Tommy Thompson, Secretary
Department of Health and Human Services
200 Independence Avenue,
Washington, DC 20201
Dear Secretary Thompson,
This letter strongly urges you to direct FDA Chief Counsel Dan Troy to agree that a criminal investigation of Metabolife be opened, as requested in a July 1, 2002, letter he was sent from Eugene M. Thirolf, Director, Office of Consumer Litigation, U.S. Department of Justice (DOJ). In that letter, the DOJ official states that Michael Ellis, the President of Metabolife, one of the nation’s largest producers of ephedrine-based dietary supplements, may have made false statements to the FDA and “thereby, if done willfully, he may have committed a Federal crime, violating 18USC§ 1001 and 1505.” The DOJ letter therefore asks if “FDA would like our office to begin investigating this matter.” The other request to the FDA in the letter is to agree that the DOJ be given the go-ahead to try to obtain a large number of adverse reaction reports of people using Metabolife, obtained by plaintiffs’ attorneys during discovery from the company, which are currently under a gag order in a product liability case pending in Federal court in Alabama.
In a March 18, 1998, Federal Register Notice, the FDA asked for comments concerning the abuse potential, actual abuse, medical usefulness and trafficking of ephedrine. In response, Michael Ellis, President of Metabolife, wrote a letter to the FDA dated April 17, 1998, in which he contended that ephedrine was being used safely and that there was no widespread pattern of abuse of ephedrine in the U.S. or the world. To support these contentions, Ellis stated in his letter that “Metabolife 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 also stated that “consequently, since there had been no serious adverse reports [AERs] of any sort, there had been no such reports of overuse or abuse of the product.” Ellis described Metabolife’s monitoring system, including how Metabolife documented each call received from a consumer.
In order to see if Ellis’ allegation was supportable and as an important source of data on the safety of these products, the FDA subsequently asked the Department of Justice “to obtain the consumer adverse reaction reports (AERs) documented by Metabolife”. Previous efforts by the DOJ to obtain these reports, filed by Metabolife under a gag order in a California state court ephedra injury case, were thwarted because the judge refused the DOJ request because of the secrecy under which the documents were obtained during discovery from Metabolife in that case. The DOJ subsequently learned from an attorney, according to the July 1 letter to Dan Troy, that in yet another product liability case against Metabolife, the company had “received consumer reports of serious injuries related to the use of Metabolife before Ellis wrote his April 17, 1998 letter to FDA claiming that Metabolife had received no such reports.” This is presumably the basis for DOJ’s allegation that Ellis may have made false statements to FDA and “thereby, if done willfully, he may have committed a Federal crime.”
The DOJ letter goes on to state that “While we were unsuccessful in getting access to the AERS in the California state court, Federal law is much more favorable to granting access to discovery materials when access to those materials will benefit the public health and safety. Gaining access to these AERs 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. Asking the Alabama court for access to the Metabolife AERS will only require the filing of a motion with the court. My office stands ready to handle making such a request if FDA wishes to seek access to these AERs.” The DOJ underscored the urgency of the July 1 request by referring to the five-year statute of limitations that exists between the commission of an alleged crime and the filing of papers concerning criminal prosecution. “The statute of limitations for this crime is five years. Any such charges would have to be brought before 4/17/03 [five years after the letter from Ellis to the FDA].”
Previous Michael Ellis Criminal Record
Metabolife President and co-founder Michael 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. He pleaded guilty to a felony charge.
Metabolife Political Influence
According to an article in The Washington Post (December 25, 2000), Metabolife had, by October 1, 2000, donated $683,000 to federal campaigns, ranking seventh among all pharmaceutical companies nationwide. In Texas, the site of a battle between ephedra-makers and the state health department efforts to more tightly regulate the dietary supplement, Metabolife spent more than $4 million between 1998 and 2000 to lobby against state regulations. In California, Metabolife ranked fourth in state “soft money” contributions, with $493,000 in 2000 and a $100,000 donation to the campaign of Gov. Gray Davis, who subsequently vetoed state legislation imposing restrictions on ephedra use.
More recently, the Los Angeles Times (September 6, 2001) reported on the role of the current Bush Administration in suspending enforcement of a Texas regulation to protect athletes and other users of dietary supplements such as ephedra. This occurred, according to the LA Times, after telephone calls to Austin, Texas, from one of your senior aides after you were approached by a lawyer representing Metabolife in August 2001.
The lawyer who approached you, Jeff Wentworth, is, according to a May 15, 2000 article in Time Magazine, 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.
As you are aware, we petitioned HHS to ban the manufacture and sale of all ephedra-containing dietary supplements last September. By now, there have been well over 100 deaths reported to the FDA in people using ephedra-containing products and, as described in our September 5, 2001, petition to ban these products, there are more reports of death, stroke, arrhythmia, heart attacks, chest pain, seizures and hypertension for ephedra than for all other dietary supplements combined. As long as the FDA delays the inevitable ban of these products, cases will continue to occur.
I urge you to free yourself from the influences that Metabolife and other ephedra-makers have had on the Texas Department of Health and their continued massive lobbying in Washington against a ban of these most dangerous “food supplements.” Any failure by your department to: a) agree to aggressively pursue a criminal investigation against Metabolife President Michael Ellis for apparently lying to the government; b) to pursue the acquisition of now-sealed court documents concerning serious adverse effects of Metabolife, many likely not to have been reported to the FDA because there is no requirement to do so; and c) to order a ban on the production and distribution of ephedra products will ultimately bring disgrace to you and your department.
Sidney M. Wolfe, M.D.
Public Citizen Health Research Group