Are ALL Pharma scientific studies published?

[MikeAparicio]

Here the questions:

Are ALL clinical trials, clinical studies and experiment results invariably published?

Who warrants unfavorable results are published as well?

Is the Pharma industry willing to admit mistakes and testing errors as well as biased tests and analysis?

Is it convenient for Pharma industries to publish favorable results to inexpensive non pharmaceutical treatment tests?

Why Pharma consistently diminishes testimonial proof?

Can testimonial proof be subject to formal scientific analysis and not only to rejection?

An example: Pfizer was conducting trials for Sildenafil as a potential blood pressure regulator. Subjects under trial started reporting a totally different outcome, TOTALLY OUT OF THE TRIAL SCOPE.
"I am having strong erections" they started saying.
Those were testimonies. The trials were NOT measuring erection rates at all!
Did or did it not Viagra's discovery come out of seriously considering the testimonial evidence?
Did such testimonials led to clinical trials on the precise ED subject?

But going farther:

Would the trials have "denied" sildenafil effects on erectile disfunction, could this convince the witnessing subjects that "after all sildenafil was not working and their erections were a "placebo" effect"?

No! So their PERSONAL experience was also a proof. An individual proof!
What the trials did was to satisfy requirements to PRODUCE the medicine. Not to make it "work or not".

But sildenafil worked no matter trials would have never been done or would denied the effect because "sildenafil was very easy to produce at home". (Which is not the case, just for the example)

NOTE: Please try to participate without personal attacks or ad hominem "acid" comments.

 

[Professor Yaffle]

Don't worry, Ben Goldacre is on the case:

http://en.wikipedia.org/wiki/Bad_Pharma
http://www.alltrials.net/

 

[Mashuna]

Can testimonial proof be subject to formal scientific analysis and not only to rejection?

An example: Pfizer was conducting trials for Sildenafil as a potential blood pressure regulator. Subjects under trial started reporting a totally different outcome, TOTALLY OUT OF THE TRIAL SCOPE.
"I am having strong erections" they started saying.
Those were testimonies. The trials were NOT measuring erection rates at all!
Did or did it not Viagra's discovery come out of seriously considering the testimonial evidence?
Did such testimonials led to clinical trials on the precise ED subject?

In addition to the Bad Pharma links provided by Professor Yaffle, you've pretty much answered your own question in this part. Testimony can be a starting point for full clinical trials. The testimony itself is not the proof, it's just a starting point. Alt. med. is notorious for stopping at the testimony stage, and never getting to the clinical trials, or ignoring the results of the clinical trials in favour of the testimonies.

 

[Lukraak_Sisser]

In answer to your question, no not all studies are published.
Those studies that show no results are often shelved in case the chemical in question might be effective against something else and thus its best not to give the competition ideas
However for something to be called a medicine a study with positive results HAS to be published to show it works and is at least harmless enough to pass trough the standard trials.

Your Viagra example show the process in action. A medicine against [A] doesn't seem to work, but testimony seems to suggest it has function . So a new trial is started to check for that. Once that was shown to be true the medicine was released. But only after the tests were done and proven to be more than just confirmation bias or placebo.

One might see pharmaceutical companies as greedy and overcharging, but at least they only charge for medication that actually has been shown to work in a controlled and published way. (Except the ones that have a branch selling Homeopathy of course)

 

[theprestige]

Is it convenient for Pharma industries to publish favorable results to inexpensive non pharmaceutical treatment tests?

Why on earth would pharmaceutical companies even be conducting tests on non-pharmaceutical treatments in the first place?

Automobile companies don't study fuel economy in container ships. Airplane manufacturers don't study total cost of ownership for submarines.

Anyway, isn't it the responsibility of whoever is actually testing non-pharmaceutical treatments, to publish those test results? What does the Pharma industry even have to do with it?

 

[MikeAparicio]

Why on earth would pharmaceutical companies even be conducting tests on non-pharmaceutical treatments in the first place?

Automobile companies don't study fuel economy in container ships. Airplane manufacturers don't study total cost of ownership for submarines.

Anyway, isn't it the responsibility of whoever is actually testing non-pharmaceutical treatments, to publish those test results? What does the Pharma industry even have to do with it?

By non pharmaceutical I mean a substance not yet further developed into a funnily named medicine. But it seems a contradiction going constantly in response arguments.

We might then question. In the Viagra example; if researchers would have not listened to the testimonies would it be sildenafil research was going to the "not good" files, hidden from anybodies eyes (To avoid "giving ideas" to competence?)

Then: Testimonies are good except if they have to do with something not done by Pharma. A NATURAL treatment (labeled now "alternative") is immediately stamped out as "quack-stuff" and anybody looking at it, thinking of it, speaking about it or plainly interested in what is about, will be called "quack promoter"... And if it happens to be a doctor or scientist then he better gets ready for some kicking out of "the circles"....

