Category Archives: Laws and Politics

The Latest Thoughts on Why Ocata is Being Bought out by Astellas

A snippet from Part 4 of Light a Candle: (warning: narrative excellence not guaranteed):

How exactly had this happened? Where had everything gone wrong, and why? We were all groping the dark for answers. I knew better than most people that it had almost certainly not happened because of problems with the science. I still winced when remembering the endless odysseys to the OHSU library, wheedling my way in to do forbidden research—or at least research that it was forbidden to do in any more convenient way if you’re weren’t either a student or a professor. It also didn’t really explain anything to say that Astellas had been willing to do the JV and then leaped on the opportunity to take over the company outright. Who wouldn’t have done that? Why were they able to do it? That was the real question, and the key.

Pentecostal protestors weren’t marching with pickets around Pfizer. The top corporate officers at Janssen Pharmaceuticals weren’t raving evangelicals. Death threats weren’t being sent to the entire board of directors at GM. Nothing immediate was happening, and perhaps it would be better if it were. The obvious and immediate threat could be confronted and fought. But the sneaky sludge clogging the gears had been building up for many years. In brief? The long-term situation created by “religious” protests had led to the current reality, which was that Ocata’s perceived worth was a fraction of its real one. The market ran on fear, uncertainty, and doubt. Logic often had little to do with value that was perceived. Ocata did not have current cures that were commercially available. People couldn’t take their blind grandmas to the retinal specialist and bring them back crying, “I can see again!” Embryonic stem cell research was buried under layers and layers and layers of smothering superstition, fear, and a strange hatred. So direct experience was all that would convince the average person. And it was still years away from happening.

Except that in Japan, it wouldn’t be. That culture simply didn’t care; they were untroubled by the shibboleths. They knew that saving people’s lives, adults’ lives, children’s lives, was more important than hysterically clinging to some insane illusion about the value of a blastocyst that would otherwise have been thrown into a dumpster behind a fertility clinic.

Another rant was definitely shaping up. I rubbed my nose.

News From Europe!:)

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.

Right to Try: The Oregonian Article Is Out!

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!

Arizona Passed “Right to Try”

So… as everyone may have heard, Arizona voters just passed Proposition 303, the “Right to Try Law.” This event didn’t get anywhere near the media press that it should have (I didn’t read anything about it until today, in a Vancouver B.C. paper.) Here’s a good summary:

The measure will allow investigational drugs, biological products or devices to be made available to eligible terminally ill patients. The term “investigational” refers to medical treatments that have completed phase one of a clinical trial but have not yet been approved for general use by the Food and Drug Administration and remain under investigation in clinical trials.

I don’t know. I’m afraid that this is one of those things that sounds better than it is… one of the main problems being that it doesn’t do anything at all towards helping patients and their families to actually afford these drugs. Insurance companies do NOT need to cover them, which really, really bothers me. And there are a lot of companies who I wouldn’t trust a zillionth as far as I could throw them with an anvil tied on when it comes to this issue.

But… four states have already approved the same kind of referendums (Colorado, Louisiana, Missouri and Michigan.) The Colorado initiative was a lot better known, and the interesting thing is that biotech company Neuralstem has been a big player. The irony is that they’re one of the very few companies I would halfway trust to do a decent job with this, and yet I think they’re clearly participating in the process of opening the door to that slippery slope– remember that anvil-tied-on thing?

Overall, another issue, of course, is that these are state laws, and they’re going to be superceded by federal law when it comes to what the FDA will and won’t do. So that may sink the whole project. And then there’s the fact that only terminal illnesses will be covered. What about AMD? What about diseases that steal all quality of life and yet aren’t strictly “terminal?” Why not cover those too, if any are going to come in under the law at all?

I think the final message is that these “right to try” laws represent an idea that is something to watch. I can see both good and bad here. And hopefully, the bad won’t predominate. YMMV.