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Information on Ephedra
Ephedra is derived from an evergreen plant called ma huang. Due to the 1994 federal law exempting ephedra from federal regulation due to its classification of supplements foods and not drugs, Metabolife has been able to market the diet pill as all-natural. Consumers often equate all natural as being all-safe, which has proved to be a deadly assumption. Metabolife International is the nation’s largest producer of an ephedra-containing product, an industry of three billion servings consumed annually. The FDA had been unsuccessfully trying to obtain Metabolife dangers from the company but Metabolife did not have to report adverse events to the FDA due to its exemption from regulation. The inability to gain access to information on ephedra for all these years has allowed Metabolife to continue to be sold as an effective weight loss pill, topping sales at $1 billion in 1999. In August 2002, Metabolife finally turned over the Metabolife danger reports when the FDA requested a criminal investigation be performed on the supplement maker. Metabolife International’s last minute attempts did not deter a federal investigation from being announced. The14,700 reports of ephedra side effects Metabolife handed over to the FDA far exceeded the agency’s realizations of potential for adverse ephedra side effects. The criminal investigation now underway is investigating if Metabolife made false statements made about ephedra dangers and failing to disclose incidents. Ephedra has been successfully marketing itself to the large number of dieting Americans looking for a miracle drug. Ephedra is an herbal stimulant that has been a successful weight loss pill due to its’ ability to create effects including low appetite and high alertness. What consumers did not initially realize is that the ephedra effects would come at a price. The FDA has been collecting information on ephedra since 1994. Reactions to ephedra varied from mild to very severe and the FDA noticed the number of ephedrine side effects was increasing over the years. It is difficult to remove supplements like ephedra from the market because there is limited data due to deregulation and Metabolife International was not cooperating with the FDA. Despite the lack of information received from Metabolife, the FDA still collected reports of over 100 deaths since 1994 amongst ephedra users. One dose of the ephedra containing Metabolife diet pill quickens the heart rate, opens up bronchial airways to allow more oxygen to become available, and constricts the blood vessels and results in increased blood pressure.
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In a letter issued to the Department of Health and Human Service’s Secretary Thompson, Public Citizen referred to Metabolife’s political involvement as made public in a Washington Post December 25, 2000 article. The article, and letter, stated that Metabolife had donated $683,000 to federal campaigns by October 1, 2000, ranking Metabolife International seventh among U.S. pharmaceutical company in highest political donations.
In Texas, the state health department has been trying to more tightly regulate dietary supplements but has been battling with ephedra makers. Metabolife has spent over $4 million between 1998 and 2000 to lobby against the state regulations.
The San Diego based company also ranked fourth in California for “soft money” contributions, giving $493,000 in 2000 in addition to a $100,000 donation to Governor Gray Davis’ campaign. Governor Davis announced, in an unusual veto message, that he agreed with virtually all the major arguments for Metabolife regulation. The governor’s office announced on August 16, 2002 that California would regulate ephedra-based dietary supplements, such as Metabolife, unless the federal government takes swift action.
Public Citizen attributes Metabolife’s large political influence to have been a partial reason for the delayed actions taken against the ephedra industry as a whole.
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