Staying Healthy and Balanced This Fall

People complain that the four seasons do not exist in the Sonoran desert. Some divide the year into the persistent heat that starts in late spring, often lasting into November, and the cool but rarely cold days and nights we enjoy from November through March. Longtime residents come to understand, however, that subtle shifts do occur, and that southern Arizona has its own quiet version of fall.

Retreat and Contraction in the Fall

Chinese medicine identifies cycles of expansion and contraction that alternate according to a regular schedule. The hours of the day, for example, are seen as a time of growth and increase from midnight until noon, referred to as the “time of the living breath”, followed by an equal period of deceleration and decrease from noon to midnight—the “time of the dying breath”. Recognizing these cycles is useful and can help determine, for example, the best times to eat, exercise, or sleep.

The seasons of the year follow a similar pattern: spring and summer see universal expansion, while all things naturally slow and contract during the autumn and winter months. Arizona’s searing desert heat may force us to stay inside during the hottest summer months, but we still experience longer days and more natural light in our homes than in fall and winter. With these obvious changes in our external environment, our internal physiology also shifts, and, as the Chinese learned over the course of millennia, altering daily routines to stay in balance with the seasons is one of the best ways to stay healthy.

Specifically, Chinese medicine recommends sleeping in a bit later in the fall. Try downshifting from more vigorous physical workouts to gentler, slower paced activity and stretching. Introduce more soups into your diet, brimming with plenty of hearty vegetables. Pull warm scarves or high collar jackets out from closets to guard against the autumnal winds. And make sure to take strolls in natural settings, stopping to admire fall colors if you live in an area where the leaves turn vibrant golds and reds.

Avoid Invasion by External Dryness

According to Chinese medical theory, every season is marked by a climatic factor which can disrupt bodily harmony. During the fall, we are cautioned about dryness and should avoid any dry winds and air which can result in unproductive cough and feelings of dryness and heat. Due to the fact that the high heat of summer—especially in the desert—can tax bodily resources and leave us vulnerable in autumn, it behooves us to take steps to minimize exposure to external threats like pollen, dust, and viruses that can lead to malaise and illness in the fall.

Desert living also necessitates actively replenishing bodily fluids during the dry, windy weather of autumn that follows the baking heat of summer. Nature is infinitely wise and will often provide exactly what we need. To insure that our bodies, in particular our lungs, remain moist and nourished, we should indulge in the bounty of ripe, fall fruits. Pears, whose skin is included in medicinal teas prescribed in the fall, are ideal for restoring moisture in the lungs, while other autumnal delights like apples and figs can also help to rehydrate at the cellular level after a long, hot summer.

The Metal Phase

In Chinese Five Phase Theory, autumn represents the metal phase and suggests the use of a scythe to reap the harvest of a productive spring and summer. Autumn is also the perfect time to make use of the metal of acupuncture needles to rebalance and restore. During the fall, our clinic assesses and regulates the defensive qi which is traditionally seen as protecting us against seasonal infections and allergies. We also evaluate each patient’s yin, blood, and body fluids which may have become depleted during hot, sweaty summer days. For optimal wellness, these individuals often benefit from a formula that can support dietary changes and help to bring yin fluids back to a healthy level. Think of these treatments as way to help “winterize” your body to ensure a harmonious and joyful fall and a secure and peaceful winter.

Effective Treatment of Sciatica

During my 25 years in practice, many patients who have come to our clinic report sciatica. It is a problem I am quite happy to tackle as the special needling method I use provides good outcomes in a situation where mainstream medical options tend to be limited. The benefits of Chinese acupuncture for patients who complain of sciatica were recently confirmed in a JAMA Internal Medicine article featuring a Chinese study which found acupuncture outperforms sham in relieving chronic sciatica.

Western Medical Analysis and Treatment of Sciatica

The sciatic nerve, which originates in the lower lumbar spine, is the largest nerve in our bodies. Functionally, the sciatic nerve allows for both sensory and motor function of the muscles of the thigh, leg, and foot. Neuralgia or nerve pain affecting the sciatic nerve is common, with up to 43% of people experiencing this condition at some time in their lives. Although sciatica resolves with time in many patients, 20%-30% experience pain lasting more than one year, and some patients suffer severe complications which can impair walking and even cause incontinence.

Studies have found surgical interventions for sciatica generally offer poor results, so many patients agree to drugs with adverse effects, regular steroid injections (which can damage tissue), or months of physical therapy. Making matters worse, the deadly opioid crisis has dramatically changed pain management strategies, leaving many people struggling with sciatica with little to no relief from pain. Fortunately, Chinese medicine offers practical, effective treatments for patients looking for good solutions to alleviate their discomfort and improve range of motion.

Using Chinese Medical Care for Sciatica

Acupuncture is based on a network of connections in the body that are referred to as channels. In the case of sciatica pain, the areas often affected are along the course of the gallbladder, stomach, and spleen channels. Depending on the location of the pain and how far down the leg the discomfort radiates, the specific acupuncture points used vary. When working with a qualified and experienced Licensed Acupuncturist, your entire health history will be assessed, and the findings will be utilized to target not only the pain but its underlying causes.

As with any medical condition, the results depend on the specifics of the case. For example, chronic or severe cases of sciatica can be harder to treat than the mild, short-term cases. In our clinic, many sciatica patients leave after just one acupuncture treatment already feeling better. Recently, one patient told us that she felt so much relief two days after her first visit for acupuncture that she sat up in bed and cried tears of joy. If you or someone you know has been dealing with painful and debilitating sciatica, please call our clinic to schedule a treatment.

STAYING HEALTHY DURING COLD AND FLU SEASON

Healthcare authorities are once again ringing the alarm bell about the uptick in cases of COVID-19. Meanwhile, in addition to the all too familiar seasonal risk of catching a cold or the flu, we are also learning more about the dangers of RSV. Vaccination is one option to reduce the chances of seasonal ailments, but many people either choose not to be vaccinated or are unable to tolerate vaccines.

Fortunately, there are time-tested natural strategies to help increase the time that you are able to enjoy the holidays with your family and friends instead of lying in bed sick and miserable.*

Regular Maintenance for Your Body

In our clinic we often hear about, or see, the remarkable benefits of regular Chinese medical care for supporting health and wellness. When Chinese Medicine is used as a complete system of medicine by a qualified, Licensed Acupuncturist, patients are evaluated and treated holistically, restoring healthy balance to all bodily systems. This includes improving our natural defense mechanisms. According to Wang (2023), “In addition to dramatically regulating immune cells and molecules, including innate and adaptive immune responses, acupuncture can stimulate and support immunological responses that are anti-inflammatory and anti-infectious.”

Ancient Chinese Wellness Secret

For 800 years, Chinese doctors have used an herbal formula called Jade Windscreen Powder to improve the overall wellness of patients who tend get sick, either from allergens or viruses, during the fall and winter seasons. The immune harmonizing effects of this classic combination have recently been confirmed by modern science. In their study, Du et alia (2013) reported that Jade Windscreen Powder showed a “bi-directional immune-modulatory role(s)…in regulating the releases of cytokines from macrophages.” Other studies have indicated that this Chinese formula may also help those with COPD or other respiratory complaints.

