The Ultimate Sacrifice That Keeps On Giving

Today we remember and honor those who gave their lives to keep our nation safe.

The thousands of cemetery flags speak volumes.

There are thousands of other veterans whom we must not forget.  They are making their ultimate sacrifice after their combat days have been completed.  They are dealing with an after-effect of military service -- ALS.  It's a difficult path to death.  It can devastate a family that has already given way more than its share to our nation.

The ALS-military connection isn't some fringe theory like those we hear about cell phones or things they put in our city water.  It's a scientific fact, shown in repeated studies.  The reason for this correlation between military service and ALS is still a mystery.

This is a message that we have failed to deliver well.  It should outrage and concern every American.

Thanks for paying attention and spreading the information.  There are thousands making their ultimate sacrifices long after the wars.

We owe them excellent care.  We owe them an explanation.  So far, we have delivered neither.

Are You Reading This On The Bad Internet Or On The Good Internet?

Yesterday at the ALS Association's Advocacy Conference, Dr. Richard Bedlack presented on "ALS Facts and Myths."  I think highly of Dr. B.  He is bright, knowledgeable, accessible, energetic, creative, and pleasant -- a rare package of traits in a neurologist in my experience.  He also provides a valuable source of information for those dealing with ALS with his ALS Untangled project, which, by the way, is available on the internet at www.alsuntangled.com .

During the webstream of his presentation, we heard Dr. B cover some "alternative" therapies that people with ALS might encounter, and he spoke of the scientific fact and (mostly) myth associated with them.  Most were found on the internet.  Many were so laughable that they drew lots of loud snickers from the audience.  Oh, that internet is so bad.

The continual laughing at the internet from the audience seemed odd to me.  Many (if not most) of those people in the audience were staff or fundraisers for our largest ALS organization that has used the internet to fuel a huge fundraising success.  The guffaws came from an audience that included paid tweeters using social media to promote the ALSA advocacy conference experience.  And there were contractors webstreaming that very session. Oh, that internet is good.

Internet tools are powerful.  With any medium, content can be dependable or not.  The internet provides us unprecedented opportunities for experts and organizations to help curate and contribute content.  The internet is the most accessible milieu for people with ALS and their caregivers.

The internet isn't the problem.  If you laughed a whole lot and rolled your eyes when Dr. B spoke of the internet, then perhaps your lack of online engagement beyond fundraising and organizational promotion is the problem.

Some Thoughts From ALS Advocacy Day on Capitol Hill

We met absolutely no resistence to the ALSA priority requests for $10 million to continue the CDC's ALS Registry and for $10 million for the DOD ALS Research Program.  None. Nada.  Not even from those who are strong fiscal conservatives.  The "ask" was easy.

Moving to metaphors...

When the exercises are easy, it's time to add some weights.

And if you're old enough to remember the great Fuller Brush sales case, you'll know that there was always another brush in there to pull out and sell as long as the customer wasn't saying no.

Some Impressions From Day One of the ALSA Advocacy Conference in Washington, DC

The live streaming of the proceedings is a wonderful addition.  Quality was good and it is bringing in many people, including those with ALS and caregivers who can't travel.

I listened with interest to the live stream of the session on the Registry.  Dr. Horton did a lot of background explanation and even started by stating that some people may know nothing of the Registry.  That's not good.  They know now. At least this group knows now.

Statistics still weren't revealed except that a little over half of the self-enrollees took the first risk-factor survey.

Further risk-factor surveys have been developed but are awaiting OMB approval.  What the OMB is looking for in their approval process wasn't explained.

It was clear from one of the questioners that the whole concept of the risk-factor surveys is not clear to the people who need to engage in them.

The scope-creep of this project is concerning to me.  Yesterday we heard about clinical trial matching services and a cost-of-ALS study and all kinds of new things that can be done with the extra funds that are not needed for the core registry.  Enough, already.  There are a lot of information-based projects that are needed in the fight against ALS, but just because ATSDR has the funds doesn't mean that it is the best organization to deliver them.  Have we overfunded a registry project that can now take on all kinds of peripheral projects?  Oh, that we had kept the registry project simple and lean and mean!

