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PRESCRIPTION DRUG TESTING TRUTH REVEALED....scary story of last 20 years...
Posted by Vishva News Reporter on May 7, 2010 |
Photo: Nick Veasey
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Half of all drugs that
fail in late-stage trials drop out of the pipeline
due to their
inability to beat sugar pills.
In many cases,
these are the compounds that,
in the late '90s, made Big Pharma more
profitable than Big Oil.
But if these same drugs were vetted now, the
FDA might not approve some of them....
(scary stuff for patients...including wastage of medicine costs... )
In
drug testing many test subjects treated with the medication
felt their hopelessness and anxiety lift.
But so did those who took a
placebo,
a look-alike pill made of milk sugar or another inert substance
given to groups of volunteers in clinical trials
to gauge how much more effective the real drug is by comparison.
The fact that taking a faux drug
can powerfully improve some people's health
—the so-called
placebo effect—
....has
long been considered an embarrassment to
the serious practice of
pharmacology....
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PVAF's primary mandate is TO FIND THE TRUE KNOWLEDGE...As per
Hippocratic Oath...the primary mandate of Medical practice and industry
is to heal humans without greed for undue or ulterior profit making
commercial motives...
Today's news story is a shocking revelation of how pharmaceutical
companies are not being honest about the TRUE effectiveness of their
drugs to heal when it comes to financial survival of the
pharmaceutical...But in turn they are also deceiving the doctors who
prescribe the medications and make them break their
Hippocratic Oath...
You must read the original to the most recent versions of Hippocratic
Oath on the next page at the end of today's news story
to really understand what medical profession and its healing medicine
producers should not be doing today in greedy pursuit of wealth.....
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Engraving of Hippocrates by
Peter Paul Rubens,
1638.
Hippocrates, the father of western
medicine, originally stated in 4 B.C. the Hippocrates Oath....
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And now to read today's news story please click on the next line to go
the second web page....
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....Placebos Are Getting More
Effective....
.....Drug makers Are Desperate to Know
Why....
(From
Wired Magazine:
By Steve Silberman August 24, 2009)
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Merck was in trouble. In 2002, the pharmaceutical
giant was falling behind its rivals in sales. Even worse, patents on
five blockbuster drugs were about to expire, which would allow cheaper
generics to flood the market. The company hadn't introduced a truly new
product in three years, and its stock price was plummeting.
In interviews with the press, Edward Scolnick, Merck's research
director, laid out his battle plan to restore the firm to preeminence.
Key to his strategy was expanding the company's reach into the
antidepressant market, where Merck had lagged while competitors like
Pfizer and GlaxoSmithKline created some of the best-selling drugs in the
world. "To remain dominant in the future," he told Forbes, "we need to
dominate the central nervous system."
His plan hinged on the success of an experimental antidepressant
codenamed MK-869. Still in clinical trials, it looked like every pharma
executive's dream: a new kind of medication that exploited brain
chemistry in innovative ways to promote feelings of well-being.
The drug
tested brilliantly early on, with minimal side effects, and Merck touted
its game-changing potential at a meeting of 300 securities analysts.
Behind the scenes, however, MK-869 was starting to unravel. True, many
test subjects treated with the medication felt their hopelessness and
anxiety lift. But so did nearly the same number who took a placebo, a
look-alike pill made of milk sugar or another inert substance given to
groups of volunteers in clinical trials to gauge how much more effective
the real drug is by comparison.
The fact that taking a faux drug can
powerfully improve some people's health—the so-called
placebo effect—has
long been considered an embarrassment to the serious practice of
pharmacology.
Ultimately, Merck's foray into the antidepressant market failed. In
subsequent tests, MK-869 turned out to be no more effective than a
placebo. In the jargon of the industry, the trials crossed the futility
boundary.
MK-869 wasn't the only highly anticipated medical breakthrough to be
undone in recent years by the placebo effect.
From 2001 to 2006, the
percentage of new products cut from development after Phase II clinical
trials, when drugs are first tested against placebo, rose by 20 percent.
The failure rate in more extensive Phase III trials increased
by 11
percent, mainly due to surprisingly poor showings against placebo.
Despite historic levels of industry investment in R&D, the US Food and
Drug Administration approved only 19 first-of-their-kind remedies in
2007—the fewest since 1983—and just 24 in 2008.
Half of all drugs that
fail in late-stage trials drop out of the pipeline due to their
inability to beat sugar pills.
The upshot is fewer new medicines available to ailing patients and more
financial woes for the beleaguered pharmaceutical industry.
Last
November, a new type of gene therapy for Parkinson's disease, championed
by the Michael J. Fox Foundation, was abruptly withdrawn from Phase II
trials after unexpectedly tanking against placebo.
A stem-cell startup
called Osiris Therapeutics got a drubbing on Wall Street in March, when
it suspended trials of its pill for Crohn's disease, an intestinal
ailment, citing an "unusually high" response to placebo.
Two days later,
Eli Lilly broke off testing of a much-touted new drug for schizophrenia
when volunteers showed double the expected level of placebo response.
