WASHINGTON — For Frank Mongiello, Jan. 30, 2018 was a day of hope. After dedicating the last few years of his life to the “right-to-try” movement, an effort to get dying patients access to experimental treatments, Mongiello heard President Trump use his first-ever State of the Union address to urge Congress to pass a federal law on the issue.
Just one year later, the law is in place. But Frank, who suffers from ALS — and for whom the national law is even named — still hasn’t gotten access to treatment.
“We had a lot of hope that if the right to try was passed it would give an incentive for the drug companies to make available the drugs. But now it doesn’t seem as though the drug companies are giving away their drugs either,” Marilyn Mongiello, Frank’s wife, told STAT. She speaks for him in interviews because he is only able to communicate via technology that turns his eye movements into text. In a brief email exchange, Frank confirmed to STAT that he has not found treatment but that he remains optimistic, despite his worsening condition.
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ALS is caused by a bacterial infection Borrelia and at times other co-infections. It is a treatable disease. http://www.winningthefight.org
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My son Frank P Mongiello was one of the original signers of The Right to Try. No pharmaceutical company expressed any interest in helping him although he has rapid progression als. So sad. I guess it’s who you know or how much money you can donate. There are thousands in the als community hanging between life and death waiting for cure. Why can’t they be a part of clinical trials? Thru all my readings American pharmaceutical companies are governed by GREED. They’re looking at the easy fix. Erectile dysfunction, sick dick is more important than saving someone’s life with als. American pharmaceutical companies lack the intelligence to find cures for complicated diseases. See the research going on in other countries. It’s no wonder why Americans are leaving their own country to go to a foreign country to receive treatment for their illnesses. Shame, shame American pharmaceutical companies and our outdated FDA.
Update: Mike Cimbura has passed away. Matt Bellina remains the only person with ALS granted treatment by BrainStorm under Right To Try; he being granted a chance at longer life because of his personal connection with the CEO.
So the CEO of brainstorm gets to choose who lives or dies?? Great system./
As I said below , RTT helped bring attention to the small, slow, broken ” Compassionate ” Use access to pre- approval drugs. RTT helped reform the FDA . We patient activists have always known that Pharma is a big part of the lack of access and needs reform . Some of the co.’s get it , most do not. Their lobbyists gutted the Andrea Sloan Compassionate Use Act a few yrs. ago. But our pressure is not going away – the 21st century drugs are getting better and better . Just like Nick Auden’s family questioned why he couldn’t get a breakthrough drug like Keytruda ( ” Save Locky’s Dad ” ) and Andrea Sloan’s family asked for Olaparib, now ALS pt.’s are speaking up . Pharma needs to step up and do the right thing morally. They are not making gadgets , they stepped into the field to produce life – saving drugs. I have met many top FDA and Pharma execs . They are not bad people – their geeks are making amazing drugs like no where else in the world. Back in 2010 when the FDA denied my wife a chance at Kadcyla , I was enraged . Couldn’t sleep . I realized that it wasn’t personal , they didn’t even know my wife. It was IMPERSONAL to them . I got many to know my wife and put a personal stamp on it. By the way , my wife , dx. stage iv at dx. in 2006, who should have died in 2011, today is cancer free since 2011, on no tx. Thousands of others could have lived from her drug alone, our friends Jay, Ann, Tracy’s mom … we speak for them .
I tried to get a prostate cancer vaccine during phase 3 trials under Expanded access, also called “compassionate use,” before this law passed and the vaccine manufacturer refused to release any. Can they still refuse to supply under the new U.S. law? Pricing not yet decided on; the President of the company (based in the EU) was initially saying his goal was to be under 30 Euros. They do research in California.
Manufacturers aren’t obligated to supply drug, but they can if they are so inclined. Unfortunately, many will fear that the FDA won’t look kindly on them working directly with patients and fear regulatory retaliation. I worked in the industry for two decades and so am very aware of these fears, real or imagined. A similar initiative, called Free to Choose Medicine, is being promoted by the Heartland Foundation and establishes a parallel track of development separate from FDA oversight once a drug has met certain safety considerations. A version of it is being used in Japan. You can learn more about it at https://www.heartland.org/search-results.html?q=free+to+choose+medicine.
als the ” I’m sorry ” disease. For to long people were told to get their things in order. Than people began to take control of their lives and fight for a cure. Unlike the past people opt for feeding tubes, trachs and ventilators. Their fighting to stay alive. Well why shouldn’t they? It’s not a old man’s disease as it was considered many years ago. People in their 20’s thru their 50’s are getting the disease and now young children are being diagnosed with als. It’s downright shameful and unAmerican that big Pharma has control over life and death. It’s shameful to see a big Pharma CEO make $22,000,000. Have they lost all compassion for another human being? Wait til it happens to them or one of their family members. I can tell you it’s heartbreaking to watch your child decline as the disease progresses. Please don’t let my son Frankie and all those who fought tiredlessly to get THE RIGHT to TRY passed go in vane. My sincere gratitude to Dr. Daniela Bota for her willingness to step out of the box to advocate for her patients to get possibly a life saving treatment. I wish more doctors had her spirit to advocate for their patients. Sincerely, Frankie’s mom, Carol. P.S. the debate over THE RIGHT to TRY is over. IT’S A LAW!
ALS is caused by a bacterial infection, Borrelia and at times co-infections and is a curable disease. go to http://www.winningthefight.org.
For the past 10 years I have been receiving reports from ALS patients who have had stem cell treatments all over the world. They get better but then their disease progresses b/c the Borrelia attacks the new cells also.
We are also finding that other neurodegenerative diseases are testing positive for infections usually the genus Borrelia but other infections also related to periodontal disease in AD. http://advances.sciencemag.org/content/5/1/eaau3333
Commercial labs do not have the necessary antigens to test for these diseases.
There are many clinical trials now underway to treat ND but they will ultimately fail b/c they fail to treat the underlying cause, bacterial infection.
This is a travesty b/c it will establish a false result dooming stem cell therapy in these cases.
Nicholas,
How much is the high cost of these treatments, like the $300,000 for NurOwn, hampering RTT and, possibly, the FDA’s expedited pathway? Is having a “right to try” moot if the cost is prohibitive and insurance won’t cover it? That’s what I got out of BrainStorm’s statement. What are your thoughts?
My wife was the first patient to testify for RTT . Lorraine Heidke McCartin . Before any als Pts had taken up the cause . She was denied a chance at a cure by the activist FDA of pres obamas 1 st term . They denied early approval for kadcyla , shocking the research medical community . Not the only obstruction of that time . See wsj ” FDA flexes its regulatory muscles ” 2011. She got her drug by traveling 450 miles each way from Boston to DC to get one of the few slots in expanded access . RTT brought light to the FDA’s paperwork delays and power with adverse effects data etc. RTT. RTT changed the FDA. Today they are more patient friendly. And flexible . Some companies are opening up more preapproval access . Janssen with myeloma drug Pfizer with Ibrance and more companies . There is much more work to be done with the companies . They can allot much more $ to early access while the FDA must remain flexible and all must listen to us the patient in the fire