Check this out!!
The EU is pulling FAR ahead of us with this one. The European Medicines Agency (EMA) has decided that trial medications for incurable and untreatable diseases can be fast tracked and approved for use with small populations– IF they’re getting great results. (Such as the success that Ocata has shown with its stem cell based cure for the most common cause of blindness in the developed world. HINT HINT HINT.) That is not happening here.There is no genuine fast track for medications that show that kind of desperately needed promise. The “breakthrough status” that is available for these types of meds is very inadequate.Very few medications have ever been granted this status until Phase III of testing; real promise might be shown much earlier than that. And quite honestly, this situation why I decided to support the Right to Try laws in the U.S. As imperfect as they are (and they do have issues, beyond a doubt) they may provide pressure for the FDA to adopt the same thing that the EMA has now done.
It’s easy to say that adopting the same policies in the U.S. would lead to little regulation, and that is a real concern. But look at what’s happening here. The EU is not somehow throwing out all regulation.In fact, that’s just what they’re avoiding with this decision. Here’s why. If you or a loved one ever have a terminal/disabling disease, reason and logic will go straight to hell. You won’t care what’s regulated or what isn’t. Believe me, you won’t. You’ll do anything at all that might help– and that means you’ll be vulnerable to some really bad choices. People do make those questionable choices right now, and there are more of them available than ever before (illegal stem cell clinics being a good example.) The only way to stop this is to give desperate people other options.
The EU is doing what they need to do in order to accomplish this. We can do it too, and we have to. We can’t play these games with people’s lives anymore here while the rest of the world figures out exactly how to help those who suffer.
I survived the disease, and I now have the only remission on record. But a remission is not a cure. The stem cell drug I need for a real cure is now rapidly moving towards approval in the rest of the world, but in the USA, it—and all other cellular therapies-- are still stuck behind prejudice, ignorance, and lack of funding. Hundreds of millions of desperate patients with incurable diseases need these drugs.
That’s why I’ve gone on to fight for greater public education on stem cell drugs, knowing that our laws must be changed so that all of us can get access to the best treatments instead of our health and our lives being held hostage by special interests.
I’m now a patient advocate whose work on stem cells and patients’ rights has been published in outlets such as the Oregonian. I am a manager at popular science and financial blog www.stemcellinvestor.com and a frequent speaker at many venues across the spectrum, including churches, scientific conferences, and atheist groups, and everything in between. I’m also an advocate for Right to Try laws that would allow access to experimental medication for terminal patients at the state level. Read the entire story in my upcoming book, And the Blind Shall See: A Skeptic Patient Surprised by Faith, Science, Family, and Miracle Cures.
Latest posts by Cathy Danielson (see all)
- A new story about shareholder determination! - January 21, 2016
- The Latest Thoughts on Why Ocata is Being Bought out by Astellas - November 29, 2015
- The Missing Word: Why we don’t have stem cell cures. - November 23, 2015