Vegetarian Discussion: Re: "human Rights" And The Great Pharma Lie Of Omission

Re: "human Rights" And The Great Pharma Lie Of Omission
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Pearl
2006-03-16 19:11:42 EST
"pearl" <tea@signguestbook.ie> wrote in message news:...
> "Leif Erikson" <pipes@thedismalscience.net> wrote in message news:REgSf.13218$S25.7550@newsread1.news.atl.earthlink.net...
<..>
> > If you didn't
> > think that - if you recognized that animal testing is
> > *not* to be taken as any kind of guarantee at all -
> > then you would *also* say that the human clinical
> > trials are a conceptual failure, as you say the animal
> > testing is. But you don't do that. That's a lie of
> > omission: if the supposed "failure" of the drug in
> > prescriptive use "proves" the conceptual failure of
> > animal testing, then NECESSARILY it must also "prove"
> > the conceptual failure of human testing.
>
> No. I have already called the clinical trials inadequate.

- Or does the following reveal why clinical trials 'fail'..

".. it is critical that all information on that drug's past
performances be available to physicians and patients
alike, for one simple reason: physicians cannot practice
evidence-based medicine, nor can patients expect to
benefit from evidence-based medical advice, if key
evidence is suppressed. " ...

American Medical Association
Policy Forum
The Need for a Centralized Clinical Trials Registry
By Christian J. Krautkramer and Shane K. Green, PhD

Learning Objective

Understand how establishing a centralized registry
for clinical trial information and outcomes would help
protect clinical research subjects and consumers of
prescription drugs.

Imagine waking up one morning to headlines touting
the discovery of a remarkable new drug, Somax. The
acclaim is based on a clinical trial with thousands of
participants, the unprecedented results of which have
just been published in one of the world's top medical
journals. Soon, television ads will offer the promise
of improved health and well-being, with a reassuring
voice encouraging you to seize the opportunity: "ask
your doctor if Somax is right for you!" And why not?
The study has been vetted by experts and the data
and conclusions have been judged sound; Somax
may be just the thing to treat your ailment.

Is this scenario too good to be true? It's hard to say,
especially if you are not given the whole story. Yet
under current clinical reporting guidelines, the
manufacturers of Somax have no obligation to disclose
"proprietary information," which may include data from
other trials, even if those data suggested that Somax
was less effective than other medications, altogether
ineffective, or even potentially harmful to those taking it.

Global sales of pharmaceuticals amount to approximately
$350 billion annually, so the makers of Somax have
powerful economic incentives to withhold all but the most
positive of findings; after all, there would be scarce
market-share for a drug shown to have questionable
efficacy or benefits that are outweighed by associated risks.
Granted, the pharmaceutical industry is a business and is,
therefore, entitled to earn a profit; these profits, in turn,
help fund further biomedical research and innovation.
There must be a point, however, at which that entitlement
is superseded by the interests of the patient-consumer-
caveat emptor should not apply to inherently vulnerable
patients.

Though the above scenario is hypothetical, the underlying
issue unfortunately is not. Concerns over the nondisclosure
of negative or inconclusive clinical trial data came to a head
this past August when an FDA review, prompted by a tragic
incident, confirmed that pharmaceutical manufacturers had
withheld study results that suggested an increase in suicidal
ideation among children taking certain antidepressant
medications (specifically, Paxil from GlaxoSmithKline
(GSK), and Pfizer's Zoloft) [1].

The practice of nondisclosure, by no means limited to
these recent high-profile cases, is finally garnering the
attention it deserves, and long overdue steps are being
taken to counter it.

Why disclose all clinical trial data?

Once a drug is approved by the FDA and reaches the
marketplace, it is critical that all information on that drug's
past performances be available to physicians and patients
alike, for one simple reason: physicians cannot practice
evidence-based medicine, nor can patients expect to benefit
from evidence-based medical advice, if key evidence is
suppressed. Indeed, it is the potential for the suppression
of evidence (ie, negative clinical trial data) to cause harm
to patients, albeit indirectly, that has brought this issue to
the fore.
..
http://www.ama-assn.org/ama/pub/category/print/13198.html

SSRI dangers for children 'suppressed'
Press Association
Friday April 23, 2004

Drug companies have deliberately suppressed evidence
that many antidepressants are unsuitable or even
dangerous for children, according to psychiatrists and
child health experts.

