Sepsis May Be Responsible for 20% of Deaths Worldwide

Sepsis is a life-threatening condition triggered by a systemic infection that causes your body to overreact and launch an excessive and highly damaging immune response. Unless promptly diagnosed and treated, it can rapidly progress to multiple-organ failure and death.

A number of studies have shown sepsis is becoming ever more prevalent, making it imperative to be on the lookout for its signs and symptoms whenever you’re ill or in the hospital.

This includes cases of suspected influenza, as sepsis can mimic many of the signs and symptoms of the flu. In fact, sepsis is one of the leading causes for influenza deaths. Studies have also identified sepsis as a top cause of death in hospitals, and one of the primary causes of serious harm due to misdiagnosis. Findings show that:

  • In the U.S., 1.7 million adults develop sepsis each year, and nearly 270,000 die as a result.1
  • Between 34.7% and 55.9% of American patients who died in hospitals between 2010 and 2012 had sepsis at the time of their death.2
  • The death rate of in-hospital patients with sepsis is 10% compared to 1% among patients without sepsis.3
  • Spending for sepsis rose by 19% from 2011 to 2013.4 It is now the most expensive condition treated in the U.S., costing $23.6 billion annually.5,6

Sepsis Responsible for One-Fifth of Global Deaths

Now, the most comprehensive global analysis7,8 done to date warns that sepsis is responsible for 1 in 5 deaths worldwide each year. The researchers call the finding “alarming,” as their updated figures are double that of previous estimates. As reported by NPR:9

“They estimate that about 11 million people worldwide died with sepsis in 2017 alone — out of 56 million total deaths. That’s about 20% of all deaths. ‘It’s a massive number,’ [lead author Dr. Kristina] Rudd says.”

An estimated 85% of these sepsis-related deaths occur in low- to middle-income countries.10 Surprisingly, the paper,11 “A Global Accounting of Sepsis,” published in the January 18, 2020, issue of The Lancet, suggests the rate of sepsis has actually declined by about half since 1990. NPR reports:12

“That’s a surprising finding, says Dr. Chanu Rhee, who studies sepsis and infectious disease at Harvard Medical School. ‘It’s really interesting that in their study, they actually found the incidence of sepsis declined over the study period,’ he says, ‘where other studies have actually suggested the opposite.'”

The authors of The Lancet study do point out that their findings “must be viewed in context with the constraints of the analysis,” as “modelling assumptions and imputation steps can introduce bias.” They explain:13

“The model inputs to estimate the burden of sepsis for 195 countries came from the vital records of four countries (Brazil, Mexico, Taiwan, and the USA), and data for hospital case-fatalities were obtained from ten countries (Austria, Brazil, Canada, Chile, Georgia, Italy, Mexico, New Zealand, Philippines, and the USA), resulting in extrapolation from countries of high and middle incomes to low-income countries.

Because some continents (notably Africa) are not represented as original sepsis data sources, longitudinal trends might be unreliable. Hypothetically, improvements in Brazil as a primary data source country could create the appearance of benefits for sub-Saharan Africa, irrespective of actual local changes.”

A significant hurdle when studying sepsis is the fact that many doctors overlook it as a contributing cause of death, and don’t list it on the death certificate. Rhee, who has investigated the sepsis burden in the U.S., tells NPR that — based on his own findings of U.S. death certificates — sepsis may actually play a role in more than 20% of deaths worldwide,14 considering most sepsis deaths occur in countries lacking the medical care available in more affluent nations.

Signs and Symptoms of Sepsis

Despite its prevalence, sepsis is frequently overlooked, even by health care professionals. For this reason, it’s really important to familiarize yourself with the signs and symptoms of sepsis, and to take immediate action if you suspect sepsis.

Also inform the medical staff of your suspicion, as time is of the essence when it comes to treatment. Hydration is of utmost importance, as much of the damage caused by sepsis begins with the loss of fluids.

While the signs can be subtle at first, sepsis typically produces the following signs and symptoms:15,16,17 Many of these symptoms may be confused with a bad cold or the flu. However, they tend to develop quicker than you would normally expect.

A high fever with chills and shivering

Rapid heartbeat (tachycardia)

Rapid breathing (tachypnea)

Unusual level of sweating (diaphoresis)


Confusion or disorientation

Slurred speech

Diarrhea, nausea or vomiting

Difficulty breathing, shortness of breath

Severe muscle pain

Low urine output

Cold and clammy skin and/or skin rash

Acronyms to Memorize

The Sepsis Alliance recommends using the acronym TIME to remember some of the more common symptoms:18

  • T — Temperature higher or lower than normal?
  • I — Have you now or recently had any signs of an infection?
  • M — Are there any changes in mental status, such as confusion or excessive sleepiness?
  • E — Are you experiencing any extreme pain or illness; do you have a “feeling you may die?”

Another acronym you could use to memorize the signs and symptoms is SEPSIS, described in the video above:

  • S — Shivering (fever, cold)
  • E — Extreme pain
  • P — Pale, clammy skin
  • S — Shortness of breath
  • I — “I feel like I might die”
  • S — Sleepy (confused)

Beware: Sepsis Plays a Role in Many Influenza Deaths

Importantly, sepsis has been identified as a major contributor in influenza deaths. According to researchers, “Severe sepsis is traditionally associated with bacterial diseases … However, viruses are becoming a growing cause of severe sepsis worldwide.”

As noted in the video above, some sepsis symptoms also resemble those of influenza, which can have tragic consequences if you do not seek medical help in time. The video offers guidelines on how to tell the difference between the two.

Sepsis, without doubt, requires immediate medical attention, whereas most people will successfully recover from flu with a few days to a week of bedrest and fluids. Just how influenza can lead to sepsis is a somewhat complex affair, described as follows:19

“In the initial response to an infection, severe sepsis is characterized by a pro-inflammatory state, while a progression to an anti-inflammatory state develops and favors secondary infections …

In the predominant pro-inflammatory state, Th1 cells activated by microorganisms increase transcription of pro-inflammatory cytokines such as tumor necrosis factor (TNF-?), interferon-? (INF-?), and interleukin-2 (IL-2).

[C]ytokines … released from endothelial cells and subsequently from macrophages can induce lymphocyte activation and infiltration at the sites of infection and will exert direct antiviral effects. Subsequently, with the shift toward an anti-inflammatory state, activated Th2 cells secrete interleukin-4 (IL-4) and interleukin-10 (IL-10).

In certain situations, T cells can become anergic, failing to proliferate and produce cytokines. Type I IFN has a potent anti-influenza virus activity; it induces transcription of several interferon stimulated genes, which in turn restrict viral replication.

However, influenza virus developed several mechanisms to evade IFN response … Viral infections such as the influenza virus can also trigger deregulation of the innate immune system with excessive cytokines release and potential harmful consequences.

An abnormal immune response to influenza can lead to endothelial damage … deregulation of coagulation, and the consequent alteration of microvascular permeability, tissue edema, and shock.”

Remember to Ask for This Life-Saving Sepsis Protocol

If you or a loved one succumbs to sepsis, whether caused by influenza or some other infection, please remember that a protocol of IV vitamin C with hydrocortisone and thiamine (vitamin B1) can be lifesaving,20 so urge your doctor to use it. Chances are, they might not even be aware of it.

This sepsis treatment protocol was developed Dr. Paul Marik, a critical care doctor at Sentara Norfolk General Hospital in East Virginia, and clinical use has proven it to be remarkably effective for the treatment of sepsis, reducing mortality nearly fivefold.

Marik’s retrospective before-after clinical study21,22 showed that giving patients IV vitamin C with hydrocortisone and vitamin B1 for two days reduced mortality from 40% to 8.5%. Of the 50 patients treated, only four died, and all of them died from their underlying disease, not sepsis.

The precise protocol used was 200 mg of thiamine every 12 hours, 1,500 mg of ascorbic acid every six hours, and 50 mg of hydrocortisone every six hours.23 Importantly, the treatment has no side effects and is inexpensive, readily available and simple to administer, so you really have nothing to lose by trying it.

Sentara Norfolk General Hospital, where Marik works, has made the protocol its standard of care for sepsis, and other hospitals are also starting to follow suit. Unfortunately, many are still dragging their heels, waiting for the completion of additional clinical trials.

According to Marik, vitamin C and corticosteroids have a synergistic effect,24 which is part of why his combo protocol is so effective. Still, simply using high-dose IV vitamin C exclusively has been shown to improve survival in patients with sepsis and acute respiratory failure, reducing mortality from 46% to 30%.25

It also reduced the number of days they needed to remain hospitalized. On average, those who received vitamin C had by day 28 spent three fewer days in the intensive care unit than the placebo group (seven days compared to 10). By day 60, the treatment group had also spent seven fewer days in the hospital overall —15 days compared to 22.26

While there are no trials that look at integrating hyperbaric oxygen therapy, my strong suspicion is that this would be a powerful synergy that could get the fatality rate from the problem far closer to zero. Sadly, this treatment is not available at many hospitals, and even if it were, it is not approved for this indication.

Educational Resources for Your Doctor

Marik’s sepsis protocol can be a lifesaver, so you’d be wise to discuss it with your doctor any time you’re hospitalized. Remember, sepsis is often the result of a secondary infection contracted while in the hospital, so it’s prudent to be prepared.

This way, should you develop sepsis while you’re admitted, your medical team already knows your wishes and can act swiftly. According to Marik, the best results are obtained when the concoction is administered within the first six hours of presentation of symptoms.27 The longer you delay treatment, the less likely it will be successful.

You can learn more about Marik’s sepsis protocol in “Vitamin C — A Game Changer in Treatment of Deadly Sepsis,” along with commonsense recommendations for how to lower your risk of sepsis in the first place. You can also review Marik’s PowerPoint presentation, “Hydrocortisone, Ascorbic Acid and Thiamine for the Treatment of Severe Sepsis and Septic Shock,” presented at the 2020 Critical Care Reviews meeting in Australia.

sepsis treatment

>>>>> Click Here <<<<<

If your doctor refuses to consider it offhand, convince him or her to review the studies cited here.28,29,30,31,32,33,34,35,36,37 Simply look up the references 27 through 36 and make copies to take to your doctor. Alternatively, you can go to PubMed38 directly and type in “vitamin C” and “sepsis” in the search engine and you will get a list of the available research.

While there are certain situations in which the hospital may still deny this treatment, if you are an adult who is sick, you will usually have the right to insist on it. I will actually be interviewing Marik shortly and hope to work with him on developing a process to make it easier for patients to implement this strategy in their local hospital.

