267% Price Increase for Ampligen

[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

This entry was posted in Uncategorized and tagged , , , , , , , , , , . Bookmark the permalink.

31 Responses to 267% Price Increase for Ampligen

  1. Bravo. That is an excellent letter. I’m not on Ampligen, but have definitely been following the trials and its success for many patients. Thank you for speaking out for all of you who are so drastically affected by this.

  2. John Gabor says:

    Agreed. This is an excellent letter. Thanks Jeannette.

  3. Thank you for doing this Jeannette. My kids have already responded with texts to the effect that the company must have learned that I just moved from the East Coast to Tahoe to make it easier to get my twice-weekly Ampligen infusions.

  4. Ess-OriG says:

    Great work on this, Jeannette; excellent points. Such a substantial increase in the cost of Ampligen and with no appropriate notice to patients is problematic in the many ways you have described. This is a real blow to patients enrolled in the clinical trials … as well as future ramifications for the use of Ampligen.

  5. leela says:

    The landscape of this illness only gets more bizarre.
    Thank you Jeannette for trying to bring a shimmer of reason to its horizons.

  6. Sharon says:

    Beautifully written, Jeanette. Thank you for your continuing advocacy. You are mighty.

  7. Linda Barossi says:

    Thank you, Jeannette.

  8. Am I glad you tolled the bell. I knew H. was rising the price of Ampligen, but am flabberghasted about the percentage. This most probably is justified by their decision to make the drug available to the European community including Turkey.

    The conclusion seems quite clear. The outcome that hardly anyone, neither in the USA, nor in Europe, will be able to afford the price asked in the future. A loss/loss situation

  9. Albert Chang says:

    Awesome! Is there some sort of petition, or the like, with which we can add our own submission? I definitely want to voice my proposition to prevent the price surge.

  10. Reblogged this on Short Blogs for the Distracted……… and commented:
    267%. Crazy… Great letter .. Rubbish abuse of sick people …

  11. Pingback: Hemispherx ramps up price of Ampligen by 267%

  12. Rhonda Ovist says:

    I don’t know what shocks me more – That people who already are sick and suffering must disrupt their lives and pay money to a pharmaceutical to participate in a drug study (which will ultimately bring profits to the company when FDA approval is given, especially with seven million or more people in the world with ME); or that the pharmaceutical company would raise the price of a trial drug midway through a drug trial to such exorbitant amount. Is this just a new form of extortion? Ie “we have a drug you desperately need, but we won’t pursue FDA approval unless you pay us for the privilege of making us rich and profitable in the long run). Yes, indeed, the USA has the best medical system….for financial exploitation of the sick and disabled.

  13. kmdenmark says:

    Thank you, Jeanette. Excellent job!

  14. Thanks, guys.

    I still have not been notified by the company. For all I know, this could be an urban legend and we can all relax. I guess I’ll find out when they charge my credit card the next time.

    • Matt says:

      Hi Jeannette,

      I am an Ampligen patient at Dr. Lapp’s clinic in Charlotte. I’m afraid that the price increase is very real. I was given a letter last week and asked to sign consent forms for a new protocol.

      From what I understand patients will not be able to miss more than four consecutive infusions under the new protocol which means no more drug holidays.

      While I agree with your letter and do feel that Hemispherex is a shady company, I think our real hope for change lies in pressuring the FDA to allow Ampligen into the REMS program. This would give it a sort of provisional approval from what I understand and allow CFS experts to administer the drug and insurance to cover it.

      I’m not sure how to achieve this, but maybe we as patients can come up with something together.

      • Thank you very much for that information, Matt!

        The elimination of meaningful drug holidays is another indication of where things are headed. I guess if one has to have major surgery, wants to visit a dying relative overseas or attend to other emergencies, one will get kicked out of the trial. Such “compassion” is truly rare.

