Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Saturday, December 19, 2015

Last week saw the approval of another genetically modified animal— this time a chicken genetically altered to produce a drug in its eggs



 


GM Chicken Approved “For Medicinal Purposes”! Are Humans Next?

 
The floodgates are open for more genetically modified animals—possibly even humans.

Last week saw the approval of another genetically modified animal— this time a chicken genetically altered to produce a drug in its eggs. The drug is designed to replace a faulty enzyme in people with a rare genetic condition that prevents the body from breaking down fatty molecules in cells.

The genetically engineered (GE) chicken is not approved for human consumption, but it is the third so-called “farmaceutical” approved in the US market. Preceding the chicken was a GE goat that produces antithrombin, an anticoagulant, in its milk. Last year the FDA also approved a drug for treating hereditary angioedema that is produced by transgenic (GE) rabbits.



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Saturday, October 24, 2015

Big Pharma Caught Manipulating Antidepressant Drug Trials Putting Teenagers in Grave Danger



Paxil
Paxil , Wkimedia.org
..........


By Kristen Anderson

The FDA requires each new drug to undergo rigorous testing and stand up to scientific scrutiny, a process that is designed to protect consumers by thoroughly examining the effects of new medications before they are available to the public. But few people stop to realize that these studies which are mandated by the FDA, are actually funded by the drug companies themselves, clearly a conflict of interest.

Big Pharma has so much influence in the field of scientific research, that the professionals who depend on peer-reviewed studies, i.e. doctors, psychiatrists, nurses, etc., prefer to read meta-analyses as a way to ensure objectivity. These meta-analyses combine evidence from multiple studies to weed out studies that produced irregular or uncommon results. In this way, the meta-analysis is regarded as the purest form of research and is heavily relied on by medical professionals. But, again, if Big Pharma has essentially infiltrated the research industry to the point that the majority of studies are being skewed, even a meta-analysis is unreliable.


Take for example Study 329. GlaxoSmithKline funded Study 329 between 1994 and 1998 and the results showed that Paxil was safe for teenagers. This study was published in 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP), a well-respected and peer-reviewed journal. It was later found, however, that the authors had downplayed the negative findings and that GlaxoSmithKline had actually hired a PR firm to ghost write the article! Paxil actually clearly increases suicidal thoughts and impulses among teenagers and this effect was downplayed in the article and not even addressed in the conclusion (the most-read section of a scientific study).


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Friday, April 11, 2014

Safe and Accurate Food Labeling Act : A proposed new federal law would outlaw state-enacted GMO labeling laws.

Consumer alert: GMO labeling to be outlawed by 'Safe and Accurate Food Labeling Act' introduced today in Congress


GMO
Thursday, April 10, 2014
by Mike Adams, the Health Ranger
Editor of NaturalNews.com (See all articles...)

(NaturalNews) A proposed new federal law just introduced by Rep. G.K. Butterfield (a Democrat) and Rep. Mike Pompeo (a Republican) would outlaw state-enacted GMO labeling laws. The new law, ridiculously called the Safe and Accurate Food Labeling Act, is actually an last-ditch, desperate effort by the biotech industry and the GMA to forever bury the truth about GMOs so that consumers don't know they're eating poison.
According to mainstream media reports (1), the bill would require the FDA to mandate GMO labeling only if those foods "are found to be unsafe or materially different from foods produced without biotech ingredients."
Because the FDA and USDA have already decided, against all scientific evidence, that GMOs are "safe" and "not materially different" from other foods, this requirement is nothing but sheer sleight of hand and a pandering to idiocy. In truth, this new bill, if passed into law, would allow food companies to permanently and insidiously hide GMOs in all their products forever, nullifying the numerous state-based GMO labeling laws which are on the verge of passing.
The Environmental Working Group calls this proposed new law the "DARK Act" (Denying Americans the Right to Know), saying:
After two states have passed GE labeling bills and more than 30 others are poised to consider similar labeling bills and ballot initiatives, the food and biotech industry have goat-roped some members of Congress into introducing legislation to block state GE labeling laws.

Push for GMOs run by criminally-minded organizations

GMOs have already been restricted or banned in over 60 countries (2), and Americans are very close to achieving victory in state-based GMO labeling campaigns. The very idea that American consumers might find out they've been eating GMO poisons in most of their favorite foods is so horrifying to the biotech industry (and the processed food front groups) that its enforcers are now seeking this "nuclear option" to legally deceive consumers about GMOs with the complicity of the FDA.

