Lose Them Pounds

Depression is common in older adults, occurring in 2% of those aged 55 years and older and rising with increasing age. Many more — from 10% to 15% — struggle with depressive symptoms, although they may not have been diagnosed with major depression.1
That being said, there’s been a major rise in the number of antidepressants being prescribed for older adults over the last two decades, without a similarly sharp increase in the number depressed, according to a study published in The British Journal of Psychiatry.2
The findings suggest seniors may be being overprescribed antidepressant drugs, which could have serious implications for their health, although the researchers weren’t willing to state this, noting instead, “we can’t infer that older patients are prescribed antidepressants unnecessarily.”3
Antidepressant Use More Than Doubles Among Seniors

In order to investigate whether the prevalence of depression and antidepressant drug use changed from 1990 to 2011 in people aged 65 and over, researchers used data from two English population-based cohort studies involving 15,397 people. The studies took place from 1991 to 1993 and between 2008 and 2011.
In the first study group, 4.2% of the adults were taking antidepressants, but this jumped to 10.7% in the later study. During this time, the prevalence of depression decreased, but only slightly, from 7.9% to 6.8%.4 Also noteworthy, among older adults living in care homes, the prevalence of depression was unchanged but the use of antidepressants rose from 7.4% to 29.2%.5
There were a few suggestions offered for why antidepressant prescribing rates increased so steeply without a similar increase in depression, including overdiagnosis or prescribing the drugs for conditions other than depression. However, most of those prescribed antidepressants had not been diagnosed with depression.
Lead study author Antony Arthur, Ph.D. of the University of East Anglia, Norwich, United Kingdom, told Medscape, “Sometimes treatment is given for mild depression which falls outside of our definition of depression ? much of the evidence for the effectiveness of antidepressants is for people with moderate or severe depression. Antidepressants are also used to treat other conditions, for example, neuropathic pain and sleep disorders.”6
He added that opportunities to deprescribe antidepressants should not be overlooked.7 “Whatever the explanation, substantial increases in prescribing has not reduced the prevalence of depression in the over-65 population. The causes of depression in older people, the factors that perpetuate it, and the best ways to manage it remain poorly understood and merit more attention,” he stated.8
A separate study, published in World Psychiatry in 2017, reviewed data collected from 1990 to 2015 from Australia, Canada, England and the U.S. It similarly found that “the prevalence of mood and anxiety disorders and symptoms has not decreased, despite substantial increases in the provision of treatment, particularly antidepressants.”
Antidepressants Risky for the Elderly

Depression is a serious mental health condition that’s associated with many negative outcomes in older adults. Along with increasing personal suffering, depression is associated with an increased risk of cognitive decline, dementia, poor medical outcomes, suicide and high mortality.9
American Psychiatric Association guidelines suggest optimal treatment for depression should include antidepressant medication along with psychotherapy, but most elderly who are treated for depression (many go without treatment) receive antidepressant medications only.10 Yet, there are a number of risks that come with antidepressant usage.
For instance, antidepressant users have an increased risk of developing Type 2 diabetes,11 even after adjusting for other risk factors, like body mass index (BMI).12 Antidepressant use has also been linked to thicker arteries, which could contribute to the risk of heart disease and stroke.13
The drugs are also linked to dementia, with researchers noting “treatment with SSRIs, MAOIs, heterocyclic antidepressants and other antidepressants was associated with an increased risk of dementia,” and as the dose increased, so too did the risk.14
The drugs are also known to deplete various nutrients from your body, including coenzyme Q10 and vitamin B12 — in the case of tricyclic antidepressants — which are needed for proper mitochondrial function. SSRIs may deplete calcium, folate and other important nutrients from your body.15 There are also risks specific to older adults, which are not necessarily seen in younger adults.
According to research published in Expert Review of Neurotherapeutics, “One particular concern is that antidepressants increase the risk of falls, osteoporosis and fractures … antidepressants have side effects and risks, some of which can be observed acutely while others may be longer-term consequences.”16
For example, one 2015 study found that, compared to perimenopausal women treated with H2 antagonists or proton pump inhibitors (indigestion drugs), selective serotonin reuptake inhibitors (SSRIs, a class of antidepressants) raised bone fracture rates by 76% in the first year of use. After two years of treatment, the fracture rate was 73% higher.17,18
What’s more, between 1988 and 2010 39% of people aged 65 and over were taking at least five prescription medications each day19 — in 2019 as many as 43% may be taking eight or more, while 24% could be taking as many as 10 day,20 which can be contraindicated, raising new risks. In 2015 when the first study was published, researchers believed the increases were driven, in part, by rising use of antidepressant drugs.
Antidepressants Are Often Ineffective

Studies have repeatedly shown antidepressants work no better than placebo for mild to moderate depression,21 so seniors may be taking serious risks for a very small chance of benefit.
In yet another study that documented the overprescription of antidepressants in older adults, researchers found they were often prescribed in the absence of major depressive disorder (MDD), although they were not effective for such purposes. Researchers concluded:22

“Providers and the public increasingly recognize depression as a medical problem meriting treatment; however, they should be aware that antidepressants are not beneficial for depressive symptoms that do not meet the criteria for MDD, but their potential side effects and costs remain regardless of whether MDD is present.”

Even in severely depressed patients, the difference in efficacy between antidepressants and placebo has been described as “relatively small,”23 while Irving Kirsch, associate director of the Program in Placebo Studies at Harvard Medical School, has conducted several meta-analyses of antidepressants in comparison to placebo, concluding there’s virtually no difference in their effectiveness.
According to Kirsch, “The difference is so small, it’s not of any clinical importance.”24 In a 2014 article, he wrote:25

“Antidepressants are supposed to work by fixing a chemical imbalance, specifically, a lack of serotonin in the brain. Indeed, their supposed effectiveness is the primary evidence for the chemical imbalance theory.

But analyses of the published data and the unpublished data that were hidden by drug companies reveals that most (if not all) of the benefits are due to the placebo effect.

… Even the small statistical difference between antidepressants and placebos may be an enhanced placebo effect, due to the fact that most patients and doctors in clinical trials successfully break blind … Instead of curing depression, popular antidepressants may induce a biological vulnerability making people more likely to become depressed in the future.”

Seniors Can Relieve Depression Via Exercise

The seriousness of depression cannot be overstated, and the need for effective treatment is a necessity. However, many seniors may be pinning their hopes of improving their mood and relieving depression on a pill solution that just doesn’t work. Importantly, there are other options available, with exercise being one of them.
In an 11-year study, people who engaged in regular leisure-time exercise for one hour a week were less likely to become depressed.26 A meta-analysis of 33 trials involving nearly 1,877 people also showed that strength training led to a significant reduction in depressive symptoms, and this held true regardless of the participant’s health status, improvements in strength or how much strength training they completed.27
According to the study’s lead author, Brett Gordon, a postgraduate researcher in the department of physical education and sports sciences at the University of Limerick in Ireland, the greatest improvements were seen among people with symptoms of mild to moderate depression, as opposed to those without depression, which suggests strength training may be most effective for people with greater depressive symptoms.28
Research has also looked into the effects of exercise and depression in seniors, particularly. In a study of older depressed adults, 80% experienced a significant reduction in depressive symptoms after taking up strength training for 10 weeks, such that researchers concluded, “PRT [progressive resistance training] is an effective antidepressant in depressed elders, while also improving strength, morale, and quality of life.”29
In yet another study of older adults with depression, those who took part in high-intensity strength training three days a week for eight weeks experienced a 50% reduction in depressive symptoms,30 whereas separate research showed strength training exercise reduced depressive symptoms in older Hispanic/Latino adults as well (endurance, balance and flexibility exercises were also beneficial for mood).31
The upside is that, unlike with antidepressants, which increase health risks, exercise provides additional health benefits to seniors. In my 2008 interview with Dr. James Gordon, an expert in using mind-body medicine to heal depression, he stated that physical exercise is at least as good as antidepressants for helping people who are depressed.
Seek Help if You’re Struggling With Depression

If you’re struggling with depression or depressive symptoms, seek help, from a counselor, a holistic psychiatrist or another natural health practitioner to start the journey toward healing. And, realize that antidepressants carry risks, including increasing the risk of suicide and violence,32 and are not the only available treatment.
In many cases, exercise, sleep and dietary changes can work wonders, especially when combined with nutritional and light therapy, along with energy psychology tools such as the Emotional Freedom Techniques (EFT). Supplements, including magnesium, omega-3 and B vitamins, along with vitamin D, can also be helpful in restoring optimal mental health.
If you’re in the throes of depression, it can be nearly impossible to commit to positive lifestyle changes, so please don’t suffer in silence. Get help from a health partner who can guide you out of crisis mode and into a mindset that allows you to make healthy changes.

The popularity of cannabidiol (CBD) — one of the nonpsychoactive components of cannabis and hemp — has exploded in recent years. As noted in a May 14, 2019, New York Times article:1,2

“… cannabidiol is everywhere. We are bombarded by a dizzying variety of CBD-infused products: beers, gummies, chocolates and marshmallows; lotions to rub on aching joints; oils to swallow; vaginal suppositories … CVS and Walgreens each recently announced plans to sell CBD products in certain states.”

This mass emergence of CBD products came on the heels of the U.S. Food and Drug Administration’s downgrading of CBD products from cannabis that contain no more than 0.1% tetrahydrocannabinols (THC, the psychoactive component of cannabis) from Schedule 1 to Schedule 5 at the end of 2018.3 Schedule 5 drugs are considered to have a lower potential for abuse than other controlled drugs.4
However, a vast majority of these CBD products are marketed illegally, as the FDA still does not recognize CBD as a nutritional supplement. Recent reports also warn that the FDA is now starting to crack down on CBD makers and sellers for illegal product claims.
As reported by Forbes5 November 25, 2019, for the first time in nearly four years, warning letters have been issued to 15 companies for CBD products sold in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA has also issued a general consumer update6 detailing various CBD safety concerns. Companies that received warning letters include:7

Koi CBD
Pink Collections Inc.

Noli Oil
Natural Native

Whole Leaf Organics
Apex Hemp Oil

Bella Rose Labs
Sunflora

Healthy Hemp Strategies (DBA Curapure)
Private I Salon

Organix Industries (DBA Plant Organix)
Red Pill Medical

Sabai Ventures
Daddy Burt (DBA Daddy Burt Hemp Co.)

