FDA Piracy Threatens CBD

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Censoring Speech and Stealing Nature the FDA Way

FDA is ignoring Congress and attacking an affordable supplement to protect Big Pharma profits. And we wonder why health care costs so much. Action Alert!

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. That’s right: an extremely beneficial, natural compound can now only be legally obtained at exorbitant cost. In typical FDA non-logical style, the Agency adds that it won’t enforce this ruling for the time being, meaning that companies which wish to ignore it may do so for the time being, but for how long? This is playing cat and mouse games with a vital supplement and making a mockery of what is supposed to be healthcare law.

Recall that CBD is a natural alternative for pain management. We are in the midst of an opioid crisis that is decimating many communities across the country. CBD is a cheap, safe, and natural alternative to these dangerous drugs, but the FDA decides to let Big Pharma have a monopoly on it and jack up the price. It is scandalous.

Unfortunately, this is par for the course in our crony medical system. There are more examples. Natural treatments are often more effective, safer, and far cheaper than synthetic drugs. But the FDA either bars any discussion of them or kicks them out of the healthcare system, thereby creating more drug monopolies.

This is exactly what happened to cherry and walnut growers, who dared to cite some of the science supporting the health benefits of cherries and walnuts. The FDA said that citing this research made cherries and walnuts unapproved drugs and was therefore illegal. In some cases, the agency threatened jail time for these “crimes.”

Science tells us that food is medicine. But the FDA will put you in jail for mentioning any medical benefit from a particular food. How does this make sense for an agency that is supposed to be safeguarding public health?

To the crony medical establishment, healthcare is drug care. The FDA and Big Pharma don’t want us to stay healthy through the use of food and food supplements because those products don’t make money for the drug companies and, by extension, the FDA. It’s a well-constructed racket: the FDA blocks free speech about the benefits of natural foods and supplements so there’s no competition with drugs, but when a nutrient shows promise for treating disease, the FDA hands it over to Big Pharma and bans the supplement. The drug company profits, and the FDA gets their drug user fees. Everyone wins but the consumer.

Keep in mind that healthcare is bankrupting this country. The US healthcare costs are a third higher than other advanced economies relative to GDP. Medicare and Medicaid spending account for $1 out of every $4 in the federal budget. Much of this spending is on expensive drugs that are ineffective and make us sicker. Unleashing the power of natural medicine—that is, allowing companies to inform consumers of the proven benefits of natural products—could substantially lower healthcare costs, but doing so would upset the crony establishment.

There is still some hope for affordable CBD. In his statement, Commissioner Gottlieb said that the FDA has the authority to issue a regulation permitting the use of CBD in food and food supplements. We must encourage him to do so, while simultaneously telling the agency to go further by ending their censorship of the benefits of natural products.

Action Alert! Write to Congress and the FDA, urging them to grant an exemption to allow CBD in food and supplements. Also tell the agency to stop censoring free speech about the benefits of natural products. Please send your message immediately.

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Will Natural Medicine Be Snuffed Out in Your State?

That’s what a secretive, private, powerful organization is seeking to do. Action Alert!

For years now, we have been reporting on the machinations of the Federation of State Medical Boards (FSMB), especially their most recent efforts to pass their Interstate Medical Licensure Compact in as many states as possible. If the FSMB isn’t opposed, its power over the practice of medicine will continue to grow—power that we expect will be wielded against integrative physicians.

Back in September 2014, the Federation of State Medical Boards (FSMB) released model legislation for the creation of an interstate medical licensing compact. The stated intent of the legislation is to streamline the licensing process for physicians who wish to apply for medical licenses in multiple states. The model legislation would allow physicians interested in practicing medicine in multiple states to apply for an expedited license.

Once enacted, an Interstate Commission comprised of representatives of each member state would be created to administer the interstate medical licensing compact.

This may look like an innocuous or even useful move by FSMB, but a deeper analysis of this proposal reveals that the opposite is true, as we’ve pointed out previously.

It should first be noted that the organization has demonstrated its antipathy toward natural health since the mid-1990s, when it discussed altering the definition of health fraud to include alternative medical care! It would appear that FSMB considers innovative approaches to healthcare to be nothing more than exercises in “quackery.” Extending the power of this organization over the licensing of doctors across multiple states—or all states, if the FSMB gets its way—gives the FSMB more opportunity to throttle or undermine integrative doctors. If that indeed becomes the case, patient access to these doctors will suffer.

