FDA approval of medical devices based on complete science fraud Posted on March 6th, 2010
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The Journal of the American Medical Association (JAMA) and the American Journal of Therapeutics (AJT) have both published papers criticizing the way in which the Food and Drug Administration (FDA) approves medical devices. Citing a lack of legitimate safety and effectiveness studies, the papers allege that the FDA is approving medical devices without proper scientific evidence proving that they work and will not harm patients.
Researchers from the University of California, San Francisco, pored over seven years worth of FDA public summaries concerning approved medical devices. Researchers from Beth Israel Deaconess Medical Center in Boston wrote the AJT piece, concluding that the FDA’s safety and effectiveness data for medical devices is inconsistent and unreliable. William Maisel, one of the researchers, indicated that the FDA needs to improve its clinical trial standards for medical devices.
When drugs are approved, they typically go through a series of studies prior to even being evaluated by the FDA. A medical device, however, can be approved based on the results of a single study which may or may not contain important specifics such as who participated in the study. Critics note that, since a medical device is usually a permanent addition to someone’s body, it deserves even more intense scrutiny than prescription drugs which can be discontinued if found to be harmful. This is especially true with heart devices that are necessary in order to keep a person alive.
Dr. Jeffrey Shuren, acting director of the FDA’s device division and co-author of one of the studies, conceded that the FDA’s process for evaluating medical devices is inadequate. He explained that the FDA is working on creating stronger standards for evaluation and approval but that device manufacturers need to work more closely with them to establish study goals.
Janet Trunzo, an executive vice president of AdvaMed, an advocacy group for the medical device industry, defended the FDA’s current approach to approving medical devices. She expressed that device manufacturers submit extensive data to the FDA who spends 1,200 hours reviewing it all prior to approving a device.
Many approved medical devices have been recalled over the years for safety reasons. The FDA maintains a list of the most serious medical device recalls for which the products in question may cause “serious health problems or death.” There are over 30 devices on the list from 2009 alone. Since 2004, there have been 137 medical devices recalled by the FDA.
Climategate: This Time It’s NASA Posted on March 6th, 2010
by Iain Murray and Roger Abbott, American Spectator
The “Climategate” scandal, which broke in November 2009, revealed what many skeptics had privately suspected. Prominent climate scientists at the University of East Anglia’s Climate Research Unit (CRU) had collaborated to keep data out of skeptics’ hands, subverted the peer review process, and used questionable methods to construct the temperature record on which the United Nations Intergovernmental Panel Climate Change (IPCC) based its recommendations.
Now a new “Climategate” scandal is emerging, this time based on documents released by NASA’s Goddard Institute for Space Studies (GISS) in response to several Freedom of Information Act (FOIA) suits filed by the Competitive Enterprise Institute (CEI). The newly released emails further demonstrate the politicized nature of climate science, revealing a number of questionable practices that cast doubt on the credibility of scientific data provided by NASA.
The emails reveal that GISS, like CRU, has done a poor job of preserving and managing its data. Although there is no evidence that GISS has destroyed its data, as CRU did in the late 1980s, Dr. Reto Ruedy of GISS admits in an email that “[The United States Historical Climate Network] data are not routinely kept up-to-date.” In another email, he reveals that NASA had inflated its temperature data since 2000 on a questionable basis. “[NASA's] assumption that the adjustments made the older data consistent with future data… may not have been correct,” he says. “Indeed, in 490 of the 1057 stations the USHCN data were up to 1C colder than the corresponding GHCN data, in 77 stations the data were the same, and in the remaining 490 stations the USHCN data were warmer than the GHCN data.”
Hat Tip: MilitantLibertarian
USDA to Dump National Animal Identification System.. Sort of Posted on March 5th, 2010
A flurry of news surrounded the announcement by United States Department of Agriculture (USDA) Secretary Tom Vilsack that the controversial National Animal Identification System (NAIS) would be scrapped. The measure met stiff resistance from homesteaders, small farmers, organic growers, and raw milk and whole foods advocates. The problem is, the news is wrong. The NAIS isn’t being scrapped, it’s just being shelved “pending more review.”
