Check this out!!
The EU agrees to fast track desperately needed meds.
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.
Posted in Laws and Politics, Right to Try
Tagged cures, EU, European Medicines Agency, European Union, incurable, miracles, ocata, patients rights, right to try, stem cells
Hey all, so here’s the archived public hearing in the Oregon Senate on Right to Try, HB 2300! Check it out.
Link to the public hearing on June 1st.
So what’s going on right now? With just a little more digging, I found out. HB 2300 is in a senate committee, and there will be another hearing on Wednesday, June 3rd, at 3:00. Let’s keep our fingers crossed!
Here’s where you can go to track the progress of the Oregon bill.
Okay, so let’s put this issue in context. I am not an atheist.(Although my sister is– hi, Chris!) But the actions of religious groups related to Right to Try laws are becoming really disturbing, and quite honestly, hypocritical as could be. Hypocrisy has got to be my least favorite quality, and the Florida Council of Bishops is putting on a big display of that quality right now.
On one hand, they’re demanding that “good Catholic business people who can’t in good conscience cooperate with this” shouldn’t have to provide contraception coverage for employees under federal law. (See? Right here. Catholic Bishops Demand All Businesses Be Given The Right To Deny Women Contraception Coverage
BUT all that concern about individual rights was trashed when it came to Florida’s Right to Try law last month.Basically, here’s what happened:
The Florida Conference of Catholic Bishops and Florida Right to Life now oppose the Senate version of the “Right to Try Act” (SB 1052) because Sen. Jeff Brandes, R-St. Petersburg, the bill sponsor, has added a provision dealing with end-of-life decisions by the patients.
The groups are specifically questioning an amendment that would let Florida join more than two dozen states that allow frail or terminally ill patients to arrange for a “physician order for life-sustaining treatment” (POLST), which outlines specific end-of-life procedures. For instance, the POLST — which is an arrangement between the patient and his or her physician — could determine whether the patient would receive tube feedings or would opt for medical care for “comfort only” rather than more intensive treatments.
So what does this really mean? They’re willing to keep terminal patients from the right to try experimental drugs so that they can keep people from the right to end their own lives. Whatever happened to ALL that concern about civil liberties they had for business owners???
See what I mean about the hypocrisy?
So Paul Knoepfler has an excellent article on his take on Right to Try on his blog (find it right here.) I think that it’s balanced in a lot of ways, and yet I do have to say that I think there are more issues that need to be take into account. There’s a piece of advice that I’ve seen floating around the web for quite a while: if you write something online that you feel is significant, make sure that it’s preserved in a more permanent way than on Facebook, as a comment on someone else’s post, etc etc etc. That’s what I’ve done here. 🙂 So… here’s my comment on Paul Knoepfler’s post on Right to Try issues.
So if you read the Oregonian, by any chance, you really should look in the op-ed section today… because my article is there! 🙂 It’s also online at this link:
Oregon Needs a Right to Try Law
I’m so grateful to the Oregonian for printing this!! Of course, that having been said, it was PAINFUL to have to keep that piece to 500 words. There was SO, so much that I had to leave out– the gap between patients and experts, the crucial role of patients’ anger and sadness and frustration, the specific criticisms against Right to Try laws, their limitations and strengths, the entire history of Right to Try, many more details about exactly how the law is making it through the states and what might happen next, and so on and on and on and on!! Well, there will be more articles, believe me. 😉 For now, check this one out!
Here it is, and you don’t want to miss this one! The ending just might be my favorite bit so far.
In the brief break between speakers, I quickly looked over my notes about ALS. 8 out of 100,000 people were affected. There were many different phenotypes, some sporadic; some genetic; some caused by God only knew what. Even when ALS was familial, the specific genes involved were very difficult to pin down. Abnormal ones could occasionally be successfully targeted with success, but that was rare. There had been 160 treatment trials in the past 5 years, and out of those, only one effective drug had emerged, which was Riluzole.. And “effective” was a relative word in that case, to say the least.
At the end of Part Six, we were finally about to learn the identity of the mystery man who’d spoken up at Tim Caulfield’s lecture the night before… and in Part Seven, we finally do…
So… we’re done with the raw notes for now, and we’re back to the writing! Believe me, you do NOT want to miss the info in today’s installment. If you’ve ever wondered whether or not you should keep your investments in a certain biotech company, for instance… the answer’s here. Enjoy!
Posted in Stem cell ethics
Tagged adult stem cells, Alison Sorkin, cure for blindness, embryonic stem cells, induced pluripotent stem cells, ipsc, japan, nanette joyce, ocata, paul knoepfler, right to try, takahashi, uc davis, yamanaka