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by Underground Panther in the Sky, Unknown News
July 10, 2006
A psychopathic
killer
wants to get away with murder. A psychopathic regime, then, studies the failings
of every other psychopathic regime. Bush's psychopathic
cohorts, I would bet, are looking to other psychopathic regimes in the past,
and
seeking to fix their flaws, the better to get away with genocide. The medical-mental health-pharmaceutical complex have also learned from their past mistakes.
One of the
Nazis' flaws was that their death camps were out there for all to see, confirmed with a simple flyover. The trains of people were visible to every
German. Who knows how long that state of denial could go
on. Eventually
it broke, and the dictators get dragged through the street.
Smart
psychopaths don't want to lose the game, so the study how other
psychopaths
were busted. When the bodies piled up and the neighbors notice something
stinks, then the jig is up. How does a smart psychopath get around that?
How would corporate psychopath Nazis hide the Death camps from the do-gooder human rights people, like Amnesty International, if it was happening all over again nowadays?
Hide them in plain sight. Hide the prisoners inside jails, hospitals and nursing homes, foster care, private homes.
Put
the death camps where forgotten people or sick, hurt people are
vulnerable and may die anyway. Just kill and call it a "clinical
trial"
done without consent.
It's much harder, after all, to see the killers, to count the
bodies murdered, to reveal the methods, when you never know what killed them... And you will never know whom is guilty of a crime if a crime
scene
is a 'clinical trial,' declared private "proprietary information" and
a
company secret. Can't know squat if everything you need to
know
has been redacted from the 'study' results to protect corporate
privacy. You'll never see a cattle car coming for you, when it looks like a hospital emergency room.
You might declare, 'Not in my body you don't', or 'Not with my life —
don't
test your poisons and potions on me. Oh, but you don't have a right to say no to
your self serving testing now, do you? Especially when you're bleeding to
death and unconscious. So your life and rights will be taken away, simply
because
they can be taken away.
Well, fuck you very much!
Fuck all these corporate sociopaths. We've got to do something
before
they go too far — oops, they already did — but nobody's looking.
It happens one by one. A mother dies from an untested drug to stop her heart
from fibrillating, and she and her family had no clue she was a lab
rat... A kid is shot on the street, taken to an ER, given fake blood and dies,
and nobody knows he was given the fake blood. A homeless guy dies from a
trial vaccine he got for the flu, but no-one had to
ask
his permission... A drug addict dies from an untested medicine and nobody
notices... An old lady in a nursing home dies from an untested drug but
who
cares, who even knows? A foster kid dies from AIDS medicines, an orphan too, a retarded kid, and they won't be missed, I'm sure. Some mother's
problem
teen gets too big a dose of psych drugs, just to test how much a body can take
before
it implodes, and nobody knows why her kid died. Must have been
stress. The company owns the results of the 'studies', the
reasons for these deaths, and the company caused these deaths, but all the evidence remains in a corporate
vault somewhere — evidence
that is "proprietary information" now.
With these new laws violating consent, we will never see the horrors
coming at us. If we keep trusting these corporate psychopaths — as if
they see us as anything but a means to their own depraved ends, more
profit, and a very sick utopian vision — they will impose their will, their tests, their death upon us
whether
we consent or not.
Drug companies can test experimental, unapproved, unsafe, deadly drugs
on
human beings without our consent now. And it's funny how particular
hospitals
and ambulance crews in poor black neighborhoods are in the scheme
Testing PolyHeme is murder in plain sight, but it gets worse.
Click the articles in the sidebar, to the right. Pay special attention to FDA's new rules sidestep safety concerns, from the science journal Nature. And cross your fingers, and hope you're not selected for a 'study' without your own knowledge.
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“The rules on testing in people will mostly benefit the large
pharmaceutical companies, by allowing 'phase zero' or 'exploratory'
trials. These are brief
trials — of seven days or less — in which human subjects are given very
low doses of experimental drugs before standard in vitro and animal
testing is complete.” |
© by the author.
FDA's new rules sidestep safety concerns
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Human experiments without informed consent:
It's now the American way...
Loyola will test blood substitute
without patients' consent
Chicago Sun-Times Feb. 9, 2004| |
Excerpt: In a rare exception to the way clinical trials are conducted, Loyola University Health System plans to test an experimental blood substitute on patients without their permission.