In most cases, you’d probably just need to sign an “Against Medical Advice — Acknowledgment and Waiver” form (samples of which can be found in the references39), which states you’ve elected to not follow the standard of care recommended by your doctor.

Contraindication for IV Vitamin C Treatment

The only contraindication is if you are glucose-6-phosphate dehydrogenase (G6PD) deficient (a genetic disorder).40 G6PD is required for your body to produce NADPH, which is a cousin of NAD+ and necessary to transfer reductive potential to keep your antioxidants, like glutathione and vitamin C, functional.

Because your red blood cells do not contain any mitochondria, the only way it can provide reduced glutathione is through NADPH, and since G6PD eliminates this, it causes red blood cells to rupture due to inability to compensate for oxidative stress.

Fortunately, G6PC deficiency is relatively uncommon, and can be tested for. People of Mediterranean and African decent are at greater risk of being G6PC deficient. Worldwide, G6PD deficiency is thought to affect 400 million individuals, and in the U.S., an estimated 1 in 10 African-American males have it.41

CAFOs Direct Food Supply, Refuse Inspection, Spread Disease

Antibiotic-resistant bacteria annually infect more than 2.8 million people in the U.S. The Centers for Disease Control and Prevention1 reports that more than 35,000 people die each year as a result. But, unlike other threats, this has a clear and well-known cause: the overuse of antibiotics.

Infections triggered by antibiotic resistant bacteria are sometimes impossible to treat and may extend hospital admissions. When antibiotics lose their effectiveness against a particular bacterium it presents a significant and severe public health threat. Many medical procedures require the use of antibiotics, such as when you have organ transplants and joint replacements.

The list of urgent and serious bacterial and fungi threats is growing, including those resistant to carbapenem, an antibiotic of last resort. Concentrated animal feeding operations (CAFOs) are notorious planet polluters. Waste products pollute groundwater, and the gas produced from thousands of confined animals in a small space overwhelms workers and neighbors.

In 2017 the World Health Organization2 called for the elimination of antibiotic use in healthy animals; in that same year the FDA introduced a rule that restricted the sale of antibiotics, requiring a visit to the vet rather than the shelves of a local feed supply store to obtain them.3 As noted in an October 2019 piece published by Modern Farmer, however,

“This is a significant problem in agriculture, as antibiotics are often used not to treat specific diseases, but for prevention or to prevent growth. (They’re also sometimes used in lieu of cleaner, safer facilities.)”

South Dakota Seeks Short-Term Gains for a Long-Term Problem

The inhumane and environmentally devastating CAFO model of agriculture is being rewarded in South Dakota as they seek to reap short-term gains while inviting long-term problems. In 2013 the state began a tax rebate program designed to attract business development. The goal was to entice new industries, thus creating more jobs and raising tax revenues.

In the spring of 2019, the state began offering financial incentives to counties in which new CAFOs were built. Joe Fiala, community development director for the Governor’s Office of Economic Development, called livestock operations “one of the few rays of sunshine in the ag economy.”4 Answering concerns about the new rule, he told the Aberdeen News:

“From an economic development standpoint, generally these types of projects, livestock- development projects, enhance our tax base because they’re putting up buildings and paying property taxes. And they’re also providing new jobs for the state, and in general they’re paying a good wage and offering good benefits.”

Kathy Tyler (HR-D 2013-2014) adamantly opposes the financial incentives to counties in exchange for new CAFOs. She said the tax rebate comes from the developer, which is then given to the state and passed to the county, which boils down to a developer paying the county to approve a project:

“It’s bribery, pure and simple. If I went to a zoning meeting and offered them $400,000 to not permit a facility, I would be put in jail for bribery.”

At the end of 2019 there were four projects submitted for approval, including a soybean processing plant, two pig barns and a dairy operation. One of the proposed sow barns promised to produce 145,000 piglets every year, along with 19 full-time positions for workers and a $1.27 million annual payroll.

During a public meeting with the county commissioners, concerns were raised over the location, manure management and water use. Before the vote when the CAFO was eventually approved, Commissioner James Wangsness spoke to Aberdeen News. Without mentioning the anticipated environmental impact and damage to neighboring properties, he said:

“It’s another piece of the puzzle and it is a big deal as far as the tax potential and the economic growth because it’s a big facility and we just don’t get those. It’s a pretty cool benefit, but it’s not impacting my feeling on this project. It’s just a big elephant in the room that we have to walk around because now everyone is accusing us of being bought and that’s just not true.”

Farmers Stop Public Health Officials From Doing Their Job

The owners of hog farms headed to South Dakota may have the same objections to inspections on their premises as the farmers in Montana, whose operations were potentially identified by Dr. Scott Lindquist as the origin of an outbreak of antibiotic-resistant salmonella.5 Lindquist serves as an epidemiologist for the Washington State Department of Health.

In an interview with Leslie Stahl of CBS News, Lindquist recounted what happened after an outbreak in which an estimated 3,000 to 4,000 people became ill. He traced the source to a slaughterhouse where bacteria were cultured. Unable to determine whether the slaughterhouse was the origin, he requested access to the farms that had sent livestock, so he could take samples.

However, Lindquist received a letter from Liz Wagstrom of the National Pork Producers Council, the primary lobbying group for the industry, denying access. She said: “I know that you do not want any inadvertent negative consequences to farms as a result of this proposed on-farm sampling.”

In what appeared to be a comment expressing more concern about the consequences to farms than to consumers, Wagstrom held her ground and refused access. During her interview with Leslie Stahl, Wagstrom defended her position by saying five months had passed since the beginning of the outbreak.

She asserted it would have been too late to determine if the salmonella DNA on the farm and at the slaughterhouse were identical. Lindquist was seeking more information with the hope of reducing the number of people getting sick. He offered to maintain the confidentiality of the farms from which the samples were taken.

When pressed, Wagstrom raised a concern about biosecurity, saying anyone entering the farms needs to shower and shampoo so they don’t carry disease to the livestock. Even an offer of submitting to those disinfecting guidelines did not sway Wagstrom.

CAFO Farmers Operate Their Businesses From Boardrooms

Lance Price, microbiologist at George Washington University, also expressed concerns that federal inspectors were not allowed to take samples without the farmers’ permission, making it nearly impossible to trace where tainted products may have originated.

Ultimately, the concern is that antibiotic resistant bacteria are being spread through tainted meat for which physicians do not have effective antibiotics. Although the pathogens can be killed during cooking, opening tainted meat in the house can release the bacteria into the kitchen, increasing the risk of illness.

CAFOs began using antibiotics to fight disease in crowded conditions but soon found they also helped the livestock to grow faster while eating less food. Price shared that, currently, most hogs are raised on industrial farms, with some of them owned by foreign companies.

He says that some multinational companies are hiding behind the portrait of the small American farmer, an image that generates sentiments of protection in most of the U.S. However, Price points out it’s not the guy in overalls who owns these CAFOs, but rather

“ … a guy in a suit with a Maserati, you know? I mean, this is — these are — these are big companies that we are protecting. And by protecting them, we’re hurting ourselves.”

When Wagstrom was asked about the use of preventive antibiotics and overcrowding she said, “That would be an improper stocking density.” Yet, as Stahl points out, farmers are denying oversight, so there is no way to be sure.

Sidestepping another issue, Stahl asked if Wagstrom would support a regulation mandating that farmers report the amount of antibiotics used on livestock. She replied, “I would support discussion around trying to figure out how to collect that data.”

Dancing to the Tune of Big Agriculture

Price also expressed concern over a new regulation the pork industry lobbied to enact that lifted a number of important oversight requirements. The USDA claims they are modernizing the process, yet Price says, “I don’t see modernization. I see just straight-up deregulation in an industry that you want regulated.”

The new regulation allows the slaughterhouse and companies to set the speed at which the carcasses are processed. Prior to this change, the limit was 20 per minute; the new regulation lifts all limits. In the old system inspectors examined each carcass. However, the number of inspectors is also reduced by 40%, with processing inspections taken over by plant employees who may or may not be trained to do so.

CAFO farms are the subject of a book called “Pig Tales,” written by The New York Times best-selling author Barry Estabrook, who set out to explore and write about the pork industry. He discovered that Big Ag wields enormous power in states like North Carolina, home to many CAFOs. He describes that power:6

“Politically, wherever pork is produced in large quantities, Big Ag is king. You think of states such as North Carolina, Iowa and Minnesota. Big Ag is a very, very, very powerful political force. It doesn’t matter whether the politicians are Democrats, Republicans or Libertarians; they dance to the tune of Big Agriculture.”

CAFO Farms Create Disease Carriers and Are Deadly

The use of antibiotics in livestock is regulated by the FDA. Before 2013, CAFOs had the option of using antibiotics for weight gain. Currently, the FDA guidelines ask pharmaceutical companies to:7

“ … voluntarily remove growth enhancement and feed efficiency indications from the approved uses of their medically important antimicrobial drug products, and move the therapeutic uses of these products from over-the-counter (OTC) availability to marketing status requiring veterinary oversight.”

The use of antibiotics for disease prevention in large, overcrowded environments is still allowed under the FDA’s guidelines. In 2015, Carbapenem-resistant Enterobacteriaceae bacteria was found on a U.S. pig farm.8 Carbapenem is one of the antibiotics of last resort.9

The finding is surprising as it’s illegal to use this antibiotic, crucial to human medicine, in food-producing animals.10 The addition of antibiotics to livestock feed increases the risk of antibiotic resistant bacterial growth. Organisms responsible for infectious diseases in humans, such as cryptosporidium, E. coli and salmonella, are common in livestock manure.11

They are a normal part of livestock gut microbiome and can grow in high concentrations. In some instances, they are beneficial to digestion in livestock. The bacteria are excreted in the manure and oftentimes that manure is sprayed onto fields as fertilizer. The excess can leach into the groundwater and waterways, which concerned wildlife services for waterfowl protection in South Dakota.

Fumes from the manure pits are so toxic that it caused the death of a father and son at an Iowa pig farm when they were trying to repair a pump.12 They were the second father and son to die in the Midwest in July 2015, overcome by noxious gas from manure pits.

Given that these fumes are regularly pumped outdoors, it’s not surprising that people living near Iowa CAFOs have elevated rates of respiratory symptoms compared to those who live elsewhere.13

Sustainable Farms Reduce Risks to the Land and People

Regenerative farming practices produce healthy soil and great success for the farmers who practice it; Will Harris is one such farmer. He is from White Oak Pastures in Bluffton, Georgia, and runs a successful farm that produces high-quality grass fed products.

