This is Part 2 of my interview with ALS and stem cell advocate, Ted Harada.
You can read Part 1 of my talk with Ted on where things stand today with ALS, the FDA, and the Ice Bucket Challenge.
What’s your opinion of the “Right To Try” law in Colorado and the concept more generally? It seems to have the potential to speed innovation, but also put patients at risk. How will this be balanced out?
Ted: I am a strong advocate for Right To Try. I even wrote an Op – Ed that ran in the Atlanta newspaper in support of it. Even when we declared our independence as a nation it was written that people have the right to life, liberty and the pursuit of happiness. So what I see the Right To Try doing in addition to speeding up innovation is giving terminally ill patients the right to try and keep living. As I stated in my Op-Ed I appreciate that the FDA is the Gold standard of drug safety, however perhaps if you are out of options you are willing to settle for the silver standard. It can take 10 – 15 years and sometimes nearly a billion dollars to complete a drug trial. Those dying do not have the luxury of waiting that time.
As far as patient risk with Right To Try the law stipulates that the patient has to have informed consent just as if you were involved in a trial. Plus I believe that the monolithic and paternalistic approach taken by the FDA actually pushes patients into taking even greater risks such as the stem-cell tourism that I referred to earlier. Another important safe guard of Right-To-Try is that the treatment has to have completed an FDA phase I portion of a trial and been approved for phase II which means in the small sample size of the first phase it showed it was safe. This is a much higher standard of safety then many patients have afforded to them when they take risks on untested treatments overseas.
One other thing I would like to point out is that it is not called the right to a cure. It is called the right to try it. It is not a promise that it will help you but if you are interested and have a Doctors and Bio or Drug companies support you have the Right To Try.
Perhaps ultimately this law may push the FDA to update the regulatory practices they themselves referred to as outdated.
What’s your view of how NeuralStem is doing? Are there other companies out there that you support and/or are excited about related to ALS?
I obviously am very partial to what Neuralstem is doing. I find them to be a very unique organization that while they understand their fiduciary obligations to their investors they want to balance that by also doing what is best for patients. Richard Garr the CEO has taken the ice bucket challenge and attends and personally donates to ALS charities. He attends the MDA night of Hope Gala, he flew to Atlanta last year and participated in my walk to defeat ALS team “Tread for Ted” in addition to donating. Their Chief Scientific Officer Dr. Karl Johe attends every surgery and sits in the waiting room during the 5 hour surgery until he knows the procedure was completed safely. It is a very different type of company. I believe they truly want to make a difference. I know Brainstorm a company from Israel has shown some preliminary positive results using a patient’s own bone marrow stem cells in an ALS trial and will be starting a trial here in the U.S. soon. That seems to hold some promise. I also know that Biogen, Knopf and Sanofi have all invested significant capital into ALS research. I am sure there are others I am forgetting.
How are you doing? (if you don’t mind me asking)
Honestly I am doing very well. I have received the stem cells twice and both times it helped me. I still have ALS but my situation is very stable as of now. This is why I am so passionate about being the best advocate possible for the ALS community. I am inspired by all of the people that are living with ALS and their caregivers I want everyone to have the same opportunity that I have had. To whom much is given, much is expected. As long as I can I will fight for the ALS community. Here is the link to my Op – Ed http://www.myajc.com/news/news/opinion/afflicted-have-the-right-to-try/nfrq2/#ba9fdfe9.3836379.735460.
My thanks to Ted Harada for all his efforts and doing this interview.