When it is determined to be safe and appropriate for our patients, we recommend starting this remarkable formula prior to the cold and flu season and continuing it throughout the peak time. Astragalus, the key ingredient in Jade Windscreen, is not only known for keeping people healthy, it can also increase energy levels without the use of a stimulant. Our sister business, Serenity Herbs and Supplements, offers several different versions of the Jade Windscreen formula, so please reach out to us to learn what would work best for you.

Play It Safe and Be Smart

In the martial arts we are taught that it is always better to avoid a fight than risk getting injured. Similarly, while boosting resistance to respiratory infections is helpful, it is best to minimize your exposure whenever you can. We know that COVID-19 spreads rapidly when large numbers of people congregate indoors, and these situations can also increase your chances of contracting other types of viruses. By avoiding problematic environments, wearing a mask as needed, and limiting the time you spend in high risk situations—supported by regular Chinese wellness care—you will spend more time rejoicing than recovering during the holidays.

*We do not promote Chinese wellness care as a substitute for FDA recommended measures. These statements in this article have not been approved by the FDA and are not intended to diagnose, treat, prevent, or cure any disease.

Western Medicine is Starting to Catch Up

This week marked the 100th birthday of former President Jimmy Carter. Carter has survived many challenges in his century of life, with the most recent being melanoma that metastasized to his liver and brain. The diehard Nobel-prize winner was first diagnosed at the age of 91, but thanks to surgery and innovative cancer care, he has lived nine years since cancer was found. The 39th President’s survival is specifically attributed to novel immunotherapy, a newer weapon in the arsenal to fight cancer.

The drug that has kept Carter alive was only approved a year prior to his diagnosis, and scientists had only learned about the potential of the human immune system to combat cancer ten years before the drug became available. Remarkably, Chinese medical expert Pan Mingji had been working on similar strategies in Chinese medicine decades prior to these Western scientific breakthroughs of the early 2000’s. Even more incredibly, Dr. Pan’s groundbreaking research is built on ancient Chinese medical theory stretching back 2,000 years or more.

Chinese Medicine’s Balanced Perspective

The discipline of medical anthropology largely derives from the core idea that every system of medicine is a product of its culture. Even Western scientific medicine reflects shared beliefs which emphasize certain perspectives on healthcare while deemphasizing others. Not surprisingly, these differences create a unique set of strengths and weaknesses in each system of healthcare.

Western medicine has always been, and continues to be, a medicine categorized by offensive attacks against pathogens. Culturally, this perspective naturally derives from our Western nomadic and colonial history where violent conflicts with other groups were commonplace. Although we are seeing a shift in recent decades, Western medicine continues to overwhelmingly favor remedial treatment over proactive prevention.

Chinese medicine, however, has always seen health as a balance between the competing forces of righteous normalcy and pathogenic disruption. It is a basic precept in Chinese medicine that diseases will only develop in individuals whose bodily function is impaired and whose defenses have failed. This astute viewpoint has resulted in a nuanced approach to healthcare that not only seeks to isolate the factors causing illness but also assesses and improves any declining bodily function as necessary.

The Role of Wellness in Cancer Prevention

Most cancers occur in older patients (although there is a disturbing recent trend towards cancer in younger individuals). The explanation of why cancer is so much more likely in the elderly primarily relates to the inevitable decrease in immunity as we age. For this reason, it is imperative that we think more about the role of the human immune system in preventing and controlling cancer cells and discover how to leverage this insight in the war against cancer.

The immunotherapy that has bought Jimmy Carter another decade of precious time to spend with family and friends is one way of using new scientific knowledge of how our immunity helps keep cancerous cells in check. The next logical step in modern Western healthcare—borrowing a strategy used for thousands of years in Chinese medicine—is to harness the power of immunity for cancer prevention. In the words of a well-known Chinese idiom, “it is too late to dig a well once you are already thirsty”. Modern science now understands enough about the causes of many types of cancer to acknowledge what Chinese physicians have known for millennia: the best oncology treats cancer before it even occurs.

Chinese Herbal Treatment for Acne

Many, if not most of us, experience acne as adolescents. Some will suffer from severe acne in their teens, which can have a devastating effect on our self-confidence and may result in permanent scarring. Others find that acne lingers into adulthood and can even persist for decades.

Recently, some disturbing studies have demonstrated that benzyl peroxide, commonly found in over-the-counter acne medications, can degrade into cancer-causing benzene, but benzyl peroxide is not the only acne treatment with serious adverse effects. Topical retinoids raise sun sensitivity, possibly leading to UV skin damage which can set the stage for skin cancer. Antibiotics, topically or internally, disrupt natural skin and intestinal flora and predispose us to a variety of chronic medical conditions. Topical azelaic acid and dapsone irritate and dry skin, while the use of oral contraceptives, anti-androgen medications, and isotretinoin are associated with serious side effects including but not limited to reproductive system cancers, inflammatory bowel disease, depression, and severe birth defects.

Sounds scary? Fortunately, there is a safe option for clear skin.

Effective Chinese Skin Formulas

For those seeking relief from the mental and physical distress of acne, Chinese internal herbal formulas with topical herbal support offer a safe and effective alternative to rolling the dice with Western medical treatments with potentially lethal side effects. A 2021 study published in Medicine (Baltimore) describes the inhibitory effects of the Chinese herbs scutellaria baicalensis and cortex phellodendri on the bacterium found in acne lesions. In the February 2016 issue of the Journal of Ethnopharmacology, a review of the literature led the authors to conclude that many Chinese acne formulas contain herbs with anti-inflammatory, anti-bacterial, anti-androgen, and even skin whitening effects. And a study in the British Journal of Dermatology discovered that Chinese licorice root, when included in formulations, resulted in 90% less acne after 12 months.

The Professional Standard in Chinese Dermatology

As with every specialty in TCM (Traditional Chinese Medicine), the professional standard for internal, Chinese herbal medicine is a formula customized for the needs of the individual patient. While acne is fundamentally caused by a pattern of imbalance described as lung channel wind-heat, the specifics of each case necessitate adjusting the formula for optimal results and safety. For example, when acne lesions occur along the jawline, herbs must be added to clear heat from the stomach and the intestines. If the patient has any scarring, many doctors will include ingredients to quicken the blood, while cystic acne, with painful and deep eruptions, may require the inclusion of phlegm-tranforming or toxin-clearing herbs, depending on any other symptoms. By modifying the formulation to best meet each patient’s needs, better outcomes, in less time, can be achieved.

If you are ready for help with a stubborn case of acne but hesitate to resort to dangerous topical or internal Western medications, please call us today to schedule an acupuncture session (which includes a complimentary herbal consult) or just book an herbal consultation without acupuncture. After a thorough review of your health history and a workup that will assess your tongue, pulse, and symptoms, we will compound a Chinese herbal formula specially designed for you. In addition, we can offer advice on simple dietary and/or lifestyle changes which can deliver clearer skin faster, and with more long-lasting results (hint: minimizing junk food is a good start).

Stay Healthy and Comfortable During the Summer

Chinese medicine, the product of an agrarian society, adheres to the rhythms of nature, advocating changes to lifestyle and the diet and adjusting treatment to harmonize with the seasons. Especially here in Arizona, where temperatures will soar into the blazing triple digits during the summer months, optimal wellness can be improved by following some simple guidelines. Below we offer you some tips to ensure that you feel your best and maintain your health during the dry, hot days preceding the monsoons.

