Mabe She Just Isn't Into You

[rory_20_uk]

I was amazed by a few aspects of the article.
The drug does not seem very effective for its target "problem".
It seems likely to be prescribed "off label" for other uses.
It's an expensive treatment, of dubious benefit, may not be fit for the use intended and may even get prescribed to treat conditions outside it target.
Just how low is the bar these days in the pharmaceutical industry?

As low as the FDA allows... Unlike the car industry we're not allowed to cheat on tests.

[Beskar]

As low as the FDA allows... Unlike the car industry we're not allowed to cheat on tests.

Doesn't mean they don't. You tend to find a lot of clinical studies somehow disappearing down the cracks when the benefits are usually none or marginal to skew the results.

[rory_20_uk]

And most if not all companies are obligated to register all clinical studies and publish results... if they can. Have you tried publishing studies that fail to reach significance? Journals don't want to have that sort of material.

You can't not include studies that didn't work. They tend to notice those things - especially phase 3 studies. But somehow Big Bad Pharma has the clout to hide data on thousands of people.

[Beskar]

You can't not include studies that didn't work. They tend to notice those things - especially phase 3 studies. But somehow Big Bad Pharma has the clout to hide data on thousands of people.

It isn't that difficult. You just go sly with the wordings, you try to obfuscate and hide the real conclusions. It is why tools such as CASP exist to help weed out those crappy studies. Invalidate a couple of results here and there... it is dumb for them to use something which has absolutely no effect, they just overstate those with little effect.

Big Pharma have done shady processes before, and unfortunately these will occur again.

[rory_20_uk]

Erm, the FDA ask for the CSRs and do their own analysis - they don't read a poster and give a Marketing Authorisation. Difficult to overstate the effect when the regulators don't ask for your conclusions.

If it is a non-registration study then it is up for the regulators to ensure it is utilised appropriately.

[Montmorency]

Have you tried publishing studies that fail to reach significance? Journals don't want to have that sort of material.

That's actually one of the problems. Significance is really kind of a useless indicator (on its own), and significant results in pharmacology are more often than not fig leafs concealing tiny effect sizes under minimal assurance (or big effect sizes if it concerns negative effects).

"Big Pharma" doesn't have to do anything special, they just have to perpetuate statistical analysis because most people don't know better, even if they should.

[rory_20_uk]

And yet so many products fail in Phase 3. Clearly companies like wasting billions to ensure that no one guesses they are so in control of the statistical analysis. Billions in alzheimer's alone. Some companies even go as far as to fold to ensure that this ruse is kept going...

Most people do not know any better - but then those that work on both sides of the fence do.