Things I Hear That Are Hard To Swallow

Yesterday was my second in-office review since I started this Phase II test.  (All is well and I still show no signs of a tail.)  Dr. M did the physical review/tests himself, which is unusual.  His time is typically gobbled up by reviews and meetings and conferences and patients.  I suspect he only had time on his hands because I was the first patient in the office.

After going through the usual dog and pony tricks that I'm used to (finger touches, foot bounces, repeating movement quickly for 30 seconds, balance testing,etc), he wrote down his opinions on the official paperwork.  Sensing he wasn't rushed, I mentioned that I'd read, via a Fox Trial Finder Update, that the Neupro patch had (once again) been approved by the FDA.  Dr. M perked up and his whole expression changed.  He became quite animated as he expressed his excitement when he'd heard this news a few weeks before it was publically announced.

BACKGROUND:  Neupro is a pharmaceutical patch that was originally approved by the FDA in 2007.  It was - and still is - the only extended-release dopamine agonist (ER DA) available as a patch.  It was created to treat symptoms associated with both early AND advanced-stage Parkinson's.  The specific benefit of Neupro is that it is able to maintain a constant level of drug throughout the length of an entire day.  This means patients using Neupro would likely enjoy longer "on" periods, even while sleeping.

The FDA pulled it from the US markets in early 2008 after complaints surfaced that the medicated-gel coating the patch was using was granulated during the manufacturing process, which prevented proper dosing of the medicine.  So the manufacturer adjusted their methods, and had to go through re-testing of their product (which they already knew was working because no other countries pulled it from their markets).  The whole thing took four years to re-create and test.  But, now that the hurdle has been cleared, it will reappear in the US this July.

Neupro was Dr. M's first choice of ER DA and he told me how he had to break the news to his patients that this medicine  - the stuff that was helping them sleep calmly at night, that every patent was able to use no matter the level of their Parkinson's affliction - was being pulled in the US, and why.  He noted that all agreed the US FDA did the right thing by pulling it ... but this was the only ER DA available as a patch, so it was a crushing thing to say to those he was treating.

Why, you may ask, is that such a big deal?

Because along with maybe screwing up your balance and/or sense of smell, along with maybe causing you to "freeze" and/or shake uncontrollably (I have a GREAT vein in the inside of my right arm - but it's useless to me now because that arm shakes.  Needles and twitching are never a good equation.), along with maybe making you stutter and/or drool, Parkinson's can take away the ability to swallow.  Thereby eliminating your ability to take pills.

Yeeaaaaaaah.  That's .... well .......... that's just a magnificent kind of evil.

I've always thought of myself as being a very lucky person.  It's strange to think of yourself as being lucky because there will still be a way for you to be medicated if you can no longer swallow.