From the Founder's Notebook

P.A.N.D.O.R.A.'s Written Input

to the CDC, provided orally on

April 27, 2009.

RESPONSE TO REQUEST FOR INPUT – April 27, 2009

CDC FIVE-YEAR Strategic Plan

Prepared by K.J. Friedman, Ph.D., Director, Public Policy, Marly C. Silverman, Founder & Public Policy & Community Advisor, and Rebecca Artman, Public Policy & Community Advisor

The purpose of the public meeting is to solicit input from interested parties on issues that CDC will consider as it develops a five-year strategic plan for its CFS research program. Input is sought only on the CFS strategic research plan, not on CDC's overall CFS program. As CDC is one of many institutions conducting research on chronic fatigue syndrome, the strategic plan will only address research that is within CDC's purview.

Topics Include: The objective of the five-year strategic plan is to conduct public health research leading to the control and prevention of medically unexplained chronically fatiguing illnesses, in particular CFS. The agenda will focus on the goals and objectives of CDC's CFS research program in five major categories:

Studies of Defined Populations 

Our organization supports the CDC’s continuance of studies of defined populations.  However we see several flaws in the current CFS definition used by the CDC.  Current and future studies, however, are critically dependent upon the diagnostic criteria used to define individuals with CFS as opposed to those without.  We express concern over the CDC’s unilateral change in inclusionary diagnostic criteria for patients with CFS.  In recent years, the CDC has broadened its definition of CFS and, in so doing, has raised its estimate of the number CFS patients within the United States from approximately 1 million to 4 – 6 million.  We caution the CDC, and express our concern, that by altering the inclusionary criteria for CFS, the previously accumulated population data is no longer compatible with the current CDC data.  It is our preference that the CDC adopts the increasingly more popular & scientifically well received Canadian case definition for its current and planned 5-year strategy. 

We suggest that the CDC expand its studies of defined populations.  We suggest that both morbidity and mortality data be included.  We suggest that long-term, longitudinal studies be incorporated into the plan.  We suggest that data be obtained not only for adult populations but for pediatric and adolescent populations as well.  We affirm our position on the need for a return to biomarker and evidence based medicine.

With regard to long-term studies, we specifically suggest that the CDC also return to Lyndonville, NY, and Incline Village, NV for follow-up studies to determine the fate of individuals in the populations which the CDC has previously studied in order to indentify who, why, how and if these individuals have experienced remission, remain disabled or have died of the potential consequences of CFS.

With respect to longitudinal population studies, we suggest long-term studies with a commitment, both in principle and financial support, for long-term studies such as a 30-year study.

Provider-based Patient Registries

We understand the rationale, or wisdom of proposing provider-based patient registries and we assume that it comes to a considerable financial cost that could be applied to more efficient ways to gather information on patient population.   It is the CDC’s own data and assertion that as little as 15 percent of the CFS patient population is identified and treated and it is done through medical diagnosis.  Moreover, the CDC recognizes and has made the public painfully aware of the lack of physician and other healthcare provider knowledge of CFS.  To that end, the CDC has launched a number of programs to educate physicians and other healthcare professionals (Train-The-Trainer, Spark-Awareness, The Physicians’ Toolkit, The Healthcare Provider Toolkit) concerning diagnostic and treatment protocols for CFS.  Until such time as the providers are calibrated and experienced in using the same diagnostic criteria for accepting registrants into the data base, we see little value in using healthcare providers as the gatekeepers of any CFS registries.

Our organization does support and suggests that patient registries be established. One suggestion we have is that online patient self-reporting be established as a viable tool and cross-referenced with patient’s medical providers. It is also our suggestion that teams of CDC-trained healthcare providers visit hospitals and medical practices in areas throughout the United States and, by reviewing patient charts and interviewing patients as they seek admission to healthcare through physician offices or hospital admission desks, identify patients who should be included in patient registries. The reason we need to cross reference these steps is because often when CFS patients reach an emergency room, and describe their health challenges and diagnosis, hospital medical personnel quickly dismisses them as having a serious health issue. The treatments approaches change and their demeanor towards the patient changes as well. (Vide In-hospital Clinical Studies below.)... to read more

EDITORIAL

February 09 Newsletter

Another controversial and recent AP article on fibromyalgia (FM) and the FDA-approved drugs hit the news. And here we go again! Should we ignore it, or must we respond? My take is that whether you are a fan of the pharmaceutical companies or not, you need to be aware of the hidden agenda behind such articles. They seem to be primarily targeting the valuable work that FM researchers, physicians, and many patient advocacy organizations around the country have accomplished in the last decade by undermining and destroying these advancements, which have proven quite beneficial for the patient community.

Do the recent FDA-approved drugs help every patient with FM? The answer is no! But it is helping some. Are they curing FM patients? The answer again is no! But for many individuals, quality of life has improved. In addition, what these reporters fail to report is that these medicines were being prescribed "off label" anyway to thousands of FM patients. The pharma companies were already making money.

