On December 4, 2001 Hemispherx Biopharma, Inc. (AMEX: HEB) (Price: $4.99) claimed that a new report issued by the U.S. Agency for Healthcare Research and Quality (“AHRQ”) on Chronic Fatigue Syndrome (“CFS”) confirmed Ampligen’s efficacy. We believe that Hemispherx’s release can only be described as a malicious attempt to mislead. The AHRQ report merely regurgitates Hemispherx’s own claims with no independent analysis or verification. The report merely compiles and summarizes currently available literature about CFS from available electronic databases.
Twice in the press release Hemispherx claims that the AHRQ report indicated that “Ampligen yielded the most promising results” in the treatment of CFS. The AHRQ report merely used Hemispherx’s own claims. The Hemispherx study referred to in the AHRQ report was supposed to be confirmed by a one year Phase III clinical trial and should have resulted in the submission of a NDA for FDA review. Hemispherx never completed the CFS trial and never submitted an NDA. In fact, in 1991 the FDA withheld Hemispherx’s application for a treatment IND to provide Ampligen to patients with CFS due to concerns about potentially life threatening side effects. Despite all this HEB still claims that the ten-year-old trials that are supposed to have lasted one-year is on going.
No other medical organization (which should not be taken to imply that Carter or his Hemispherx colleagues are members in good standing in this very broad category) has had the audacity to claim it possesses an effective CFS treatment. The Hemispherx study is out-dated, used a 13-year-old obsolete CFS case definition and highly questionable end-points. The Hemispherx study is self-generated. Finally, despite all these drawbacks, the Hemispherx study is inconclusive. As a result the medical community largely ignores Hemispherx’s Phase II CFS trials. Hemispherx used the fact that the AHRQ found Hemispherx’s own study in its electronic database search and included Hemispherx’s own unadulterated claims, without any independent AHRQ review or analysis, to issue a misleading statement.
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