Today, Derek on "changing the goalposts" by fixing the "endpoints"!!

fuelair

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Today, Derek on "changing the goalposts" by fixing the "endpoints"!!

So, as noted (actually yesterday), Derek writes rightly on the fun topic of changing the endpoint(s) expected of the drug you are testing on real people - not to fool real medical people or the FDA, but to mislead investors on how the trials are going and help them to decide to pony up more fundage. This is some popular, but some less than ethical. Anyway, both Derek and his commenters enlighten us on this completely expected and unethical move on behalf of a new drug In the Pipeline!! Here's the site: http://pipeline.corante.com/archives/2014/11/19/wait_we_didnt_tell_you_about_that_endpoint.php
 
What with this being the science section and what with Derek being a real chemist and having a blog a rather large number of real chemists (and many in other fields) like to read and comment in - I pass on some of his items (especially where related well to science some here might be interested in). As to questions of who he is beyond that, the site provides that info also. Oddly, prior to very recently no one seemed concerned beyond what info was being provided. Hope this helps!!!!:D:D:D:D
 
fuelair said:
What with this being the science section and what with Derek being a real chemist and having a blog a rather large number of real chemists (and many in other fields) like to read and comment in - I pass on some of his items (especially where related well to science some here might be interested in). As to questions of who he is beyond that, the site provides that info also. Oddly, prior to very recently no one seemed concerned beyond what info was being provided. Hope this helps!!!!:D:D:D:D
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Then make a single "what Derek thinks" thread. What with this not being a blog, we don't need a new thread for every thought that crosses his mind.
 
Beelzebuddy said:
Then make a single "what Derek thinks" thread. What with this not being a blog, we don't need a new thread for every thought that crosses his mind.
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Oh, trust me, this is not nearly that - this is the specific stuff there have been threads on (or related to) or stuff that is purely new - and if the search function worked way better/faster than it does I would just add these to those - but, the search function has been crap as long as I have been posting here. And I say that as my librarian part, not my science part.:jaw-dropp:(:eek:
 
Note: crap is here defined as claiming a single or two word search term/phrase is too common, not found and others (but those two are the most often that appear). Which would be fine if they were not/not one of the search terms used when the OP was entered .

Besides which - and with no offense - you are not required to go to any of these - I post them for those who might be interested - as generally that is how I pick threads to go to. The titles doe not mislead on the topics of the post. Thus, I am not sure what the actual problem is.?????
 
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fuelair said:
Oh, trust me, this is not nearly that - this is the specific stuff there have been threads on (or related to) or stuff that is purely new - and if the search function worked way better/faster than it does I would just add these to those - but, the search function has been crap as long as I have been posting here. And I say that as my librarian part, not my science part.:jaw-dropp:(:eek:
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Perhaps part of the issue is that the first post in the thread doesn't seem like a first post. Rather than explain the topic, it appears to refer to things elsewhere. I was very confused when I saw it.
 
BowlOfRed said:
Perhaps part of the issue is that the first post in the thread doesn't seem like a first post. Rather than explain the topic, it appears to refer to things elsewhere. I was very confused when I saw it.
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To clarify (and the people likely to be interested would be likely to recognize the endpoints thing). Endpoints (and Derek explains it in context better ) are things you are checking off by testing on real volunteer patients. The endpoints are supposed to be set for a certain success percent in the group of patients - if this is met the FDA and investors are happy and lay approval and money on you. If the endpoints do not behave positively (not as many patients are helped/more patients suffer harmful effects) the FDA and investors view you with approbation and investors remove you from their accounts. Knowing that, some companies have been known to substitute in their reports (NOT the ones that go to the FDA!!!) changed endpoints with good looking values to fool the investors. The new endpoints would not fool the FDA as the company has to have notified them what endpoints they were looking for for any FDA approval in their initial request and require FDA approval for any changes on the material sent to the FDA, but the stuff they send investors does not require endpoints or related.
 