Smart Cooling

In Southern Arizona, either AC or a swamp cooler is an essential for life during the hot summer months. Nevertheless, the Chinese have long considered wind to be a primary source of disease, and, in our 23 years in practice, many of our patients have reported malaise or pain after prolonged exposure to drafts of cold, refrigerated air. We recommend you avoid positioning yourself directly in the path of frigid, moving air and suggest that you set your thermostat to the highest temperature that still provides comfort. By minimizing the temperature extremes, you will acclimate better to the differences between indoor and outdoor temperatures.

The Thermal Nature of Food

Many ancient cultures recognized the thermal nature of foodstuffs. Put another way, some foods stoke metabolism, warming us up in cold weather, while others depress physiological activity and cool us down. Based on the Chinese classification of foods (and herbs) as cold, cool, neutral, warm, and hot, you can select the right foods for your constitution and the seasonal weather.

Books like Bob Flaws’ Tao of Healthy Eating offer lists of foodstuffs with their thermal nature, but an alternative to memorizing or looking up the properties of every food to try to eat our foods in season, as Mother Nature often gives you exactly what you need. For example, watermelon and eggplant, classic summertime crops, are naturally cold and cool, respectively. Another cold summer veggie is Chinese bitter melon. Very bitter in flavor, this strange looking produce can usually be found in Asian grocery stores, and, if prepared properly, becomes mildly bitter and delicious.

COOLING SUMMER FOODS AND DRINKS

• Mint tea and chrysanthemum tea—Both of these herbal teas clear heat, especially from the head and face.

• Mung bean sprouts—Bean sprouts are a famous cooling food which can be used raw or cooked in the summertime.

• Tofu—Tofu helps cool down the body and can be eaten raw (the Japanese eat it raw with spring onions, ginger, and soy sauce) or used in cooked dishes.

Head for the Hills

The oppressive summer heat of the Sonoran desert not only takes a toil on many of us physically, it can also be psychologically difficult to get through the long summer season in Arizona. Mentally, you may benefit from a change of scenery, whether it be a long vacation to a different part of the country or world or a day trip into the mountains. In Japan, it is even popular during the summer to visit aquariums or haunted houses at amusement parks with the idea that the sight of cool water or the icy chill of fear, respectively, will offer psychological respite from the hot temperatures of the season.

Warm Tea on a Hot Day?

Most of us are accustomed to drinking ice-cold drinks. While lightly chilled beverages can be refreshing, drinking room temperature or even warm drinks is a strategy to avoid temperature extremes and supports good digestion and circulation. And it is always smart to avoid eating any physically cold food so quickly that it actually gives you a headache or “brain freeze”.

Tea, specifically traditional varieties from the camellia sinensis plant, is actually a diaphoretic herb that encourages sweating. Sweating is an innate physiological mechanism to lower body temperature which can help cool you off. As counterintuitive as it may sound at first, we encourage you to enjoy a cup of warm tea on a hot day and see if it does not make you, in fact, feel cooler (if maybe slightly sweaty).

Instead of just dialing the thermostat down to a low setting, consider some of these innovative ways of staying cool. You might find that these suggestions are not only healthier (and cheaper) than relying solely on AC, but that they also keep you more comfortable than the refrigerated air alone. And may nature bless Southern Arizona with a year of early and productive monsoon rains!

A Different Approach to Cancer

According to cancer.org, the current lifetime risk of being diagnosed with cancer in the United States U.S. is roughly 40%, with men at slightly higher risk than women. Most of us are surprised to learn this grim statistic, and many are also unaware of the recent trend of troubling rising rates of cancer among the young. In fact, despite all of the advances in our understanding, diagnosis, and treatment of cancer, Americans today are actually more than twice as likely to die from cancer than in 1900, almost 125 years ago.

Shifting the Focus to Causes

Well-known Chinese proverbs state that it is “ too late to dig a well after you are thirsty” and “too late to forge weapons after the battle has begun”. In terms of cancer, these sayings could describe the many forms of cancer considered incurable but preventable. Cancer care often degrades our quality of life and is usually incredibly costly, but the suffering and financial burden of cancer treatment would both be greatly reduced if medicine shifted its emphasis from treatment to prevention.

Granted, identifying the causes of cancer is challenging. One of the predominant findings of cancer research is that cancer often results from multiple factors in combination rather than a single cause. For example, a genetic predisposition could make one more vulnerable to a carcinogen, while a lack of exercise as well as an unhealthy diet might further raise the risk by decreasing immune function. In fact, it is unusual to be able to definitively point to a singular “smoking gun” in most cancer cases.

Using the Cardiovascular Model for Cancer Prevention

Cardiologists are increasingly turning to formulas to determine the risk of a cardiovascular event and better understand how necessary it is for a patient to take a medication or have a certain procedure performed. Risk factors, including weight, age, family history, and blood pressure and cholesterol levels, are used to calculate the potential for a stroke or heart attack, for example, to improve the quality of treatment planning. This approach save lives.

Similarly, healthcare providers could actively assess cancer risk as part of regular care. Currently some testing is done for women with a family history of breast cancer, but there is a need for many more patients to receive genetic and blood testing to evaluate cancer risk. Test results should then be considered in light of other factors—age, weight, diet and lifestyle, and family history, for instance—to identify those patients at high risk.

Recognizing and Avoiding Carcinogens

Especially for those individuals with multiple cancer risk factors, it is good preventative healthcare to minimize exposure to carcinogens that could tip the scales and lead to cancer. This includes avoiding the usual suspects of smoking and alcohol, but other cancer-causing agents should also be considered. For the high risk patient, the best strategy is to err on the side of caution and play it safe.

Unfortunately, there is always tension between industry, which has an economic stake in continuing to market, and avoiding the liability for, agents that may be causing cancer. For example, although the FDA considers BPA to be a proven carcinogen, industry websites continue to argue with the science, offering alternative studies that purport to show their safety. Since the latency period—the time from exposure to a carcinogen to a diagnosis of cancer—can be years or even decades, it can be challenging to prove the cancer link beyond the shadow of a doubt.

A Natural Strategy

With as much as 70% of the chemicals in daily use untested for their long-term affects on human health, we advise our patients to choose the most natural options available. This not only includes selecting organic foods as much as possible, but also opting for the safest and most non-toxic products for use in the home, kitchen, office, and car. While this lifestyle change may be essential for those with numerous risk factors for cancer, getting back to basics with simple products, free of harsh, synthetic ingredients, can improve anyone’s quality of life and reduce the likelihood of many serious, chronic diseases.

Artificial Wisdom & Atomic Bombs

We hear a lot these days about Artificial Intelligence, and, in fact, AI is already here. Post on eBay, and the site’s AI feature will write a grammatically flawless and persuasive description that only needs tweaking. Meanwhile, the full potential of AI looms menacingly in the distance, with the possibilities scaring European leaders enough that some have called for legislation to regulate what they view as a threat to the very stability of society. For alarmists, a dystopia not unlike The Matrix lurks just around the corner.

Despite the spotlight on AI, it is worth nothing that no one seems to be suggesting Artificial Wisdom (AW). This total lack of interest in AW is not too surprising, however, if you stop to consider how little time modern people spend aspiring to wisdom—a quality which once enjoyed a lofty position in the hierarchy of virtues. Of course, we do not know if Artificial Wisdom would even be feasible, if humanity ever did decide to explore the possibility. All of which begs the question, “What is wisdom, exactly, and how does it differ from intelligence?”.

