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.
After the U.S. Food and Drug Administration’s (FDA) approved Merck’s HPV-9 Gardasil vaccine for use in adults age 27 to 45 in 2018, the Centers for Disease Control’s (CDC) Advisory Committee on Immunization Practices (ACIP) of the Department of Health and Human Services (HHS) is evaluating whether to expand their current HPV vaccine recommendation to include this new age group. ACIP’s current recommendation is that boys and girls ages 9 through 15 should get two-doses of HPV-9. The “catch-up” vaccine schedule is a three- dose series for females above age 15 through age 27 and males above 15 years of age to 21 years of age, if not previously vaccinated with HPV vaccine. Should ACIP expand their recommendations for use of HPV-9 vaccine in the newly approved age group, the CDC won’t be alone in the push to increase the use of the HPV vaccine by children and adults in the U.S. During the September meeting of the National Vaccine Advisory Committee (NVAC), a federal advisory committee that makes recommendations to the National Vaccine Program Office (NVPO), the HHS Assistant Secretary ADM Brett Giroir M.D. emphasized that HHS supported the NVAC’s HPV vaccine recommendations published in June 2018. Dr. Giroir stated that increasing HPV vaccination in America would be a focus for HHS in 2019. The federal government’s focus on increasing the use recommendations for the HPV vaccine may result in a renewed effort by state legislators to introduce legislation in many states to mandate HPV vaccine for school entry.
FDA is ignoring Congress and attacking an affordable supplement to protect Big Pharma profits. As we reported earlier this year, the Farm Bill approved by Congress legalized hemp, which is a major step towards ensuring consumer access to affordable CBD oil supplements. Unfortunately, the FDA is still throwing up roadblocks because CBD is now also available as an FDA-approved drug. It is a perfect case study for why healthcare is so expensive in this country. Shortly after the passage of the Farm Bill, FDA Commissioner Scott Gottlieb reiterated the FDA’s position that, regardless of hemp’s legalization, it is still illegal to sell CBD in supplements or food. This is because CBD is the active ingredient in a recently-approved drug for a rare form of epilepsy. The only legal source of CBD, then, is this drug, which costs $32,500 a year.
In response to a Freedom of Information Act (FOIA) lawsuit, the FDA has admitted, for the first time, that government agencies, including the CDC, are recommending vaccines for pregnant women that have neither been licensed for pregnant mothers by the FDA nor tested for safety in clinical trials. The lawsuit, filed by Children’s Health Defense (CHD) attorney, Robert F. Kennedy, Jr. on behalf of Informed Consent Action Network (ICAN), a vaccine safety advocacy group, sought all clinical trial data used by FDA to approve influenza vaccines for pregnant women. The FDA’s terse reply: “We have no records responsive to your requests.” Robert F. Kennedy, Jr. says, “As a nation, we can no longer pretend our trusted agencies are protecting our children. It is time to hold federal agencies accountable.”