Infinite Product Company

CBD Excluded From Dietary Supplement Definition

According to the FDA’s consumer update, dated November 25, 2019, there’s a lack of scientific information supporting the safety of CBD in food, stressing that “It is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement.”
In short, CBD is not legal for use in food, animal feed or supplements. The only FDA approved CBD product is a prescription drug for the treatment of two severe forms of epilepsy.8
In fact, the FDA’s downgrading of CBD with minimal THC content to a Schedule 5 drug was in direct response to its approval of Epidiolex, which is approved for the treatment of Lennox-Gastaut syndrome and Dravet syndrome.
As mentioned, CBD can also be derived from hemp, which can now be grown and sold legally in the U.S. per the 2018 Farm Bill. In order to not fall within the definition of marijuana in the Controlled Substances Act, however, the hemp must (under the Farm Bill) contain less than 0.3% THC on a dry weight basis.9
With the legalization of hemp, hemp-derived CBD products grew fast and furious. However, it’s important to recognize that CBD isolates from hemp are still illegal as a dietary ingredient. By approving a CBD-only drug (Epidiolex), CBD cannot — per FDA rules — be sold as a supplement, even if it’s derived from legal hemp.
So, to clarify, whole hemp oil can be legally sold across the U.S., even if it contains naturally occurring CBD, but CBD isolates cannot be sold as a nutritional supplement, even if it’s derived from legal hemp.
What’s more, to stay within the legal framework, companies cannot advertise or list CBD on the label. Nor can they make any specific health or disease claims. As reported by Forbes, the 15 companies that received warning letters from the FDA:10

“… are using product webpages, online stores and social media to market CBD products in interstate commerce in ways that violate the FD&C Act, including marketing CBD products to treat diseases or for other therapeutic uses for humans and animals. Other violations include marketing CBD products as dietary supplements and adding CBD to human and animal foods.”

Considering the FDA’s strengthened position on CBD, it would be wise to leave any CBD products at home when traveling. In May 2019, a 69-year-old woman was arrested and spent 12 hours in jail after Disney World security found CBD oil in her purse.11
The woman said she used it to alleviate arthritis pain. CBD is legal in her home state of North Carolina and is widely available in stores across Florida. The woman also had a doctor’s note for the CBD oil. While the drug charges against her were dropped, her case serves as a chilling warning to CBD-using travelers.
Valuable Health Benefits Ignored

In the 1980s, a St. Louis University Medical School scientist named Allyn Howlett identified the cannabinoid receptor type 1 (CB1) in the human brain. We now know there are two types of cannabinoid receptors throughout the human body, CB1 and CB2.
We also know the body produces endogenous cannabinoids that influence these receptors, and that this endocannabinoid system (ECS) plays an important role in human health, as it regulates homeostasis by orchestrating communication between your bodily systems, such as your respiratory, digestive, immune and cardiovascular systems.
According to Project CBD, at least 50 conditions12 are believed to be improved by CBD, including pain, seizures, muscle spasms, nausea associated with chemotherapy, digestive disorders, degenerative neurological disorders such as multiple sclerosis and Parkinson’s disease, mood disorders, anxiety, PTSD and high blood pressure.
Importantly, CBD has also been shown to provide valuable benefits for those struggling with opioid addiction. To learn more about the benefits of CBD, see “The Endocannabinoid System and the Important Role It Plays in Human Health.”
FDA Overstates Risks

According to New Hope,13 the FDA’s updated consumer guidance “’raises significant concerns’ among the hemp CBD industry because the FDA undersells its benefits and overstates the risks …” Loren Israelsen, president of the United Natural Products Alliance told New Hope:14

“This is a significant, concerted and highly orchestrated effort by FDA to put the brakes on the CBD market. The viewpoints and perspectives of the respective interests in this issue are becoming clearer as the anticipated struggle to determine the status of CBD and the other cannabinoids has begun …
The agency has yet to target companies that are not making claims, but it has expanded its concerns over common claims, such as stress, anxiety and pain.”

The U.S. Hemp Roundtable, which lobbies on behalf of the hemp industry, also expressed concern about the tone of the FDA’s consumer update document, stating the agency “severely overstates the health risks of hemp-derived CBD and … ignores much of the scientific evidence of CBD’s safety, in particular at dosage levels typically found in foods and dietary supplements.”15
Don’t Buy CBD Products on Amazon

Despite its overly negative tone, the FDA does raise an important issue in its consumer update, namely that of quality control. There are plenty of bad actors out there, looking to make a quick buck, so it’s important to do your research before buying.
The worst place to source your CBD is from Amazon. As reported by the Organic & Natural Health Association16 on October 15, 2019, Amazon’s policy prohibits the sale of CBD products, yet, when you search for “CBD” in its search engine, thousands of products match that search term.
The reason for this is because Amazon allows vendors to tag their products with whatever search words they want — including terms that are prohibited per its own policy, apparently. 
Amazon also allows vendors to purchase advertising space for CBD products, again despite the fact that they don’t actually allow CBD products to be sold. To investigate this paradox, the Organic & Natural Health Association hired a third-party laboratory to test Amazon’s best-seller, New Age Premium Hemp Oil 1000 MG, for the presence of cannabinoids. 
In what appears to be a clear violation of Amazon’s policy, the product was found to contain approximately 1% CBD17 (7.7 milligrams of CBD per 30 drops). It does not list CBD on the label, however.
As mentioned, companies are not allowed to list CBD content if they want to sell hemp oil legally, and this really puts consumers in a tough bind, as it’s impossible to know just how much CBD any given hemp oil might contain. In a statement, Karen Howard, CEO and executive director of Organic & Natural Health, said:18

“It’s really important for consumers to know that because Amazon doesn’t allow the sale of products with CBD, there are no reputable companies selling CBD on their site …

Amazon states it has banned the sale of CBD supplements on its site, but allows advertising and tagging of CBD instead, inviting an influx of products to consumers that the FDA has been warning about …

Essentially, the public is being defrauded twice. First, Amazon’s best-seller, New Age Premium Hemp Oil contains CBD even though its label does not list CBD. Second, those searching for CBD products are being misled into buying products containing zero CBD.”

The Case for Organic CBD
Also keep in mind that since CBD oil became a focus of popular holistic medicine almost overnight, effective quality control has not caught up yet and some products do not meet the claims made on the label.19 Until such a system is in place, it’s important you purchase your CBD products from a trusted source.
The need for more stringent quality control has already been demonstrated in studies20 showing 26.19% of 84 CBD products tested contained less CBD than advertised, and 42.85% of them contained more. Only 30.95% were accurately labeled.

The FDA also rightly points out that heavy metal contaminants can be a concern. Indeed, heavy metal testing is particularly important component of quality control for hemp-based CBD products, as the plant is known to extract heavy metals from the soil.
Hemp is actually used for bioremediation purposes21 to clean heavy metals out of soils, which is great if the hemp is used for rope, fuel and other nonmedical uses. When made into medicine, however, this soil-cleansing feature could pose significant problems.
As a general rule, I recommend seeking out certified organic CBD products to ensure the least amount of contamination with pesticides and other harmful contaminants.

The U.S. has recorded declining life expectancy and increasing mortality for people in midlife,1 despite spending a disproportionate amount on health care per person relative to wealth than any other country.2 Those in wealthy countries tend to spend more per person on health care yet, on average, the U.S. spends nearly double the amount that most other wealthy countries spend per person.
Per capita, in dollars, the U.S. spent $10,224 per person in 2017 as compared to the second-highest spender, Switzerland, at $8,009 per person. Following far behind is third-place Germany at $5,728 per person.
The gap between U.S. health care spending and that of other countries began to widen in the 1980s when comparable countries spent, on average, 7% of their gross domestic product (GDP) while the U.S. spent 9%. By 2015, comparable countries were spending 11% of their GDP while the U.S. was spending 17% of its GDP.
Yet, it appears the high financial burden of health care in the U.S. is not paying dividends in lengthening life expectancy or reducing rates of disease. For instance, the CDC reports the prevalence of diabetes rose from 0.93% of the population in 19583 to 9.4% in 2015, with more than 100 million living with diabetes or prediabetes in 2017.4
Life Expectancy Rises in Other Countries; Falls in US

Under the premise that U.S. life expectancy has fallen behind other wealthy countries, researchers examined vital statistics and mortality rates to identify contributing factors.5 Life expectancy data from 1959 through 2016 and mortality rates from 1999 through 2017 were gathered for analysis.
The researchers focused on those who died during midlife, from ages 25 to 64 years. The data were broken down further by sex, socioeconomic status, geography, race and ethnicity. The researchers found a decline in life expectancy after 2014 for three consecutive years. From 2010 to 2017, all-cause mortality during midlife rose from 328.5 deaths per 100,000 to 348.2 deaths per 100,000.
The largest increases occurred in the New England states of New Hampshire, Maine and Vermont as well as the Ohio Valley states of West Virginia, Ohio, Indiana and Kentucky. The increase was estimated to produce 33,307 extra premature deaths, 32.8% of which were found in the Ohio Valley. The researchers believe major contributors have been from specific causes such as suicides, drug overdoses and organ system diseases.
Dr. Steven H. Woolf from Virginia Commonwealth University was lead researcher on the study. He believes many factors were at play and though the opioid epidemic is a major driver, it is far from the sole trigger, indicating there may be a broad erosion in health. Woolf commented to The Washington Post:6

“Some of it may be due to obesity, some of it may be due to drug addiction, some of it may be due to distracted driving from cellphones … it suggests that the cause has to be systemic, that there’s some root cause that’s causing adverse health across many different dimensions for working-age adults. It’s supposed to be going down, as it is in other countries. The fact that that number is climbing, there’s something terribly wrong.”

Past Choices Reflected in Current Health

Many risk factors manifest themselves in your health gradually. For instance, obesity is a significant part of the rising number dealing with metabolic related diseases. The authors of one study called the recent unprecedented rise in obesity in the developed world7 “perhaps the most rapid population-scale shift in human phenotype ever to occur.”
People do not become overweight immediately but, rather, through consistent lifestyle choices that reduce their activity level and increase the amount of energy they consume each day. A function of eating high-carbohydrate foods triggers rising hunger, ultimately feeding a diet of excesses.
Obesity8 can lead to Type 2 diabetes, high blood pressure, heart disease, cancer and nonalcoholic fatty liver disease (NAFLD). Each of these conditions is triggered by past lifestyle choices linked to the risk of increased premature death.
Death Epidemic Planned by Manufacturer Doubles in One Decade

A group of scientists recognized that the rising number of Americans dying from drug overdoses was one of the underlying causes of a declining life expectancy in the U.S. The National Institute on Drug Abuse9 records the number of deaths from illicit drugs and prescription opioids and found a twofold increase in 10 years.
Overdose deaths involving any type of opioid rose from 8,048 in 1999 to 47,600 in 2017. In the face of a rising epidemic to addictive opioid painkillers, an advisory committee to the U.S. Food and Drug Administration in October 2018 sanctioned the most powerful synthetic opioid painkiller released to date — Dsuvia (sufentanil).
The drug tests 1,000 times stronger than morphine, 50 times more potent than heroin and 10 times stronger than the synthetic opioid fentanyl. While this rapid increase in deaths from drug overdoses is overwhelming, it is heartbreaking to realize drug manufacturers may have planned this to feed their bottom line.
The underhanded dealings of one company were made public in early 2019 when a Massachusetts a judge ruled to release an unredacted account of a complaint filed with the state attorney general’s office against Purdue Pharma.
The documents show how one owner of Purdue, Kathe Sackler, developed a confidential program called Project Tango to expand their business from the development and sale of opioids to include the treatment of opioid addiction. The goal was to become “an end-to-end pain provider” by spanning the pain and addiction spectrum, providing both the addictive drug and the treatment.
After finding profits had doubled from 2009 to 2014, they concluded the next opportunity was opioid addiction treatment to continue selling opioids and treatment drugs to a vulnerable population, feeding rising mortality rates.
The team mapped out how patients could first get addicted to opioids through prescription drugs or heroin, and then become consumers of the company’s new drug. They noted even after patients were finished with a first round of treatment, up to 60% would relapse and need it again.
Accidental OTC Overdoses Killing Children and Adults