Loyola will use a blood substitute, PolyHeme, on car accident victims and other trauma patients who are unable to give their consent. |
Researchers tested AIDS drugs on children
Associated Press May 4, 2005| |
Excerpt: Government-funded researchers tested AIDS drugs on hundreds of foster children over the past two decades, often without providing them a basic protection afforded in federal law and required by some states, an Associated Press review has found.
The research funded by the National Institutes of Health spanned the country. It was most widespread in the 1990s as foster care agencies sought treatments for their HIV-infected children that weren’t yet available in the marketplace.
The practice ensured that foster children — mostly poor or minority — received care from world-class researchers at government expense, slowing their rate of death and extending their lives. But it also exposed a vulnerable population to the risks of medical research and drugs that were known to have serious side effects in adults and for which the safety for children was unknown. |
Bad blood?
San Diego Reader July 28, 2005| |
Excerpt: By the very definition of the study, all patients are in hemorrhagic shock and unable to refuse the PolyHeme. As noted by Northfield: "It is expected that patients enrolled in this trial will be unable to provide informed consent because of the nature and extent of their injuries." The lack of consent was justified on the grounds that the existing blood substitute currently used by paramedics is simple saline solution and that almost anything, even an experimental substance like PolyHeme, would be an improvement for desperate trauma patients. |
Ethicists blast study testing fake blood
Associated Press March 2, 2006| |
Excerpt: Imagine being in a car crash, lying unconscious and bleeding in an ambulance. With no blood on board, paramedics give you an experimental substitute, but even at the hospital, you get fake blood for several hours before doctors try the real thing.
Medical ethicists say a study that is doing just that on hundreds of trauma patients without their consent should be halted. |
FDA's new rules sidestep safety concerns
Nature March 28, 2006| |
Excerpt: The manufacturing guidelines relax strict requirements for early-stage drug-making. For instance, they allow more than one drug to be made at the same facility, and specify that production and quality control can be done by the same person in small operations. Until January, requirements about everything from ventilation to staffing levels had put drug-making beyond the reach of most university researchers.
The rules on testing in people will mostly benefit the large pharmaceutical companies, by allowing 'phase zero' or 'exploratory' trials. These are brief trials — of seven days or less — in which human subjects are given very low doses of experimental drugs before standard in vitro and animal testing is complete. |
Artificial blood experiment: Is your city participating?
ABC News July 7, 2006| |
Excerpt: Northfield Lab's experimental blood substitute PolyHeme is currently in randomized phase III clinical trials recruiting patients without informed consent all over the country. At one point, it was being tested in as many as 27 cities; it is still being tested in 23 hospitals in 20 cities.
With the FDA's approval, Northfield Lab has recruited hospitals to participate in the trial study with exemption from informed consent requirements on study participants. Although Northfield Lab claims that extensive information on the study has been made public, a vast majority of the general public has never heard of the trial. ... |
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by Meredith Wadman, Nature
March 22, 2006
David Curiel has just spent four years and US$4 million building a
state-of-the-art plant to make molecules that could deliver gene therapy to
patients.
Now it may never be needed. Earlier this year the US Food and Drug
Administration (FDA) announced new rules that will allow small doses of
experimental drugs to be tested in people before full-scale clinical trials
begin. At the same time, it loosened manufacturing requirements for early-stage
drug candidates so Curiel will be free to make his delivery molecules in a
cheaper and more convenient workshop.
"We built a palace," says Curiel, director of the gene-therapy center at the
University of Alabama, Birmingham. "If these guidelines had been in place five
years ago, we would have saved a lot of time and effort."
Nonetheless, like other medical researchers, Curiel warmly welcomes the rules,
which will let him walk down the hall to pick up a batch of vector molecules,
instead of crossing eight blocks of the Birmingham campus. And he won't have to
scramble for more money to run the center: the FDA had told him that it would
need five dedicated staff. "Who was going to pay for that?" he asks.
Not everyone is so thrilled with the change. In London last week, six healthy
men suffered multiple organ failure after taking part in a phase I trial of a
biological drug candidate. In light of this, some question
whether this is the time to ease up on controls.
The London event was "absolutely horrific", says Thomas Murray, a bio-ethicist
and president of the Hastings Center in Garrison, New York. "There will be a
profound desire not to repeat this experience, and to make sure that the FDA
policy changes do not tip the balance too much towards speed and risk."
