Hemispherx Biopharma, Inc. (AMEX symbols: HEB and HEBWS) (Price: $5.875) issued a press release on September 29, 1998. The release concerned the incidence of Chronic Fatigue Syndrome (“CFS”) and cited a Harvard study “led by the eminent Dr. Anthony Komaroff.” As detailed below, there is no Harvard or Dr. Komaroff led CFS incidence study. Hemispherx claims the alleged Harvard study states that the number of incidences range between 500,000 and 2,000,000.
The National Institute of Allergy and Infectious Diseases (“NIAID”) and the National Institutes of Health (“NIH”) stated that “Without objective diagnostic criteria, the prevalence of CFS is difficult to measure.” In any case, the number of CFS cases is irrelevant to Hemispherx. Contrary to its statements, Hemispherx does not have approval to sell Ampligen as a CFS treatment. We believe this release is another attempt to mislead investors and is a continuation of Hemispherx’s fraudulent stock promotion. Regardless, we disagree with their claims and proceed to prove Hemispherx is disseminating false information.
According to an August 1, 1998 report by the US Census Bureau, the Population Bureau records show that there are 200,444,000 persons, age 18 or older, living in the United States. This number and the CFS prevalence rate are all that is necessary to calculate an estimate of the number of CFS cases. The calculation supports our estimate and does not remotely support Hemispherx’s CFS case estimate.
Hemispherx stated in its press release that “Asensio & Company’s research report cited a U.S. adult incidence level of only 26,000. The Asensio report apparently relied on outdated estimates made by the Centers for Disease Control in the early 1990’s, which the CDC itself has since repudiated.” Our report did not rely on any early 1990’s CDC study. The CDC has not repudiated its CFS rate.
An article titled “New directions in chronic fatigue syndrome” was published in the September 15, 1998 issue of Patient Care. The authors of the article state that “The Centers for Disease Control and Prevention (CDC) estimates that the minimum CFS prevalence rate in the United States is 4 to 10 cases per 100,000 adults aged 18 or older.” Using the number of adults over the age of 18 discussed above, we calculate that the minimum number of CFS incidences ranges from 8,018 to 20,044 in the United States. Thus, a minimum average of 14,031 total persons, age 18 or older, are subject to CFS in the U.S. Our ten page research report reads, “The CDC has estimated the minimum prevalence rate of CFS in the United States at 4 to 10 cases per 100,000 adults 18 years of age or older. If one uses the entire population of the United States, the range of cases is between 10,400 and 26,000.” Using the Census information the high-end number of CFS cases drops to 20,044.
The Centers for Disease Control and Prevention (“CDC”) publish CFS demographics on its web site. The demographics page was last updated on September 17, 1998. We believe that the statistics included on the page are accurate and the most recently accepted by CDC. At this site, CDC states that the maximum estimate of adults that are subject to CFS is 265 per 100,000 adults. This data comes from a study done in the Seattle area. A small, regional study cannot be extrapolated to the entire U.S. Despite this study being faulty, the number yields a maximum incidence level of 531,176 adults in the U.S. This number is 73% smaller than the 2,000,000 maximum rate claimed by Hemispherx.
The press release also cites “an independent study from Harvard University School of Medicine, led by eminent Dr. Anthony Komaroff, Professor of Medicine.” Hemispherx introduced the report as being “the latest authoritative research on CFIDS incidence,” and being “published in the August 1995 issue of Annals of Internal Medicine.” In actuality, there is neither a study in the August 1, 1995 edition nor the August 15, 1995 edition of Annals of Internal Medicine. There is an article titled “Chronic Fatigue and the Chronic Fatigue Syndrome: Prevalence in a Pacific Northwest Health Care System” in the July 15, 1995 edition of Annals of Internal Medicine. The study was not conducted, published, or funded by Harvard or any of its affiliates. Dr. Komaroff is listed in this study but not as the lead author. In fact, Dr. Komaroff is only one of six authors and is the last mentioned.
Hemispherx’s press release claims, “The Harvard study states that there are between 500,000 and 2,000,000 Americans suffering from Chronic Fatigue Syndrome.” No place in the study does it cite that the number of U.S. CFS cases ranges from 500,000 to 2,000,000. The study was done in Seattle. 4000 people in a Seattle health maintenance organization were surveyed by mail. 3066 people responded and “only 3 met the CDC criteria for the chronic fatigue syndrome.” In addition, the survey started in January 1990 and ended in March 1991. The original, 1988 CFS criteria was used, which is dated and was modified in 1994 after the study was concluded but before the study was published in July 1995.
In addition, this study received grant support from the NIAID. In September 1996, over one year after the report was published, the NIAID and the NIH published an information brochure for physicians on CFS. The brochure states, “The Centers for Disease Control and Prevention (CDC) estimates the minimum CFS prevalence rate in the United States is 4 to 10 cases per 100,000 adults 18 years of age or older.” NIAID and NIH cite the exact same sources for their incidence rate as we do in our reports. They do not cite the statistics listed in the above study which they helped fund. We believe that this plethora of information supports our statements and disproves claims made by Hemispherx.
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