One common over-the-counter drug associated with accidental poisonings in young children is acetaminophen, brand name Tylenol. A review of poison control centers data showed a surprisingly high number of calls were made related to unintentional ingestion of acetaminophen.
Liver damage from acetaminophen is also problematic in adults. In one published study,10 researchers found hepatotoxicity from Paracetamol, the brand name of acetaminophen in the U.K., is the most common form of acute liver failure in the U.K. Staggered high doses were repeatedly used for pain control and were associated with a reduced survival compared to a single large overdose.
Delaying medical attention after a single overdose or a staggered overdose pattern is associated with adverse outcomes, increasing the risk of multi-organ failure. The antidote to acetaminophen toxicity is N-acetyl cysteine (NAC). It’s worth knowing about or keeping in your home if you ever use acetaminophen.
The liver damage associated with acetaminophen may largely be due to a depletion of glutathione, an antioxidant secreted by the liver in response to toxic exposure. By keeping glutathione levels up, the damage from acetaminophen may be preventable.
Medication More Harmful Than the Condition

Data from a study published in 2017 showed 1 in every 6 Americans from 18 to 85 years were on psychiatric drugs in 2013; most of those drugs m were antidepressants. During that year, 84.3% reported using antidepressants long-term, having filled three or more prescriptions.
Unfortunately, while the drugs are routinely used as a first line of treatment for depression, studies show they are no more effective than placebo. They also come with serious side effects often ignored or purposefully hidden.
Among those is the risk of self-inflicted violent acts and/or violence against others. Further research shows antidepressants increase aggression in children and adolescents by two to three times. This is an important finding since in many school shootings the killer was on antidepressants.
An internal GlaxoSmithKline analysis of their own data showed “patients taking Paxil were nearly seven times more likely to commit suicide than those on placebo.” Eli Lilly, maker of Prozac, may have been behind the worst mass shooting in Kentucky history. Dr. Peter Breggin, scientific and medical expert for over 100 plaintiffs who sued Eli Lilly in the early ‘90s, wrote about the case:

“Joseph Wesbecker was on Prozac in September 1989 when he walked into his workplace, a Louisville, KY printing plant, shot dead eight colleagues, wounded 12 others, and killed himself. Survivors and relatives of the dead took Lily to court in 1994. They claimed that Wesbecker’s violence was due to Prozac.”

In his book about the trial, during which the jury decided in favor of Eli Lilly, he recounted how the judge later discovered Eli Lilly had “paid the plaintiffs to throw the trial by withholding damaging evidence.” The number of antidepressants prescribed across the U.S. continues to grow and contribute to a rising number of violent acts resulting in suicide and bystander death.
Common Liver Disease Raises Risk for Early Death

NAFLD, a side effect of obesity, is associated with an increased risk of overall death in those also suffering with diabetes. In a study11 of 337 diabetic participants, those with NAFLD tended to be younger females who were obese. Those who also had NAFLD and diabetes suffered a mortality rate of 29%, with most common causes liver cancer or liver complications.
The prevalence of NAFLD is increasing, with approximately 25% across the world affected.12 The condition places you at increased risk for severe and decompensated liver diseases, including hepatocellular carcinoma, cardiovascular disease and Type 2 diabetes. One method reducing your risk of NAFLD is maintaining optimal levels of choline.
In one study researchers looked at the impact choline had on the severity of NAFLD and found a reduction in intake could significantly increase symptoms, including fibrosis of the liver tissue (thickening and scarring of connective tissue). Although your liver does produce small amounts, the rest must be supplied through the food you eat.
Unfortunately, it is estimated that 90% of Americans are deficient in choline. Healthy sources of choline include eggs, grass fed beef liver, wild-caught Alaskan salmon and organic pastured chicken.
While a dietary reference intake value has not yet been established for choline, the Institute of Medicine set an “adequate daily intake” value of 425 mg per day for women, 550 mg for men and 250 mg for children to help prevent a deficiency and potential organ and muscle damage.

Aspirin has a long history, dating back nearly 4,000 years when Sumerians wrote of using willow bark for pain relief.1 The ancient Egyptians used willow bark to reduce body temperature and inflammation, and the Greek physician Hippocrates used it to help relieve pain and fever. By the early 1800s Europeans were researching the effects of salicylic acid and how to determine a correct dosage of it.2
In 1899, Bayer begin distributing the powder, and it was sold as tablets over the counter in 1915. Doctors gave aspirin to Alexi Nicholaevich Romanov of Russia, who had hemophilia. The aspirin likely made the bleeding worse. When the family’s mystic Grigori Rasputin advised the family to stop modern treatments and rely on spiritual healing, the bleeding improved.
In an article published in 2010 in CNN, one physician from Harvard Medical School recommended reducing the risk of stomach bleeding associated with aspirin by taking a second medication — Prilosec.
By 2012, the U.S. Food and Drug Administration reversed their recommendation, concluding data did not support aspirin as a preventive medication for those who had not had a heart attack, stroke or cardiovascular problems.3 In this population, not only had benefit not been established, but “dangerous bleeding into the brain or stomach” was a significant risk.
Salicylates Found Naturally in Some Foods

In the same year the FDA withdrew their recommendation for daily aspirin intake to reduce cardiovascular risk, one meta-analysis was published showing a reduction and cancer mortality in those taking daily low-dose aspirin.4 The researchers hypothesized the effect was the result of inhibition “of cox-2 in preneoplastic lesions.”
Their results were supported by a second meta-analysis5 published in the same year finding a reduction in nonvascular deaths and cancer with low dose aspirin. In another study published in 2018,6 researchers found data suggesting aspirin is associated with a lower risk of developing several types of cancer, including colorectal, esophageal, pancreatic, ovarian and endometrial.
As New York Times best seller author and nutrition expert Dr. Michael Greger writes,7 animal products made up 5% or less of their diet before Japanese citizens began adopting a Western diet.8 During the same period, there was a vast difference in cancer deaths between the U.S. and Japan.
The age-adjusted death rates for colon, breast, ovary and prostate were five to 10 times lower in Japan, and leukemia, lymphoma and pancreatic cancer death rates were three to four times lower. In part, this protection may have been the result of phytonutrients found in the plant-based diet, including salicylic acid, the active ingredient in aspirin.
The highest concentrations in plants is found in herbs and spices with the greatest amount in cumin. Researchers have found eating a teaspoon of cumin will spike your blood levels of salicylic acid to the same degree that taking a baby aspirin does. Greger9 quotes one study describing the lower incidence of colorectal cancer in areas where people eat diets rich in salicylic acid:10 

“The population of rural India, with an incidence of colorectal cancer which is one of the lowest in the world, has a diet that could be extremely rich in salicylic acid. It contains substantial amounts of fruits, vegetables, and cereals flavored with large quantities of herbs and spices.”

In another analysis11 comparing organic versus nonorganic vegetables, scientists found soup made with organic vegetables contained more salicylic acid. Salicylic acid is produced by plants in response to stress, such as when they’re being bitten by bugs. Plants treated with pesticides do not undergo this type of stress, and studies show they contain six times less salicylic acid than those grown organically.
Is Aspirin Overrated?

Evidence supports the assertion that a plant-rich diet offers protection against certain cancers. Aspirin used to be recommended to reduce clotting time and the risk of heart attack and ischemic stroke, triggered by a clot to the brain. However, long-term use of aspirin has been associated with harmful effects, including hemorrhagic stroke, or bleeding in the brain when a clot doesn’t form.
In addition to aspirin side effects, results from a trio of studies published in the New England Journal of Medicine demonstrated daily low-dose aspirin had no measurably significant health benefits for healthy older adults. Instead, the data demonstrated it did not prolong disability-free survival and contributed to the risk of major bleeding.
In one study the authors found those with helicobacter pylori (H. pylori) infection who used low dose aspirin had a higher risk of upper gastrointestinal bleeding then those who took aspirin without the infection.
In another study12 researchers found those who used aspirin regularly, which they defined as at least once a week for one year, experienced an increased risk of neovascular age-related macular degeneration (AMD). Results from a separate study13 also point to a connection between frequent aspirin use and AMD, linking increasing frequency of use to higher risk.
Nattokinase: Aspirin Alternative Without the Side-Effects

Cardiovascular disease is the leading cause of death14 in people of most racial and ethnic groups in America. The Centers for Disease Control and Prevention reports one person dies every 37 seconds from heart disease and cardiovascular deaths account for 25% of all deaths reported.
Using aspirin to reduce the risk of clot formation comes with significant risk. A better alternative is nattokinase, produced by the bacteria bacillus subtilis when soybeans are being fermented to produce natto. This is a fermented soybean product that has been a traditional food in Japan for thousands of years.
Without using conventional drugs, nattokinase has demonstrated the ability to reduce chronic rhinosinusitis and dissolve excess fibrin in blood vessels, which improves circulation and reduces the risk of serious clotting. Another benefit is the ability to decrease blood viscosity and improve flow, which consequently lowers blood pressure.
Data also showed consuming nattokinase decreased systolic and diastolic blood pressure and demonstrated effectiveness in reducing deep vein thrombosis in those who were on long-haul flights or vehicle travel. Studies have demonstrated administration of a single-dose can enhance clot breakdown and anticoagulation.
Each of these factors affects your long-term cardiovascular health and risk for heart disease. In one study,15 researchers wrote nattokinase is a “unique natural compound that possesses several key cardiovascular beneficial effects for patients with CVD and is therefore an ideal drug candidate for the prevention and treatment of CVD.”
Could Earthworms Hold One Key to Heart Health?

