More evidence that the drug approval process is completely broken. A pharmacy recently alerted the FDA to the presence of a cancer-causing chemical in the popular blood-pressure drug valsartan, putting millions of patients at risk. Incredibly, this isn’t even the first time dangerous chemicals have been found in this class of drugs. Generic forms of Valsartan have been recalled since 2018 when three other carcinogenic compounds were found in various versions of the drug. In this current episode, a solvent called dimethylformamide (DMF) was discovered in valsartan pills still on the market in the US, which the FDA was recommending as an alternative to recalled versions. The World Health Organization classifies DMF as a “probable carcinogen.” Note that the FDA allows drugs to contain small amounts of DMF. That’s right—the agency charged with protecting public health allows drug manufacturers to put a cancer-causing solvent in their pills. The contamination of this heart drug highlights, among other things, the pitfalls of the drug manufacturing process. According to one expert, “Medicines are kind of like used cars: By the time you get it it’s already five or six years old, it’s touched hundreds of hands and it’s got 100,000 miles on it.” This puts the supposed safety of the medications that millions of Americans take—often more than one—in serious question.
Angela C. Erickson and Thomas Berry of the Pacific Legal Foundation have just published a new report examining illegally issued regulations at the Department of Health and Human Services (HHS). Their study found that: "Unconstitutional rulemaking procedures are rife at HHS, especially at the FDA." They analyzed who were the people making these rules at HHS in what they claim is the largest study ever done on this subject. "[This] has never been studied before: a large expansion of rulemakers who are not democratically accountable. These unaccountable rulemakers are not constitutionally authorized to issue final rules that have the force of law. But, as this study shows, that hasn’t stopped them."
FDA Cover-up? New Data Obtained Shows MMR Vaccine Approved on Clinical Trials of Only 342 Children – Half Suffered Side Effects
As we have previously reported here on Health Impact News, pharmaceutical giant Merck has been fighting a criminal case regarding its MMR (Measles, Mumps, Rubella) vaccine in court for over 8 years, as their own scientists became whistle-blowers regarding fraud in the development of the vaccine. Now, Del Bigtree, founder of the non-profit Informed Consent Action Network (ICAN), has announced that a new Freedom of Information Act disclosure from the Federal Food and Drug Administration (FDA) has revealed that the MMR vaccine was licensed based on clinical trials which in total had less than 1,000 participants, and only 342 children. “Thanks to the laws in this country that for now at least permit access to various government records, we now know the MMR vaccine was licensed using an irresponsibly small and limited group of children,” says Bigtree. “But what’s even more alarming is learning about the serious adverse events that were known and acknowledged, yet ignored in order to license the MMR vaccine,” Bigtree adds, noting “This was after only tracking adverse events for 42 days after injection – imagine what they might have found had they tracked safety for three years against an appropriate control, like they do for drugs.”
We’ve been monitoring the FDA’s treatment of CBD oil, a cheap, safe, and effective natural medicine for pain and other ailments. The agency has stated that CBD is not a supplement, and part of their justification is that it wasn’t marketed as a dietary ingredient before 1994. Recent evidence has surfaced, however, that clearly shows cannabis was consumed as food for centuries in many different countries. But because of a technicality, it is unlikely that the FDA will consider this evidence that would allow CBD to remain on the market as a supplement—meaning that consumers will have to shell out $32,500 a year for CBD oil.
Representative Morgan Griffith (R-VA) has reintroduced a bill to ensure continued consumer access to customized natural medicines made at specialized pharmacies (known as compounding pharmacies). While other challenges remain, the Preserving Patient Access to Compounded Medications Act is an important step toward curbing the attack on these important natural medicines. The Act does several important things. It amends section 503A of the Food, Drug, and Cosmetic Act (which pertains to “traditional” pharmacies, as opposed to larger “outsourcing” facilities) to unequivocally permit “office use” of compounded drugs, which allows a doctor to keep a supply of certain medications in his or her office in order to provide immediate treatment to patients who need it. For example, without office use, a patient in extreme pain would have to wait for days, get his or her prescription filled, and then return to the doctor for an injection. The bill also mandates the FDA to accept USP monographs for dietary supplements. This is a pivotal issue.
Just as we suspected, the FDA is coming after supplements once again. Recently we told you about a statement made by Commissioner Scott Gottlieb (who has since resigned his post) concerning the FDA’s regulatory approach to dietary supplements. The statement was short on details but gave us cause for concern. Now it appears as if those fears were warranted: the FDA is attempting to create a mandatory list of all supplement products in the US. Such a list could be used to target certain supplements and remove them from store shelves, and we must oppose it.
