Friday, January 25, 2013

Ampligen update from Klimas

Chronic Fatigue Syndrome Patients Need an Effective Therapeutic

Released: 1/24/2013 4:00 PM EST
Source Newsroom: Nova Southeastern University
(more news from this source)

Newswise — Ampligen, the first drug ever seeking approval to treat
chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), recently
hit another roadblock with the U.S. Food and Drug Administration
(FDA). In its long quest to treat 1 million Americans suffering from
this debilitating illness, the FDA advisory panel did not recommend
the drug to be sold on the market, largely because CFS/ME doesn't have
clear biomarkers such as blood tests to define patients who most
likely to respond to the drug. Data from clinical trials of Ampligen
has not convinced the FDA so far.

The real loser is not Ampligen, but CFS/ME patients whose daily suffering continues to be unabated. CFS/ME feels like you've been run
over by a truck – pain, inflammation, utter exhaustion and trouble

I have been caring for patients with CFS/ME for 26 years now. It's
heartbreaking seeing them struggle and suffer from this serious
illness that has been trivialized by science and society. One of the
early controversies quickly disproven suggested that CFS/ME is a form
of depression. This led to enduring public policies that allowed
insurance companies to limit coverage to CFS/ME to either mental
health or exercise therapy, neither get to the root cause of CFS/ME.

CFS/ME researchers, including myself, have seen major advances in our
understanding of the biology of CFS/ME. It seems to resemble an
illness we know how to treat like multiple sclerosis (MS), chronic
viral diseases and autoimmune diseases.

Around since the late 1980s, this drug is not new to science and
medicine. Two phase 3 clinical studies have been completed. The data
shows that a subgroup of CFS/ME patients showed marked improvement,
even recovery on the drug.

Yet, that's not enough evidence for the FDA advisory committee to
approve because they would like to see a conclusive biomarker. As a
physician, I could live with this decision if I had other effective
therapies to treat my CFS/ME patients. But I do not.
Moreover, it defies common logic in used in drug approval for other
complex immune mediated diseases.

Take for example, MS: Its earliest approved treatments had opposite
immune effects. One interferon increased immune activity and a second
interferon quieted immune activity. In the studies that led to
approval, MS drugs, like Ampligen, had about a 40 percent success

Clinical research for these early MS drugs produced no biomarkers
other than a patient's successful response to therapy, such as the
case of Ampligen. The biomarker the FDA relied on for approval of MS
--- seeing if the lesions in a patient's brain decreased -- had no
correlation to the patient's improvement.

Why would the FDA approve MS drugs before there were concrete biomarkers to determine success? The answer is simple. The advisory panel saw MS as a serious disease that required interventions ASAP, and were willing to accept that clinicians would better understand where to use the first drugs with more experience using them. Now there are seven approved drugs for MS that have significantly improved quality of life for patients. But they are not willing to use the same logic for Ampligen.

Because CFS/ME patients are stilling waiting for their first
therapeutic, Nova Southeastern University (NSU) in Fort Lauderdale,
Fla. has brought on board a nationally renowned group of experts to
form the NSU College of Osteopathic Medicine Institute for Neuro
Immune Medicine, which will open in February. These doctors and
scientists will conduct basic research using genomics to help further
develop drugs to treat this disease, while they treat patients. They
are also doing clinical testing for Ampligen.

With or without a biomarker, the FDA should recognize the seriousness
of CFS/ME and approve Ampligen, and open the door for other targeted
therapies now.

Nancy Klimas, M.D., one of the world's leading researchers and
clinicians in chronic fatigue syndrome/myalgic encepahalomyelitis
(CFS/ME), is the director of the Nova Southeastern University's
College of Osteopathic Medicine Institute for Neuro Immune Medicine

1 comment:


America's Biggest Cover-Up: 50 More Things Everyone Should Know About The Chronic Fatigue Syndrome Epidemic And Its Link To AIDS

by Neenyah Ostrom

This is Chapter 46 from the book --> PUBLISHED IN 1993!

"An Experimental Drug That Appears Promising For CFS And AIDS Is Being Evaluated By The FDA

In February 1993, the Food and Drug Administration's Anti-Viral Drug Advisory Committee met to consider the merits of an experimental drug, Ampligen, that appears to have promise for treating CFS (and, in earlier trials, AIDS). So far, no drug has been approved for the treatment of CFS by the FDA.

Ampligen appears to correct a defect in a very important natural anti-viral pathway. When this pathway isn't working properly, viruses aren't attacked by the body's natural defenses. In CFS patients, as in AIDS patients, this anti-viral pathway is defective; furthermore, Ampligen appears to correct the defect in both sets of patients.

At the February meeting at the FDA, Kim Kenney of the CFIDS Association of America (in Charlotte, NC), told the FDA that approving a drug to treat CFS is extremely important to patients, many of whom are desperate to get better. She told the FDA that "the reactions of our constituents range from impatience to desperation, depending on the severity of their condition. Impatient to get back to work, to enjoy their families again. And for some, desperation to reverse the severely debilitating effects of CFIDS, including dementia, unrelenting muscle and joint pain, severe encephalitis, not to mention the problems that accompany a severely impaired immune system."

Dr. Daniel Peterson, one of the two physicians who identified the original outbreak of CFS in Incline Village, Nevada, in 1984, told the FDA committee that "a significant number" of his patients who fell ill in 1984 "never recovered." Dr. Peterson also said that, over the last eight years, 20 percent of the patients he'd examined had become completely disabled. Dr. Peterson also cautioned that the CDC's "crude incidence" of four per 100,000 "most certainly vastly underestimates the true incidence of the disease."

Dr. Peterson told the FDA that, although Ampligen "appears to have great potential in this disease process, it has been bogged down in a corporate and bureaucratic quagmire, and yet the disability and anguish of the patients and treating physicians remains unaddressed." …

Similar testimony from other patients, or their families if they were too impaired to deliver or prepare testimony themselves, was also presented to the FDA committee.

The FDA, however, has yet to grant approval to Ampligen or any other drug to treat CFS."

The actual book is:

The entire book transcribed here:


When are CFSers' going to realize that "insanity is doing the same thing over and over again, and expecting different results (Einstein)"?