Our mothers would say to finish your peas before you put anything else on your plate.

I arrived at the live meeting late and for a short period.  It was nice to see the old "Strike Out ALS" stickers on the JW Marriott staff again. The crowd in the meeting room was huge.  I was amazed at how jam-packed it was.  Unfortunately most of the faces in this crowd change every year.  And next year...

Other commitments kept me from seeing the live stream of the dinner last evening, but I enjoyed the tweets and am so glad that O.J. Brigance and Steve Gleason helped set the tone to emphasize the power and the responsibility that we all own in the fight to beat this beast of a disease.

More to follow today on Capitol Hill.  On the morning news we learned that Prince Harry will be on Capitol Hill today, too.  We will not have succeeded until there is a picture of Prince Harry wearing a "Strike Out ALS" sticker!

Recidivism Isn't Always Bad

We read how some people just keep going back to jail, year after year, crime after crime.  That's bad.

Oh, that people would keep coming back to the fight against ALS year after year!

Annually there are ALS advocacy activities in Washington, DC, in May.  Every year the repeat faces are those of employees in the fight against ALS and board members who are vested in ALS organizations.

The faces of the people with ALS who manage a trip to Washington seldom repeat.  The disease itself makes them short-timers.

The faces of the caregivers and families who manage a trip to Washington also seldom repeat.  That's a concern.  After a person with ALS dies, those are exactly the people who can advocate relentlessly with a special kind of rage.  They have the benefit of longer memories and know where the fight has failed and needs change.

Why do we lose them?  Why do they leave the front lines of the fight?  Does it have something to do with their longer memories and rage and challenges to the status quo?

Perhaps the registration form holds a big clue.

"Other?"  Clearly not a core constituency.

This Was ALS Awareness

From May, 2011, there were three days of display of the Piece by Piece exhibit in three very visible venues in Washington, DC --

This was grass-roots, volunteer driven (literally) and there has not been anything like it in our nation's capital for ALS awareness since.

RT to Defeat ALS

In case you had not seen Steve Gleason at the NFL draft, here he is --

http://deadspin.com/steve-gleason-announced-the-saints-third-round-pick-483478798?utm_campaign=socialflow_deadspin_twitter&utm_source=deadspin_twitter&utm_medium=socialflow

Pretty good, eh?  Important image of sports fans everywhere to see of ALS, eh?

This morning on twitter, I simply asked five sports journalists with huge followings to retweet the link with the coverage of Steve.  Within an hour, that link had been retweeted to 100,000 people who follow those sports journalists.  My wild guess is that the majority of those who got the tweet hang onto the words of sports journalists they follow and are not very familiar with ALS.

Bingo.  That's how ALS awareness happens in 2013.

For May, ALS Awareness Month in the U.S., perhaps all tweeps can work hard at getting the big RT. We're only a few retweets away from millions of people who are ALS-clueless.

These Are My Questions Du Jour On The MODDERN Cures Act

I may just be dense, but I'm having trouble understanding how the patent part of this works.  I've tweeted pleas, and @modernmeds was kind enough to respond, but I think I need more than 140 characters to ask my questions.

Here is some material from the National Health Council, whence this proposed legislation comes --

http://rareadvocates.org/wp-content/uploads/2012/10/MODDERN-Cures-Overview-2-7-12-2.pdf

It includes a lot of features, but I sense that the patent protection is the most pertinent for ALS today.

Here are the descriptions of the patent aspects --

TITLE II — CAPTURING LOST OPPORTUNITIES FOR PATIENTS


Sec. 201 – DESIGNATION OF DORMANT THERAPIES

This section creates a new class of drugs, named “dormant therapies.” A dormant therapy is a new drug or biological product that has insufficient patent protection and meets the FDA definition of “unmet medical need.” The Secretary is required to establish a methodology and criteria for this designation. In its request for designation as a dormant therapy, the manufacturer must provide a list of all patents and applications for patents to which the manufacturer has rights, and must agree to waive those rights in order to receive the designation.