His focus changed from figuring out how many heads of cattle he could feed to building a process that feeds microbes in the soil, which in turn helps crops yield more every year. Working with natural cycles, he and other regenerative farmers have improved productivity and carbon sequestration.

There are several organizations that may help you source farm-fresh food in your local area. For a list of those and a discussion of regenerative farming practices, see, “How Regenerative Farming Methods Can Restore Ecology and Rebuild Communities.”

Statins Trigger Brain Changes With Devastating Effects

Data from the CDC1 in 2017 show heart disease causes one death every 37 seconds in America and that it is the leading cause of death in the U.S. It created a financial burden of $219 billion in 2014 and 2015. Every 40 seconds someone has a heart attack. Those at higher risk are smokers and those who have high blood pressure, high blood cholesterol and/or diabetes.2

Since researchers believed cholesterol levels contribute greatly to heart disease, pharmaceutical companies focused on developing a drug that might be marketed to millions when they first began searching for a “cure” to what is known as “hardening of the arteries.” After a historical journey beginning in the mid-20th century,3 the first statin drug was released in 1987 — lovastatin.

The way statin drugs work is by preventing a certain enzyme from carrying out its function in the body. This was first tested with fungi broths and then later in animals, and in both cases it lowered plasma cholesterol. Millions of people now take statins on the advice of their physicians with the hope of extending their life and reducing their risk of heart disease. One Johns Hopkins cardiologist explains a dangerous evolution of statin use:4

“Traditionally, statins were viewed as purely cholesterol-lowering drugs. So it made sense just to use them for people with high cholesterol. But we’ve learned that they also benefit people with lower levels of cholesterol who are at a high risk of heart disease. So we now think of statins as risk-reducing drugs.”

As mainstream medicine continues to prescribe statin medications to a growing number of patients whether they currently have cholesterol levels deemed higher than normal or not, others are warning this trend is likely placing more people at risk than it is helping.

As I have reported, a 2015 review of statin trials found that in primary prevention trials, the median postponement of death in those taking statins was just 3.2 days. In exchange for an additional 3.2 days, those taking statins may experience heart damage and have an increased risk of dementia.5,6

Do You Experience Statin Brain?

Dr. Beatrice Golomb is a professor of medicine at the University of California, San Diego, whose recent research has focused on statin use. In her answer to a question by a Scientific American reader, she writes about how statins affect your neurological system and, more specifically, your brain:7

“Between 2003 and 2012 roughly one in four Americans aged 40 and older were taking a cholesterol-lowering medication, according to the Centers for Disease Control and Prevention. But studies show that statins can influence our sleep and behavior — and perhaps even change the course of neurodegenerative conditions, including dementia.

In 2015, my colleagues and I observed that women taking statins, on average, showed increased aggression; men typically showed less, possibly because of reduced testosterone levels. Some men in our study did experience a marked increase in aggression, which was correlated with worsening sleep.”

By 2016, the recommendations for statins widened when the U.S. Preventive Services Task Force published new guidelines in which they indicated statins should be started in people between the ages of 40 and 758 who have at least one risk factor for heart disease. This recommendation resulted in 35 million who are currently prescribed statin medications.9

Golomb has found the drugs produce different effects based on a person’s medical history, the drug they are taking and the dose.10 She’s found that while adverse drug reactions have been reported with statin use, there are not a lot of published studies having to do with mood and behavioral changes related to statin use.

In 12 case studies, Golomb found changes that started after statin use was begun and persisted or progressed as the drug was continued. Reports of violent ideation, suicide, irritability and depression were resolved when the drug was discontinued. A sample of the reports include:

  • Suicide after simvastatin was taken for 5 days
  • Depression in a woman in her 50s after taking simvastatin 10 mg for 2 weeks
  • Depression and aggression in a man in his 50s after taking atorvastatin 20 mg for 1 month
  • Suicide in a man in his 40s after taking atorvastatin 10 mg for several months

Other reported symptoms included suicide attempts, cognitive compromise, nightmares and anxiety. Golomb first suspected a connection between statins and mental health changes nearly 20 years ago. She found more evidence in the literature than she anticipated. She then conducted a study in Sweden, comparing the cholesterol levels of 250,000 to local crime records and commented to the BBC:11

“There are lines of evidence converging. Even adjusting for confounding factors, it was still the case that people with lower cholesterol at baseline were significantly more likely to be arrested for violent crimes.”

Science Ignoring Impact of Drugs on Personality Change

While physiological changes are testable, psychological and personality changes are less objectively measured. Results from one survey12 in 2016 demonstrated that despite media attention to normalize mental health issues, 12 million adults in the U.K. with mental health issues did not seek help, mainly because they were embarrassed.

There is evidence to support that those with naturally low cholesterol may experience greater aggression and anger. In a study13 of 4,852 children ages 6 to 16, researchers found that those whose cholesterol was less than 145 mg/dL were three times more likely to be suspended from school than those whose levels were higher.

The researcher speculated the stress from being suspended may have reduced cholesterol concentrations. However, other studies demonstrate that stress increases, rather than reduces, cholesterol levels.14 Lowering cholesterol levels appears to affect serotonin levels in the brain as demonstrated in animal studies involving fruit flies15 and fish.16

In the fish study, as cholesterol levels reduced, levels of serotonin altered, and the fish became more aggressive. Golomb is convinced lowering cholesterol levels by using statins influences the way your brain functions.

However, she is more concerned about the lack of interest in the science community of the impact that seemingly ordinary drugs have on personality and aggression. One pain researcher from Ohio University also noticed this issue:17

“There is a remarkable gap in the research actually, when it comes to the effects of medication on personality and behaviour. We know a lot about the physiological effects of these drugs – whether they have physical side effects or not, you know. But we don’t understand how they influence human behaviour.”

The BBC reports the U.S. purchases 49,000 metric tonnes (54,013 tons) of paracetamol (acetaminophen) every year, enough for each person to take 298 tablets in a year. At the same time, Americans are spending an average of $1,200 per person on prescription drugs. As people get older, the dependence on drugs may get even worse.

Statins Increase Your Risk of Health Problems

One of the side effects of statin medications is that they deplete your body of coenzyme Q10 (CoQ10). This might explain some of the devastating, long-term results experienced by those taking the medication. As early as 2002 it was strongly suggested18 that the FDA should issue a black box warning to advise patients and physicians of the depletion of CoQ10, but in 2014 the FDA decided against it.19

CoQ10 is important because it can help manage heart failure.20 When taking statins, you may find yourself dealing with a reduction in vitamin K221 and, by extension, a higher risk of osteoporosis,22 brain disease23 and inappropriate calcification throughout the body.24

The use of statins also comes with an increased risk of neurodegenerative diseases,25 cataracts26 and musculoskeletal disorders.27 While the FDA reports liver complications are rare, one physician’s search28 of the FDA’s Adverse Event Reporting System (FAERS) found 5,405 people who reported hepatitis or liver function abnormalities that were associated with only two different statin medications between 2006 and 2013.

Researchers also found that those taking statins have a higher risk of Type 2 diabetes.29 In one published study,30 22 professional athletes with familial hypercholesterolemia were followed for eight years and treated with different statins. Of the 22, only six tolerated at least one drug. In only three of the six could training performance continue without limitation.

Rising Number of Seniors Taking Too Many Prescriptions

In the U.K. more than 10% of the general population over age 65 takes at least eight prescribed medications every week.31 The New York Times32 reports the average person in their mid- to late 60s in the U.S. takes 15 prescription drugs each year, which doesn’t consider the number of over-the-counter products they might also be taking.

The use of multiple prescription drugs is called polypharmacy, which is common among the elderly and especially those in nursing homes. Polypharmacy may increase hospitalizations with a high number of complications, increased rates of death and excessive health care costs.33

One of the hidden dangers of taking drugs with significant side effects, such as statins, is that one drug is often prescribed in order to take care of the side effects of another. Drug interactions can then cause hospitalization and sometimes the interactions may lead to death.

Simple Strategies to Normalize Your Cholesterol Levels

Consider using simple strategies to normalize your cholesterol levels. I believe a total cholesterol measurement has little benefit in evaluating your risk for heart disease unless the number is over 300.

In some instances, high cholesterol may indicate a problem, provided it’s your LDL or triglycerides and you have low HDL. A better evaluation of your risk of heart disease are the following two ratios in combination with other lifestyle factors, such as your iron level and diet:

  • HDL/Cholesterol ratio — Divide your HDL level by your cholesterol. This ratio should ideally be above 24 percent
  • Triglyceride/HDL ratio — Divide your triglyceride level by your HDL. This ratio should ideally be below 234

You have control over your health and may protect your heart and lower your risk of heart disease by following suggestions affecting your lifestyle and exposure to environmental toxins. In my article, “Cholesterol Managers Want to Double Statin Prescriptions,” I share a list of suggestions to help minimize your toxic exposure and improve your body’s ability to maintain good heart health.

Additionally, in my article “Nearly Half of American Adults Have Cardiovascular Disease,” I summarize additional strategies you may use to improve microcirculation in your heart. I also talk about mitochondrial function and insulin resistance, which are related to strong heart health.

Roche Flu Medication Fraud Stole Billions

A whistleblower lawsuit has been filed against drugmaker Roche, alleging the company made false claims and misrepresented studies, causing the U.S. government to stockpile $1.5 billion of its influenza medicine Tamiflu (oseltamivir).1

The lawsuit was filed by Dr. Thomas Jefferson, a researcher associated with the Cochrane Collaboration research network, under the False Claims Act, in which individuals may file suit on behalf of the government. Jefferson has been questioning Tamiflu’s effectiveness since 2009.

The lawsuit, which was unsealed in September 2019, alleges Roche duped the U.S. government into stockpiling Tamiflu while mispresenting its effectiveness. According to the Houston-based Lanier Law Firm, which filed the suit:

“The lawsuit claims the drugmaker’s scheme involved publishing misleading articles falsely stating that Tamiflu reduces complications, severity, hospitalizations, mortality and transmission of influenza.

The company then used those articles to aggressively market the drug to the government for pandemic use. Relying on the supposed truthfulness of Roche’s claims, federal and state governments spent about $1.5 billion to stockpile Tamiflu to combat influenza pandemics.”2

‘Multisystem Failure’ Involved in Tamiflu’s Success

Antiviral drugs like Tamiflu are still recommended by government agencies like the U.S. CDC,3 despite long-standing studies questioning their effectiveness and safety.

