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.

Advocating for Vaccines — More Faith, Less Science?

Recent developments with the COVID vaccines are troubling. In our last blog, we explored some of the possible methodological issues in the studies from Modern, Pfizer, and Astrazeneca, and the red flags keep coming. Astrazeneca announced that participants in the trial in Oxford were accidentally given an initial half dose which, curiously, increased the efficacy of the vaccine from 70% to 90%. Meanwhile, Pfizer’s rolling study has generated better outcomes, coincidentally bringing the efficacy of their product to just within 1% of the Moderna offering.

In the media, healthcare experts speak in absolutes preliminary to the public release of any firm data. Vaccine approval and efficacy are assumed, based on faith in the integrity of the pharmaceutical industry and the reliability of government regulatory agencies. So frenzied is the race ahead of solid scientific evidence, UK approval for distribution of the vaccines appeared to occur overnight—rapidly enough, in fact, as to lead vaccine czar Dr. Anthony Fauci to publicly accuse British healthcare authorities of cutting corners.

Undoubtedly these experimental vaccines will provide a benefit, but many questions remain unanswered. What will the true efficacy rate be in a much large population that includes those excluded—obese, hypertensive, diabetic, and immunocompromised individuals—from the Pfizer and Moderna studies? For those vaccine recipients who do respond well, how long will immunity last? Finally, what adverse effects may occur outside of a controlled trial limited to very healthy individuals once billions of people actually receive these vaccines?

Clearly there is little appetite in the healthcare industry to rigorously challenge the science behind the vaccines already beginning to roll out for emergency use by consumers. The combination of demand from an anguished and weary public and peer pressure within the medical field to consider all vaccines “perfectly safe” has resulted in healthcare professionals trading in judicious scientific skepticism for blind faith. We can only hope that in what essentially to amounts to final “phase 4” of clinical trials, where vaccinations are administered to all willing recipients, will demonstrate outcomes as extraordinary as those seen in drug company research.

How Reliable Are the COVID Vaccine Studies?

With the announcement of a third successful COVID-19 vaccine trial from UK researchers at Oxford, candidates for a viable vaccine are multiplying rapidly. Media reports focused on the exceptionally high efficacy rates of the three forerunners have given all of us the good news we crave, tempered only by the reminder that the logistics of production and distribution will delay the effort of getting everyone vaccinated. Our review of the available Pfizer data, however, also raises some questions about the core research—issues which could apply to the trial from Moderna as well.

One factor that threatens to distort the accuracy of any COVID-19 vaccine trial is the uniquely confounding role of human behavior during this pandemic. Clearly most individuals who are willing to receive an investigational vaccine are also often more likely to take measures such as mask-wearing and social distancing. Although this applies to the placebo and vaccine recipients alike, one might reasonably conclude that the majority of study participants would experience less frequent and concentrated viral exposure than the statistically average person. Accordingly one could expect the 95% efficacy rate to shrink once the vaccine is administered to the public where a significant percentage of people are unwilling or unable to use NPI measures but may, nevertheless, eventually acquiesce to taking a vaccine.

Many of the studies into potential COVID-19 vaccines use antibody assays to directly assess the response to vaccination. In contrast, both Pfizer and Moderna decided to test effectiveness indirectly by administering either the vaccine or placebo followed by monitoring for symptoms and testing of symptomatic subjects. The research concluded with approximately 170 subjects in the Pfizer study who tested positive for COVID-19 being separated into a vaccine and a placebo group, yielding a efficacy rate of 95% in the experimental arm of the study.

We now know from extensive investigation into COVID-19 that there are many people who are asymptomatic but contagious. Moreover, vaccines often reduce the severity of the symptoms of disease. If only participants who report clinical manifestations are tested, there is a risk of missing subjects with mild or no symptoms—possibly due to the effects of the vaccine—who are nonetheless infectious. In a national vaccination program, this could lead to the dangerous situation of increases in the number of asymptomatic spreaders.

