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Study: Natural Compound Doubles Cancer Survival Rates – Will the FDA Ban it?

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.

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Congress Gives CBD Oil Green Light but FDA Still Has Stop Sign Up

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.

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Do You Know About These Hidden Chemicals in Common Foods?

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.

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Public Petitions FDA to Investigate Gardasil Vaccine Fraud

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.

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Study: Science Used to Approve Antidepressant Drugs Does Not Show Efficacy

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."

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FDA Decision to Approve Gardasil Vaccine for Adults Will Likely Increase Cervical Cancer Rates

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.

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Taxpayer Money Used to Fund Drug Research – Drug Companies Robbing Americans

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.

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The FDA Turned Your $10 Supplement into a $40,000 Drug

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.

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Study: FDA’s “Safe Limits” for BPA Not So Safe

The first U.S. study of the effect on people of exposure to a hormone-disrupting chemical widely used in food packaging showed that levels the Food and Drug Administration deems “safe” can alter insulin response, a key marker for diabetes. The groundbreaking study, published in the Journal of the Endocrine Society, administered low doses of bisphenol A, or BPA, to 16 people, then tested their insulin production in response to glucose, commonly called blood sugar. When insulin and blood glucose levels were compared to the same measurements taken without exposure to BPA, researchers found that BPA significantly changed how glucose affected insulin levels. Similar insulin and glucose tests are used by doctors for diagnosing diabetes.

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FDA Wants to Turn CBD Oil Into a Drug that Will Cost $32,500 as They Ban all Other CBD Oils

For years, consumers have benefitted from access to cheap, safe, and effective CBD oil supplements. But now the FDA says that CBD is a drug, not a supplement—a drug which will be sold for $32,500 a year. Legally the FDA could at any time remove all CBD supplements from the market, on its own volition, or if the drug company which holds drug market exclusivity requests FDA do so. Unless we change the rules, we may see a government-sponsored monopoly on CBD oil, and in the near future, additional monopolies on other cheap, safe, and effective supplements. This threat to affordable CBD oil shows how broken this system is. An opioid epidemic is ravaging our country, with drug overdose deaths surpassing car accident fatalities. People are addicted to and dying from FDA-approved drugs, yet the agency is poised to eliminate consumer access to a non-addictive, cheap, safe, and effective alternative in CBD oil—all so one drug company can charge tens of thousands of dollars for what currently costs a few dollars. The FDA will not protect us—they’re in on it! More drugs mean more user fees—more money—for the agency, so don’t expect the FDA to defend your access to supplements.

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FDA to Ban More Supplements?

On September 12, the FDA’s advisory committee on compounded medicine—medicine made for individual patients at specialized pharmacies—will meet to discuss five ingredients: alpha lipoic acid, CoQ10, creatine monohydrate, pyridoxal 5 phosphate (P5P), and quercetin dihydrate. If the agency doesn’t hear from patients and concerned citizens, we may lose access to individualized preparations of these important dietary ingredients. The Pharmacy Compounding Advisory Committee (PCAC) advises the FDA in writing new rules regarding what supplements and drugs can be made individually for patients with specific needs by compounding pharmacies. The main motivation behind the FDA’s attacks on compounded medicine is to protect the pharmaceutical industry from competition. With no other choice, patients who rely on compounded medicine would have to buy Big Pharma’s drugs. We can’t let them whittle away the ingredients allowed to be compounded. This “death by a thousand cuts” could end access for us to compounding pharmacies altogether.

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FDA Approves Experimental Hepatitis B Vaccine for Adults Despite Higher Incidence of Heart Attacks

In February 2018, the FDA and CDC approved the recommendation for a new hepatitis B vaccine, Heplisav-B for adults over the age of 18. The U.S. Food and Drug Administration (FDA) had twice rejected the application for licensure for Heplisav-B in the past four years because of safety signals. Heplisav-B differs from other licensed hepatitis B vaccines in that it contains a new synthetic adjuvant known as cytosine phosphoguanine 1018 (CpG 1018) composed of short synthetic DNA molecules. In 2016, the FDA rejected an application for licensure for the Heplisav-B vaccine, because the agency was concerned about an increased rate of heart attacks and deaths in people who had been given the vaccine. During the trial, approximately 14 subjects had heart attacks. In July 2017, the FDA committee convened to re-evaluate the scientific evidence and make a decision on whether Heplisav B should or should not be approved for use in the U.S. This committee had only one cardiologist on the team, Milton Packer, MD, who is a distinguished scholar in cardiovascular science at the Baylor University Medical Center in Dallas, Texas. According to Dr. Packer, it was possible that the Heplisav B vaccine’s novel adjuvant was related to the higher number of heart attacks in study participants who received the experimental vaccine. He stated: "To know if the 7 -1 heart attack imbalance represented a real risk, we’d need comparative data in 50,000 people." However, the only way to conduct such a large trial would be to approve the vaccine and see what happens in the public. With Dr. Packer abstaining in his vote to recommend the vaccine, the FDA committee approved it anyway. Dr. Packer stated: "Why did I abstain? Based on the available data, it was impossible for anyone to know if the increase in heart attack risk was real. There is a simple rule in life: if you don’t know, you should say you don’t know." The vaccine is now available to the public, and all those who receive it are basically guinea pigs to find out if heart attacks will result from the experimental vaccine, and if it will continue to have FDA approval.