At one point, the World Health Organization (WHO) even classified Tamiflu as an “essential” medicine,4 “selected with due regard to public health relevance, evidence on efficacy and safety, and comparative cost-effectiveness” — but downgraded the drug’s status in 2017.

In July 2017, WHO moved Tamiflu from a “core” essential medicine to a “complementary” drug, which is used for those that are less cost effective.5 (To clarify, a correction to the article was published in November 2017, saying the drug was still on the essential list, but “downgraded.”6)

In a BMJ editorial, Mark Ebell, professor of epidemiology at the University of Georgia, called the move “far too late” and described a multisystem failure that allowed Tamiflu to become a blockbuster medication.7 According to Ebell:8

“Oseltamivir (Tamiflu) was approved by the US Food and Drug Administration in 1999 for the treatment of uncomplicated influenza within 48 hours of the onset of symptoms. The manufacturer’s press release stated that the drug was studied in two randomised trials enrolling a total of 849 patients with influenza and reported a 1.3 day mean reduction in the duration of symptoms.

The drug was described as safe, with less than 1% of patients discontinuing it because of adverse effects. It was approved by the European Medicines Agency in 2002. On the basis of these limited (and ultimately revealed as incomplete) data, governments acted.

Concerned about a possible outbreak of avian influenza, as well as the H1N1 pandemic in 2009, the UK government stockpiled oseltamivir at a cost of over £600m (€680m; $770m) from 2006 to 2014. Similarly, the US government has spent over $1.5bn stockpiling the drug, based on recommendations from the Centers for Disease Control and Prevention (CDC).”

Examples of system-wide failures that let Tamiflu slip through regulatory cracks included a failure to publish all available evidence and make that data available at the individual patient level, along with a failure of recognizing the limitations inherent to observational data.

It wasn’t until repeated requests from The BMJ were honored that data from unpublished trials were released to researchers, revealing the true extent of Tamiflu’s effectiveness — or lack thereof.9

Tamiflu Reduced Duration of Flu by Just 16.8 Hours

In the BMJ review of Tamiflu it’s found that Tamiflu shortened the duration of flu symptoms by less than a day, specifically, by just 16.8 hours, and did not affect the number of hospitalizations.10 In exchange for this very modest benefit, Tamiflu caused nausea and vomiting and increased the risk of headaches and renal and psychiatric syndromes.

“The trade-off between benefits and harms should be borne in mind when making decisions to use oseltamivir for treatment, prophylaxis or stockpiling,” the researchers added.11 What’s more, in a Cochrane Review of the data on both Tamiflu and Relenza (zanamivir), another antiviral drug, Jefferson and colleagues noted:12

“Based on our assessments of the regulatory documents (in excess of 160,000 pages), we came to the conclusion that there were substantial problems with the design, conduct, reporting and availability of information from many of the trials … We identified problems in the design of many of the studies that we included, which affects our confidence in their results.”

Further, the review noted that the drugmakers’ proposed mechanism of action, which suggests the drugs work via a multisystem and central action, does not fit with the clinical evidence they reviewed. Any beneficial effects of the drug may have occurred due to lowering levels of pro-inflammatory cytokines or via depressing the central nervous system, not by actually inhibiting the replication of the influenza virus.13

Tamiflu Causes Psychiatric Symptoms

Tamiflu and Relenza are part of a group of anti-influenza drugs called neuraminidase inhibitors, which work by blocking a viral enzyme that helps the influenza virus to invade cells in your respiratory tract.

The problem is that your nervous system also contains neuraminidase enzymes essential for proper brain functioning, and when blocked with these dangerous drugs, severe neurotoxicity may ensue, especially in the infants and children whose blood-brain barrier has not yet developed sufficiently.

Serious side effects include convulsions, delirium or delusions and suicidal behavior. In January 2020, an Oregon woman warned that her son experienced hallucinations while taking the drug, telling a news outlet, “He was saying that everything was going fast and that everything was in fast forward. He was hearing voices. He was seeing things. He was crying and grabbing his head and it was really scary.”14

The boy’s pediatrician said the hallucinations were due to Tamiflu, and Dr. James Shames, Jackson County medical health director, likewise stated, “Psychiatric symptoms are more unusual. It wasn’t even recognized until after the drug had been released and they started doing further studies. It does look like it occurs more commonly in children.”15

In another report, a 6-year-old girl in Texas also had hallucinations while taking Tamiflu and even tried to jump out of a second story window.16 A 16-year-old boy with no prior suicidal thoughts or depression also committed suicide less than 24 hours after taking the drug, which his parents believe is what caused the suicide to occur.17

Japan banned the use of Tamiflu in children and teens in 2007, after cases of teenagers trying to dump from apartment building windows while taking the drug. In 2018, the country lifted the ban, but still said the relationship between Tamiflu and the unusual actions is unclear and patients should be warned of such side effects.18

Corruption Surrounding Tamiflu

Corruption has surrounded Tamiflu from the start. Former U.S. Defense Secretary Donald Rumsfeld was made the chairman of a company called Gilead in 1997. While drug company Roche manufactured Tamiflu, it was developed by Gilead decades ago, and they gave Roche the exclusive rights to market and sell the drug in 1996 (an agreement they attempted to terminate in 2005).19

Rumsfeld held major portions of stock in Gilead and was reported to have made more than $5 million from selling shares of the company around the time of the bird flu hoax in 2005. Rumsfeld was on the board of Gilead between 1988 and 2001, and when he left to join the Bush administration he reportedly retained a large shareholding (worth $25 million or more).

Roche also engaged in extensive lobbying to influence countries to stockpile Tamiflu, including in Denmark. In a 2018 review published in the Journal of Public Health, researchers investigated how members of Denmark’s pandemic planning committee experienced lobbying efforts by Roche, noting:20

“Roche promoted Tamiflu using two arguments: that the procurement deal had to be signed quickly because the drug would be delivered on a first-come, first-served basis, and that Denmark was at heightened risk in the event of a major influenza outbreak because it had a smaller Tamiflu stockpile than other countries.

One informant pointed to how Roche ‘toured’ Denmark and neighbouring countries to ratchet up the volume of Tamiflu stockpiles. Interestingly, and in line with this allegation, in March 2005 Roche sent an official letter directly to the Swedish Minister of Health and Social Affairs (and copies to the Director Generals of the National Board of Health and Welfare and the Crisis Management Agency) that exactly repeated these two arguments …

Furthermore, Roche practised tactics that included both lobbying through direct contact and lobbying through a seemingly independent third party, i.e. the DSI [Danish Health Institute].

In addition, some interviewees suspected third party lobbying via colleagues. The DSI was established by the public sector to conduct independent research, yet it still agreed to act on behalf of the company — quite a disturbing finding.”

Lawsuit Alleges Roche Knew Tamiflu Was Ineffective

The whistleblower lawsuit alleges that Roche knew Tamiflu was ineffective at fighting influenza pandemics but went ahead and “masterfully marketed this drug to fill Roche’s coffers at taxpayer expense,” Clayton Halunen of Halunen Law said. “This is precisely the type of corporate behavior the False Claims Act is designed to stop.”21

Because the False Claims Act mandates payment of triple damages along with civil penalties, Roche could face a judgment in excess of $4.5 billion. Attorney Mark Lanier, of Lanier Law Firm, added:22

“As alleged in the complaint — Tamiflu does not do what Roche promised. Roche hid this fact for many years by selectively citing its studies and suppressing the data about Tamiflu. The company utilized lobbyists, key opinion leaders and ghostwriters to promote Tamiflu with a deceptive promise to governments fearful of an influenza pandemic.”

While Roche is on trial for fraud, the fact remains that Tamiflu is likely to do little to help in the event you or a loved one comes down with flu, and it could end up causing harm. Prevention is a far better option, and along these lines vitamin D testing and optimization has been shown to cut your risk of respiratory infections, including colds and flu, in half if you are vitamin D deficient.23,24

In my view, optimizing your vitamin D levels is one of the absolute best respiratory illness prevention and optimal health strategies available. Influenza has also been treated with high-dose vitamin C,25 and taking zinc lozenges at the first sign of respiratory illness can also be helpful.

Following other basic tenets of health, like eating right, getting sound sleep, exercising and addressing stress are also important, as is regularly washing your hands — sound advice for staying healthy not only during flu season but also year-round.

Glyphosate Is a Primary Cause of Kidney Damage

Application of glyphosate, the active ingredient in Roundup herbicide, is unprecedented in scale, and we haven’t even reached the tip of the iceberg when it comes to understanding its far-reaching environmental and human health effects. Since genetically engineered (GE) “Roundup Ready” crops, which are tolerant of glyphosate, were introduced, global usage of glyphosate rose nearly fifteenfold.1

Usage is so pervasive that researchers have stated, “no pesticide has come remotely close to such intensive and widespread use” in the U.S., and this is likely the case globally as well.2 Cancer has emerged as one of the leading health risks of glyphosate, and approximately 42,700 U.S. lawsuits from individuals alleging that glyphosate caused them to develop cancer have already been filed.3

However, other chronic diseases have also been linked to the chemical, including kidney disease. In January 2020, research published in Environmental Pollution identified glyphosate in the urine of 11.1% of the infants and young children they tested, and this rose to 30% among newborns.4

Despite the detectable levels of glyphosate, the study did not find an association between low-level glyphosate exposure and markers of kidney injury, but the researchers noted the study was limited by a small sample size and, “The lack of evident renal toxicity in association with glyphosate exposure in young children does not exclude a potential adverse impact of longer term exposure to the pesticide.”5

The researchers further noted, “Further studies of larger sample size are indicated to better understand putative deleterious effects of the herbicide after different levels of exposure.”6

Glyphosate’s Link to Kidney Damage

Significant bioaccumulation of glyphosate has been documented in the kidney, an organ with known susceptibility to glyphosate. Glyphosate-induced kidney toxicity has been associated with disturbances in the expression of genes associated with fibrosis, necrosis and mitochondrial membrane dysfunction.7

Further, as noted by the Environmental Pollution study researchers, “Previous studies have associated glyphosate exposure with changes in renal function, kidney injury, and chronic kidney disease of unknown etiology. There is growing evidence linking glyphosate exposure with the epidemic of chronic kidney disease of unknown origin in farmworkers in Central America, Sri Lanka and central India.”8

Dr. Sarath Gunatilake, professor of health science at the University of California and Channa Jayasumana, Ph.D., a faculty member of Medicine and Allied Sciences at the Rajarata University of Sri Lanka, have published papers linking glyphosate exposure to chronic kidney disease of unknown etiology (CKDu) in Sri Lankan farmers.9

In 2014, they hypothesized that consumption of glyphosate-contaminated water may contribute to chronic kidney disease by facilitating the transport of heavy metals such as arsenic and cadmium into the kidneys.10 Sri Lankan Agricultural Nephropathy (SAN), a form of chronic kidney disease among paddy farmers that was first reported in 1994, has become the most debilitating public health issue in parts of Sri Lanka.

