Ethan A. Huff - FDA monopoly enforcement goes after Google for $500 million in online pharmacy ad profits

(NaturalNews) The U.S. Food and Drug Administration (FDA) recently snagged a hefty $500 million forfeiture, one of the largest in history, from search engine giant Google for running advertisements on its AdWords service for Canadian pharmacies. The agency claims these ads, which were also viewable by Americans, facilitated the illegal shipment of prescription drugs into the U.S. in violation of the Federal Food, Drug and Cosmetic Act, as well as the Controlled Substances Act.

A trophy in the FDA's trophy case of strong-armed regulatory enforcement actions, the $500 million forfeiture demonstrates the agency's intolerance for the sale of any drug that is not officially FDA-approved. But what it also embodies is a whole new level of government reach into private business practices, which in this case did not necessarily constitute a violation of the law on Google's part.

Read More:

http://www.naturalnews.com/034930_FDA_Google_online_pharmacies.html

Heidi Stevenson - Neotame, New Neurotoxic Sweetener: FDA Says No Label Needed, Not Even in Organics

Monsanto developed Neotame as their Aspartame patent was expiring, and had no trouble in gaining FDA approval in 2002. They added 3-dimethylbutyl, a chemical listed as hazardous by the Environmental Protection Agency (EPA), to Aspartame, making it both sweeter and more toxic.

Toxicity

Both Aspartame and Neotame contain substances that are metabolized into formaldehyde, a highly toxic poison, and an excitotoxic amino acid that agitates, thereby damaging, nerves.

At the time Neotame was originally approved by the FDA, Feingold.org, which battles the addition of many dodgy food additives, stated:

We did a search of MedLine to find studies of adverse effects or side effects of Neotame. Only four studies appeared, two of which were not studies, and the other two of which were actually a single study done by NutraSweet company researchers.

Read More:

http://articlesofhealth.blogspot.com/2012/01/new-acidic-neurtoxic-sweetener-from.html

Paul Tullis - Do You Know Where Your Medicine Came From? Over 40% of Pills Made Overseas -- Many in Unregulated Factories

Headaches. Insomnia. Anxiety. American medicine cabinets are packed with remedies for these common maladies. And up to 40 percent of them are manufactured overseas (along with 80 percent of active ingredients for pharmaceuticals). But a recent report by the U.S. Government Accountability Office estimated that in fiscal year 2009, the U.S. Food and Drug Administration visited just 11 percent of the 3,765 foreign factories it is responsible for inspecting — compared to 40 percent of domestic factories. In 2008, the GAO found that the FDA took two to five years to follow up with foreign plants it cited for safety issues — if it followed up at all. 

In 2008, 30 products made by a single Indian company were banned by the FDA, and a tainted batch of the blood thinner heparin from one of many hundreds of Chinese pharmaceutical plants was linked to 81 U.S. deaths.

Read More:

http://www.miller-mccune.com/health/your-medicine-cabinets-foreign-inspection-free-drugs-38808/

GMW - Undisclosed infection calls into question GM salmon claims

Coalition calls for FDA to halt approval of genetically engineered salmon
December 20 2011
http://truefoodnow.org/2011/12/20/coalition-calls-for-fda-to-halt-approval-of-genetically-engineered-salmon/

*Discovery of undisclosed infection of salmon eggs calls into question company claims that GE salmon are safe for the environmen

Washington DC – Yesterday afternoon a coalition of 11 food safety, environmental, consumer and fisheries organizations sent a letter to the U.S. Food & Drug Administration (FDA) calling for a halt to its approval of a genetically engineered (GE) salmon after learning that the company’s – AquaBounty Technologies, Inc. – research site was contaminated with a new strain of Infectious Salmon Anaemia (ISA), the deadly fish flu that is devastating fish stocks around the world.  

“This new information calls into question the reliability of AquaBounty’s data and the validity of its claims that their fish are safe for the environment” said Andrew Kimbrell, Executive Director of the Center for Food Safety. “The FDA must respond appropriately and conduct their own environmental impact statement that looks at a broad range of environmental risks from these genetically engineered salmon, including the risk of spreading diseases such as ISA and antibiotic use for other diseases.”

AquaBounty has claimed that the company’s process for raising GE fish is safer than traditional aquaculture.        However, documents that were revealed last week indicate that their production site was found by Canadian Authorities to have been contaminated in Nov. 2009.  This information was hidden from the public and potentially FDA and other Federal agencies consulting on the GE salmon application.  ISA is a deadly disease and is classified as a ‘Listed’ disease by the World Organization for Animal Health (OIE) – alongside diseases such as Anthrax, Bovine spongiform encephalopathy (BSE), Foot and mouth disease, rabies, sheep pox, swine fever, avian influenza, West Nile fever, scrapie, fowl cholera, bovine tuberculosis and myxomatosis. 

