Every American Needs To Hear This Today

Here is a 30-second message that is direct, clear, and important. Please listen, then pass it along.

This Is Outrageous

Shame on us.

http://www.king5.com/news/investigators/Veteran-dies-waiting-for-benefits----133338928.html

Perhaps this Veterans' Day we need to stop patting ourselves on the back for the past work done for veterans with ALS and start fixing a few things!

Millions of People Looking for Bargains Are Made Aware of ALS

Thanks, Walgreens and NOVA, for helping good business intersect with vital ALS awareness in today's ad.

Wish We Could Go Back To GI-Bill Education And A Great Home Loan

... rather than having our vets get the awful fringe benefit known as ALS.

Reverse Engineering To Defeat ALS

Consider a disease that seems to find very smart people. The disease strips them of their motor functions, but it lets them remain very smart. The disease has no known cause. The disease has no cure.

Consider a disease with a history of disappointing clinical trials... trial after trial after trial... until this summer when one product (Neuraltus NP-001) seemed to have some positive effects on some individuals. It wasn't a miracle of biblical proportions, but it was like a parting of the Red Sea by ALS standards.

Consider a disease whose clinical trials involve a placebo group and have a timeline that is longer than the life expectancy of many patients. Consider a disease that leaves thousands of patients on the bench because they have had the condition too long to qualify for a clinical trial.

Should it surprise anyone that the same smart people whose lives are at stake have turned out to be a pretty impressive online band of reverse engineers? Give them a slight glimmer of hope and they don't sing and dance. They put their minds to work figuring it out. Smart people from every walk of life get ALS, and it has been pretty impressive how they found each other and decided not to be spectators in a life that dealt them a really bad hand.

Take a look --

http://www.als.net/forum/Default.aspx (Oral Sodium Chlorite thread)

https://sites.google.com/site/alschlorite/home

Certainly it's risky. There is no doubt that these are courageous people who are cornered by a relentless disease and a drug development system that has failed them in the past. They're not going without a really good fight and an attitude to do something so that the next person will have a fairer fight.

This Is Why The Great Nolan Ryan Is Still Great

Thanks, Nolan Ryan. Thanks, Texas Rangers. Thanks, MLB.



I'm still for the Cards but feeling awfully guilty about that now ;-) This is huge visibility for ALS.

Here Is A Perspective On A Birthday

Oh, that some creative minds might find effective ways to increase self-enrollment and patient participation in the supplemental surveys for the CDC's ATSDR National ALS Registry!

Here is some perspective on a "birthday" and on keeping our eyes on the prize --

http://alsspreadtheword.blogspot.com/2011/10/its-project-for-petes-sake.html

Let's make this registry work to provide the epidemiological clues that scientists need. Let's not sing until the data speak.

Is This A Sign Of New Things To Come?

On the main page of http://www.thehill.com/ ... there was a scrolling ad about a veteran with ALS. It had an ALSA logo and was promoting PDUFA.

We can't wait to see if this is a sign that ALS is about to have some in-your-face awareness!

Veterans - Time To Be Seen And Heard!

Here is a nice website from the ALS Association...

http://www.alsa.org/advocacy/veterans/

If you are a veteran who has ALS or you have lost a loved one to ALS who served in the military, please add a picture. This will give the mysterious connection between military service and ALS some much-needed visibility!

Please pass this word along. Thank you.

Let's Hope

Let's hope that Jason Alexander noticed the new shoes on the man with ALS. Those shoes will never be worn out. Let's hope that Jason Alexander noticed that the man with ALS didn't sip on coffee like the others in the room. Let's hope that Jason Alexander takes Steve and his disease personally. Lets hope that Jason Alexander will talk off-script about this outrageous disease. Let's hope.

From the statement from the ALS Association :

"Over the coming weeks the ALS community will begin seeing these materials launched as part of The Association’s more aggressive public awareness efforts. 'We are determined to bring ALS out of the shadows and into the light of public awareness' said Gilbert."

Let's hope that it will be aggressive and part of everything ALSA does. Let's hope.

Let's deliver.

YOYO (You're On Your Own)

For the recently diagnosed ALS patient, it's not quite as easy as it sounds. Here are some things that may help.

