Ed Silverman - Grassley Probes FDA Over Employee Whistleblowers

How does the FDA treat employees who blow the whistle? US Senator Chuck Grassley, a long-standing agency nemesis, wants to know. And so he has written FDA commish Margaret Hamburg to explain the circumstances surrounding a controversial episode in which several current and former agency employees say they were harassed and dismissed after complaining about device reviews to Congress. 

Their charges were contained in a sensational lawsuit filed last month, in which they accused the agency of secretly reading their personal email accounts, while the agency maintained they illegally disclosed confidential business information after writing to Congress to complain they were being coerced to approve devices that posed unacceptable risks (back story).

For instance, the employees, who are all scientists and doctors and worked in the Center for Devices and Radiological Health, charged three devices could have missed signs of detecting breast cancer; one device risked falsely diagnosing osteoporosis, and an ultrasound device could malfunction while monitoring pregnant women in labor.

Read More:

http://www.pharmalot.com/2012/02/grassley-probes-fda-over-employee-whistleblowers/

FDA STOMPS ON THE FIRST AMENDMENT: TAKE ACTION

As reported in the Washington Post on January 30, 2012, six current and former FDA employeesare suing to stop the agency from illegally spying on private communications to Congress and otheroversight agencies. The problem began in 2007 when nine scientists and doctors in the Office ofDevice Evaluation complained internally that the FDA was in the process of approving at least twelveradiological devices which were potentially harmful and posed risks to millions of patients. Insteadof investigating the devices, the FDA set up a secret surveillance system to monitor those who hadcomplained. Information illegally gathered from personal email accounts was used to harass thewhistleblowers. The FDA twice asked Health and Human Services to launch an investigation, accusingthe scientists of releasing confidential business information about devices they believed to be unsafe.Of the six scientists who have filed suit against the FDA, two were fired, two did not have their contractsrenewed, and two continue to suffer harassment and have been passed over for promotion.

Stephen Kohn, host of PRN’s Honesty Without Fear: The Whistleblower’s Radio Hour, is one of thelawyers representing the six FDA whistleblowers. Please take action by clicking on the following linkto let the FDA, the President, and your legislators know that the FDA must stop harassing doctors andscientists who are trying to protect Americans from defective and unsafe medical devices: http://www.whistleblowers.org/index.php?option=com_content&task=view&id=1333.

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/

Gary Null, Ph.D., and Nancy Ashley, VMD - GARDASIL: CHILD ABUSE BY BIG PHARMA

By Gary Null, PhD and Nancy Ashley, VMD

January 9, 2012

In 1987, I was asked to debate a group of 6 scientists about the very promising AIDS drug, AZT.  Signs around NYU Medical School exhorted everyone to “Put Time on Your Side”, and the vast majority of activists, including ACT UP, were pushing the government to allocate all available funds to get this drug into as many people as possible who had been diagnosed with AIDS.  I was the only one who was dissenting and there was a simple reason:  I had spoken with John Lauritsen.

Lauritsen, an investigative journalist who wrote for the New York Native in the 1980s and 1990s, knew that AZT was a fraud.  Originally a chemotherapy drug that was rejected due to excessive toxicity, AZT was resurrected for use as an AIDS treatment and fast tracked by the FDA for approval in just six months.  Lauritsen looked closely at the one single study used as a basis for this approval, and found:  “the description of methodology was incomplete and incoherent.  Not a single table was acceptable according to statistical standards – indeed, not a single table made sense.  In particular, the first report, on “efficacy” was marred by contradictions, ill-logic, and special pleading.”  Lauritsen discovered that this poor-quality study was unblinded early, allowing both doctors and patients to know whether AZT or the placebo was being taken, thus completely invalidating the study.  Then the study itself was terminated early, ostensibly so that all participants would be able to take AZT, which appeared so effective at preventing death from AIDS.  The real-life follow up, however, at no time repeated the stunning results of this mangled study.  Instead, according to Lauritsen, “More than 96% of all “AIDS” deaths in the U.S. occurred after AZT was approved for marketing in 1987. Those deaths were not caused by a virus, but by AZT. “

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Karen McVeigh - FDA Draws Criticism After U-Turn on Antibiotics in Animal Feed

Published on Thursday, December 29, 2011 by The Guardian/UK

http://www.guardian.co.uk/world/2011/dec/29/fda-u-turn-antibiotics-animal-feed

Environmental groups dismayed after agency drops long-held plan to regulate use of human antibiotics fed to healthy animals

by Karen McVeigh

Environmental and consumer groups have condemned the US Food and Drug Administration's move to renege on its long-held policy to regulate the use of human antibiotics in animal feed.

Last week, the agency quietly announced it was withdrawing its plan to limit the use of antibiotics fed to healthy livestock intended for human consumption.

Critics say the U-turn, which comes amid the FDA's own stated concerns over food safety, is at odds with its obligations to protect the public.

The groups also criticized the timing of the announcement, which was made during the holiday season and disclosed only in the federal register.

The use of low doses of antibiotics in agricultural animal feed contributes to drug-resistant superbugs, according to food and health experts.

One leading food policy writer described the policy reversal as "pathetic" and "dismaying."

"It's dismaying, and obviously something they felt sheepish about, otherwise it wouldn't have been released this week," Michael Pollan, author of the Onmivore's Dilemma and Food Rules: An Eater's Manual, told the Guardian.

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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. 

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Ed Silverman - Should The FDA Be An Independent Agency?

PHARMALOT

By Ed Silverman // December 14th, 2011 // 8:58 am

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.

Yesterday, 14 US Senators wrote Sebelius for an explanation. “We ask that you share with us your specific rationale and the scientific data you relied on for the decision to overrule the FDA recommendation. On behalf of the millions of women we represent, we want to be assured that this and future decisions affecting women’s health will be based on medical and scientific evidence” (see here).

To opponents, Plan B is problematic because the pill prevents a fertilized egg from implanting in the womb, which equate this with abortion. But supporters of greater access argue that nearly half of all pregnancies are unintended, and that preventing teenage girls from gaining easier access denies them a safe and effective way to prevent unintended pregnancies (see more here).

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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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PF Louis - Exposing the hidden epidemic of crippling, painful neurological adverse effects of antibiotics

by PF Louis, NaturalNews.com

http://www.naturalnews.com/034384_antibiotics_neurological_effects_toxicity.html

(NaturalNews) The adverse reactions from a certain specific class of antibiotics resemble the crippling adverse reactions of the vaccine injured. But there is much less notoriety among these agonized and debilitated victims of the Medical Mafia, except for one PBS Nightly News special from June 16th, 2011. (PBS, source below)

Most antibiotic victims are adults with no one to look after them. Unlike unfortunate autistic or paralyzed vaccine injured kids who have parents dedicated to taking care of them. Thanks to social networking and internet forums, these victims have some support.

Unfortunately, most of them are locked into the Medical Mafia system of harmful drugs and brain washed medicine. Their complaints are often disregarded as delusional, or they're misdiagnosed for rheumatoid arthritis, fibromyalgia, or MS. And that's because their symptoms are similar, and worse. They often suffer from the constant pain of extreme neuropathy.

Very few adverse event reports make it to the FDA's Adverse Event Reporting System (AERS). It's estimated by even the FDA that less than ten percent of actual adverse events make it into this system. It's not advertised to patients as the complaint department of choice, and doctors tend be averse to reporting adverse events from drugs they've 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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