In this new book, Hunter Lewis shows how private interests and politicians rely upon one another—political favors in exchange for money. Where do private interests such as those on Wall Street or in the drug industry stop and Washington begins? It’s impossible to say anymore. Take a behind-the-scenes look at just how deeply the US Food and Drug Administration has enmeshed itself with the pharmaceutical industry.
The FDA is zeroing in on egg farmers who provide outdoor access (required in certified organic production) for their flocks. The agency has issued a Draft Guidance that will make it difficult, expensive and perhaps even impossible to maintain medium-sized poultry flocks outdoors. This could spell the end for commercial-scale, truly organic eggs where hens live outdoors, free to exhibit their native behaviors, as required by the USDA’s organic regulations. The FDA’s guidance seeks to prevent outbreaks of Salmonella Enteritidis in shell eggs, and was sparked by a major 2010 salmonella outbreak in eggs, centered on “factory farms” in Iowa, confining tens of thousands of hens indoors in filthy and dangerous conditions. The fact is, based on published-reviewed research, that the biggest risk to human health comes from caged hens in giant factory farms—not organic birds enjoying a good life outdoors! Read more, and make your voice heard before September 23rd!
Earlier this year we covered a new study conducted at the China Medical University in Taiwan showing how non-drug therapies such as the ketogenic diet and hyperbaric oxygen therapy were being used to cure cancer. So it should come as no surprise that the FDA, in an obvious effort to protect the lucrative drug market for treating cancer, has issued a statement saying that hyperbaric oxygen therapy is "not approved" by them for such treatment.
While the FDA says that silver has no therapeutic value, in an effort to protect the interests of Big Pharma, the EPA, on the other hand, allows its widespread use as a germ killer in clothing, bedding, cosmetics, electric shavers, baby bottles, and food containers. Silver has been used as an antimicrobial for thousands of years—that’s why forks, spoons, and platters were traditionally made out of silver. Nanosilver sprang out of the new science of nanomaterials, which involves creating objects smaller than 100 nanometers. Objects this small can penetrate parts of the body that larger sizes of silver cannot and thus potentially increase silver’s antimicrobial effect. The difference between drug company products and silver is of course that the latter is natural. As such, it is not easily patented, and not being patentable, no one can afford to spend $1 billion on FDA approval. This is a scandalous situation. How many millions of people will have to die as a result?
It appears that the FDA is working with state medical boards behind the scenes -- sometimes in violation of the law. Professional medical boards are launching investigative actions against integrative physicians not because of patient complaints, but because of materials forwarded to them by the FDA before they are made public. These boards are treating the FDA documents as if they were formal complaints. In other words, the US Food and Drug Administration, which is barred from interfering with the practice of medicine, is in fact deliberately but secretly ignoring the rules -- something practitioners and consumers alike need to be warned about.
Besides the obvious food safety concerns expressed by Ken Ward, a former USDA poultry inspector, there is quite possibly a far greater risk here in this new USDA plan to privatize poultry inspection. This rule change may exclude small pastured poultry producers from being able to comply and market their products, thereby eliminating your option to buy chickens raised outdoors on pasture.
Want to manage your diabetes through medicinal foods? The FDA says no. “Medical foods,” by federal definition, aren't simply a diet plan prescribed by a doctor. They are foods that are specifically formulated and processed for a sick patient. They form a separate category from conventional foods and dietary supplements in that they are intended to meet specific nutritional requirements for the management of a disease or condition, and are used under medical supervision. The FDA has just issued an updated draft guidance on medical foods, and this new version drastically limits the number of medical conditions that medical foods can be used to manage. What we need are better medical foods, not the elimination of them.
The US Food and Drug Administration (FDA) is warning that acetaminophen (Tylenol) products may cause three serious skin reactions, two of which typically require hospitalization and can be fatal. The most serious skin reactions linked to acetaminophen are Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TENS), both of which often start with flu-like symptoms and can cause the top layer of your skin to slough off, exposing you to a serious risk of fatal infections. The skin reactions can occur at any time after taking acetaminophen, even if you've taken the drugs with no issue in the past.
Recent guidance from the FDA will place an impossible burden on farmers who raise true free-range chickens. The FDA guidance suggests that farmers must cover their outdoor pastures with either roofing or netting, or use noise cannons to scare away wild birds. Perhaps it has escaped FDA that noise cannons would also scare the chickens? Or that putting a roof over a multi-acre pasture is not only cost-prohibitive, but would prevent rain and sun from reaching the living things in the pasture? The FDA also advocates walls around the pasture, to prevent mice, rats, and cats from entering, and then put a roof over it. That’s right—walls and roofing. In other words, they want the chickens to be kept in a building! This completely contradicts what “free-range” is supposed to be about!
In 1998, the FDA approved a new class of anti-inflammatory drugs called TNF-alpha blockers. The best-known drugs in this class are Enbrel and Humira, which are used to treat juvenile rheumatoid arthritis, Crohn’s disease, and other inflammatory diseases. But these drugs have dangerous side effects. In 2008, 2009, and 2011, the FDA determined that these drugs increase the risk of different—but all potentially fatal—infections and cancers, including tuberculosis and childhood leukemia. Despite all their well-documented dangers, as of 2013, TNF blockers remain on the market. The FDA has simply asked manufacturers of TNF blockers to let them know when someone got cancer—essentially taking a “wait and see” approach to a drug that has caused at least thirty-five deaths from cancer, at least fourteen deaths from Legionnaire’s Disease, and at least seven deaths from listeria infections. Over fifty people have died, and the FDA is still at the “information-gathering” stage.