There is a mixture of good and bad news in the USDA’s decision. The decision was likely not made to benefit the small producer or the homesteader. Rather, it was probably made in order to take them out of the debate so that the tracking system could go through.
The original NAIS plan would have required onerous costs on small agricultural producers – whether they were selling product or not – and distinctly favored the large agricultural conglomerates, who could easily afford the new rules. Rules which applied differently to them.
In the NAIS, each animal on a farm would require a tracking number and 48-hour reporting of its whereabouts and condition. This applied to everything from backyard poultry to cattle herds in the hundreds of thousands. The big difference was that large (industrial) livestock herds could be tracked as a single unit, whereas small homestead or farm herds had to be tracked as individual animals.
Besides the economic reasoning, however, whole foods advocates like Judith McGeary of the Farm and Ranch Freedom Alliance say that the system itself is a waste of taxpayer’s money. Tracking the animals does nothing but allow for finding the source after the fact, but nothing to prevent anything up front. The whole excuse for the NAIS was to be able to prevent diseases like mad cow from spreading.
“USDA’s claim that we need 48-hour traceback of all animal movements is not supported by scientific studies or logic. The agency should focus on high risk situations, namely the factory farms. The agency should also look at the specific diseases of concern and how they are spread. A one-size-fits-all approach will not work.”5
Now, any animal that does not cross state lines upon its sale is not required to be tracked. This eliminates most small farms, local sellers, and homesteaders out of the equation, which would, in turn, give them no reason to combat the USDA’s plans for a future NAIS.
However, it will still effect many of us in the whole foods and organic lifestyle movements. Anyone who has homesteaded realizes that you cannot produce everything you need all on your own. You need neighbors with whom you can barter and do business. A small farmer on the eastern edge of Wyoming, for instance, may need chicks to replenish his hen house after an unfortunate fox attack. He is as likely to go into Nebraska, next door, as anywhere else. Except now he`s crossed state lines, so those chicks must be registered with NAIS.
That is only one example and assumes that the USDA will not expand the reach of its program once it’s in place. Further, it’s obvious that the USDA’s plan to track animals will do nothing to prevent disease and only allow them to point the finger to lay blame when an outbreak occurs.
The real problem here are the huge, commercial meat producers who handle their cattle as if they were merely cogs in the wheel at a factory. This industrial agriculture means huge stockyards with thousands of pens holding hundreds upon hundreds of animals packed in shoulder-to-shoulder, wallowing in their own filth. This is a disease bomb just waiting to explode onto the market.
The USDA’s plan for NAIS is not to scuttle the project, but only to change it and re-introduce the same idea in a couple of years. This does nothing to prevent disease and everything to cater to the huge agricultural conglomerates and industrial meat producers.
All while making life more difficult, even impossible, for the small farmer and homesteader.
Resources:
1 – USDA Plans to Drop Program to Trace Livestock, William Neuman, New York Times, Feb. 5, 2010
2 – USDA Announces New Framework for Animal Disease Traceability, USDA, Feb. 5, 2010
3 – Farm and Ranch Freedom Alliance Weighs in on NAIAS, Hartke Is Online, June8, 2009
4 – Q&A: New Animal Disease Traceability Framework, USDA APHIS, February 2010
5 – Farm and Ranch Freedom Alliance Weighs in on NAIAS, Hartke Is Online, June 8, 2009
Herbicide Chemical in Drinking Water Could Pose Much Greater Danger to Health Than Previously Thought Posted on March 4th, 2010
by David Gutierrez, NaturalNews
Contamination of drinking water by a common herbicide poses a greater health threat than previously believed, according to a report issued by the nonprofit environmental organization Natural Resources Defense Council (NRDC).
The Environmental Protection Agency (EPA) monitors average yearly levels of the popular herbicide atrazine in drinking water supplies, based on four tests per year. But the NRDC notes that levels of the toxin in drinking water regularly spike after heavy rains or during the spring when it is being widely applied, and that the four yearly testings may miss these events. The organization’s researchers found several such spikes in its own testing of water supplies in towns in agricultural regions of the South and Midwest.