But my questions have not been answered yet! HOW do we know those "reports" on "not working" NATURAL cures are true? Or how do we know if some positive findings on the same are NOT hidden to (avoid giving ideas to competence) or because, if manufactured, they would be impossible to patent or their market value could not be justified by a complex manufacturing process?

How do we know?

 

[MikeAparicio]

Don't worry, Ben Goldacre is on the case:

http://en.wikipedia.org/wiki/Bad_Pharma
http://www.alltrials.net/

Thanks Professor!

It seems Goldacre speaks with a mouth full of truth!

 

[Reality Check]

By non pharmaceutical I mean a substance not yet further developed into a funnily named medicine.

So you mean every single substance that pharmaceutical companies test?

Then: Testimonies are good except if they have to do with something not done by Pharma.

Thta is wrong.
Testimonies are good when they give scientists (and pharmaceutical companies) reasons to run clinical tests to confirm what the testimonies state.

Testimonies are neutral when they have not been tested.

Testimonies are bad when the people taking them believe them and refuse to test them. Testimonies are bad when they fail the clinical tests.

I should also emphasis what has already been stated: Alt. med. is notorious for stopping at the testimony stage.
Taking your Viagra example: Alt. Med. would have never have even got to the testimony stage because they would never have used sildenafil citrate (a man-made chemical) to treat angina.

 

[Segnosaur]

Then: Testimonies are good except if they have to do with something not done by Pharma.

Uhhh... no. Testimonies are only (at best) suggestions for things that can be studied, whether it is something done by pharmaceutical companies or some sort of "alternative medicine". However, they are not proof of anything.

To build a case for effectiveness, you need actual double blind peer reviewed studies, published in a reputable journal. And that applies whether you're dealing with something manufactured in a test tube or something found in nature.

But my questions have not been answered yet! HOW do we know those "reports" on "not working" NATURAL cures are true? Or how do we know if some positive findings on the same are NOT hidden to (avoid giving ideas to competence) or because, if manufactured, they would be impossible to patent or their market value could not be justified by a complex manufacturing process?

Well, lets see...

Roughly $34 billion was spent last year on "Alternative medicine" in the U.S. Given the profit margins involved (Remember, there's no development cost, and often very little manufacturing cost), people selling such "cures" could easily afford to fund studies to show their effectiveness. Even if the seller of these "alternative medicines" couldn't patent their products, successful tests would still benefit them (as it would still increase sales.)

The fact that you don't see positive studies in reputable medical journals funded by companies like (for example) Schwabe (homeopathic manufacturer) or Norso (magnetic therapy manufacturer) is a pretty good indication that they don't work. If they did, they'd be eager to sing the praises of their products to the moon, in the hopes of getting more sales.

 

[Mashuna]

Thanks Professor!

It seems Goldacre speaks with a mouth full of truth!

He's equally good on why alternative medicine tends to be at best ineffective, at worst actively harmful or deadly.

 

[theprestige]

But my questions have not been answered yet!

I think the answers to your questions are pretty obvious, actually:

HOW do we know those "reports" on "not working" NATURAL cures are true?

We know by reading the reports and judging for ourselves whether they are good reports. Conversely, if we haven't read the reports, then we don't know if they are good reports.

Do you have a specific report that you can provide as an example, that we can review together and see what we can conclude?

Or how do we know if some positive findings on the same are NOT hidden to (avoid giving ideas to competence)

This is pretty obvious: If a pharmaceutical company knows a treatment might work, but they aren't prepared to market it themselves, they will almost certainly NOT publish. Obviously.

Why would you expect anything else?

But pharmaceutical companies aren't the only ones that study substances and treatments. They're not the only ones that publish results.

or because, if manufactured, they would be impossible to patent or their market value could not be justified by a complex manufacturing process?

Also pretty obvious: If there's no business to be done with a substance or treatment, there's no point in publishing studies about that treatment. Indeed, if the preliminary studies show that there's no business there, it's likely the pharmaceutical company will terminate the research before even producing anything worth publishing.

How do we know?

I hope this helps. Have a nice day!

 

[Professor Yaffle]

He's equally good on why alternative medicine tends to be at best ineffective, at worst actively harmful or deadly.

Indeed. I get the feeling that our friend MikeAparicio would benefit greatly from reading his first book:

http://en.wikipedia.org/wiki/Bad_Science_(book)

 

[MikeAparicio]

I think the answers to your questions are pretty obvious, actually:

This is pretty obvious: If a pharmaceutical company knows a treatment might work, but they aren't prepared to market it themselves, they will almost certainly NOT publish. Obviously.

Why would you expect anything else?