Researchers uncovered unpublished data about clinical trials
of the most popular antidepressants on the market, known
as selective serotonin re-uptake inhibitors (SSRIs), which
raise serious doubts about prescribing them to children.

Published studies have so far indicated that the benefits
have outweighed risks for all five drugs studied - Prozac,
the brand name for the drug fluoxetine, paroxetine,
sertraline, citalopram, and venlafaxine.

But the review published today in medical journal the
Lancet showed this was true of only one, the leading brand,
Prozac. The others at best were not proven to help children
and at worst linked to an increased risk of suicide or suicidal
thoughts.

A separate editorial in the Lancet added that an internal
memo from drug giant GlaxoSmithKline, the makers of
paroxetine, had demonstrated how it "sought to
manipulate the results of published research".

It said: "The story of research into SSRI use in childhood
depression is one of confusion, manipulation, and institutional
failure. In a global medical culture where evidence-based
practice is seen as the gold standard for care, these failings
are a disaster."

The six psychiatrists and child health experts who carried
out the research also suggested that negative clinical
information about the drugs had been deliberately withheld.

The researchers obtained information about the unpublished
clinical trials from the government's committee for the safety
of medicines, which has access to confidential data. But the
pharmaceutical companies involved refused every request
for access to their unpublished data.

The researchers, led by Dr Craig Whittingdon from University
College London, wrote: "We understand that some trials might
have been submitted for publication, and that negative results
could be more difficult to get published.

"Nevertheless, the possibility remains that researchers writing
these reports might not have been able to disclose the findings
from negative unpublished trials."
..'
http://society.guardian.co.uk/mentalhealth/story/0,8150,1201844,00.html

Law Firms Prepare For Celebrex Cases After Pfizer Says
1999 Trial Revealed Cardiovascular Risks, Says Weitz &
Luxenberg, PC

NEW YORK, Feb. 9, 2005 -- Manhattan personal injury firm
Weitz & Luxenberg has launched an aggressive marketing
campaign seeking patients injured by the arthritis and pain
medication Celebrex after the drug's manufacturer
acknowledged that a 1999 clinical trial showed clear
cardiovascular risks in elderly patients taking the drug.

As late as October of 2004, in response to the Vioxx recall,
Pfizer said that no studies had ever shown increased
Celebrex-related cardiovascular risks. Now Pfizer has
acknowledged that, in a 1999 study where Celebrex was
tested as a treatment for Alzheimer's disease, patients
taking Celebrex quadrupled their risk for a heart attack
versus those taking a placebo. This study was not published
until June of 2001, four months after the FDA conducted a
safety review of Vioxx and Celebrex.
...'
http://www.weitzlux.com/lawfirmcelebrexlawsuitpfizertrial_472.html

'US regulator suppresses vital data on prescription drugs
on sale in Britain

'IoS' investigation: Despite calls for more transparency after
revelations about the side effects of ibuprofen, the FDA has
withheld 28 pages of information on a new wave of painkillers.

by Roger Dobson and Jeanne Lenzer

June 12, 2005

Vital data on prescription medicines found in millions of British
homes has been suppressed by the powerful US drug regulators,
even though the information could potentially save lives.

An investigation by The Independent on Sunday shows that,
under pressure from the pharmaceutical industry, the American
Food and Drug Administration routinely conceals information
it considers commercially sensitive, leaving medical specialists
unable to assess the true risks.

One team of investigators found that 28 pages of data had
been removed from the FDA files on one of a new family
of painkillers because of confidentiality.

Last week a major research study led by Professor Julia
Hippisley-Cox at Nottingham University, revealed that
ibuprofen, the supposedly "safe" painkiller, increases the
risk of heart attack by almost a quarter. The finding was
a particular blow to thousands of users who have already
switched from the best-selling drug Vioxx, which was
withdrawn last year after evidence that it too could
increase the risk of heart attacks.