Three years ago major concessions were won for small farmers, including an exemption for producers making less than $500,000 a year in sales who also sold most of their food locally. Now it’s all in danger. The FDA had proposed two troubling Food Safety Modernization Act (FSMA) rules that will drastically hurt small farms. The first one concerns standards for the growing and harvesting of raw agricultural produce, exempting foods that are sterilized by irradiation (even though “nuking” it harms the food’s nutritional value can cause a wide range of health problems). Obviously, organic foods cannot be irradiated, so they will never be exempted. The second amended the FDA’s Current Good Manufacturing Practices (CGMP) guidelines by creating hazards analysis requirements and risk-based protections with lots of detailed recordkeeping. Most farmers will likely need a team of lawyers to make sure they’re complying with the new rule properly. The new rules are written in vague language and geared to discriminate against small farmers and food producers who wish to diversify, as well as give the FDA the right to revoke the above exemption for small farms or facilities, even if there is no proof that the farm is the cause of the outbreak, and even though there may not be an immediate threat to public health!
The government threat to restricting or even eventually eliminating organic pastured chickens is back. Not only is the idea that organic pastured poultry are more dangerous than confined factory birds ridiculous, but the practice of continuing to allow factory chickens to continue using the UDSA organic certification without meeting the requirement of allowing the birds outdoor access, continues to this day. Cheap factory chickens and turkeys fed cheap government subsidized corn, soy, and wheat (much of which is genetically modified) is a big business in the U.S. So don't expect the market of humanely raised poultry outdoors on pastures and organic non-GMO feed to increase too much without a fight from Big Ag and the government agencies that protect them.
Given the enormous potential for great harm, one has to wonder how the Food and Drug Administration, FDA, gets away with giving its stamp of approval on a new “brain wave test,” that allegedly will “help confirm an ADHD diagnosis,” when there is no scientific or medical proof that any physical abnormality exists. What part of approving a “brain waive test” for a psychiatric diagnosis that doesn’t exist is “assuring the safety and effectiveness?” More to the point, since there is no proof that the alleged psychiatric diagnosis exists, how can the FDA possibly claim that any test, least of all one that consists of interpreting squiggly lines on a piece of paper, is safe or effective?
In the compelling follow-up to the internationally award-winning documentary, Burzynski, the Movie; Burzynski: Cancer is Serious Business, Part II explores the current status of Antineoplastons' clinical testing sanctioned by the United States Food & Drug Administration—and features a modern story of the struggling journeys of cancer patients being treated today at the Burzynski Clinic in Houston, Texas. For most patients undergoing Burzynski's treatment, their advanced cancer itself runs secondary to the constant barrage of skepticism coming not only from their local oncologists, but also from friends and family who feel their loved ones are making suspect treatment decisions—even though mainstream oncology has already left many for dead. As the story unfolds, you will observe a real-time change of hearts and minds from many of these doctors and families. Unlike the first documentary, Part II showcases interviews with board-certified oncologists, surgeons and neurosurgeons, who witnessed patients leave their care, soon to return in great health after opting for the Burzynski Clinic.
As though double-digit increases in insurance premiums weren’t enough, how about triple-digit cost inflation for drugs? It is really simple to do, and the U.S. Senate is about to do it. If you’re a drug manufacturer, and you’d like to make 100 times more than a person would otherwise have to pay for a drug, get Congress to expand the tremendous power of the Food and Drug Administration (FDA), perhaps already the most powerful anti-competitive force on the planet. The proposed bill is S. 959, the Pharmaceutical Compounding Quality and Accountability Act, also known as the “FDA power-grab bill,” still another example of “never letting a crisis go to waste.”
Drug companies are deliberately keeping the public—and the medical community—in the dark about “unfavorable” clinical trials. Drug study data can be manipulated by pharmaceutical companies and the FDA, but what's worse is that even if a study finds a drug isn’t very safe or effective, it’s likely you and your doctor will never hear about it.
Remember the controversial diabetes drug Avandia? In 2010, two FDA drug safety reviewers warned the agency that Avandia posed serious risks of heart attack and heart failure when compared with other diabetes drugs. Since then, the drug has been removed from the market in most countries and has been under severe restrictions in the US. Recently, in a combined meeting of separate FDA advisory committees, 20 of 26 panelists voted to recommend removing or modifying Avandia’s highly restrictive label and distribution system.
Pesticides? Yes. GMOs? Maybe. Hormones? Maybe not. ANH-USA’s executive and legal director, Gretchen DuBeau, was a member of the US delegation to the Codex Committee of Food Labeling (CCFL), which met in Canada last week. We were honored to bring the voice of the consumer to the table at Codex, especially since it is otherwise heavily influenced by big corporate interests. At this meeting, four areas of concern were discussed: GMO labeling; Whether the pesticide ethylene may be used on organic produce; Organic standards for aquaculture and seaweed; and Biofortification of grains.
The FDA continues to trample free speech in order to limit your access to supplements. Their actions have scary implications for the government regulation of Internet searches and speech. It's time we all stood up and said “Enough is enough!”.
If you were buying chocolate milk, would you think to check the ingredients for artificial sweeteners like aspartame? I wouldn't have, until I found out that the dairy industry wants to change the legal definition of milk (along with 17 other dairy products) to allow it to include aspartame and other artificial sweeteners. Can you take action to make sure that milk can only be called milk if it doesn't include aspartame? The dairy industry claim that they're being good samaritans by adding aspartame in milk to fight childhood obesity, but they're afraid that consumers, especially kids, won't buy chocolate milk (or other flavors) if it's labeled differently than regular chocolate milk. Can you imagine a kid in the school lunch line reading the ingredients on the back of her milk box to figure out if it has aspartame? Urge the FDA to keep the definition of milk as-is, so people won't be misled about their dairy products.