Wisdom Versus Intelligence

The Cambridge Dictionary online defines wisdom as “the ability to use your knowledge and experience to make good decisions and judgements”. This definition does not bode well for the creation of a wisdom correlate to AI: the possessive pronoun your intimates a living, breathing human being, while the caveat of experience might be understood to exclude a computer sitting in a building. If we accept these basic parameters, then wisdom is exclusively human, the product of living life, and one which a computer would not be able to replicate.

On the other hand, one might ask, “if AI has the ability to learn (one of the defining characteristics of Artificial Intelligence), does that not suggest the use of experience to improve the process of decision making?” It is a fair question. And, yet, the odds appear stacked against AI’s becoming wise, just as we cannot expect that solving a tough problem in math will confer wisdom on the mathematician.

What the Wise Say About Wisdom

Wisdom is not the product of schooling but of the lifelong attempt to acquire it. —Albert Einstein

Wisdom is the power to put our time and knowledge to the proper use. —Thomas Jefferson.

The saddest aspect of life right now is that science gathers knowledge faster than society gathers wisdom. —Issac Asimov

These quotations from three great thinkers round out the dictionary definition by concluding that wisdom is, indeed, the product of our lived experience, and that wisdom must also lead to appropriate, or righteous, action. While not stated explicitly, experience denotes the consequences of a lifetime of decisions, the product of learning lessons in the school of hard knocks. Wisdom apparently demands skin in the game, feeling the joy of our good decisions and suffering the pain of our bad ones. In other words, emotional investment is a prerequisite for wisdom—bad news for any AI which might strive to become wise. AI may correct mistakes, but it cannot feel personally (emphasis on person) responsible for its errors.

Jefferson and others also posit that wisdom presupposes a sense of right and wrong. Certainly, a programmer can provide AI with a set of ethical rules and expect that AI will exactly adhere to those programmed mandates. But making the right choice, the ethical choice, cannot always be determined by using a rubric and needs to be performed on an ad hoc basis. Deciding whether something is right or wrong depends on multiple variables and, once again, comes back to compassion for the other human beings who will shoulder the consequences of the decisions which we make. Ultimately, the process requires a person who can envision himself or herself in someone else’s shoes—something a device or system, no matter how advanced, cannot do.

The Manhattan Project

This year Christopher Nolan’s epic Oppenheimer, a retelling of the important story of J. Robert Oppenheimer’s journey to develop the atomic bomb, is set to sweep the Oscar’s. The movie chooses to focus on Oppenheimer as its protagonist, but it tells the bigger story of a team of extraordinary minds, arguably the greatest think tank ever assembled, that produced an invention so terrible that it hangs ominously like the sword of Damocles over humanity even today. In our current advanced computer age, the creation of a first atomic bomb would probably be aided by AI, but the decision of whether or not, and how and when, to use it, would be just as problematic in 2024 as it was back in 1945. As the rational scientists who created the A-bomb discovered, the somber prospect of detonating atomic bombs in cities teeming with people would preclude dispassionate problem-solving.

In the spring of 1945, Leo Szilárd, a Hungarian-American physicist, delivered a letter to Secretary of State James F. Byrnes. Signed by 70 prominent scientists involved in designing the atomic bomb, the missive encouraged the President to inform Japan of its intention to use the new weapon, allowing them a chance to surrender. In their eloquent letter, the authors even foresaw the future Cold War and the potential impact of the bomb not only on the Japanese, but on all human beings in perpetuity, writing

Thus a nation which sets the precedent of using these newly liberated forces of nature for purposes of destruction may have to bear the responsibility of opening the door to an era of devastation on an unimaginable scale.

Since Secretary of State Byrnes, who paid little attention to experts from the State Department and would later be accused by Truman of trying to set White House foreign policy, decided not to pass the letter on to the Oval Office, the President never heard the scientists’ plea. In August of the year the letter was written, two atomic bombs were dropped on the cities of Hiroshima and Nagasaki, killing an estimated 130,000 to 230,000 people in an inconceivable storm of annihilation.

Today, the letter, dubbed the Szilárd Petition by historians, rests in the National Archives, immortalizing the thoughts and opinions of some of the most brilliant scientists of the 20th century. It is not, however, a testament to their intelligence, but, rather, proof of their collective wisdom. Szilárd himself, along with his colleague Wigner, another signatory on the letter—both Jews who left Germany just as the Nazis had begun rising to terrifying power—understood all too well the suffering humanity is capable of inflicting on itself. Their learned experience, and the cumulative learned experience of the other 68 people who drafted the letter, afforded them the human compassion to try to change the trajectory of human history. Due to the actions of a hawkish Secretary of State, however, what might have happened if Truman had actually heard the plaintive case of those who invented the nuclear bomb, will never be known.

Whether or not the bombings of Hiroshima and Nagasaki on August 6th and 9th of 1945 were right or wrong continues to be discussed to this day, a lively debate centered mainly around the question of how necessary the atom bombs were to end the war. Nevertheless, the compassion, and morality, of the team of scientists who drafted the Szilárd Petition are beyond dispute, and, today, the letter, fragile and yellowed with age, endures as a courageous act of human, and deeply humane, wisdom. It is an accomplishment that no Artificial Intelligence, regardless of its sophistication, could ever endeavor to achieve, as computers may have CPUs, but only human beings are gifted with the human heart.

The Newest Weight Loss Miracle

People have been searching for a magic weight loss pill for a long time. In the modern era, the story begins with doctors’ prescribing thyroid medication to their overweight patients in the 1920’s. Once it became apparent that HRT resulted in hyperthyroidism in many patients without a diagnosis of hypothyroidism, however, hormonal supplements were replaced by a new weight loss medication called DNP (2,4-dinitrophenol) in 1933. Due to adverse effects including fatal hypothermia and cataracts, DNP would also fail, with the FDA prohibiting the human consumption of DNP in any form just 5 years after its introduction (it was later repurposed as a pesticide but would ultimately be banned even for agricultural usage in 1998).

As DNP was being taken off the market for serious safety concerns, another class of medications was already becoming popular for weight loss. Amphetamines, and the many adverse effects and addictive qualities associated with these potent stimulants, would become synonymous with the term “diet pill” for decades. In the late 1960’s, Congress finally passed stricter laws restricting access to these notorious weight loss drugs. Today, amphetamines are much less likely to be used by adults hoping to drop some weight than they are to be taken by children with trouble concentrating.

While stories of weight loss medications from the early through the middle part of the 20th century may strike us as anachronistic and quaint today, the cautionary tale of fen-phen is disturbingly recent. By combining phentermine, originally approved by the FDA back in 1959, and fenfluramine, FDA approved in 1973, a new weight loss aid was born. Two separate studies demonstrated that fen-phen effectively assisted participants in shedding pounds, leading many to demand the drug from healthcare providers. By 1996, more than 18 million prescriptions were being written. Unfortunately, like all of the weight loss pills approved by the FDA in the 20th century, the evidence of adverse effects—in this case, valvular heart disease in up to 30% of patients—would eventually outweigh proof of benefits, and fen-phen, too, was banned in 1997.

