Big drug companies want the entire hormone therapy market to themselves. If they’re successful, the price of bioidentical hormone replacement therapy could go through the roof. And you won’t be able to get the therapy in the right form, either. In 2014, TherapeuticsMD, a drug company specializing in women’s healthcare, was granted two new patents for the company’s combination bioidentical-estradiol-and-progesterone drug. The patents are for the particular “recipe” of bioidentical hormones (presumably a particular ratio of estradiol to progesterone, combined with a proprietary solubilizing agent), and for the “method”—that is, the claim that this formulation is a method of treating menopause symptoms in women. The company is also in the midst of conducting a Phase III clinical trial on this drug, meaning that it could be very close to coming to market. Keep in mind that this is occurring against the backdrop of the FDA’s war on natural medicine.
At FDA.gov, it states, “FDA (U.S. Food and Drug Administration) is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.” That sounds good to me. Too bad it is simply not true. Folks, the FDA does not work for us. It works for Big Pharma. The FDA has started sending letters to companies manufacturing CBD oil informing them to stop producing and marketing it. Then, a Big Pharma company will come in and offer CBD oil for a price many times above what people are paying now. If the FDA was working for us, the citizens, it would not wait 19 years to ban something that has been proven to be harmful. Nor would it allow the second most toxic chemical known to mankind—mercury—in any vaccine. For that matter, it would not allow neurotoxins such as aluminum and MSG in vaccines as well. These failures are mammoth and criminal. Folks, the FDA is beyond fixing. It needs to be replaced with a true agency that is looking out for our health.
It is hard to believe only four senators opposed the confirmation of Robert Califf, who was approved [recently] as the next FDA commissioner. Califf, chancellor of clinical and translational research at Duke University until recently, received money from 23 drug companies including the giants like Johnson & Johnson, Lilly, Merck, Schering Plough and GSK according to a disclosure statement on the website of Duke Clinical Research Institute. Not merely receiving research funds, Califf also served as a high level Pharma officer, say press reports. Medscape, the medical website, discloses that Califf “served as a director, officer, partner, employee, advisor, consultant or trustee for Genentech.” Portola Pharmaceuticals says Califf served on its board of directors until leaving for the FDA. In disclosure information for a 2013 article in Circulation, Califf also lists financial links to Gambro, Regeneron, Gilead, AstraZeneca, Roche and other companies and equity positions in four medical companies. Gilead is the maker of the $1000-a-pill hepatitis C drug AlterNet recently wrote about. This is FDA commissioner material?
More supplements face the axe at the next meeting of the FDA’s Pharmacy Compounding Advisory Committee. If recent history is any indication, the outlook is not good—unless we push back.
The United States Department of Agriculture (USDA) and the Food and Drug Administration (FDA) are the two federal agencies in the United States responsible for protecting consumer rights in regards to food safety. Millions of dollars of U.S. taxpayer funds are spent on testing foods annually to monitor the presence of pesticides and herbicides in the nation's food supply. However, the most commonly used herbicide which is sprayed on to genetically modified crops is routinely not tested. Glyphosate, the main ingredient used in Roundup Ready, is the most common herbicide in the world, sprayed on many billions of acres of crops each year. Neither the FDA nor the USDA routinely test for the presence of this herbicide in the nation's food. That is apparently about to change. Civil Eats is reporting that the FDA will now start testing certain foods for the presence of glyphosate.
Dr. Burzynski on Trial Again – Will His Life-saving Cancer Treatments Ever be Available to the Public?
After several years of FDA trial restrictions and medical bureaucratic harassment by the Texas Medical Board (TMB) through the courts system, it appeared that Dr. Burzynski was completely cleared in 2012 of all charges brought against him. The final court decisions that favored Burzynski were upheld in higher courts despite TMB appeals. It was a long, costly and bitter battle, with many former cancer free patients coming to testify on behalf of Dr. Burzynski's treatment authenticity and efficacy. The charges are different this time. Instead of attacking his ingenious new antineoplaston approach, they're charging him and his immediate staff of personal misconduct within various medical guidelines with the intention of removing their medical licenses. The central issue appears to be that Dr. Burzynski is not affiliated with a pharmaceutical company, but he owns the patents for his antineoplastons. In 1982, Dr. Richard Crout, Director of the FDA's Bureau of Drugs openly asserted: "I never have and never will approve a new drug to an individual, but only to a large pharmaceutical firm with unlimited finances."
