Tuesday, April 16, 2013

Waiting to see what my Senators are REALLY made of

Just sent both senators modifications of the below. If you want to help (or stop my incessant whining), you can write your senators, too. Tell them that my whining keeps you up at night. That me and my kid are (or are like) family. That we matter. And that a sucky painful and slow death will just make everything suckier.

I know people are freaking out about the bombings. But see, that wasn't preventable. IV drug shortages? Those are kinda preventable. And what a lot of folks don't realize is that LOTS of people will be impacted when the well truly runs dry (even, for instance, all those injured in the Boston attack; tiny babies in the NICU, their families; anyone who gets in a car-crash and needs IV supplementation; cancer patients who need the same; you see where this is going).

So you have something to crib from, this is what I wrote. When I'm feeling ultra-creative, I will try and post a letter you can just copy and paste and not have to edit one bit. Until then, let this be your muse:

Dear Senator:

I left a voicemail on your office phone a few weeks ago regarding my dismay over the IV drug shortages. Your office hands were kind enough to remit a letter acknowledging receipt of said message, and declared you would need further details.

Here they are: 
I live in xxxxxxxxxxx with my family of 4. I am the primary wage-earner, and a native Michigander. I have 2 advanced degrees and choose to live in Michigan. 

My son has an ultra-rare (there are fewer than a dozen living in the world) disease (microvillous inclusion disease) whereby he absorbs nothing through his gastrointestinal tract. He is alive by receiving all his fluid and nutrition requirements intravenously. His infusion company has been heroic in their efforts to meet his nutritional needs through many of the shortages, until now. 

The current IV phosphate shortages have almost stymied us. There are only 2 products with this as their salt: potassium phosphate (also known as "K-phos") and sodium phosphate. There are only 2 FDA-approved manufacturers of this product (as many other companies made the business decision in the '90's up till now, to exit this business for not generating any profit): American Regent (Luitpold), and Hospira.

Apparently Hospira's enormous 483 compelled them to fire their CEO and hire one who promised to fix it. They poured $125MM into it (probably a bunch of charlatan "consultants"), and got reinspected by FDA. They received a scathing additional 483, the new hotshot CEO was replaced, and we are still in critical shortage situation.

When I say critical, what I mean is, my son already has bones that are not as dense as they should be. He is FIVE years old. He should not be getting osteoperosis. But without phosphorous, the calcium has nothing to hang onto, and then the bones fall apart. His bones will start dissolving, little by little. He will start to get fractures. Many, small hairline fractures. His growth will stop. He will be in chronic and unquenchable pain. He will be in a wheelchair. At some point, if this goes on for long enough, this bone disease will progress beyond fixing, even if this product comes back online to full volume of supply.

I need your help. I don't know what you can do. Maybe help us source from Europe? Maybe help these companies get compliant? Maybe send a few bucks to FDA to get these places reinspected sooner? I really am at a loss, which is saying a lot, considering I trained as a mircrobiologist academically and spent my first 3 years in industry working to get a big pharmaceutical company out of its sterile injectables' 483.

To see how far we have come with my child's health only to face this long, dark tunnel of uncertainty lined with threats of suffering and pain seems excruciatingly cruel. UMich doctors told us he would not live to see his 1st birthday without a multimillion dollar multi-visceral organ transplant. And that without that, he definitely would not live to see 5. He has never been transplanted. He has not died, yet. His 6th birthday is this coming June. He goes to the public school around the corner. He reads at a 6th grade level. He loves to do robot dances. And antagonize his 2 year old sister. He loves to find science books at the library. And play board games with his nurses.

Please help my son. 

Respectfully yours,

PS I have voted at every election, no matter where I was living, and always voted for you at every opportunity. I'm only slightly pandering (you can see why), but honestly, it's because I believe that you are truly putting Michigan's best interests first.