The rules are part of an FDA drive to open bottlenecks and streamline drug
development as estimates of the cost of bringing an original drug to market soar
above $1 billion.
"The problem is that researchers conducting very early studies were required to
follow the same manufacturing procedures as companies that mass-produce products
for broad-scale distribution," explains Janet Woodcock, the FDA's deputy
commissioner for operations.
The changes should benefit academics, she notes, by allowing them to make small
batches of experimental drugs and do early testing in people giving them a
better shot at snaring industrial partners to take drugs further.
It's a tremendous opportunity for us to rapidly explore many compounds.
The manufacturing guidelines relax strict requirements for early-stage
drug-making. For instance, they allow more than one drug to be made at the same
facility, and specify that production and quality control can be done by the
same person in small operations. Until January, requirements about everything
from ventilation to staffing levels had put drug-making beyond the reach of most
university researchers.
The rules on testing in people will mostly benefit the large pharmaceutical
companies, by allowing 'phase zero' or 'exploratory' trials. These are brief
trials — of seven days or less — in which human subjects are given very low
doses of experimental drugs before standard in vitro and animal testing is
complete.
Phase zero studies do not examine safety or effectiveness; instead, they gather
data on the targeting, action and metabolism of a drug in the body. The goal is
twofold: to allow drug-makers to identify and jettison failing candidates early,
and to generate data that will help them design smarter phase I studies of
promising compounds.
That has drawn plaudits from drug-makers, who are frequently forced to use animal
data alone to choose the one drug from a panel of candidates that will be
propelled into phase I trials.
"We are very interested in pursuing this," says Tim Wright, the deputy head of
exploratory clinical development at Swiss drug-maker Novartis. "It's a tremendous
opportunity for us to rapidly explore multiple compounds" with limited
laboratory and animal testing, he says, adding that his company hopes to start
several of the early trials within a year.
Pfizer has already conducted two phase zero studies, and is planning more,
according to Liam Ratcliffe, the company's global chief of clinical research and
development. He estimates that one of the studies, conducted on eight volunteers
last September, shaved five months off the development time of an anticoagulant.
"It's a welcome change," he says.
The phase zero trials eat up some time before phase I can begin, however, and
this may deter small biotechnology companies from doing them. Julian Adams, an
organic chemist and chief scientific officer at Infinity Pharmaceuticals, a
Massachusetts developer of cancer drugs, says that he has had two opportunities
so far to run phase zero trials. He rejected both. "It just wasn't worth it for
us," he says. "It saves some money up front. But it doesn't save you time."
At the US National Cancer Institute, however, plans are under way to make use of
both changes to the system, says Joe Tomaszewski, deputy director of cancer
treatment. He says that production and pre-clinical toxicology now cost between
$1 million and $1.5 million for a typical cancer drug. "To get into a phase zero
trial, you could cut that in half. So you could put twice as many compounds in
the clinic."
Some cancer specialists point out that, at the tiny doses administered in phase
zero trials, there isn't going to be any benefit to trial participants. In
healthy volunteers, this need not be an issue. But in cancer, "you're dealing
with dying patients," says Cy Stein, an oncologist at Albert Einstein College of
Medicine in New York. "In phase I, at least we can tell them: 'We really think
we've got something here'." But in phase zero, he says, "you're offering
nothing. I can't agree to that. Certainly not to save big pharma some time."
Others, including Sidney Wolfe, director of the health-research arm of Public
Citizen, a Washington-based advocacy group, have argued that phase zero studies
are ethically troublesome. By reducing the pre-clinical testing required before
an experimental drug goes into humans, says Wolfe, the FDA "increases the risk
to the subjects".
Senator Chuck Grassley (Iowa, Republican) put it more bluntly in a statement
when the regulations were released. "The FDA is loosening the reins on drug
companies," he said. "I'm concerned for those who will be receiving these
experimental drugs."
But Woodcock says the approach will protect patients. "Study in people early in
the process is going to decrease human exposure to compounds that ultimately
fail," she says, "Which right now is the majority of them."
Curiel, for his part, hopes to capitalize on the manufacturing changes,
cannibalizing the first-class hardware and equipment of his white-elephant
facility and moving it to a corner of his existing lab. Complying with the old
rules was "complicated, difficult and time consuming", he says. "The new
guidelines will make all of this dramatically easier."
As originally published
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Underground Panther in the Sky
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