It is also necessary to recognize that the Pfizer study recruitment applied extensive exclusion criteria. Individuals with hypertension, diabetes, chronic lung disease, asthma, and immune disorders were all excluded, despite the fact that these are exactly the people most susceptible to the most serious complications of COVID-19, not to mention more likely to contract a virus. Those who smoke or vape and obese persons, the latter which represent more than 40% of the American population, were also excluded, as well as healthcare professionals and others whose occupation puts them at a higher risk. Healthcare professionals, subject to special circumstances (heavy exposure mitigated by PPE) not tested by the Pfizer study, are, incidentally, the first demographic slated to receive the vaccine.

Regarding vaccine efficacy among older patients, the Pfizer press releases and website information tout a 94% rate of effectiveness among subjects 65 years and older. As promising as this number may be, it is difficult to ascertain how many subjects weren actually included in this group. Pfizer boasts a whopping 41% international and 45% domestic percentage of elderly participants in their clinical trial, but these sizable figures were adjusted—ostensibly for optics—by including subjects as young as 56 years of age. Ultimately, how many of the study participants actually fell into the standard senior age bracket of 65+ is not immediately clear, calling into question the true statistical significance of the 94% efficacy rate.

Many have voiced apprehension that current vaccine research may be too accelerated to guarantee efficacy and safety. In the case of the Pfizer study, the goal posts for the study end date were moved all the way from the proposed date in June of 2021, mentioned in their governmental application, to last week. Not unlike the NIH study of the drug Remedesivir—recently shown ineffective against COVID-19 in a WHO study—the research parameters were altered to stop the trial when the target number of infected subjects was reached. This breakneck pace of vaccine development, a mad race to take credit for saving the world while reaping staggering financial reward for medicating most of humanity, increases the probability for research errors.

Desperate for some promising weapons to battle the pandemic, we all hope for the best with these novel vaccines. Nevertheless, it is vital that we cultivate realistic expectations to prepare the public for the possibility of disappointment and to ensure the continued use of the proven NPI precautions. Here, that familiar adage, expect the best, but prepare for the worst, may be the best advice.

A Call for Cautious Optimism

Now that the traditional cold and flu season is upon us, predictions of a second wave of COVID-19 have become an all too grim reality. The epidemic is worse than ever before with Texas, where bodies are literally pilling up faster than the local morgues can make room, becoming the first state to surpass one million infections. There is, however, good news: both Pfizer and Moderna have announced extraordinary outcomes in sizable vaccine studies, a ray of hope welcomed by a weary world in these dark days of despair.

Originally developed by Chinese doctors almost a millennium before Edward Jenner figured out how to use cowpox to reduce the risk of contracting smallpox, vaccines have evolved from the use of actual tissue from infected individuals to the live attenuated and inactivated vaccines we know today. Now the newest vaccines utilize the novel method of harnessing messenger RNA, allowing for improved safety profiles and more rapid development.

Pfizer stocks soared on the news that their vaccine might offer 90% efficacy, while Moderna upstaged the latter with the report that their vaccine could be as much as 95% effective. In both cases, we have yet to see the raw data to confirm these claims, and these numbers seem almost too good to be true. Approval is, nevertheless, likely to occur rapidly via emergency access, and some Americans—most likely the healthcare workers at highest risk—might receive their first dose of one of these two vaccines as early as next month.

Absent the typical due diligence which takes time, it may be months before the full picture of the efficacy and safety of these vaccines comes into clear focus. In the meantime, health officials must tackle the daunting task of convincing a skeptical American public, many of which are unwilling to even wear a mask or follow social distancing rules, to take what is essentially an investigational drug. As more doses are administered, reports of worrisome adverse events and failed efficacy are increasingly likely, further impeding efforts towards the final goal of reaching the 50% herd immunity needed to rein in the pandemic.