One of the drawbacks of pharmaceutical interventions, including thrombolytics, antiplatelets and anticoagulants, is that they interfere with the anticoagulation system and carry a risk of major bleeding.16 Lumbrokinase is a secondary option that works as a fibrinolytic enzyme, activating the plasminogen system and direct fibrinolysis.
The compound also indirectly achieves anticoagulation through inhibition of platelet function. Additionally, lumbrokinase has an enzyme opposing the coagulation system. Research has demonstrated it promotes fibrinolysis but also fibrinogenesis, meaning it may have a built-in balance system that contributes to the safety record.
Interestingly, this complex enzyme is extracted from earthworms and is sometimes referred to as earthworm powder enzymes. Eastern medicine has used earthworms for thousands of years, and Chinese medicine practitioners believe they possess properties to “invigorate blood, resolve stasis and unblock the body’s meridians and channels.”
They are commonly found in a traditional herbal formula used to treat ischemic or thromboembolic conditions. To date, those producing lumbrokinase cannot make any therapeutic claims. Available studies have demonstrated safety and effectiveness in the treatment of acute ischemic stroke and impressive results in the treatment of coronary arterial disease including those with unstable angina.
Lumbrokinase has also been evaluated as an antimetastatic and antitumor agent, with evidence demonstrating a potential use in anticoagulation to limit cancer growth and metastasis. The authors of two review papers found adverse rates to be 0.7% to 3% with most symptoms being a mild headache, nausea, dizziness and constipation, which resolved when the enzyme was discontinued.
Neither of the reviews found the enzyme triggered bleeding or adverse effects in the kidney or liver. Both nattokinase and lumbrokinase have a lower side effect profile than aspirin and provide much of the same benefits to the cardiovascular system. While aspirin is no longer universally recommended, consider speaking with your physician to include nattokinase or lumbrokinase in your heart health regimen.

The New York Times1 reports that the average person in their mid- to late 60s today is taking 15 prescription drugs a year — and that doesn’t even count the number of over-the-counter products they may be taking.
That’s a lot of medications, especially when you consider that a survey released by the American Association of Retired Persons (AARP)2 not quite four years ago, in 2016, indicated that 75% of the respondents — all over age 50 — said they take at least one prescription medication on a regular basis.
In that AARP survey, more than 80% reported taking at least two, and more than 50% took four or more. Compared to a 2005 Gallup survey,3 which showed 52% of all Americans said they were taking at least one prescription medication, it’s obvious that seniors are taking more drugs than they did in the past.
Specifically, from 1988 to 2010, adults over age 65 doubled the number of prescriptions they took from two to four.4 The proportion of adults taking five or more tripled in that same time period. Yet, despite the rising number of prescriptions, more drugs don’t add up to better health.
According to the researchers, “Contemporary older adults on multiple medications have worse health status compared to those on fewer medications, and appear to be a vulnerable population.” This translates to a negative effect on activities of everyday living as well as increased confusion and memory problems.
The term used to describe a condition in which a person takes multiple medications, drugs, supplements and over-the-counter remedies is polypharmacy. As evidenced by the quoted research, the clinical relevance and consequences of polypharmacy — of seniors taking fistfuls of medications each day — are far-reaching as the aging population across the world continues to grow.
Polypharmacy Raises Safety Risk

Polypharmacy is common among the elderly, especially for those who reside in nursing homes. Some end up in a nursing home because of adverse drug reactions, which places financial and emotional burdens on communities and families. They also may result in a significant number of hospitalizations with a high number of complications, increased rates of death and excessive health care costs.5
What’s worse, you may believe the federal government, medical associations or pharmaceutical companies have tested the effects that combinations of drug chemicals would have in your body but, unfortunately, this doesn’t always happen.
Researchers report these adverse drug reactions are responsible for up to 12% of all hospital admissions of seniors. Yet, even being in the hospital doesn’t ensure against, or reduce, polypharmacy.
In one study,6 a team in Italy evaluated 1,332 inpatients who were at least 65 years old and who took at least five medications. They found polypharmacy was present in 51.9% of the patients when they arrived at the hospital; this increased to 67% by the time they left.

Taking One Drug to Offset Side Effects of Another Drug
One of the hidden dangers of polypharmacy is the chemical interactions that occur in the body when medications are mixed. Another problem is the number of times one drug is prescribed to take care of the side effects of another. This has become known as a “prescribing cascade.” The New York Times writes:7

“One common example is the use of anti-Parkinson therapy for symptoms caused by antipsychotic drugs, with the anti-Parkinson drugs in turn causing new symptoms like a precipitous drop in blood pressure or delirium that result in yet another prescription.”

To that end, drug interactions can cause hospitalizations in and of themselves — and sometimes these interactions can even lead to death. The authors of one study8 noted a 50% increase in this problem when seniors are taking five to nine medications.
Dr. Michael Stern, geriatric emergency medicine specialist at New York Presbyterian Hospital, told a New York Times reporter that polypharmacy accounts for more than one-fourth of all admissions to the hospital and that it would be considered the fifth leading cause of death if it were categorized that way.9
Antidepressant Use Has Doubled in Seniors

In a study10 published in 2013, scientists looked at participants who were prescribed antidepressants by their physicians. Of those who were over age 65, only 14.3% met the DSM-4 criteria for having had a major depressive episode — indicating they most likely were overprescribed or not necessary. The authors noted the importance of providing better diagnoses to patients as well as more appropriate treatments of their symptoms.
And again, statistics show more prescriptions don’t translate into fewer depressive illnesses. For example, in a 2017 study,11 researchers reviewed data from 1990 to 2015 that had been gathered in England, Canada, the U.S. and Australia and found the incidence of symptoms had not decreased despite an increase in the number of prescriptions of antidepressants.
This is important because the risks associated with depression in seniors include cognitive decline, dementia and poor medical outcomes. Those suffering from depression in any age group also experience higher rates of suicide and mortality.
This is one reason the American Psychiatric Association writes that in some cases, treatment for the elderly “should parallel that used in younger age groups.”12 Unfortunately, even though therapy for depression can include psychotherapy and alternative treatments, such as addressing vitamin deficiencies, good sleep habits, proper nutrition and exercise, too often, seniors are only prescribed medication — and that only adds to the multiple prescriptions they’re probably already taking.
Studies Link Depression to Inflammation

In related studies, researchers have found that inflammation contributes to many chronic diseases including heart disease and dementia.13 They also have found a link between inflammation and depression. The authors of one literature review14 included results from 30 randomized control trials with a total of 1,610 participants. Data analysis showed anti-inflammatory agents could reduce depressive disorder when compared to a placebo.
Results from another large meta-analysis15 revealed similar findings: Anti-inflammatory medications were helpful for those dealing with depression.
Yet another group of researchers16 found that those treated with immunotherapy for an inflammatory disorder experienced symptomatic relief of depressive symptoms. All of this points toward other ways of addressing depression than resorting to a prescription antidepressant. For a discussion of how to reduce inflammation naturally, see the articles below and consider optimizing your melatonin, adding fiber to your diet and grounding.
Seek Out the Root of the Health Condition

Before adding one more prescription medication or over-the-counter drug to your daily regimen, consider seeking the help of a natural health physician who can help get to the root of the problem. Too often medications mask symptoms but do not address the underlying condition. A vicious cycle may begin when the first medication triggers a side effect that a second medication will be prescribed to treat.
While your pharmacy computer may flag some drug interactions, the chemical complexity involved when more than three drugs are prescribed make it unnecessarily challenging to avoid adverse reactions. The real solution is to take control of your health and introduce foundational strategies to improve your overall health.
There is no magic pill that will fix symptoms, remove your illness and restore the vigor of youth. However, there are lifestyle choices you can make that will go a long way toward achieving your health goals. Consider starting with the strategies in the following articles to move toward better health:

The Science of Sleep and Sleep Deprivation

Autophagy — How Your Body Detoxifies and Repairs Itself

How to Make Fasting Easier, Safer and More Effective

Incorporate the Nitric Oxide Dump

In recent years, the devastating effects of wanton opioid use have become unmistakable, with opioid overdoses killing 47,600 Americans in 2017 alone.1 As of June 2017, opioids became the leading cause of death among Americans under the age of 50,2 and President Trump declared the opioid crisis a public health emergency that year in October.3
I’ve written many previous articles detailing the background of how the U.S. ended up here. While the opioid crisis was largely manufactured by drug companies hell-bent on maximizing profits, leading to exaggerated and even fraudulent claims about the drugs’ safety profile, the increased availability of opioids isn’t the sole cause.
A Perfect Storm of Poverty, Trauma, Availability and Pain

As noted in a January 2020 article4 in The Atlantic, “researchers … say opioid addiction looks like the result of a perfect storm of poverty, trauma, availability and pain.”
Commenting on some of the research cited in that article, David Powell, senior economist at Rand, told The Atlantic that to produce the most lethal drug epidemic America has ever seen “you need a huge rise in opioid access, in a way that misuse is easy, but you also need demand to misuse the product.”5
Poverty and pain, both physical and emotional, fuel misuse. If economic stress or physical pain (or both) is a factor in your own situation, please be mindful that seeking escape through opioid use can easily lead to a lethal overdose. The risk of death is magnified fivefold if you’re also using benzodiazepine-containing drugs.
The Hidden Influence of Poverty and Trauma

Several investigations seeking to gain insight into the causes fueling the opioid epidemic have been conducted in recent years. The findings reveal common trends where emotional, physical and societal factors have conspired to bring us to the point where we are today.
Among them is a 2019 study6 in the Medical Care Research Review journal, which looked at the effects of state-level economic conditions — unemployment rates, median house prices, median household income, insurance coverage and average hours of weekly work — on drug overdose deaths between 1999 and 2014. According to the authors:7

“Drug overdose deaths significantly declined with higher house prices … by nearly 0.17 deaths per 100,000 (~4%) with a $10,000 increase in median house price. House price effects were more pronounced and only significant among males, non-Hispanic Whites, and individuals younger 45 years.
Other economic indicators had insignificant effects. Our findings suggest that economic downturns that substantially reduce house prices such as the Great Recession can increase opioid-related deaths, suggesting that efforts to control access to such drugs should especially intensify during these periods.”

Similarly, an earlier investigation, published in the International Journal of Drug Policy in 2017,8 connected economic recessions and unemployment with rises in illegal drug use among adults.
Twenty-eight studies published between 1990 and 2015 were included in the review, 17 of which found that the psychological distress associated with economic recessions and unemployment was a significant factor. According to the authors:9

“The current evidence is in line with the hypothesis that drug use increases in times of recession because unemployment increases psychological distress which increases drug use. During times of recession, psychological support for those who lost their job and are vulnerable to drug use (relapse) is likely to be important.”

Abuse-related trauma is also linked to unemployment and financial stress, and that too can increase your risk of drug use and addiction. As noted in The Atlantic,10 when the coal mining industry in northeastern Pennsylvania collapsed, leaving many locals without job prospects, alcohol use increased, as did child abuse. Many of these traumatized children, in turn, sought relief from the turmoil and ended up becoming addicted to opioids.
Free Trade Effects Implicated in Opioid Crisis

Another 2019 study11 published in Population Health reviewed the links between free trade and deaths from opioid use between 1999 and 2015, finding that “Job loss due to international trade is positively associated with opioid overdose mortality at the county level,” and that this association was most significant in areas where fentanyl was present in the heroin supply.
Overall, for each 1,000 people who lost their jobs due to international trade — commonly due to factory shutdowns — there was a 2.7% increase in opioid-related deaths. Where fentanyl was available, that percentage rose to 11.3%. The study “contributes to debates in the social sciences concerning the negative consequences of free trade,” the authors note, adding:

“Scholars have long focused on the positive effect of international trade on the overall economy, while also noting that it causes layoffs and bankruptcy for some groups.
Recent influential work by Autor, Dorn, and Hanson demonstrates that these negative impacts of trade are actually highly localized, with layoffs, unemployment, and lower wages concentrated in specific labor markets.
This study furthers our understanding of the local consequences of international trade by looking beyond wages and employment levels to the potential impact on opioid-related overdose death.”

