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(Guardian)   Drug companies drag out the big guns to keep their failed clinical trials a secret   (guardian.co.uk) divider line 26
    More: Obvious, clinical trials, drug companies, pharmaceutical research, trade secrets, pharmaceutical industry, AstraZeneca  
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3249 clicks; posted to Business » on 22 Jul 2013 at 10:17 AM (1 year ago)   |  Favorite    |   share:  Share on Twitter share via Email Share on Facebook   more»



26 Comments   (+0 »)
   
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2013-07-22 08:46:09 AM
"In any sensible world, when researchers are conducting trials on a new tablet for a drug company, for example, we'd expect universal contracts, making it clear that all researchers are obliged to publish their results, and that industry sponsors - which have a huge interest in positive results - must have no control over the data."


http://www.ted.com/talks/ben_goldacre_what_doctors_don_t_know_about_ th e_drugs_they_prescribe.html

http://blog.ted.com/2012/09/27/5-prescription-drugs-doctors-had-no-i de a-could-hurt-their-patients/
 
2013-07-22 10:24:04 AM
Simple explanation as to why this is important:

Randomized drug trial might produce no statistically significant result 19 times out of 20.

Drug company runs the trial 20 times, publishes the one time they get the result they're looking for, keeps the other 19 a secret.
 
2013-07-22 10:26:16 AM

CokeBear: Simple explanation as to why this is important:

Randomized drug trial might produce no statistically significant result 19 times out of 20.

Drug company runs the trial 20 times, publishes the one time they get the result they're looking for, keeps the other 19 a secret.


This.

I used to work in our research department, and from those short three years, I learned several drugs that my family SHOULDN'T take.

Well, the ones I like at least.
 
vpb [TotalFark]
2013-07-22 10:29:27 AM

CokeBear: Simple explanation as to why this is important:

Randomized drug trial might produce no statistically significant result 19 times out of 20.

Drug company runs the trial 20 times, publishes the one time they get the result they're looking for, keeps the other 19 a secret.


True, but eventually enough people will die so that you can figure it out by the time it goes generic.

See?  Self regulation works, with no need for government bureaucracy burdening the job creators.
 
2013-07-22 10:33:59 AM
The urban legend solution to water purity in Sweden - making the executives and their families drink the effluent - suggests a solution. All clinical trials are conducted on the executives, their family members, and their children.

/No, not really.
 
2013-07-22 10:48:45 AM

vpb: CokeBear: Simple explanation as to why this is important:

Randomized drug trial might produce no statistically significant result 19 times out of 20.

Drug company runs the trial 20 times, publishes the one time they get the result they're looking for, keeps the other 19 a secret.

True, but eventually enough people will die so that you can figure it out by the time it goes generic.

See?  Self regulation works, with no need for government bureaucracy burdening the job creators.


Look at Vioxx.  Not all that many people died from taking it.  And some of them only had heart attacks and strokes.

The system works.
 
2013-07-22 10:51:44 AM
This, ladies and gents, is why I don't like the thought of taking medication.

/That and I'm still in my 20's and therefore impervious to all medical maladies.
 
2013-07-22 11:01:57 AM
FTA: The pharmaceutical industry has "mobilised" an army of patient groups to lobby against plans to force companies to publish secret documents on drugs trials

Are the pharmaceutical industry selects patient groups that suffer server debilitating side effects to their products or are they going to selectively select the patient groups the same way they selectively select their research results?
 
2013-07-22 11:02:57 AM

demaL-demaL-yeH: The urban legend solution to water purity in Sweden - making the executives and their families drink the effluent - suggests a solution. All clinical trials are conducted on the executives, their family members, and their children.

/No, not really.


Why?
 
2013-07-22 11:07:14 AM
Every time I see "drug trials" I think of TGN 1412. Thanks rotten library.

/shudder
 
2013-07-22 11:15:18 AM

feanorn: demaL-demaL-yeH: The urban legend solution to water purity in Sweden - making the executives and their families drink the effluent - suggests a solution. All clinical trials are conducted on the executives, their family members, and their children.

/No, not really.

Why?


Stickler for informed consent.
Executives who act this way now are sociopaths who would not hesitate to sacrifice their own mothers and children on the altar of Mammon.
 
2013-07-22 11:18:37 AM

Elegy: Every time I see "drug trials" I think of TGN 1412. Thanks rotten library.

/shudder


You should see the effects of Zetia on your digestive system
 
2013-07-22 11:47:38 AM
What exactly are the "patient groups" they reference?
 
2013-07-22 11:50:52 AM

Oliver Twisted: What exactly are the "patient groups" they reference?