Dr. Raeford Brown is a pediatric anesthesia specialist at the UK Kentucky Children’s Hospital. He also chairs the Food and Drug Administration (FDA) Committee on Analgesics and Anesthetics. Dr. Brown has been openly critical of the FDA and their lack of oversight on the pharmaceutical industry, claiming "Congress is owned by pharma.” His comments were recently reported by Adriana Belmonte at Yahoo Finance. "Pharmaceutical companies are under the spotlight with congressional hearings on the cost of drug prices and allegations of the industry’s role in the opioid crisis. Dr. Raeford Brown, a pediatric anesthesia specialist at the UK Kentucky Children’s Hospital and chair of the Food and Drug Administration (FDA) Committee on Analgesics and Anesthetics, has been openly critical of big pharma and the lack of proper oversight from the FDA. Despite many politicians, particularly declared presidential candidates, beginning to speak out against big pharma, Brown does not think that anything will come out of it 'because Congress is owned by pharma.'" The article documents how pharmaceutical companies are making significant financial contributions to politicians and political candidates. Statistics are based on OpenSecrets, a website operated by the nonpartisan Center for Responsive Politics, which tracks money in U.S. politics. “The pharmaceutical industry pours millions of dollars into the legislative branch every single year,” he told Yahoo Finance. “In 2016, they put $100 million into the elections. That’s a ton of money.” Dr. Brown went on to say: “I’m really much more concerned because Congress is supposed to have oversight for the FDA. If the FDA isn’t going to hold pharma accountable, and Congress is getting paid to not hold pharma accountable, then it really doesn’t matter who the president is because it’s really about Congress.”
FDA Wants to Regulate Human Poop and Let Only Big Pharma Sell it as a Super Probiotic Drug for Profit
The FDA is on the verge of deciding the future of fecal microbiota transplants (FMT), a promising new treatment that harnesses the power of the gut microbiome to fight illness. The agency is poised to regulate FMT as new drugs, which means patients will be paying thousands of dollars for human poop. This is yet another example of why medicine is so expensive in this country: the FDA takes affordable, natural treatments—as natural and humble as human feces!—and gifts them to Big Pharma to reap mega-profits. Left on its own, we know that the FDA will once again serve Big Pharma by classifying FMT as a new drug. To develop a new drug costs billions of dollars, which can only be recouped through market exclusivity (read: FDA-granted monopoly). What can now be had for free will then cost tens of thousands of dollars. The only way we can prevent it is to respond in force to tell the FDA to keep its hands off our poop!
Last year (2018) Netflix produced a documentary about corruption in the medical device industry, which is a 300 BILLION dollar a year industry worldwide. Industry insiders boast that the medical device industry has more power than Big Pharma, and is more powerful than most governments around the world. Earlier this month (March, 2019), Kaiser Health News published an investigation into the FDA and their public database that tracks medical device failures. Their investigation found that the FDA maintains a hidden database that records malfunctions of medical devices that is not available to the public. Dr. Douglas Kwazneski was helping a Pittsburgh surgeon remove an appendix when something jarring happened. The surgical stapler meant to cut and seal the tissue around the appendix locked up. Kwazneski later turned to the Food and Drug Administration’s public database that tracks medical device failures and “there was nothing,” he said. Yet when he surveyed leading surgeons on the matter, he discovered that more than two-thirds had experienced a stapler malfunction, or knew a peer who did. Such failures can have deadly consequences. Kwazneski had no idea the FDA had quietly granted the makers of surgical staplers a special “exemption” allowing them to file reports of malfunctions in a database hidden from doctors and from public view. “I don’t want to sound overdramatic here, but it seemed like a cover-up,” said Kwazneski.
The Food and Drug Administration (FDA) is considering approving Johnson & Johnson’s new nasal spray antidepressant, esketamine (Spravato) after an FDA advisory committee voted on February 12, 2019 in its favor. The drug is a chemical mirror of ketamine, a potent “dissociative anesthetic” that is abused as the illegal “club drug,” Special K, and generates an intense high and euphoric effects, and hallucinations. If approved, it would add to the mind-numbing of America that an FDA-psychiatric collusion is causing, says the Citizens Commission on Human Rights (CCHR). The group said the FDA’s continuing clearance of potentially addictive and dangerous psychotropic drugs and, more recently, electroshock treatment devices, fuels a lucrative $35 billion a year industry at the cost of consumers’ mental health and lives. Astoundingly, with more than 43.6 million Americans each year now taking antidepressants once touted as “miracle pills,” psychiatrists now claim that the drugs don’t work in one out of every three people taking them.