Opioid Makers Have Had a Direct Impact
The National Bureau of Economic Research has also contributed to the discussion with the working paper12 “Origins of the Opioid Crisis and Its Enduring Impacts,” issued November 2019.

In it, they highlight “the role of the 1996 introduction and marketing of OxyContin as a potential leading cause of the opioid crisis,” showing that in states where triplicate prescription programs were implemented, OxyContin distribution rates were half that of states that did not have such programs.

“Triplicate prescription programs” refers to a drug-monitoring program requiring doctors to use a special prescription pad whenever they prescribed controlled substances. One of the copies of each prescription written had to be submitted to a state monitoring agency.

Since it involved additional work, many doctors avoided prescribing drugs requiring the use of triplicates, and as a consequence, Purdue (the maker of OxyContin), did not market its opioid as aggressively in those states.

The fact that triplicate prescription states had lower rates of lethal overdoses led the authors to conclude “that the introduction and marketing of OxyContin explain a substantial share of overdose deaths over the last two decades.”

According to this paper, death rates from opioid overdoses could have been reduced by 44% between 1996 and 2017 had triplicate prescriptions been implemented in nontriplicate states.

Importantly, the relationship between triplicate prescription programs and opioid overdose deaths held true even when economic conditions were taken into account, which shows that poverty alone did not contribute to the opioid crisis — aggressive marketing to doctors and the ease with which patients could get the drugs were an inescapable part of the problem.
Pain as a Source of Addiction
Naturally, physical pain is also a driving force behind the opioid epidemic, especially the inappropriate treatment of back pain with opioids and dentists’ habit of prescribing narcotics after wisdom tooth extractions.13,14
(While American family doctors prescribe an estimated 15% of all immediate-release opioids — the type most likely to be abused — dentists are not far behind, being responsible for 12% of prescriptions, according to a 2011 paper15 in the Journal of the American Dental Association.)
Statistics16 suggest 8 in 10 American adults will be affected by back pain at some point in their life, and low-back pain is one of the most common reasons for an opioid prescription.17 This despite the fact that there’s no evidence supporting their use for this kind of pain. On the contrary, non-opioid treatment for back pain has been shown to be more effective.18
Research19 published in 2018 found opioids (including morphine, Vicodin, oxycodone and fentanyl) fail to control moderate to severe pain any better than over-the-counter (OTC) drugs such as acetaminophen, ibuprofen and naproxen, yet most insurance companies still favor opioids when it comes to reimbursement, which makes them culpable for sustaining the opioid crisis, even as doctors and patients try to navigate away from them.
As noted by Dave Chase, author of “The Opioid Crisis Wake-Up Call: Health Care Is Stealing the American Dream. Here’s How to Take It Back,” in an article for Stat:20

“Our entire health care system is built on a vast web of incentives that push patients down the wrong paths. And in most cases it’s the entities that manage the money — insurance carriers — that benefit from doing so …
An estimated 700,000 people are likely to die from opioid overdoses between 2015 and 2025,21 making it absolutely essential to understand the connections between insurance carriers, health plans, employers, the public, and the opioid crisis.
We will never get out of this mess unless we stop addiction before it starts … the opioid crisis isn’t an anomaly. It’s a side effect of our health care system.”

According to the American College of Physicians’ guidelines,22 heat, massage, acupuncture or chiropractic adjustments should be used as first-line treatments for back pain. Other key treatments for back pain include exercise, multidisciplinary rehabilitation, mindfulness-based stress reduction, tai chi, yoga, relaxation, biofeedback, low-level laser therapy and cognitive behavioral therapy.

When drugs are desired, nonsteroidal anti-inflammatory drugs (NSAIDs) or muscle relaxants should be used. Opioids “should only be considered if other treatments are unsuccessful and when the potential benefits outweigh the risks for an individual patient,” according to the American College of Physicians’ guideline.23
Struggling With Opioid Addiction? Please Seek Help

It’s vitally important to realize that opioids are extremely addictive drugs that are not meant for long-term use for nonfatal conditions. Chemically, opioids are similar to heroin, so if you wouldn’t consider using heroin for a toothache or backache, seriously reconsider taking an opioid to relieve these types of pain.
If you’ve been on an opioid for more than two months, or if you find yourself taking a higher dosage, or taking the drug more often, you may already be addicted. Resources where you can find help include the following. You can also learn more in “How to Wean Off Opioids.”

Your workplace Employee Assistance Program
The Substance Abuse Mental Health Service Administration24 can be contacted 24 hours a day at 1-800-622-HELP

Nondrug Pain Relief
The good news is that many types of pain can be treated entirely without drugs. Recommendations by Harvard Medical School25,26 and the British National Health Service27 include the following. You can find more detailed information about most of these techniques in “13 Mind-Body Techniques That Can Help Ease Pain and Depression.”

Gentle exercise

Physical therapy or occupational therapy

Hypnotherapy

Distracting yourself with an enjoyable activity

Maintaining a regular sleep schedule

Mind-body techniques such as controlled breathing, meditation, guided imagery and mindfulness practice that encourage relaxation. One of my personal favorites is the Emotional Freedom Techniques (EFT)

Yoga and tai chi

Practicing gratitude and positive thinking

Hot or cold packs

Biofeedback

Music therapy

Therapeutic massage

In “Billionaire Opioid Executive Stands to Make Millions More on Patent for Addiction Treatment,” I discuss several additional approaches — including helpful supplements and dietary changes — that can be used separately or in combination with the strategies listed above to control both acute and chronic pain.

In decades past, a daily low-dose aspirin regimen was frequently recommended as a primary prevention strategy against heart disease. However, the evidence in support of it was rather weak, and kept getting weaker as time went on.

I stopped recommending daily “baby aspirin” use for the prevention of heart disease over two decades ago, due to the growing evidence of harmful side effects.

The primary justification for a daily aspirin regimen has been that it inhibits prostaglandin production,1 thereby decreasing your blood’s ability to form dangerous clots. However, in more recent years, most public health authorities have reversed their stance on the practice of using aspirin for primary prevention.
‘Baby’ Aspirin No Longer Recommended as Primary Prevention

The U.S. Food and Drug Administration reversed its position on daily low-dose aspirin as primary prevention for heart disease in 2014,2 citing clearly established side effects — including dangerous brain and stomach bleeding — and a lack of clear benefit for patients who have never had a heart attack, stroke or cardiovascular disease.
In 2019, the American Heart Association (AHA) and American College of Cardiology updated their clinical guidelines on the primary prevention of cardiovascular disease,3 spelling out many of the controversial findings on prophylactic aspirin use.
Importantly, studies have found that prophylactic aspirin use in adults over the age of 70 is potentially harmful, primarily due to the increased risk of bleeding in this age group. As noted in one 2009 paper,4 long-term low-dose aspirin therapy nearly doubles your risk for gastrointestinal bleeding.

Older people are, of course, more likely to be at high risk for heart disease, and thus more likely to be put on aspirin therapy. In younger adults, the risks are less clear-cut.

As noted in the AHA guideline, in adults younger than 40, “there is insufficient evidence to judge the risk-benefit ratio of routine aspirin for the primary prevention of atherosclerotic cardiovascular disease.”5

That said, the conventional recommendation to avoid a daily aspirin regimen only applies to primary prevention of heart disease in those with no history of heart problems, or those with low or moderate risk for heart disease. As reported by the AHA:6

“The new recommendation doesn’t apply to people who already have had a stroke or heart attack, or who have undergone bypass surgery or a procedure to insert a stent in their coronary arteries.
These individuals already have cardiovascular disease and should continue to take low-dose aspirin daily, or as recommended by their health care provider, to prevent another occurrence …”

Is Aspirin Regimen Safe for Heart Disease Patients?
While daily low-dose aspirin continues to be recommended for patients who already have heart disease, there’s evidence suggesting it may not be an ideal solution for them either. 

For example, the WASH (warfarin/aspirin study in heart failure) study7 published in 2004 — which assessed the risks and benefits of aspirin and the blood thinner warfarin in heart failure patients — found those who received aspirin treatment (300 mg/day) actually had the worst cardiac outcomes, including worsening heart failure. According to the authors, there was “no evidence that aspirin is effective or safe in patients with heart failure.”

Similarly, a 2010 study8 found older heart disease patients who had a prior history of aspirin use had more comorbidities and a higher risk of recurrent heart attack than those who had not been on aspirin therapy.

Aspirin has also not been proven safe or effective for diabetics, who are at increased risk for heart disease and therefore likely to be put on an aspirin regimen.

For example, a 2009 meta-analysis9 of six studies found no clear evidence that aspirin is effective in preventing cardiovascular events in people with diabetes, although men may derive some benefit.

Another 2009 study10 that examined the effects of aspirin therapy in diabetic patients found it “significantly increased mortality in diabetic patients without cardiovascular disease from 17% at age 50 years to 29% at age 85 years.”
On the other hand, it did lower mortality in elderly diabetic patients who also had cardiovascular disease. A meta-analysis11 published in 2010 also concluded aspirin did not reduce the heart attack risk in diabetic individuals.
Why Phlebotomy May Be a Better Option Than Aspirin Therapy
While the benefits of low-dose aspirin may outweigh the risks for some people, I believe you may be able to achieve similar cardiovascular protection by doing therapeutic phlebotomies.
There’s evidence to suggest that the bleeding caused by aspirin may in fact be part of why it lowers your risk of heart attack and stroke, as bleeding will lower your iron level. Aspirin’s ability to lower inflammation may be another factor at play.
As shown in a 2001 study,12 people taking seven aspirins per week had 25% lower mean serum ferritin than nonusers. The effect was most marked in diseased subjects, compared to healthy ones. As explained by the authors:

“Atherosclerosis, a primary cause of myocardial infarction (MI), is an inflammatory disease. Aspirin use lowers risk of MI, probably through antithrombotic and anti-inflammatory effects.
Because serum ferritin (SF) can be elevated spuriously by inflammation, reported associations between elevated SF, used as an indicator of iron stores, and heart disease could be confounded by occult inflammation and aspirin use if they affect SF independently of iron status …
Aspirin use is associated with lower SF. We suggest this effect results from possible increased occult blood loss and a cytokine-mediated effect on SF in subjects with inflammation, infection, or liver disease.”

Most people, physicians included, fail to appreciate that — aside from blood loss, including menstruation — the body has no significant way to excrete excess iron. There are very minor amounts lost through normal bodily processes, but not enough to move the needle on overall iron levels.

Between supplementation, fortification and the iron that occurs naturally in foods, it’s very easy to end up with excessive levels. In fact, most adult men and postmenopausal women are at risk for excess iron and need regular blood testing for ferritin.

