Thursday, March 12, 2009

Number 10 more FDA and a thought about pain...

Hi Everybody,
Well, as you know if your read the comments from my "top ten" blog post that someone very accurately pointed out to me that #10 in the "not in order top ten list of what keeps me sane" is this very blog and the other writing that I'm doing. I've mentioned before that it is cathartic for me to write and get some of this out of my system. It's also hard to share some of the personal stuff we are going through, given that this is a public blog and that I have a professional life as well. At the end of the day, though, it's about helping as much as you can while staying sane and in control yourself, so that is what I strive to do every day.

A couple of thoughts have come across my mind in the past couple of days. Since I read the FDA the riot act a few blog posts ago, they have actually approved IND's for some undetermined number of people. I am very happy for those that received it, but I'll also say that the report that I read from the FDA was one of the most CYA (cover your ass) comprehensive buckets of bullshit I have ever read. They effectively addressed all my complaints while at the same time announcing that they were only going to provide IPLEX to people that has successfully submitted their IND's prior to March 6th, three days BEFORE they released their notice.

Adding a link to the FDA's official statement so you can see what I mean:

It is very well written and extremely politically savvy. It makes me nauseous.

We requested that our physician submit the IND back in November and did not find out until 6 weeks later that not only had he not done it, that he was not going to do it because "his insurance company advised him not to" and because "he did not feel qualified to monitor progress on this medication." Of course we would have been willing so sign any waiver requested by him or his insurance company, but this does not seem to matter. Now, the FDA decides to only give the drug to people that somehow found an MD that would be willing to "go out on a limb" for their patients and announce it in a way that gives no one that could not find a cooperative doctor a chance to find one? Very Sad.

Of course, they seem to have very good reason for this. Apparently, there is a "limited supply" of the drug and between those that had their IND's in, and the "lottery" that they are going to run for some "lucky" few to get into the clinical trial (where you may or may not get the drug) there just wouldn't be enough of it to go around for everyone that wants it.

Talk about a "convenient truth." This is a manufactured drug. It's not like we have to wait around until the fall to harvest another round of IPLEX from the Great Plains or the Steppe of Peru. Somebody please explain this to me. Please. Can I chip in for a couple more centrifuges or rubber gloves please? Need some of my spinal fluid for development? Sign me up. Maybe A-Rod or Sly Stallone can source some HGH for you to manipulate. I'll call them.

By the way, I'm not suggesting that my post had anything to do with the FDA's final decision to allow access to the successful few. I am suggesting that the fact that they did what they did is totally unfair and to me seems pointed at silencing the most active and connected people among the group seeking the drug.

Well, in that I don't think that they have succeeded because I don't believe that "Team IPLEX" is going to give up just because some of them got the drug. Eddie and his army have already announced their dismay with the limited supply and are fighting for everyone that wants to try it to have access to it.

I'm also not suggesting that I believe that this drug is going to be a panacea to anyone with ALS and to that end, I humbly request that anyone that DID get the drug to please keep the community posted as to it's efficacy (or lack thereof.) Please do that for us waiting in the wings.

Here's a note that Eddie sent to us all:

Dear friends,
First of all, I would like to extend a heartfelt personal thanks to any and all that helped us , (Team IPLEX) in our drive to gain access to IPLEX, as a possible therapeutic for ALS.
Although we (Team IPLEX & ALS worldwide) are pleased at the availability of Iplex for some under this condition, we are very displeased with its present unavailability to others. Accordingly, Barbara & Stephen Byer will continue their planned meetings with the Health Policy Staffs of ( 12 ) US Senators and ( 3 ) US Representatives in Washington, DC on Wednesday, March 11 through Friday, March 13, 2009 in an effort To Expand - Both the Allowable Number of Patients Accessing IPLEX and its manufacturing capacity by Insmed, perhaps with government assistance.
For further information concerning IPLEX please contact:

Stephen Byer
608 663-0920 Office
608 698-4200 Cellular
608 237-2274 Fax
125 N. Hamilton Street
Madison, WI 53703

On Pain...

On a totally different note, the teenage daughter of some good friends of ours was just "dumped" by her first "real" boyfriend. I remember when a similar thing happened to me a long time ago and the real pain that I felt. Looking back, of course, this was not a significant or defining event in my life, but the hurt, having never felt this before, was real to me at the time. Maybe something similar happened to you once.

This reminds me that all pain that is felt by anyone is real. It is real to them, no matter how it might seem to others. There's plenty of pain to go around and I think that what defines you is not how much you have been handed, but how you emerge from it.

My humble advice on this topic: You can never let yourself be defined by someone or something else. YOU have to figure out who you are, where you stand and what you are all about. The agendas and circumstances that are out of your control are not defining criteria for who you are. How you react, deal with and emerge from them are. Be strong.



  1. Team Iplex represents a miniscule percentage of the ALS community...can you imagine the excitement of any PALS/CALS or friend/family member of PALS/CALS just finding out that Iplex even exists and then the outrage of the FDA ruling? I imagine that in a matter of days the FDA, Insmed, the ALSA, MDA, neurologists and other doctors will be flooded with requests for information and thousands of people will want answers. The ensuing disgust that Iplex will only be available for a select few will hopefully be cause for re-evaluation. How bizarre that the drug, which as you stated, can be manufactered, has a limited supply. Can you imagine if there were only a few ventilators for PALS...or a lottery for access to a ventilator...or feeding about vaccines for newborns or chemo for cancer patients? This makes absolutely NO sense!

  2. Oh the insanity of it ALL! I have no clue where the Byers find their strength, considering they already lost their son to ALS. It must come from seeing how disturbing the FDA and big Pharma operate on a daily basis. They take their loss and anger and use it in a positive way.
    Try to follow the politics while you become paralyzed... Keep up with the sale of Genentech to press releases bringing excitement, only to be lead down the path to total disappointment. You put your trust in your Doctor only to learn, "his insurance company told him not to try a drug", a drug which just became accessible (sort of). And how could it possibly be legal, like who wrote the law, that a drug could be put into a lottery, as if the lucky winner may receive an extended stay on earth? I mean, I'm no genius here, although sometimes I wonder....
    Well said Bill.
    Stay tough. Fight hard