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Are ALL Pharma scientific studies published?

Pixel42 said:
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.
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Yep - specify in advance what you are testing for or you cannot use the results as evidence for that effect.

What possible objection could there be?
 
MikeAparicio said:
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.
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A) No, not all trials are reported, not all reports are published/made available,
not all bad/problem effects are reported and, if they are, they may be minimized with lies or statistical games (applies to all reports).

BUT
B) this is not really the best place to look into this although you may get some info here. This is the (or at least one of the) best place to go for these things: http://pipeline.corante.com/

Yes, the blogger/columnist works in the industry but I (and many others) have gotten far more insight, information, exposures of bad/mistaken tests, papers/ drug releases and non-releases, known but not well covered bad effects (etc.,etc., ad inf.) here than from any other source - and the comments sections frequently add to what Derek knows and reports. Also, the part on Things I won't work with is rioutously funny as well as VERY informative as to things that go boom (or really, really stink up) your lab. All in all, the most useful blog on the internet by my standards..........
 
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MikeAparicio said:
There is NO human ethics in pharma interests, no matter the customer is a human being!

Very clear!
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Actually, there are very clear laws and procedures in place to make sure human volunteers in medical studies are treated ethically. And it's certainly within the interests for pharmaceutical companies to deliver a quality product.

But no, it's not within the interests of pharmaceutical companies to invest money researching something that they believe will have a very low return, even if it may be effective and useful. Why would it be? They're businesses, not scientific institutions. To them, research is an investment, not a goal.

I don't see what this has to do with human ethics.
 
FrederickEason said:
...But no, it's not within the interests of pharmaceutical companies to invest money researching something that they believe will have a very low return, even if it may be effective and useful. Why would it be? They're businesses, not scientific institutions. To them, research is an investment, not a goal.
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While this is true, the situation is slightly complicated by the current rules and laws covering pharmaceutical patents. Specifically, where a drug is expected to be useful only for rare conditions, patents are protected for longer than usual. This is purely to encourage research into drugs for those rare conditions. Without the extra protection, such products would be unprofitable.

http://en.wikipedia.org/wiki/Orphan_drug
 
theprestige said:
Plain chemicals? Aspirin.
Natural sources? Bottled water.
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What about the Willow tree?

IS it not the cortex tea delivers plain natural aspirin?

And OF COURSE aspirin would be of monetary interest to pharma!

Zillions of tablets sold every month! Wow!

Big business....

P.S. Do you want me to list quite a few Natural Source true medicines? Not only water!!!!
 
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FrederickEason said:
Actually, there are very clear laws and procedures in place to make sure human volunteers in medical studies are treated ethically. And it's certainly within the interests for pharmaceutical companies to deliver a quality product.

But no, it's not within the interests of pharmaceutical companies to invest money researching something that they believe will have a very low return, even if it may be effective and useful. Why would it be? They're businesses, not scientific institutions. To them, research is an investment, not a goal.

I don't see what this has to do with human ethics.
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Well.... Buy some eyeglasses!
 
I think we all agree that it is unethical to withhold research data - positive as well as negative.

But as explained by others, this is no excuse to let testimonials have a decisive impact on how to do the right thing. Conclusions based on even perfectly good testimonials (or case reports if you will) can and do occasionally lead to horrible things.

A good example comes to mind (for which I don't have the references at hand) that illustrates this point.

Back in the 1960's a few case reports were published about infants sleeping on their backs who had died because they had vomited and the gastric content entered the airways. These case reports led to the recommendation that infants should not sleep on their backs. They should sleep on their stomachs instead. This recommendation even made it to pediatric textbooks - All based on case reports.

Then followed increasing rates of sudden infant deaths. In the early 1990´s a case-control study and a follow-up study were published showing that sleeping on the stomach was correlated to higher risk of sudden infant death (SID). This led to a change in recommendations, in that from then on, parents were advised to let the infants sleep on their backs. This led to a rapid decline in the number of SID.

