I think there is a balance to be had between the years long billion dollar struggle to get a drug approved, and being careless about letting one go through.
There are huge numbers of drugs out there which gained approval despite despite nasty side effects, unknown until release, after FDA approval.
Thalidomide, while released in large quantities for testing in the US was never approved in the 50s and 60s for sale and distribution as a sedative. https://en.wikipedia.org/wiki/Thalidomide That still did not stop some brutal birth defects.
Currently, however, getting a drug through phase 1 and 2 trials has bankrupted many small pharmacy and biotech firms, to the benefit of "Big Pharma", who buys up the distressed company's patents and takes the drug through to market. Cui bono?
Sorry Joe, Pharma's one of the very few sectors I will not compromise or negotiate on.
1st, there is no such thing as a 'Side Effect'. There are only Direct Effects. Side Effect is weasel speak designed to CYA the maker and distributor's legal liability in Court After the fact.
As to the $Billion spent to get a drug through trials and approved, the tanking, hiding, and misrepresenting of clinical trial data is a byword with Pharma.
The control group requirement for drugs is placebo.
All the drug maker has to show with its trial data is that their drug outperformed NOTHING, a Sugar Pill.
With the entire class of antipsychotic drugs, used to treat the SYMPTOMS of an Opinion of a disease, the control group is often people suffering from withdrawal rebound by being taken off whatever sledgehammer antipsychotic drug they Were on. It's called Washout.
And it is a female dog for mirror imaging psychosis.
So the control group is jonesing at mach 3 or 4 as the active group is beaten into semi slumber acquiescence from the new drug.
BINGO! 'Our New Drug Is SO MUCH BETTER than even WE Ever Imagined. Our subjects outperformed people who were NOT ON ANY DRUG that it would be, well, almost Criminal to deny suffering humanity our drug's obvious, and (grossly rigged) Clinically Proven, (on Our dime) benefits.'
http://psychroaches.blogspot.com/2011/06/sc-judge-calls-j-actions-detestable-so.html "this Court finds the actions of the Defendants, upon this audience, to be detestable." "Annual Sales of Risperdal worldwide per annual reports of Johnson & Johnson, Inc.
1994: $0.172 Billion
1995: $0.343 Billion
1996: $0.502 Billion
1998: $0.588 Billion
1999: $0.892 Billion
2000: $1.083 Billion
2001: $1.845 Billion
2002: $2.146 Billion
2003: $2.512 Billion
2004: $3.05 Billion
2005: $3.552 Billion
2006: $4.180 Billion
2007: $4.697 Billion
2008: $1.309 Billion
2009: $1.425 Billion
2010: $1.50 Billion
Total for the period: $29.796 Billion
Testimony at trial indicated that the profit margin for sales of Risperdal was 97% or $28.90 Billion for the period of 1994-2010"
Note; the link to the pdf of that slip opinion is no longer valid, but anyone who would like a copy of it can PM me a valid email and I'll put it in your mailbox.
South Carolina's just one State, but here's the blog's post tag for South Carolina:
http://psychroaches.blogspot.com/search/label/South%20CarolinaAnother winner. (they're all beauts)
South Carolina Calls Janssen's Risperdal Defense "If We Lied, Nobody Fell For It."http://psychroaches.blogspot.com/2015/05/south-carolina-supreme-court-calls.htmlClinical Trials are usually run for 4, 6, or 8 weeks, but the destructive effects of the drug don't manifest themselves as permanent brain and CNS damage perceivable by the naked eye until months down the road.
Welcome to Pharma World, where 'The Benefits Outweigh The Risks'. (That's GSK speak to peddle Paxil.)
Hi, My Name Is Kristi And I Have Tardive Dyskenisia
http://www.youtube.com/watch?v=QXPnngZUFLYThis is because the entire Class of these drugs Shrinks the pre-frontal cortex of human brains.
I don't care how big or how small a drug maker is. Almost all of them belong in prison.