No News is No News

The ME/CFS advocacy community has been hopping recently, with participation in the FDA meeting on Ampligen, my effort with Public Citizen, and Bob Miller’s hunger strike. We’ve been anticipating some sort of response from HHS, especially in the wake of Bob Miller ending his strike. Yesterday, a February 22, 2013 letter from Secretary Sebelius to Senator Reid was released but there is not much news in it. Let’s go point by point:

a few HHS employees have come forward to share their stories with me, and I share their frustration that neither a clear cause nor a cure have been identified despite some 30 years of scientific pursuit.

I’ve been hearing rumors about this meeting of patients with Secretary Sebelius for awhile. I don’t know when this meeting happened, or who the HHS employees are, but this is a good step and it’s nice to have it confirmed.

As you likely know, the Food and Drug Administration (FDA) recently convened a formal advisory group meeting to provide recommendations on the safety and efficacy of the drug Ampligen for the treatment of CFS. . . A CR letter described all of the specific deficiencies that the agency has identified in an application, allowing the company an opportunity to correct those clearly defined deficiencies in a re-submission . . . . I understand the frustration and pain of ME/CFS patients and their caregivers and how important it is that we continue to work toward development of treatments.

No news there.

FDA planned a series of activities to explore the burden of disease that impacts the quality of life for ME/CFS patients . . . During the past five months FDA hosted a teleconference and a webinar with ME/CFS patients and advocates. Additionally, the agency will hold a drug development workshop this spring to explore what is needed to facilitate development of safe and effective treatments for ME/CFS.

Again, nothing new. I summarized the September teleconference in this post and the November webinar in this one. The spring drug development workshop was announced in July 2012, and has been scheduled for April 25-26, 2013.

Other, ongoing cross-Departmental efforts take a comprehensive approach to addressing ME/CFS. The Chronic Fatigue Syndrome Advisory Committee (CFSAC) is an advisory committee that meets twice a year . . . I also established an Ad Hoc Workgroup on ME/CFS in February 2012 to increase and better coordinate the efforts of individual HHS components related to ME/CFS.

I’ve covered both of these efforts extensively. Assistant Secretary Dr. Howard Koh has been providing updates on the Ad Hoc Workgroup (which is chaired by Dr. Nancy Lee) at each of the recent CFSAC meetings. The most recent update was in Dr. Koh’s November 2, 2012 response to the CFSAC (pdf link).

The National Institutes of Health (NIH) is funding research activities that may help patients with ME/CFS. NIH is taking action to stimulate all facets of ME/CFS clinical research including clinical trials at the NIH Clinical Center with the help of its Trans-NIH ME/CFS Research Working Group. The agency . . . has also implemented a process to review applications proposing to use biological samples obtained from ME/CFS patients who participated in a recent NIH-funded study.

Dr. Susan Maier of NIH reports on the Trans-NIH ME/CFS Research Working Group at each CFSAC meeting. The opportunity for clinical trials at the NIH Clinical Care Center was announced on December 14, 2012. I covered the opportunity to use samples from the Lipkin study on September 22, 2012.

The Centers for Disease Control and Prevention (CDC) is in the final stages of a seven-site study of the clinical characteristics of ME/CFS. This study was launched in September 2011 to collect standardized data from clinical practices of clinicians with expertise in ME/CFS. The data will be used to evaluate variation in the illness among clinics, to characterize all domains of illness in ME/CFS patients, and to provide data that could be used in evaluation of a research case definition and diagnostic criteria.

This study has been the topic of much discussion at CFSAC meetings and in the patient community since it was announced, but there is nothing new here.

The Agency for Healthcare Research and Quality provided technical support to the International Association for CFS/ME for the development of a primer for clinical practitioners that has been added to the National Guideline Clearinghouse. . . The Substance Abuse and Mental Health Services Administration and the Health Resources and Services Administration are hosting webinars to educate providers in their networks about ME/CFS.

Both of these efforts were discussed at the October 2012 CFSAC meeting.

I’m not knocking this letter, nor am I knocking the advocacy efforts that led to it. It is vitally important that ME/CFS issues be on Secretary Sebelius’s radar – and Congress’s radar too. It is very possible that many of the updates in this letter were news to Senator Reid, depending on how extensively he was briefed before reaching out to Secretary Sebelius. And it’s always good to have these things in writing and on the record. This is, after all, how Washington works: communication between the legislative and executive branches give us a clue into what is (and is not) being done.

It is a little disappointing, though, that there is nothing new to us in the letter. Rumors and expectations and hopes for a stronger and renewed effort from HHS on ME/CFS have been swirling around the last few months. Did President Obama raise the priority level of ME/CFS research, as we heard last summer? Would HHS participate in the April FDA meeting in a new way? Many patients engaged in an intense email and phone campaign during Bob Miller’s hunger strike, and when the hunger strike ended Bob asked patients to stop the campaign because they had been heard.

The question is: did hearing us translate into anything new? The answer embedded in this letter is: “not yet.”

I believe that progress will be made in baby steps, rather than a big bang. We need to have realistic expectations. But we also need to see what’s in front of us. We were hoping for a new commitment or enhanced effort. This letter offers neither. I hope that concrete improvements and involvement are forthcoming, and that this letter is not just another in the long train of Free Turkeys handed out to the patient community.


This entry was posted in Advocacy, Commentary and tagged , , , , , , , , . Bookmark the permalink.

2 Responses to No News is No News

  1. Kelly Latta says:

    I’m not knocking the response either – it was a standard reply to an inquiry by a congressman and I doubt it was intended to be more. For those who are dissatisfied I think you would have to go back five years and ask yourself what news the letter would have contained at that time.

    Like Jennifer and Hilary Johnson I think there is progress, although perhaps not as much as patients would like at the speed patients would like. Unfortunately, from a financial standpoint the progress isn’t as great as it could be due to underfunding – everyone’s funding is static or reduced. Jennifer thank you so much for your hard work on behalf of patients.

  2. Anne says:

    Thanks for this, Jennie! I had the same initial reaction (“this is nothing new”) – great to see it analyzed like this. I too want to thank you for your hard work.

Comments are closed.