  15. Pingback: CFSAC Comments August 2015: Ampligen Update | Thoughts About M.E.

  16. HEB has an open house coming up on August 25, 2015 at 10am to show off their expanded facilities in New Brunswick, NJ to their stockholders. I wonder if HEB is effectively moving forward to try to meet the FDA requirements for Ampligen approval or are they focusing their money and efforts on promoting their other drug in development for genital warts. Apparently the new facility is mainly for development of that drug. The CEO makes in excess of $2 million per year in salary. Usually a drug company provides the drug for free during clinical trials. By increasing the cost to study participants they will have fewer, and seemingly less chance of satisfying FDA requirements. I am wondering if the information about the upcoming meeting of stockholders could be helpful to us in any way. If we were ACT UP we would protest this increase and show the stockholders that there is resistance from the community to the price increase and the seeming inability for HEB to satisfy FDA requirements including a larger clinical trial. We are not ACT UP and can’t do the kinds of protests they did, but is there something we can do with this? Looking for some “hive brain” on this thought.

  17. The above lawsuit could be part of the reason the price has gone up. Hemispherx doesn’t seem to be conducting the necessary clinical trails to get FDA approval. If large scale clinical trails were done to meet FDA satisfaction HEB may have a chance of approval. The FDA is unduly influenced by the money of large and powerful pharma companies and Hemispherx seems incompetent and shady. Put that together and we will likely never see approval unless something big changes. Just my thoughts here.

    • The company has made many mistakes over the years. And getting sued certainly isn’t helping. It’s not just the settlement amount, but also the legal fees that hurt their budget.

      But the FDA has the power to approve Ampligen conditionally, like it has done with drugs that are much less needed than Ampligen. The problem is that once they approve an immune modulator, all of HHS has to finally admit (beyond lip service) that this is a real and serious disease. Nobody at HHS wants that.

      Many in the trial have put a lot of effort into helping get the drug approved. But it’s a bit tough to remain supportive of them when they totally sell you down the river. They went too far this time.

      • Kelly says:

        I’m sorry Jeannette, I’m not buying that the reason Ampligen hasn’t been approved is because HHS would have to admit this disease is real. The FDA asked Hemispherx to follow very specific guidelines for a new study after they were turned down in 2009. It’s been six years and have they even started that FDA-requested study?

        • I hear you. But other drugs, some with a much scarier safety profile for diseases with other approved treatments, have been approved by FDA. I honestly think this is a situation with not just one party at fault.

  18. Thank you Jeannette for writing the letter to the FDA. I’m sure you are right about HHS and I know you are right about other drugs being approved that are much less needed and with less evidence of safety and efficacy. I have watched the FDA approve “me too” drugs for HIV that were equally as effective as the ones available but less safe. Stribild for instance was less safe, more expensive and only approved for treatment naive patients; which meant there was really no reason to approve the drug. The big pharma companies like Gilead have power. It is disgusting. As I’m sure you are aware, about 50% of the FDA budget is from big pharma.

    With that in mind, I know Hemispherix is up against a big fight. I do think Ampligen would have a better chance in the hands of a different company. Of course, we don’t have that option.

    • Absolutely. It would have been approved a long time ago if the patent was owned by big pharma. But then again, it might have been approved for HEB if it hadn’t cut it’s placebo-controlled trial short way back when.

      You know things don’t look good when you are up against two big road blocks, the FDA and the company. This move (the price increase) by HEB was so hostile, so lacking in compassion, so irresponsible and cruel (and I could add a lot more adjectives) that it really highlighted the fact that it’s not just the FDA who is at fault here. That is a convenient talking point by HEB. But they just showed their true colors, again.

  19. Pingback: Ampligen på enkel svenska och svårigheterna att få det godkänt – Patienter far illa | Går kroniska sjukdomar att bota?

  20. Reblogged this on Sunshinebright and commented:
    Ampligen’s manufacturer really doesn’t want the clinical trials to continue; otherwise, why would they slap on a 267% price increase? From $15,600 to $41,600 per year? It may be impossible for trial participants, who have uprooted their lives and their families’ lives, and moved to where the trials are being held, to continue.

    Please read the following letter that Jeannette Burmeister wrote to Dr. Janet Woodcock, the FDA’s Director of the Center for Drug Evaluation and Research. asking for reasons and answers about this unbelievable price increase by the manufacturer, Hemispherx Biopharma, Inc.’s (“HEB”).

  21. Ess-OriG says:

    One does wonder if there is another layer / power to this … behind the Hemispherx 267% Ampligen price increase for persons in their trial, no less. Just sayin’ . . . it’s the pattern — continuing roadblock after roadblock every step of the way. And now another turn for Ampligen.

  22. Pingback: Hemispherx ramps up Ampligen price by 267% | Shoutout About ME

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s