GLP-1 Analogs — The Next Generation

Recently celebrities and influencers have shone the spotlight on the latest and greatest development in pharmaceutical weight loss, the GLP-1 analogs. Originally approved for the treatment of diabetes, these medications activate receptors found on the pancreas and in the brain that control blood sugar by stimulating insulin secretion. Not only is blood glucose lowered, food intake also decreases, allowing patients to painlessly and, in a relatively short time, lose weight.

With benefits which include better blood sugar, less cardiovascular illness, improved mood in patients with depression, and reversal of non-alcoholic fatty liver disease, this novel class of medications is becoming popular, and, like fen-phen, the number of patients using these drugs has soared. Cost can be prohibitive, since a pen with enough doses for a month runs $935 (despite a production cost of $4-$8 for the 1.5 ml contained within). Safety is another serious consideration with these drugs, with preliminary data suggesting adverse effects ranging from hair loss to thyroid cancer. Like all of the other weight loss drugs of the last century, will we discover that the pros of GLP-1 analogs come with severe, even potentially fatal, cons?

The Real Risks of Chemical Weight Loss

Only time will tell if GLP-1 analogs are sufficiently effective and safe, and, for some patients, these injections may be their best options. It is, however, undeniable that for many overweight people, any form of chemical weight loss is dangerous. By offering weight loss without exercise or diet modification—a body “hack” of sorts—healthcare providers are enabling an unhealthy lifestyle. A patient loses 15, 20, even 30 pounds, but without improvements in their core strength or better nutrition, resulting in a thinner, but weak and malnourished, body. Can this be considered “healthcare”? Even as treatment for diabetes, GLP-1 analog injections are little more than a substitute for the real diabetic cure of healthy diet and exercise. We seem to have simply given up on good life choices in favor of a medicated America where the future of health for many of us, and even our very survival, may ultimately depend on a daily cocktail of drugs.

Chinese Medical Treatment for Alzheimer’s Patients

Alzheimer’s disease is a devastating disorder that affects 50 million people worldwide and 6% of the elderly. Unlike vascular dementia, Alzheimer’s tends to progress rapidly from simple memory loss to a wide variety of symptoms. Not only do patients suffer, Alzheimer’s will also impact patients’ families and friends as normal recognition and communication decline.

Currently, diagnosis and treatment of Alzheimer’s disease are both difficult. No diagnostic test is definitive, and the treatment options available only target the symptoms. Due to the enormous monetary costs and emotional trauma, extensive efforts are being made to improve diagnosis and care. Recently, a novel diagnostic test has been developed, and new research, like the study from McGill University researchers published yesterday that links H pylori gut infections and Alzheimer’s, provides hope for tackling this terrible disease.

Benefits of Chinese Medical Treatment

Chinese medicine offers some clear advantages in the treatment of Alzheimer’s patients. First, unlike Western medical treatment that relies on a specific and accurate disease diagnosis, treatment in Chinese medicine is based on a pattern comprised of symptoms, tongue inspection, and pulse palpation. Regardless of Western disease diagnosis, as long as the patterns are correctly identified, Chinese medical treatment can be helpful in improving the patient’s quality of life. Studies of gingko biloba, an herb used in Chinese medicine for centuries, support this assertion, as gingko is the only substance which has been shown to benefit both Alzheimer’s and vascular dementia sufferers alike.

One of the challenges of Alzheimer’s is the wide variety of causes and clinical symptoms. Alzheimer’s has been linked to everything from head trauma to diet, and it now seems likely that many cases are the result of multiple causes. Similarly, each Alzheimer patient faces a unique group of problems, depending on the individual case and the duration of the illness. One patient might alternate between sorrow and joy, while another could be more prone to anger and violent outbursts. Some patients may report pain, but others find themselves very weak. Alzheimer’s might make a patient mute, or the speech may come out garbled and unintelligible.

Given the various clinical scenarios, Alzheimer’s patients require a treatment appropriate for their unique situations. Chinese medicine, based on complex pattern groupings rather than a singular Western disease diagnosis, identifies more than half a dozen basic patterns in Alzheimer’s. Patients may present some combination of these patterns, and additional patterns may be differentiated by the skilled practitioner. Customized Chinese medical care which can address all of the systemic issues simultaneously offers Alzheimer’s patients a sophisticated and personalized care regimen which is unlike pharmaceutical treatment.

A Chinese Medical Care Plan

Options for effective Chinese medical care for Alzheimer’s patients include acupuncture, herbal teas, and diet and lifestyle counseling. Acupuncture is a safe, drug-free treatment, but it is only appropriate for patients who will permit insertion and lie still while the needles are retained. Generally, a caregiver needs to be present throughout the acupuncture treatment.

Herbal teas are another treatment choice and may be more suitable as the disease progresses. For some patients, drinking a tea may be easier than taking pills, so herbal decoctions may be preferable. In other cases, an over-the-counter formulation or an encapsulated custom blend can improve compliance for those who experience difficultly swallowing liquids.

Finally, as a system with many effective self-help methods to offer, Chinese medicine can evaluate each patient and give caregivers a program that includes targeted dietary advice, simple exercises, and acupressure and gentle massage techniques. While not every home care recommendation will be appropriate for all patients, these time-proven care methods can be effective and cost-free aids to help to control symptoms and improve life quality. If you are a caregiver for someone dealing with Alzheimer’s, we would love to work together with you to craft an individualized treatment plan.

Acupuncture Treatment – The Future of General Practice?

When I opened my practice 22 years ago, I shared space with an MD who had been in practice for decades.  Although he specialized in cardiology, he basically served his patients as a family medicine practitioner, continuing a grand tradition of compassionate general healthcare.  The patients trusted him implicitly and would consult him even on non-medical matters.  He was always available when needed and would still make a house call.  Late into his 80’s, the cardiologist finally retired, but for years, every now and again, one of his faithful patients would show up and stand in front of the empty office until being told that the clinic had closed.

Today, of course, general practice is very different.  MD’s who still practice family medicine normally have very heavy patient loads that necessitate abbreviated appointments and lengthy wait times to get in to see the doctor.  Much of general practice has been relegated to Nurse Practitioners or Physician Assistants—healthcare providers with significantly less formal training than is required of an MD. As as healthcare corporations have bought out our hospitals, urgent cares, and clinics, the economic incentive to employ an NP or PA at a third of the yearly salary of a Medical Doctor has led to a dramatic shift in hiring practices, while MD’s, bedraggled and burned out, have fled the profession in droves, unable to sustain an impossible workload. The beloved family doctor of decades past is now an endangered species.

Interestingly, many of our patients comment that their acupuncture sessions recall old school, mainstream medical family practice. In contrast to the MD’s who have now moved into group practices with shared facilities and large clinical and clerical support staffs, most Licensed Acupuncturists maintain modest, personable practices that create strong bonds between patient and practitioner. While many doctors now spend only 10 minutes or less with each patient, most acupuncture appointments last a generous hour, giving time not only for assessment and treatment, but also opportunity for patients to be heard. Finally, since traditional Chinese medicine diagnosis does not require lab tests or imaging, patients enjoy interacting firsthand with their acupuncturists who utilize observation, questioning, and physical exam to directly determine the best course of care.

Experts are predicting a future where urgent care clinics will replace our own personal doctors for general care services. Not only does this evolution of family practice promise to be dehumanizing, it will greatly impact the continuity of general care. Fortunately, for those patients who prefer a more traditional personal relationship with a healthcare provider, CAM practitioners in general, and Licensed Acupuncturists specifically, offer a reassuring alternative to walk-in services at an urgent care clinic.