There are more reasons to oppose the FSMB’s project. The Compact takes autonomy away from the states. The Missouri Board of Registration for the Healing Arts noted that:

the Compact [takes]away the state’s autonomy and authority to grant licenses.…If [an]applicant is deemed “compact eligible” by any other compact state, all member states must grant licensure based on that eligibility. There is no discretion to look at moral character, malpractice history, training irregularities, or other requirements. There is also no opportunity for a state to disagree with another state’s interpretation of the compact requirements or their determination that a particular applicant meets those requirements.

States’ rights is a foundational principle of this country; the FSMB’s Compact takes power away from states and gives that power to an organization with no public funding, transparency, or accountability.

Which brings us to the next point. The lack of accountability is another critical issue with the FSMB’s legislation. While we’ve been critical of the actions of some state medical boards, at least there is some degree of process by which the public can weigh in when rules are created. But when one bad rule can affect multiple states, how can the public have any input? If the FSMB decides that bioidentical hormone replacement therapy, or IV vitamins, or some other form of natural medicine is outside the standard of care and prohibited, what recourse is there to challenge them?

Third, the FSMB would entrench Maintenance of Certification (MOC) requirements as mandatory for any physician licensed through the Compact. Recertification would be overseen by the ABMS, which many physicians see as little more than a money-making endeavor—just take a look at what some of the executives make. These certifications are often used as a requirement for hospital employment. As with monopolistic nutrition licensure laws, FSMB’s interstate compact could be a similar attempt to exercise undue control over the practice of medicine.

In short, FSMB’s proposal is an underhanded attempt to increase its control over the practice of medicine—power that would likely be wielded against integrative doctors. Currently, more than two dozen states have passed FSMB’s model legislation. Again, despite having little transparency or accountability, the FSMB wields a tremendous amount of power over the practice of medicine in all fifty states. We must push back against their power grab.

Action Alert! Write to your state legislature and tell them to oppose the FSMB’s Interstate Compact. Please send your message immediately.

If your state is below, click the link to oppose FSMB legislation in your state.

Georgia

Kentucky

North Dakota

New Mexico

Oklahoma

South Carolina

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FDA’s Deafening Silence on Ebola Cures

In the midst of another terrible outbreak, why doesn’t the agency discuss natural treatments that can protect us? Action Alert!

The Democratic Republic of Congo (DRC) is in the midst of the second largest Ebola outbreak in history (the worst was in West Africa in 2014). Since August 2018, 740 people have been infected—30 percent of whom are children—and 460 have died. In the absence of effective cures one would think that health authorities would turn to natural antivirals that have a proven track record. Unfortunately, there’s no money to be made with these treatments, so the FDA remains silent.

The main driver of this is the Catch-22 of drug economics: no one will spend the exorbitant sums needed to run clinical trials if the product can’t receive full patent protection (which, generally, natural products cannot) and turned into a huge moneymaker. This ensures that natural alternatives are ignored. But there is reason to believe that some of the world’s oldest antivirals could be used to inhibit the transfer of the virus, or perhaps even cure it.

Silver has been used as an antimicrobial for thousands of years. It’s a powerful antibiotic, attacking all kinds of bacteria in a three-pronged attack. More and more research (study 1; study 2; study 3; study 4; study 5) is also heralding silver’s promise as a method of disinfecting water of both bacteria and viruses. Since disinfecting contaminated environments is the most effective method of halting Ebola’s spread, silver could be a potent weapon in the battle.

Silver has also showed great promise as an antiviral, in both attacking the virus and in inhibiting transmission. So far, silver has been tested on HIV (study 1; study 2; study 3; study 4) and herpes (study 1; study 2; study 3). Silver has also been used to clear HPV warts; inhibit the replication of the hepatitis B virus; kill the H1N1 virus; fight ocular infection; and kill the tacaribe virus, which also causes hemorrhagic fever, as well as the bacteriophage viral strain.

Intravenous vitamin C also shows promise for viral infections like Ebola, but would presumably be harder to administer in places where Ebola outbreaks occur. In the words of one doctor, “To date, not a single virus has been tested that is not inactivated (killed) by a large enough dose of vitamin C (ascorbic acid).”

There are even more natural medicines that show promise in fighting diseases like Ebola that we’ve discussed elsewhere.