“Infectious Salmon Anaemia threatens wild fisheries around the world and the communities whose livelihood depend on those fish” said Erich Pica, President of Friends of the Earth US. “ISA infections in Chile cost the industry around two billion dollars. A similar infection in Canada and the U.S. could be the last blow to wild Atlantic salmon populations and bring a collapse in wild salmon fisheries.”

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Ed Silverman - Should The FDA Be An Independent Agency?

PHARMALOT

By Ed Silverman // December 14th, 2011 

http://www.pharmalot.com/2011/12/should-the-fda-be-an-independent-agency/

The outrage and hand-wringing continues over the unprecedented decision last week by US Human & Health Services Secretary Kathleen Sebelius to overrule the FDA and thwart a move to ease access to the Plan B pill, which is also known as the morning after pill. The move has generated intense debate that the White House politicized the FDA in favor of promoting sound science.

Those who supported approval of the pill saw the move as not only dangerous, but ironic, given that President Barack Obama had made a point, earlier in his administration, of insisting that decision making must favor science, not politics. Now, though, he is being widely criticized, by some, for pandering to conservatives as he campaigns for re-election. The FDA had favored making it possible for girls who are 17 and younger to get the pill without a prescription.

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Martha Rosenberg - In Shocking "Pharmalateralism," FDA Strips Critic of Voting Rights

http://www.opednews.com/articles/In-Shocking-Pharmalateral-by-Martha-Rosenberg-111213-278.html

December 13, 2011 By Martha Rosenberg It's said that it takes 22 FDA safety officers to change a light bulb: 12 to defend the decision to install it, 8 to call it another "lighting option," 6 to quote Big Pharma studies and one to say it doesn't need changing, it just needs a better label. This week's hearings into birth control pills Yaz, Yasmin, Beyaz and Safyral confirm the FDA's dedication to pharmalateralism. It's said that it takes 22 FDA safety officers to change a light bulb: 12 to defend the decision to install it, 8 to call it another "lighting option," 6 to quote Big Pharma studies and one to say it doesn't need changing, it just needs a better label. This week's hearings into birth control pills Yaz, Yasmin, Beyaz and Safyral confirm the FDA's dedication to pharmalateralism. Bayer launched Yaz in 2006 as a pill that goes "beyond birth control" to treat acne and severe PMS, all the while avoiding the water retention of traditional birth control pills. But soon, previously healthy teenagers experienced "beyond birth control" effects they hadn't expected. Fifteen-year-old Katie Ketner had her gallbladder removed after taking Yaz, Susan Gallenos had a stroke and part of her skull removed and Michelle Pfleger, 18, collapsed and died of a pulmonary thromboemboli, according to published reports.

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Alliance for Natural Health - Merck—Too Big to Prosecute?

Alliance for Natural Health On December 6, 2011

http://www.anh-usa.org/merck-too-big-to-prosecute/

There is a surprising reason why the government won’t go after drug companies for serious crimes.

It is because government programs like Medicare, Medicaid, and the Veterans Administration would then be barred from doing business with them!

In 1999 the FDA approved Vioxx, a drug created by Merck and Co. to treat arthritis. Vioxx was pulled off the market in 2004 because evidence showed it greatly increased the risk of heart attack in the 25 million Americans who had taken the drug. Some 50,000 patients sued [1], and 27,000 of the plaintiffs received $4.85 billion in settlement of their claims.

Last week the Department of Justice announced that Merck has agreed to pay a $321 million criminal fine [2] and plead guilty to one misdemeanor count of illegally introducing a drug into interstate commerce. Merck also is paying $426 million to the federal government and $202 million to state Medicaid agencies. Those payments will settle civil claims that its marketing caused doctors to prescribe and bill the government for Vioxx they otherwise would not have prescribed.

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Alliance for Natural Health - “FDA is Violating Federal Law”—Emord

Alliance for Natural Health On December 6, 2011

http://www.anh-usa.org/fda-violates-federal-law/

Bolstered by a massive outpouring of support from you, we are asking the agency to withdraw its New Dietary Ingredient (NDI) draft guidance completely!

The period for comments to the FDA on the draft guidance on NDI notifications closed on December 2. Along with the hundreds of thousands of messages you sent and the 20,000 phone calls you made to FDA and Congress, ANH-USA also submitted formal comments [1].