Lungs in a Time of COVID

Recent research proves that asymptomatic cases of COVID-19 may be much more widespread than previously assumed. Even more unsettling, a new study shows that even patients who are unaware of having ever been infected may develop a pulmonary abnormality, specifically a phenomenon known as ground-glass opacity or GGO. In radiological imaging, this aberration of the lung tissue appears as hazy infiltrates or spots. While benign in some individuals, GGO in other cases may be a precursor to deadly lung cancer.

Traditional Chinese Medicine states that “the lungs are the delicate organ”. This perspective is generally supported in modern Western medicine which recognizes both the fragility of the thin walls of the lungs, a mere 1/8 to 1/4 inch thick, and the vulnerability of the lungs which can be permanently damaged even by a single episode of minor illness. Research over the last few years has demonstrated that polluted air in our urban environments may be as detrimental to respiratory function as chain smoking, raising grave concerns about the possibility of a widespread future epidemic of lung cancer in non-smokers.

Enter SARS-CoV2, a virus with the ability to ravage our lungs and set into motion degenerative changes even in asymptomatic cases. On the bright side, the primary risk factor for lung cancer, cigarette smoking— which makes an individual 15 to 30 times more likely to eventually develop malignant lung tumors—has declined 65% in the last 50 years. The bad news is that vaping is on the rise, and, given that pulmonary cancers on average occur 55 years after first being exposed to carcinogens, the real risks of vaping may not be clearly understood anytime soon. This fact is especially troubling in light of surveys which have shown that 25% of 12th graders and, even more shockingly, 5% of middle school students report having tried vaping.

With more than 20,000 cases of non-smoker lung cancer annually and the new potential risk factors for lung cancer of COVID-19 and vaping, it pays to take steps to maintain healthy lungs. There are several things you can do which may help reduce the risk of lung cancer in the future as well as other severe, chroniclung conditions—chronic obstructive pulmonary disorder (COPD), for example. Measures worth consideration include

• Monitoring for asymptomatic COVID-19 infection with regular testing, especially for high-risk individuals and even for those who have been vaccinated (at least until evidence shows that vaccines prevent asymptomatic disease).

• Daily low-impact aerobic exercise, including tai ji, yoga, cycling, or swimming, to strengthen and stimulate lung function.

• Eating pears, recommended by Chinese medicine, for improved lung health in drier climates, while those who live in humid areas are advised to consume warming, spicier foods like cilantro and daikon radish.

• Receiving professional help for conditions of persistent, chronic grief, which, according to Chinese medical theory, may impact pulmonary health.

• Taking a dietary herbal supplement, like Serenity Herbs’ Herbal Defender, which contains herbs traditionally used to protect the lungs.

• Spending time in the mountains near streams and lakes—areas preferred by ancient Daoists and shown by modern research to be rich in healthy, negative ions that supercharge your lungs.

Finally, remember to breathe and be assured that the pandemic, too, shall pass!

Cases High in Israel Despite Widespread Vaccination

We are all anxious to get back to some semblance of normalcy. In response, our government officials have begun easing restrictions and reopening shuttered businesses and suspended institutions. Similarly, healthcare authorities have started advising Americans about how completing immunization might allow us to relax and return to more intimate human interaction.

Meanwhile, 7,000 miles away, Israel leads the world with 40% of the population and an even higher percentage of older citizens already vaccinated. While these current figures satisfy the lower estimates for full herd immunity, at the breakneck pace of Israel’s efficient vaccination program—an impressive 1% to 2% of the total country daily—even the loftiest targets for herd protection are just weeks away. Israel has become the proverbial canary in the coal mine, foreshadowing the future for the rest of the world as we scramble to catch up with the prodigious Middle Eastern nation.

Unfortunately, there is an alarming conundrum: despite the large percentage of the Israeli population who have already received the vaccine, new cases remain twice the number per capita in the U.S. (only partially explained by more testing), and the number of deaths due to COVID-19 appears to be declining less than expected.

In contrast to recent studies which have shown good outcomes in Israel, the broader epidemiology is indeed troubling. Like trends in many countries, Israel is seeing a predictable gradual drop in both cases and fatalities following a steep post-holiday spike, but the precipitous fall in numbers that demonstrate clear vaccine efficacy has not yet occurred. With so many Israelis already inoculated, one might expect the epidemiological curve to be markedly distinct from other countries.

One explanation that has been offered blames human behavior, the primary confounding variable in the analysis of the pandemic. In accord with the precedent followed around the globe, Israel began its massive vaccination roll-out with jabs for its healthcare workers and the elderly. Some experts speculate that this may have led to younger citizens indulging in risky behavior, inadvertently increasing the spread of disease and dampening the overall effectiveness of the vaccination program.

It is also conceivable that herd immunity does not lie at 50% or 60%, but will ultimately require, as Dr. Anthony Fauci has proposed, 85% of the population to be vaccinated. If true, here in the U.S.—where only 10% of Americans have been inoculated—we have a long way to go before we can even begin to let down our guard. Not only must we greatly improve the logistics of vaccine roll-out, we are also faced with convincing the overwhelming majority of vaccine-hesitant individuals to submit to a jab.

A third, more disheartening, possibility exists: if drug companies, as some critics have argued, distorted their research with questionable research practices, our high expectations for vaccine efficacy could be grossly inflated. In the case of the Pfizer study, for example, the vaccine advisory panel discussion indicated that volunteer bias may have resulted in recruitment of a population unusually predisposed to hyper vigilant behavior, significantly reducing their viral exposure. Furthermore, since many vaccine recipients report telltale reactions to the vaccine and in light of the fact that testing was ordered by investigators based on subjective identification of participants who appeared to have contracted COVID, it is also possible that clinical trial findings were wildly skewed by a confirmation bias. Similar issues could have impacted the Moderna research which yielded outcomes curiously analogous to the Pfizer study.

Assuming the Israelis can sustain their laudable rate of vaccination, we may have some answers to these burning questions before the end of this month. In the meantime, the dip in U.S infections and deaths from a combination of some degree of natural herd immunity and the passing of time since super spreader events in December and early January is finally giving Americans a glimmer of hope for a brighter future in 2021. We will, however, still have to be patient as the now familiar, pervasive, and maddening uncertainty about the future of just about everything continues a bit longer.

Providing Continuity of Care

In the early days of the pandemic, 77% of U.S. acupuncture clinics made the decision to just close their doors. Faced with conflicting information on the virus and the legal requirements of their states, many felt the most prudent course was to hunker down for several months until normalcy returned and patients could be treated safely. Unfortunately, the pandemic has progressed through fits and starts, leading to the current, and most severe, third wave of transmission that has paralyzed the nation. Normality has never been restored, mask-wearing, social distancing, and frequent hand-washing are now more necessary than ever, and some acupuncture clinics will, sadly, never reopen.

The healthcare industry, including acupuncture and traditional Asian medicine, has an advantage over other businesses in that principles and procedures to prevent infection are part of standard professional training and practice. Although the specific routes of transmission for the SARS-Cov2 virus were unknown (and are still being examined), the universal precautions followed by all healthcare professionals can be modified for the setting, nature of the pathogens, and the specific patient population. This allows for continuity of care while controlling and reducing risk.

