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