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FDA Approving Dangerous Drugs that Are Injuring and Killing People

As pharma companies underwrite three-fourths of the FDA’s budget for scientific reviews, the agency is increasingly fast-tracking expensive drugs with significant side effects and unproven health benefits. Nuplazid, a drug for hallucinations and delusions associated with Parkinson’s disease, failed two clinical trials. In a third trial, under a revised standard for measuring its effect, it showed minimal benefit. Overall, more patients died or had serious side effects on Nuplazid than after receiving no treatment. Patients on Uloric, a gout drug, suffered more heart attacks, strokes and heart failure in two out of three trials than did their counterparts on standard or no medication. Nevertheless, the U.S. Food and Drug Administration approved both of these drugs — with a deadly aftermath. Uloric’s manufacturer reported last November that patients on the drug were 34 percent more likely to die from heart disease than people taking an alternative gout medication. And since the FDA fast-tracked approval of Nuplazid and it went on the market in 2016 at a price of $24,000 a year, there have been 6,800 reports of adverse events for patients on the drug, including 887 deaths as of this past March 31. The FDA is increasingly green-lighting expensive drugs despite dangerous or little-known side effects and inconclusive evidence that they curb or cure disease. Once widely assailed for moving slowly, today the FDA reviews and approves drugs faster than any other regulatory agency in the world.

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FDA Bows to Public Pressure: Compounding Pharmacies Can Continue Making Natural Medicines

ANH members played a key role in thwarting efforts to eliminate access to personalized medicine. Two years ago, the FDA released a draft guidance saying that a compounding pharmacy (a pharmacy that makes customized medicines for individual patients) cannot register as both an “outsourcing” (503B) and a traditional (503A) facility. We issued an action alert to ANH members to speak out against this policy and submitted detailed legal comments drafted by our general counsel. The agency just released the final guidance, and the FDA listened to our criticisms. The bottom line is that this change will make it much easier for many compounding pharmacies to stay in business, meaning patients will be better able to get the medicines, such as nutrient IV infusions and bioidentical hormones like progesterone and estriol, that they need. This is an important victory.

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The U.S. Needs an Independent Vaccine Safety Organization Separate from the Corrupt FDA and CDC

Most Americans are oblivious to the huge annual burden of chronic illness, injuries and deaths linked to vaccines. Some of the blame for the public’s ignorance belongs to a complicit media that “pretends that vaccine-related injuries do not occur.” However, the lion’s share of culpability for the buried story likely rests with the two federal agencies charged with vaccine oversight—the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC)—both of which regularly engage in various forms of deception to uphold their bland narrative that vaccines are unambiguously safe. One of the most significant criticisms has to do with the FDA’s and CDC’s business-as-usual reliance on external experts with financial ties to the pharmaceutical companies and/or products that they are evaluating. Little has changed since a congressional Committee on Government Reform outlined this problem nearly two decades ago. The Reform Committee examined the doings of the FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC), which determines whether new vaccines should be licensed, and the CDC’s Advisory Committee on Immunization Practices (ACIP), which recommends vaccines for inclusion in the childhood vaccine schedule. The congressional committee noted that FDA and CDC advisory committee members and chairpersons own stock in the vaccine companies under consideration, as well as own vaccine patents. The CDC “grants conflict of interest waivers to every member of their advisory committee a year at a time and allows full participation in the discussions leading up to a vote by every member,” even if a member has a financial stake in the decision.