It's not only trials of new drugs that are crossing the futility
boundary. Some products that have been on the market for decades, like
Prozac, are faltering in more recent follow-up tests.
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In many cases,
these are the compounds that, in the late '90s, made Big Pharma more
profitable than Big Oil.
But if these same drugs were vetted now, the
FDA might not approve some of them.
Two comprehensive analyses of
antidepressant trials have uncovered a dramatic increase in placebo
response since the 1980s. One estimated that the so-called effect size
(a measure of statistical significance) in placebo groups had nearly
doubled over that time.
It's not that the old meds are getting weaker, drug developers say. It's
as if the placebo effect is somehow getting stronger.
The fact that an increasing number of medications are unable to beat
sugar pills has thrown the industry into crisis.
The stakes could hardly
be higher. In today's economy, the fate of a long-established company
can hang on the outcome of a handful of tests.
Why are inert pills suddenly overwhelming promising new drugs and
established medicines alike?
The reasons are only just beginning to be
understood.
A network of independent researchers is doggedly uncovering
the inner workings—and potential therapeutic applications—of the placebo
effect.
At the same time, drug makers are realizing they need to fully
understand the mechanisms behind it so they can design trials
that
differentiate more clearly between the beneficial effects of their
products and the body's innate ability to heal itself.
A special task
force of the Foundation for the National Institutes of Health is seeking
to stem the crisis by quietly undertaking one of the most ambitious
data-sharing efforts in the history of the drug industry.
After decades
in the jungles of fringe science, the placebo effect has become the
elephant in the boardroom.
The roots of the placebo problem can be traced to a lie told by an Army
nurse during World War II as Allied forces stormed the beaches of
southern Italy. The nurse was assisting an anesthetist named Henry
Beecher, who was tending to US troops under heavy German bombardment.
When the morphine supply ran low, the nurse assured a wounded soldier
that he was getting a shot of potent painkiller, though her syringe
contained only salt water. Amazingly, the bogus injection relieved the
soldier's agony and prevented the onset of shock.
Returning to his post at Harvard after the war, Beecher became one of
the nation's leading medical reformers. Inspired by the nurse's healing
act of deception, he launched a crusade to promote a method of testing
new medicines to find out whether they were truly effective.
At the
time, the process for vetting drugs was sloppy at best:
Pharmaceutical
companies would simply dose volunteers with an experimental agent until
the side effects swamped the presumed benefits.
Beecher proposed that if
test subjects could be compared to a group that received a placebo,
health officials would finally have an impartial way to determine
whether a medicine was actually responsible for making a patient better.
AND now to have a benchmark to evaluate the morality, ethics
and accountability of the above you need to understand Hippocratic Oath
which was originally stated in 4 B.C. by Hippocrates, the father of
western medicine.....please keep reading below...... |
......Hippocratic Oath....
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Hippocratic Oath is an oath traditionally taken by
doctors swearing to ethically practice medicine. It is widely
believed to have been written by
Hippocrates, the father of western medicine, in the 4th century
BC, or by one of his students[1],
and is usually included in the Hippocratic Corpus. Classical scholar
Ludwig Edelstein proposed that the oath was written by
Pythagoreans, a theory that has been questioned due to the lack
of evidence for a school of Pythagorean medicine.[2]
The phrase "first, do no harm" is often, incorrectly, attributed to
the oath. Although mostly of historical and traditional value, the
oath is considered a rite of passage for practitioners of medicine,
although nowadays the modernized version of the text varies among
the countries.
[edit]
Oath text
[edit]
Original
Original, translated into English:[/span>3]
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“ |
I swear by
Apollo, the healer,
Asclepius,
Hygieia, and
Panacea, and I take to witness all the gods, all the
goddesses, to keep according to my ability and my judgment,
the following Oath and agreement:
To consider dear to me, as my parents, him who taught me
this art; to live in common with him and, if necessary,
to share my goods with him; To look upon his children as my
own brothers, to teach them this art.
I will
prescribe regimens for the good of my patients according
to my ability and my judgment and
never do harm to anyone.
I will not
give a lethal drug to anyone if I am asked, nor will I
advise such a plan; and similarly I will not give a woman a
pessary to cause an
abortion.
But I will preserve the purity of my life and my arts.
I will not
cut for stone, even for patients in whom the disease is
manifest; I will leave this operation to be performed by
practitioners, specialists in
this art.
In every house where I come I will enter only for the
good of my patients, keeping myself far from all intentional
ill-doing and all seduction and especially from the
pleasures of love with women or with men, be they free
or slaves.
All that may come to my knowledge in the exercise of my
profession or in daily commerce with men, which ought not to
be spread abroad, I will
keep secret and will never reveal.
If I keep this oath faithfully, may I enjoy my life and
practice my art, respected by all men and in all times; but
if I
swerve from it or violate it, may the reverse be my lot.
