Friday, March 6, 2009

Well, it's only been 4 days...

But is seems to me like an eternity since I've posted.
There have been several interesting things going on in the ALS community.
The most being the fact that the FDA has continued to stonewall all IND (Investigational New Drug) applications for IPLEX for all ALS patients. Other than the fact that it is a ridiculous government agency that has no heart, I really don't understand the rationale behind complete lack of human compassion and decency.

So do you know what an IND is? It is the authorization of a drug by the FDA on an individual basis in a "last ditch effort" to help someone that is suffering a diagnosis with no more alternatives as determined by their physician. It is an application that must be submitted by a licensed doctor with good reason and in the best interest of his patient.

Historically, the FDA only denies IND requests when they fear that the drug might kill the patient or cause significant harm. This, of course, is very ironic for ALS patients. Many have reminded the FDA that there is no treatment, there is no cure, and everyone dies from this disease eventually, most within 5 years after having been paralyzed for 60% of their post-diagnosis life.

I don't think that there is an ALS patient on the planet that would prefer to die from ALS than take their chances with some sort of possible, undocumented, never reported reaction to a drug that is already approved by the very same agency for use in infants and small children with short stature syndrome.

What is the agenda of this agency? Why do they prevent people from trying this drug? These are people who would most certainly sign any kind of waiver of responsibility either to the FDA, their doctors or to the company that produces it. Why?

There were several theories circulating initially. One was that there was this "fear of deadly consequences" that loomed over the drug, which of course does not hold any water for ALS patients, who are already holding a death sentence decree much worse than any reaction to a drug might be.

A second one was that in some sense this group "The Bloggers" would use the information derived form its use to form unfounded conclusions as to it's efficacy and the drug company sell more???? Please. Even the most ignorant political dinosaur should know that at this point the Web/Internet community is large enough and educated enough to sniff out blatant commercialization of almost anything. I personally am an Internet veteran with 15 years of experience and connections througout the technology, media, publishing, social media, and advertising communities. Nothing is going to get past me and my group of peers that are connected and discussing these issues every day. It would be a disaster for any drug company to try and pull this off.

I now believe that the latest, ridiculous conclusion is essentially "if we give IND's to everyone now requesting them, there will be no one left to do a double blind study to prove or disprove it's value in treating ALS patients." Does anyone NOT see the shocking irony here? Let me rephrase this (as I understand it) "Let's deny dieing people a drug that we have already deemed safe to give in large doses to infants, so we can actually give it to 1/2 of a control group and test whether or not it works for real."

Let me state an obvious fact: People are dieing of ALS every DAY. These people have been lieing motionless for months, if not years, with only their perfectly healthy minds and their caregivers to help them get through this. Some of them, as I've recently learned, are abused by those closest to them, and they are helpless to save themselves.

There is no time to wait around and see if this works. It is a new world, people can share information. Scientists should seek to leverage the worldwide communication platforms that exist now rather than fear them. Please don't let academic arrogance kill people in the name of good science. Figure out how you can distribute this drug and others to a wider group, figure out how you can gather control data without being sadistic to people that are already suffering an unfathomable pain. Stand up and honor your vows of compassion and those "to do no harm."

And if you are an official that has not had to take those vows, or a drug company executive seeking profit or power, rethink your pathetic stance and have some compassion for the thousands of people and their families suffering from this horrible disease. Think about my post of last week. You, Mr. High and Mighty official, YOU could wake up tomorrow and not be able to turn your ignition or button that last button on your shirt. You, my friend, will then wish you had not been such a complete arrogant jerkoff.

My friends tell me "you catch more..(what...jerks?) with honey than you do with vinegar", so let me rephrase that last statement. Just forget for a second that I called you an arrogant jerkoff... "Please look past yourself to the pain of others and let people that need to try this drug try it." You have nothing to lose, if it works, you are a hero, if it doesn't then so be it. Our situation will not be harmed. You will have given us hope for at least some small period of time. A gift of hope. I have already bought this gift many times without efficacy AND without remorse or demand for compensation.