While case reports may be good for hypothesis formation (eg. sleeping on the back increases the risk of SID), they are not good enough for decision making.
 
Segnosaur said:
...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.
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A telling point.

MikeAparicio said:
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!
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You've widely misunderstood thePrestige's post.

Pixel42 said:
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.
Click to expand...

Yes. That's a good idea.

MikeAparicio said:
What about the Willow tree?

IS it not the cortex tea delivers plain natural aspirin? ...
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No, it doesn't.

Mike, in the OP you asked

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

Would you you please use that same guideline, please?
That would avoid such replies as this

MikeAparicio said:
Well.... Buy some eyeglasses!
Click to expand...
 
jli said:
But as explained by others, this is no excuse to let testimonials have a decisive impact on how to do the right thing.
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I would say that using just testimonials is an example of unethical behavior. Testimonials are biased toward positive results (dead subjects tell no tales). Any researcher relying on testimonial evidence alone is essentially withholding the negative evidence.

Maybe we need a medical database of testimonial evidence where the researcher is obliged to provide "testimonies" from every subject, including dead subjects :D.
 
pakeha said:
Would you you please use that same guideline, please?
That would avoid such replies as this
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Pakeha: I agree and apologize.

There is something in my defense: This is the VERY first forum where I found a harsh treatment everywhere, just for bringing up subjects with which the majority (selective indeed) does not agree!

I progressively had to increase my "bickering" in response to gross things, including a very "educated" guy who spoke at Taking or giving a ---- job!

Why is it very difficult (with rare and honorable exceptions) to exchange ideas, no matter how "bizarre" they are for the audience?

I am not insisting at all on getting agreements, but simply let expose ideas and convey responses without being labeled. "quack lover", "woo vendor", "Altmed fanatic", "uneducated brat", even being suggested of lacking intelligence or reasoning or having never seen a book!

If the audience has an atom of understanding for the psychological basics of social exchange, mainly when pretending being a higher level of persons, will agree with me and make an effort to recover equanimity, friendship, sociability, and mutual respect.

Is this too much to ask?
 
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Reality Check said:
I would say that using just testimonials is an example of unethical behavior. Testimonials are biased toward positive results (dead subjects tell no tales). Any researcher relying on testimonial evidence alone is essentially withholding the negative evidence.

Maybe we need a medical database of testimonial evidence where the researcher is obliged to provide "testimonies" from every subject, including dead subjects :D.
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Well... Dead persons are a very good testimony of those cases out of the % rates reported of failing medicine!

Better: Dead persons in pursue of healing are excellent testimonies of failure. They don't need to talk. They are not here anymore! Whatever the therapy was...

And the idea of extending the data base to include a testimonial section, no matter is just a crude joke, is good!
 
Foster Zygote said:
And you can't trust big business.
Yes, please.
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OK! A brief partial list and a link!

Google books

Penicillin
Taxol
Marinol
Aspirin
DMSO (not natural, but certainly not patentable)
Lovaza
Digoxin
Belladonna
any opiate, but most notably opium
Atropine
Estrogen/testosterone/most other hormones
Cocaine
Nicotine
Vincristine
Marihuana (glaucoma and fun)
Lithium carbonate
L-arginine
Amrubicin
Anidulafungin
Apomorphine
Artemotil
Aztreonam
Biapenem
Bivalirudin
Bleomycin
Capsaicin
Caspofungin
Cefditoren
Codinaeopsin
Colchicine
Daptomycin
Dimethyltryptamine
Doripenem
Dronabinol
Ergotamine
Ertapenem
Everolimus
Exenatide
Fumagillin
Galantamine
Ixabepilone
Lisdexamfetamine
Mescaline
Methylnaltrexone
Micafungin
Miglustat
Mycophenolate
Nitisinone
Orlistat
Paclitaxel
Phenethylamine
Pimecrolimus
Retapamulin
Romidepsin
Rosuvastatin
Spiruchostatins
Telavancin
Telithromycin
Temsirolimus
Tigecycline
Tiotropium
Trabectedin
Ziconotide
Zotarolimus

All the above come either directly from refined natural sources and others come from extraction from natural sources. Just a few for space!

