactions to ephedra, way more reports than the FDA has."
The sealed documents were discovered by Justice Department officials, who were looking into the credibility of Ellis' claims at the request of the FDA, Wolfe said. The cases, one in Alabama and one in California, involve liability charges against Metabolife, which is promoted as a weight loss enhancer and contains the controversial ingredient ephedra.
Public Citizen filed a petition with the HHS last year calling for a ban on ephedra because it considers the substance a dangerous dietary supplement that has caused more than 100 deaths and numerous other adverse events. The HHS announced in June it would delay taking any action on Public Citizen's petition until a review of scientific studies of the supplement was completed.
Metabolife denied the allegations. Company spokeswoman Jan Strode told UPI, "Michael Ellis has not made any false statements to the FDA."
Wolfe acknowledged it is difficult to prove what is in the sealed documents because the Department of Justice was unable to persuade a judge to release them, and Metabolife as a dietary supplement manufacturer is not required to report deaths or injuries caused by their product to the FDA.
The Justice Department said in its letter to FDA it would be easier to gain access to the sealed documents if it could be determined public health and safety are involved.
According to Public Citizen, the Justice Department letter stated: "Gaining access to these (adverse event reports) will not only give FDA a substantial amount of data with which to study the safety of ephedrine-based dietary supplements, it will also permit FDA and our office to assess the accuracy of Ellis' 4/17/98 letter to FDA and any potential criminal liability Ellis may have for writing that letter."
Justice Department officials declined to comment on the story, with spokesman Charles Miller telling UPI, "The Department does not comment on these cases."
HHS officials did not return phone calls from UPI seeking comment. FDA spokeswoman Laura Bradbard told UPI, "FDA will review the request and respond to the Citizen Petition once the information has been reviewed. FDA cannot comment any further on this topic except to say that it is under review."
Wolfe said Thompson and the FDA have been slow to take action because of the political clout exerted by Metabolife. Public Citizen said in the letter to Thompson that Metabolife has contributed hundreds of thousands of dollars to federal and state political campaigns, particularly in California and Texas, in an effort to stifle strict regulations against ephedra.
Public Citizen also charged one of Thompson's senior aides was very influential in suspending enforcement of a Texas regulation against ephedra. This occurred after Thompson was approached by a lawyer representing Metabolife who was "from a San Antonio law firm headed by some of President Bush's closest political associates and was hired by Metabolife when Bush was governor of Texas in order to influence the regulation of ephedra by the Texas State Health Department."
Despite Metabolife's political influence, however, Wolfe said FDA was in a "lose-lose situation" and would have to give the go ahead on the Department of Justice investigation because it was the agency that had originally asked the Justice Department to look into Ellis' claim.
As Public Citizen also pointed out in its letter, Ellis was "convicted in 1990 on a drug-related charge involving the illegal manufacture and sale of methamphetamine which, interestingly, can be produced from ephedra."
HHS is expected to make a decision regarding the continued sale of ephedra products in the next few weeks. If the agency decides not to ban the supplement, Wolfe said his organization is "seriously thinking about suing them."
