Lou Gehrig's Disease - Motor Neuron Disease - Amyotrophic Lateral Sclerosis
Thought it had been cured by now? Still no known cause. Still no cure. Still quickly fatal. Still outrageous.

Friday, October 31, 2008

Iplex - Demonstration on November 11 in Washington

Details are at


  1. ALS Association Statement Regarding IPLEX Demonstration:
    FROM Steve Gibson, Vice President Government Relations and Public Affairs

    As Chapters receive inquiries from people with ALS regarding a November 11, 2008 demonstration in Washington, DC about the drug IPLEX, we wanted to provide the following information to help you respond to these inquiries. As The Association obtains additional research and clinical information about IPLEX, we will share it with you.

    The ALS Association currently is pursuing additional scientific and clinical information about the drug IPLEX in consultation with the ALS clinical and research communities, as well as those familiar with the use of IPLEX in other populations and the drug manufacturer. We also continue to monitor information arising from the use of the drug in Italy, where it is being used by a limited number of patients with ALS. We are committed to pursuing any potential therapy and our actions will continue to be guided by the needs of patients as well as the scientific and clinical expertise of the ALS community.

    However, The ALS Association does not support plans proposed by some in the ALS community to hold a demonstration about IPLEX in Washington, DC on November 11, 2008, Veterans Day. We have never supported or pursued an advocacy strategy that targets Federal officials on a day when the United States Congress is not in session, when most every Member of Congress is traveling outside of Washington, when the Executive Branch is in the initial stages of a transition to a new Administration and when the entire Federal Government and most every private business in Washington, DC is closed for a Federal holiday. We also believe that such a demonstration at this time could undermine advocacy and other efforts to advance ALS issues including ALS research and the development of meaningful treatments.

    Our advocacy successes are the result of strategic and targeted efforts, which are guided by science and supported by the grassroots outreach of people with ALS and families, ALS Association Chapters, and the ALS clinical and research communities. This approach has helped The Association accomplish a number of critical successes for the people with ALS and their families, including:

    • Enactment of the ALS Registry Act in October 2008, which will create the first nationwide ALS patient registry, potentially the single largest ALS research program ever established.
    • Implementation of historic new regulations at the Veterans Administration in September 2008 that establish ALS as a service connected disease. The regulations provide veterans with ALS, their survivors and dependents with access to health benefits and monthly disability compensation worth more then $500 million over the next ten years.
    • The Appropriation in September 2008 of an additional $5 million to fund the ALS Research Program at the Department of Defense, the only ALS specific program at the DOD. The program, which has received a total of $10 million over the past two years, is focused on translational research, with the specific goal of finding new treatments for ALS.

    An overview of our Advocacy successes is attached to this statement. These successes are the direct result of our strategic outreach and grassroots efforts that are targeted and timed to position us for success.

    We also have attached a sample letter-to-the editor that we encourage Chapters and people with ALS to distribute as Veterans Day approaches. The letter raises awareness of how this disease impacts military veterans, but more importantly it builds support for our cause and encourages people to take action to support continued funding for the ALS Research Program at the Department of Defense. The letter can be sent directly to local media outlets via the Advocacy Action Center of our website, here:

    As The Association obtains additional clinical and scientific information about IPLEX, as well as guidance from ALS researchers, clinicians and patients, we will share it with the entire ALS community. We also will continue every effort and develop strategies, including advocacy strategies, that will provide people with ALS access to a treatment as soon as possible.

  2. To: Steve Gibson, Vice President Government Relations and Public Affairs, ALSA

    Dear Mr Gibson,

    In response to your post below:

    1. November 11, 2008 was specifically selected to coalesce with the large number of veterans also demonstrating that day in Washington, DC, in that so many veterans are impacted by ALS and similar neurological diseases as a possible or probable byproduct of their military service.

    2. Members of Congress do not have to be in session on that specific day for their awareness to be heightened by the demonstration, particularly with the press coverage that we hope to obtain.

    And sometimes, peaceful demonstration or protest accomplishes as much for the protestor as for those protested against.

    3. As for the imperfect relationship between a demonstration date and changes in government administration, that applies to almost every day of every year. As you should know, those with ALS and their families are not subject to the luxury of waiting for the perfect time. If and when that were to occur, it would likely be too late for many of those persons with ALS.

    4. I’m truly sorry that you feel the common sense, empirical evidence and scientific judgment shown by Drs Richard Moxley and Martin Savage in their endorsements of testing Iplex for those with ALS nearly two years ago is not worthy of consideration or even response between then and now.

    5. Your statement “such a demonstration at this time could undermine advocacy and other efforts to advance ALS issues including ALS research and the development of meaningful treatments” is just silly. Will it really anger Congress or the FDA? Will it compete with your own efforts? Will it cause research and development to slow down or stop? We both know the answers to that are “no, no and no.” And if we simply advance the use of Iplex by one month, it could save or extend the lives of around 600 ALS patients in the US and countless others worldwide in that one month.

    6. I’m surprised, no I’m amazed, that even if you haven’t endorsed this demonstration by showing the slightest interest or involvement in it, that you so cavalierly attempt to denounce it. If IPLEX was known to harm or further degrade those with ALS in any way, or if there wasn’t such a solid suggestion of its efficacy in Italy and in the US (albeit with a handful of patients), and if there was not such obvious scientific foundation as to its superiority over free IGF-1, then I would understand your posture.

    7. If you can’t or won’t do anything constructive, then at least don’t do anything destructive.

    8. And finally, I have great respect for the research accomplished and the palliative care provided by ALSA during its many years. And I see this effort at peaceful protest, directed toward Genentech, Tercica, Ipsen and Insmed in the venue of the US Capitol Building, as supportive of the efforts of ALSA and not, in any way, as contradictory. I hope, after further thought, you will even agree with that.

    I have blind copied several hundred persons with ALS. I feel they deserve to know more than you have divulged. I suggest each of them forward this email to others in the ALS community.

    Stephen Byer

  3. I'm glad I live in a country where comedians can make light of candidates for national office.

    I'm glad I live in a country where people have the right to demonstrate (or not).

    I'm glad I live in a country where there are legal and practical reins on the political activities of organizations that enjoy 501c(3) tax status.

    The IPLEX situation seems to me (a layperson)to be a patent dispute that could be solved as a civil matter by some willing parties and some attorneys. If a demonstration of independent citizens will help add pressure to the parties to step up to the table to find a solution, then why should they be discouraged from demonstrating?

  4. Could it be that the idea of a demonstration moved some parties to action?

    This was posted at forum