Key information about Vioxx and other drugs that form
part of the new generation of painkillers called Cox-2
inhibitors had been suppressed, it emerged. Now
researchers are questioning the reliability of the data
about other drugs, including the full range of painkillers.

Dr Peter Juni, one of the team of Swiss investigators
who helped to expose the risk of the new-generation
drugs, claims his efforts were obstructed by the FDA.

"As part of the Freedom of Information Act, the agency
is required to make available its reports on all drugs that
are approved. Unfortunately, these reports are not as
useful as they could be,'' he and his team say in an
editorial in the British Medical Journal.

"For example, only 16 out of at least 27 trials of celecoxib
that were performed up to 2002 in patients with
musculoskeletal pain were included in the relevant reports...
In the case of valdecoxib, we found that many pages and
paragraphs had been deleted because they contained trade
secret and/or confidential information that is not disclosable.''

Dr Juni, senior research fellow in clinical epidemiology at
the University of Berne, is demanding that drug companies
be legally required to make public any adverse effects as
soon as they become available. Researchers also want
more independent research, with financial firewalls between
drug companies and doctors carrying out clinical trials.

Last year The Lancet published trial results that showed
that unacceptable heart risks linked to the drug rofecoxib
(sold as Vioxx) were evident four years before it was
finally withdrawn by its maker.

The Lancet's editor, Richard Horton, said at the time that
the discovery pointed to lethal weaknesses in the FDA's
approach. He said: "Too often the FDA saw and continues
to see the pharmaceutical industry as its customers, a
vital source of funding for its activities, and not as a
sector of society in need of strong regulation."

It emerged that FDA supervisors had attempted to
suppress a report by Dr David Graham, associate director
of the FDA's own Office of Drug Safety, showing that
patients taking Vioxx suffered five times as many heart
attacks as patients taking another pain reliever, naproxen.

Dr Graham's supervisors refused to allow him to present
his conclusions at a meeting in France and later sought to
interfere with the publication of his study results when
they were scheduled to appear in The Lancet. Merck, the
drugs company behind Vioxx, subsequently acknowledged
the risk of heart attacks, and the article was published.

Speaking yesterday, Dr Juni said: "In some instances we
had great difficulty in disentangling data. Not all the trials
were reported, and it was difficult to see which results
went with which trial. In some cases it took my group
more than 1,000 hours to disentangle the information.
We say that safety data from trials should be made
available publicly."

The older drugs involved - ibuprofen, naproxen and
diclofenac - have been around for so long that all are
out of patent. Some earlier studies have suggested
that they increase heart attack risks but this has been
overlooked because they cause the more serious side
effects of bleeding in the stomach or the development
of ulcers.

The FDA has also run into trouble over antidepressants.
Internal memos and a secret government report showing
an increased incidence of suicide among children taking
antidepressants surfaced in July last year. The report,
by Dr Andrew Mosholder, an expert at the FDA's Office
of Drug Safety, presented an analysis of 22 studies of
4,250 children on nine different antidepressants, and
found that their risk of "suicide-related events" was
twice that of children given a placebo. But that
information was suppressed by the agency. After the
report was leaked, Dr Robert Temple, formerly the
associate director of medical policy at the FDA's drug
evaluation centre, defended the FDA's actions saying
the results were "premature". The agency is investigating
the leaking of the report.

In later reviews, Dr Mosholder's findings were confirmed
and the FDA ordered a stringent black-box warning to
appear on the labels of anti-depressants.

The relationship between the FDA and the drug companies
has triggered congressional investigations in the United States.
But when it comes to revealing data and FDA analyses,
Dr Temple said that non-approved data - as well as some
safety and efficacy data regarding drugs currently on the
market - is "proprietary information" and that it would be
a "criminal offence" to reveal it. "That is something only
Congress can change," he said.
...'
http://www.thenhf.com/fda_31.htm