If you read my blog, you know i'm not, generally, an angry person. This situation really pisses me off though, and I apologize, once again, if I offended you.

PS, believe me, Jerkoff was NOT my first choice of words. I've become a bit more judicious in my choice of words, really only so this post might appeal to a wider range of email filters.

PSS, will someone please forward this to the human being that keeps stamping "REJECTED" on all the IND's for IPLEX that come across his desk? I would welcome his response to this blog at any time.

Monday, March 2, 2009

The book I mentioned

Hi all,
Well, I have not been posting much over the last few days, as the time I have had, which has not been all that much, has been spent writing chapters in the book that I am working on.

So, I have had some trepidation in bringing it up here, but I have come up with a name for it and I have created a simple web site that discusses what it will be.  In fact, though I have no idea whether normally a book's title precedes the book itself, it did in my case.

As far as progress is concerned, I have written about half as many words in the book as I have in this blog so far: about 9000.  The funny thing is that in this story of ours, after that many words, we are only approaching our wedding, so roughly two out of 17 years.  If you have been reading the blog and know how much content is here, then you realize that this might be a LONG book.  I decided to tell about our life together and even a bit before we met, to help readers understand the context of where I was coming from when we met.  

Heidi always says I was "homeless" when we met, which makes for a funny story, and is true in a way.  I was not homeless in the sense that I was living under a cardboard box somewhere, but I didn't have a place to call my own because I had recently moved out from living with someone and had not found a roommate or a place of my own yet.  I was bouncing between the apartments of some of my beach volleyball buddies and that was good enough for me for then. Anyways, I'll leave the rest for the story.

I do want to tell you the name of the book and explain it.  The book will be called "My Finder's Keeper."  The name came to me in a dream one night, or at least I woke up with it in my head In so many ways, H is my Finder.  I have always been a wandering spirit in many ways and was somewhat lost when we met.  My direction in life was set when she found me.  That doesn't mean that I knew what I would "be" in that moment but just that I had found a purpose when she found me.  We have been defining that purpose ever since, yet the definition is not finished and the story is not over...

As our life together has progressed, we have gone through so many stages of relative care and contribution to our relationship, but the bottom line is that now, I am her Keeper.  It is my job, 100% to take care of her.  She would not have it this way in a million years if she had a choice.  In fact, she would be taking care of other people...our daughters, me, our friends, anyone that asked, really.  It hurts her to not be able to do that, and to be the one that needs to be cared for. It is shockingly the opposite of perfect.

It also took me a while to understand that this was fully my responsibility.  It is.  There is so much help that we have, but no one can do what I do, nobody can replace who I am in this house, and I have to make sure everything is taken care of.  This is very poignant and heavy for me.  It is awesome in both the best and the worst of ways.  When you are a father, you already understand what it means to have someone depend on you 100%, so I get that.  When you are a husband, you don't really expect to be the one that is 100% responsible for the well being and care of your wife.  It is a shocker when it hits you.

But it is OK.  As I've said before, the bucket never comes up empty when you drop it in the well with a wish for love.  And Strength.  Did I mention strength before?  Do you know what the well is?  

Anyhow, I'm very excited about writing.  I have no idea how long it will take me, or how much detail I will put in the book.  For now, I'm putting in as much as comes to me.  The stories, even after 15 years or so are fresh in my mind, the details take on a life of their own as my fingers flow across the keyboard.  Right now, I'm wondering if I can really publish everything I have even written so far.

As I mentioned, I've created a web site about the book here:

It's a simple site, but it's a start.

Did anyone see Airplane?  There was this ridiculous scene where they were trying to get a heart to the Mayo Clinic and it was beating by itself all alone in an ice chest and then it starts bouncing around the Dr's office.  Right now, my heart feels like the one beating in the ice chest all alone, but I put it out there for Heidi, for my girls, and for you.