The FDA has extended the comment period on its completely unacceptable guidance that shifts how the agency will regulate homeopathic medicines. While the agency says that it will exercise enforcement discretion and focus on certain categories of homeopathic drugs, the wording of the guidance, in fact, says that all homeopathic drugs are currently being marketed illegally, leaving the door open for the agency to take action against any and all products. Concerned consumers must make their voices heard to stop this draconian guidance from moving forward.
In 2017, McGuff Pharmaceuticals received FDA approval for an intravenous vitamin C (IVC) product for the treatment of scurvy, and thus market exclusivity. The FDA notified other manufacturers of IVC that they must stop producing it, giving them a one-year grace period that has now expired. McGuff has subsequently raised the price of IVC. The FDA-created monopoly on IVC will hurt patients. This is a medicine that is ubiquitous in integrative medicine practices as a key ingredient in Myers’ Cocktails, chelation, and cancer IVs. IVC is not normally covered by insurance, so patients need to pay out of pocket. Intravenous administration of nutrients is crucial, as it allows patients to achieve serum concentrations of nutrients that are not obtainable through oral administration. For example, vitamin C’s antiviral effect has been demonstrated to occur at 10-15 mG/dL, a level that can only be achieved intravenously. Cancer patients require multiple vials in a single session and can have multiple sessions per week. IVC is also a potent antiviral, so these patients will also have to pay a premium or simply go without it. Like CBD, the case of IVC is a prime example of the crony medical system—a cheap, safe, and effective natural medicine widely available to consumers is once again turned into an expensive monopoly drug. We must demand that the FDA not enforce market exclusivity for McGuff’s IVC product.
Earlier this year, the FDA fired off warning letters to seventeen companies that, in the agency’s view, were illegally marketing supplements to treat Alzheimer’s disease. One of the supplements targeted in the FDA’s action was piracetam, a derivative of GABA, continuing an FDA trend of attacking brain health supplements to protect drug industry profits. Piracetam has been on the market as a supplement for years. It is approved as a drug in Europe and prescribed for cognitive impairment and dementia. Researchers think that piracetam helps the brain by boosting energy production in brain cells. As we age, our brain cells decline in their ability to generate energy; this decline in energy causes cellular “debris” to accumulate which can kill brain cells and eventually lead to senility. The FDA has also moved against vinpocetine and picamilon, two other brain health supplements. At the same time, major trials for Alzheimer’s drugs keep failing…and failing. Is the FDA clearing the way for Big Pharma to turn these natural compounds into expensive drugs? Given the agency’s recent history, this seems the most likely explanation.
Last month the Food & Drug Administration published its latest annual analysis of the levels of pesticide residues that contaminate the fruits and veggies and other foods we Americans routinely put on our dinner plates. The fresh data adds to growing consumer concern and scientific debate over how pesticide residues in food may contribute – or not – to illness, disease and reproductive problems. Over 55 pages of data, charts and graphs, the FDA’s “Pesticide Residue Monitoring Program” report also provides a rather unappetizing example of the degree to which U.S. farmers have come to rely on synthetic insecticides, fungicides and herbicides in growing our food. We learn, for instance, in reading the latest report, that traces of pesticides were found in 84 percent of domestic samples of fruits, and 53 percent of vegetables, as well as 42 percent of grains and 73 percent of food samples simply listed as “other.” Roughly 94 percent of grapes, grape juice and raisins tested positive for pesticide residues as did 99 percent of strawberries, 88 percent of apples and apple juice, and 33 percent of rice products, according to the FDA data.
Unless the FDA makes an exception, consumers will lose access to affordable CBD oil. Over the last couple of years, ANH has been reporting on the many benefits of CBD oil, a non-psychoactive compound found in the hemp plant. Among other things, CBD oil is extremely helpful in managing pain. You might think that, in the midst of a crippling epidemic of opioid addiction, a public health agency would be interested in preserving access to affordable, non-addictive pain remedies. But the FDA could shut the door permanently on consumer access to affordable CBD oil, unless concerned citizens make their voices heard. The agency has sent warning letters to several CBD companies for making illegal disease claims. It is shocking that this issue has come to this. Deaths from fentanyl, an FDA-approved drug, and other synthetic opioids reached an appalling 30,000 in 2018. When a safe, non-addictive, and effective alternative to deadly opioids is found, it is snatched away by Big Pharma with the help of the FDA, whose mission it is to protect public health. It is one of the most shameful examples of crony capitalism in recent memory.
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.