ALS Advocacy

ALS Advocacy
Lou Gehrig's Disease - Motor Neuron Disease - Amyotrophic Lateral Sclerosis
Thought it had been cured by now? Still no known cause. Still no cure. Still quickly fatal. Still outrageous.

Friday, March 8, 2013

Meanwhile, Back At The Ranch

On Monday, February 25, dozens of people with ALS and their caregivers got themselves to the FDA for the historic full-day hearing on ALS.  Dozens of scientists left their labs to speak to the FDA, too. Our ALS not-for-profits pulled out all their stops to be there.  For a full day, stakeholders gave persuasive and urgent messages to the FDA on the need to speed up drug development for ALS.  The FDA panel listened for almost eight hours.

There was only one "industry" speaker that day, the CEO of a self-described "baby biotech."  He asked for specifics that would help him bring his company's candidate to and through clinical trials.

It was disappointing that there were no others from industry who chose to speak that day.  At the time I thought that there were probably good reasons since they are regulated by the FDA and I'm sure they need to be careful about what they say to a regulator.  There are some pharmaceutical companies who have put significant dollars into bringing an ALS drug to market, and we are grateful for that.  In addition, there are a lot of reasons why making drug development and approval for ALS would be a wonderful pilot project for a lot of disease areas.  We wish they had spoken, but at the end of the day, their actions will be more important than words.

Then came yesterday's bombshell from Bloomberg News.  On the very day we were at the FDA, a big lawsuit was being filed...
http://www.bloomberg.com/news/2013-03-07/biogen-asked-in-suit-to-return-als-biosamples-to-knopp.html

That could explain some reticence to talk at the FDA.

I have no idea who is on the right side of the law in this matter, but I do know that it will slow down the very processes that dozens of ordinary people fighting an extraordinary foe begged for the FDA to speed up.

"See you in court," is not a good drug development strategy from the patients' perspectives.

Please, parties in this suit, sit down in a room and figure out what is right quickly.  There are two quickly ticking clocks -- your attorneys' billable-hours clocks and our patients' ALS clocks.  I'm guessing that the attorneys aren't nearly as sensitive to the latter as they are their own.

If this drags on to a trial, let's fill the courtroom with people with ALS.  It's all about the patients, right?

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