Panel rejects experimental chronic fatigue syndrome drug.

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Date Joined Feb 2008
Total Posts : 255
   Posted 1/18/2013 4:53 AM (GMT -6)   


A drug for chronic fatigue syndrome that spent decades in clinical development and won fervent patient support has been turned down for approval by a committee of advisers to the US Food and Drug Administration (FDA) who voted 9–4 against it. The drug, named Ampligen (rintatolimod), has not been shown to be effective or safe, the committee determined on 20 December.

Ampligen is a double-stranded RNA molecule (called poly I:poly C) which is thought to stimulate the immune system. The FDA does not have to follow the recommendations of its advisers, but briefing documents released by the agency strongly suggest that it will. The FDA’s list of deficiencies in the drug application submitted by Hemispherx Biopharma is stunning and encompasses nearly every aspect of clinical testing.

“Key deficiencies included inadequate evidence of effectiveness or safety, inadequacy of drug–drug interaction studies, lack of carcinogenicity assessment, lack of anti-drug antibody determination, and inadequate analytical methods and drug product specifications,” the agency wrote in one of several sections listing problems associated with the application.

FDA representatives also expressed concern over inconsistencies in the data and statistical analyses. An agency representative says of the data: “It raises our eyebrows and makes us wonder what else is in the database that we’re not seeing.”

Despite these weighty caveats and the drug’s middling performance in the clinic when averaged across all patients, several people with chronic fatigue syndrome (CFS; also called myalgic encephalomyelitis) testified that Ampligen yielded dramatic improvements in their symptoms. Some moved to Reno, Nevada, to be near the clinical-testing site and to receive infusions of the drug.

Alaine Perry, who served as a patient representative on the advisory committee, acknowledged that the Ampligen data are slim, but noted that CFS symptoms can be so severe that some patients would willingly take on a significant mortality risk for the promise of even minor relief of their symptoms. “A very small improvement in a disease like this is life altering,” she said. There are no other approved treatments specifically for CFS.

All Orthopedic problems due to prednisone.Replaced 1-hip and shoulder so far.
Severe restrictive/obstructive pulmonary disease due to both lungs collapsing due to a disease called empyema.
Intercostal Neuralgia
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Became sick in 2005 at 38 now 46

Post Edited (rjbeck) : 1/20/2013 4:27:21 AM (GMT-7)

Veteran Member

Date Joined Jun 2008
Total Posts : 731
   Posted 1/18/2013 9:43 PM (GMT -6)   
rjbeck, thank you for sharing this information, I had not heard anything & had been wondering if a decision had been reached. I am saddened that we don't have a drug to help us but I think I would have had to bow out of this one anyway. While I would love any kind of improvement in my health, I would not use it due to the risk factor. Hugs, Denise
Fibromyalgia-dx'd: 2006, ME/CFS-dx'd: 2006, Holt-Oram Syndrome dx'd 1975, reduced lung capacity dx'd 2009, nasal allergies, food allergies, depression (lifetime problem) IBS, neuropathy in hips

I have 4 children & 7 grandchildren.

As apples of gold in silver carvings is a word spoken at the right time for it. Prov. 25:11

Regular Member

Date Joined Jul 2012
Total Posts : 335
   Posted 1/20/2013 5:47 PM (GMT -6)   
I certainly hope we won't be slamming the FDA on this one, they are doind Exactly what we expect them to do. Keeping us safe from unscrupulous doctors and pharmacutical compies that would unleash a untested/poorly tested/high mortality rate drug on an unsuspecting population who would never even be aware of the testing let alone read it. Lastly to the advocate(she does not deserve that title), No Dead is the only acceptable drug trial outcome. I don't mean from overdose accidental or otherwise or drug interactions not expected nor complications from other medical issues not expected. I'm not a fanatic, this is just an issue close to my "sense of justice" bone, its right next to my "pain in
the heart bone" so sometimes they overlap, done now. Keep In Touch.
Crainiotomy Lg. Meningioma Dec.02, Bi-Polar 2004, SMI 06, Gluten/Wheat/Dairy Intolerance, IBS 06, Migraines w/pseudo-seizures 07, Dev. Septum Sur. Sept.07, 2nd Men./Tumor Gamma Knife Rad. Dec.08, Radical Hysterectomy Sept.09 w/instant Menopause, Fibromyalgia 09, Disability since 09, EBV/CFS 11,Vomiting/Multiple Ulcers, Vertigo 12, Chronic Fatigue Moderator 2013.No meds list I ran out of space.
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