I should point out that this reporter also failed to note that there are many other drugs that FM patients take because of the illnesses or other co-morbidities that are acompany FM. I could probably list them from A to Z. Are these pharmaceutical companies also exploiting the FM patient community?

Unless FM patients go totally holistic and take natural supplements (the ones without FDA approval), chances are they will be taking a medically prescribed drug. The vitamin and supplement markets are also a huge cash machine, which FM patients support through their purchases. I must point out that all of the neuroendocrineimmune disorders (NEIDs) P.A.N.D.O.R.A. embraces are part of this cash machine too: CFS/ME, CLD, GWS, and EI/MCS.

There is an inherent benefit if the medicines highlighted in the article are under FDA-approval guidelines. The FDA requires a track record and a paper trail to be kept. Scientific research studies have to be conducted and ongoing guidelines must be met. Some may say that the approval for these drugs were on the "fast track." (Yes, perhaps we should question FDA guidelines, but cancer patients do not go through such a huge scrutiny, and although I want safety and health concerns be in place, we also need choices. Discussion of this issue will be a topic for another article.)

By giving a voice to one or two egotistical physicians who harbor a misguided disdain for the pharmaceutical companies as well as for patients diagnosed with FM, is the media doing a public service? I say no! If media outlets are supposed to be the watch dogs for the "little guy," they are failing miserably at this task. All they are doing is subjecting the FM patient to another emotional beating by shortsighted reporting.

In the article in question, the writer significantly ignores the feedback of our patient community. The physicians who are being highlighted are individuals who have not contributed in recent years to worthwhile scientific research on FM. Do they think that they are the only ones who are "expressing the truth" on issues that affect FM patients? Who released our rights? What scientific credentials do they hold that are more fundamentally important than those, for example, of Dr. Steven Croft, a caring, knowledgeable physician/clinical researcher in South Florida, who has dedicated his whole medical career to treat and care for FM patients? Or of Dr. Robert Bennett in Oregon; Dr. Benjamin Natelson in New York; Dr. Lucinda Bateman in Utah; Dr. Phillipe Saxe in Florida? Dr. Roland Staud in Florida? and the list goes on.

Is the doctor quoted in this article (and others in previous controversial articles) mightier than the physicians and researchers who truly are in the trenches practicing medicine with potential treatments that are beneficial and comforting to FM patients? What happened to doing no harm? And why should their point of view be imposed across the board, without patient input or feedback? A battle is being orchestrated and we, the patients, are left sitting on the sidelines.

I should point out that the doctor pictured in the article - Dr. Frederick Wolfe, was among the scientific researchers that developed the fibromyalgia criteria after considerable research in partnership with Dr. Robert Bennett and Dr. Mohamad B. Yunus decades ago. While these two researchers have gone on to expand their FM research, Dr. Wolfe is stuck in a time warp. He has since then taken a complete 360 degree turn on the issue and has blatantly ignored the newest research findings on FM in the areas of virology, brain imaging, and neuroendocrineimmune theories that are confirming the pathology of this illness and how it overlaps with CFS/ME, GWI, CLD, EI/MCS and even MS. If I were a "hip hop" young individual with FM, I would probably be prompted to ask him "Dude, what's up with you? Dude, who gave you my power?"

I read once that Dr. Wolfe's concerns are about the fact that doctors are enabling a large number of FM patients to be labeled with an illness that "does not exist," and, in the process, they are given a death sentence. His views are that FM patients are not empowered to get better. "Dude, do I sound like an un-empowered helpless FM patient?" I may have certain disabilities, but FM does not define me.

As a veteran FM patient, I also know that for the most part FM is a secondary illness and is not the main reason why I have serious health challenges. But when you combine FM with other associated illnesses, FM plays havoc in a patient's body systems. And in too many cases can be can be life-threatening. It is not what you know that will hurt you, but the lack thereof. FM research must continue, no matter how many naysayers are trying to obstruct it.

It saddens me to realize that in the 21st century, in a country that allegedly excels in medical and scientific technology, vision, innovation, and invention, there are physicians who still question whether FM exists. They are simply being stuck in outmoded scientific concepts. Why do they find it so difficult to embrace neuroendocrineimmune disorders? These illnesses may not fit in the traditional outdated science model, but they are real! And they are emerging illnesses found worldwide.

The task of a reasonable scientist is to use the newest tools to investigate the scientific unknown. Mathematical theories with the aid of computer science, brain imaging, and photography are expanding science to a point of no return. To assume that American scientists cannot break through FM is to say that our scientific community lacks motivation, resources, and innovation. We are Americans! We placed a man on the moon and are traveling to distant galaxies, and yet we cannot tackle this task? "Dude, what gives?"
 
Neuroendocrineimmune disorders are affecting a large population, translating to an estimated economic impact of billions and billions of dollars annually in our national economy. Do the math. If the estimate that 20 million Americans are stricken with NEIDS is multiplied by the CDC's published amount of $20,000 per individual for productivity losses in one given year, what do we get? The amount is staggering! It is the size of several large state budgets.

The time to respond is now! The time for a health revolution within our community is now. Join this "Dude."

To be continued...