›William A. Carter, M.D. Chief Executive Officer Hemispherx Biopharma, Inc. One Penn Center 1617 JFK Boulevard Philadelphia, PA 19103
July 7, 2000
Re: AMPLIGEN (POLY I:POLY C12U)
Dear Dr. Carter:
This letter concerns materials disseminated by Hemispherx Biopharma, Inc. (Hemispherx) for its product, Ampligen, which is an unapproved new drug and the subject of an Investigational New Drug Application (IND) with the Food and Drug Administration (FDA). The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed these materials as part of its routine monitoring and surveillance program. From its review, DDMAC has concluded that Hemispherx is promoting Ampligen as safe and effective prior to approval, in violation of the Federal Food, Drug, and Cosmetic Act (Act) and its implementing regulations.
BACKGROUND
We previously issued an untitled letter, dated October 15, 1998, to Hemispherx for promoting Ampligen as safe or effective while the product was under investigation. In our letter, we informed you that your activities were in violation of the Act and applicable regulations. In your response, dated October 29, 1998, you assured us that Hemispherx would discontinue or revise all materials concerning Ampligen to conform with the Act and regulations.
However, notwithstanding your assurances, you continue to promote Ampligen as safe and effective prior to approval in your press releases and on your Internet website. Such activities constitute promotion of an investigational new drug as safe or effective in violation of the Act and its implementing regulations. In addition, your promotional materials are false or misleading in that they fail to disclose facts that are material in light of representations made about Ampligen.
PRESS RELEASES
Hemispherx promotes Ampligen as safe and effective in several press releases. In addition, Hemispherx fails to reveal facts that are material in light of representations made about Ampligen.
Safety
In press releases, Hemispherx promotes Ampligen as “generally well tolerated” or “well tolerated” but fails to disclose risk information associated with the use of Ampligen. For example, in your press release dated February 17, 2000, entitled “Hemispherx Files for HlV Emergency Treatment IND and Phase II/III Trials,” you state, “To date, Ampligen has been studied in 126 patients and has been consistently well tolerated in its trials.” However, toxicities that have been reported in dose-escalating studies of Ampligen in HIV-infected patients include, but are not limited to, flushing, chills, fever, chest tightness, nausea, malaise, shortness of breath, flu-like symptoms, leukopenia, neutropenia, and leukocytosis.
Effectiveness
In your February 22, 2000 press release, you present that, “…Ampligen demonstrated synergistic activity with anti-retroviral therapy leading to potential enhanced suppression of replicating HIV virus...” Similarly, in your press release of December 16, 1999, entitled “Hemispherx Announces New Approach to HIV Multi-Drug Resistance,” you state, “...multiple HlV genetic mutations that made the 14 anti-HIV drugs approved by the Food and Drug Administration (FDA) ineffective did not diminish the pronounced anti-viral effectiveness of Ampligen.” These statements make conclusions concerning the effectiveness of Ampligen, an investigational new drug, in violation of the Act and its implementing regulations.
INTERNET WEBSITE
…Your website, www.hemispherx.com, contained a direct link to transcripts of Dr. Mazien’s CFS Radio Program, which promote Ampligen as safe or effective. For example, the linked transcript from Dr. Mazien’s CFS Radio Program from February 28, 1999, presents the following conversation between Dr. Mazien and Dr. Paul Cheney:
• “…there’s no doubt in my mind as I’ve seen it in clinical practice that this drug [Ampligen] is bioactive in this syndrome [CFS]”
• “Ampligen also has potent antiviral properties as well...”
• “The other parallel issue for Ampligen is that it appears that the longer that you take it, if you are responding to it, the better the outcome...”
Further, your website is directly linked to a web page containing anecdotal reports of CFS patients who participated in clinical trials. For example, on the “Other CSF Links” page on your website there is a link entitled, “The ‘Ampligen 511 Panel’ Patients Speak About Their Experiences with Ampligen at the AACFS Conference.” The link goes directly to the patient testimonials that are located at www.cfids-me.org. These patient testimonials promote Ampligen as safe or effective prior to approval. The following statements are examples of patient testimonials:
• “... .after 10 years of consistent abnormality, a return to normal ranges/or the first time, with Ampligen being the only new variable in my life, clearly demonstrates the efficacy of this drug.”
• “Unlike IV gamma globulin, Ampligen is not offering me only symptomatic relief. I am healing from the inside out.”[ROTFLMAO!]
• “Call me Lazarus—the only reason Jam here and functioning pretty well today is Ampligen. I have absolutely no doubts about its efficacy in the treatment of my illness.”
• “No adverse effects—and immediate benefits to boot: The Ampligen Bounce!”[LMAO]
REQUESTED ACTIONS
Hemispherx should immediately cease dissemination of materials or activities that contain these and similar claims, representations, and conclusions concerning the safety or effectiveness of Ampligen. In addition, Hemispherx should respond in writing no later than July 21, 2000 describing its plan to comply. Hemispherx should also include a list of materials being discontinued, as well as the date of discontinuation.
Sincerely,
Ele-Ibarra-Pratt, RN., M.P.H. Regulatory Review Officer Division of Drug Marketing, Advertising, and Communications [DDMAC]‹
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