Dear Brothers and Sisters,
We ( Team IPLEX ) are respectful requesting help from any and all family, friends, & supporters . Please Review attachments I have provided
You can... cut and paste certain talking points from the attachments , or you can just cut and paste the entire document -- as is... of course,change the address , name, and salutation's. -- Then utilize the Web link that I have provided, to send your elected representatives (2) senators & ( 1) Congressperson a quick e-mail voicing your support for this (PALS) cause. All we are asking is that they elected representatives) looked into the shady nature of this matter -- end of story... is that too much to ask?... just looked into the matter, on behalf of terminally ill people? --
Please Take 10-15 minutes and Help, because for PALS, it truly is -- A Race against Time.
The whole Iplex story significantly highlights the lack of care and concern by institutes such as the FDA. The human factor has been totally removed. The FDA's response has been unbelievable & shameful. They (FDA) are in effect shutting patients out of a drug/therapeutic , that they themselves have already (2006) approved for infants/children. Now, they (FDA) are claiming that it is necessary to shut/turn down all IND applications for IPLEX for reasons that it -- kills people? And get this, all based on unsubstantiated data. A Drug Well-Tolerated by Babies?
In plain speak, there is something very fishy going on here. The company (INSMED) that developed & owns the property rights, refuses to release any data, from a 100 patient, 2 year trial/Italian program. We, (team IPLEX & supporters) feel that the FDA should be forcing this information out, in order to make a more concise data-driven argument, or at least before they start making claims that IPLEX kills people... Insmed has been supplying Iplex to Italian, PALS for over 2 years now to over 100 patients, respectively review this is Insmed has issued many, a statement that IPLEX is safe and well tolerated. IPLEX is already an FDA approved drug and has already been proven safe for an indication for infants/kids dwarfism ).
Stephen & Barbara Byer parents of Ben Byer (famed, movie producer of the award-winning film "Indestructible" ) explain how their son, Ben, after 14 days of taking the drug (IPLEX ), went from "oatmeal and pudding to a Whoppers ." But was subsequently forced to stop taking the drug (IPLEX) when it was pulled/forced off the market by the terms of a patent lawsuit. We (team IPLEX & supporters) fought too hard in 2008, to get the companies to come to terms, (to make IPLEX available ) to shut up now... .
Bottom line, WHAT DO WE (PALS ) HAVE TO LOSE? --
If our (PALS & supporters) current letter writing campaign, is able to inspire, motivate, and or raise awareness to the plight of PALS. I will definitely feel like --Mission Accomplished!! Even if we are able to get the FDA to immediately change, there bogus position, I will still feel that victory is just around the corner, this fight will not be over... not by a long shot!!
If whatever we're able to accomplish with our current e-mail/ letter writing campaign helps the next generation of PALS dream bigger, work harder and once and for all, finish the work we've started, I'll always believed in my heart that we have made our mark as true champions.
But Don't Get Me Wrong, I Want to Win This Thing ASAP... If It's Wrong and or Selfish to Want to Live Longer, well then,... I'm Wrong, & Selfish -- End of Story.
PS: We Really Need Your Help