BowlOfRed said:
Perhaps part of the issue is that the first post in the thread doesn't seem like a first post. Rather than explain the topic, it appears to refer to things elsewhere. I was very confused when I saw it.
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My writing style (you may have noticed) is kind of free flowing - I type much slower than I think and it often shows. But what it meant was : I saw this post of Derek's today but he actually posted it yesterday. It is about goalpost moving in the industry done by changing the endpoints to trick more money from investors by making them think the tests are going well!!.
 
fuelair said:
My writing style (you may have noticed) is kind of free flowing - I type much slower than I think and it often shows. But what it meant was : I saw this post of Derek's today but he actually posted it yesterday. It is about goalpost moving in the industry done by changing the endpoints to trick more money from investors by making them think the tests are going well!!.
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Is the company telling investors that the endpoints they see are the same ones the company estimated to the FDA?
 
theprestige said:
Is the company telling investors that the endpoints they see are the same ones the company estimated to the FDA?
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No. That's the point. They are just claiming endpoints - none of which are the one's they gave the FDA.

Note the claimed endpoints are not incorrect numbers - but they are not the proper endpoints the FDA got - they were pulled truthfully out of the data but the implication is the work was successful when, for the important endpoints it was not. Technically what they are doing is misrepresentation. It would only be illegal and transforming for them if they misreported to the FDA.
 
Your op title falsely assumes a fairly high level of familiarity with 'Derek' while appearing to assign some apparent baseless level of authority to this 'Derek' at the same time.

Most if not all woo thinking is also free flowing, although there, volatile thinking would perhaps be a better descriptor.

Best not to assume familiarity :)
 
"In the pipeline" is a good blog - I recommend googling "Sand won't save you this time" for an example of his writing style...
 
fuelair said:
No. That's the point. They are just claiming endpoints - none of which are the one's they gave the FDA.

Note the claimed endpoints are not incorrect numbers - but they are not the proper endpoints the FDA got - they were pulled truthfully out of the data but the implication is the work was successful when, for the important endpoints it was not. Technically what they are doing is misrepresentation. It would only be illegal and transforming for them if they misreported to the FDA.
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I assume it would also be illegal and "transforming" (whatever that means) if they were actually defrauding their investors.

Anyway, I don't see a huge problem with estimating one set of targets for FDA review, and reporting the actual real progress made to their investors, even if it happened to fall short of their initial FDA estimate.

I suppose the investors might complain that a comparison of actual progress to the initial FDA estimate should have been part of the report, but that seems relatively minor to me. Sooner or later, any serious investor will ask to see progress made towards FDA approval and commercialization. Until that day? Caveat emptor.

I'd be more concerned if the company were deceiving the FDA, or the general public. I'd be more concerned if they were actually deceiving their investors (though, not being an investor, I wouldn't be very concerned). I'd be more concerned if it was an actual case of shifting the goalposts, which it isn't. I'd be more concerned if it was an industry-wide practice as you say, rather than a single instance of a single company. I'd be more concerned if Derek didn't flatly admit he has no idea what the actual industry accepted practices are. I'd be more concerned if Derek's "bearish investor" were a proper authority, instead of a one-dimensional cartoon, cited on the Internet to lend verisimilitude to an otherwise weak conclusion.
 
When I was in third grade I decided to start referring to myself as Derek for some strange reason...
 
commandlinegamer said:
I guessed correctly who Derek was when I saw the thread title. Where's my prize?
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This does not work if you watch Dancing with the Stars. In fact, it messes with one's head quite badly. Is this thread about some new dance step?
 
commandlinegamer said:
I guessed correctly who Derek was when I saw the thread title. Where's my prize?
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Ben will be delivering it to your door any moment now. (At least, I think Ben is on duty today, otherwise it might be either Al or Chad.)

They're my personal assistants, BTW. They're often called by their nicknames. Al is known as A2, because that's his favourite paper size. Ben is B3, because that's his favourite vitamin of the B complex. And Chad is C4, because while generally very nice, he does have a bit of a temper on him at times, leading him to blow up occasionally. I can post a picture for identification if you like.
 
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