Drastic changes to Ampligen clinical trial hurts ME patients – sign the petition to fight it

Author:

Share on facebook
Share on twitter
Share on email

Patients in the Ampligen clinical trial are bearing the brunt of drastic changes Hemispherx has implemented that will force many to stop getting this medicine and may endanger prospects for FDA approval.
We need the community’s help in telling Hemispherx to put patients first, so we can continue to fight for FDA approval of the first medicine for ME. Sign the petition.
Four changes made by the drug maker are forcing patients off the medicine and threaten the continuation of the clinical trial:

  1. A 167% price increase.
  2. Ending the compassionate care program, which supports less than a handful of patients who need the assistance.
  3. Restricting access to current full-time enrollees only, which is prohibiting participants who take a “break” or holiday from the drug.
  4. Closing the trial to new participants.

These changes obviously affect those who are in the trial, but they also restrict future access to ME patients.
Ampligen patients have met with the company and petitioned the Board of Hemispherx saying: “Hemispherx’s changes to the program are predatory and cruel, given the desperate need for treatment among this patient population.”
Meanwhile, Hemispherx announced this week that it was shipping Ampligen inventory to Europe for use in the Early Access Program in the EU.
Ampligen patients also believe these drastic changes will harm prospects for FDA approval of this first ME medication, pointing out  to the company the central role patients have played in pushing the FDA to recognize ME and approve Ampligen:
“Patients on Ampligen have been the force behind urging the FDA to approve it. We have led dramatic efforts to change FDA’s beliefs about the disease and Ampligen’s efficacy, including 700 testimonies during the advisory committee hearing, a 5,000 plus petition to the FDA, a patient hunger strike protesting FDA denial, a stakeholder and other important meetings at FDA, and Congressional and HHS outreach.”
The entire ME community has an interest in the successful pursuit of FDA approval for the first medicine for our disease. Approval of the first ME medication will lead to more clinical trials and investment by the larger pharmaceutical industry. Reducing the Ampligen trial is not a successful strategy for FDA approval.
Please join Ampligen patients in making sure Hemispherx puts ME patients first to prevent damage to participants’ health and future approval prospects.
Sign the petition to tell Hemispherx to reverse these draconian changes to the Ampligen clinical trial that will hurt the ME community.
 

Share on facebook
Facebook
Share on twitter
Twitter
Share on whatsapp
WhatsApp
Share on google
Google+
Share on email
Email

2 thoughts on “Drastic changes to Ampligen clinical trial hurts ME patients – sign the petition to fight it”

  1. This type of issue requires civil disobedience targeting the pharma company. I would be surprised if pharma did anything after receiving a petition.

  2. I seriously do not understand this article.
    To the best of my knowledge, there is no current trial of Ampligen in the US. So how can there be any changes to it, if it doesn’t exist?

Leave a Comment

Your email address will not be published. Required fields are marked *

Latest News

NHS England omits advice to apply clinical judgement re vaccine

It has come to light that a letter from NHS England and NHS Improvement to all vaccination centres and GPs in the UK has omitted advice that health professionals can and should apply their clinical judgement when placing people in group 6. Vaccination of people with underlying health conditions that put them at risk of

Read More »
Waiting for Superman Book on table

Waiting for Superman – UK Book Giveaway and Review

Do you want to win a free copy of Waiting for Superman? We have three copies to give away to people in the UK!  To enter, all you have to do is follow #MEAction UK on Instagram, like and comment on this post. The deadline is 9am (GMT) Monday 8th March! Win a copy! Thank

Read More »
#MEAction activists outside Scottish Parliament

Scottish Election! Ask your MSPs to support people with ME

If you live in Scotland, please join our campaign to ask your MSPs to pledge their support for people with ME. Email your MSPs The Holyrood elections are coming up on 6 May 2021 and we want to make sure that MSPs are aware of ME and the desperate need for support. There are more

Read More »

Help keep our work going

We rely on donations from people like you to keep fighting for equality for people with ME.

Donate

Get actions alerts and news direct to your inbox

You can choose what you want to be kept up to date on.

Subscribe
Scroll to Top