GAO: Metabolife Records Report Five Deaths

WASHINGTON--In a report released by the U.S. General Accounting Office (GAO) April 30, the agency reported that from 14,684 call records provided by Metabolife International, users of the company's ephedra-based Metabolife 356 reported 18 heart attacks, 26 strokes, 43 seizures and five deaths. However, these findings do not necessarily point to ephedra as the cause of these events. GAO reported, "Because of the inherent limitations of adverse event reports (AERs) and the incomplete nature of these call records, it can not be established from the information available to [us] that the adverse events reported were caused by Metabolife 356."

These records were the subject of a public reprimand given to Metabolife International by the Food and Drug Administration's (FDA) Deputy Commissioner Lester Crawford in August 2002. Crawford called the company's turning over of the AERs "disingenuous." "Since 1997, FDA has tried to get these AERs from industry," Crawford said last year. "Metabolife International has refused and resisted us every step of the way." The records in question were taken for the most part from phone calls made to Metabolife International from May 1997 through July 2, 2002.

GAO's report, "Dietary Supplements: Review of Health-Related Call Records for Users of Metabolife 356," was commissioned by the Subcommittee on Wellness and Human Rights, chaired by Rep. Dan Burton (R-Ind.). Burton asked for GAO to answer three questions during its review of Metabolife International's AERs: 1) To what extent was consumer information in call records comprehensive and recorded; 2) How many records reported health-related problems, and of those, how many were serious; and 3) How do GAO's counts of AERs compare with those tabulated by Metabolife International? The report was submitted to the committee in late March and was just made public, even though Burton and colleagues had been given the opportunity to make these findings public earlier.

Regarding the first question on consumer information collection, the agency noted that the company's records were far from comprehensive. "The information in the Metabolife International call records was limited," GAO noted in its report. "Call records were sometimes difficult to understand, and consumer information was not consistently recorded." The agency reported only 73 percent of records noted the amount of Metabolife 356 used, 67 percent recorded duration of use and 45 percent logged a person's medical history. GAO noted that typewritten forms recorded more information than handwritten ones.

In terms of how many records reported health problems, consumer complaints included a long list of ailments. Besides the aforementioned serious AERs, GAO also noted 433 reports of chest pain, 181 of systemic rash, 110 of urinary tract infection, 93 of elevated blood pressure, 47 of losses in consciousness and 31 of abnormal heart rhythm. Yet again, GAO followed these findings with the disclaimer that it could not establish these adverse events were caused by the use of Metabolife 356. Also, the agency classified AERs based on what was recorded in records, and it did not attempt to diagnose conditions or determine the validity of claims made in call records.

The third question asked by Burton--how the agency's AER findings compared to Metabolife International's--yielded interesting findings. Metabolife International only reported a total of 78 serious AERs, compared to GAO's 96; one conflicting number included Metabolife counting only three deaths among Metabolife 356 users compared to GAO's findings of five.

The agency clarified in its report that FDA has not conducted its own review of Metabolife International's call records; also, in Metabolife International's review of the report, its primary concern was the agency's use of the term "adverse events" to describe the call records' consumer health complaints.

GAO informed Burton in its report that of the 1,800 AERs reported to FDA as of Sept. 27, 2002, from ephedra users, 322 concerned Metabolife 356. The report can be found at www.gao.gov.

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