Hemispherx’s CFS prevalence disclosures proven false.

Hemispherx Biopharma, Inc. (AMEX symbol: HEB) (Price: $7.25) has issued press releases and an investor publication titled “General Information on Chronic Fatigue Syndrome” that report false and exaggerated, national U.S. prevalence rates for Chronic Fatigue Syndrome (“CFS”). In its investor publication Hemispherx claims that studies from Harvard University and the Centers for Disease Control and Prevention (“CDC”) support the belief that 1000 of 100,000 Americans or 2.5 million people in the United States suffer from CFS. This statement is completely false. No such studies exist. None of the studies cited are related to Harvard. None are national and none support Hemispherx’s claimed CFS prevalence rate.

In its October 14, 1998 press release, Hemispherx stated “that a new publication from the U.S. Centers for Disease Control (CDC) confirms Company [Hemispherx] investor publications stating that Chronic Fatigue Syndrome afflicts approximately half a million persons in the U.S.” Hemispherx did not mention its published 2.5 million estimate. The CDC did, in fact, prepare a new pamphlet dated October 1998 to be distributed for the first time at the American Association for Chronic Fatigue Syndrome’s (“AACFS”) Fourth International Research, Clinical and Patient Conference (“CFS Conference”) on Chronic Fatigue Syndrome. The CFS Conference occurred the weekend of October 10-12, 1998, in Cambridge, Massachusetts. The pamphlet cites two studies that estimate CFS and CFS-like prevalence rates. They are a Seattle study with rates between 75 to 265 per 100,000 persons and a San Francisco study with a rate of 200 per 100,000 persons. Both these studies are small and regional. They should not be used to estimate a national CFS prevalence rate. Furthermore, they are fundamentally flawed. The San Francisco study included patients that reported non-medically diagnosed CFS like symptoms. The Seattle study’s estimate for a national CFS prevalence rate was determined after finding that only 3 out of 3066 patients met the 1988 CDC criteria for CFS. In any case, the CDC concludes its prevalence reporting in this pamphlet stating “In general, it is estimated that perhaps as many as half a million persons in the United States have a CFS-like condition,” not CFS and not 2.5 million as Hemispherx has claimed.

In both its September 29, 1998 and its October 14, 1998 press releases, Hemispherx referred to the “most recent medical study” on CFS prevalence and stated it was published in the Annals of Internal Medicine. In the September 29th press release Hemispherx stated “The Company [Hemispherx] said today that the latest authoritative research on CFIDS incidence is an independent study from Harvard University School of Medicine, led by the eminent Dr. Anthony Komaroff, Professor of Medicine. The Harvard study states that there are between 500,000 and 2,000,000 Americans suffering from Chronic Fatigue Syndrome. Dr. Komaroff’s latest study is published in the August 1995 issue of Annals of Internal Medicine.” We discovered that Hemispherx had made four blatant misrepresentations in this statement. There, in fact, was no Harvard study, no Dr. Komaroff led study, and it was not published in either of the two August 1995 issues of the Annals of Internal Medicine. However, we found a CFS prevalence study in the July 15, 1995 edition. Dr. Komaroff was one of six authors of this study. The study did not state that the number of incidences of CFS ranged between 500,000 and 2,000,000 persons. We cited and responded to these misrepresentations in our September 30, 1998 research report titled “Hemispherx attempts to use false CFS prevalence rate in an attempt to mislead investors.”

Hemispherx’s October 14, 1998 press release cited the so-called “Harvard study” and stated that “The most recent CDC studies are consistent with the estimates that appear in the most recent medical study as reported in the July 15, 1995, Annals of Medicine article (p. 81) that is co-authored by Dr. Anthony Komaroff, Professor of Medicine at the Harvard University School of Medicine.” In fact, the summarized conclusion section at the beginning of the study on page 81 states, “Using different assumptions about the likelihood that persons who did not participate in the study had the chronic fatigue syndrome, the estimated crude point prevalence of the syndrome in this community ranged from 75 to 267 cases per 100,000 persons.” This prevalence rate is based on a regional study done in the Seattle area that found 3 people that met the old 1988 CDC criteria for CFS. Even using these 3 claimed CFS patients to estimate a national prevalence rate and the 200,444,000 people, age 18 and older, living in the United States as published in a August 1998 report by the Population Bureau of the US Census Bureau (“US Census Report”), the CFS incidence ranges would only be between 150,333 and 531,186 persons in the US.

On the contrary, this “Harvard study,” as Hemispherx refers to it, is not the most recent study conducted on CFS prevalence. The most recent study by the CDC as reported at the CFS Conference on October 10-12, 1998 is a “Wichita Population-Based Study of Fatiguing Illness” (“Wichita Study”) by Drs. M. Reyes, R. Nisenbaum, W.C. Reeves, and Mr. G. Stewart. The results of this study have not been published and are not being released nationally yet by the CDC.

Dr. Reeves is responsible for CFS research at the CDC. Dr. Reeves took a great personal risk when he reported to congressional leaders under “The Whistle Blower Act” that he believed CDC officials misspent and misrepresented CFS funding. Based upon conversation with Dr. Reeves, a reporter produced an article that was published by Reuters on October 15, 1998. This article cited a telephone poll that is part of CDC’s Wichita Study “involving residents of over 34,000 households in Sedgwick County, Kansas. Respondents were asked to answer a series of detailed questions about their personal medical histories.” The CDC confirms the article’s report that about 183 of every 100,000 US citizens, age 18 or older, has a constellation of CFS-like symptoms. Using this estimate and the statistic that 200,444,000 people, age 18 or older, live in the United States as recorded in the US Census Report, there are around 366,813 persons, age 18 or older, that report having CFS-like symptoms. The actual number of medically diagnosed CFS cases would necessarily be lower. This estimate then is over 26% lower than the incidence rates published in CDC’s most recent pamphlet

Hemispherx’s investor publication stated the prevalence rate in the Overview of Chronic Fatigue Syndrome (CFIDS) section. It stated that “1000 of 100,000 Americans or 2.5 million people in the United States, it is now believed to suffer from CFIDS, based on studies from Harvard University and CDC.” However, the studies Hemispherx has referred to do not support, in fact they contradict, Hemispherx’s claim that 2.5 million people suffer from CFS. The so-called “Harvard study” estimates an average of 340,780 people in the United States are affected by CFS-like symptoms. The CDC published in its new pamphlet that approximately 500,000 persons in the US have a CFS-like condition. The most current study as discussed in the previous paragraph suggests 366,813 persons, may have CFS-like symptoms. None of these studies should be used to make claims about national, medically diagnosed CFS cases. These numbers are all over 80% less than the 2.5 million incidences that Hemispherx reports in its investor promotions. Hemispherx not only misrepresents the incidence of CFS, but is inconsistent in the statistics it reports.

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