Tag Archives: FDA buyers’ club

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…
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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, The Whole Story: Part Two

At the end of part one, Tim Caulfield, keynote speaker at the conference, was addressing the problem of illegal stem cell clinics worldwide…

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Tim Caulfield looked up. “So what’s the harm?” he asked.

I wasn’t sure if anyone in the audience was supposed to answer the question, but I did not have a good feeling about whatever was coming next.
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UC-Davis Stem Cell Ethics Conference On Feb 12th

I’m leaving for the conference today, yay! I’m really excited about this one. There are so many important issues in this area with stem cells right now, especially with the Gordie Howe story. So much of the stem cell field is unregulated right now the second you get out of the U.S., and that’s an issue that has to be addressed. Here’s the link to the pdf of the agenda for the day:
Symposium Flyer 2.12.15 (1)

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.