B
B1ackwater
Guest
CNN
CHICAGO, Illinois (AP) -- Two new reports involving the painkiller
Vioxx raise fresh concerns about how drug companies influence the
interpretation and publication of medical research.
A journal report criticized Merck for ghostwriting, minimizing Vioxx
deaths.
The reports claim Merck & Co. frequently paid academic scientists to
take credit for research articles prepared by company-hired medical
writers, a practice called ghostwriting.
They also contend Merck tried to minimize deaths in two studies that
showed that the now withdrawn Vioxx didn't work at treating or
preventing Alzheimer's disease.
Merck called the reports in Wednesday's Journal of the American
Medical Association false and misleading. Five writers of the articles
were paid consultants for people who sued Merck over Vioxx's heart and
stroke risks; the sixth testified about Merck and Vioxx's heart risks
before a Senate panel. Merck says those connections makes the reports
themselves biased.
While Merck is singled out, the practices are not uncommon, according
to JAMA's editors. In an editorial, they urge strict reforms,
including a ghostwriting crackdown and requiring all authors to spell
out their specific roles.
Dr. Catherine DeAngelis, JAMA's editor-in-chief, said those are
already policies at JAMA but not at many other journals.
"The manipulation is disgusting. I just didn't realize the extent,"
she said.
The practices outlined in JAMA can lead editors to publish biased
research that can result in doctors giving patients improper and even
harmful treatment, she said.
DeAngelis said doctors, medical researchers and journal editors bear
some responsibility for those harms.
"We're the ones who have allowed this to happen. Now we've got to make
it stop," she said.
- - - - -
There are some REASONS for all this manipulation too.
First and foremost, the FDA just doesn't have the people
or budget to study these drugs and trial results in the
exacting detail that's desired. So, someone ELSE has
to fill in the boxes, don't they, unless you want a
situation where it takes 25 years for drugs to get to
those who need them.
The next obvious factor is MONEY. Drug companies spend a
HUGE amount of money developing and testing new drugs.
The testing procedures are VERY expensive ... and the
FDA gets a huge cut. Final review & licencing, another
big wad to the Feds. Millions, hundreds of millions
total depending.
Anything in the process that puts the potential drug in
a bad light scares the hell out of the pharmas. They are
HIGHLY MOTIVATED to pretty-up the results of the tests -
and since FDA is making THEIR people do most of the
paperwork, well ... the words "irresistable temptation"
come to mind.
The sad truth is that even the "bad" drugs may be very GOOD,
for MOST people. The nature and tone of FDA reviews make
adverse side-effects count heavily against a drugs approval,
so the pharmas are motivated to hide this info.
A far better approach is to determine the circumstances
under which a drug can be "bad". Is it just people with
pre-existing conditions or physiological biases - or are
bad results pretty much random so far as anyone can tell ?
Are there ways to reduce side effects without sacrificing
the good the drug does ?
If telling the WHOLE truth doesn't necessarily mean a
hundred megabucks and 10 years research down the drain
then the pharmas won't be so hesitant to tell the whole
truth. Vulnerable patients can be protected or rejected
and those who can be helped WILL be helped. The pharma
can make back its money and more too ... instead of
having to raise the price of its other drugs just to
cover their big lost investment.
But how to get FDA bureaucrats - and they ARE ass-covering
bureaucrats - to not freak out if they see the words
'adverse side-effects' on a sheet of paper ? They'll get
this vision of humiliation, demotion, unemployment, lost
pensions, lawsuits and CNN reporters climbing in their
windows if they dare approve a drug with 'adverse side
effects' - documented, parameterized and managable or not.
Maybe the final review committees shouldn't BE made up
of "bureaucrats" per-se - but of practicing doctors and
biochemist types merely supervised by the FDA. Recruit
a pool of volunteers, pay 'em a flat rate regardless of
how they decide on a drug, and then ABIDE BY THEIR
DECISION. This is vastly better than relying on career
b-crats who have risen to or beyond their level of
incompetence.