Why would the FDA attack a company that seeks to bring affordable, convenient testing to millions of Americans? We suspect that the agency is doing everything it can to throttle innovators in this area to protect large, established testing companies and hospitals, which have been funding their deficits, in part, by charging exorbitant prices for tests.
Our national government's attempts at issuing dietary guidelines are usually inappropriate and ludicrous. Unfortunately, those guidelines dictate what the average certified dietitian offers as sound dietary advice. If you've ever had to eat hospital food, you were the recipient of a dietitian's control over the hospital's kitchen. Today there are virtual food fights over different dietary approaches. It seems the advocates of each diet want to create a following and promote how their particular approach to eating assures longevity and good health. But there is no one size fits all diet. This isn't about therapeutic diets for overcoming specific diseases, especially cancer. Rather, this commentary is about assigned bureaucrats effort to decree a day to day dietary intake for maintaining one's health. A recent article decrying current national efforts at dictating dietary advice by journalist Nina Teicholz was recently published in the BMJ (British Medical Journal). Nina authored The Big Fat Surprise: Why Butter, Meat and Cheese Belong in a Healthy Diet. Her book received accolades from literally hundreds of Amazon reviewers and some New York based magazines. Those responses struck this author as a carnivores' chorus of affirmation with a prolonged amen.
Now it appears that Barack Obama’s FDA is going after our best domestic artisanal cheeses, also often made from raw milk. What is the stated rationale for this? The FDA and Health Canada issued a joint assessment claiming a higher incidence of listeriosis—the disease caused by the food-borne pathogen listeria—in cheese made from raw milk as compared to cheese made from pasteurized milk. Consider these facts about listeria. Recent evidence from the Centers for Disease Control and Prevention (CDC) shows that, between 2009 and 2011, cheese made from raw milk accounted for one listeria outbreak and fifteen illnesses, whereas cheese from pasteurized milk caused five outbreaks and thirty-six illnesses. Let’s put this in further perspective. The CDC determined that between 1993 and 2006, all raw milk products combined caused 202 hospitalizations and two deaths. If the FDA is truly motivated by food-safety concerns, why not take a more aggressive stance towards Concentrated Animal Feeding Operations (CAFOs), since contaminated meat and poultry sicken an estimated one million people and kill at least one thousand each year? If the FDA receives enough messages protesting the path they are clearly on to ban raw milk cheese, they will likely back off for fear of offending Congress, which has to listen to the voters—so please take action on this issue!
A recent news report revealed an FDA proposal from 2011 that would have told dentists to avoid using mercury fillings in pregnant women, nursing mothers, children, and people with mercury allergies, kidney diseases, and neurological problems. It also contained a more general alert to dentists asking them to consider alternatives to mercury fillings on all patients. Unfortunately, the FDA’s proposal was rejected by senior officials at the Department of Health and Human Services (HHS) after a so-called cost-benefit analysis was performed. It was then hushed up. Mercury is a deadly neurotoxin. When mercury gets into the central nervous system, it has a half-life of between fifteen and thirty years. Once it’s inhaled into the lungs, it enters the bloodstream and can accumulate in the kidneys, liver, and brain. The effects of exposure to mercury are devastating. Studies have shown mercury fillings to be associated with Alzheimer’s disease, autoimmunity, kidney dysfunction, infertility, polycystic ovary syndrome, neurotransmitter imbalances, food allergies, multiple sclerosis, thyroid problems, and an impaired immune system. Mercury in the nervous system is especially harmful, causing all sorts of problems: tremors, insomnia, polyneuropathy, headaches, weakness, blurred vision, and more. That the proposed FDA warning, half-hearted as it was, remained secret for so long is especially worrisome. How much other information is being withheld from the public at the behest of special interests—or for other political reasons? This story is also a reminder that even the FDA has overseers who exercise control over it. In this case, the agency tried to move in the right direction and was overruled by its political masters. Action Alert! Write to the Department of Health and Human Services and tell them how disappointed you are to learn that this warning from the FDA was rejected and then kept secret. Mercury is a dangerous neurotoxin and should be removed from all fillings to protect the health and safety of all Americans. Please send your message immediately.