T Nation

Maybe SOME Good News from the FDA


#1

http://www.forbes.com/sites/patrickcox/2016/12/14/trumps-fda-chief-may-implement-progressive-approval-for-drugs/#5990c0d91c34


#2

What if one of your more liberal news sources has a negative spin article on this? Which one do you believe?


#3

I almost pulled up the darealnewz to check…


#4

With all this fake news everyone has been talking about its nice of them to name it with the word “real” so you know its legit.


#5

There will most likely be some good news in relation to this news if it comes to fruition. That being Big Pharma may not be able to hold back the positive momentum gotten by stem cell research. And they will not be able to hold back smaller companies that may have something positive to add but currently cannot as they can’t afford Phase II and Phase III “trials”. I believe Japan has only a Phase I for regenerative type treatments(stem cells, tissue regeneration) The potential bad news is that Big Pharma can get around the expensive approval process and release more dangerous drugs than they already do.


#6

More legit than the corporate sources you most likely read as they do not take corporate advertising or government hand-outs. They generally survive on donations. Where do those donations come from? Evil viewers.


#7

The real news started with a Macarthur grant. Where do you suppose the money for said grant came from? The nasty capitalist couple who founded the grant.


#8

Correct, so they placate to the biases of those viewers, which is progressive left, ie: commies.

No different than the Young Turks.


#9

And the corporate media placate to those who makes them money regardless if it’s true or not. And the difference is it often comes at the expense of the majority. Externalities of corporations, etc.


#10

They are no different than the “corporate” media. None. If they started running center left or GASP center, center/right stories they would lose the viewers funding and go under.

Darealznewz is just as beholden to biases as everyone else.

Biased reporting isn’t inherently bad, as it’s all biased. It’s when people think their bubble news is the ultimate truth and unbiased, when that isn’t the case is when it’s bad.

If someone reads Breitbart everyday, or Drudge headlines, and thinks “this is right wing bubble reporting” they will be okay. If someone reads Huffington Post and thinks “this is the actual truth and Breitbart is Fake News”, they aren’t going to be okay, and neither is society.


#11

So it’s better to be biased to the interest of those who control the information to their monetary benefit rather than the opinion of the people?


#12

There is ZERO difference between the two.

All of them, Briebart, Realnews and CNN, all “control the information to their monetary benefit”.

That you can’t see this is the problem. Them being biased or controlling the flow of information isn’t.


#13

They are the same. The people who report the news, or twist it, or just make shit up- do so as a reflection of what their readers want. They track each and every click and gauge viewer sentiments very carefully.

You do realize that these outlets come out of demand for their product, right?

No one is just doing this shit for some noble or higher cause. Darealnewz crying poormouth and asking for donations is just playing on their target audience need to feel like they are supportive and part of something. (thats you!)


#14

Out of curiosity, do you know what the purpose of Phase II and Phase III trials are?

If you do, could you please explain your reasoning for supporting the marketing of pharmaceutical products backed by no efficacy data in humans, and with safety data limited to however well a handful (e.g., up to 100) of (typically) healthy individuals tolerated various dosages?

Do you know how many trials are dropped during either Phase II (hint: ~70%) or III (hint: ~50%) due to safety / efficacy concerns?

Look, I can appreciate the cost of drug development – I work in the industry – but proposing to gut the process in such a manner is stunningly irresponsible. It’s a knee jerk attempt to answer a question that doesn’t yet need to be asked.

Tell y’all what: before we talk about how to make the drug development process more affordable, why don’t we first talk about why it costs so damn much in the first place? It’s not just because of Big Brother’s red tape and Big Pharma’s greed.


#15

Just a guess on my part, but it’s probably really hard to come up with a new molecule. It’s not like they’re just slapping a bunch of atoms together and hoping for the best.

(just a layman’s guess. I don’t actually know shit about chemistry.)


#16

As a physician, I can say with confidence that this is a terrible idea–an example of Peter Thiel’s extremist political views run amok. One can’t make ethical treatment recommendations/decisions without efficacy/effectiveness data concerning the treatments under consideration, and it would be virtually impossible to get such data outside of the constrained conditions employed in Phase II and III trials.

The FDA approval process can be maddeningly slow, and I’m sure there are ways it could/should be tweaked. But wholesale abandonment of the requirement that a treatment be demonstrated effective prior to being made available to the public is not the way to go about doing this.


#17

When you’re in a post-facts state, data doesn’t matter anymore. Lol


#18

Coming up with new molecules is (surprisingly) pretty straightforward in and of itself, particularly nowadays with advances in combinatorial chemistry, high throughput screening, computer-aided drug design processes, and an increasingly robust understanding of the human body. But IIRC this is Aragorn’s wheelhouse, not mine.

Coming up with drugs that are able to run the gauntlet to become one of those cheerfully dismal commercials you see on TV is much more difficult. And that’s not just because one commercial of middle-aged couples watching sunsets from twin bathtubs on a beach is exactly one more commercial of that type than anyone ever asked for. I don’t know the failure rate prior to earnest preclinical investigation (they get shelved for any number of reasons), but after entering the pipeline, figures commonly thrown around report that it takes anywhere from 5,000 to 10,000 new chemical entities to produce 1 FDA-approved product.

90% of all drugs that make it to human testing fail, with specific therapies flopping in rates generally proportional to the complexity of the disease or system being targeted. The vast majority (again, 90%+) are pulled due to safety / efficacy considerations, which is why I think this discussion is preposterous.

These in-human trials constitute the largest financial hurdle for a pharmaceutical company looking to bring a drug to market, and as someone who is familiar with the implementation and execution of such endeavors, I’m curious if Zep is arguing the merits of amputation without actually understanding the rot, itself.


#19

Hear hear. I wish I could like that more than once.


#20

Pretty close for a layman! Obviously there’s a lot else that goes into it regarding mid/late stage trials which anonym was referencing, but that is one significant aspect.

We can make molecules galore…making them with receptor binding properties that are both STRONG (but not too strong to where they suicide the receptor) and SPECIFIC, and also soluble and partition into the right tissues at pHs that are physically relevant, and can survive digestion intact or be delivered IV, AND don’t have a high percentage of dangerous side effects…well yeah. That’s kind of difficult.

And, quite obviously, something one cannot carry to completion in a petri dish (although one can start the process).