GAO: Metabolife Records Report Five Deaths 30997

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 14,684call records provided by Metabolife International, users of the company'sephedra-based Metabolife 356 reported 18 heart attacks, 26 strokes, 43 seizuresand five deaths. However, these findings do not necessarily point to ephedra asthe cause of the events. GAO reported, "Because of the inherent limitationsof adverse event reports (AERs) and the incomplete nature of these call records,it cannot be established from the information available to [us] that the adverseevents reported were caused by Metabolife 356."

These records were the subject of a public reprimand given toMetabolife International by the Food and Drug Administration's (FDA) DeputyCommissioner Lester Crawford in August 2002. Crawford called the company's delayin turning over the AERs "disingenuous."

GAO's report, "Dietary Supplements: Review ofHealth-Related Call Records for Users of Metabolife 356," was commissionedby the Subcommittee on Wellness and Human Rights, chaired by Rep. Dan Burton (R-Ind.).Burton asked GAO to answer three questions during its review of MetabolifeInternational's AERs: 1) To what extent was consumer information in call recordscomprehensive and recorded; 2) How many records reported health-relatedproblems, and of those, how many were serious; and 3) How do GAO's counts ofAERs compare with those tabulated by Metabolife International? The report wassubmitted to the committee in late March and was subsequently made public, eventhough Burton and colleagues had been given the opportunity to publicly releasethese findings 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 waslimited," GAO noted in its report. "Call records were sometimesdifficult to understand, and consumer information was not consistentlyrecorded." The agency reported only 73 percent of records noted the amountof Metabolife 356 used, 67 percent recorded duration of use and 45 percentlogged a person's medical history. GAO noted that typewritten forms recordedmore information than handwritten ones.

In terms of how many records reported health problems, consumercomplaints included a long list of ailments. Besides the aforementioned seriousAERs, GAO also noted 433 reports of chest pain, 181 of systemic rash, 110 ofurinary tract infection, 93 of elevated blood pressure, 47 of losses inconsciousness and 31 of abnormal heart rhythm. Yet again, GAO followed thesefindings with the disclaimer that it could not establish these adverse eventswere caused by the use of Metabolife 356. Also, the agency classified AERs basedon what was recorded in records, and it did not attempt to diagnose conditionsor determine the validity of claims made in call records.

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

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

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