FDA // Current TV

Gov't to Start Making Pharmaceuticals

The Obama administration has become so concerned about the slowing pace of new drugs coming out of the pharmaceutical industry that officials have decided to start a billion-dollar government drug development center to help create medicines.

The new effort comes as many large drugmakers, unable to find enough new drugs, are paring back research. Promising discoveries in such illnesses as depression and Parkinson's that once would have led to clinical trials are instead going unexplored because companies have neither the will nor the resources to undertake the effort. Drug companies have typically spent twice as much on marketing as on research, a business model that is increasingly suspect.

The initial financing of the government's new drug center is small compared with the $45.8 billion that the industry estimates it invested in research in 2009. The cost of bringing a single drug to market can exceed $1 billion, according to some estimates.

Groundwork for drug firms

The National Institutes of Health has traditionally focused on basic research, such as describing the structure of proteins, leaving industry to create drugs using those compounds. But the drug industry's research productivity has been declining for 15 years, "and it certainly doesn't show any signs of turning upward," said Dr. Francis Collins, director of the institutes.

The job of the new center, to be called the National Center for Advancing Translational Sciences, is akin to that of a home seller who spruces up properties to attract buyers in a down market. In this case, the center will do as much research as it needs to do to attract drug company investment.

Read more: Federal agency to spearhead new drug-development center - The Denver Post http://www.denverpost.com/nationworld/ci_17171570?source=rss#ixzz1BsgqBwLu
Read The Denver Post's Terms of Use of its content: http://www.denverpost.com/termsofuse

So, since the drug companies aren't spending on R&D with their record profits, the tax payer will fund it with a government agency, who will then sell it to the drug companies, who will then sell it to us at more record profits. Oh by the way, when was the last time a pill cured anything?The Obama administration has become so concerned about the slowing pace of new drugs... more

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Nuclear Sludge Chew Bars recalled over lead concerns

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Monsanto is the Real Food Terror Threat

31st December 2010

By Chris Hinyub
Intependent Voter Network | December 24, 2010

" Control The Food Supply, and you control the people."

Acting on information from a “key intelligence source,” CBS News claimed that terrorists are trying to poison our food supply on Monday. This may come as a shock, but some researchers have already identified several thriving “food-terror cells” who’ve been operating from within our borders for years. One is based in St. Louis, Missouri under the cover of a trans-national chemical manufacturer turned bio tech firm. It turns out that Monsanto has been poisoning Americans with the FDA’s approval for at least 12 years.

Mary Nash Stoddard of the Aspartame Consumer Safety Network informs us:

“In 1998, Monsanto applied for FDA approval for a monster molecule, ‘based on the aspartame formula,’ with one critical addition: 3-dimethylbutyl [listed on EPA's most hazardous chemical list]. Neotame is touted as being 13,000 times sweeter than sugar.

On July 5 2002, Monsanto’s Neotame molecule was approved by the US FDA over formally registered objections of the Aspartame Consumer Safety Network and others. Long term effects on humans are unknown. Read the full release at the Aspartame Consumer Safety Network. The food labeling requirements for aspartame have now been dropped for Neotame, and no one is clear why this was allowed to happen. Neotame has been ruled acceptable, without being included on the list of ingredients, for USDA Certified Organic food items and Certified Kosher products with the official letter k inside the circle on labels.

Ever ready to give the public what it craves – guilt-free, low calorie treats that taste as good as sugar, is the multi-billion dollar sweetener industry. The sugar industry pales by comparison in the profit-generating arena. Fake sugars, in the form of Aspartame and now the Aspartame super clone, Neotame, give ‘foodies’ and fitness fanatics false hope and the empty promise that all can ‘have our cake and eat it, too.’ “Not necessarily so.” Don’t think that by avoiding sweet things you won’t get a 3-dimethylbutyl dose. Neotame is quickly displacing molasses as a feed amendment at industrial cattle lots, helping to make those cows’ GMO grain-based diet “more palatable.”

With an even more questing spirit than the alleged al Qaeda plotters, who supposedly planned to put cyanide in our restaurant salad buffets, Monsanto has already managed to put their genetically modified crops into 70 percent of the processed food products on grocery store shelves. The FDA does not require labeling of these disease-causing ingredients. Monsanto’s continued expansion and its infiltration of rural America has been funded by a massive subsidy program authorized by the USDA. Many have written about the revolving door leadership policy between federal food agencies and the corporate behemoth, but few seem to grasp the grave dangers such a good-ol’-boy network entails. The fact is, Monsanto has not produced a “food” product that independent, non-corporate sponsored studies have found to be safe for prolonged human consumption.

Case and point: recombinant Bovine Growth Hormone (aka rBGH or rBST). This refers to a genetically modified hormone injected into dairy cows to boost their milk production. Together with being more plentiful (and more puss-filled), milk from rBGH treated cows (despite what the milk-jug label wants you to believe) is detrimental to human health. Sold to factory dairy farmers under the brand name Posilac, rBGH has successfully evaded crucial labeling laws in the U.S. and abroad since it was approved by the FDA in 1994. Posilac was perhaps the most prevalent Weapon of Mass Disease in Monsanto’s well-stocked arsenal until the first wave of unbiased scientific scrutiny forced them to pawn their cancer-causing product off on pharmaceutical giant Eli Lily.