Excessive iron causes significant oxidative stress, catalyzing the formation of excessive free radicals that damage your cellular and mitochondrial membranes, proteins and DNA. It is a potent contributor to increased risks of cancers, heart disease and neurodegenerative diseases. You can learn more about the ins and outs of excess iron in “Why Managing Your Iron Level Is Crucial to Your Health.”
While dangerous, iron overload is easy and inexpensive to treat. All you really need to do is monitor your serum ferritin and/or gamma-glutamyl transpeptidase (GGT) levels, avoid iron supplements, and be sure to donate blood on a regular basis.
By doing this, you can avoid serious health problems, and donating blood is a far safer way to lower your iron stores than taking aspirin and losing blood via internal bleeding.
Aspirin Linked to Lower Risk of Death

Interestingly, a 2019 study13 found prophylactic aspirin use may lower the risk of all-cause cancer, gastrointestinal (GI) cancer and colorectal cancer mortality among older adults.
The study included 146,152 individuals with a mean age of 66.3 years who participated in the Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial. The median follow-up time was 12.5 years. Those taking aspirin at least three times a week had a:

19% lower risk of death from all causes
15% lower risk of death from any cancer
25% lower risk of death from GI cancer
29% lower risk of death from colorectal cancer 

Having a higher body mass index (BMI between 25 and 29.9) lowered these percentages by 1%, with the exception of colorectal cancer. In this group, colorectal cancer death decreased by 34%.
No observable benefit of aspirin use was found in underweight individuals (BMI below 20), which led the researchers to hypothesize that “the efficacy of aspirin as a cancer preventive agent may be associated with BMI,”14 although this theory needs to be confirmed in future studies. The authors also warn that prophylactic aspirin therapy for cancer prevention would need to be weighed against the increased risk of bleeding. 
Other Health Risks Associated With Long-Term Aspirin Use

Overall, there’s a lot of evidence against long-term daily aspirin therapy. The risk of internal bleeding is one significant concern, which is further magnified if you’re taking antidepressants or blood thinning medications such as Plavix.
Using aspirin in combination with SSRI antidepressants has been shown to increase your risk of abnormal bleeding by 42%, compared to those taking aspirin alone,15 and taking aspirin (325 mg/day) with Plavix has been shown to nearly double your risk of major hemorrhage and significantly increase your risk of death, while not affecting your risk of recurrent stroke to any significant degree.16
Aside from damaging your gastrointestinal tract,17,18 routine aspirin use has also been linked to an increased risk for cataracts,19 neovascular (wet) macular degeneration,20 tinnitus21 and hearing loss in men.22
Nattokinase Reduces Clot Formation Without Side Effects

Aside from donating blood to lower your iron level (provided it’s elevated), nattokinase is another far safer alternative to a daily aspirin regimen. Nattokinase, produced by the bacteria Bacillus subtilis during the fermentation of soybeans to produce natto,23 is a strong thrombolytic,24 comparable to aspirin without the serious side effects.

It’s been shown to break down blood clots and reduce the risk of serious clotting25 by dissolving excess fibrin in your blood vessels,26 improving circulation and decreasing blood viscosity. These effects can also help reduce high blood pressure.27

As noted in a 2018 paper,28 nattokinase appears to be a promising alternative in the prevention and treatment of cardiovascular diseases, and has been linked to a reduction in cardiovascular disease mortality.
Lumbrokinase Is Even Better Than Nattokinase
Yet another alternative is lumbrokinase, a complex fibrinolytic enzyme extracted from earthworms. Like nattokinase, lumbrokinase boosts circulatory health by reducing blood viscosity, reducing blood clotting factor activity and degrading fibrin, which is a key factor in clot formation.29,30

Some researchers have suggested lumbrokinase could be used “as secondary prevention after acute thrombosis,” such as heart attacks and stroke.31 A 2008 study32 that explored “the mechanisms involved in the anti-ischemic action of lumbrokinase (LK) in the brain,” found it protected against cerebral ischemia via several mechanisms and pathways. As explained by the authors:

“These data indicated that the anti-ischemic activity of LK was due to its anti-platelet activity by elevating cAMP level and attenuating the calcium release from calcium stores, the anti-thrombosis action due to inhibiting of ICAM-1 expression, and the anti-apoptotic effect due to the activation of JAK1/STAT1 pathway.”

A 2009 pilot study33 that used lumbrokinase in patients with coronary artery disease and stable angina found it improved angina symptoms in 40% of patients and lowered the summed stress score by 29% (the summed stress score is a risk indicator for a cardiac event over the next 12 months34). According to the authors, “Oral lumbrokinase improves regional myocardial perfusion in patients with stable angina.”

Millions of people take acetaminophen, commonly known as the brand name drug Tylenol, frequently. People use acetaminophen for treating everything from fevers and muscle aches to headaches, hangovers and other pain. Because acetaminophen is available over the counter and is an ingredient found in many other preparations such as those for cold and flu, few people think twice about taking it. They should.
Acetaminophen is the top cause of acute liver failure in the U.S.1 and overdoses are a leading cause of emergency department visits and hospitalizations.2 According to UT Southwestern Medical Center, more than 200 people a year die from acetaminophen poisoning in the U.S. and there are 15,000 hospital visits due to accidentally taking too much.3
Acetaminophen is also correlated with serious side effects4 such as certain skin conditions, abdominal and gastrointestinal problems and allergic reactions. As I mention later in this article, it also could be dangerous for pregnant women. And, if California state regulators are correct, the latest risk to be associated with acetaminophen may be cancer. The regulators are in the process of determining whether to classify acetaminophen as a carcinogen on the Proposition 65 list.
Public Hearing on Carcinogenicity May Be in Spring 2020

California’s Proposition 65, enacted in 1986, requires the state to maintain a list of chemicals known to cause cancer or reproductive toxicity. Businesses are required to provide a warning if the products they sell or use expose the public to chemicals on the Proposition 65 list.5,6
California state regulators reviewed 133 acetaminophen studies in peer-reviewed journals and are considering whether to classify the drug as a carcinogen. They will hold a public hearing in spring 2020. According to The Associated Press, acetaminophen is:7

” … known outside the U.S. as paracetamol and used to treat pain and fevers. It is the basis for more than 600 prescription and over-the-counter medications for adults and children, found in well-known brands like Tylenol, Excedrin, Sudafed, Robitussin and Theraflu. Acetaminophen has been available in the U.S. without a prescription since 1955.

Concerns about its potential link to cancer come from its relationship to another drug: phenacetin. That drug, once a common treatment for headaches and other ailments, was banned by the FDA in 1983 because it caused cancer.”

Since the drug is so popular, some fear that a warning will unnecessarily worry the public but Thomas Mack, chairman of the Carcinogen Identification Committee, the group appointed by the governor to identify chemicals linked to cancer,8 dismisses the fears. “That’s not what our mandate is,” he says.9
In addition to the tremendous popularity of acetaminophen, inclusion of a chemical on the Proposition 65 list can pave the way for lawsuits, so industry is resisting the classification.10 For example, reports The Associated Press:

“After the state listed glyphosate — widely known as the weed killer Roundup — as a carcinogen in 2017, a jury ordered the company that makes Roundup to pay a California couple with cancer more than $2 billion. A judge later reduced that award to $87 million.”

What Are the Possible Cancer Links to Acetaminophen?

Suspicion of acetaminophen’s carcinogenic potential stems from the fact that it is a major metabolite of phenacetin, a drug connected with cancer more than three decades ago. In 2001, researchers in the International Journal of Cancer wrote:11

“Concern has been raised about the carcinogenic potential of paracetamol (acetaminophen) because it is the major metabolite of phenacetin, which was classified as a human carcinogen by the International Agency for Research on Cancer (IARC) in 1987 and has been withdrawn from the market in most countries …

Because of the established link between phenacetin and malignant tumors of the urinary tract, most epidemiologic studies of paracetamol and cancer have focused on these tumors.

Some of these have reported slightly elevated risks of renal cell cancer or transitional cell cancers of the renal pelvis, ureter or urinary bladder with regular or long-term use of paracetamol, whereas other studies have failed to demonstrate such associations.”

Still, the researchers added that they did not find what you would interpret as very strong cancer links with acetaminophen:12

“We found no evidence of an association between use of paracetamol and risk of urinary bladder cancer, but some evidence of an association with upper urinary tract cancers, including cancers of the renal parenchyma, renal pelvis and ureter.”

Nearly 20 years later, in January 2020, the Los Angeles Times weighed in on the possible risks and downplayed them, saying the “standards for inclusion” for the Proposition 65 list are so low, even coffee was put on it.13
Acetaminophen Can Cause Liver Damage

As I wrote before, acetaminophen is the top cause of acute liver failure in the U.S. It can even be toxic to your liver at recommended doses when taken daily for just a couple of weeks.14 Part of the reason for the risk is that acetaminophen’s recommended dose and the amount of the drug that causes an overdose are very close. There is not much margin of safety.
In fact, studies reveal that taking just a little more acetaminophen than the recommended dose over a few days or weeks (referred to as “staggered overdosing”) can be deadlier than one large overdose.15 Research in the Journal of Clinical and Translational Hepatology found:16

“Hepatic injury and subsequent hepatic failure due to both intentional and non-intentional overdose of acetaminophen (APAP) has affected patients for decades, and … it accounts for more than 50% of overdose-related acute liver failure and approximately 20% of the liver transplant cases.

… Although APAP hepatotoxicity follows a predictable timeline of hepatic failure, its clinical presentation might vary. N-acetylcysteine (NAC) therapy is considered as the mainstay therapy, but liver transplantation might represent a life-saving procedure for selected patients.”

Acetaminophen Is Linked to Fatal Skin Reactions

Few people have heard of three serious skin reactions linked to acetaminophen, but they are concerning enough that the FDA issued a warning in 2013:17

“Reddening of the skin, rash, blisters, and detachment of the upper surface of the skin can occur with the use of drug products that contain acetaminophen. These reactions can occur with first-time use of acetaminophen or at any time while it is being taken …

Anyone who develops a skin rash or reaction while using acetaminophen or any other pain reliever/fever reducer should stop the drug and seek medical attention right away.”

The three skin conditions that the FDA warns of are very rare but also life-threatening:

Stevens Johnson Syndrome (SJS) — This reaction begins with flu-like symptoms that progress into a painful rash that blisters and causes the top layer of the skin to slough off. This can lead to serious infections, blindness, damage to internal organs, permanent skin damage and death.
Toxic Epidermal Necrolysis (TEN) — TEN also typically begins with flu-like symptoms (cough, headache, aches and fever) and progresses into a blistering rash. Layers of the skin may peel away in sheets and hair and nails may fall out. TENS is often fatal.
Acute Generalized Exanthematous Pustulosis (AGEP) — This skin eruption causes numerous pustules to appear on the skin, often accompanied by fever. This condition typically resolves within two weeks once the acetaminophen is stopped.

