Thursday, July 3, 2008

Obama policy shifts being in earnest

As the focus of the Obama campaign shifts from securing the Democratic vote to securing the national vote, the clear line that so many of his supports clung to in almost militant fashion begins to blur. As he reaches out to the Fundamentalist right wing and softens his position on a swift withdrawal from Iraq.

While the need to secure a base of support to win the election is paramount, there is also the post-election to consider. Few people now believe that a fast withdrawal from Iraq is even possible, and clearly this is something the Obama campaign would rather address now that as the election comes to a close.

Pressures from the aggressive Israeli position perhaps adding to the urgency of this slow but important shift.

"My 16-month timeline if you examine everything I've said was always
premised on making sure that our troops were safe," said Obama. "I said
based on what the information we had received from our commanders that
1-2 brigades per month could be pulled off safely from a logistical
perspective."

Further distancing himself from the rapid withdrawal statements of the past. Obama added "And my guiding approach," he added, "continues to be that we've got to
make sure that our troops are safe, and that Iraq is stable. And I'm
going to continue to gather information to find out whether those
conditions still hold."

This is a wonderful piece of marketing because no one can fault him for looking out for the troops and by tying to this the stability of Iraq he leaves room to add the stability of the region later.

Who broke the FDA prt 2

Like Prescription Drug User Fee Act (PDUFA) the Animal Drug User Fees Act (ADUFA) puts the economy of the FDA and it's duties to the people squarely at odds. And like PDUFA the ADUFA, the big fees are up front on a per item basis.
There is also an annual sponsor fee of $43,900.

The Animal Drug User Fee Act of 2003 (ADUFA), amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and authorized FDA to collect fees to support the review of animal drugs. These additional resources support FDA's responsibilities under the Act to ensure that new animal drug products are safe and effective for animals as well as human consumers with respect to animals intended for food consumption.

This one pretty much covers the food supply because everything we eat either eats or gets eaten.

So now you and I are both thinking about not having a hamburger this weekend and wondering if this was the point everything got broken right? Well it's a long story. It was actually already broken at this point, this was just another nail in the coffin.

We have to go all the way back to 1937. The administration of BST was shown to increase the milk yield in lactating cows by preventing mammary cell death in dairy cattle. Until the 1980s, there was very limited use of the compound in agriculture as the sole source of the hormone was from bovine cadavers.

Monsanto developed a recombinant version of BST, brand named Posilac, in 1994,[4] which is produced through a genetically engineered E. coli.

Now don't get all crazy because you see E. coli it's a good choice for doing this. I'm not a scientist so I won't try to explain why, trust me it's safe. And according to the FDA rBST is safe too.

But what's with the baby 'r' this is America and we like out acronyms big. The little 'r' stands for recombinant DNA and it's only a small part of the story. But an important part because the use of cloning is interrelated with Recombinant DNA

In other words they cloned BST, using E. coli as a host. But it was already broken. More or less this statement is true depending on how you want to look at things. But no matter which side of the cloning argument you are on the implications are pretty big.

Monsanto is by far the leading producer of genetically engineered (GE) seed, holding 70%–100% market share. Including Roundup Ready soybean seed. It is the world's leading producer of the herbicide glyphosate, marketed as "Roundup".

But this isn't about Monsanto, it's about the FDA and money and ideology.

In January 2005, Monsanto agreed to pay a $1.5m fine for bribing an Indonesian official. Monsanto admitted a senior manager at Monsanto directed an Indonesian consulting firm to give a $50,000 bribe to a high-level official in Indonesia's environment ministry in 2002, in a bid to avoid Environmental impact assessment on its genetically modified cotton. Monsanto told the company to disguise an invoice for the bribe as "consulting fees". Monsanto also has admitted to paying bribes to a number of other high-ranking Indonesian officials between 1997 and 2002. Monsanto faced both criminal and civil charges from the Department of Justice and the SEC. Monsanto has agreed to pay $1m to the Department of Justice and $500,000 to the SEC to settle the bribe charge and other related violations.[23]

Monsanto has a partnership with BASF's Agricultural Products & Nutrition, supply chemicals for agriculture and animal nutrition. The big push here is Nutrigenomics. As a point of interest I'll mention here that BASF is a very old and reputable company praised by the Climate Leadership Index for their efforts in problems with climate change and greenhouse gasses in our world.

Under the leadership of
Carl Bosch, BASF founded IG Farben together with Hoechst, Bayer and three other companies, thus losing its independence.

I should probably mention at this point that Monsanto is owned by Bayer.

In 2002 Bayer AG acquired Aventis CropScience and fused it with their own agrochemicals division (Bayer Pflanzenschutz or "Crop Protection") to form Bayer CropScience. The company is now one of the world's leading innovative crop science companies in the areas of crop protection (i.e. pesticides), non-agricultural pest control, seeds and plant biotechnology. In addition to conventional agrochemical business it is involved in genetic engineering of food. The Belgian biotech company Plant Genetic Systems, became part of the company by the acquisition of Aventis CropScience.

Bayer AG sponsored the experiments of Nazi Dr. Josef Mengele. In 1956 Fritz ter Meer became chairman of Bayer after having been sentenced at the Nuremberg trials to seven years' imprisonment for his part in carrying out experiments on human subjects at Auschwitz.

Through a confusing series of transactions, the Monsanto that existed from 1901–2000 and the current Monsanto are legally two different corporations. Although they share the same name, corporate headquarters, many of the same executives and other employees, and responsibility for liabilities arising out of its former activities in the industrial chemical business, the agricultural chemicals business is the only segment carried forward from the pre-1997 Monsanto Company to the current Monsanto Company.

