FDA approves new ALS drug
CNN reports that the Federal Drug Administration has approved a new drug to treat amyotrophic lateral sclerosis, or ALS, also known as Lou Gehrig’s disease. The drug, Radicava, also known as edaravone, is the first to be approved since riluzole, which was approved for use in the United States in 1995.
Tests conducted in Japan found that ALS sufferers who received edaravone experienced a smaller decline in their level of daily functioning compared to those who received a placebo. MT Pharma, the maker of edaravone, said the drug slowed the decline of physical function by 33%.
“After learning about the use of edaravone to treat ALS in Japan, we rapidly engaged with the drug developer about filing a marketing application in the United States,” Eric Bastings, the deputy director of the FDA’s neurology products division, said in a statement. “This is the first new treatment approved by the FDA for ALS in many years, and we are pleased that people with ALS will now have an additional option.”
From Fox6;
The CDC estimates that 12,000 to 15,000 people have ALS in the United States. People usually find out they have it between 55 and 75 years of age. On average, sufferers live two to five years after symptoms develop.
ALS is slightly more common in men than women. No one knows what causes the disease, but 5% to 10% of all ALS cases occur within families. People with familial ALS live an average of only one to two years after symptoms appear.
ALS is quickly becoming a veteran issue since the disease is twice as likely to appear in veterans than in the general population, although neurologists can’t explain why. From the ALS Association;
Scientists have yet to find a cause for why America’s military veterans are approximately twice as likely to develop ALS than other segments of our population. The U.S. Department of Veterans Affairs recognizes ALS as a service-connected disease and provides financial and medical support to those with at least 90 continuous days of military service.
Study after study continues to demonstrate this to be true: If you serve in the military, regardless of the branch of service, regardless of whether you served in the Persian Gulf War, Vietnam, Korea, or World War II, and regardless of whether you served during a time of peace or a time of war, you are at a greater risk of dying from ALS than if you had not served in the military.
Factors that might contribute to the increased risk of ALS in veterans include exposure to lead, pesticides or other environmental contacts.
Category: Veteran Health Care
“Other environmental contacts.” Gee, what could be some of the things that GI’s are exposed to that other folks aren’t?
Immunizations? MRE’s? Uniforms?
Lead? Are they talking about bullets or plumbing? Because plenty of cops are exposed to bullets. Is their incidence of ALS higher than the general population?
I dunno, but good that there is another treatment available to those with ALS.
I wonder for how many years hazardous materials were improperly disposed of on military instalations?
I bet it is the level of unmitigated and smelly bullshit all service members have to wade through.
Wow. Vets are twice as likely? I wonder is that true for all branches or whether one branch is contributing more than the others, percentage wise.
Jonn, any time line on when FDA testing will start in the U.S.?
Apparently it’s been approved here.
That is good, I had read in the past that new drugs had 5 or more years of testing before going on the market.
When do you start this treatment? Last week wouldn’t be soon enough.
Pesticides? Nerve agents like Sarin and Soman are just juiced-up pesticides. Who’s to say that our own combat activities didn’t release some of Saddam’s nerve agent stockpiles into the atmosphere?
According to Sean Penn, President Hussein was a good guy and would never think about possessing those kind of weapons as he was too busy handing out lollipops and cute puppies.
My cousin’s wife also has ALS and the medical support that she gets, as a civilian, pales in comparison to what the VA does for me.
Jonn,
Whatever the reason is, I hope we find out. One of Martin’s former bosses named Willy Neal, who was a chemist and then ran the USAREUR aka !0th Med Lab EPA in Landstuhl tried to sound the bells and just a few years ago, someone started paying attention but this was when Willy was a very young man…and we knew him 30 years ago. I’ll see if I saved the article somewhere…I’m thinking that they should check the rates of ALS among the 82nd around Bragg because of that.
I hope this works for you, Jonn.
^^^Word^^^
Good news for you, Jonn.
I wonder what the cost of that drug is in Japan vs the cost in the US?
Not sure about Japan, but heard 120+k a year in US.
When you are dealing with such a tiny percentage n the first place, “twice as likely” is also still quite tiny. This makes the search rather challenging for the “why the difference” leading perhaps to to the “aha!” of a cause and then a cure.
Sometime, when you run the numbers enough, the odd numbers turn out to be “clumping”, essentially “dumb luck”.
On the other hand, sometimes, you find something remarkable.
ALS is neurological. What if “people who think it valuable to serve their country” do so because of a genetic variation in their brains? This might also be the source of increased vulnerability. The military tends to weed out the dummies, either entry-level-rejected or getting them killed by presenting them with hazards. Does ALS track IQ? ASVAB? Does the survival rate also track IQ/ASVAB/other? Do either track baldness? Color perception? preferred adult beverage? Use of floor buffers and Johnsons Paste Wax? (Not to make light of ALS. Sometimes you have to look in odd places for answers.)
Statistics can show some werideness. Correleation is not causation, but sometimes you find a pattern previously overlooked, and a key clue.
Stay strong.
Good news.
Jonn, I hope you get this drug soon? I will be praying for you!
Does anyone now how long it will take the VA National Formulary to approve this Radicava drug? I called my VA clinic today and they told me even though the FDA has approved the new ALS drug the VA will not prescribe it until the National Formulary approves.