Of course, even if the evidence demonstrates the power of a nutrient to fight disease, the federal government blocks companies from telling us about it—until drug companies create a drug that costs thousands of dollars a year and the FDA hands them a monopoly.

The status quo in which government creates and protects drug company monopolies was always outrageous. Now with the threat of major and deadly pandemic in sight, it is completely unacceptable. It is essential that voters become aware of what is going on behind closed doors in Washington so they can speak up and move the political system.

Action Alert! Tell the FDA, with a copy to Congress, and tell them to stop gagging free speech about proven benefits of natural medicines. Please send your message immediately. 

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The Fallacy Game

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Natural Compound Doubles Cancer Survival Rates

New evidence on a key nutrient offers hope to cancer patients; will the FDA snuff it out? Action Alert!

A new study on annatto-sourced delta-tocotrienol (one of the compounds contained in vitamin E) has showed 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.

The study found that delta-tocotrienol, used in combination with Avastin, an FDA-approved drug, was able to stabilize and control ovarian cancer after surgery by 50% at six months; Avastin alone was only able to control the disease by 25%. Delta-tocotrienol used in combination with Avastin nearly doubled survival of ovarian cancer patients after surgery.

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. If it were a drug, delta-tocotrienol would be celebrated as the next breakthrough and sold for tens of thousands of dollars a year. But 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.

The FDA has in fact shown that it is willing to go to absurd lengths to protect the drug industry from natural products. The agency went after walnut growers for daring to list some of the scientifically proven benefits of walnuts. Similarly, the FDA attacked cherry growers for citing Harvard research indicating cherries can reduce inflammation and pain. For these “crimes,” the FDA threatened jail time.

The FDA even bans many legal structure function claims, arguing that some are “implied disease claims,” a fabricated term meant to further restrict what can be said about supplements and other natural products. For example, a legal claim can describe the role of a nutrient on the structure or function of the body, such as “calcium builds strong bones.” But if the FDA thinks that the structure or function referenced in a claim indicates a disease state, it will ban the claim. The truthful claim that magnesium lowers blood pressure is banned by the FDA because they think it implies that magnesium is a treatment for hypertension, and only FDA-approved drugs can claim to treat hypertension.

When the FDA fails to censure free speech, the FTC picks up the baton. We saw this in the FTC’s case against POM Wonderful, the pomegranate juice company that spent millions on research only to be told by the FTC that it wasn’t the right research, so the claims were illegal. POM even had qualifying language in their claims so as not to mislead consumers, but the FTC wasn’t satisfied, outrageously demanding that POM conduct two randomized clinical trials to substantiate their claims.

These overt attacks on free speech subvert Americans’ ability to take charge of their health by learning about the established benefits of natural products. This isn’t good for anyone but the drug industry monopoly. If the FDA actually cared about cancer patients, they would be shouting from the rooftop about the benefits of delta-tocotrienol. But in our crony medical system, not only will we not hear a peep—the FDA will actively block companies that try to inform the public about its benefits, even though the companies are in the best position to tell us about the science since they are the entities performing the applicable studies.

The FDA’s conduct in this arena is truly shocking. Scientists continue to understand more about the many benefits of natural products, from fish oil to coconut oil, from CoQ10 to vitamin D, but rather than trumpeting these discoveries, the federal government is doing everything in its power to throttle the industry and protect Big Pharma profits. We must stop them.

Action Alert! Send a message to the FDA telling them to permit free speech about natural products, in particular to revise their position on implied disease claims. Please send your message immediately.

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NY Times Calls for Universally Mandated Vaccines

This is what happens when a free press seeks to eliminate free choice. Action Alert!

A recent editorial piece in The New York Times suggests that more states should enact mandatory vaccination laws, kicking kids out of public and private schools if they do not follow the state’s vaccine schedule. That’s just one of a number of tips given for how to deal with “anti-vaxxers,” which the World Health Organization has deemed one of the top world health threats for 2019. But in decrying the perceived anti-scientific stance of those who question whether vaccines are safe, the NYT editorial writers, like many who agree with them, betray a lack of the skepticism needed for good science to flourish.