Sec. 202 – PROMOTING THE DEVELOPMENT OF DORMANT THERAPIES

This section provides for a 15-year period of data exclusivity after FDA approval to encourage the development of dormant therapies. The Secretary is required to make its determinations available to the public. This bill will establish a predictable pathway for introducing low-cost generic equivalents to dormant therapies.

Some examples would really help me understand.

1. What if there is a drug that is within a year of losing its patent and the manufacturer holding the patent decides to pursue testing of that drug for ALS?  It will take years to test the drug for ALS.  What happens?  What does it mean to waive the old patent rights?  What does the 15-year period of "data exclusivity" mean?

2. What if there is a drug that is within a year of losing its patent and another manufacturer is interested in pursuing it for ALS?  How would that work?

3. What if there is an old drug whose patent protection has long since passed.  Can it get new patent protection with this?

Thanks to anyone with insights. 

Thank You, Chicago

Special thanks to @irishoconnor and @bio1x1 for the tweets that showed us this marvelous picture from Chicago last night.  As the scientists and business interests from #BIO2013 sought dinner and their evening's entertainment, they that got a big reminder of what's really important.

Please Mark Your Calendars And Help Spread The Word

The fourth annual Worldwide Weekend of Prayer for Those Dealing with ALS is coming up May 10-12, 2013.

Please visit http://www.wehaveaprayer.org and help spread the word to anyone who might like to join in.

Thank you.

A Month Is A Terrible Thing To Waste

In a few days it will be May -- ALS Awareness Month in the United States.

How many people who are clueless (or even semi-clueless) about ALS today will be aware of ALS by the end of May.

Don't count those 500+ Americans along with their families and co-workers and friends and neighbors who are going to find out the hard way with an ALS diagnosis.

How many?

Don't You Wish You Could Have Been There?

Click here for the background materials for ALSA's Advocacy Conference and the day on Capitol Hill.

Their public policy priorities are again --

• Appropriate $10,000,000 to continue the National ALS Registry at the CDC
• Appropriate $10,000,000 to continue the ALS Research Program at the DOD
• Enact the National Health Council's MODDERN Cures Act

Don't you wish you could have been there when they brainstormed, challenged, evaluated, analyzed, measured, questioned, disagreed, innovated, calculated, dreamed, disrupted, listened, questioned more, argued, and finally fleshed these out as the best 2013 legislative priorities possible for people with ALS?

ALS Is A Crime

What if on Thursday, May 9, every person with ALS donned a little crime scene tape?  It makes an inexpensive belt, tie, scarf, headband, or accoutrement to a wheelchair or cane.  Ah, wheelchair streamers!

Everyone who would see the tape would ask, "What's with the crime scene tape?"  The conversation about ALS begins.

On that day dozens of people with ALS will invade Capitol Hill to talk with legislators.  Wouldn't the crime scene tape be an interesting visual in those hallowed halls?  And think of the photo ops.

And what if people with ALS everywhere donned a few strands of the tape and were seen wherever they might be that day?  Oh, and some digital pics of people with ALS, famous or not, could invade the social media.  Viral?

ALS is a crime against people and their loved ones.  Crime scene tape is inexpensive.  Anyone up for some ALS awareness?

Time To Ditch The Blinders And See Whom We've Left At The Side Of The Road

It's always easier to get a large group moving in a common direction if you try to keep them focused on one goal.  Cut the distractions.  Beam in on a clear deliverable. Deliver.

Over the years an annual legislative priority for ALSA's Advocacy Conference has been to provide funding for the DOD ALS Research Program.  The case is built on the fact that those who have served in the military are much more likely to be diagnosed with ALS than the rest of us.  The science is still a mystery.  The solution is a mystery.  Research funding will help solve those mysteries, and we owe that to those who give so much to keep us all safe.

Focus. No distractions. Make the case. Deliver.  But while we're making the case for those long-term research goals, can't we slip off the blinders for a few minutes and see the near-term problems that our veterans with ALS face every day today?

Take a look -- http://scjohnson63.tumblr.com/

Many of us are clueless about the VA healthcare delivery system and rules.  Add to that the complicated and difficult disease that ALS is every day.  What we see when we slip off those blinders and peek at the here-and-now is not as easy as asking for research funds.  It involves an arcane healthcare system and a disease that presents unbelievable challenges for patients and caregivers, many of whom are spouses and children.  Those challenges change rapidly, and the word "rapidly" isn't used in many sentences that also contain "VA."