I think it’s about time for Americans to be a little more proactive in fighting food-terrorism. Though most of use don’t have the luxury of producing our own food, we can at least use our powers as consumers to opt-out of supporting terrorist organizations. Just say no to Monsanto products and to a genetically altered, chemically perverted food supply. Let’s stop funding organizations that wreak economic, ecological and biological terror on the civilized world.31st December 2010 By Chris Hinyub Intependent Voter Network | December 24, 2010... more

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Brainstem Glioma survivor using Antineoplastons - Jessica Ressel - clip from Burzynski, the Movie

Visit: http://www.burzynskimovie.com/ for more information and to obtain the DVD.

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Food Safety Bill Passes Senate, Including the Tester Amendment

Editor's Note: Thanks to all the groups who campaigned tirelessly on this issue. OCA is pleased that the Tester Amendment passed along with the bill, but like the Farm and Ranch Freedom Alliance (quoted below), we have some concerns about the implementation of these regulations and will continue to monitor this issue and keep our eye on the FDA.

WASHINGTON - The Senate on Tuesday passed a sweeping overhaul of the nation's food-safety system, after recalls of tainted eggs, peanut butter and spinach that sickened thousands and led major food makers to join consumer advocates in demanding stronger government oversight.

The legislation, which passed by a vote of 73 to 25, would greatly strengthen the Food and Drug Administration, an agency that in recent decades focused more on policing medical products than ensuring the safety of foods. The bill is intended to get the government to crack down on unsafe foods before they harm people rather than after outbreaks occur.

Despite unusual bipartisan support on Capitol Hill and a strong push from the Obama administration, the bill could still die because there might not be enough time for the usual haggling between the Senate and House of Representatives, which passed its own version last year. Top House Democrats said that they would consider simply passing the Senate version to speed approval.

Both versions of the bill would grant the F.D.A. new powers to recall tainted foods, increase inspections, demand accountability from food companies and oversee farming. But neither version would consolidate overlapping functions at the Department of Agriculture and nearly a dozen other federal agencies that oversee various aspects of food safety, making coordination among the agencies a continuing challenge.

While food-safety advocates and many industry groups preferred the House version because it includes more money for inspections and fewer exceptions from the rules it sets out, most said the Senate bill was far better than nothing.

"This is an historic moment," said Erik Olson, deputy director of the Pew Health Group, an advocacy group. "For the first time in over 70 years, the Senate has approved an overhaul of F.D.A.'s food safety law that will help ensure that the food we put on our kitchen tables will be safer."

Among the Senate bill's last major sticking points was how it would affect small farmers and food producers. Some small-farm and organic food advocates warned that the legislation would destroy their industry under a mountain of paperwork, and Senator Jon Tester, a Democrat of Montana, pushed for a recent addition to the bill that exempts producers with less than $500,000 a year in sales who sell most of their food locally.

...Judith McGeary, executive director of the Farm and Ranch Freedom Alliance, an advocacy group that sees government regulation as a threat to small farms, said she was satisfied with changes made to the bill to reduce paperwork for small farmers and exempt them from some requirements.

"We still have concerns about the scope of the power that F.D.A. has and its tendency to write rules and regulations that favor agribusiness instead of small farmers," Ms. McGeary said.Editor's Note: Thanks to all the groups who campaigned tirelessly on this issue.... more

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FDA: Gilead ad for Truvada 'misleading'

Editor's Note: I would recommend that you do some research about any new medication on the market, even those approved by the FDA considering the close relationship which exists between the FDA and the Pharmaceutical industry. A revolving door exists between many drug companies and the FDA. I also recommend that you watch the video below in which a scientific researcher admits that AIDS was developed by the U.S. during the development of the polio vaccines.

Regulators have warned Gilead Sciences Inc. about direct-to-consumer print advertising for its HIV drug, Truvada.

The Food and Drug Administration said Gilead's ad for Truvada touts the drug as "better or more effective than has been demonstrated." It asked Foster City-based Gilead (NASDAQ: GILD) to "immediately cease" the ads.

Specifically, the FDA takes issue with ads that show photographs of a woman who takes Truvada as part of her HIV combination therapy — at graduation, in an office setting and as a married woman sitting on a sofa — and appears to be happy and in good health. The headline above the images states, "HIV doesn't have to change the hopes and dreams I have now." Among the claims below the images is the line, "With once a day Truvada for my HIV, I can plan for long-term success."

"The print ad is false or misleading because it overstates the efficacy of Truvada, makes unsubstantiated claims and minimizes the risks associated with the drug," the FDA regulatory review officer Aline Moukhtara said in a letter to Joyce Acbay, Gilead's director of regulatory affairs.

The FDA said the "totality of these claims and presentations misleadingly suggests" that patients using Truvada can manage their HIV-1 RNA levels, or viral load, and increased CD4 cell count on a long-term basis. That, however, "has not been demonstrated by substantial evidence or substantial clinical experience," the FDA said.

Gilead does note in the ad — "in small, non-prominent font," the FDA said — that Truvada was evaluated "through 3 years of a clinical study" and "proven over the long term … in 3 years of a clinical study."

"However, this contextual information does not mitigate the overwhelming impression created by the prominent images and claims in the print ad, which suggest that patients can expect long-term treatment success with Truvada as they achieve their hopes and dreams, such as graduation, a career and marriage," the FDA said in its letter. "Any of these goals can easily take more than three years to accomplish."

Biogen Idec also was warned by the agency for a webcast promoting the multiple sclerosis therapy Tysabri.

Read more:
http://globalpoliticalawakening.blogspot.com/2010/11/fda-gilead-ad-for-truvada-misleading.htmlEditor's Note: I would recommend that you do some research about any new... more

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GLOBAL POLITICAL AWAKENING: BREAKING: Senate votes cloture on S 510 – must now be voted on in 60 days

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