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.

Tuesday, March 8, 2022

Mislead or Lead

 Dear. CDC and ATSDR,  

You can lead or you can choose to continue to mislead.  The choice is yours.

ALS Prevalence and Incidence in the US

Option 1: Mislead. 

This is unfortunately the path you have chosen.

We sporadically get prevalence reports based on the people with ALS you find rather than the population of people with ALS in the US.  You do not have a population-based registry, yet you issue reports with demographics as if you do.

There are some important examples of how misleading you have been in the past few months --

Dr. Walter Koroshetz, the head of NINDS at NIH, testified the following to Congress in July, 2021:

"Neurodegenerative disorders also include rare but devastating conditions like ALS, a rapidly progressive, fatal disease that affects the nerve cells controlling voluntary movement. The CDC estimates that 12,00015,000 Americans have ALS, and approximately 5,000 Americans are newly diagnosed with ALS each year."

You misled one of the top neurologists in the country, and as a result you misled the Congress.

News outlets also turn to the CDC as a trusted source.

"Amyotrophic Lateral Sclerosis (ALS) affects between 12,000 to 15,000 people across the U.S., according to the CDC."

"More than 16,000 people in the United States were estimated in 2015 to have ALS..."

More than 16,000, indeed.  Way more.

And there is the draft scoping document that ICER produced for their study on pricing related to two anticipated FDA product approvals.  ICER is in the numbers business and turned to the CDC for a very basic number.

"There are about 16,500 people living with ALS in the United States, with a prevalence of 5 to 6 per 100,000 persons."

ALSA issued comments related to this draft but failed to mention the understatement of prevalence of ALS by the CDC.  ALSA is a "partner" (another misleading word since ALSA is actually a paid contractor on the project) and for some reason decided to be misleading, too, by ignoring the problem.  Thank heavens ICER did correct the data based on an individual pointing out the incompleteness. of the CDC's data.

Option 2: Lead

Stop publishing prevalence (and now incidence) reports as if your data are complete.  Be clear that this is a sample of the people you found and you don't know what you don't know.  The people you didn't find don't necessarily look like the people you found.  And based on a past analysis, you miss almost as many people with ALS as you find.  Be clear.  Give us details that are actually meaningful such as how many people self-enroll, how many are in the Medicare files, etc.  And please publish data. simply and promptly.   Leaders understand the importance of meeting due dates.

Clinical Trial Notification

Option 1: Mislead

Again, this is the path you have chosen.

People are encouraged to sign up for clinical trial notification and they infer that you will let them know of trials.  They do not understand that you will inform them of a tiny fraction of enrolling interventional trials.  They sit back, relax, and wait for the magic email from the CDC  telling them of the right trial while their eligibility windows evaporate.  

And your matching capabilities are limited.  The fact that dead people can receive trial notifications is a testament to that problem.

Option 2: Lead

Stop using 1980 email tactics.  You have access to a list of all enrolling interventional trials via  Work with your "partners" to design trial notification that is more effective and less onerous than yours.  The best way may not involve you at all.  That's fine.  We need what is best for those with ALS and sponsors.


In an attempt to constantly celebrate success of the project, it has been easy for you to mislead.  Please stop. 

The CDC and ATSDR should lead, and that means being honest and. clear about what we have and what we need to do.  

Please lead.

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