Brave scientists and physicians working for the FDA speak out against it’s corruption
America urgently needs change at FDA because FDA is fundamentally broken, failing to fulfil its mission, and because re-establishing a proper and effectively functioning FDA is vital to the health of the nation.
The purpose of this letter is to inform you that the scientific review process for medical devices at FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk. Through this letter and your action, we hope that future FDA employees will not experience the same frustration and anxiety that we have experienced for more than a year at the hands of FDA managers because we are committed to public integrity and were willing to speak out. Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around.
This is an excerpt from a letter written by FDA scientists and doctors accusing top FDA officials and attorneys of violating laws, suppressing and altering scientific findings and conclusions, abuse of power and authority, and retaliation against those who have spoken out. The scientists’ and physicians’ names have been withheld for their protection.
The letter also states that the Director of the Office of Device Evaluation (ODE) has:
- Ordered physicians and scientists to ignore FDA Guidance documents.
- Knowingly allowed subordinates to issue written disciplinary actions for failure to change scientific opinions.
- Issued illegal documents that are not publicly available and would circumvent scientific and legal requirements.
- Failed to properly document significant decisions.
- Made and allowed false statements in FDA documents.
- Allowed manufacturers to market unapproved devices.
- Removed Black Box warnings FDA experts recommended.
- Bypassed FDA experts and failed to properly label devices.
- Excluded FDA experts from meetings when manufacturers didn’t want them there.
Three specific device approvals referenced were:
- Interference by former FDA chief Andrew von Eschenbach in approval of a knee device.
- A computer-aided mammography device’s approval over the unanimous vote against it by all FDA experts after a phone call from Congressman Christopher Shays.
- Daniel Schultz’s approval of a device to prevent scar tissue in spite of the scientists’ unanimous opinion against it..
OBAMA APPOINTS MONSANTO’S VICE PRESIDENT AS SENIOR ADVISOR TO THE COMMISSIONER AT THE FDA
just in case you forgot..
Folks, it just keeps getting more insane.
Michael Taylor was just appointed senior advisor to the commissioner of the FDA. This is the same man that was in charge of FDA policy when GMO’s were allowed into the US food supply without undergoing a single test to determine their safety. He “had been Monsanto’s attorney before becoming policy chief at the FDA [and then] he became Monsanto’s Vice President and chief lobbyist. This month [he] became the senior advisor to the commissioner of the FDA. He is now America’s food safety czar. This is no joke.”
Here’s the full story:
You’re Appointing Who? Please Obama, Say It’s Not So!
The person who may be responsible for more food-related illness and death than anyone in history has just been made the US food safety czar. This is no joke.
Here’s the back story.
When FDA scientists were asked to weigh in on what was to become the most radical and potentially dangerous change in our food supply — the introduction of genetically modified (GM) foods — secret documents now reveal that the experts were very concerned. Memo after memo described toxins, new diseases, nutritional deficiencies, and hard-to-detect allergens. They were adamant that the technology carried “serious health hazards,” and required careful, long-term research, including human studies, before any genetically modified organisms (GMOs) could be safely released into the food supply.
But the biotech industry had rigged the game so that neither science nor scientists would stand in their way. They had placed their own man in charge of FDA policy and he wasn’t going to be swayed by feeble arguments related to food safety. No, he was going to do what corporations had done for decades to get past these types of pesky concerns. He was going to lie.
Dangerous Food Safety Lies
When the FDA was constructing their GMO policy in 1991-2, their scientists were clear that gene-sliced foods were significantly different and could lead to “different risks” than conventional foods. But official policy declared the opposite, claiming that the FDA knew nothing of significant differences, and declared GMOs substantially equivalent.
This fiction became the rationale for allowing GM foods on the market without any required safety studies whatsoever! The determination of whether GM foods were safe to eat was placed entirely in the hands of the companies that made them — companies like Monsanto, which told us that the PCBs, DDT, and Agent Orange were safe.
GMOs were rushed onto our plates in 1996. Over the next nine years, multiple chronic illnesses in the US nearly doubled — from 7% to 13%. Allergy-related emergency room visits doubled between 1997 and 2002 while food allergies, especially among children, skyrocketed. We also witnessed a dramatic rise in asthma, autism, obesity, diabetes, digestive disorders, and certain cancers.
In January of this year, Dr. P. M. Bhargava, one of the world’s top biologists, told me that after reviewing 600 scientific journals, he concluded that the GM foods in the US are largely responsible for the increase in many serious diseases.
In May, the American Academy of Environmental Medicine concluded that animal studies have demonstrated a causal relationship between GM foods and infertility, accelerated aging, dysfunctional insulin regulation, changes in major organs and the gastrointestinal system, and immune problems such as asthma, allergies, and inflammation
In July, a report by eight international experts determined that the flimsy and superficial evaluations of GMOs by both regulators and GM companies “systematically overlook the side effects” and significantly underestimate “the initial signs of diseases like cancer and diseases of the hormonal, immune, nervous and reproductive systems, among others.”
