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US42366C5094 HEB

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HEMISPHERX BIO : document intéressant à traduire et à li

20 mai 201316:26

et à lire .

C'est un résumé de la réunion avec le FDA du 25avril 2013


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  • JVC14
    20 mai 201319:55

    voici les passages qui qui font reference a l'Ampligen

    Patient Mary Schweitzer, a tenured history professor, reported on Ampligen, and what her life was like without it: “Without Ampligen I don’t have a life.”

    Executive Vice Chairman of Hemispherx BioPharma Thomas Equels offered some interesting history about the company's involvement with CFS. Thirty years ago FDA asked Hemispherx to team up with Dr. Peterson and Dr. Lapp to treat the "Tahoe flu." They conducted a trial of Ampligen on a woman who made a remarkable recovery, and then treated twelve more patients with success. He remarked that it has been a long difficult journey for a company as small as his. Mr. Equels concluded with: “Now we’ve expended a great deal of time and money to get where we are today and I just want to say we’re prepared to enter into a real partnership with the FDA, with the clinicians, and with the patients to bring relief for these people who so desperately need it.”

    Physician Charles Lapp has treated patients with CFS since 1985, and has used Ampligen since 1988. He reported using Ampligen with great success - 50% of his patients have responded very well to Ampligen and roughly 30% have had significant improvement. In all the time he has used Ampligen. he has not seen any serious side effects. He compared Ampligen to other new drugs that have been brought into the field, like AZT for AIDS and interferon for MS. Once they were approved, many other players and pharmaceutical companies came into the field and opened up treatment for these two diseases. “We hope that Ampligen will do that for Chronic Fatigue Syndrome.”

    Patient Jeannette Burmeister urged the FDA to play a more proactive role in working with Hemispherx to put Ampligen on an accelerated track for approval. "At the Ampligen FDA Advisory Committee meeting, the FDA stated that there is no path for Ampligen’s approval under any fast-track program. No explanation was given. In contrast, the FDA has recently developed new guidelines for an accelerated-approval process for Alzheimer’s drugs for patients who are not even sick yet! Why the drastically different standard, I wonder? Looking back at the approval of AZT as the first drug to treat HIV and AIDS, it becomes clear that the FDA does indeed have discretion to adopt looser rules if the circumstances warrant it. At the end of last year, the FDA approved—under an accelerated approval program—Sirturo, a drug to treat tuberculosis that is five times more likely to kill patients than the standard drug treatment for the disease without proof of increased efficacy. I am not convinced that the FDA’s hands are indeed bound when it comes to an accelerated approval of Ampligen. Instead, it seems that an unfortunate double standard applied by the FDA to ME and Ampligen compared to other diseases and drugs has Ampligen headed straight towards the cliff, as Hemispherx is running out of money and the drug is going away, potentially forever."

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