Our overall sense of national outrage about VA waits rose last week.  We should also be willing to take off those blinders and look at our ALS veterans in the eye.  If we step up for them with a fraction of the effort that they gave for us, this can't be a difficult set of problems to solve.  But first we have to look.  Then we need  to work.  No show-horses needed.  This is work-horse time.

Mittens and Duct Tape To Defeat ALS?

This morning I saw a tweet from a woman with ALS --

@buffandblue697h If u want to understand my life , put on thick mittens then dress, eat, and type. ALS sucks!

Several weeks ago there was a posting by a man with ALS on the patientslikeme forum --

As I was fighting an itchy nose last night I had an idea how to let unaffected people have a glimpse of what life with this disease is like.  Today I challenged my facebook friends to go for two hours without touching their face or head.  Not to scratch their nose or move the hair out of their face.  So far the shortest time is fifteen minutes and the longest is 39 minutes.

Perhaps at a big ALS event, the healthy ALS advocates can volunteer to duct tape themselves with constrictions that are small outward reminders of what ALS steals from people.  Arms strapped down or a mouth covered or feet taped into an awkward position or immobilized fingers would represent a small fraction of the reality of ALS.

How would it be if people calling on legislators in Capitol Hill in May wore their duct-tape limiters... and then handed the legislative assistants, Members of Congress, or Senators some nice big mittens to wear during their meetings?  Oh, and no scratching of any itches allowed.

A stunt?  Yes.  Would it be remembered?  Absolutely!

Can We Lead With A New Meeting Standard?

Over the years we've grown accustomed to ALS meetings that feature expert speakers, a very short question-and-answer period at the end of each presentation, verbal questions from the live audience, and never enough time to address all of the questions adequately.  That is followed by the small mob that surrounds the speaker at the break where lots more questions are asked, and we assume, answered.

We can do better.

• Every question deserves to be asked and heard by all stakeholders.
• Every question deserves to be answered and heard by all stakeholders
• Every speaker deserves adequate time and resources to answer those questions.

For a disease where there are lots of questions, accessibility and speech are problems, and time is of the essence, we can certainly be a little more creative about insuring that every question is asked, answered well, and heard by all would would benefit from the information.  And surely we can archive those questions and answers to be a valuable resource for all of those involuntarily recruited by ALS before the next meeting.

When agendas are published, questions can be solicited in advance.  After a presentation, questions can also be accepted with a promise that they will be answered in a public space.  Speakers can understand that this is an important part of their engagements.

Every person with a stake in the fight against ALS has the right to ask good Qs.

Every Q deserves a good A.

Everyone will benefit.

Please Don't Lose Our Most Valuable Resource Against ALS

Over and over and over, year after year, decade after decade, ALS has become a deja-vu disease.  People with ALS try things.  People with ALS experience things.  People with ALS have theories about possible triggers to their condition.  When these people with ALS die, many of the clues that their lives and experiences harbor are buried with them.  We waste our most valuable resource in the fight against ALS -- information.

There are important ways that people with ALS can contribute their information for those who follow.

1. The National ALS Registry administered by the CDC has a self-enrollment portal that will insure that a person with ALS's basic epidemiological data are captured.  There are also periodic risk-factor surveys that will address some of those possible triggers.  Please encourage those with ALS to participate at www.cdc.gov/als .

2. Every person with ALS tries things.  Some of those things are simple like a special diet or vitamins.  Some of those things are exotic treatments.  Regardless of what those things are, it is a terrible waste not to capture some basic data around the things tried and the results (or lack thereof) that the patient experienced.  A convenient place for tracking such things so that others may learn is in the patient profile area at www.patientslikeme.com .  The website provides an orderly framework for storing and searching for data.

Information lost in the fight against ALS makes it the disease where new patients constantly have to re-invent wheels.  Information lost also means that scientists often ignore some of the simple things that past patients have found helpful.  This is a dreadful waste.