The Fox Guarding the Chickens
If GMOs are indeed responsible for massive sickness and death, then the individual who oversaw the FDA policy that facilitated their introduction holds a uniquely infamous role in human history. That person is Michael Taylor. He had been Monsanto’s attorney before becoming policy chief at the FDA. Soon after, he became Monsanto’s vice president and chief lobbyist.
This month Michael Taylor became the senior advisor to the commissioner of the FDA. He is now America’s food safety czar. What have we done?
The Milk Man Cometh
While Taylor was at the FDA in the early 90’s, he also oversaw the policy regarding Monsanto’s genetically engineered bovine growth hormone (rbGH/rbST) — injected into cows to increase milk supply.
The milk from injected cows has more pus, more antibiotics, more bovine growth hormone, and most importantly, more insulin-like growth factor 1 (IGF-1). IGF-1 is a huge risk factor for common cancers and its high levels in this drugged milk is why so many medical organizations and hospitals have taken stands against rbGH. A former Monsanto scientist told me that when three of his Monsanto colleagues evaluated rbGH safety and discovered the elevated IGF-1 levels, even they refused to drink any more milk — unless it was organic and therefore untreated.
Government scientists from Canada evaluated the FDA’s approval of rbGH and concluded that it was a dangerous facade. The drug was banned in Canada, as well as Europe, Japan, Australia and New Zealand. But it was approved in the US while Michael Taylor was in charge. His drugged milk might have caused a significant rise in US cancer rates. Additional published evidence also implicates rbGH in the high rate of fraternal twins in the US.
Taylor also determined that milk from injected cows did not require any special labeling. And as a gift to his future employer Monsanto, he wrote a white paper suggesting that if companies ever had the audacity to label their products as not using rbGH, they should also include a disclaimer stating that according to the FDA, there is no difference between milk from treated and untreated cows.
Taylor’s disclaimer was also a lie. Monsanto’s own studies and FDA scientists officially acknowledged differences in the drugged milk. No matter. Monsanto used Taylor’s white paper as the basis to successfully sue dairies that labeled their products as rbGH-free.
Will Monsanto’s Wolff Also Guard the Chickens?
As consumers learned that rbGH was dangerous, they refused to buy the milk. To keep their customers, a tidal wave of companies has publicly committed to not use the drug and to label their products as such. Monsanto tried unsuccessfully to convince the FDA and FTC to make it illegal for dairies to make rbGH-free claims, so they went to their special friend in Pennsylvania — Dennis Wolff. As state secretary of agriculture, Wolff unilaterally declared that labeling products rbGH-free was illegal, and that all such labels must be removed from shelves statewide. This would, of course, eliminate the label from all national brands, as they couldn’t afford to create separate packaging for just one state.
Fortunately, consumer demand forced Pennsylvania’s Governor Ed Rendell to step in and stop Wolff’s madness. But Rendell allowed Wolff to take a compromised position that now requires rbGH-free claims to also be accompanied by Taylor’s FDA disclaimer on the package.
President Obama is considering Dennis Wolff for the top food safety post at the USDA. Yikes!
Rumor has it that the reason why Pennsylvania’s governor is supporting Wolff’s appointment is to get him out of the state — after he “screwed up so badly” with the rbGH decision. Oh great, governor. Thanks.
Ohio Governor Gets Taylor-itus
Ohio not only followed Pennsylvania’s lead by requiring Taylor’s FDA disclaimer on packaging, they went a step further. They declared that dairies must place that disclaimer on the same panel where rbGH-free claims are made, and even dictated the font size. This would force national brands to re-design their labels and may ultimately dissuade them from making rbGH-free claims at all. The Organic Trade Association and the International Dairy Foods Association filed a lawsuit against Ohio. Although they lost the first court battle, upon appeal, the judge ordered a mediation session that takes place today. Thousands of Ohio citizens have flooded Governor Strickland’s office with urgent requests to withdraw the states anti-consumer labeling requirements.
Perhaps the governor has an ulterior motive for pushing his new rules. If he goes ahead with his labeling plans, he might end up with a top appointment in the Obama administration.
To hear what America is saying about GMOs and to add your voice, go to our new non-GMO Facebook Group.
Jeffrey M. Smith is the author of Seeds of Deception: Exposing Industry and Government Lies About the Safety of the Genetically Engineered Foods You’re Eating and Genetic Roulette: The Documented Health Risks of Genetically Engineered Foods from Chelsea Green Publishing. Smith worked at a GMO detection laboratory, founded the Institute for Responsible Technology, and currently lives in Iowa—surrounded by genetically modified corn and soybeans. For more information, visit Chelsea Green.
Yet the FDA wants to ban natural stuff like supplements. The world is on its head!
The Food and Drug Administration has completed its highly anticipated evaluation of the world’s first genetically engineered (GE) fish for human consumption, and passed a document supporting its commercialization on the US market to the White House Office of Management and Budget for final approval, reports the Talking Points Memo.
The FDA findings, however, weren’t released to the public, preventing people from making their own completely informed decision on whether or not to eat genetically engineered fish.
Still, experts have plenty to say about why genetically modified salmon could be dangerous to our health. (continue reading…)
Obama Unveils New Executive Orders.