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” |
[edit]
Modern
Modern translation of the English:[4]
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“ |
I swear by Apollo Physician and Asclepius and Hygieia and
Panaceia and all the gods, and goddesses, making them my
witnesses, that I will fulfil according to my ability and
judgment this oath and this covenant:
To hold him who has taught me this art as equal to my
parents and to live my life in partnership with him, and if
he is in need of money to give him a share of mine, and to
regard his offspring as equal to my brothers in male lineage
and to teach them this art–if they desire to learn
it–without fee and covenant; to give a share of precepts and
oral instruction and all the other learning to my sons and
to the sons of him who has instructed me and to pupils who
have signed the covenant and have taken the oath according
to medical law, but to no one else.
I will apply dietic measures for the benefit of the sick
according to my ability and judgment; I will keep them from
harm and injustice.
I will neither give a deadly drug to anybody if asked for
it, nor will I make a suggestion to this effect. Similarly I
will not give to a woman an abortive remedy. In purity and
holiness I will guard my life and my art.
I will not use the knife, not even on sufferers from
stone, but will withdraw in favor of such men as are engaged
in this work.
Whatever houses I may visit, I will come for the benefit
of the sick, remaining free of all intentional injustice, of
all mischief and in particular of sexual relations with both
female and male persons, be they free or slaves.
What I may see or hear in the course of treatment or even
outside of the treatment in regard to the life of men, which
on no account one must spread abroad, I will keep myself
holding such things shameful to be spoken about.
If I fulfil this oath and do not violate it, may it be
granted to me to enjoy life and art, being honored with fame
among all men for all time to come; if I transgress it and
swear falsely, may the opposite of all this be my lot.
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” |
A widely used
modern version of the traditional oath was penned by Dr.
Louis Lasagna, former Principle of the
Sackler School of Graduate Biomedical Sciences of
Tufts University.[5]
In the 1970s, many American medical schools chose to abandon the
Hippocratic Oath as part of graduation ceremonies, usually
substituting a version modified to something considered more
politically and medically correct, or an alternate pledge like the
Oath or Prayer of
Maimonides.
The Hippocratic Oath has been updated by the
Declaration of Geneva. In the
United Kingdom, the
General Medical Council provides clear modern guidance in the
form of its Duties of a Doctor[6]
and Good Medical Practice[7]
statements.
[edit]
Modern relevance
The original text of the
Hippocratic
Oath is usually interpreted as one of the first statements
of a moral of conduct to be used by physicians, assuming the respect
for all human life, even unborn. Most Christian tradition interprets
the original Hippocratic Oath as a condemnation of abortion and
infanticide.
According to
Margaret Mead : "For the first time in our tradition there was a
complete separation between killing and curing. Throughout the
primitive world, the doctor and the sorcerer tended to be the same
person. He with the power to kill had power to cure, including
specially the undoing of his own killing activities. He who had the
power to cure would necessarily also be able to kill... With the
Greeks the distinction was made clear. One profession, the followers
of Asclepius, were to be dedicated completely to life under all
circumstances, regardless of rank, age or intellect – the life of a
slave, the life of the Emperor, the life of a foreign man, the life
of a defective child..."
[1]
Derivations of the oath have been modified over the years in
various
countries. Most Medicine schools administer some form of oath.
It has been suggested that a similar oath should be undertaken by
scientists, a
Hippocratic Oath for Scientists.
Modern challenged parts of the oath:
- To teach medicine to the sons of my teacher. In the
past, medical schools gave preferential consideration to the
children of physicians.[citation
needed]
- To practice and prescribe to the best of my ability for
the good of my patients, and to try to avoid harming them.
This beneficial intention is the purpose of the physician.
However, this item is still invoked in the modern discussions of
euthanasia.
- I will not give a lethal drug to anyone if I am asked,
nor will I advise such a plan. Physician organizations in
most countries have strongly denounced physician participation
in
legal executions. However, in a small number of cases, most
notably the
U.S. states of
Oregon,[9]
Washington,[10]
Montana,[11]
and in
the Kingdom of the Netherlands,[12]
a doctor can prescribe
euthanasia with the patient's consent. In addition, abortion
in many western countries is legal, rendering the forbiddance of
abortive remedies irrelevant in some circles of medicine.
- SSimilarly, I will not give a woman a pessary to cause an
abortion. Since the legalization of abortion in many
countries, the inclusion of the anti-abortion sentence of the
Hippocratic oath has been a source of contention.br />
- To avoid violating the morals of my community. Many
licensing agencies will revoke a physician's license for
offending the morals of the community ("moral
turpitude").
- I will not cut for stone, even for patients in whom the
disease is manifest; I will leave this operation to be performed
by practitioners, specialists in this art. The "stones"
referred to are
kidney stones or
bladder stones, removal of which was judged too menial for
physicians, and therefore was left for barbers (the forerunners
of modern surgeons). Surgery was not recognized as a specialty
at that time. This sentence is now interpreted as acknowledging
that it is impossible for any single physician to maintain
expertise in all areas. It also highlights the different
historical origins of the
surgeon and the physician.
- To keep the good of the patient as the highest priority.
There may be other conflicting 'good purposes,' such as
community welfare, conserving economic resources, supporting the
criminal justice system, or simply making money for the
physician or his employer that provide recurring challenges to
physicians.
[edit]
See also
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