If you are a patient, please don't let your data go to waste.

If you are in a position to influence or help patients, please step up.

Thank you.

Which Campfire Will Defeat ALS?

Some people build a campfire as a nice place to sit around and sing "Kumbaya."

Other people build a campfire to provide light and heat.

This Is Almost As Good As A T-Shirt

Well, maybe not as good as a t-shirt, but it's not bad.

Last year for ALS Advocacy Day I had some nice buttons made up for PALS who had self-enrolled in the CDCs National ALS Registry or who were in clinical trials (or both!).  The idea was for them to let their peers and others know of the good deeds they had done.  This encourages others to participate and starts some good conversations.  It was nice to see so many wearing them when we went to Capitol Hill.  They are large and readable buttons.

I still have some buttons left and would love for them to find PALS who will wear them proudly.  I would also love for them to find PALS and support group leaders who will help spread them to other PALS and will help spread the word on the importance of Registry self-enrollment and in clinical trial participation. 

All I ask in return is that they be put to work and worn by those in the Registry or a trial.  If anyone would send me some pictures of PALS wearing them, you can be assured that they'll be posted.

Please send a snail mail address and how many Registry buttons and how many clinical trial buttons you need to alsadvocacy at gmail dot com.  You can be assured that your address will be deleted after the buttons are sent.  I'm just an individual trying to spread Registry and clinical trial awareness.

While supplies last.  Please help put these to good use!  If I win the lottery, there will be t-shirts ;-)

Thanks, all.

Patient-focused? Fiddle Dee Dee

I submitted an online request for a prescription refill last week.  It seemed like such an efficient way to give the doctor's office what they needed in writing so that they could process at their convenience.

Their online request form was a little awkward for the many people whose health plans expect the use of a mail-order pharmacy.

It was pre-coded "I will pick up at pharmacy."  I simply entered the name and out-of-state address of the well-known mail-order pharmacy along with their fax number.

My phone rang on Sunday morning (overtime?).  It was the nurse from the physician's office.  She wanted to know why I had said that I would pick up the prescription at an out-of-state mail-order pharmacy.  Perhaps she was concerned that I'm losing my marbles.  She clearly had never looked at the prescription renewal form that has "I will pick up at pharmacy" precoded.

That transaction that should have been extremely efficient was much more complicated and expensive than it needed to be, and it certainly wasn't patient-focused.

The problem wasn't a doddering patient.  It was a poorly designed form and a healthcare deliverer who wasn't familiar with it.

I wonder if anyone acted on that experience to fix the problems... or will they leave that to the customer satisfaction survey people?

It's Still Nuts

About a year ago after having received some chest-thumping appeals from multiple ALS organizations, I wrote this blog entry about how nuts it is that we are kept so uninformed about our ALS research investment portfolio.

A few days ago I listened to a  compelling segment on The Diane Rehm Show regarding choosing effective and efficient charities.

We need to be able to take a serious look at our ALS research investment portfolio, and that can't be done with the selected and selective bits and pieces of information that our ALS charities and our government agencies give us today.  Take a look at some examples --

ALSA
ALSRP
ALSTDI
MDA
PRIZE4LIFE
PROJECT ALS

The investors are left pretty much in the dark about the business basics -- who gets how much, start dates, end dates, and outcomes.  The investors simply aren't given essential information to make informed decisions about the investments they are constantly asked to fund.

Organizations, please don't fly off and slap together competing, duplicate tools to give us this information.  That would be neither effective nor efficient.  We need a single, common tool that every grantmaking ALS organization and government agency keeps current.  It simply needs to include things like we see today on your websites, but with dollars granted, start dates, end dates, and outcomes.  We also need more than active projects.  The history is extremely valuable.  It all needs to be searchable, shared, and accessible from your websites.

We need a common tool that tells your investors the common-sense basics.   You need to make the commitment to keep the content current.  Your investors are tired of being kept in the dark and fighting through scattered bits and pieces of information and your 990s.

One tool...  One way to show that ALS organizations are efficient and effective at spending ALS research dollars... One place to shine some light for your investors.