No one knows why acetaminophen can cause these extreme skin conditions and there is no way to predict who may be at risk before they take the drug. Even more concerning, as the FDA points out in its warning, the reactions can occur in someone who has safely taken acetaminophen before.
Acetaminophen Not Safe During Pregnancy

Acetaminophen is likely not safe to take for women who are pregnant. A study in JAMA Pediatrics found disturbing links between hyperkinetic disorders (HKD), a severe form of attention-deficit/hyperactivity disorder (ADHD), and ADHD itself.18 The study found a 29% increased risk for ADHD in the children whose mothers had used acetaminophen during pregnancy in the first seven years of their lives and a 37% increased risk of being diagnosed with HKD.19
In a 2015 communication, the FDA cited the JAMA Pediatrics ADHD study. It also cited research that found a possible connection between the use of acetaminophen and other drugs called nonsteroidal anti-inflammatories (NSAIDs) and miscarriage but found the evidence inconclusive.20
The fetal exposure of mothers taking acetaminophen during pregnancy may also increase a child’s chances of developing asthma.21 Researchers analyzed data from the Norwegian Mother and Child Cohort Study, which includes many mother/child pairs, and found that prenatal acetaminophen exposure was associated with an increased risk of asthma in offspring.22
Finally, use of acetaminophen during pregnancy may cut levels of testosterone in the womb, negatively affecting males, according to research in mice.23 It’s possible that this apparent testosterone reduction interferes with the development of the male reproductive system and explains genital birth defects, infertility and testicular cancer, according to other research.24
In addition to harm to male fetuses, a rat study found that the use of acetaminophen or NSAIDs in pregnancy could reduce the size of ovaries and follicles, and if applied to humans, might indicate that it could affect fertility of resulting daughters and granddaughters.25
Other Acetaminophen Risks

Acetaminophen may not be safe to take when you are drinking alcohol. Research suggests it can greatly increase your risk of kidney dysfunction — even if the amount of alcohol is small.26 Combining alcohol with acetaminophen was found to raise the risk of kidney damage by 123% compared to taking either of them individually.
Besides alcoholics, young adults are particularly at risk of kidney harm as they’re more likely to consume both alcohol and acetaminophen.27
Acetaminophen can also affect the immune system. According to a study in Human Vaccines & Immunotherapeutics,28 infants who received acetaminophen right after getting a vaccination experienced lowered immune response and developed significantly fewer antibodies against the disease they were vaccinated against.
Acetaminophen’s anti-inflammatory activity might explain the apparent effects by interfering with the body’s immune system antibody response, say the researchers.
Other risks that have been associated with the use of acetaminophen include chronic obstructive pulmonary disease (COPD) and reduced lung function, brain damage, increased blood pressure and hearing loss. Finally, acetaminophen may have psychiatric effects, according to research conducted by University of British Columbia researchers in 2016.29
The researchers found that use of acetaminophen may both lessen the ability of people to recognize errors that they make and their concern about whether or not they have made an error.30
Past research has also revealed subtle cognitive effects associated with acetaminophen use, like a 2010 study that indicated acetaminophen may reduce the pain of social rejection.31 Research also showed that acetaminophen had the ability to blunt both positive and negative emotions.32
Regardless of whether acetaminophen is added to California’s Proposition 65 as a carcinogen, there are many reasons to avoid this drug when possible and use it cautiously. Further, there are many pain-relieving herbs and practices that you can use to replace acetaminophen for natural relief.

Aside from causing a wide variety of side effects in those who take medications, the widespread routine use of pharmaceuticals also pose a serious risk to children who get their hands on them.
As of 2016, nearly half of the U.S. population were on at least one medication.1,2 Twenty-four percent used three or more drugs, and 12.6% were on more than five different medications.3 According to the 2016 National Ambulatory Medical Care Survey, 73.9% of all doctor’s visits also involved drug therapy.4
As one would expect, drug use dramatically increases with age. As of 2016, 18% of children under 12 were on prescription medication, compared to 85% of adults over the age of 60. While this trend is troubling enough, with prescription drugs now being a staple in most homes, the number of children suffering accidental poisoning is also on the rise.
Medications Pose Serious Risks to Young Children

According to a 2012 article5,6 in The Journal of Pediatrics that reviewed patient records from the National Poison Data System of the American Association of Poison Control Centers, 453,559 children aged 5 or younger were admitted to a health care facility following exposure to a potentially toxic dose of a pharmaceutical drug between 2001 and 2008.
In that time, drug poisonings rose 22%. Ninety-five percent of cases were due to self-exposure, meaning the children got into the medication and took it themselves, opposed to being given an excessive dose by error.
Forty-three percent of all children admitted to the hospital after accidentally ingesting medication ended up in the intensive care unit, and prescription (opposed to over-the-counter) medications were responsible for 71% of serious injuries, with opioids, sedative-hypnotics and cardiovascular drugs topping the list of drugs causing serious harm. As noted by the authors:7

“Prevention efforts have proved to be inadequate in the face of rising availability of prescription medications, particularly more dangerous medications.”

Keep All Drugs in Childproof Containers

If you’re older, you may recall your parents or grandparents would have a lockable medicine cabinet where drugs were stored. Few people keep their medications in locked cabinets or boxes these days, failing to realize the serious risk they pose to young children.
The hazard is further magnified if you sort your medications into easy-open daily pill organizers rather than keeping each drug in its original childproof container.
A 2020 paper8,9 in The Journal of Pediatrics, which sought to “identify types of containers from which young children accessed solid dose medications during unsupervised medication exposures” found 51.5% involved drugs accessed as a result of having been removed from its original childproof packaging.
Remarkably, in 49.3% of cases involving attention deficit hyperactivity disorder medications and 42.6% of cases involving an opioid, the drug was not in any container at all when accessed. In other words, the child found the pill or pills just laying out in the open. In 30.7% of all cases where a child ingested a drug, the exposure involved a grandparent’s medication. As noted by the authors:

“Efforts to reduce pediatric SDM [solid dose medication] exposures should also address exposures in which adults, rather than children, remove medications from child-resistant packaging.
Packaging/storage innovations designed to encourage adults to keep products within child-resistant packaging and specific educational messages could be targeted based on common exposure circumstances, medication classes, and medication intended recipients.”

Teen Drug Overdoses Are Also on the Rise
While infants are notorious for putting anything and everything in their mouth, making them particularly vulnerable to accidental drug exposures, drug overdoses, particularly those involving opioids and benzodiazepines, are also becoming more prevalent among teens with access to these drugs.
According to a 2019 study10 published in the journal Clinical Toxicology, 296,838 children under the age of 18 were exposed to benzodiazepines between January 2000 and December 2015. Over that time, benzodiazepine exposure in this age group increased by 54%. According to the authors:11

“The severity of medical outcomes also increased, as did the prevalence of co-ingestion of multiple drugs, especially in children ages 12 to <18 years. Nearly half of all reported exposures in 2015 were documented as intentional abuse, misuse, or attempted suicide, reflecting a change from prior years … Medical providers and caretakers should be cognizant of this growing epidemic to avoid preventable harm to adolescents, young children, and infants.” A similar trend has been found with opioids. A 2017 study12 looking at prescription opioid exposures among children and adolescents in the U.S. between 2000 and 2015 found: “Poison control centers received reports of 188,468 prescription opioid exposures among children aged<20 years old from 2000 through 2015 … Hydrocodone accounted for the largest proportion of exposures (28.7%), and 47.1% of children exposed to buprenorphine were admitted to a health care facility (HCF). The odds of being admitted to an HCF were higher for teenagers than for children aged 0 to 5 years or children aged 6 to 12 years. Teenagers also had greater odds of serious medical outcomes … The rate of prescription opioid-related suspected suicides among teenagers increased by 52.7% during the study period.” Commonsense Precautions The U.S. Centers for Disease Control and Prevention promotes and supports the Up and Away and Out of Sight campaign, which centers “around several simple, data-driven actions that parents and caregivers can take to prevent medication overdoses in the children they care about and care for.”13 These commonsense precautions include the following:14 Store your medications (and supplements) in their original packaging in a place your child cannot reach. Don't store medications in your nightstand, purse or end table where little hands are likely to explore and find them. Any medication stored in the refrigerator should be in childproof packaging. Also make sure drugs are safely stored in areas your child visits frequently, such as a grandparent’s house or a baby sitter. Put all medications away after each use. Make sure to relock the safety cap after each use. Teach your children about medicine safety; never tell them medicine is “like candy” in order to get them to take it. Remind guests to place bags, purses and coats that have medicine in them in a safe place while visiting. What to Do in Case of Accidental Drug Exposure Be sure to keep the Poison Help number in your phone, and make sure your baby sitter or caregiver has it. In the U.S., the Poison Help number is 800-222-1222. If you suspect your child has taken a prescription or OTC medication, even if he or she is not yet exhibiting symptoms, call the Poison Help line immediately. If you’re unsure what medication your child may have taken, call 911 or the emergency number in your area for transportation to the nearest medical facility. Although your child may appear fine in the initial minutes, this can rapidly change. You want to start treatment as soon as possible to reduce the risk of permanent damage or potential death. Remember to bring with you the names of any medications your child may have accidentally ingested, as well as any medications your child has taken in the past 24 hours as prescribed by their doctor, any allergies they have, and any changes or symptoms you may have observed. Unfortunately, symptoms of a medication overdose can vary widely, depending on the drug, dosage and age of the child. That said, symptoms of an overdose may include:15 Nausea Vomiting or diarrhea Drooling or dry mouth Convulsions Pupils that grow larger or shrink Sweating Loss of coordination and/or slurred speech Extreme fatigue Yellow skin or eyes Flu-like symptoms Unusual bleeding or bruising Abdominal pain Numbness Rapid heartbeat Should your child exhibit any of the following symptoms, call 911 (in the U.S.) immediately:16 Won’t wake up Can’t breathe Twitches or shakes uncontrollably Displays extremely strange behavior Has trouble swallowing Develops a rapidly spreading rash Swells up in the face, including around the lips and tongue Opioid Epidemic Takes Toll on Pediatric Population It’s crucial to realize that many drugs can be life threatening to a young child, even in low doses. This is particularly true for opioids and buprenorphine, a drug used to treat opioid dependence. As noted in a 2005 paper17 on opioid exposure in toddlers: “Ingestions of opioid analgesics by children may lead to significant toxicity as a result of depression of the respiratory and central nervous systems. A review of the medical literature was performed to determine whether low doses of opioids are dangerous in the pediatric population under 6 years old. Methadone was found to be the most toxic of the opioids; doses as low as a single tablet can lead to death. All children who have ingested any amount of methadone need to be observed in an Emergency Department (ED) for at least 6 h and considered for hospital admission. Most other opioids are better tolerated in ingestions as small as one or two tablets. Based on the limited data available for these opioids, we conclude that equianalgesic doses of 5 mg/kg of codeine or greater require 4 to 6 h of observation in the ED. Data for propoxyphene and all extended-release preparations are limited; their prolonged half-lives would suggest the need for longer observation periods. All opioid ingestions leading to respiratory depression or significant central nervous system depression require admission to an intensive care unit.” Similarly, a 2006 paper18 on the adverse effects of unintentional buprenorphine exposure in children noted that: “Buprenorphine in sublingual formulation was recently introduced to the American market for treatment of opioid dependence. We report a series of 5 toddlers with respiratory and mental-status depression after unintentional buprenorphine exposure. Despite buprenorphine's partial agonist activity and ceiling effect on respiratory depression, all children required hospital admission and either opioid-antagonist therapy or mechanical ventilation … The increasing use of buprenorphine as a home-based therapy for opioid addiction in the United States raises public health concerns for the pediatric population.” The take-home message here is that as drug treatment increases and becomes ever-more prevalent among all age groups, the risk of unintentional exposure increases as well. Toddlers will stick just about anything in their mouth, and young children will often not recognize there’s a difference between pills and candy. As parents and caregivers, we simply must take the necessary precautions to keep all medications in a safe place, well out of reach of curious hands. Failure to safeguard your medications can have profoundly tragic consequences, so please, do not take this matter lightly.

