Watching a ‘circus act’ out on the deck. The pups are now able to hit the top of the picnic table from a stand. Yesterday they got a bunch of bananas off the counter. Fought over them and rolled on them. On the living room rug. If nothing else they get points for unique and creative.
As with everything, the pups’ exploits bring mixed reactions. Some of you are laughing. Others are appalled.
The ‘big news’ of the week is making a lot of people pretty excited and happy. I imagine you heard Pete Coffey, of the London Project and University of California – Santa Barbara, is saying he will make stem cell treatments readily available to all comers in five years. He is reporting utterly amazing results for a phase 1 stem cell experiment. [Lin/Linda here: to see the list of articles from various sources, click here.]
Whoa! Hold on for a minute! Unfortunate I must take the loyal opposition stance on this one! I am – to understate things – a tad skeptical. There are problems here.
Lin has her ways of getting things. She has a pretty good network of spies and other secret agents. One of her spies shared the published article with us. I have not read it all yet, as a matter of fact, I have barely started it – things are just not calming down around here – but some stuff I did see made me concerned.
Let us start with the timelines they lay out. This research was done in the summer of 2015 but we are just hearing about it now. Where have they been for the past two and a half years?!?!?! If this stuff is so hot, they should have been shouting it from the rooftops a lot earlier than now.
Even more suspicious? The submission date for publication was November, 2016 but the acceptance date was February, 2018! Anyone who has written a thesis or a dissertation knows what that year and a half lapse represents: a whole pot load of rewrites! What was wrong with the original work? Inquiring minds and all that.
There are other things that are wrong, wrong, wrong. Now, I applaud Douglas and the second person who wishes to remain anonymous. I really do and I will come back to why in a second. But seriously, how often can you be on a first name basis with half of a subject pool? There were two people in this study! The FDA suggests 20 to 100 people is the appropriate number of subjects for a phase 1 study. What happened to the other 18 people? This study sounds likes it is providing more anecdotal information than research findings.
And why do I applaud Douglas and the other person? They had enough guts to participate in phase 1 research. Phase 1 research is safety and tolerability, folks. They are looking for weird reactions like growing hair out of your eyeballs or having your head spin around. ( OK, so I am a little fanciful. You still get the idea.) This is not the proof of concept phase.
The Food and Drug Administration (FDA) gives an estimate of six to eleven years to get a medication or treatment through phases 1, 2 and 3. Coffey is saying he will have his treatment on the proverbial shelves in five years. Now granted, he is talking about availability in the United Kingdom, but I assume they also have a cautious regulatory agency working there. How does this get shelf ready in five years?
And these are just questions I have off the top of my head!
My emotional self would love to believe this is happening. My rational self is very skeptical. My advice would be to stay hopeful but also remain skeptical. Like puppies mashing bananas into my carpet, this study may create some positive emotions but I think there is still something wrong with the picture.
Lin/Linda here: I’ve created a page with some other concerns that we have: Considerations in Evaluating Recent Stem Cell Clinical Trial in the UK
Written March 19th, 2018