I parsed that as people with medical conditions they've targeted for off-label uses of the drugs.
 
2013-07-22 12:07:28 PM

demaL-demaL-yeH: Oliver Twisted: What exactly are the "patient groups" they reference?

I parsed that as people with medical conditions they've targeted for off-label uses of the drugs.


Couldn't they just use the names of the people who join class action suits?  Woman who have had their bladders removed because they used Yaz would probably like some input.
 
2013-07-22 01:18:03 PM

vpb: CokeBear: Simple explanation as to why this is important:

Randomized drug trial might produce no statistically significant result 19 times out of 20.

Drug company runs the trial 20 times, publishes the one time they get the result they're looking for, keeps the other 19 a secret.

True, but eventually enough people will die so that you can figure it out by the time it goes generic.

See?  Self regulation works, with no need for government bureaucracy burdening the job creators.


A less detectable problem would be one where a drug does nothing at all and was found to have a positive correlation in one trial out of 20. The company could then go on making huge profits off of essentially selling a placebo.
 
2013-07-22 01:18:54 PM

Muta: demaL-demaL-yeH: Oliver Twisted: What exactly are the "patient groups" they reference?

I parsed that as people with medical conditions they've targeted for off-label uses of the drugs.

Couldn't they just use the names of the people who join class action suits?  Woman who have had their bladders removed because they used Yaz would probably like some input.


GAH! That sounds horrible. Do they have to wear diapers? I'd never heard of that.
 
2013-07-22 01:25:03 PM

Muta: demaL-demaL-yeH: Oliver Twisted: What exactly are the "patient groups" they reference?

I parsed that as people with medical conditions they've targeted for off-label uses of the drugs.

Couldn't they just use the names of the people who join class action suits?  Woman who have had their bladders removed because they used Yaz would probably like some input.


Really? I thought it just caused DVTs. Ewww.
 
2013-07-22 03:33:57 PM

Elegy: Every time I see "drug trials" I think of TGN 1412. Thanks rotten library.

/shudder


Well they certainly won't be getting arthritis in their toes, so,  win?
 
2013-07-22 03:52:08 PM

Tommy Moo: vpb: CokeBear: Simple explanation as to why this is important:

Randomized drug trial might produce no statistically significant result 19 times out of 20.

Drug company runs the trial 20 times, publishes the one time they get the result they're looking for, keeps the other 19 a secret.

True, but eventually enough people will die so that you can figure it out by the time it goes generic.

See?  Self regulation works, with no need for government bureaucracy burdening the job creators.

A less detectable problem would be one where a drug does nothing at all and was found to have a positive correlation in one trial out of 20. The company could then go on making huge profits off of essentially selling a placebo.


It wouldn't make any financial sense. Phase III trials, which are what's needed for approval, cost many millions of dollars and take years. Not to mention that if you did that many trials, you'd never succeed in keeping them quiet. Considering that drugs have a limited patent life and most are not all that profitable anyways (the vast majority of profits come from a handful of blockbusters), it's pretty unlikely it would ever be smart for a company to do that. It's like people who think drug companies are holding back cures for cancer and AIDS so they can keep selling treatments. If you think about the fact that drug development costs hundreds of millions and that once a drug hits the market the producer controls it for  maybe15 years before generics show up and drive down prices, it just doesn't add up. Not to say drug companies are nice or benevolent, but they will only do things that make financial sense, and most conspiracy theories don't. I think this is probably mostly about protecting share prices from bad news coming out, or protecting drugs with a bad result in one area that might have other potential uses. Covering up side effects is a possibility too, but if you ever read the full label for an approved drug (the FDA website has them), the side effects seen in the trials are listed pretty thoroughly.
 
2013-07-22 04:05:27 PM
It's misleading, if not an outright lie, to say that drug companies publish only 10% of their clinical trials results. If Compound X is the lead candidate for rheumatoid arthritis, initial trials won't use Compound X directly because it's required (repeat, REQUIRED) to publish the results of your lead candidate which will eventually be filed for NDA. Even certain animal studies are required to be reported.

So, pharmaceutical companies will do the studies on Compound Y and Z, which are structural analogs to Compound X, but aren't Compound X, and thus don't need to be reported. The tradeoff is that structural analogues have limited applicability to its parent compound - small changes in molecular formula can lead to large changes in pharmaceutical behavior. More often than not the studies are done as a test run to get an initial read on what to expect during the real trial using Compound X.
 
2013-07-22 05:30:07 PM

CokeBear: Simple explanation as to why this is important:

Randomized drug trial might produce no statistically significant result 19 times out of 20.

Drug company runs the trial 20 times, publishes the one time they get the result they're looking for, keeps the other 19 a secret.


