Mabe She Just Isn't Into You

[HopAlongBunny]

Have no fear!
Perhaps everymans dream is just around the corner; supposedly working at the level of desire for sex, can we hope for a herd of over prescribed women to be hitting the streets soon?
Paradise, it may be coming soon:

http://www.scientificamerican.com/ar...female-viagra/

[Brenus]

Ah, yeah. A drug that will make women who doesn't want sex to want sex.
Isn't mind controlling?
Viagra is a drug to help men who want sex but can't for physical reason to have sex. Great idea, it cure a physical problem, basically a blood flood problem.
Now, guys, if women don't want to have sex, that is their prerogative, you know, the right to say no. It is the reason why Assenge is in the Ecuadorian Embassy, because he had sex once with a woman who agreed with it but she is not sure she agreed with the second time.
So, if you want you women to have sex with you, time to brush-up your seduction, have a shower, shave, disodorant (don't forget arm-pits), dress-up, in short get her out, make her feel sexy and perhaps she will have a libido up again.
All right, perhaps cheaper to give her a pills.

[a completely inoffensive name]

From a scientific standpoint, I am impressed that they succeeded at making a potent aphrodisiac.

[Montmorency]

Amphetamines and derivatives are well-known for aphrodisiac effects.

The drug in question hasn't even been shown effective, especially given its proposed treatment-cost.

[rory_20_uk]

The benefit is pretty borderline - but some women really do want it. Yes, probably some are really against it, but that is the case for most things.

To say that brushing up on seduction is the answer is as unhelpful as saying that if she was wearing a short skirt she wants it.

Another quality of life product that helps make people a smidge more happy at massive expense. Well, that's what pays my salary!

[Montmorency]

I thought you were an OB/GYN?

[HopAlongBunny]

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?

[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.

[HopAlongBunny]

With the "gaming" of the system and the enormous reach of Big Pharma, I guess we should be happy that some drugs actually fail.
Perhaps we could be comforted by an industry study showing how fair the process is.

http://www.scientificamerican.com/ar...any-influence/

[Papewaio]

“We need to highlight that these meta-analyses are more a marketing tool than a science,” - Ouch

I know in IT most companies want all their support staff to be sales people too. Seems Big Pharma wants all their scientists to be marketing pros as well.

[rory_20_uk]

Wow! The makers of the drug do most of the studies - that's really big news!!!

Conflict of interest - which means having received any funding, or given advice - was present in 80% of the people!! Wow!! Companies ask experts for help and experts ask for money for their time!!!

Meta-analysis uses the same data - wow!!

I have to love the jump that when stats is done by people in industry it must be poor research compared. In fact the drivel that many universities churn out is often far worse and just as open to bias - MMR scare, anyone?

I am sure that the Cochrane group would be very upset regarding meta-analysis utility.

Others can do research on any topic they like.

Finally, as the article finally says, those that publish the material are paid extremely well to do so partly because the time they are supposed to spent in getting the material peer-reviewed. If they can't even check that conflicts of interest have been missed this is pretty dire.

[rory_20_uk]

...

[Montmorency]

In fact the drivel that many universities churn out is often far worse and just as open to bias

I disagree that it is worse, but otherwise this is just what I was pointing out with respect to shoddy statistics.

The vast majority of pharmacological medications are simply not at all fit for the market or for general use. This would not change even if all development was conducted under public or governmental organizations. Since there is a poor understanding of what constitutes rigorous design or statistical validation, there is a general trend for even approved medications to be less effective and/or riskier than was initially thought. This isn't even an issue of hindsight, as applying the appropriate techniques to old studies and reports often demonstrates that, hey, we should have realized this from the beginning and factored it into the cost-benefit analyses.

This is all without taking obfuscation, cheating, or fraud into account.

[rory_20_uk]

I disagree that it is worse, but otherwise this is just what I was pointing out with respect to shoddy statistics.

The vast majority of pharmacological medications are simply not at all fit for the market or for general use. This would not change even if all development was conducted under public or governmental organizations. Since there is a poor understanding of what constitutes rigorous design or statistical validation, there is a general trend for even approved medications to be less effective and/or riskier than was initially thought. This isn't even an issue of hindsight, as applying the appropriate techniques to old studies and reports often demonstrates that, hey, we should have realized this from the beginning and factored it into the cost-benefit analyses.

This is all without taking obfuscation, cheating, or fraud into account.

[Montmorency]

I would crack a joke about studying internal medicine, but that's the very thing - the only people who seem to care about these problems are mathematicians, physicists, computer scientists, and theoretically-oriented individuals in all other fields.

I like null-hypotheses, and I don't like Bayesianism, but "significance-testing" is just useless.

[rory_20_uk]

Oh, so that explains the ignorance.

If you'd like to continue trolling that biological sciences are not pure maths, be my guest.

[Beskar]

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.

You won't believe what happened today in my life which makes this very relevant.

My main issue is examples such as this: http://www.dailymail.co.uk/news/arti...tion-5500.html
Really gives big pharma a bad name.

[Papewaio]

I wish they could strip the name Turing from this company as it is an insult to his memory.

Definitely cannot confuse it with a human. Irony that the drug in question treats an oppourtunist parasite, sounds like the company in question too. Is this an actual operating entity or is it a pharmaceutic patent troll. At some point it moves from profit to pay for research to profiteering out of people's lives. Highway robber mentality should mean that the directors are seen as unfit and the patents stripped and given to society. At some point corporations either act as good citizens or are dissolved for the greater good.

Corporations doing things like what is in that article should be treated as criminals. Want benefits of personhood as a corporation then expect the responsibilities of one.

[Montmorency]

Not really. It's just a PR move by a failing enterprise.

http://www.wallstreetdaily.com/2015/...euticals-immy/