CHICAGO, Illinois (AP) -- Two new reports involving the painkiller
Vioxx raise fresh concerns about how drug companies influence the
interpretation and publication of medical research.
A journal report criticized Merck for ghostwriting, minimizing Vioxx
deaths.
The reports claim Merck & Co. frequently paid academic scientists to
take credit for research articles prepared by company-hired medical
writers, a practice called ghostwriting.
They also contend Merck tried to minimize deaths in two studies that
showed that the now withdrawn Vioxx didn't work at treating or
preventing Alzheimer's disease.
Merck called the reports in Wednesday's Journal of the American
Medical Association false and misleading. Five writers of the articles
were paid consultants for people who sued Merck over Vioxx's heart and
stroke risks; the sixth testified about Merck and Vioxx's heart risks
before a Senate panel. Merck says those connections makes the reports
themselves biased.
While Merck is singled out, the practices are not uncommon, according
to JAMA's editors. In an editorial, they urge strict reforms,
including a ghostwriting crackdown and requiring all authors to spell
out their specific roles.
Dr. Catherine DeAngelis, JAMA's editor-in-chief, said those are
already policies at JAMA but not at many other journals.
"The manipulation is disgusting. I just didn't realize the extent,"
she said.
The practices outlined in JAMA can lead editors to publish biased
research that can result in doctors giving patients improper and even
harmful treatment, she said.
DeAngelis said doctors, medical researchers and journal editors bear
some responsibility for those harms.
"We're the ones who have allowed this to happen. Now we've got to make
it stop," she said.
- - - - -
There are some REASONS for all this manipulation too.
First and foremost, the FDA just doesn't have the people
or budget to study these drugs and trial results in the
exacting detail that's desired. So, someone ELSE has
to fill in the boxes, don't they, unless you want a
situation where it takes 25 years for drugs to get to
those who need them.
The next obvious factor is MONEY. Drug companies spend a
HUGE amount of money developing and testing new drugs.
The testing procedures are VERY expensive ... and the
FDA gets a huge cut. Final review & licencing, another
big wad to the Feds. Millions, hundreds of millions
total depending.
Anything in the process that puts the potential drug in
a bad light scares the hell out of the pharmas. They are
HIGHLY MOTIVATED to pretty-up the results of the tests -
and since FDA is making THEIR people do most of the
paperwork, well ... the words "irresistable temptation"
come to mind.
The sad truth is that even the "bad" drugs may be very GOOD,
for MOST people. The nature and tone of FDA reviews make
adverse side-effects count heavily against a drugs approval,
so the pharmas are motivated to hide this info.
A far better approach is to determine the circumstances
under which a drug can be "bad". Is it just people with
pre-existing conditions or physiological biases - or are
bad results pretty much random so far as anyone can tell ?
Are there ways to reduce side effects without sacrificing
the good the drug does ?
If telling the WHOLE truth doesn't necessarily mean a
hundred megabucks and 10 years research down the drain
then the pharmas won't be so hesitant to tell the whole
truth. Vulnerable patients can be protected or rejected
and those who can be helped WILL be helped. The pharma
can make back its money and more too ... instead of
having to raise the price of its other drugs just to
cover their big lost investment.
But how to get FDA bureaucrats - and they ARE ass-covering
bureaucrats - to not freak out if they see the words
'adverse side-effects' on a sheet of paper ? They'll get
this vision of humiliation, demotion, unemployment, lost
pensions, lawsuits and CNN reporters climbing in their
windows if they dare approve a drug with 'adverse side
effects' - documented, parameterized and managable or not.
Maybe the final review committees shouldn't BE made up
of "bureaucrats" per-se - but of practicing doctors and
biochemist types merely supervised by the FDA. Recruit
a pool of volunteers, pay 'em a flat rate regardless of
how they decide on a drug, and then ABIDE BY THEIR
DECISION. This is vastly better than relying on career
b-crats who have risen to or beyond their level of
incompetence.
