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A Drug Goes Down in a Perfect Storm

  [ 8 votes ]   [ Discuss This Article ]
By Llewellyn King • • February 15, 2013

A man you have never heard of has ended a hunger strike in Reno, Nev. The hunger strike which lasted just 11 days was a desperate petitioning of the government to do something to help bring a drug you have never heard of to some very sick people. The man is himself sick and his health collapsed starting on day six of the fast.

He is Robert Miller, a former miner and bartender, who suffers from Chronic Fatigue Syndrome (CFS), also known as Myalgic Encephalomyelitis (ME). And the drug, which stimulates the immune system, is Ampligen.

Miller and the drug are at the heart of a perfect storm involving bureaucratic procedures, corporate ineptitude and a community of patients who have no Washington presence and therefore no strident voice.

Instead of a lobby, there are individuals — many of them very sick — who form a rag-tag pressure group, a small irregular army, who speak out on behalf of what is believed to be a million CFS sufferers in the United States.

The problems start with the disease itself, which like AIDS is a dramatic compromise of the immune system. It is hard to diagnose: There are no biological markers; there is no way to quickly identify it. Instead, it is what doctors call a waste-basket diagnosis: If it is not any of a list of ailments, then it must be CFS.

Some suffers report flu-like symptoms at the onset, building to a total collapse. Others simply collapse after exercise. Recovery is very rare – and only men. The disease undulates; good days and bad days, good years and bad years. In bad days and years, the victims are bedridden with intolerance of light and sound; restricted to bed and darkened rooms. Suicide is common, the suffering endless and severe.

I have talked to dozens of sufferers — the most heartrending are the teenage girls who are denied schooling, social life and the prospect of marriage by their ghastly affliction.

Enter Ampligen. It is an anti-viral compound developed in the 1970s and administered intravenously. Every patient is not helped by Ampligen, but many are restored to mobility after being bedridden. Robert Miller is one of these.

Last December, the Food and Drug Administration (FDA) heard from more than 700 patients praising Ampligen, with accounts of the choice it presented for them between functioning or being dependent on others.

Yet this month, the FDA rejected certification of the drug. The agency acknowledged the patient support, but castigated the company that makes Ampligen for incomplete data, a lack of scientific evidence of its efficacy and the way that it had handled the clinical trials.

There is a more-in-sorrow-than-in-anger tone in the FDA’s rejection of application for the drug by its maker Hemispherx Biopharma, Inc. of Philadelphia.

The FDA said: “As evidenced by the hundreds of letters, emails, and testimonies submitted to FDA, Myalgic Encephalomyelitis (ME) Chronic Fatigue Syndrome (CFS) is a devastating disease with a serious impact on quality of life. We are acutely aware of the seriousness of this disease, that no FDA approved treatments are available, and of the community's strong desire to see rintatolimod injection (Ampligen) approved.”

The bottom line is that the patients are to be denied a drug which helps some of them. Dr. Daniel Peterson of Simmaron Research in Incline Village, Nev., estimates that 70 percent of his patients are helped. Dr. Nancy Klimas of Nova Southeastern University in Florida, a dedicated supporter, puts the success rate lower.

For the patients, the dispute of methodology is irrelevant. What is relevant is that methodology has triumphed over humanity — and medicine.

Miller’s hope is that as a result of his hunger strike the National Institutes of Health can be persuaded to conduct its own trials as they can and do sometimes. But even if they do, it will be years before the FDA will rule again. “It has cost us 10 years,” Courtney Alexander, Miller’s wife, said.

Reprinted with kind permission from the White House Chronicle.

Editor’s Comment: Mr. King suggests in this article that only men recover from ME/CFS. There are numerous  accounts of recovery among women.


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