February 6, 2009
Below is a recap of recent activity regarding our mutual quest for securing Iplex and a suggested course of action. Some of what is written below is already known to many of you, but others may not be as up-to-date, so please excuse any repetition.
1. Between January 16-30, 2009 the initial (8) Iplex Investigational New Drug applications were summarily rejected by Dr. Russell Katz, FDA Director, Neurological Products Division. The reasons cited were “reports of increased mortality” about another drug, Myotrophin, and concern about ALS patients networking and their resultant determination to seek and use Iplex prior to a clinical test study. The reasons cited were judgmental, fallacious, and destructive to the ALS community for obvious reasons.
2. In order to provide legal foundation for several additional patient families and to further test the FDA waters, five additional IND applications, with Institutional Review Board support, were submitted to the FDA on February 3, 2009 by ALS WORLDWIDE. These IND applications incorporated logic and fact to counter the FDA reasons for rejecting the original group (submitted by individual physicians directly) but we nonetheless expect these new applications will also be denied.
3. We, and others on Team Iplex, have had extensive conversations with all interested parties including patient families, FDA, legal advisors, involved and uninvolved pharmaceutical companies, judiciary and elected officials (both state and federal levels). The consensus is that the quickest, & best way of successfully countering current FDA posture is to apply ongoing political pressure on Dr. Katz and his superiors by both US Senators and Representatives and their state-level counterparts.
4. Immediately following this email will be another separate email with attachments. This should be sent to each of your (2) US Senators and your (1) US Representative. It should be directed to them at both their Washington and in-state offices at their respective email addresses. Some of you may not know who your elected officials are and, if so, I have provided you with the Web link...http://www.visi.com/juan/congress/ Now at this point, all you have to do is double-click the Web link, find your particular state, then click your state and follow the prompts. The attachment/cover letter has been written to apply “across the board” or, as is said, “one size fits all” or if you choose as a template the. In addition to your federal officials, we believe the email should also be directed to your state’s Governor and the elected state officials from your area.
5. Brothers and sisters, please... be aware that this effort will not work , if any of you reading this assumes that it will suffice if others , do the work. This will only work... if you assume that your emails are the only ones going out. Please, I beg you... spend part of this weekend preparing the emails to go out on -- Monday morning -- February 9. They won’t be in their offices on the weekend and Monday is always the best time for new issues to be presented. When sending the email and any attachments, mark it “Urgent” and follow it with the same email on Wednesday, February 11 and Friday, February 13 with the following sentence typed at the top of Monday’s email: Senator (or Governor, representative or otherwise) – Did you read my prior email and will you act on behalf of our family and every other ALS family by forcing the FDA to allow Iplex for patients dieing ALS? Please tell me immediately you are doing to stop this travesty. I am your constituent, supporter and part of an ALS family.
6. After locating your elected officials contact information, also find and record their office telephone numbers, both in Washington DC (for the federal officials) and within your state for them and the state elected officials. We (PALS & supporters) will begin a coordinated (follow-up) calling, beginning on Monday, February 16, followed up with a repeated coordinated calling on Wednesday, February 18 & Friday, February 20, if you have not heard from them with a responsible answer by email, US mail or telephone. A responsible answer does not include “Thank you for your inquiry. We always listen to our constituents” or anything like that. A responsible answer will tell you exactly what they are doing, when and with whom. In your telephone efforts beginning on Monday, February 16, first ask for the elected official and when you’re unable to get that person on the phone, then ask for the Administrator of Medical Affairs or the generalist who fits that category. Don’t get off the phone until someone has listened, you have an individual’s email to whom you can re-direct the original email and attachments, and you feel they are serious about doing something.
7. We are not saying this is the only way, what we are saying is that we think it is the best way to get Iplex for all of our loved ones. You may wish to slightly modify the cover email but the attachments are in PDF files so they cannot be changed. The letter has been written to appeal to a busy, and undoubtedly preoccupied, elected official who will then hopefully forward it and the detailed attachments to the staff person specializing in medical affairs (for whom the attachments will be meaningful). The cover email and attachments are also intended to be courteous, accurate, honest, legible and personalized enough to instigate quick and responsible action by the elected officials. The email and its attachments are not intended to be offensive to the FDA or Dr. Katz. Rather, it is to get the FDA to agree that Iplex does not, and should not, require formal clinical test studies prior to its usage by the ALS community. Further, the letter and attachments are intended to clearly refute the reasons stated by Dr. Katz and FDA for declining Iplex usage in the sample denial letter included.
8. Some of you have asked whether this type of communication should be posted on the various forums. I personally think that doing so may diffuse our collective efforts because none of you or me has the time to argue the merits or demerits of Iplex and, even more importantly, free choice by a physically devastated patient community if we are using our time more effectively by organizing political pressure. Understand there is nothing secretive or contradictory to anyone else’s rights by the suggested application of political pressure for a just cause, but I am certain that most of you reading this remember the periodic condemnation of free choice decision-making by Drs Bedlack, Silani and Cudchavitz in the Journal of ALS, Steve Gibson of ALSA on his blog site and certain always-negative posters on various forums. I suggest instead that your and our efforts be confined, or at least directed primarily, toward the application of political pressure on the FDA.
9. Finally, our immediate goal is to both secure the annulment of the FDA denial of IND applications submitted and equally as importantly, to allow Iplex to be used by the ALS community from this point forward through simple cross-label prescription by licensed physicians. This was the case when Iplex was initially used by those with ALS is early 2007 with unilaterally excellent results. We want the same appropriate plan implemented now, as it was then, in that the only differences between February 2007 and February 2009 are a) the settlement of the legal dispute between Genentech, Tercica and Insmed, and, b) the loss of thousands of ALS lives and the dramatic further decline of those still living whose death or decline might have been dramatically lessened by their use of Iplex.
10. Now look for the next email which needs to be carefully read, then filled in to the political figures as discussed above and emailed this upcoming Monday morning, February 9 as outlined. Please help..., for people with ALS, it really is a race against time
Eddie spaghetti) Esparza.
Team IPLEX Capt.-, PALS since 2005