Leif Erikson
2006-03-16 19:30:20 EST
pearl wrote:
> "pearl" <tea@signguestbook.ie> wrote in message news:...
> > "Leif Erikson" <pipes@thedismalscience.net> wrote in message news:REgSf.13218$S25.7550@newsread1.news.atl.earthlink.net...
> <..>
> > > If you didn't
> > > think that - if you recognized that animal testing is
> > > *not* to be taken as any kind of guarantee at all -
> > > then you would *also* say that the human clinical
> > > trials are a conceptual failure, as you say the animal
> > > testing is. But you don't do that. That's a lie of
> > > omission: if the supposed "failure" of the drug in
> > > prescriptive use "proves" the conceptual failure of
> > > animal testing, then NECESSARILY it must also "prove"
> > > the conceptual failure of human testing.
> >
> > No. I have already called the clinical trials inadequate.
>
> - Or does the following reveal why clinical trials 'fail'..
>
> [snip *classic* lesley obfuscation with mountains of text she doesn't understand]

NONE of that shows animal tests to be a conceptual failure. You
fucking moron.


Shrubkiller
2006-03-18 14:47:23 EST

Leif Erikson wrote:
> pearl wrote:
> > "pearl" <tea@signguestbook.ie> wrote in message news:...
> > > "Leif Erikson" <pipes@thedismalscience.net> wrote in message news:REgSf.13218$S25.7550@newsread1.news.atl.earthlink.net...
> > <..>
> > > > If you didn't
> > > > think that - if you recognized that animal testing is
> > > > *not* to be taken as any kind of guarantee at all -
> > > > then you would *also* say that the human clinical
> > > > trials are a conceptual failure, as you say the animal
> > > > testing is. But you don't do that. That's a lie of
> > > > omission: if the supposed "failure" of the drug in
> > > > prescriptive use "proves" the conceptual failure of
> > > > animal testing, then NECESSARILY it must also "prove"
> > > > the conceptual failure of human testing.
> > >
> > > No. I have already called the clinical trials inadequate.
> >
> > - Or does the following reveal why clinical trials 'fail'..
> >
> > [snip *classic* lesley obfuscation with mountains of text she doesn't understand]
>
> NONE of that shows animal tests to be a conceptual failure. You
> fucking moron.



Animal tests are a failure you stupid Goober. 99.99% of the shit the
pharmas are selling would NEVER be approved if the testing was done on
humans.

Rats were used to test ASPARTAME because rats have TEN times the
resistance to methanol toxicity that humans have.


Dave
2006-03-18 16:49:54 EST

shrubkiller wrote:
> Leif Erikson wrote:
> > pearl wrote:
> > > "pearl" <tea@signguestbook.ie> wrote in message news:...
> > > > "Leif Erikson" <pipes@thedismalscience.net> wrote in message news:REgSf.13218$S25.7550@newsread1.news.atl.earthlink.net...
> > > <..>
> > > > > If you didn't
> > > > > think that - if you recognized that animal testing is
> > > > > *not* to be taken as any kind of guarantee at all -
> > > > > then you would *also* say that the human clinical
> > > > > trials are a conceptual failure, as you say the animal
> > > > > testing is. But you don't do that. That's a lie of
> > > > > omission: if the supposed "failure" of the drug in
> > > > > prescriptive use "proves" the conceptual failure of
> > > > > animal testing, then NECESSARILY it must also "prove"
> > > > > the conceptual failure of human testing.
> > > >
> > > > No. I have already called the clinical trials inadequate.
> > >
> > > - Or does the following reveal why clinical trials 'fail'..
> > >
> > > [snip *classic* lesley obfuscation with mountains of text she doesn't understand]
> >
> > NONE of that shows animal tests to be a conceptual failure. You
> > fucking moron.
>
> Animal tests are a failure you stupid Goober. 99.99% of the shit the
> pharmas are selling would NEVER be approved if the testing was done on
> humans.

Eh? All the medicines sold by pharmas have been tested on humans!
It's just that they are tested on animals first.

> Rats were used to test ASPARTAME because rats have TEN times the
> resistance to methanol toxicity that humans have.

Aspartame - isn't that a food additive?


John Beardmore
2006-03-18 18:30:16 EST
In message <1142711243.387290.59780@v46g2000cwv.googlegroups.com>,
shrubkiller <shrubkiller@excite.com> writes

>Animal tests are a failure you stupid Goober.

We'll see if you've got any better ideas then...