Glyphosate May Be a Primary Cause of Kidney Disease

In 2015, Gunatilake and colleagues noted that people living in areas with endemic SAN are exposed to multiple heavy metals and glyphosate, adding further support that the condition is toxicological in origin:11

“Although we could not localize a single nephrotoxin as the culprit for SAN, multiple heavy metals and glyphosates may play a role in the pathogenesis. Heavy metals excessively present in the urine samples of patients with SAN are capable of causing damage to kidneys. Synergistic effects of multiple heavy metals and agrochemicals may be nephrotoxic.”

In another 2015 study published by the team, it was found that people who drank water from wells where glyphosate and heavy metal concentrations are higher had a fivefold increased risk of CKDu.12 In 2019, researchers again named agricultural chemicals, including glyphosate and paraquat, as possible primary factors in CKDu, noting:13

“ … [G]lyphosate causes insidious harm through its action as an amino acid analogue of glycine, and … this interferes with natural protective mechanisms against other exposures.

Glyphosate’s synergistic health effects in combination with exposure to other pollutants, in particular paraquat, and physical labor in the ubiquitous high temperatures of lowland tropical regions, could result in renal damage consistent with CKDu in Sri Lanka.”

Controversy Over Scientific Freedom and Responsibility Award

Gunatilake and Jayasumana’s research linking glyphosate to chronic kidney disease was so significant that they received notable recognition from the American Association for the Advancement of Science (AAAS), the world’s largest scientific society and publisher of several journals, including Science.

Since 1980, AAAS has presented an annual award for Scientific Freedom and Responsibility to “scientists, engineers or their organizations, whose exemplary actions have demonstrated scientific freedom and responsibility in challenging circumstances.”

As noted by AAAS, “Some awardees have risked their freedom and even physical safety by their actions, while others have been honored for their advocacy and their leadership.”14 In 2019, AAAS was slated to present the Scientific Freedom and Responsibility to Gunatilake and Jayasumana, who certainly faced their share of adversity in speaking out against glyphosate.

An AAAS press release even noted that the researchers “faced death threats and claims of research misconduct while working to determine the cause of a kidney disease epidemic that has claimed tens of thousands of lives in their home country of Sri Lanka and around the world. Ultimately, their advocacy led to the culprit, an herbicide called glyphosate, being banned in several affected countries.”15

Jessica Wyndham, director of the AAAS Scientific Responsibility, Human Rights and Law Program, further noted, “To right a wrong when significant financial interests are at stake and the power imbalance between industry and individual is at play takes the unique combination of scientific rigor, professional persistence and acceptance of personal risk demonstrated by the two scientists recognized by this year’s award.”16

The award announcement was met with significant backlash from industry, however, leading AAAS to backtrack and retract the award, stating they agree to “taking steps to reassess the 2019 Award for Scientific Freedom and Responsibility, after concerns were voiced by scientists and members. This award will not be presented … as originally planned while we further evaluate the award selection.”17

Science Prevails, Glyphosate Scientists Awarded After All

After implementing a lengthy peer review to evaluate the 2019 award, AAAS decided their original decision was the right one after all and have now formally listed Gunatilake and Jayasumaa as the recipients of the 2019 Scientific Freedom and Responsibility award, noting the scientists “investigated a possible connection between glyphosate and chronic kidney disease under challenging circumstances.”18

The wording is notably different, however, from AAAS’ original description,19 which has since been taken down but once referred to the researchers as “public health researchers who battled powerful corporate interests to uncover the deadly effects of industrial herbicides.”20

Jayasumana had suspected that industry had negatively influenced the AAAS initially, but with their research vindicated, he told Monga Bay, “Science has prevailed. That’s why, after certain groups opposed our selection and undermined our professional work, the research work has been upheld as credible.”21

Glyphosate’s Link to Chronic Disease

Gunatilake and Jayasumaa are not alone in their findings that glyphosate is capable of causing chronic disease. A number of animal studies have linked glyphosate to liver damage, for instance, including one that dates back to 1979, which showed the chemical could disrupt mitochondria in rat livers.

While the actual study is behind a paywall — meaning you have to pay to read it it — it is referenced and duplicated in a 2015 study that affirmed that chronic exposure to the chemical “can result in liver and kidney damage.”22,23

Glyphosate is also known to trigger the production of reactive oxygen species, leading to oxidative stress. As noted in Scientific Reports, “Elevation in oxidative stress markers is detected in rat liver and kidney after subchronic exposure to GBH [glyphosate-based herbicides] at the United States permitted glyphosate concentration of 700??g/L in drinking water.”24,25

Researchers from King’s College London also showed an “ultra-low dose” of glyphosate-based herbicides was damaging.26

Stephanie Seneff, a senior research scientist at the Massachusetts Institute of Technology (MIT), has also been studying glyphosate for years and determined that the increase in glyphosate usage in the U.S., as well as in Canada, is extremely well correlated with the concurrent increase in the incidence of multiple diseases, including breast cancer, pancreatic cancer, kidney cancer, thyroid cancer, liver cancer, bladder cancer and myeloid leukemia.27

Research scientist Anthony Samsel is one of Seneff’s co-authors, and together they’ve suggested that one of the ways glyphosate is harmful is via disruption of glycine homeostasis. Glyphosate has a glycine molecule as part of its structure (hence the “gly” in glyphosate). Glycine is a very common amino acid your body uses to make proteins.

Samsel and Seneff believe your body can substitute glyphosate and its metabolite aminomethylphosphonic acid (AMPA) into peptides and proteins, which results in damaged peptides and proteins being produced.

Glycine also plays a role in quenching inflammation, as explained in “Glycine Quells Oxidative Damage by Inhibiting NOX Superoxide Production and Boosting NADPH,” and is used up in the detoxification process. As a result of glyphosate toxicity, many of us may not have enough glycine for efficient detoxification.

How to Detox Glyphosate

Glyphosate residues are found in many foods, including genetically engineered crops and non-GE grains, such as oats. One of the best ways to avoid exposure is to eat organic or biodynamically grown food, and invest in a good water filtration system for your home to lower exposure that may occur via drinking water. You’ll also want to avoid using glyphosate-based products around your home, garden or workplace.

If you’re interested, the Health Research Institute (HRI) in Iowa developed the glyphosate urine test kit, which will allow you to determine your own exposure to this toxic herbicide. They’re also in the process of doing hair testing for glyphosate, which is a better test for long-term exposure.

If it turns out that you have measurable levels of glyphosate in your body, Seneff recommends consuming organic, unpasteurized apple cider vinegar, as it contains acetobacter, which can break down glyphosate. She also suggests eating garlic and cruciferous vegetables, which are good sources of sulfur.

Glycine supplementation may also be a good option to help detoxify glyphosate, as to eliminate glyphosate, you need to saturate your body with glycine.

Dr. Dietrich Klinghardt, who is a specialist in metal toxicity and its connection to chronic infections, recommends taking 1 teaspoon (4 grams) of glycine powder twice a day for a few weeks and then lower the dose to one-fourth teaspoon (1 gram) twice a day. This forces the glyphosate out of your system, allowing it to be eliminated through your urine.

I personally have been taking 1 gram twice a day for some time now. Glycine is inexpensive and tastes sweet. Ideally it is best to take it around the time you are eating food that might be contaminated with glyphosate, of which, unfortunately, there are many.

New Jersey Defeats Mandatory Vaccine Bill

Everywhere we look, we find signs of out-of-control Big Pharma influence on medical policies and public health laws. This shouldn’t come as a surprise, considering drug ads account for the vast majority of most media outlets’ advertising revenues.

As a result, the media are no longer providing us with fair and balanced reporting on the prevention and treatment of disease, and this certainly includes the subject of drugs and vaccines. As reported by Periscope News Group editor-in-chief, Christina Morales:1

“Prescription medications are a multi-BILLION-dollar industry that’s making not only the pharmaceutical companies tons of money, but also the network television stations … Did you know that pharmaceutical advertising has soared 62 percent since 2012 and is projected to cost $610 billion by 2021? …

The average American watches 16 hours of pharmaceutical commercials each year which is more time than they spend with their primary physician. One-third of these people ask their doctors about a drug advertisement and most request a prescription.

Clearly this type of advertising in generating a huge response from the public, but it also is having an impact that consumers rarely think about: if these companies are paying television networks billions of dollars to advertise their drugs, would their news stations risk losing big money accounts by reporting negative information about the company?

Public figure and activist Robert F. Kennedy Jr. once shared that, ‘I ate breakfast last week with the president of a network news division and he told me that during non-election years, 70% of the advertising revenues for his news division come from pharmaceutical ads … He also told me that he would fire a host who brought onto his station a guest who lost him a pharmaceutical account.’

Drug Industry Is the Hidden Hand Behind Vaccine Laws

During the 2019 U.S. legislative session, 22 bills were introduced in 17 states proposing to eliminate vaccine exemptions.2 One of them was New Jersey bill S2171, which tried to repeal the religious vaccine exemption and require students of all ages to be fully vaccinated or lose their right to a school education.

December 12, 2019, a hearing on the bill was held by the New Jersey Senate Health Committee, which voted in favor (6 to 4) of sending it to the floor.3 However, while the bill was widely expected to breeze through the Senate, it came to a screeching halt due to the massive uprising of concerned citizens who publicly protested against it.
As reported by The New York Times January 13, 2020:4

“It began as one of the nation’s broadest proposed bans on religious exemptions to childhood vaccines. But after weeks of sustained and boisterous protests … as well as a last-minute effort to amend the proposed bill to win the support of key lawmakers, the effort collapsed on Monday in the New Jersey State Senate …

Senator Loretta Weinberg, a Democrat and a sponsor of the legislation, said that the Senate would immediately reintroduce a new version of the bill and begin the process anew. This time, she said, the Legislature might hold public hearings with doctors and scientists to debunk opponents’ concerns. ‘The science is settled on this,’ Ms. Weinberg said.”

