an editorial by Roger Burns, publisher of CFS-NEWS
The text below is a revised version of an editorial that originally appeared in CFS-NEWS edition #81 on June 30, 1999.
It was like a dream come true. The proposed project was to create an independent monitoring group that would force the development of the drug Ampligen to be responsible, safe and quick. The drug would help many CFS patients. But it would also immediately be used off-label by AIDS patients facing the new multi-drug-resistant form of HIV. The lives that would thereby be saved from an indisputably recognized deadly disease would, in a sense, be credited to the CFS research into Ampligen. This would go far to legitimize CFS in single bold stroke. AIDS activists were teaching CFS activist how all of this could be accomplished. CFIDS leaders who only weeks before were engaged in the usual antagonistic politics had come together in an incredible show of unity. And the president of Hemispherx Biopharma, Dr. William "never spend a nickel" Carter, was donating big bucks to make this proposed project work.
This is not a fairy tale. The project described above was being put together during mid-1999.
But then the unified effort began to come apart, and some of the dream unraveled with it. A self-proclaimed "chairman" of the project worked to push the vital safety issue off to the side while at the same cleverly asking people why her critics "oppose" the safety issue, since after all she is more for safety than they are. Four of the five original sponsors of the project called for a renewed commitment to the project's original goal, and they undertook plans to promote a pro-safety program at the project's scheduled national meeting in July of 1999, to be held in Las Vegas, Nevada (all CFS patients were to be invited). The AIDS "advisor" to the project, an ex-Army commando with an often uncontrolled temper who had allied himself with the self-proclaimed chairman, had declared that he personally was controlling the project and he threatened bodily harm to CFS leaders who would disagree with him.
The proposal was to create a Community Advisory Board (CAB) that would independently monitor the scientific trials of Ampligen. CABs have been used with great effect in HIV/AIDS drug trials to insure patient safety, and expedite development and official approval. Ampligen could certainly use some help since its development had been kicking around for years, accompanied by controversies over both its safety and effectiveness, and the ways in which the manufacturer has been managing the drug's development.
Karen Lang is a CFS patient who is responding well to Ampligen. She and others are have been paying tens of thousands of dollars per year for the drug. If Ampligen is approved for CFS, that expense will be paid by insurance. But the common wisdom is that if Ampligen is approved first for the lucrative HIV market (those trials are now in progress), the manufacturer may well stop pressing for CFS approval. Then Lang and others would continue to bear the heavy expense themselves.
Lang has claimed leadership of the CAB formation project. She had in the past staunchedly denied that there were any serious adverse reactions to Ampligen -- this despite reports that the drug has prompted severely increased pain in some instances, and in two of those cases the pain may have contributed to suicide. There have also been reports of liver toxicity and other important health problems.
Lang has effectively blocked efforts by fellow project members to implement a safety program for the current trials. Now, why would any CFS patient do such a thing? Perhaps Lang perceives that any thorough safety monitoring program will needlessly (in her view) slow down the drug approval process within the CFS trials, and thus put her in danger of ever getting financial relief through insurance. Lang is a stockholder in Hemispherx Biopharma, the manufacturer of Ampligen. NOTE: the proposed CAB is supposed to provide an independent oversight of the manufacturer.
David Miller is an AIDS activist working with the project, and his stated goal is to use the CFS Ampligen CAB as a means of making the drug more quickly available (by off-label use) to the AIDS community. From his perspective, it would seem that any genuine safety program for CFS trials would slow down the approval process, and any delay would harm the AIDS community. Should CFS patients have their health endangered by an overly rapid approval process that might value the health of AIDS patients over that of CFS patients? Miller has strong incentives to favor the needs of his fellow AIDS patients over those of any other group of people. He has joined Lang in pushing aside any discussion of implementing an effective safety program for the CFS trials, which was one of the core principles of creating the CAB.
Lang and Miller have recently confused the issue by claiming that they are now for safety and that their critics "oppose safety". Those who are close to the situation view these claims as incredibly blatant lies and manipulations.
The original sponsors of the CAB formation project who continue to fight for a genuine safety program, are: Sheryl Jefferies, publisher of Chronic Relief; Elaine Katz, president of CFIDS Emergency Relief Services, Inc.; Gail Kansky, president of the National CFIDS Foundation; and Gayle Babykin, president of WECAN. They are now joined by Ray Colliton, manager of the Co-Cure Project, and myself, Roger Burns, publisher of CFS-NEWS.
I am proud to stand with these leaders, and to work to help insure that the most good can be made of whatever opportunity may come before us.
David Miller can be crude and explosive. Yet he is also brilliant and charismatic, and can be very knowledgeable about medical issues. He had planned to bring his own supporters to the CAB formation meeting in Nevada. The writer of this editorial expected that Miller would surely dazzle the crowd with ideas and plans, several of which would be quite thoughtful and that would address many issues regarding the science and politics of CFS. His energetic presentation would likely wear out many CFS patients.
Based on their own comments, Miller and Lang were quite likely to try to lead the meeting to elect their friends to control the new Community Advisory Board -- which is supposed to be an independent body that would have the interests of the CFS community, and the welfare of Ampligen trial subjects, as its highest priorities.
The original sponsors of the CFS Ampligen CAB formation project, most of whom are too ill to attend the formation meeting that had been planned, issued a public statement asking all interested CFS patients to make their way to the meeting and to promote the following program:
The 1999 formation meeting which was to officially create the CAB was cancelled by Hemispherx president William Carter. Self-proclaimed chairman Lang has suggested that the formation will occur at a later time.
The original formation process was to be open to the entire CFS community. Chairman Lang has announced that the next time they try to form a CAB, "membership will consist of present and former Ampligen patients only."
The original sponsors of the CAB formation project hope that many CFS organizations and support groups will be able to participate directly in whatever next steps thee may be in this process.
To see further news and updates from the Lang/Miller faction, see the web page at
To contact the CAB project's original sponsors who are fighting for safety standards for CFS patients in Ampligen drug trials, write to them at cfids-cab@egroups.com .
For general information about Ampligen, see the web page at