Hemispherx’s Dr. Carter tied to “advocacy group” promotion of Ampligen despite FDA violation notice and restriction.

On October 15, 1998 the FDA sent a violation notice to Dr. William Carter, CEO of Hemispherx Biopharma, Inc. (AMEX: HEB) (Price: $7.9375), that required Hemispherx to cease making claims of safety and efficacy for Ampligen. Since that time, Dr. Carter has met with and agreed to finance certain members of an advocacy group called the CFIDS Ampligen Citizens Advisory Board (“CAB”). The group’s stated purpose is to promote Ampligen. According to an announcement on the CAB’s website, David Miller, a founder of the CAB who is also responsible for a May 17, 1999 press release promoting Ampligen, met in May and again on June 1 with Dr. Carter. Mr. Miller’s press release was paid for by an HEB insider shareholder.

Mr. Miller’s release, attributed to the AIDS Treatment Technical Assistance Council (“ATTAC”), claims that AIDS clinicians and activists are defending Ampligen as “a clinically promising therapy for HIV.” In fact, Ampligen failed over a decade ago in HIV clinical trials. Furthermore, Ampligen has been tested on 6 different diseases, including, since 1993, FDA-approved Phase III CFS trials, without a single FDA new drug application ever being filed.

The release describes ATTAC as “a non-profit AIDS service organization” and “a leading NGO [non-governmental organization].” We found no record of a nonprofit group registered or incorporated under that name. Furthermore, ATTAC had never previously issued a release via the PR Newswire, and the persons quoted in the release are all directly connected to that group’s only publicly known member, Mr. Miller. Mr. Miller is also described in the release and on the CAB website as a member of ACT UP New York, a respected AIDS activist organization. He is, however, neither an authorized spokesperson nor an official for ACT UP.

The publication cost of the ATTAC release was paid by Mitchell Abrahams, a self-described “investor and advocate for CFIDS.” According to a December 3, 1998 posting by Mr. Abrahams that was published on a Canadian CFIDS website, Mr. Abrahams also arranged for Hemispherx to fund “The CFIDS Radio Show.” On January 3, 1999, David Miller appeared on this program and discussed Ampligen as an HIV treatment. In an SEC filing dated June 23, 1999, Hemispherx registered 20,000 shares of privately obtained, insider HEB stock for Mr. Abrahams. Hemispherx paid for the cost of registration, which allows Mr. Abrahams to sell his privately obtained shares to the public without further notice or disclosure.

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