Also pretty obvious: If there's no business to be done with a substance or treatment, there's no point in publishing studies about that treatment. Indeed, if the preliminary studies show that there's no business there, it's likely the pharmaceutical company will terminate the research before even producing anything worth publishing.


I hope this helps. Have a nice day!

Oh Theprestige:

Very disconcerting. I do accept most of what you say and certainly it does not speak well of pharmaceutical industries.
-People would expect those companies would have as primordial goal to have a deep interest in human well being. You clearly explains why it is NOT the case.
-They will NOT mind if a treatment works if they cannot make profit from it!
-They will never release good information on a treatment they will not adopt for further tests.
-Pharma does not get involved in treatment studies where the result would be usage of plain chemicals or natural sources as they would mean no profit at all.

Thanks for those clarifications! I can confirm then there is no humanist foundation in pharmaceutical activities, which WORRIES me a lot and I suppose it worries thousands of people who have noticed that.

We could say in a set of few words:

There is NO human ethics in pharma interests, no matter the customer is a human being!

Very clear!

 

[MikeAparicio]

Indeed. I get the feeling that our friend MikeAparicio would benefit greatly from reading his first book:

http://en.wikipedia.org/wiki/Bad_Science_(book)

I appreciate being cited as your friend! Truly I am!

I would have to say I am not an advocate for ANY writer, pharma industrialist, Altmed proponent, TV commentator or boasting quack!

What I say is part of my own convictions and thoughts. If I cite some article, video or book it might be because it pertains to the topic or gives an insight to other persons thinking!

Maturity showed me the best way to go is by my own experience, my own findings, my own convictions and my own acceptance or refusal of facts. For the same reason I like to speak my own words and ideas, inner feelings and perceptions.

Books many times if not all are good to replace a broken piano leg!

Condensing, I am not part of any trend's herd...

 

[Wolrab]

Wow. Using Viagra as an example?

See, the thing is, getting a boner as an unintended effect from taking a drug is pretty easy to test. Erections also sell so there would be an incredible market.

A "natural" pill that only has Susie Smith saying,"I tried everything doctors pushed at me and the only thing that relieves my (insert disease/syndrome that has natural remission states) is Moth Feces supplement." isn't quite enough to do full scale clinical trials.

 

[theprestige]

-Pharma does not get involved in treatment studies where the result would be usage of plain chemicals or natural sources as they would mean no profit at all.

Plain chemicals? Aspirin.

Natural sources? Bottled water.

 

[TsuDhoNimh]

Here the questions:

Can testimonial proof be subject to formal scientific analysis and not only to rejection?

"Testimonials" or case studies can be a starting point for developing the formal hypothesis and the investigation. However, they can't replace them.

An example: Pfizer was conducting trials for Sildenafil as a potential blood pressure regulator. Subjects under trial started reporting a totally different outcome, TOTALLY OUT OF THE TRIAL SCOPE.
"I am having strong erections" they started saying. Those were testimonies.

No, those were side effects of the drug.

Did or did it not Viagra's discovery come out of seriously considering the testimonial evidence?

NO! It came out of analyzing any reported SIDE EFFECT for the persons in the study and realizing that the side effect might of itself be useful.

Similar useful results have resulted from analyzing clinical trial results and discovering that one group that benefited more than the average from a certain anti-cancer drug was also taking an anti-diabetic drug ... leading to the use of that drug plus the anti-cancer drug instead of just the anti-cancer drug alone.

This was not a "testimony" because the participants were unaware of the results.

 

[Cinnamon Life]

The only class of drugs I know the particulars of are anti-depressants. All the drug companies have to do is show that these drugs work in two studies. It doesn't matter if they did 50 studies that showed no effect, and two that show an effect, that two is enough for the FDA.

A scientist, having to use the Freedom of Information Act to access the unpublished trials, then compared the unpublished results with the published ones. The conclusion:

Meta-analyses of antidepressant medications have reported only modest benefits over placebo treatment, and when unpublished trial data are included, the benefit falls below accepted criteria for clinical significance.

http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0050045

Basically it's extreme cherry picking.

 

[Pixel42]

Yes, the file drawer problem must be addressed. I like the proposed solution that all clinical trials must be registered in a database before they take place.

 

[Reality Check]

TsuDhoNimh's post raises a point that should be emphasized.
There is a difference between testimonial evidence and the evaluation of the effects of drugs in clinical trials.

Testimonial evidence is one or more individuals volunteering information about their own personal experience with a drug. It may or may not contain medical information. Testimonial evidence is subjective, hard to analyze and full of ambiguities.

Clinical trials of new drugs include the evaluation of possible medical side effects of the drug being tested. The evaluation is performed by professionals interviewing the subjects and conducting tests on the subjects.