“Our biggest concern is early-life-stage development,” said Jennifer Sass of the NRDC. “If there’s a disruption during that time, it becomes hard-wired into the system. These endocrine disrupters act in the body at extremely low levels. These spikes matter.”
Because atrazine is compatible with no-till farming, it is popular among farmers seeking to acquire a “green” label by reducing their carbon footprint. It is known to disrupt the hormonal system, and may cause cancers and menstrual problems in adults. It is considered especially dangerous to the developing reproductive systems of fetuses and children. The chemical has been shown to kill aquatic microorganisms and suppress the immune systems of larger animals, and it can cause limb or reproductive deformities in amphibians at levels as low as 0.1 parts per billion.
The EPA has set a threshold of 3 billion parts per billion for permissible atrazine levels, which the NRDC says would be too high even without periodic spikes. The NRDC analysis of 139 different municipal water systems found that 54 of them had a one-time spike higher than 3 parts per billion at some point in 2003 or 2004.
Home or municipal carbon filters can remove atrazine from water, but many municipal treatment plants do not use such procedures.
Sources for this story include: www.washingtonpost.com.
The New Surge Towards Codex Alimentarius Posted on March 3rd, 2010
Several of the latest items in the news are all pointing towards a new surge in the rapid implementation of Codex Alimentarius. John McCain’s Dietary Suplement Safety Act of 2010 (S.3002), Canada’s recent approval of genetically modified pigs, and the huge proliferation of genetically modified foods at market are all spelling total food control, coming fast.
McCain’s bill requires all dietary supplement manufacturers (vitamins, herbs, minerals, etc.) to come under FDA control and registration. Further, everyone in the supplement supply chain, from manufacturers to retail stores, must be registered so they can be monitored.1
Meanwhile, the Canadian government is on the brink of approving genetically modified pigs (called “enviropigs”) for use in the food supply. This is the first step towards pigs that have been crossed with mice being on the dinner plates of Canadians throughout the provinces.2
At the same time, a Canadian regulatory authority has told pharmacies to remove supplements from their shelves unless they have met with Health Canada standards – standards which have a five year backlog, currently.3
The biggest threat to the World Health Organization’s (WHO) Codex Alimentarius implementation is the health supplement market and the well-educated people who tend to purchase those products for their own use. Despite health supplements not being able to list their health benefits on their packaging in America, supplements are one of the fastest-growing markets in the health industry overall.
The enemy of Codex Alimentarius, therefore, is people like you and I and the companies who provide us with the supplements and whole foods we rely on for our own health.
Health Canada, for its part, is good friends with the Codex Alimentarius.4 The United States isn’t far behind, with the USDA having a special task force within the Food Safety and Inspection Service (FSIS) for the Codex.5 That’s not all, the primary force behind the World Health Organization’s Codex Alimentarius agenda is.. the United States.6
This, of course, is done on behalf of the multi-national pharmaceutical (aka Big Pharma) companies, conglomerate agribusiness, and (as always) the banks that back them. So far, the WHO’s Codex group has been instrumental in insuring the adoption of GMO and GM food crops around the world, especially in many of the world’s major food producers in the second and third worlds.
The ultimate goal of the Codex, once you look past it’s feel-good mission statement, is to remove the real health movement and its supplements and foods, so that they can be replaced with the “well regulated” foods of the huge corporate conglomerates that mass-produce garbage and poison and call it “food.”
We are well on the way towards full implementation of the Codex Alimentarius. Will you stand by and watch it happen?
Resources:
1 – McCain’s Dietary Supplement Bill, by Brandon Turbeville, Black Listed News
2 – Canada to approve GM ‘enviropigs’, UPI
3 – Natural Remedies and Supplements Take Blow in Canada, Brace for One in U.S., by Aaron Turpen, NaturalNews
4 – Health Canada Codex Alimentarius page
5 – USDA FSIS Codex Alimentarius page
6 – Codex Alimentarius: Population Control Under the Guise of Consumer Protection by Dr. Gregory Diamato, PhD, NaturalNews