If you want us to believe that you can figure out a complicated disease like ALS, then you can surely solve this simple business problem for us.  It would be efficient and effective, and that's what we expect of you.

Perhaps Some Smart, Energetic College Students Could Solve Some Problems

For over a decade military service has been associated with increased risk of ALS.  Yes, over a decade.

We have some big problems now.  Perhaps some bright and creative college students could find some solutions.

Marketing 101,  Political Science 101
The message about ALS in the military has not stuck.  Every year advocates go to Washington and talk with legislative staff members.  They use the story of ALS in the military as a logical lead-in to get the listener's interest and commitment for some modest DOD research investments.  Every year the staff members and legislators looked surprised and act interested.  Every year.  Year after year.   ALS in the military should be more than a quickly forgotten factoid.  This should be a source of national outrage and meaningful action.

Communications 101,  Instructional Design 101
Veterans with ALS are entitled to service-related disability benefits. Period.  Parts of the VA system didn't seem to get the memo. Stories of veterans who have difficulty getting the help to which they are entitled continue.  Time is important when you have ALS.  Energy is precious when you have ALS.  They need a low-hassle VA that delivers for them efficiently.

Pre-Med 101
Veterans continue to report having difficulty getting basic medical services related to ALS.  Bi-Pap and DPS are allowed by insurance and Medicare for civilian ALS patients.  Why would there be any question for veterans?  Civilians with ALS have access to one-stop clinics where they can see a number of specialists.  It's actually quite efficient and effective.  Why don't veterans have access to such healthcare.

Management 101
Consistency with handling of veterans' benefits often doesn't happen until an appeal is filed.  That wastes precious time for veterans dealing with the ticking ALS clock.  That wastes tax dollars.  Why can't the VA get things right the first time, every time?

Social Work 101, Common Sense 101 
We all know that military families carry a large part of the burden of military service, yet we as a nation often forget when it's time to actually do something.  When many soldiers get back home, the healing for the whole family begins.  For those with ALS, it's a different story.  Dealing with ALS is huge.  It's the most physically and emotionally difficult job that you can imagine, and spouses and children rise to the role; however, we need to give them some help.  That's just common sense.  When a young Army officer forced into retirement by ALS has to open a Paypal plea to friends and strangers to get some overnight caregiver assistance for his family, something is very wrong.  Much is revealed about the character of a nation in how it treats those who have kept its people safe.


Are there any bright students out there who can swarm on a project and come up with some clever solutions to problems of a bureaucratic morass?  We need you.

We Have Ten Days

The FDA has asked the public for comments related to drug development and ALS.  So far very few have taken them up on their offer to listen.

We need everyone who has ever lost a loved one to ALS to speak up.

We need everyone who has ever donated a dollar to an ALS charity to speak up.

We need everyone who has ever been employed in the battle against ALS to speak up.

We need everyone who has ever volunteered for an ALS organization to speak up.

Around 60 people gave their six-minute comments in person to the FDA on February 25.  Only 393 more have submitted comments to the FDA online as of today.  That is just not enough. The FDA is bombarded with requests every day.  We need to make sure they know that ALS needs to move to their front burner.

Don't know what to say?  It doesn't have to be technical or fancy or long.  Ask the FDA to listen directly to patients and caregivers.  Ask the FDA to be willing to let people with ALS take some risks.  Ask the FDA to help come up with some clever ways to move their approval process faster for ALS therapy candidates.  Ask the FDA to let us know what they need to do a better job for ALS.  Simply remind the FDA that the status quo is not acceptable.  Let them know that they're protecting people with ALS to death.

Please speak up.  Nobody speaks on your behalf as well as you do yourself.

Here's the link --

http://www.regulations.gov/#!docketDetail;D=FDA-2013-N-0035

The deadline is March 25.

They have asked.  It would be a crime for us to fail to respond.

Monday Morning Quarterbacks, Where Were You When The Trial Was Designed?

It's easy to criticize clinical trial design after the fact.

We need smart input up front from more stakeholders, including people with ALS and caregivers.

We need open standards for data sharing.

We need more smart statistical eyes on the data.

You know what they say -- If you're not part of the solution, ...

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?