1. Some neurologists aren't current on the status of clinical trials. Some neurologists discourage clinical trial participation lest the trial may do harm to the patient (like ALS isn't the ultimate harm). Some neurologists advise patients only of clinical trials in which they are investigators. Some neurologists advise patients only of clinical trials in which they are not investigators. Some physicians have the human "not invented here" frailty. Patients shouldn't stop with the neurologist. Ask questions and ask more questions and contact the Clinical Trials Expert (who is a physician sponsored by several ALS organizations and should be able to provide objective information) alstrials@partners.org or (877) 458-0631. That contact information isn't easy to find on any organization's website, yet it's probably one of the single most important resources for a patient who might qualify for a clinical trial. Go figure. Nothing is easy with ALS.
2. Going to the ALS Association website isn't going to provide you with a current or comprehensive list of clinical trials. Try www.clinicaltrials.gov and search for "amyotrophic." There you will find the most current list of trials and their locations and current status. It's a more up-to-date database of trials than any other organization's website provides.
3. Look at forums at www.patientslikeme.com (also includes patient data reported by patients in formal clinical trials and in diy treatments) and www.als.net and www.alsforums.com ... and realize that not everybody there is an expert (and it's always easy to fall into the trap of listening to what you want to hear)... but you may find some information that will help you make a more informed decision about a clinical trial.
4. Time is of the essence. Many trials limit participation to those within 24 months of onset. Many patients have lost much of that eligibility window just trying to get a correct diagnosis.

ALS is unfortunately the ultimate YOYO disease. You're on your own to dig and find answers. Don't stop with one neurologist and one website.

p.s. To ALS organizations lurking here... Please try an experiment. Pretend you were just diagnosed with ALS and want to find out about clinical trials. Do it when you're exhausted and after you've whirled like a dervish for three minutes since that's the feeling that a lot of people with ALS and caregivers have all the time. Google. Look around at websites. Confused? Try to find the phone number or email address for the Clinical Trials Expert. Confused? Look at the CDC's website. Should you expect a phone call telling you that you are a candidate for a trial? Confused?

Now We're Cooking

Video from a recent "Ask The Experts" ALS research conference in California is available here .

Thanks to the organizers and the organizations for finding a practical and considerate way to deliver information for patients, families, and other interested people.

This Red Sox's Fan Is A Champion

Thanks, Clear Channel Outdoor!

http://www.boston.com/Boston/businessupdates/2011/10/clear-channel-billboards-help-umass-and-cellucci-fight-als/ctFFUD67WW6i78aAPSiKlK/index.html

What We Have Here Is A Failure To Communicate

Last week the Diaphragm Pacing System (DPS) was approved by the FDA for people with ALS.

For years patients who were in the clinical trial of this pacemaker to keep the diaphragm working attributed it to enhancing their quality of life. Finally all patients have access to this option which could be a valuable tool as an early intervention. It's a simple concept.

This week patients are asking their physicians about the DPS and some of the docs don't seem to know about the DPS. "I'll have to look into that," translates into wasted weeks for a person dealing with the ticking ALS clock.

If there were a new prescription drug for ALS, you can be sure that docs would be ready, able, and willing to get patients started. Why the DPS, only the second FDA approved product for ALS, is such a secret among healthcare professionals is just incredible.

So, in case this is of help for those reading this, here are some links with information --

ALSA Announcement

Synapse Biomedical Information (site includes Medicare information and locations with expertise)

Important Patient Q&A Document (Dr. Onders at The Cleveland Clinic is the developer of the DPS for people with ALS)

Information Letter

C'mon healthcare delivery system. It's past time to start delivering for people with ALS! This is an early intervention that is a much simpler decision than those later interventions. When dealing with ALS, "first do no harm" involves some added responsibilities.

Is There A Lesson For The Fight Against ALS Here?

Now, Can The Organizations Execute?

That was "organizations" (plural). Please. It's all in the execution now.

"The Facts Are Not Discouraging"

And that's a big deal with an ALS trial.

CNN covers news from the Neuralstem Phase I trial --

http://www.cnn.com/2011/09/28/health/early-als-trial-results-encouraging/index.html

Are The Right Agencies Doing The Right Things?

A perspective on some of the proposed "enhancements" to the CDC's ATSDR ALS Registry...

http://alsspreadtheword.blogspot.com/2011/09/whoa-government-is-moving-too-fast.html

It's troubling to see such expensive "feature-itis" growing from a project that needs to be focused on a successful core mission.

NFL ALS Roll Call Grows - September, 2011 Edition

Steve Gleason

Eric Scroggins
O.J. Brigance
Glenn Montgomery
Pete Duranko
Peter Demmerle
Steve Smith
Tony Proudfoot (CFL)
Bob Waters
Matt Hazeltine
Gary Lewis
Orlando Thomas
Wally Hilgenberg
Kevin Turner
Bob Hohn

There are thousands more who have played college football.

This mystery needs to be solved!

p.s. If anyone knows of other NFL players who have been stricken with ALS, please let me know. Thanks.

He Continues To Wow Us

Five years ago Steve Gleason wowed his city and a world of football fans with a blocked punt. Today he wows everyone involved in the fight against ALS with his attitude and courage.

Dan Dierdorf broke the news on the CBS pregame show, and he was visibly moved.

http://www.nola.com/saints/index.ssf/2011/09/new_orleans_saints_cult_hero_s.html

The troubling list of NFL players with ALS grows. In the meantime, we watch Steve Gleason make some remarkable good come from the rotten cards he was dealt.

http://www.team-gleason.com/

When Dealing With ALS, It Pays To Read Things Twice

When I read Tuesdays With Morrie, I found warm messages on values and life. When I read it a second time, I found wisdom that I didn't see the first time. I saw a wise man's path through the ALS journey.