In the Biz, we call this the "Probiotic Effect"

In all seriousness, most trials are too small to be anything other than suggestive, and would likely not be very helpful to the public. And the big ones are so expensive, no-one in their right mind would repeat them 20 times.
 
2013-07-22 07:05:02 PM

neon_god: Tommy Moo: vpb: CokeBear: Simple explanation as to why this is important:

Randomized drug trial might produce no statistically significant result 19 times out of 20.

Drug company runs the trial 20 times, publishes the one time they get the result they're looking for, keeps the other 19 a secret.

True, but eventually enough people will die so that you can figure it out by the time it goes generic.

See?  Self regulation works, with no need for government bureaucracy burdening the job creators.

A less detectable problem would be one where a drug does nothing at all and was found to have a positive correlation in one trial out of 20. The company could then go on making huge profits off of essentially selling a placebo.

It wouldn't make any financial sense. Phase III trials, which are what's needed for approval, cost many millions of dollars and take years. Not to mention that if you did that many trials, you'd never succeed in keeping them quiet. Considering that drugs have a limited patent life and most are not all that profitable anyways (the vast majority of profits come from a handful of blockbusters), it's pretty unlikely it would ever be smart for a company to do that. It's like people who think drug companies are holding back cures for cancer and AIDS so they can keep selling treatments. If you think about the fact that drug development costs hundreds of millions and that once a drug hits the market the producer controls it for  maybe15 years before generics show up and drive down prices, it just doesn't add up. Not to say drug companies are nice or benevolent, but they will only do things that make financial sense, and most conspiracy theories don't. I think this is probably mostly about protecting share prices from bad news coming out, or protecting drugs with a bad result in one area that might have other potential uses. Covering up side effects is a possibility too, but if you ever read the full label for an approved drug (the FDA website has them), the side effects seen in the trials are listed pretty thoroughly.


It isn't their plan from the getgo to do it. It what happens when you are balls deep in a product and the only way out is to find a way to sell it.

Way to shill though.
 
2013-07-22 11:16:16 PM
I'll have to try to dig up the website that published the math behind meta-analyses of multiple drug tests.  It turned out that if you just leave out the null results (not the negative results!), the math yields a 42% positive result from a study that, if all results are included in fact has a zero (neither positive or negative result).

The article wasn't going after the drug companies, but the journals.   It's almost impossible to get a study that had a null result published even though it's just as valid and valuable as a positive or negative result.  That is simply a function of the way journals select articles.

The upshot of the all this is that no meta-analysis shows a positive result unless the magnitude of the effect found is more than 42%.   Ponder that the next time you read that a meta-analysis has shown that drug A is 35% more effective than drug B and you should therefore buy drug A.

It also applies to all those meta-analysis of environmental exposures that claim that chemical A exposure resulted in a 25% increase in cancer incidence.
 
2013-07-23 01:50:06 AM

neon_god: Tommy Moo: vpb: CokeBear: Simple explanation as to why this is important:

Randomized drug trial might produce no statistically significant result 19 times out of 20.

Drug company runs the trial 20 times, publishes the one time they get the result they're looking for, keeps the other 19 a secret.

True, but eventually enough people will die so that you can figure it out by the time it goes generic.

See?  Self regulation works, with no need for government bureaucracy burdening the job creators.

A less detectable problem would be one where a drug does nothing at all and was found to have a positive correlation in one trial out of 20. The company could then go on making huge profits off of essentially selling a placebo.

It wouldn't make any financial sense. Phase III trials, which are what's needed for approval, cost many millions of dollars and take years. Not to mention that if you did that many trials, you'd never succeed in keeping them quiet. Considering that drugs have a limited patent life and most are not all that profitable anyways (the vast majority of profits come from a handful of blockbusters), it's pretty unlikely it would ever be smart for a company to do that. It's like people who think drug companies are holding back cures for cancer and AIDS so they can keep selling treatments. If you think about the fact that drug development costs hundreds of millions and that once a drug hits the market the producer controls it for  maybe15 years before generics show up and drive down prices, it just doesn't add up. Not to say drug companies are nice or benevolent, but they will only do things that make financial sense, and most conspiracy theories don't. I think this is probably mostly about protecting share prices from bad news coming out, or protecting drugs with a bad result in one area that might have other potential uses. Covering up side effects is a possibility too, but if you ever read the full label for an approved drug (the FDA website has them), the ...


Yep. Plus, any drug company would JUMP at the chance to be known as the company that had the cure for AIDS or cancer. It would make them a fortune.
 
2013-07-23 08:50:33 AM
Old news.  I saw this on Law & Order and McCoy kicked their asses.
 
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