White Pine Clinic has operated without interruption and is pleased to announce that we have avoided even a single case of transmission within our clinic during the pandemic. Our patients deserve much of the credit as they have shared their symptoms honestly with us and many have made responsible decisions about when to stay at home. For any healthcare provider, careful triage is always the best way to keep everyone safe.

Meanwhile, we have maintained our early safety measures and have added to these procedures as our understanding of COVID-19 has evolved. Despite evidence that fomites—contaminated surfaces—may only play a minor role in disease transmission, we continue to disinfect the common points of contact after use by each individual. Once researchers determined that the main avenue of transmission was respiratory droplets, we implemented new strategies to enhance airflow in both treatment rooms and common areas. It is hard work to maintain a practice while protecting our patients and ourselves, but we remain committed to providing our community with effective traditional Asian medical healthcare.

COVID Vaccine Update

While the media lauds two vaccines now approved by for emergency use as light at the end of a long tunnel, some healthcare experts remain circumspect. Earlier this week, the WHO (World Health Organization) warned of a possible six more months of severe disease spread in the Americas. Meanwhile, roll out of the Pfizer and Moderna products is facing both logistical hurdles and new questions about safety.

Shaky Scientific Basis

As mentioned in previous blogs, multiple concerns remain regarding the design and methodology of the Pfizer clinical trial. A variety of questionable research practices have been identified in the study including confirmation bias, volunteer bias, optional stopping, and lack of blinding. Far from the wild speculation of fringe conspiracy theorists, these research flaws have been pointed out by respected medical experts such as Peter Doshi, Assistant Editor of the British Medical Journal. Whether or not the study findings were skewed by volunteer bias was even a subject during the FDA vaccine advisory panel meeting, but Pfizer representatives responded with the claim that researchers cannot control who is recruited for clinical trials.

If the Pfizer research—which was stopped halfway to the estimated date of completion—was hurried, the findings announced by their competitor Moderna almost 2 years early were far more premature. During a second FDA vaccine advisory panel meeting convened to decide whether to recommend Emergency Use Authorization for the Moderna jab, a vigorous discussion revealed significant gaps in the company’s science. The panel of advisors, however, apparently took vaccine guru Dr. Paul Offit’s plea to simply ignore numerous questions unanswered by Moderna scientists to heart, voting unanimously to recommend the experimental shot for immediate public use by all adults 18 and older.

Early Days and Adverse Events

Within 48 hours of the first public vaccination administered in the UK, two recipients had already experienced life-threatening anaphylaxis after being vaccinated. Another serious adverse event occurred in Alaska, soon followed by a report of four recipients of the Pfizer jab in Libertyville who seemed to suffer severe allergic reactions. In the last case, Advocate Condell Medical Center temporarily suspended giving the vaccines, but the program was quickly reinstated.

The suggestion that some individuals might have a sudden adverse response to vaccine products appears to have blindsided both Pfizer spokespeople and healthcare officials. The drug makers insists that its study did not identify any severe allergic reactions. Meanwhile healthcare officials on the ground have speculated that the issue may involve bad batches of vaccines rather than the safety of the drug itself.

Compared to many pharmaceutical drugs, vaccines generally boast a reasonably good safety profile. As with any drug, however, a risk of adverse events does exist. Despite familiar claims to the contrary, no vaccine is “perfectly safe”, and the emerging pattern with Pfizer’s investigational COVID jab warrants closer analysis and further study. In the meantime, all vaccine recipients should be fully informed and asked to stay vigilant and communicate clearly with their healthcare providers.

Sending the Wrong Message

Even if the remarkable claims of efficacy over 90% are accurate, Pfizer and Moderna have only demonstrated that their vaccines prevent symptomatic disease. Asymptomatic vaccine recipients could still be spreading infection, and, in the studies from both companies, a small percentage of those who were vaccinated did become infected and showed clinical symptoms (Pfizer confessed to failing to further investigate these 8 cases). If public health officials and media outlets continue to tout vaccine benefits without strongly urging the public to continue employing all recommended NPI measures including mask wearing and social distancing, those who receive the vaccine might let their guard down and the number of cases and deaths could climb even higher.

Expedited Approval of a Second Vaccine

An FDA vaccine advisory panel meets today to discuss whether or not to recommend a COVID-19 vaccine developed by Moderna for Emergency Use Authorization. This follows closely on the heels of FDA authorization of a Pfizer vaccine for emergency use, a product already being administered to thousands of Americans. Depicted by many as magic bullets, the Pfizer and Moderna vaccines are raising the hopes of finally waking from the viral nightmare of SARS-Cov2.

Granting Emergency Use Authorization for Moderna’s jab, however, raises some concerns. Despite the reassurances from public health officials and vaccine advocates that research, development, and approval of these drugs was not hurried, company filings with the U.S. government by these two drug makers tell a different story. At Pfizer, although researchers designed their study to continue for 15 months, a decision was made to announce study outcomes after just 7 months. Moderna, on the other hand, planned a 27-month study but stopped it abruptly after only four months—clear evidence of just how much the science was rushed.

Nevertheless, there is tremendous pressure on FDA regulators to grant Moderna its EUA. According to reports, the U.S. government declined an earlier offer from Pfizer to preorder tens of millions of extra doses of their vaccine, a decision that threatens to bring the entire vaccination program to a screeching halt in March until more product becomes available, possibly in June. Meanwhile, the other options are currently limited. Research from Astrazeneca, the third runner-up, has been discredited to the point that the British-Swedish multinational is considering launching a second clinical trial. And, while there are other candidates, many hail from countries like China or Russia and are highly unlikely choices due to political pressure and negative public opinion.

Assembling the group of experts meeting as this blog entry is being written is clearly just a formality in the authorization process. With an advisory panel comprised primarily of vocal vaccine proponents wooed by authoritative presentations from Moderna representatives and FDA regulators making the case for the effectiveness and safety of the drug, there is little room for dissent. Although concerns from public interest groups and pointed questions on the science from the panel members are again expected, Moderna, like Pfizer, should be able to reasonably deflect problematic queries and plead ignorance wherever necessary. This will allow the FDA, which is expected to give an almost immediate green light to the Moderna jab, to make a specious claim that due diligence has been done.

What Does Emergency Use Authorization Mean?

Normal approval from the U.S. FDA for medicines involves applying for and receiving a BLA or Biologics License Application. In unusual cases, however, the regulatory agency will grant a drug company an alternate form of permission to distribute their medication via EUA or Emergency Use Authorization. FDA EUA’s can only be granted if and when three criteria are met: 1) No other treatment exists for the disease in question; 2) The condition causes deaths; 3) Preliminary research demonstrates provisional safety and efficacy.

In yesterday’s vaccine advisory panel meeting, a representative from the FDA characterized EUA drugs as underproven. In other words, EUA medications are essentially experimental and require further research and evidence before full FDA licensure can be conferred. As investigational medicines, EUA status comes with certain caveats and limitations. For example, pharmaceutical companies are barred from marketing EUA products via the usual advertising methods.