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Sunday, April 6, 2014

Koch ally to introduce Monsanto-backed bill to bar state GMO labeling laws

Published time: April 04, 2014 04:00

(AFP Photo / Dieter Nagl)
(AFP Photo / Dieter Nagl)
Rep. Mike Pompeo will introduce legislation backed by powerful trade groups to prevent states from passing laws requiring the labeling of genetically-modified foods, according to reports. The bill is linked to biotech giant Monsanto and Koch Industries.
Pompeo will offer the bill in the US House before Congress leaves for Easter recess later this month, The Hill newspaper reported, citing industry sources. Politico also reported on the impending proposal. Pompeo’s office would not comment on the congressman’s intentions for a labeling restriction.
The bill includes a “prohibition against mandatory labeling,” according to The Hill, echoing powerful interest groups that have already declared war against such “right to know” labeling laws around the nation.
It was revealed in recent months that powerful farming and biotechnology interest groups like Monsanto were joining forces – under the name 'Coalition for Safe Affordable Food' – to push a federal voluntary labeling standard for food made with genetically-modified organisms (GMOs) in an effort to stem the tide of state legislation seeking to mandate labeling.
In recent years, voters in states such as California and Washington have narrowly defeated ballot initiatives proposing mandatory GMO labeling, though not without dragging members of the new Coalition into expensive campaigns to defeat the measures. Many other states are now considering their own proposals to label GMO food.
A top member of the Coalition – the Grocery Manufacturers Association (GMA), a major food industry lobbying group – raised and spent the bulk of the overall $22 million that opponents of labeling sank into defeating Washington State’s ballot initiative on GMO labeling last year. That total number was three times the amount that proponents of labeling spent in the state. GMA was joined in its effort by allies such as biotech giants Monsanto, Bayer, and DuPont.
The Coalition said in February that it would seek to empower the US Food and Drug Administration (FDA) “to establish federal standards for companies that want to voluntarily label their product for the absence-of or presence-of GMO food ingredients.” In addition, the Coalition proposes the FDA mandate labels for GMO food or ingredients that the agency deems a “health, safety or nutrition issue,” though no consumables currently fall in such a category.
“The legislation we’re proposing would preclude state legislation that conflicts with the federal standards,” GMA president Pamela Bailey said of the Coalition’s aim, The Hill reported.

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Tuesday, January 28, 2014

Leading Scientist On Fukushima Radiation Hitting West Coast of North America: “No One Is Measuring So Therefore We Should Be Alarmed”

Washington's Blog



Federal, State and Local Governments Refuse to Test for Radiation on the West Coast of North America

Numerous models show that – while the ocean dilutes radiation – pockets and streams of concentrated radiation may still hit the West Coast of North America.
West Coast residents are very concerned.  Indeed, many local and state government officials have said that residents are inundating them with questions about Fukushima radiation.
And yet the government isn’t measuring seawater or fish on the West Coast for radiation.
Ken Buessler is the head scientist at Woods Hole in Massachusetts,  one of the world’s top ocean science institutions.  Much of Buessler’s career has focused on measuring radioactive particles in the ocean, and he’s been studying groundwater and ocean samples in and around Fukushima since the accident in March of 2011.
Buessler has consistently tried to downplay the risks from Fukushima, and yet even he admits that we won’t know unless we test.  Buessler noted this week:
The predictions are rather low and are not of direct concern, but no one makes measurements of these isotopes along the [West] coast .
***
No one is measuring so therefore we should be alarmed. I really try to take the approach that we shouldn’t trivialize the risks of radiation and shouldn’t be overly alarmed.
Buessler said last week:
What we don’t really know is how fast and how much is being transported across the Pacific. Yes, models tell us it will be safe, yes the levels we expect off the US West Coast and Canada we expect to be low, but we need measurements — especially now, as the plume begins to arrive along the West Coast and will actually increase in concentration over the next 1 to 2 years. Despite public concern about the levels, no public agency in the US is monitoring the activities in the Pacific.
***
Without careful, extensive, consistent monitoring, we’ll have no way of knowing how much radiation from Fukushima is reaching our shores, and how it could affect life in the ocean.
And:
Buesseler says no US government agency currently tests radiation levels in the Pacific Ocean.“I don’t expect the radiation levels to be high but we can’t dismiss the concerns that the public has.”
“The effects of Fukushima will be increasing as the front edge of a large water plume coming from the nuclear plant will reach California soon and increase over the years,” said Buesseler.
Buesseler recently took his concerns to Washington where he met with US government officials at the various agencies responsible for monitoring radiation levels in air, food, and water.
He said he visited officials at the Department of Energy, the National Oceanic and Atmospheric Administration, the Food and Drug Administration, and the Environmental Protection Agency.
“They all said that it’s not their responsibility to test the Pacific Ocean for radiation. This issue is falling between the cracks of government responsibility. It’s a health and safety issue here,” Buesseler said.
And Buesseler points out the circular reasoning which the government is using (at 10:00):
I completely agree that no radiation has been seen in the regards that we’re not really testing for it [laughter] in any organized way … We have very few data; it’s not really being organized. The government says we don’t really need to do that because we’re predicting very low levels.
This type of circular reasoning is – unfortunately – common these days. For example, when bad policy led to the 2008 financial crisis, the Gulf Oil spill, factory-farming caused disease, runaway pesticide use, and other problems, the government simply stopped testing or changed allowable levels.
U.C. Berkeley professor of nuclear engineering Eric Norman raises a similar point:
There is no systematic testing in the US of air, food, and water for radiation, continuous testing is needed”
***
“I’m not terribly confident in the information Japan is sharing about the plant’s activities and clean up. That’s why it’s even more important now to advocate for continuous testing of air, food, and ocean water for radiation.”
University of Alaska Fairbanks researcher Doug Dasher notes:
There’s a lot of unknowns, a lot of uncertainties. There are others that also have the same message that they want to get out, we really need to sample to understand this and we really need to look at what’s happening out there in the ecosystem at the same time. There’s an opportunity to do this. It’s a huge amount of initial release, and the models do not address the continuing release [the models all assume that Fukushima was totally contained by about June 2011 ... in fact, it has leaked continuously hundreds of tons of radioactive water every day for more than 2/12 years]. Fukushima has continued to leak ….
***