> 99.99% of the shit the
>pharmas are selling would NEVER be approved if the testing was done on
>humans.

But they are tested on humans !


>Rats were used to test ASPARTAME because rats have TEN times the
>resistance to methanol toxicity that humans have.

So ?


J/.
--
John Beardmore

Leif Erikson
2006-03-18 19:20:14 EST
impotent homo fudgepacker ronnnnnnnnnnie hamilton shrieked:

> Leif Erikson wrote:
>
>>pearl wrote:
>>
>>>"pearl" <tea@signguestbook.ie> wrote in message news:...
>>>
>>>>"Leif Erikson" <pipes@thedismalscience.net> wrote in message news:REgSf.13218$S25.7550@newsread1.news.atl.earthlink.net...
>>>
>>><..>
>>>
>>>>>If you didn't
>>>>>think that - if you recognized that animal testing is
>>>>>*not* to be taken as any kind of guarantee at all -
>>>>>then you would *also* say that the human clinical
>>>>>trials are a conceptual failure, as you say the animal
>>>>>testing is. But you don't do that. That's a lie of
>>>>>omission: if the supposed "failure" of the drug in
>>>>>prescriptive use "proves" the conceptual failure of
>>>>>animal testing, then NECESSARILY it must also "prove"
>>>>>the conceptual failure of human testing.
>>>>
>>>>No. I have already called the clinical trials inadequate.
>>>
>>>- Or does the following reveal why clinical trials 'fail'..
>>>
>>>[snip *classic* lesley obfuscation with mountains of text she doesn't understand]
>>
>>NONE of that shows animal tests to be a conceptual failure. You
>>fucking moron.
>
>
>
>
> Animal tests are a failure

Wrong.

Steve Firth
2006-03-19 08:26:43 EST
John Beardmore wrote:
> In message <1142711243.387290.59780@v46g2000cwv.googlegroups.com>,
> shrubkiller <shrubkiller@excite.com> writes
>
>> Animal tests are a failure you stupid Goober.
>
> We'll see if you've got any better ideas then...
>
>
>> 99.99% of the shit the
>> pharmas are selling would NEVER be approved if the testing was done on
>> humans.
>
> But they are tested on humans !
>
>
>> Rats were used to test ASPARTAME because rats have TEN times the
>> resistance to methanol toxicity that humans have.
>
> So ?

It's not even true, rats were among the animals used because government
testing regimes require rats to be used for metabolic studies.

Steve Firth
2006-03-19 08:48:56 EST
shrubkiller wrote:
[snip]

> Animal tests are a failure you stupid Goober. 99.99% of the shit the
> pharmas are selling would NEVER be approved if the testing was done on
> humans.

Every pharmaceutical on sale is tested on humans before being offered
for sale to humans. In the UK at present we have become painfully aware
of that fact.

> Rats were used to test ASPARTAME because rats have TEN times the
> resistance to methanol toxicity that humans have.

So you're saying that rats are not a suitable model to use for testing
aspartame?

That means that you consider all of the research done by the Ramazzini
Foundation to be invalid?


Pearl
2006-03-19 09:33:58 EST
"shrubkiller" <shrubkiller@excite.com> wrote in message news:1142711243.387290.59780@v46g2000cwv.googlegroups.com...
>
> Leif Erikson wrote:
> > pearl wrote:
> > > "pearl" <tea@signguestbook.ie> wrote in message news:...
> > > > "Leif Erikson" <pipes@thedismalscience.net> wrote in message news:REgSf.13218$S25.7550@newsread1.news.atl.earthlink.net...
> > > <..>
> > > > > If you didn't
> > > > > think that - if you recognized that animal testing is
> > > > > *not* to be taken as any kind of guarantee at all -
> > > > > then you would *also* say that the human clinical
> > > > > trials are a conceptual failure, as you say the animal
> > > > > testing is. But you don't do that. That's a lie of
> > > > > omission: if the supposed "failure" of the drug in
> > > > > prescriptive use "proves" the conceptual failure of
> > > > > animal testing, then NECESSARILY it must also "prove"
> > > > > the conceptual failure of human testing.
> > > >
> > > > No. I have already called the clinical trials inadequate.
> > >
> > > - Or does the following reveal why clinical trials 'fail'..
> > >
> > > [snip *classic* lesley obfuscation with mountains of text she doesn't understand]
> >
> > NONE of that shows animal tests to be a conceptual failure. You
> > fucking moron.