Vaccine Science Is Far From Settled

Is the science on vaccine safety really settled? Far from it. There’s a broad base of scientific studies questioning both the safety and effectiveness of vaccines. The growing number of people filing vaccine-injury claims with the national Vaccine Injury Compensation Program (VICP) also speaks to the fact that there’s a problem, as does the scientific evidence showing industry-funded vaccine studies are riddled with bias.5,6

What’s more, the more we learn about infectious diseases and how vaccines work, the more we realize just how little we actually know, and how many of our assumptions are seriously flawed.7

One of the primary reasons we’re not getting objective reporting on these issues from the media is, again, because most news organizations make the bulk of their money from the drug industry (i.e., drug ads). They simply cannot afford to bite the hand that feeds them, and so they become complicit in the cover-up by default.

New Jersey Bill S2171 Is Defeated

In its original form, S2171 eliminated the religious vaccine exemption for children attending daycare and schools in New Jersey, established a state-run review board to approve all medical exemptions, and required students of all ages enrolled in daycare, primary school and higher education, both public and private, including higher education online classes, to be fully vaccinated.

As reported by Children’s Health Defense legal counsel, Mary Holland,8 “under the terms of the law, a 60-year old taking a cooking class at a community college could be required to prove vaccination status before enrollment. This could include even online courses at any institution of higher education in New Jersey.”

As such, it was the broadest vaccine exemption elimination bill introduced so far, which is why its defeat on January 13, 2020, was such a major victory. Make no mistake, it was the participation of thousands of people who showed up for the hearings at the state capitol that allowed for this victory.9 Without that overwhelming pressure, there’s no doubt in my mind the bill would have passed.

In an effort to push the legislation through, amendments were made so that the religious vaccine exemption would be available in private schools but not public schools. However, as reported by The New York Times,10 this only raised new concerns. Many argued the amendment gave wealthy families the ability to exempt their children attending expensive private schools, while denying the same right to children whose parents cannot afford to pay for private school.

As reported by News24 in the video above, New Jersey Senate president Stephen Sweeney — who remains adamant the bill eventually will become law – effectively “bought” votes to try to pass S2171 by offering Senators who were planning to vote “no” on the bill financial support in future elections through the General Majority super PAC funds in exchange for their “yes” vote.

News24 also highlights Sweeney’s deep connections to the drug industry, which appear to be part and parcel of why he’s such a determined advocate for mandatory vaccinations and the removal of exemptions. Fortunately, not even these highly questionable last-ditch efforts were enough to pass the bill.

Informed Consent Is the Bedrock of Medical Ethics

A January 17, 2020, Health Impact News post11 reviews the scientifically referenced testimony submitted by Dr. Meryl Nass before the Massachusetts legislature, which is also considering legislation that will eliminate the religious vaccine exemption. In her testimony, Nass stated pointed out that:12

There is no crisis (no epidemic of deaths or disabilities) from infectious diseases caused by lack of vaccinations, either in Massachusetts or the United States …

The elephant in the auditorium today is Pharma profits … The pharmaceutical industry has undertaken a very ambitious campaign to legislate away vaccine exemptions in the United States and Canada. France, Italy and Germany have rescinded vaccine exemptions too, suggesting the campaign is worldwide …

This is an industry that has thrived by taking big risks — even when manufacturers knew in advance that their products killed … Pharma’s latest risky strategy is trying to rid the world of vaccine exemptions, to prevent vaccine opt-outs before a new crop of vaccines with inadequate safety and efficacy testing — and for which they will have no liability once placed on the childhood schedule — are approved …

It has been claimed that vaccines are, by nature, extremely safe. Yet vaccines are usually injected, bypassing all the body’s natural barriers. Even minute contamination or inadequate microbial inactivation can maim or kill … Vaccines have caused many autoimmune disorders, from Guillain-Barre syndrome to narcolepsy …

Vaccines appear safe because the immediate side effects are usually mild and temporary. Serious vaccine side effects often take weeks or months to surface, and by then it is difficult to know what caused them. Only when vaccinated individuals have rates of illness at least 10 times higher than the unvaccinated, is the side effect likely to be linked to the vaccine.

A 2009 European swine flu vaccine (GSK’s Pandemrix) caused over 1,300 cases of severe narcolepsy, mostly in adolescents. This vaccine was linked to narcolepsy because 15 times the usual number of narcolepsy cases suddenly appeared in clinics.

Countries that bought the swine flu vaccines … were required to waive manufacturer liability as a condition of purchase … It should be apparent, but isn’t: Government waivers of vaccine liability discourage manufacturers from ensuring that the vaccines they sell are as safe and effective as possible.

The removal of vaccine exemptions, combined with liability waivers for vaccine side effects and recently loosened standards for licensing vaccines, create a highly toxic mix.”

Nass goes on to cite statistics showing why the claim that draconian laws are required to control the “crisis” of vaccine-preventable diseases is false. She also points out that:

“The bedrock expectation of medical ethics is that patients must give informed consent13 for all medical procedures, including vaccines. Informed consent means that patients must be informed about the procedure, have the right to refuse, and may not be coerced to accept it.

Isn’t withholding an education an extreme form of coercion? Without any discussion of its moral or ethical dimensions by media, medical societies or government officials, the requirement for informed consent for medical procedures, including vaccinations, vanishes in the blink of an eye when patients are not allowed the right to refuse.”

Doctors Are Selling Out to the Drug Industry Too 

Media corporations and politicians aren’t the only ones beholden to the drug industry. In 2013, ProPublica exposed how drug companies bribe hundreds of thousands of American doctors to prescribe expensive and often dangerous drugs.14

One way in which drug companies enlist medical professionals to push their wares is to offer them lucrative speaking engagements, in which they promote the company’s drugs. While presented as “educational,” these expert lectures are nothing but thinly veiled sales pitches.

Despite rising concern over these kinds of conflicts of interest, ProPublica’s latest Dollars for Doctors report reveals the trend has only grown and gotten worse over the years. In its October 2019 report, ProPublica writes:15

“Back in 2013, ProPublica detailed what seemed a stunning development in the pharmaceutical industry’s drive to win the prescription pads of the nation’s doctors:

In just four years, one doctor had earned $1 million giving promotional talks and consulting for drug companies; 21 others had made more than $500,000. Six years later — despite often damning scrutiny from prosecutors and academics — such high earnings have become commonplace.

More than 2,500 physicians have received at least half a million dollars apiece from drugmakers and medical device companies in the past five years alone. More than 700 of those doctors received at least $1 million …

There has been almost no change in how much the industry is spending. Each year from 2014 to 2018, drug and medical device companies spent between $2.1 billion and $2.2 billion paying doctors for speaking and consulting, as well as on meals, travel and gifts for them …

Roughly the same number of doctors — more than 600,000 — received payments in any given year … For context, there are about 1.1 million doctors in the United States.”

Vaccines Give a ‘Healthy Boost’ to Doctors’ Bottom Line

In a 2015 Family Practice Management article,16,17,18 Dr. Jamie Loehr shared with other family physicians how giving every CDC recommended vaccine to all patients, regardless of age, can provide a “strong, healthy boost to the bottom line” of their medical practice.

“Minimizing costs and maximizing reimbursement can make immunizations profitable,” Loehr writes. He then goes on to explain where and how to get the needed vaccines for the lowest price, and how to properly code for the service in order to maximize insurance reimbursements.

Ironically — considering the vast majority of doctors do not disclose the full range of potential side effects of a given vaccine — one of the biggest money-makers is the code for vaccine counseling for patients under 18, as combined vaccines such as the MMR and DTaP allow the doctor to bill for three and four counseling components respectively.

For the MMR, they can bill for informing you about the risks and benefits of the measles, mumps and rubella vaccines (i.e., three counseling components) and for the DTaP, they can bill for informing you about diphtheria, tetanus, pertussis, and polio (i.e., four counseling components).

Some of the potential side effects actually listed on vaccine inserts and adverse events for which victims have received compensation from the federal Vaccine Injury Compensation Program (VICP) are listed in my previous article, “How Much Do You Really Know About Vaccine Safety?

I suggest reading through those lists and comparing them to what your child’s pediatrician or your doctor have told you about vaccine side effects. Many doctors are not providing parents with the Vaccine Information Statement (VIS) required under the 1986 National Childhood Vaccine Injury Act to be given to parents before children are vaccinated, and rarely are more serious side effects mentioned before a vaccine is given.

Parents can always ask doctors for a copy of the actual manufacturer vaccine product insert, which accompanies vials of vaccines shipped to doctors’ offices, and is required by FDA regulations to list known and reported side effects.

Conflicts of Interest Rule the Roost

Doctors have a longstanding history of being revered as experts, whose morals and integrity are above reproach, and whose knowledge should not be questioned. This is why doctors were featured in cigarette ads in the 1930s and ’40s,19 before the dangers of smoking became firmly established.

It is also why doctors like Dr. Paul Offit, Dr. Peter Hotez and Dr. Richard Pan are now pervasively featured in articles insisting that everyone should be legally required to purchase and use all vaccines recommended by the federal Centers for Disease Control (CDC) and medical trade associations like the American Academy of Pediatrics (AAP) and American Medical Association (AMA).

Offit, Hotez and Pan are hardly the only vaccine experts in the U.S., let alone the world, yet the views of these two are routinely brought forth as the voices of medical consensus on vaccine safety.

This, despite the fact that Offit is a vaccine developer who has been caught making false statements20 and has significant conflicts of interest with the vaccine industry,21 including owning vaccine patents, and Pan, in his role as California Senator, has received significant amounts of money from corporations marketing vaccines.

Between 2013 and 2014, Pan received more than $95,000 from drug companies and their trade groups.22 In February 2015, he introduced bill SB277,23,24 which repealed the Californian personal belief vaccine, which included religious and conscience or philosophical beliefs. Coincidence?

Another vaccine developer and mandatory vaccination proponent with industry ties is Professor Peter Hotez.25,26 He also has financial ties The Bill and Melinda Gates Foundation,27 which is has poured hundreds of millions of dollars into global vaccination programs. 

Resistance Is Never Futile

The fact that New Jersey managed to thwart the latest attack on medical freedom is an encouraging sign. Never underestimate the power of the people! The key is numbers — you have to actually take action by contacting your legislators ahead of time to communicate your concerns about a bill you oppose (or support) and showing up at public hearings and on days when votes are taken in your state Capitol.

Thousands of individuals gathered in hallways and outside the Capitol building in Trenton to protest of S2171 on multiple occasions, and it was undoubtedly the sheer size of the opposition that greatly helped to defeat the bill.