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Monday, June 10, 2013

Scientists Find Holes in Monsanto GM Wheat Denial



- Jacob Chamberlain, staff writer
 

(Boris Grdanoski / AP)


Monsanto claimed Wednesday that the Oregon field found last week to be contaminated with Monsanto's unapproved GM wheat was an "isolated" incident, and that it was likely either the result of an accident or "sabotage." However, scientists warned Thursday that the biotech giant's denial has many holes.
Monsanto claims that it has since tested 31,200 seed samples in Oregon and Washington and found no evidence of contamination—insisting there is no cause for concern in the world market.
However, researchers this week said that Monsanto's tests are misleading and that the genetically modified gene, not yet approved for use in the U.S., will likely continue to be found in wheat seeds.
"We don’t know where in the whole chain it is,” said Carol Mallory-Smith, the weed science professor at Oregon State University who tested the initial wheat plants and determined they were the unapproved Monsanto seed.
“I don’t know how Monsanto can declare anything. We obviously had these plants in the field."
“You introduce something into the environment, and genes move around in the environment, whether transgenic or not," she added.
The U.S. Department of Agriculture is currently investigating how the wheat gene, which was taken out of test fields eight years ago, is now showing up.
Monsanto claims that all of the tested seeds had been either destroyed or recovered and sent to a USDA facility in Colorado for storage.
However, David Andow, a professor of entomology at the University of Minnesota, said in an interview with Bloomberg that these claims are misleading and that the tests cited by Monsanto this week, which displayed clean wheat in the state of Washington, are shortsighted.
“Sure they tested it, but that doesn’t mean it’s all clean,” Andow said. “It just means it’s not so widespread that it could be detected easily.”
And Doug Gurian-Sherman, senior scientist at the Union of Concerned Scientists in Washington, said that this is not the first time Monsanto has been less than forthcoming on the extent of its seed contamination: "In previous cases, such as during the outbreak of herbicide-resistant weeds in recent years, Monsanto has initially played down the risks."
“The reality is that nobody knows what happened until extensive testing is done."
Additionally, Bloomberg reported recently that even if Monsanto's claims about this specific wheat strain were proven true, Monsanto has resumed trials of other and very similar GM wheat seeds, according to information posted in a U.S. Department of Agriculture (USDA) database.
Monsanto planted 150 acres of GM wheat in Hawaii last year and 300 acres of GM wheat in North Dakota this year—meaning the risk of genetic pollution from unapproved Monsanto wheat is even greater than most people are aware.
Meanwhile, the discovery of the GM wheat in Oregon caused fast moving international backlash, with Japan suspending some imports of US wheat, South Korea testing all of its US wheat imports, and the EU urging its members to test some of its US wheat imports.
The extent of contamination from Monsanto's GM wheat seeds in Oregon, let alone Hawaii and North Dakota, remain unknown.
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