Earlier this year, I reported that carcinogenic N-nitrosodimethylamine (NDMA) had been found in certain blood pressure, heartburn and diabetes medications. As of February 2020, drugs recalled due to contamination with this poison included:1

Valsartan, losartan and irbesartan (high blood pressure medications)
Zantac2 and Axid (heartburn medications)
Metformin (diabetes medication)

In the case of valsartan, the three companies whose drugs were recalled in 2018 had all purchased the active ingredient from a Chinese company called Zhejiang Huahai Pharmaceutical Co. It’s one of China’s largest manufacturers of generics.3
Since 2018, the recall has been expanded dozens of times to also include losartan and irbesartan, made by more than 10 different companies with distribution in some 30 countries.4
As reported5 by Bloomberg in December 2019, the U.S. Food and Drug Administration checks less than 1% of imported drugs for impurities (or potency for that matter). Clearly, the regulatory system, which is meant to safeguard patients, is broken, and trust in drug manufacturers is often misplaced.
Disturbingly, Bloomberg’s report6 suggests the NDMA contamination at Huahai may have been intentional, at least in the sense that profitability was prioritized over thorough quality testing and perfecting of novel manufacturing methods.
What Is NDMA?

NDMA is a water-soluble chemical known to cause cancer in animals. In humans, it’s classified7 as a probable carcinogen and causes serious liver damage and liver failure.8
According to the Environmental Protection Agency’s technical fact sheet,9 NDMA, which can form in both industrial and natural chemical processes, is a member of N-ni-trosamines, a family of potent carcinogens.

“Potential industrial sources include byproducts from tanneries, pesticide manufacturing plants, rubber and tire manufacturers, alkylamine manufacture and use sites, fish processing facilities, foundries and dye manufacturers,” the EPA notes. However, we now know the chemical can also be produced during the manufacturing of drugs.

Historically, there are several cases10 in which NDMA was used as a poison. In 1978, a German teacher’s wife died after he put NDMA in her jam and a Nebraska man was sentenced to death that same year for spiking lemonade with it, killing two people.
In 2013, a Chinese medical student died as a result of an April Fool’s prank when NDMA was put into the water cooler, and in 2018, a Canadian graduate student poisoned a post-doctoral fellow by injecting it into an apple pie. Meanwhile, hundreds of millions of patients around the world have been taking drugs contaminated with this poison, oftentimes daily, for years on end.
Can FDA Ensure Drug Safety?
Bloomberg’s report11 reviews the history of how carcinogens like NDMA have crept into the generic drug supply, and raises serious questions about the FDA’s ability to ensure drug safety.

The article features the story of Karen Brackman, who after taking generic valsartan for two years suddenly found herself with a diagnosis of a rare and aggressive liver cancer, despite having no family history of cancer, and no specific risk factors for it.

As reported by Bloomberg,12 some of the contaminated valsartan pills contained as much as 17 micrograms of NDMA per pill, an amount estimated by European health regulators to give 1 in 3,390 people cancer. Brackman suspects she’s one of the unlucky ones.

While generics are a boon to patients in that they’re far less expensive while still providing the same benefits, there’s more room for error as they also receive far less scrutiny by regulators, and manufacturers are trusted to regulate themselves.
Most Active Ingredients Are Manufactured in China and India
An estimated 80% of all active drug ingredients are manufactured in China and India, and overseas plants are rarely inspected by U.S. authorities. At present, the U.S. has just one FDA inspector’s office in China. In the case of valsartan, even when a plant is inspected and found wanting, it can take years before problems are addressed — if ever.

“Huahai, the first manufacturer found to have NDMA in its valsartan, is also the one whose product had the highest concentration,” Bloomberg reports.13
”When an FDA inspector visited in May 2017, he was alarmed by what he saw: aging, rusty machinery; customer complaints dismissed without reason; testing anomalies that were never looked into.
He reported that the company was ignoring signs its products were contaminated. Senior FDA officials didn’t reprimand Huahai; they expected the company to resolve the problem on its own. Huahai didn’t …
It wasn’t until a year later that another company … found an impurity in Huahai’s valsartan and identified it as NDMA. That was when the FDA demanded drugmakers begin looking for NDMA in their valsartan. They found it again and again.”

As David Gortler, a drug safety consultant and former FDA medical officer, told Bloomberg, “Valsartan is just the one we caught. Who knows how many more [tainted drugs] are out there?” Well, we now know the NDMA contamination affects many other drugs as well, including metformin, used by more than 78.6 million Americans as of 2017.14
Huahai’s Mistake
Bloomberg goes on to recount some of the historical details of Huahei, from its inception in 1989 to its current status as one of the largest generic’s companies in China, and the first Chinese company to gain FDA approval to export finished drugs to the U.S. — a generic HIV medication.

When Novartis’ patent on Diovan (the brand name for its valsartan drug) expired in 2011, Huahai became one of the companies to manufacture valsartan for generic drug companies. Valsartan, being a simple compound to make and used daily by millions, looked like it could be just what Huahai needed to grow and improve its bottom line.

Now, as explained by Bloomberg, if a company like Huahai wants to create its own version of a generic drug and then export it to the U.S., they must first get FDA approval. However, if they’re just manufacturing and supplying the active ingredient to a U.S. company that then produces the finished product, then FDA approval is not required. All they have to do is inform the FDA if there are any changes to the manufacturing process.

In the case of Huahai’s valsartan, the company did make a change to its manufacturing process, but downplayed its significance. In November 2011, Huahai stopped using the solvent used by Novartis in the manufacturing of the brand name drug, and started using another called dimethylformamide (DMF).

This turns out to have been a massive mistake, as side reactions ended up producing NDMA, which could not be removed from the drug. “The chemists at Huahai either didn’t realize that or didn’t consider it a potential hazard,” Bloomberg writes, adding that, in 2018, after the recall began, vice chairman of Huahai, Jun Du, told an FDA inspector that “The purpose of the change was to save money,” thus increasing their profits.

The cost-savings were so substantial, it allowed Huahai to dominate the global market share for valsartan. Making matters worse, since Huahai’s patent was public, other generic companies copied the new, toxic, process. According to Bloomberg,15 this is “one reason so much of the world’s valsartan supply is now contaminated.”
Incompetence or Intentional Poisoning?
It’s hard to justify a defense of ignorance, though, seeing how the 2017 FDA inspector’s report noted multiple problems at the plant, including suspicious contaminants showing up in quality tests.

Du claimed the tests showed “ghost peaks … from time to time for undetermined reasons.” In another instance, he referred to the residual spike showing in testing as “noise.” Huahai never investigated to determine what the contaminants might be, or how they got there. Instead, they simply omitted the incriminating tests from official reports.

The FDA inspector recommended the agency issue a warning letter, which would have meant Huahai would have to pass another inspection before continuing its manufacturing. But the FDA didn’t send a warning letter. Instead, they urged Huahai to resolve the issues on their own — which they didn’t.

Disturbingly, a lax FDA approach to inspections that reveal faked quality testing is not unusual. Bloomberg spoke to Michael de la Torre, who runs a database of FDA inspections. According to Torre, in the five years up to 2019, the FDA issued warning letters in response to faked data just 25% of the time.

The only element who cares in this whole global supply chain is patients. ~ David Light, CEO Valisure LLC

Bloomberg also recounts a number of quality problems discovered at Indian drug manufacturing plants. Clearly, FDA is failing in its mission to regulate the generics industry overseas.

The industry is expected to regulate itself, and profit wins over quality concerns most of the time when no one is around to hold the companies accountable. A company is only as ethical and conscientious as the people running it.

Quality problems are really not uncommon. The New Haven, Connecticut-based online pharmacy Valisure LLC tests every drug it orders, and reports rejecting more than 10% of all batches it receives — in some cases due to inaccurate amounts of active ingredient, in others due to contaminants or other inconsistencies in quality.16

Kevin Schug, analytical chemistry professor at the University of Texas, told Bloomberg17 Huahai “certainly should have caught” the NMDA contamination, and “should have modified the procedure to correct it.” Former FDA medical officer Gortler agreed, saying, “Any well-trained analytical chemist would know to check. If it’s not intentional, it’s incompetence. At some point, those are the same.”

Valisure CEO David Light told Bloomberg that while people in the industry are well aware of the problems, the overwhelming consensus is that it’s not “their” problem. “There’s no liability at any one point,” he said. “The only element who cares in this whole global supply chain is patients.”

The FDA didn’t send a warning letter18 to Huahai until November 2018, stating the obvious: The company should have anticipated the possibility that changing the process to use DMF solvent might cause problems, and when testing revealed anomalies, they should have identified the impurity.

Brackman filed a lawsuit against Huahai in April 2019. About 140 others have also sued Huahai and other drugmakers involved in the valsartan recall, and lawyers are reviewing several hundred additional cases, Bloomberg reports.
Bottom Line
This devastating and pervasive toxic exposure results largely from people’s reliance on using drugs as symptomatic bandages that in no way, shape or form treat the cause of the disease. They trust their physicians to help them but sadly they have been captured by the drug industry and are nearly universally clueless on how to identify and address the underlying cause of most diseases.

That is why it is crucial to understand that YOU are responsible for your own health and need to use physicians as your consultants, and not implicitly trust them. If you provide your body with what it needs, it typically tends to self-correct and get better so you can avoid these dangerous medications which, rarely, if ever, resolve the foundational cause.

Fortunately, this COVID-19 crisis has shown us the two most important physical strategies to optimize your health: vitamin D and metabolic flexibility. The ability to eliminate insulin resistance is a strategy that addresses the majority of illnesses that you will ever encounter in your lifetime.

This is why time-restricted eating, eliminating industrially processed seed oils like soy, corn and canola oils, eating a cyclical ketogenic diet, exercising and sleeping well can improve, if not eliminate, most conditions that you would need to take medications for. As you can see, drugs can harm you just because they were made with shortcuts to increase company profits.

When you follow these health principles you will decrease, if not eliminate, your need for these dangerous medications. You will also enjoy a high degree of health and freedom from the pain, disability and suffering associated with these conditions.