A number of medications have already been granted EUA’s by the FDA in 2020, with several authorizations offering cautionary tales. Hydroxychloroquine was granted EUA status on March 28th which was summarily revoked on June 15th for lack of reliable scientific evidence. Remdesivir—a drug its maker Gilead prepared to mass produce in January, in advance of any research findings—received EUA status for treating COVID-19 based on an NIH study stopped prior to its completion date. Despite a later WHO analysis of trials featuring over 7,000 participants showing that Remdesivir to be ineffective, the agency not only chose not to rescind the EUA but actually moved forward, granting a BLA. Most recently, baricitinib, a drug from Eli Lilly for treating arthritis, was given EUA for its ability to shorten recovery time in COVID patients by just 24 hours. Given the drug’s known potential for severe adverse effects, including blood clots, and its high cost—approximately $1,500 per patient—the FDA has drawn sharp criticism from healthcare watchdogs.

As the number of COVID cases skyrockets and more Americans die, appropriate EUA’s granted for safe and effective vaccines and drugs are a matter of life-and-death. Issuing EUA’s, however, demands solid science, free from the influence of politics or profit, and astute judgment fueled by an unflinching commitment to public welfare. Prematurely granting an EUA for hydroxychloroquine played a role in driving global research into its use for treating COVID-19 patients, squandering enormous financial and human resources. One can only hope that the FDA will exercise more rigorous oversight in the future to justify the trust it is asking from the American people as regulators approve more EUA’s with the hope of preventing and treating COVID-19.

FDA Approval of Pfizer Vaccine in the Bag

The FDA advisory panel charged with making a recommendation regarding emergency use for the Pfizer vaccine convened earlier today. After a packed scheduled which included a presentation by Pfizer, public comments, and an FDA discussion of their review process, 77% of the 23-member panel answered affirmatively to the question of whether the benefits outweighed the risks for use of the Pfizer product in individuals 16 years of age and older. When asked about the timeline for the final approval, an FDA spokesperson indicated that final Emergency Use Authorization could come in a few weeks but then corrected herself, suggesting the agency may make its decision in just a few days.

The pharmaceutical giant came prepared to defend its blockbuster drug. Contrary to its initial government filing which can be found on clinicaltrials.gov, Pfizer had data on most categories excluded from the original research design. While efficacy and safety findings on individuals with co-morbidities including hypertension and obesity were reassuring, it is clear that the drug company must continue its research and closely monitor the data long-term as the vaccine is rolled out to the community.

Pfizer offered more granular data that revealed that the percentage of study participants over the age of 65—the typical age bracket that defines the elderly in trials—was 16.7%, well below the 45% touted in Pfizer press releases that redefined the elderly as anyone 56 years old and above. This smaller sample size of the age with the weakest innate immune response demands consideration as the first doses are administered to the elderly care homes. If any single demographic is likely to see a drop in the whopping 94% efficacy claimed by the drug manufacturer, it will probably be this group.

Most of the concerns voiced during the advisory meeting revolved around safety, while the study design and the effectiveness of the vaccine received few challenges. Nevertheless, there were some red flags. Pfizer’s own data showed that a large number of those who received the experimental vaccine had telltale reactions. For example, approximately 30% in the experimental arm experienced chills, compared to about 3% who were given the placebo. These were minor reactions but may have allowed investigators to infer who had received the actual drug. If the blinding was affected, then researchers may have ordered more testing, which was left to the discretion of investigators, for the placebo group which could have, in turn, distorted the figures of vaccine effectiveness.

Also worth noting is the fact that the percentage of participants to contract the infection, both in those who got the real vaccine and the placebo arm, was lower than expected. As one panel member astutely pointed out, this potentially indicates volunteer bias. In other words, if a high percentage of clinical trial participants were unusually scrupulous regarding use of NPI measures such as social distancing and mask wearing, this also could have had the effect of inflating overall efficacy rates.

While the FDA pauses before issuing an inevitable approval, on the other side of the pond thousands of UK care home residents and medical professionals have already received the first doses of the Pfizer vaccine. Alarmingly, by the second day of the vaccination program, two healthcare workers had already experienced allergic reactions to the shot which resulted in life-threatening anaphylaxis. Absent from Pfizer’s clinical trials, these severe adverse events early in the British vaccination program beg the question of whether or not the study design generated accurate findings or strategically guided evidence to facilitate approval and enhance marketability. For many of us scrutinizing the details behind this developing story, it is hard not to wonder if more unpleasant revelations might lie ahead.

Safety of the COVID Vaccines in Pregnancy

Previously we have revealed that the Moderna and Pfizer vaccine trials employed numerous exclusions, including high blood pressure, diabetes, and even obesity. Pregnancy was an additional category of exclusion, which now, with vaccine rollout being imminent, raises questions regarding just how safe these experimental drugs might be for pregnant women and their unborn children. In the absence of even a single case from the clinical studies, one can only speculate based on general vaccine safety during pregnancy.

There are many reasons for study exclusions. Fundamentally, many drugs are only appropriate for certain individuals; for example, we do not test medications for ovarian cancer on male subjects. Some types of participants may be difficult to recruit, slowing development and increasing costs. In other cases, there is a concern that some study subjects might be at high risk of serious adverse events. For instance, the flu vaccine is not tested on the elderly for fear that the placebo recipients might contract a fatal case of influenza. Finally, pharmaceutical companies, who invest heavily in their R & D, have a vested interest in obtaining excellent outcomes which become more likely in a carefully selected population.

While there are good reasons for clinical trial exclusions, there also needs to be acknowledgment that the development of vaccines used to prevent COVID-19 infections ought to be different. To effectively bring the pandemic to an end, we need to reach the point of global herd immunity, necessitating that the vaccine be given to as much of humanity as possible. The clinical trials should have reflected this goal by minimizing exclusions to generate the most reliable data on the safety and efficacy of the vaccines across a broad and diverse population. Instead, we are left hoping that these medications will work similarly for all recipients, and special categories of individuals, such as pregnant women, are relegated to making independent risk and benefit assessment without even general guidance from drug manufacturers.

Making the Same Public Health Mistake Twice?

The CDC has formulated guidelines prioritizing healthcare workers and individuals in assisted care facilities for the first limited batch of the experimental COVID-19 vaccines. CDC officials reason that the former group operates in an environment with heavy exposure to the SARS-COV2 virus, while the latter is comprised of individuals at high risk for serious complications of COVID-19. Medical considerations aside, this decision also pays tribute to the sacrifices and courage of hospital staff and demonstrates compassion to our vulnerable and cherished elderly friends and family members.

But is this the ideal strategy given the current unprecedented surge? To reign in escalating numbers of infections and fatalities and keep Americans out of the hospital, the best approach is to target those individuals most likely to infect others. Medical professionals, who receive training in universal precautions, tend to be careful on and off the job and are rarely a source of community spread. Similarly, the risk of seniors quarantined in care homes transmitting disease to the larger population is low. So, even if the vaccines prove safe and effective in these first two groups, we may not see an immediate or marked shift in the transmission and spread of COVID-19.

Earlier in the pandemic, U.S. health authorities discouraged the use of masks by the public as late as April. They argued that although mask-wearing was necessary for any healthcare professionals who experienced frequent and concentrated exposure to the virus, it was not appropriate for the average American citizen. This misguided policy not only put the whole country at risk, it also placed immense strain on our hospitals and clinics, overwhelming staff and, ironically, increasing the chances for healthcare workers to become infected. Once again, one cannot help but wonder if the recommendation to vaccinate medical workers first is a case of a road paved with good intentions that will not lead to the desired destination.