"The human clinical trials are in three stages. The first trial
involves healthy human volunteers, typically about 20-80.
At this stage eleven out of twelve animal-modelled drugs fail.
Nature Biotechnology, 1998; 16, p1294.
http://vivisection-absurd.org.uk/xunrel.html

> Animal tests are a failure you stupid Goober. 99.99% of the shit the
> pharmas are selling would NEVER be approved if the testing was done on
> humans.

It's tested on humans, but may be sold even if found to be
very harmful, on the back of selective reporting of results.

Here's the deal: ~jonnie~ is claiming that because the drugs
authorised for prescription but later withdrawn or relabelled
due to serious adverse effects and fatalities were also tested
on humans, we cannot say that the fault lies with the testing
on animals for risks prior to the clinical trials - even though,
in his own words, "the animal testing is done primarily to
show that the drugs may be safely *studied* in humans,";
IOW, the animal tests should eliminate unacceptable risk.

No such indications of serious risks were discovered, but
instead of accepting that the initial tests on animals were
misleading, ~jonnie~ tries to foist upon us *his* ridiculous
notion that because some very dangerous drugs pass the
clinical trials, if we consider testing on animals to be a
conceptual failure, then we should also say that testing on
humans is a conceptual failure, which is patently absurd,
and not content with that, attacks us for not doing so!

There are failures alright, but of a very different nature.

Acknowledge the truth about why and how dangerous
drugs make it to prescription, causing injury and death?
Not ~jonnie~. His response to substantial evidence of
suppression of negative data from clinical trials ..

[snip *classic* lesley obfuscation with mountains of text she doesn't understand]

The guy is clearly insane.



John Beardmore
2006-03-19 11:30:38 EST
In message <dvjpqv$ds$1@reader01.news.esat.net>, pearl
<*a@signguestbook.ie> writes
>"shrubkiller" <shrubkiller@excite.com> wrote in message
>news:1142711243.387290.59780@v46g2000cwv.googlegroups.com...

>It's tested on humans, but may be sold even if found to be
>very harmful, on the back of selective reporting of results.

Well it my, but that would be unethical. You have a civil duty to
report any such cases to the relevant authorities.


>Here's the deal: ~jonnie~ is claiming that because the drugs
>authorised for prescription but later withdrawn or relabelled
>due to serious adverse effects and fatalities were also tested
>on humans, we cannot say that the fault lies with the testing
>on animals for risks prior to the clinical trials - even though,
>in his own words, "the animal testing is done primarily to
>show that the drugs may be safely *studied* in humans,";
>IOW, the animal tests should eliminate unacceptable risk.

Nonsense. Safe enough to study does not mean that problems will never
arise later in larger populations.

I thought you were claiming not to be making this claim ?

It is a question of what risks are acceptable at each stage in the
process.


>No such indications of serious risks were discovered, but
>instead of accepting that the initial tests on animals were
>misleading, ~jonnie~ tries to foist upon us *his* ridiculous
>notion that because some very dangerous drugs pass the
>clinical trials, if we consider testing on animals to be a
>conceptual failure, then we should also say that testing on
>humans is a conceptual failure, which is patently absurd,
>and not content with that, attacks us for not doing so!

Well, if both animal and human trials were inadequate, but the
limitations of both were understood, clearly they were of value as far
as they went, but the researchers should have gone further. What's your
problem ?


>There are failures alright, but of a very different nature.
>
>Acknowledge the truth about why and how dangerous
>drugs make it to prescription, causing injury and death?

Don't see anybody having a problem with that.


>Not ~jonnie~. His response to substantial evidence of
>suppression of negative data from clinical trials ..

Where ?


>[snip *classic* lesley obfuscation with mountains of text she doesn't
>understand]
>
>The guy is clearly insane.

The guy is clearly impolite, but maybe he's been driven to it ?


J/.
--
John Beardmore
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