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FDA Has Acknowledged That Vaccine Technology is Outpacing Ability to Predict Adverse Events

Recently, top-tier autoimmunity researchers described vaccine safety science as a “hazardous occupation.” In their view, this is because uncompromising vaccine proponents are instantly ready to mount vociferous personal attacks on anyone who raises questions about any aspect of vaccine safety, even if the questions are buttressed by impeccable, high-quality science. Vaccine safety was not always such a taboo topic. In 1961, a leading polio researcher put forth the view in Science that “even after licensing, a new vaccine product must be considered to be on trial” because of the many “new variables” that accompany large-scale vaccine production and rollout. A leading Food and Drug Administration (FDA) official contended in 1999 that modern advances in vaccine technology were rapidly “outpacing researchers” ability to predict potential vaccine-related adverse events” and argued for closer attention to safety issues from the earliest stages of vaccine development. “One of the important things is that the technology used to make these vaccines actually exceeds the science and technology to understand how these vaccines work and to predict how they will work,” stated Dr. Peter Patriarca, MD, Director of the Viral Products Division of the FDA Center for Biological Evaluation and Research (CBER). “So this has the potential for ending up in a situation which I call a 'black box' vaccine referring to a situation of unforeseen and unpredictable vaccine outcomes.” Dr. Patriarca also voiced concerns that with live attenuated vaccines “there is the potential for these vaccines, many of which have been poorly characterized, to recombine with viruses that may be present in the vaccine. Some of these viruses are latent and persist for a while, so it is very important to assure that these things are safe before they are given to people.” In the two decades since the FDA official’s prescient words of warning, numerous published studies have highlighted vaccine safety concerns that were either unexplored or neglected prior to the introduction of the vaccines in question.

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FDA Wants to be Your Doctor and Restrict Access to Customized Medications

FDA wants to act as your physician and regulate your access to customized medications. Action Alert! With its new guidance, the FDA is further tightening the screws on pharmacies that produce customized medications for individual patients. The agency is inserting itself into the role of “doctor” by deciding for patients whether there is a “clinical need” for certain medicines to be made at pharmacies. The reason? We believe they want to protect the monopoly of FDA-approved drugs. In its latest guidance, the FDA is signaling that it will further restrict the medicines that can be made at outsourcing pharmacies by adopting a stringent definition of “clinical need” if there is already an FDA-approved drug for a given condition.

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FDA Threatens Homeopathy – Congressional Action Needed

The FDA wants to up-end the homeopathic industry—because it’s become too popular. Help us stop this insanity! Action Alert! Considering the myriad public health problems facing this country, including the opioid epidemic and the overuse of antibiotics, it is ludicrous that the agency is focusing on homeopathic drugs. Could it be that, like supplements, homeopathic drugs compete with pharmaceutical drugs? Recall, too, that the FDA has announced that they are targeting alternatives to opioids in the midst of an epidemic of opioid addiction that is killing 115 Americans every day. We must encourage our senators and representatives to sign on to the Hatch and Costello letters and send a clear message to the FDA: the previous regulatory policy was sufficient to ensure consumer access to safe homeopathic remedies, and we don’t need to fix what isn’t broken.

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FDA Declares All Homeopathic Drugs Illegal Threatening Remedies for Millions of Americans

In one fell swoop, the FDA has declared that virtually every single homeopathic drug on the market is being sold illegally. The FDA says that it does not intend to take action against such products at this time, but the writing is on the wall. If it wants to, the FDA could go after any homeopathic drug currently on the market. FDA’s process started two years ago, when the agency held a public hearing to evaluate its enforcement policies for homeopathic products. We suspected the agency was planning to tighten its grip on homeopathy, which, after all, competes with the pharmaceutical drugs that fund the FDA. We cannot let the FDA eliminate consumer access to homeopathy.

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Is the European Medical Agency Experimenting on Babies with the Meningitis Vaccine Only Approved for Age 10 and Above?

In 2016, we published an article on the dangers of the meningitis B vaccination, Bexsero, titled, Are Ineffective New Meningitis B Vaccines Causing Harm to Children? At the time of publication, according to the FDA product information leaflet, the vaccine had in fact only been approved for children over the age of ten. Despite this fact however, in the UK, the meningitis B vaccine Bexsero is being administered to infants as young as 2 months, despite the fact that we could find no evidence to support that this vaccine was safe to be administered to babies. It has been brought to our attention that there are in fact two product information leaflets on the same vaccination. However, what is different about the second product information leaflet, published on January 14, 2015, by the European Medical Agency (EMA) is that the information that it provides, is the polar opposite, of the information provided by the FDA. Is the UK government conducting clinical trials on infants, and if they are, then are parents aware of this fact?

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