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.”
New evidence on a key nutrient offers hope to cancer patients; will the FDA snuff it out? A new study on annatto-sourced delta-tocotrienol (one of the compounds contained in vitamin E) has shown incredible results for extending the life of ovarian cancer patients. It is a stunning finding that should be hailed as a major breakthrough, but don’t expect to hear much about it from the crony medical establishment, which does everything it can to prevent you from learning about the benefits of natural products. It’s hard to over emphasize how ground-breaking this study is. There have been studies on the anti-cancer effect of certain nutrients, but these are generally smaller in scale and use animal or in vitro models; never before has the ability of a nutrient to significantly prolong survival in cancer patients been demonstrated in a study of drug-level quality. Further, the authors of the study don’t explicitly say it, but implicit in the study’s results is that Avastin might not be required. Overall survival in patients on just Avastin was 5-7 months; for Avastin plus delta-tocotrienol, it was 11 months. This could mean that delta-tocotrienol is just as effective, if not more so, than Avastin—but more study would be required to establish this. These are astonishing results and great news for women with ovarian cancer. Because natural medicines generally cannot be patented—meaning the drug industry can’t make mega-profits from them—the government suppresses what the public can know about their benefits, lest drug companies lose some market share. The feds don’t tell us, for example, about the promising cancer research on vitamin C. In fact, the agency will try to block you from knowing about the benefits of these nutrients because they aren’t FDA-approved drugs, and only drugs can make claims to treat or prevent a disease. The FDA wouldn’t want to upset the cancer drug industry’s more than $100 billion market.
While Congress gives CBD the green light, FDA still has its stop sign up. For a while now, we’ve been telling you about the threats to cheap CBD oil. One of those threats has been that the DEA includes hemp and CBD in the definition of marijuana, which is a Schedule 1 drug—that is, it has no recognized medical benefit. This was plainly inaccurate, and Congress has rectified the error: the Farm Bill removes “hemp” from the definition of marijuana. While there are still some challenges and uncertainty, this is an important step towards ensuring consumer access to affordable CBD oil. The legalization of hemp means that so long as CBD oil is extracted from hemp and has less than 0.3% THC (the compound that gives the “high” associated with marijuana), it is no longer considered a controlled substance. The main hurdle that is still in place is the FDA. After the Farm Bill was approved, FDA Commissioner Scott Gottlieb released a statement reminding us that, while CBD may no longer be a controlled substance, it is still subject to FDA jurisdiction.
Recently, the FDA announced that a group of six artificial flavors would no longer be permitted to be used as food additives. They are: synthetically-derived benzophenone, ethyl acrylate, methyl eugenol, myrcene, pulegone, and pyridine. If you’ve never heard of these, you’re not alone. Most Americans are completely unaware of the additives put into their food because the food industry does not need to list the chemicals they use in the ingredients. Instead, the federal government allows these chemicals to be obscured by being listed as “artificial flavors” or “natural flavors.” It’s time to stop letting Big Food and their crony capitalist friends get away with hiding the contents of their products and require them to list the chemicals they use in our food.
The following open letter to FDA Commissioner, Dr. Scott Gottlieb, calling for immediate investigations into many facets of the clinical trials for Gardasil sponsored by Merck was emailed today. Dear Dr. Gottlieb: This open letter, written on behalf of medical consumers around the world, is an urgent request for you to investigate potential malfeasance perpetrated by Merck during their clinical trials of Gardasil, the human papillomavirus vaccine that the FDA approved in June 2006. A new book, The HPV Vaccine on Trial: Seeking Justice for a Generation Betrayed, by Holland, Rosenberg, and Iorio, outlines at least four areas requiring the FDA’s urgent attention.
The largest, most expensive antidepressant efficacy study involving over 4,000 initial participants ended in 2006. The purported intention of the study was to provide real-life results instead of the shorter clinical trial results that are done to get antidepressant drugs approved. But the results were not clear regarding antidepressants' true efficacy compared to clinical trials. Safety was not a consideration, just efficacy at reducing depression. A new study has recently re-analyzed this massive STAR*D (Sequenced Treatment Alternatives to Relieve Depression) study funded by the National Institute of Mental Health (NIMH) and found evidence that there was obfuscation, intended or unintended, that made antidepressant efficacy look better than it actually is. Earlier this year, 2018, a published paper, Do outcomes of clinical trials resemble those “real world” patients? A reanalysis of the STAR*D antidepressant data, demystified this study and provided a clearer picture of real-world antidepressant efficacy. As one psychiatrist skeptical of antidepressants, Dr. Joanna Moncrieff, reported after reviewing the 2018 reanalysis of the STAR*D paper: "[The 2018 reanalysis was done] 14 years after the [STAR*D] study was finished. What in the world were the main findings of the world's largest ever antidepressant trial doing being presented now in a little-known journal? The answer may lie in the fact that they show how miserably poor the results of standard medical treatment for depression really are! … people taking antidepressants do not do very well. In fact, given that for the vast majority of people depression is a naturally remitting condition, it is difficult to believe that people treated with antidepressants do any better than people who are offered no treatment at all."
The HPV vaccine was just approved for adults, despite Merck’s concerning research data. The FDA made its determination in the face of substantial evidence of the dangers of the HPV vaccine and the existence of safer alternatives. For women who have already been exposed to certain strains of the HPV virus, vaccination can actually increase the risk of precancerous lesions by 44.6%. That’s right: if you are already infected with HPV, getting vaccinated could increase your risk of getting cancer. To put this in perspective, 79 million Americans are thought to be infected with HPV, and about 14 million are newly infected each year, making HPV the most common sexually transmitted infection. Often there are no symptoms. The CDC says that “HPV is so common that almost every person who is sexually active will get HPV at some time in their life.” A large, government-backed push to get more people vaccinated for HPV could actually increase many people’s risk of getting cancer.
The high cost of prescription drugs has recently made headlines, evidenced by price-gouging schemes that cause drug prices to skyrocket 5,000% (as in the case with the infamous Martin Shkreli and the drug Daraprim) or Mylan’s more recent price hike on EpiPen’s to over $600 for a two-pack. What’s often left out of these stories, however, is how the federal government helped the pharmaceutical industry have this kind of power over drug pricing by allowing the industry to take advantage of publicly-funded research. Universities get government money to do research, patent any novel inventions that arise from that research, and sell the patents to the pharmaceutical industry. Consumers are forced to pay monopoly prices for drugs that their tax money helped develop. We see pharmaceutical companies turning supplements into drugs, selling them at exorbitant prices, and removing the supplement versions. Our tax dollars fund their blockbuster drugs, and with those profits they are taking our supplements away. This cannot be allowed to stand.
Last year, the FDA announced the approval of Endari, a drug for sickle cell disease. Endari is an oral powder comprised of L-glutamine, an important amino acid currently available as a supplement. The drug company, Emmaus Medical, Inc., filed an investigational new drug (IND) application—demonstrating their investigation of L-glutamine as a drug. If a drug company begins investigating a nutrient for use in a drug before a supplement company files an NDI notification on that nutrient, the company can ask the FDA to have supplement version removed from the market, leaving consumers with no other option than the drug. Currently, a 120-pill bottle of L-glutamine can be purchased for less than $10; a year’s worth of Endari will reportedly cost consumers more than $40,000. CBD oil faces a similar threat.