These aren't evil companies it's not a great conspiracy. They simply have an ideology that is not compatible with a regulatory system that have anything to do with funding.

Justice Clarence Thomas worked as an attorney for Monsanto in the 1970s. Thomas wrote the majority opinion in the 2001 Supreme Court decision J. E. M. AG SUPPLY, INC. V. PIONEER HI-BREDINTERNATIONAL, INC. which found that "newly developed plant breeds are patentable under the general utility patent laws of the United States." This case benefitted all companies which profit from genetically modified crops, of which Monsanto is one of the largest.[64][65][66]

In August 2006, it became apparent that the United States rice crop had been contaminated with unapproved genetically engineered Bayer CropScience rice as undisclosed amounts were found in commercial rice supplies.[6]

Michael R. Taylor was an assistant to the F.D.A. commissioner before he left to work for a law firm on gaining F.D.A. approval of Monsanto’s artificial growth hormone in the 1980s. Taylor then became deputy commissioner of the F.D.A. in 1991.[67]

Dr. Michael A. Friedman was a deputy commissioner of the F.D.A. before he was hired as a senior vice president of Monsanto.[68]

Linda J. Fisher was an assistant administrator at the E.P.A before she was a vice president at Monsanto from 1995 - 2000. In 2001, Fisher became the deputy administrator of the E.P.A.[69]

Former Secretary of Defense Donald Rumsfeld was chairman and chief executive officer of G. D. Searle & Co., which Monsanto purchased in 1985. Rumsfeld personally made at least $12 million USD from the transaction.[70]

We can literally run the Small world experiment here forever. But this isn't our cell phones or our automobiles this is our food supply and we should error on the side of caution in it's regard.

The answer to who broke the FDA is, we did.



Who broke the FDA prt 1

With the tomato problem unsolved and E.coli in the beef, many people are looking at there grill and asking who broke the FDA.

It was a slow decline that started a long time ago. It's a long story and it starts back in the mid- and late 1980s ACT-UP and other HIV activist organizations accused the FDA of unnecessarily delaying the approval of medications to fight HIV and opportunistic infections, and staged large protests. In August of 1990, Dr. Louis Lasagna, then chairman of a presidential advisory panel on drug approval, estimated that thousands of lives were lost each year due to delays in approval and marketing of drugs for cancer and AIDS.[22]

Partly in response to these criticisms, the FDA issued new rules to expedite approval of drugs for life threatening diseases, and expanded pre-approval access to drugs for patients with limited treatment options.[23]

There is no doubt these reforms saved countless lives and helped revolutionize the way and speed at which drugs get to market it was also a crack in the armor.

1992 Prescription Drug User Fee Act (PDUFA) Now I know this sounds a little crazy, but that's because it is. This created a situation in which the companies the FDA is supposed to be regulating pay fees in order to have their drugs approved by the FDA. And these are big fee, some of them are in the 7 digit range. But there is a problem. The big one is the application fees currently at $1,178,000. It can only be charged once per product. There is no re-application fee.

This law has been tweaked and played with many times over the years, arguably it's been made worse.


On September 27, 2007, President Bush signed into law the Food and Drug Administration Amendments Act of 2007 which includes the reauthorization and expansion of the Prescription Drug User Fee Act. The reauthorization of PDUFA will significantly broaden and upgrade the agency's drug safety program, increase resources for review of television drug advertising.

But it's a long story so to keep it short we will skip over the Medical Device User Fee and Modernization Act and head right into the Animal Drug User Fees. Because what we really want to know is why are our hamburgers in trouble.

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Beef Recall

The FDA had it all wrong it wasn't the Salmonella in the Tomatoes it was the E. coli in the Beef, or was it the Salmon Moose?

Just in time for the 4th of July weekend expands a recall on ground beef to stores in more than 20 states, holy shit we have more than 20 states?

I am I the only person that's starting to get past the wtf stage and moving into the falling on the floor laughing hysterically stage? This is one big joke isn't it?

It's America's God give right to throw a burger on the grill this weekend. I'm not one to call for blood often but someones head needs to start rolling pretty damn fast.


Uribe Machina

An amazing story Hollywood couldn't out do. Details are still coming out but in the words of kidnapped presidential candidate Ingrid Betancourt "God, this is a miracle," and later. "Such a perfect operation is unprecedented."

According to CNN
Colombian spies tricked leftist rebels into handing over the hostages. Owned! 15 hostages in total have been freed.

Uribe is now calling for the rebels to release all hostages in hopes of ending the 44 year rebellion.

But for some it's also a very stark reminder where the power in the region lies. This is a military that has been trained by some of America's finest. Many suggest it was paid for to the tune of 143.4 billion dollars by 1998.[12] but that's crazy.

I wasn't going to bring up drugs, people like drugs so lets call it terror now. In fact now that we have terror people probably need drugs.

Make no mistake about it, this Columbian army is a force to be reckoned with. There is nothing that can even compare to it in South America, and while the US population is unaware of how there tax dollars are spent no one in South America is kidding themselves.

Tough guy and ruthless dictator Hugo Chavez, one of Time magazine's 100 most influential people.[6][7] in 2005 and 2006, sat across from these guys and blinked.

FARC was at it's height maybe 18,000 strong and that was a while ago. The population of Columbia is around 43 million.

Geographically Columbia lies as the lynch pin to South America, Militarily it's Deus.

Mr. Harsh Guy