The fight is not over though. Senator Weinberg has promised to reintroduce the bill in some altered form, and hopefully, residents will rise to the occasion yet again when it does.

Stay up to date on vaccine-related bills that are moving in your state this year, including bills proposing to take away (or expand) your right to obtain a vaccine exemption for yourself or your child. Register to become a user of the free online NVIC Advocacy Portal operated by the National Vaccine Information Center and access bill analyses and talking points to educate your legislators.

Maine Could Become the First State to Overturn Bad Vaccine Law

In related news, Maine is fighting to repeal a new vaccine law that eliminated non-medical vaccine exemptions in 2019 and urgently needs your support. The veto referendum to overturn the bill (LD798) which was enacted into law in 2019 will be on a March 3, 2020 ballot.

The new law revokes religious and philosophical vaccine exemptions and prevents access to work and education for those who have not received every state mandated vaccine.28

Maine is the first state to put government vaccine mandates and repeal of exemptions to a popular vote through a veto referendum included on a ballot. To succeed and set the precedent for other states to follow, they need your support now.

Smaller states are easier to win because there are fewer people to educate on the issue at hand, which means less money is required for advertising. Maine has an advertising saturation point of about $3 million, meaning if you spend $3 million, you will reach a majority of residents and further advertising will not make a significant difference.

The “Yes on 1 Reject Big Pharma” campaign needs to raise at least $1 million within the next 30 days to stand a chance against the pharmaceutical industry’s deep pockets. You can make a difference by making a donation to this campaign below (and, if you are a registered voter in Maine, by making sure to cast a vote on Mar. 3, 2020 to restore vaccine exemptions in the state).

Do FODMAP Foods Trigger IBS Symptoms?

While irritable bowel disease (IBD) and irritable bowel syndrome (IBS) have similar names, they are two different conditions with a few similar symptoms. IBD is an umbrella term, under which are several gastrointestinal diseases including ulcerative colitis and Crohn’s disease.

The severity of IBD can depend on genetic markers and the effect of microbes on your immune system.1 The most common symptom of both IBS and IBD is diarrhea. Those suffering with IBD may also experience anemia, fever, extreme weight loss and bloody stool.

IBS can cause constipation, diarrhea or both. Some have complained of being gassy or bloated and 70% diagnosed with IBS report having suffered severe food poisoning.

The intensity and severity can vary and is often induced by specific foods, the size of a meal or even stress. Currently, treatment methodologies are focused on diet, lifestyle and stress reduction as the symptoms frequently disrupt life and social interactions.

Each year IBS accounts for up to 12% of the total number of primary care visits and the financial burden is estimated to start at $21 billion, including direct and indirect medical costs as well as loss of productivity and work performance.2

An Elimination Diet May Reduce Your Symptoms

Symptoms of IBS include depression and anxiety.3 Many find these symptoms are reduced or avoided through eliminating specific foods from their diet. Discovering which foods should be excluded is most easily done using an elimination diet.

The premise of an elimination diet is to exclude foods that negatively affect the gastrointestinal system. Once your symptoms have subsided, it’s safe to begin adding foods back slowly, one group at a time. If symptoms recur, then eliminate the food group that was just added. Try adding just one new group a week so it will be clear what’s causing the problem.

It’s best to start with foods that are known suspects, such as dairy and gluten. However, it turns out there are several foods you may not be aware of that trigger symptoms.4 Each of the culprits have carbohydrates that are difficult to digest and that ferment rapidly in the gut, producing CO2.

The four groups of carbohydrates that meet these criteria are fermentable oligosaccharides, disaccharides, monosaccharides and polyols, more commonly known as FODMAPs.

These foods don’t cause issues in everyone but they do create problems in those who have an intolerance that may be related to a different microbial environment in their gut. The list of short-chain FODMAPs foods you may not have considered include:5

  • Oligosaccharides — This group contains galacto-oligosaccharides (GOS) and fructans. Foods containing GOS include lentils, kidney beans, chickpeas and soy, while fructans are in broccoli, asparagus, garlic and onions as well as wheat and rye.
  • Disaccharides — Lactose containing foods such as those made with cow’s milk are part of this group; these include cheese (including mascarpone), yogurt, ice cream and custard to name a few.
  • Monosaccharides — These are fructose-containing foods such as fruit, honey and high fructose corn syrup.
  • Polyols — Apples, apricots, pears, peaches and blackberries contain polyols, as well as products made with sweeteners found in gum, cough drops and mints. These are sometimes listed as xylitol, isomalt, sorbitol and mannitol.

Not all foods high in FODMAPs will trigger symptoms. Adding some back to the diet will be less restrictive and add a greater range of nutrients from whole foods as you watch for recurring symptoms. Many who have tried the diet end up sticking with it since it improves their quality of life. According to Harvard Publishing, some of the foods known to trigger symptoms of IBS are on the FODMAP list, including:6






Fatty foods




Wheat and rye products

Dairy products


Carbonated beverages

Orange and Grapefruit Juices

Products sweetened with fructose or sorbitol

Gut Dysfunction and System-Wide Inflammation

Researchers have found a correlation between gut inflammation and mental health issues such as depression and anxiety, especially in those with IBS. The authors of one study found a high prevalence of anxiety and depression in those with IBS;7 as noted in another, researchers theorized alterations in the gut-brain axis may be involved in the association between IBS and depression.8

Results from a meta-analysis demonstrated “depression and anxiety levels to be higher in IBS patients than in healthy controls, regardless of the IBS-subtype.”9 Gut dysfunction is also associated with system-wide inflammation, affecting more than just mental health.

An increased number of inflammatory cytokines released throughout the body with gut inflammation may affect numerous aspects of your health. They are involved in a spectrum of autoimmune diseases including rheumatoid arthritis, lupus, multiple sclerosis and psoriasis.10 Cells involved in the process and development of atherosclerosis are activated by cytokines.11

In my article, “Healthy Gut, Healthy You: A Personalized Plan to Transform Your Health,” Dr. Michael Ruscio, author and clinical investigator who focuses on gastrointestinal (GI) health, explains development of the connection between the gut and system-wide inflammation.

Think of your gut as a tube running through the inside of your body that starts at your mouth. This may help you may visualize how the gastrointestinal system is central to supporting the entire body.

Since the largest density of immune cells in your body are living in your small intestines and the small intestines are a selective barrier between the outside world and the inside of your body, when this barrier malfunctions you may experience symptoms of inflammation.

You may have “neurological, rheumatological or even dermatological reactions from foods that don’t agree with your gut, because of this very broad-acting inflammatory impact,” according to Ruscio.

Histamine Food Intolerance May Trigger Symptoms

Another trigger for gut dysfunction is histamine-rich foods. Histamine is a neurotransmitter like serotonin, epinephrine and dopamine.12 There is always a small amount circulating throughout your body helping to regulate sleep and physiological functions in the gut.

Your body balances ingested histamine by using diamine oxidase (DAO), an enzyme in the gut that breaks it down.13 If you have a DAO deficiency it can allow histamine to build up in the body. Histamine also plays a role in the secretion of acid in the stomach. Excess levels can result in dizziness, headaches, sleep dysfunction, high blood pressure and fatigue.

Researchers believe the wide variety of symptoms may mask the extent of histamine intolerance in the general population. Foods rich in histamine and those that liberate it include:







Citrus fruit



Red wine vinegar

Frozen or smoked fish

Fermented foods such as aged cheese, cured meat and yeast products

Personalize a Plan to Heal Your Gut

Your first step to a personalized plan is to eliminate all FODMAP foods for two to six weeks, or at least until most of your symptoms have resolved.14 Since it’s not likely all FODMAP foods are triggering symptoms, it’s now time to add one group of FODMAPs to your diet.

By the end of testing you should be able to identify the groups that trigger the most severe symptoms and those you might be able to eat in small amounts. Your goal is to test slowly and in increments to learn your limits and then test more strategies to reduce symptoms of IBS. The process of eliminating foods from your diet may be overwhelming but there are a few things you may consider to make the journey a little easier:

  • Keep a food diary and log your symptoms as you go through the process, so you aren’t relying on memory.
  • Gather recipes before starting the elimination diet so you have some go-to meals and won’t have to expend energy after work trying to think of something to make.
  • Keep FODMAP friendly foods in the homes of people you spend a lot of time with, such as your parents or your partner. Include snacks and ingredients for a meal or two. Pack healthy snacks you can bring with you or keep at work.
  • Remember, while it may be next to impossible to eat out in the beginning, the process will get easier and you’ll start to feel better, which is a powerful motivator.

Weekly Health Quiz: Water, Pregnancy and Avocados

1 Why might hard water be healthier for your heart than soft water?

  • Because hard water is more acidic
  • Because hard water contains higher levels of zinc and calcium
  • Because hard water contains higher levels of magnesium

    Research has shown people drinking soft water on a regular basis are more susceptible to lethal arrhythmias than those drinking hard water. One hypothesis that can account for this is magnesium deficiency, as hard water contains higher levels of magnesium than soft water. Learn more.

  • Because soft water is less hydrating

2 Research shows long-term annual vaccination may render young children who have not previously been infected with an influenza virus:

  • Immune to infection with a pandemic influenza virus of a novel subtype
  • Less likely to contract a novel pandemic influenza virus
  • Guaranteed to contract a novel pandemic influenza virus
  • More susceptible to infection with a pandemic influenza virus of a novel subtype

    Research shows long-term annual vaccination may render young children who have not previously been infected with an influenza virus more susceptible to infection with a pandemic influenza virus of a novel subtype. Learn more.

3 Which of the following has been identified as the driving mechanism of harm behind electromagnetic field (EMF) damage to human health?

  • Oxidative stress triggered by the production of peroxynitrites

    The primary danger of EMFs — and what drives the processes of chronic disease — is the mitochondrial damage triggered by peroxynitrites, one of the most damaging types of reactive nitrogen species. Learn more.

  • Exaggerated antioxidant response triggered by overproduction of glutathione
  • Ionizing damage similar to that of X-rays
  • Lowered immune defense by inhibiting vaccine effectiveness

4 Research shows drinking fluoridated water during pregnancy has which of the following health effects on offspring?

  • Raises children’s IQ
  • Lowers children’s IQ

    One of the most recent studies highlighting the dangers of fluoride was a U.S. and Canadian government-funded observational study published in JAMA Pediatrics, which found that drinking fluoridated water during pregnancy lowers children’s IQ. Learn more.

