Tag Archives: investigational drugs

UC-Davis Stem Cell Ethics Conference, Part 4

So here it is, y’all– the fourth installment! This is the LAST “notes from raw slides” section, SO please keep hanging in there… because this is important. Reading these notes may not the most entertaining activity on earth; believe me, I know. (I had to transcribe them from horrible blurry pics!) But there’s a lot to be gleaned here. If you’ve ever wondered how a drug goes from concept to market, this is one you want to read. (Just go down to Slide 9.)

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UC-Davis Stem Cell Ethics Conference, Part 3

At the end of Part 2, the opening night of the conference had just ended. We pick up the next day with the main speakers. More secrets of illegal stem clinics are revealed…

At the main conference the next day, I searched through tired-looking pastries on the side table, keeping a close eye on the other attendees. Virtually everyone seemed to be an academic. Paul Knoepfler was like an adorable teddy bear, huggable and self-effacing, all but blushing when I asked for a picture and an autograph.

There was the bouncy-ball-man again. He was leaning forward and talking loudly to a woman whose name tag proclaimed she was Alison Sorkin, a UC-Davis professor of bioscience. I tried to read his name tag, but he was turned away from me. He certainly did sound enthusiastic. A tall man leaned partly against a pillar, listening with a faint smile on his face, the corners of his eyes gently creased. I guessed his age at around sixty-five; he had the healthy, fit look of a man who had spent his life doing rigorous physical work. But his eyes were very sad. A woman stood listening to them all, a few feet away, her dark hair cut in a pixie shape around her soft face. Her hands nervously plucked at each other, and she seemed to be taking a series of short deep breaths, as if building a sentence that never quite got all the way to her lips. I wondered who all of them were. The identity of the woman mystified me just as much as the bouncy-ball man. I would be willing to bet that she wasn’t an academic either.

We all took our seats (and very uncomfortable ones they were, too,) and the presentations began.
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The UC-Davis Stem Cell Ethics Conference, Part One

So… I’ve been promising to post material from the Feb 12th conference for a while, and here it FINALLY is! I’ve been moving to a new house… and I didn’t have net access for weeks and weeks… and the dog ate my homework… and, okay; enough already. I think I’ve been trying to fit these notes into literary form, because they will become an important aspect of the book. But it’s more important to get them out there for people to read. So… keeping in mind that these are fairly rough… here’s Part One!

The scene opens on February 11, at Tim Caulfield’s introductory talk…
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UC Davis 2nd Annual Stem Cell Ethics Symposium: Feb 12th.

Now that the holidays are finally over, I’m really getting some of these stem cell activities in motion. Yay! That includes a wonderful opportunity to go to UC-Davis for this Feb 12th event. They might still have some spaces left, so if anyone reading this is within any reasonable drive of Davis, I URGE you to check out Paul Knoepfler’s post on the subject. Here’s the piece on his blog, and that’s how I found out about it. What it makes this so exciting is that they’re apparently going to be talking about some REAL, GENUINE ethical issues. To wit… what on earth are we going to do about all of those stem cell clinics popping up in various and assorted countries? You know, the ones with the weird, dubious, expensive treatments that the FDA would never approve in a gazillion years? And while we’re on the subject, when is the FDA going to do anything about regulating, say, $10,000 stem cell creams? And what about those “Right to Try” laws? They passed in four states in November, but what is the federal government going to do, if anything? What should they do?

Anyway… it looks like it’s going to be an amazing seminar, and I’ll come back with lots and lots and lots of notes!! 🙂

The State of Alzheimer’s Research

So I just finished Dancing With a Stranger, by Meryl Comer, and… it’s not exactly the feel-good book of the year. She is a caregiver for BOTH her husband AND her mother, and both have Alzheimer’s. Oh, yeah– and she has both of the genes associated with the disease. Just the fact that some people are able to keep going in the face of unbearable problems is hard to believe.

I’ve been looking into the current state of stem cell based AD trials, and here’s what I’ve found out. As of December 2014, there’s not a lot going on at the clinical level right now. There’s one trial in South Korea using cord blood-derived cells, but even though they completed the preliminary outpoint in 2012, there does not seem to have been any information released on what the outcome was, which isn’t very encouraging to me. Dr. Lanza’s article about preliminary interim results in Ocata’s RPE trials for AMD was released months into the study. So, for it to be fully two years after the completion of Phase I, and still nothing… not that great. Another study in China is now recruiting, but I’m not sure how much better that one looks.

There are a few meds in development that look promising… but the problem with drug trials is that there’s a long history of meds looking great for AD until they’re actually released, and then they turn out to not accomplish much of anything over the long term. I’ve seen a couple of drugs really help people in the early stages, but only for about one year (Aricept and Namenda are good examples.)

The most promising thing I’ve seen, IMHO, is Neuralstem’s animal studies on Alzheimer’s. They released results in October, and the conclusion is that their cells “rescued spatial learning and memory deficits in mice with an animal model of Alzheimer’s disease.” The problem obviously is that we’re only talking about mice at this point, and there is, unfortunately, a history of stem cell treatments looking wonderful in mice and then not translating to humans. Still, if I had more money, I would definitely invest in this company!

So that’s pretty much the AD story for now!

Incredible News About Stargardt’s Cure

So, I was posting a summary for my book on the NaNoWriMo Facebook page, thinking that it sounded over the top… stem cell-based cures for horrible incurable diseases within 2-10 years, that kind of thing… well….

There’s no link for this, because it is insider info from shareholders who went to Ocata’s quarterly meeting in Boston, which was not open to the public. (There is a LOT about Ocata in the book– they’re the biotech company that just changed their name from Advanced Cell Technology.) Ocata is the company developing the first cure (or even treatment!) for age-related macular degeneration, a disease that slowly causes blindness for 30 million people in the U.S. and Europe alone. The interim published results for the clinical trials have looked great, but as far as when this treatment might actually come to market… it’s everybody’s guess.

But in the quarterly meeting… several attendees have all said the same thing. The drug already has orphan treatment approval for a genetic disease caused Stargardt’s, which has exactly the same effects and eventually causes blindness. But it attacks much younger people, including children as young as six. (Yep, six years old.) AND… the CEO of Ocata said that the drug will be available in the U.K. in 2018. We don’t have absolute confirmation of this yet. But it’s apparently what was officially said at that meeting.

One of the lines of thought on the forums is that the date might be earlier for AMD approval in the U.S, even quite a bit earlier if the drug is fast tracked here… we just don’t know. But this is INCREDIBLE!!!~ There has never ever been any kind of treatment for Stargardt’s before, and now there will be, and it will be STEM CELL BASED. As of now, that will be the first drug approved anywhere in the WORLD that is embryonic stem cell based.

YES! IT’S THE START OF A NEW ERA IN MEDICINE!!! And it will be in the book!
(sorry about the capslock…

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.