How come pharma got involved with those?

Because of Traditional Medicine usage TESTIMONIALS.
Once they heard the bells ringing, they knew where the mass was taking place!
 
jli said:
I think we all agree that it is unethical to withhold research data - positive as well as negative.
...
While case reports may be good for hypothesis formation (eg. sleeping on the back increases the risk of SID), they are not good enough for decision making.
Click to expand...

Fine Dr. jli!

Too bad NOT all agree! You can read it right in this thread!

Decision making really depends on "who" is deciding...
IF we are talking of the pharma world their decision might be totally different to the one from an ill patient, sick person, third world country doctor, poor hospitals, etc.

Are we derailing a little bit?
 
MikeAparicio said:
OK! A brief partial list and a link!

Google books

Penicillin
Taxol
Marinol
Aspirin
DMSO (not natural, but certainly not patentable)
Lovaza
Digoxin
Belladonna
any opiate, but most notably opium
Atropine
Estrogen/testosterone/most other hormones
Cocaine
Nicotine
Vincristine
Marihuana (glaucoma and fun)
Lithium carbonate
L-arginine
Amrubicin
Anidulafungin
Apomorphine
Artemotil
Aztreonam
Biapenem
Bivalirudin
Bleomycin
Capsaicin
Caspofungin
Cefditoren
Codinaeopsin
Colchicine
Daptomycin
Dimethyltryptamine
Doripenem
Dronabinol
Ergotamine
Ertapenem
Everolimus
Exenatide
Fumagillin
Galantamine
Ixabepilone
Lisdexamfetamine
Mescaline
Methylnaltrexone
Micafungin
Miglustat
Mycophenolate
Nitisinone
Orlistat
Paclitaxel
Phenethylamine
Pimecrolimus
Retapamulin
Romidepsin
Rosuvastatin
Spiruchostatins
Telavancin
Telithromycin
Temsirolimus
Tigecycline
Tiotropium
Trabectedin
Ziconotide
Zotarolimus

All the above come either directly from refined natural sources and others come from extraction from natural sources. Just a few for space!

How come pharma got involved with those?

Because of Traditional Medicine usage TESTIMONIALS.
Once they heard the bells ringing, they knew where the mass was taking place!
Click to expand...
See: http://www.badscience.net/2007/10/543/

Herbs contain bioactive compounds. That’s why they can be effective, but it’s also why they can have side effects (some will inactivate your contraceptive pill, others will cause renal failure). Huge numbers of bioactive compounds extracted or derived from plants are used today in medical practice, including even common stuff like aspirin. There is little difference between herbal medicine and medicine in terms of what is used, only in how. Digoxin in foxglove is very good at treating atrial fibrillation, a common kind of irregular heart movement. Unfortunately the dose range is very narrow, so it’s really quite easy to kill your patient. From the moment of its discovery, pharmacologists worked hard to standardise the dose.
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I've only quoted a small portion of the post and it really is worth reading in full.
 
TsuDhoNimh said:
No, those were side effects of the drug.
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.
This was not a "testimony" because the participants were unaware of the results.
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I don't understand....

Not being aware of "results" makes a testimony "not a testimony"?

On the contrary! How did the researchers doing the Sildenafil tests knew about the erectile properties?
I suppose not because every guy coming for checkups entered the clinic showing a wonderful erection!:jaw-dropp
As a matter of fact, they were shy about the subject but researchers entered suspicion when the participants didn't want to return the purple pills...
So they asked and the shy guys started telling "powerful" bedtime stories; just like "anecdotes" of a pink and red novel.

Their testimonies of course came from a side effect but the effect wasn't the lead into finding Viagra... Were the hot stories from participants, mainly old folks who made researchers open their mouth!

Hot anecdotes! Ain't that lovely?
 
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