[Please see here for my follow-up letter to Dr. Woodcock.]

I just sent the following message regarding Hemispherx’s extraordinary 267% price increase for Ampligen to Dr. Janet Woodcock, the FDA’s Director of the Center for Drug Evaluation and Research:

Dear Dr. Woodcock,

I am writing to you regarding a matter of grave concern for the patients in Hemispherx Biopharma, Inc.’s (“HEB”) AMP-511 open-label clinical trial for Ampligen, a drug highly effective for many ME (or as the FDA calls it “ME/CFS”) patients. I have testified at the Ampligen Advisory Committee meeting and other federal committee meetings in favor of FDA approval of the drug and I remain convinced that this drug should be approved by the FDA without further delay because many patients would benefit from it and because there are no other FDA-approved pharmaceutical interventions for ME.

I have been a study participant for over three years. Last night, I learned through ME Action’s blog (http://www.meaction.net/2015/08/10/ampligen-price-increases-substantially-available-soon-in-europe/) that the price of the drug will go up 267%, from $15,600 to $41,600 per year, effective immediately as of July 24, 2015. Because it has not been approved by the FDA, the cost of the drug is currently not covered by private insurance or Medicare/Medicaid. Patients pay the entire cost out of pocket. Nevertheless, I have not received any notification from HEB of this extraordinary price increase.

HEB seems to claim that the price increase is necessitated by their increased cost in providing the drug to trial participants and that the increase has been verified by an accounting firm. However, accounting firms can avail themselves of a number of different methods to establish cost. For example, I understand that HEB recently expanded its facilities. Was the cost of this expansion, which would be a sunk cost at this point, included in the cost justification for the price increase either through depreciation or amortization? Moreover, HEB’s position itself is apparently contradictory as to the basic fact whether the new price includes merely manufacturing cost or also the cost of continued research and FDA-approval efforts. These points are merely illustrative of the various types of cost that may or may not have been included in the price-increase justification. It just does not seem probable that HEB’s cost increased that dramatically over night. A gradual increase seems much more plausible and would have been much easier to absorb for patients.

As you know, there are only four Ampligen trial sites in the country. Patients move and either leave their families behind or uproot them, either buy and sell houses or rent second homes, give up or change jobs, mortgage their houses, enroll their kids in new schools, etc. in order to relocate to a trial site and, in doing so, incur substantial long-term expenses far beyond just the price of the drug and the related infusion/physician’s cost. At the very least, HEB could have informed study participants of the fact that it is considering an increase at the time when it hired the accounting firm. The entire process from hiring the firm to the firm’s completed report typically takes time. That would have at least provided patients some advance notice. Some patients have very recently invested in relocating to a trial site just to find out now that they will not be able to afford the drug at the new price.

To be completely blindsided, not only without any advance warning, which was entirely feasible, but without any notification from HEB whatsoever upon effectiveness of the increase—more than two and a half weeks ago—is inexcusable and I would like to confirm with you that HEB followed any applicable federal rules both with respect to the magnitude of the price increase and the lack of notice.

I am looking forward to your response. Obviously, the matter is of utmost urgency, as many trial participants will be unable to afford the new price and will have to re-plan their lives without the drug. Most importantly, suddenly being cut off from a potent drug that patients’ immune systems have come to rely on might very well put the health of the current trial participants at risk.

Sincerely,

Jeannette Burmeister

cc :

Dr. Stephen Ostroff, FDA Acting Commissioner

Nancy McGrory, Hemispherx Patient Advocate