The problem with the FDA’s draft guidance on New Dietary Ingredients is that it allows FDA to arbitrarily deny the sale of any supplement created (or modified) in the past seventeen years [2]. If you’re a supplement manufacturer or distributor or possibly even a health food store, and you don’t file a NDI “notification” (actually a request for approval) for each ingredient in each product developed since 1994 in just the way prescribed by the FDA, and the court later decides the FDA is right, then you are guilty of product “adulteration,” which is punishable by prison. With your favorite supplements off the market, it also would allow the drug industry to adapt and patent them [3], and sell them back to you—by doctor’s prescription only—for 10 or 100 (or even more) times what you’re paying now.

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Gary Null, PhD and Jeremy Stillman - Prescription for Disaster: The Dirty Dozen FDA-Approved Pharmaceutical Drugs

By Gary Null, PhD and Jeremy Stillman

The Food and Drug Administration is mandated with the responsibility to ensure that our foods and medications are safe and effective. Hence, when a physician, primary health care provider or pharmacist provides a consumer with these medications, there is a fundamental belief that these work and will do minimal harm. Then we meet reality. The FDA has not only allowed extraordinarily inefficient, extremely toxic drugs onto the market, but then has ran interference on behalf of pharmaceutical companies and other special interests to protect their profits instead of immediately withdrawing their drugs from the market.

The consequence of eating at a restaurant you don’t like is that you won’t go back again. The consequence of taking a toxic drug is injury or death. The FDA has a long history of allowing deadly drugs to be promoted and marketed. The FDA has not sought prosecution when prima facie evidence proves that the manufacturers and their scientists, boards of directors and marketers knew all along that these drugs did not work as claimed or had dangerous side effects that they withheld from the FDA . These companies have engaged in overtly criminal activities and instead of ending up in prison or bankrupt, rarely is anyone ever held accountable. Bonuses are given and the value of their corporate holdings goes up- it’s all part of the cost of doing business today.

This article is to show you clear and exact examples of lethal and harmful drugs that should never have been marketed – some of which are still available to consumers. They are drugs that an honest and diligent FDA would never have allowed to be released on the market. Cumulatively, tens of thousands of Americans have died and hundreds of thousands more have been injured. And in the few cases that do make it to court, what is the standard penalty meted out for such brazen criminality? Pay a fine. Smile. You got out of jail free.

Fen-Phen (fenfluramine/dexfenfluramine/phentermine)

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Gary Null, PhD and Nancy Ashley, VMD, MS - FLU VACCINE: THE COVERUP – THE FRAUD

By Gary Null, PhD and Nancy Ashley, VMD, MS 

The CDC is just beginning its annual Influenza Vaccination Week which runs from December 4^th through the 10^th.¹ There will be a media onslaught as they try to persuade us that the end is near if we don’t get the flu vaccine. All of the regulatory bodies and the opinion leaders, the CDC, the FDA, the Institute of Allergies and Infectious Diseases, the AMA, the American Academy of Pediatrics and all the health care providers would have us believe that flu is a serious illness that can only be prevented by annual vaccination of everyone from 6 months of age on up. They try to instill us with fear: flu is unpredictable, it can be severe, it can kill -- and there might not be enough vaccine for everyone! What if there is a pandemic? Should we be worried? Should we get the vaccine to protect our friends and loved ones? Maybe not. Let’s take a look at some of the facts the CDC would rather you didn’t know.

Is It Really Dangerous Not to Get the Flu Vaccine?

The CDC’s website used to state that 36,000 Americans die of flu each year, but this number was never accurate. First, the CDC inflated the numbers by lumping together deaths from flu and pneumonia as though they were all from flu when actually, the annual deaths from pneumonia unrelated to flu have always been far greater than those from flu. More significantly, this number was never based in actual deaths. It comes instead from a statistical model which only estimates mortality but doesn’t actually count the numbers of deaths.² This year, however, the CDC’s website reflects the criticism they have received about this overstatement. In an impressive downward revision, the CDC now states that “over a period of 30 years, between 1976 and 2006, estimates of flu-associated deaths in the United States range from a low of about 3,000 to a high of about 49,000 people.”³ Quite a difference! For 2007, the CDC’s own statistics show that the number of deaths actually caused by influenza was just 411, and the death rate was therefore only 0.1 out of 100,000 people.⁴

The Vaccine Does Not Prevent the Flu or Flu-Like Illness

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Alliance for Natural Health - New FDA Food Detention Powers Could Endanger Your Access to Food and Supplements

Alliance for Natural Health On November 29, 2011

http://www.anh-usa.org/fda-food-detention-powers-endanger-food-and-supplements

They no longer need evidence that a product is harmful. Just a suspicion that there’s an error in the paperwork.