Yesterday there was a beautiful, short biographical piece on Lou Gehrig written by Reinhardt Krause in Investor's Business Daily --

What Put Gehrig First? Quiet Dignity, Iron Will - Investors.com

The first reading reminded me of much that I knew about the remarkable Lou Gehrig. The second reading turned on some lights in my mind on how much Lou Gehrig's life teaches us personally on winning and achieving greatness. The fight against ALS has not yet been won, and "greatness" is not a concept would be associated with our teams fighting ALS today.

Please read the article. If you are involved in the fight against ALS, please read the article twice. The self-help is right under our noses.

We Remember

As we remember the all of the heroes lost ten years ago today, here is a piece that speaks volumes about the American spirit --

HETRICK: Ten years after 9/11, keep doing what you do | 2011-09-10 | Indianapolis Business Journal | IBJ.com

May we achieve the national greatness that we saw in so many individuals ten years ago today. May that greatness include finding a treatment for ALS. We have lost over 60,000 Americans to ALS in the last decade, many of whom served bravely defending our country (and were never counted in our casualties of war) or served us all in public safety roles.

Will People With ALS Get The FDA They Need From This?

Here is some reading about the FDA's latest PDUFA reauthorization proposal. If you're not familiar with PDUFA, google and enjoy the trip on how we have chosen to fund and improve the FDA over the past decades. Here is some overview information on the PDUFA V Technical Agreement.

Below are some organizational perspectives.

National Health Council Announcement

The National Health Council applauds the FDA for agreeing to include in its recommendations three proposals championed by patients: the development of an objective, qualitative benefit-risk framework that includes robust patient input; the advancement of new therapies through the expanded use of biomarkers and patient-reported outcomes in clinical trials; and the creation of regulatory policy, procedures, and guidance to encourage the development of treatments for rare diseases.

All three of these components are necessary for advancing access to desperately needed treatments and cures. To exclude any one of these elements would be to offer a reauthorization package that would not meet the needs of patients – particularly those with few or no treatment options.

ALSA Announcement

Since July 2010, The ALS Association participated in monthly meetings with FDA officials to bring the perspective of people with ALS to the discussion on the reauthorization of PDUFA. Three key provisions advocated by The Association were included in the proposed agreement. They include:

•Developing Treatments for Rare Diseases: Directs FDA to issue regulatory policies and guidance that encourage the development of drugs to treat rare diseases and to include patients as active participants in this process.
•Assessing Risk-Benefit: Instructs the agency to develop an objective and qualitative framework for assessing risk and benefit during the drug review process and to ensure patient involvement. The provision takes into account the fact that people with ALS who have no treatment options and who will die in just two to five years have a much different view of risk and benefit than does someone with a treatable or chronic condition.
•Utilizing Biomarkers in Clinical Trials: The proposal encourages greater use of biomarkers and other markers, or “sign-posts,” to help determine risk and benefit when reviewing new drugs. Biomarkers have the potential to significantly accelerate access to new drugs by helping to determine much sooner whether a treatment works and in which patients.

Comments From A Pharmaceutical Industry Representative

PDUFA is only part of larger FDA reforms needed to improve public health.

____________________

It's not a done deal. There are aspects that are a matter of life and death for people with ALS who are currently without an effective treatment and without a biomarker. It's important that we all pay attention as this proposal moves forward. Mission has not been accomplished.

Also, for ALS, a disease without biomarkers, are we going to slow down trials that might be mixing biomarker theories with efficacy theories? Sure, it would be great to use proven biomarkers in efficacy trials, but ...

Here Are Some Words On Health Activism

...from a health activist.

http://barbarabrenner.net/?p=299

It's terrible that ALS has drafted another, but we're glad for Barbara Brenner's perspective. The fight is perhaps changing for the better very soon.

The plot definitely thickens.

...and Ron Leuty continues to pay attention to how the course of a disease may be changed thanks to enabling technologies...

http://www.bizjournals.com/sanfrancisco/blog/biotech/2011/09/als-lou-gehrig-facebook-twitter-youtube.html

Don't you love it when the plot really thickens?

Patients Are Changing The Same Old Same Old

Organizations are joining the conversation.

Many thanks to Ron Leuty of the San Francisco Business Times for an interesting piece of journalism on patients taking the lead in clinical trial enrollment. Very seldom have we seen so many important perspectives reflected in one article related to ALS.

http://www.bizjournals.com/sanfrancisco/print-edition/2011/09/02/patients-enlist-in-fight-against-als.html

It's definitely worth your time to read!

ALS often steals a person's ability to speak. These patients will not let it silence their voices.