The Editorial board states, for example, “Yes, there are chemicals in vaccines, but they are not toxic.” This is undeniably false. As we’ve stated previously, many vaccines contain aluminum, which is a neurotoxin, formaldehyde, and even mercury. Take aluminum: It is normal to ingest aluminum in some of the foods we eat, but the liver clears it. It is a different matter when aluminum and other vaccine ingredients are injected directly into the blood, where they bypass the liver and the gastrointestinal tract. This isn’t pseudo-science: new studies provide stunning information about what happens to aluminum after it’s injected into muscle. In some mice, it travels to the brain, where it can still be detected a year later. It also travels to the spleen and lymph nodes, where it can still be detected 270 days after vaccination.

And that’s not all. As we’ve noted elsewhere, testing proving aluminum adjuvants are safe has never been done. Health authorities rely on EPA safety levels that determine how much orally-ingested aluminum is safe which, as stated above, is a different issue altogether from injected aluminum.

These are facts. To say, “Yes, there are chemicals in vaccines, but they are not toxic,” is a blatant misrepresentation. There are many questions about vaccines that the science has yet to resolve. This isn’t the opinion of a “fringe” organization, as the NYT puts it, but the government’s own National Academies of Science, who conclude in a 2013 report that “key elements of the [vaccine]schedule—the number, frequency, timing, order, and age at administration of vaccines—have not been systematically examined in research studies.”

We’re also told unequivocally by the NYT that unvaccinated kids were the cause of measles outbreaks in California and other states. Again, this widely held theory does not hold up. A recent study looked at 1,789 measles cases reported to the Centers for Disease Control and Prevention (CDC) between 2001 and 2015, reporting that 70% were unvaccinated—but the authors admit that there was a “lack of verifiable immunization on nearly half of the adult cases”—meaning that they don’t really know how many of the 1,789 were actually unvaccinated or unvaccinated.  Even if we accept the study’s numbers at face value, it means that 30% of measles cases occurred in those who were vaccinated. So vaccinated kids were still getting the disease.

There have even been cases where measles was transmitted in a school with a documented immunization level of 100%. What this tells us is that vaccination is not as effective at preventing disease as the public is often led to believe. Multiple studies have shown that vaccinated kids, especially those recently vaccinated, can spread disease, because the vaccine contains live virus (vaccines that contain the live virus include chicken pox, measles, rubella, nasal flu, polio, and smallpox).

We were told the same thing about a recent spike in mumps—that the cause was unvaccinated kids. But according even to the CDC, a staunch supporter of the government vaccination schedule, most mumps patients said they had received both shots of the MMR (measles, mumps, and rubella) vaccine. The states with the most cases of mumps had vaccination rates of 90% or higher—a threshold where herd immunity should exist if it is ever going to exist. (The herd immunity hypothesis states that a very high percentage of a community must be vaccinated in order to protect everyone (the herd) from a disease.) The fact that the disease spreads in highly vaccinated communities suggests 1) that the herd immunity hypothesis is incorrect and 2) that the source of the problem isn’t unvaccinated kids, but the ineffectiveness of the vaccine.

Mumps has even occurred in schools that have a 98% vaccination rate. It is also spreading among vaccinated kids on college campuses. At the University of Missouri, there were 193 reported cases of mumps, and all patients treated by the university had received two MMR shots.

The NYT also decries the “dismal rates of HPV vaccination, which doctors say could effectively wipe out cervical cancer if it were better utilized.” Really? Are the editorial writers unmoved by the 57,287 adverse events that have been reported from HPV vaccination, including 419 deaths, which is far more than any other vaccine? What about a recent study showing that women aged 25-29 who received the HPV vaccine have a lower probability of becoming pregnant? Or the fact that, 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%? Or is all of this evidence just the ravings of pseudo-scientific anti-vaxxers, so it can be dismissed without further comment or study?

Herein lies the problem. There are legitimate safety concerns with some vaccines and with some ingredients. These issues should be studied and explored further so vaccines can be made safer. Saying that all vaccines are safe and cannot be improved will not accomplish this. Rather than undertaking the crucial work of making vaccines safer, members of the media and government health authorities instead cover their ears and insist that anti-vaxxers are irrational idiots who need to be taught a lesson.

Of one thing we can be sure: no real scientist would be so dogmatic, emotional, and combative. A real scientist examines all the evidence dispassionately before reaching a conclusion, and the evidence is clear: many vaccines are simply not effective, are dangerous, or both.

Action Alert! Write to your state legislators and tell them to preserve vaccine choice! Please send your message immediately. 

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