Uploaded by PigMine3 on Oct 25, 2011
October 25, 2011 - President Obama’s focused his three-day West Coast trip on a series of executive orders to boost the economy, including new rules to help refinance mortgages. Bill Plante reports.
The FDA’s Attack on Supplements Can be Stopped
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In an end-run worthy of an NFL halfback, the National Health Federation is spearheading the introduction of legislation to counter the FDA’s infamous new Draft Guidance on New Dietary Ingredients (NDIs). The Guidance, if finalized and acted upon, would result in the loss of access to countless safe natural health products Americans consume daily. The Guidance would require perfectly safe dietary-supplement ingredients to undergo very expensive, burdensome, and unnecessary testing and FDA approval or else be removed from the market.
Four steps to a free market health care system
Article is pretty old but I think just as relevant.
1. Eliminate all licensing requirements for medical schools, hospitals, pharmacies, and medical doctors and other health care personnel. Their supply would almost instantly increase, prices would fall, and a greater variety of health care services would appear on the market.
Competing voluntary accreditation agencies would take the place of compulsory government licensing—if health care providers believe that such accreditation would enhance their own reputation, and that their consumers care about reputation, and are willing to pay for it.
Because consumers would no longer be duped into believing that there is such a thing as a “national standard” of health care, they will increase their search costs and make more discriminating health care choices.
2. Eliminate all government restrictions on the production and sale of pharmaceutical products and medical devices. This means no more Food and Drug Administration, which presently hinders innovation and increases costs.
Costs and prices would fall, and a wider variety of better products would reach the market sooner. The market would force consumers to act in accordance with their own—rather than the government’s—risk assessment. And competing drug and device manufacturers and sellers, to safeguard against product liability suits as much as to attract customers, would provide increasingly better product descriptions and guarantees.
3. Deregulate the health insurance industry. Private enterprise can offer insurance against events over whose outcome the insured possesses no control. One cannot insure oneself against suicide or bankruptcy, for example, because it is in one’s own hands to bring these events about.
Because a person’s health, or lack of it, lies increasingly within his own control, many, if not most health risks, are actually uninsurable. “Insurance” against risks whose likelihood an individual can systematically influence falls within that person’s own responsibility.
All insurance, moreover, involves the pooling of individual risks. It implies that insurers pay more to some and less to others. But no one knows in advance, and with certainty, who the “winners” and “losers” will be. “Winners” and “losers” are distributed randomly, and the resulting income redistribution is unsystematic. If “winners” or “losers” could be systematically predicted, “losers” would not want to pool their risk with “winners,” but with other “losers,” because this would lower their insurance costs. I would not want to pool my personal accident risks with those of professional football players, for instance, but exclusively with those of people in circumstances similar to my own, at lower costs.
Because of legal restrictions on the health insurers’ right of refusal—to exclude any individual risk as uninsurable—the present health-insurance system is only partly concerned with insurance. The industry cannot discriminate freely among different groups’ risks.
As a result, health insurers cover a multitude of uninnsurable risks, alongside, and pooled with, genuine insurance risks. They do not discriminate among various groups of people which pose significantly different insurance risks. The industry thus runs a system of income redistribution—benefiting irresponsible actors and high-risk groups at the expense of responsible individuals and low risk groups. Accordingly the industry’s prices are high and ballooning.
To deregulate the industry means to restore it to unrestricted freedom of contract: to allow a health insurer to offer any contract whatsoever, to include or exclude any risk, and to discriminate among any groups of individuals. Uninsurable risks would lose coverage, the variety of insurance policies for the remaining coverage would increase, and price differentials would reflect genuine insurance risks. On average, prices would drastically fall. And the reform would restore individual responsibility in health care.
4. Eliminate all subsidies to the sick or unhealthy. Subsidies create more of whatever is being subsidized. Subsidies for the ill and diseased breed illness and disease, and promote carelessness, indigence, and dependency. If we eliminate them, we would strengthen the will to live healthy lives and to work for a living. In the first instance, that means abolishing Medicare and Medicaid.
Judge Blocks FDA Plan for Graphic Cigarette Warnings: The U.S. Food and Drug Administration’s plans to require graphic warning labels on cigarette packs was derailed temporarily Monday when a federal judge blocked the effort, suggesting it was a violation of the tobacco industry’s First Amendment free-speech rights.
Judge Richard Leon of the U.S. District Court in the District of Columbia said it was likely that the tobacco industry would succeed in a lawsuit to overturn the requirement, so he blocked the FDA initiative until the court case is resolved, which could take years, the Associated Press reported.
Good, the FDA has no right putting labels on stuff we consume.
FDA warns against needle-free flu vaccine
The U.S. Food and Drug Administration has warned against giving flu shots with needle-free injectors.
Several retailers who have been administering vaccines with the devices have stopped.
The FDA has approved the use of jet injectors only for the vaccine against measles, mumps and rubella and has no data to support its use for other vaccines, the agency said.
FDA says walnuts are a “drug”, threatens to prosecute a company for saying they are healthy
Guys… you can’t make this shit up. Really.