The Food Safety Modernization Act [1] (FSMA) was signed into law on January 4 of this year. For the past several months we’ve been sharing our concern over one of the FSMA’s mandates that eventually developed into the disastrous NDI draft guidance [2]. There are only a few days left to tell the FDA what you think about these new anti-supplement rules—FDA’s public comment period ends this Friday [3], December 2. Please take action today [4], if you haven’t done so already!

There is another rule mandated by the FSMA, which is currently being implemented, that we also want to highlight. It gives the FDA wider authority to detain food products, including supplements [5]. Under the previous law, in order to administratively detain food, the FDA had to show “credible evidence” that a food presents “serious adverse health consequences or death to humans and animals.” The new rule gives the FDA enhanced authority to detain any food or supplement they have “reason to believe” may be “adulterated” or “misbranded.”

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Alliance for Natural Health - An FDA-Approved Treatment for Osteoporosis that Actually Makes Bones Worse!

Alliance for Natural Health On November 29, 2011

http://www.anh-usa.org/fda-approved-treatment-makes-bones-worse

FDA’s prescription for bone health and osteoporosis has been shown to make bones far more fragile in the long term, and may even cause jaw death and esophageal cancer.

Bisphosphonate drugs are used for treatment of osteoporosis, a disease in which the bones become extremely porous, are subject to fracture, and heal slowly, occurring especially in post-menopausal women. The drugs, which are sold under the brand names Actonel, Atelvia, Boniva, and Reclast, have supposedly been shown to reduce the risk of breaking a hip by 40 to 50 percent and fracturing a vertebra by between 40 and 70 percent.

However, this FDA-approved therapy has become even more controversial now that it has been linked to atypical bone fractures after long-term use. The drugs have also been linked to deterioration of jawbone, jaw death, and potential esophageal cancer [1]. An FDA advisory committee now wants the FDA to limit how long a patient may be on bisphosphonate therapy, but committee members cannot agree on an appropriate time limit [2].

As osteoporosis expert Lara Pizzorno explains, bisphosphonate drugs help prevent fractures in the short-term by suppressing osteoclasts, the cells that remove injured and damaged bone. In doing so, there is no space to replace the damaged bone with healthy bone tissue. Eventually unhealthy bone accumulates and becomes extremely fragile.

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Garret Wood - Supplements Set to Become Illegal in 2012 under FDA

FoodFreedom.com   October 30, 2011

http://foodfreedom.wordpress.com/2011/10/30/supplements-set-to-become-illegal-in-2012-under-fda/

http://foodfreedom.wordpress.com/2011/10/30/supplements-set-to-become-illegal-in-2012-under-fda/

By Garret Wood

The FDA has issued new rules that, if enacted, will enable them to ban many of the supplements you are now taking.

Think I’m exaggerating? Then please listen to the full story …

Back in the early 1990s, the FDA tried to make many supplements illegal.  Consumers were so alarmed by the FDA’s bullying that they staged a massive revolt. The result was that Congress passed the Dietary Supplement Health and Education Act (DSHEA). That law protected supplements from the FDA unless the FDA could prove a supplement wasn’t safe.

There was, however, a loophole in the 1994 law. The FDA was given the authority to regulate new ingredients introduced after October 15, 1994.

So what happened?  Nothing at first.  For 17 years, the FDA took no action, gave no guidance, and launched no enforcement of these “New Dietary Ingredients.”

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James J. Gormley - Petition to Demand that the NDI Draft Guidance Be Withdrawn

Hi,

Let's call on Congress to demand that the FDA summarily withdraws the NDI Draft Guidance and goes on the record stating that the agency will not, now or ever, review, consider, surveil or engage in enforcement activities according to the re-interpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) evident in its Guidance document but, instead, will honor the law that the American people gave to the FDA (via Congress) to uphold via regulation according to both the spirit, letter, and plain and intended meaning of DSHEA.

That's why I created a petition to The United States House of Representatives, The United States Senate and President Barack Obama, which says:

"I hereby join with Citizens for Health (CFH) and its over 100,000 citizen supporters in calling on Congress to withhold funding appropriations for the FDA until the agency summarily withdraws its NDI Draft Guidance and goes on the record stating that the agency will not, now or ever, review, consider, surveil or engage in enforcement activities according to the re-interpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) evident in the NDI Draft Guidance, but, instead, will honor the law that the American people gave to that agency to uphold via regulation according to both the spirit and letter of DSHEA."

Will you sign this petition and please send out far and wide? 

Please click below:

http://signon.org/sign/save-our-supplements-2?source=c.em.cp&r_by=1374912

Thanks! 

James J. Gormley

VP and Senior Policy Advisor

Citizens for Health

Phone: 202-695-2027