  • Improves math scores
  • Raises risk of sudden infant death syndome

5 The lead investor among a group of 18 that helped make NewsGuard a reality is:

  • The Grocery Manufacturer’s Association of America (GMA), a lobbying group for junk food makers
  • Drug company Eli Lilly
  • Publicis Groupe, a giant global communications group with strong ties to Big Pharma

    While Publicis has been busy solidifying its strong ties with Big Pharma, it was also the lead investor among a group of 18 that helped make NewsGuard a reality. Learn more.

  • The American Council on Science and Health (ACSH), a nonprofit organization that’s really an industry front group

6 The major drawback to the world popularity of avocados is:

  • Their high cholesterol
  • The high calories found in the fruit
  • Their high price at grocery stores
  • The tremendous amount of water required to grow them

    Avocados require so much water to produce, compared to other crops, that their plantations have led to severe water shortages in Chile. Some local people now have to have their water trucked in because of the plantations. Learn more.

7 What percentage of national elections in the world has been determined by biased Google search results and biased search suggestions, according to research by Robert Epstein, senior research psychologist for the American Institute of Behavioral Research and Technology?

  • 100%

    Robert Epstein has shown biased web searches can shift the opinion of 48% to 63% of undecided voters toward or against a particular political candidate. Search suggestions is another powerful manipulation tool capable of turning a 50/50 split among undecided voters into a 90/10 split. Because more than 90% of searches worldwide are conducted on Google, the company has likely determined the outcomes of 25% of the national elections in the world. Learn more.

  • 75%
  • 50%
  • 25%

Psychedelic Mushroom Compound Found Nontoxic in Large Study

There have been rapid changes when it comes to the embracing of psychedelic and hallucinogenic substances by mainstream medicine and municipalities. Marijuana, despite its longtime federal classification as a Schedule I drug, the FDA’s most restricted class, is now legal in many U.S. states for medical purposes.1 States are also increasingly legalizing marijuana for recreational use, as Illinois did in 2020.2

Ketamine, a rapid acting anesthetic and established street drug sometimes called “Special K,” was approved by the FDA for treating depression last year.3 And now there are signs that psilocybin, the ingredient in so-called “magic” mushrooms and also classified as a Schedule I drug,4 may soon be used medically for depression.

Psilocybin has already been decriminalized in Denver,5 Oakland6 and Chicago,7 perhaps paving the way for its consideration in medical uses. Now, in the largest controlled study of psilocybin to date, conducted at Kings College London, the “magic mushroom” substance was found safe for human consumption.8

The Largest Controlled Study of Psilocybin

In 2018, the FDA authorized Compass Pathways, a life sciences firm founded in London, England, to conduct initial clinical trials with psilocybin for possible use in treatment-resistant depression.9 The Phase I trials, as they are called, were designed to test the safety of Compass Pathways’ psilocybin preparation, COMP360, not its effectiveness.10

Eighty-nine healthy volunteers who did not suffer from depression were given a 10- or 25-milligram (mg) dose of psilocybin or a placebo and followed up with therapy sessions to assess for adverse effects for up to 12 weeks.11

While some minor adverse effects of a psychedelic nature occurred,12 the effects resolved swiftly within hours,13 and the participants did not suffer residual cognitive or emotional effects or hallucinatory flashbacks in the weeks after taking psilocybin, said the researchers.14

The King’s College London researchers and Compass Pathways representatives announced the results at the annual meeting of the American College of Neuropsychopharmacology in December 2019. The results establish the feasibility of using psilocybin to treat chronic depression, said the researchers.

The Next Step in Psilocybin Trials

Having established COMP360 to be well tolerated, Compass is now running a Phase II b clinical trial with 216 patients diagnosed with treatment-resistant depression to determine clinical efficacy of COMP360 and the correct therapeutic dose range.15

If the Phase II b clinical trial proves successful, Phase III studies will follow, which will compare the psilocybin preparation with conventional treatments, such as antidepressants.16

In 2018, the FDA designated Compass’ psilocybin treatment as a “breakthrough therapy,” a vote of confidence label that can fast track a drug’s review and approval and usually means the drug is thought to have benefits over existing treatments.17 In January 2020, Compass announced that the U.S. Patent and Trademark Office had granted it a patent for its synthesized investigational psilocybin formulation.18

“Too many people are suffering with treatment resistant depression,” said CEO and co-founder of Compass George Goldsmith.19 “We are committed to developing innovations, such as psilocybin therapy, to address this rapidly growing problem.”

More Psilocybin Clinical Trials Are in Progress

The Compass trials are not the only studies to look at the possible effects of psilocybin on human conditions. A Phase II clinical trial with 80 participants at seven different U.S. sites is also planned by the Usona Institute, a Madison, Wisconsin-based nonprofit medical research organization.20

The group says it is “dedicated to supporting and conducting preclinical and clinical research to further the understanding of the therapeutic effects of psilocybin and other consciousness-expanding medicines.”21

Like the drug used in the Compass trials, the Usona psilocybin compound has been granted “breakthrough therapy” status by the FDA.22 Unlike the Compass trials, however, which address treatment-resistant depression, the Usona trial will examine psilocybin’s use in major depressive disorder (MDD).23

Usona’s director of clinical and translational research Charles Raison said that MDD represents a much larger group of sufferers with an “unmet medical need” and that “psilocybin may offer a substantial clinical improvement over existing therapies.”

While it is certainly true that many people suffer from sad and depressed moods, antidepressants including selective serotonin reuptake inhibitors (SSRIs) like Prozac and antipsychotics like Seroquel are not always the best option. Simple, healthy lifestyle practices can often lift depression.

Antidepressant drugs may not work at all and can cause serious and paradoxical side effects. If a natural substance such as psilocybin could help people avoid these strong psychiatric drugs, it is certainly a good a thing. Here is how the British paper, Independent, casts the issue:24

“UK is undergoing a burgeoning mental health crisis, which has created an urgent unmet need for the development of new treatments. Prescriptions for antidepressants more than doubled between 2006-2016 … and distressingly, suicide is now the leading cause of death among the young (with psychedelic usage linked to lower suicide risk).

Psilocybin-assisted psychotherapy can provide … a new approach to treating mental illness. Rather than putting the patient on a daily drip of SSRIs, which like a plaster hopefully suppresses the symptoms but leaves the root-causes unaddressed, psychedelics can increase neuroplasticity and reset the brain, so that maladaptive thought … patterns can be unlearned.”

A Psilocybin Clinical Trial at a Psychedelic Research Center

Before the Compass trial, there have been several studies that support psilocybin benefits, some at Imperial College London, which launched the first formal center for psychedelic research in the world — the Imperial Centre for Psychedelic Research — in 2019.25

Imperial was the first research center to investigate the effects of psilocybin on severe depression and, using modern brain imaging, the effects of LSD on the brain.26

In a psilocybin study led by Dr. Robin Carhart-Harris, head of psychedelic research at Imperial, 20 participants who were suffering from severe depression were treated with the compound. After three months, they experienced greater antidepressant effects than from typical antidepressants and therapy, said reports.27,28

“Patients said they went from feeling ‘totally disconnected’ with themselves and the world to ‘connected’, and from repressing and avoiding emotions and memories to accepting them.”29

The new connectedness sensations are thought to come from deactivation of the default mode network (DMN) of the brain that is active when not focused on the outside world. Here is how Carhart-Harris’ study, published in Scientific Reports, explains the DMN phenomenon apparently induced by psilocybin:30

“Much recent research has focused on the involvement of the default-mode network in psychiatric disorders, and particularly depression. We previously observed decreased DMN functional integrity under psilocybin and LSD, and others have with ayahuasca.

Here however, increased DMN integrity was observed one-day post treatment with psilocybin, both via seed and network-based approaches. Previous work has suggested that increased DMN integrity may be a marker of depressed mood and specifically, depressive rumination.

On this basis, increased DMN integrity post psilocybin may be surprising. The post-treatment increases in within-DMN RSFC and sgACC-PCC RSFC did not relate to symptom improvements but vmPFC-ilPC RSFC did. This apparent divergence from previous findings is intriguing, and deserves further discussion.”

Putting the research in laypeople’s terms, Carhart-Harris says, “If you ask people who are taking SSRIs chronically, they often say ‘I feel blunted.’ With psilocybin therapy they say the opposite, they talk about an emotional release, a reconnection, and this key emotional center being more responsive.”31

More Theories About Psilocybin Effects

The actions behind the apparent benefits of psilocybin may involve the same neurotransmitters that traditional SSRIs are said to affect, but possibly in different ways. Says Newsweek:32

“Psilocybin is known to bind to a receptor normally used by serotonin, one of the brain’s most important neurotransmitters, which is involved in everything from mood to perception to sleep.

MRI studies done at Imperial College London show that this activity changes the activity of neurons throughout the brain, allowing different regions to communicate that aren’t usually connected. This is thought to help facilitate breakthroughs that people report while under its spell.”

Research published in Biological Psychiatry further analyzes the apparent ability of psilocybin to dramatically change behavior:33

“Psilocybin reduced associative, but concurrently increased sensory brain-wide connectivity. This pattern emerged over time from administration to peak-effects. Furthermore, we show that baseline connectivity is associated with the extent of Psilocybin-induced changes in functional connectivity …

These results suggest that the integration of functional connectivity in sensory and the disintegration in associative regions may underlie the psychedelic state and pinpoint the critical role of the serotonin 2A and 1A receptor systems.

Furthermore, baseline connectivity may represent a predictive marker of the magnitude of changes induced by psilocybin and may therefore contribute to a personalized medicine approach within the potential framework of psychedelic treatment.”

More Encouraging Psilocybin Studies

Smaller studies than the large Compass study have also yielded encouraging results. A 2006 study at the University of Arizona found that psilocybin helped temporarily reduce symptoms of obsessive-compulsive disorder in nine subjects.34

A 2016 study by New York University and Johns Hopkins University researchers published in the Journal of Psychopharmacology found a single dose of psilocybin decreased symptoms of anxiety in cancer patients for eight months when compared to a placebo.35 Testing psilocybin on those with eating disorders is also being planned at London’s Imperial College.36

A kind of “psychedelic renaissance”37 is occurring in which hallucinogenic compounds like psilocybin are viewed as potential therapeutic agents to treat serious mental illnesses like post-traumatic stress disorder, obsessive compulsive disorder and eating disorders as well as depression and anxiety.

Hopefully, psilocybin will continue to prove its safety and become more widely accepted and available for relieving the symptoms with which many suffer and freeing them from harsh medications.