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GlaxoSmithKline to pay $3bn in US drug fraud scandal
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Customers haven't directly paid this bill; shareholders have as the fine was paid from cash reserves.
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No directly maybe but where do the profits come from to amass the reserve.?"If you act like an illiterate man, your learning will never stop... Being uneducated, you have no fear of the future.".....
"big business is parasitic, like a mosquito, whereas I prefer the lighter touch, like that of a butterfly. "A butterfly can suck honey from the flower without damaging it," "Arunachalam Muruganantham0 -
why aren't the results of all clinical trials freely available by law?
They have been for some time - http://clinicaltrials.gov/ As above, event in question were largely in the 90s.No directly maybe but where do the profits come from to amass the reserve.?
Reduction in shareholder return, coupled with massive reduction in global expenditure. Less investment in research, fewer global head count. In my limited understanding you aren't allowed to increase the cost of medicine to increase profit.
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I'm not condoning what happened at all, but perplexed at all this cash being paid from a UK company to the US government.Legal team on standby0 -
does it actually say that all trials MUST be published?0
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All trials need not be published. To be published they need to be submitted (which trials that don't say anything interesting won't be) and accepted (ditto).
There is a widely understood 'publication bias' (e.g. link)
I think you have a slight misunderstanding. Your comments refer to submitting and publishing clinical studies in journals (eg The Lancet), which get a wide readership.
Details of all clinical studies must be submitted to appropriate regulatory bodies. The company in question above also publush details of all of their studies online for all to read. I think many others do the same.When studies are initiated, GSK posts protocol summaries on internet registers [eg. http://www.clinicaltrials.gov/ and http://www.gsk-clinicalstudyregister.com/]. Following their completion we also post result summaries - irrespective of the outcome of the study.
From - http://www.gsk.com/policies/GSK-on-disclosure-of-clinical-trial-information.pdfLegal team on standby0 -
I think you have a slight misunderstanding. Your comments refer to submitting and publishing clinical studies in journals (eg The Lancet), which get a wide readership.
Details of all clinical studies must be submitted to appropriate regulatory bodies. The company in question above also publush details of all of their studies online for all to read. I think many others do the same.
From - http://www.gsk.com/policies/GSK-on-disclosure-of-clinical-trial-information.pdf
I'm still unclear
are you saying that is it a legal requirement for all drug trials to be published i.e made available to anyone that chooses to look?0 -
Yes - That's my understanding. Of course, it's something thats only come into play recentky(ish) based on events above in the 90s and other similar incidents.
However, the term "published" usually means it appears in print in a journal. "Available" means it's logged in one of the databases above where you can browse at your lesuire.Legal team on standby0 -
That's my understanding. Of course, it's something thats only come into play recentky(ish) based on events above in the 90s and other similar incidents.
I'll do some research
but I think I read last week in the papers that even NICE doesn't have access to all the trial data
and goldacre writes endlessly on the subject.
but I accept that this is anecdotal.0 -
The EU clinical trials directive
http://ec.europa.eu/health/human-use/clinical-trials/index_en.htm
Database of clinical trials in Europe
https://eudract.ema.europa.eu/Mostly happened in the 90s - those responsible have long since left the company. Current directors played no part, yet are dealing with the consequences.
Customers haven't directly paid this bill; shareholders have as the fine was paid from cash reserves.
Scandal is the $3bn in cash going from a UK company in the pocket of the US government. The investment potential of that money into UK science would have been fantastic.
They were caught doing things that were morally reprehensible. Doctors in America get free reign over their patients and GSK were basically bribing the doctors to prescribe the drugs for off-label uses.0 -
In my limited understanding you aren't allowed to increase the cost of medicine to increase profit.
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Who tells them what to sell something for?
Surely they will charge what the market will stand until it loses it's license for branded production."If you act like an illiterate man, your learning will never stop... Being uneducated, you have no fear of the future.".....
"big business is parasitic, like a mosquito, whereas I prefer the lighter touch, like that of a butterfly. "A butterfly can suck honey from the flower without damaging it," "Arunachalam Muruganantham0
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