Based on his study of the history of epidemics, Yale medical doctor and sociologist Nicholas Christakis and author of Apollo’s Arrow has predicted that the pandemic will probably persist through 2022. As much as we would all prefer an easy way out via some miracle drug or a massive vaccination program, even the basic logistics point towards at least another year before we can begin to let our guard down. If the recent surge in COVID infections is any indication, a false sense of complacency may ultimately be as dangerous as the virus itself. Especially during this convivial holiday season, please, take precautions, be careful, and stay well.

Remdesivir - Better Than Nothing for COVID-19?

As the world struggles to find solutions to the pandemic, numerous treatments have been proposed, offered by sources ranging from credible experts to fringe crackpots. The U.S. government has made both formal and informal suggestions, but at this time the only medicine with provisional FDA approval is Gilead’s remdesivir, a nucleoside analogue prodrug. The curious and convoluted story of this medication raises questions, however, both about its efficacy and safety, as well as the possible political and financial motivations behind the FDA recommendation.

Gilead debuted remdesivir in 2009 as a potential cure for hepatitis C. After proving ineffective, the drug was proposed as treatment both for ebola and the Marburg virus, but no benefits were seen in the clinical trials. Based on animal research that suggested activity against the corona viruses, a Chinese study earlier this year took another look at this three-time loser as a treatment for COVID-19. Although the study was discontinued early owing to serious safety concerns, preliminary data showed no improvement in either clinical symptoms or mortality rates. Even more telling, the research found no detectable decrease in viral load in the upper respiratory tracts of infected patients.

Nevertheless, the governmental National Institute of Allergy and Infectious Diseases—whose director is Anthony Fauci, well-known as the spokesperson for White House Corona Virus Task Force—launched the ACTT-1 study on February 21st to look at whether or not remdesivir offered any benefits to patients with COVID-19. On March 20th, President Donald Trump announced to the nation that remdesivir has been approved for extended use access. Two days later, an NIAID team met behind closed doors and agreed to change study parameters. Instead of a set end date, the ACTT-1 research would conclude when 400 patients had recovered, with the revised study evaluating only three, rather than eight, general criteria. The update in study methodology was followed the next day, on March 23rd, by Gilead’s decision to voluntarily suspend extended use due to supply shortages.

The well-connected pharmaceutical company, whose past board members include conservative Secretaries of State George Schultz and Donald Rumsfeld, had, in fact, begun preparations early in 2020 for approval and distribution of remdesivir. In January, Gilead not only began testing of the orphaned drug for COVID-19 benefits, the reactors at its Edmonton, Alberta plant were also reactivated for the production of large quantities of remdesivir, while the raw materials poured in from their contract manufacturers. On February 2nd, one hundred kilograms of residual stock from the Ebola production was sent to the factory in LaVerne, California to be packaged in vials. When a fresh batch of the drug was completed in Edmonton in April, Gilead was poised for formal FDA approval for extended use on May 1st. Although public announcements for extended use access had first occurred on March 20th and, later, on May 1st, it has been revealed that the earliest compassionate use for COVID-19 patients had actually begun on January 25th, long before study outcomes indicating effectiveness.

As the available facts demonstrate, both production and clinical use of remdesivir occurred before the tax-payer funded ACTT-1 study began. Extended use continued despite Chinese study evidence showing the drug was ineffective and risky, and the NIAID modified its study just two days after the drug was enthusiastically touted by the White House. Many have since criticized the ACTT-1 study for its failure to establish whether remdesivir improves mortality rates in patients, as well as for flaws in its research methodology.

In the face of facts that indicate that remdesivir was likely approved not on the basis of solid scientific evidence but largely for political and financial gain, we can only wait for objective findings from the WHO’s international Solidarity Trial to either deny or confirm the conclusions of the ACTT-1 study. In the meantime, NIAID’s own Clinical Director, H. Clifford Lane, M.D. may have said it best when he characterized the use of remdesivir for COVID-19 as “better than nothing”. On the other hand, as a drug with an number of serious known adverse effects, including respiratory failure, there seems to be insufficient proof to show that remdesivir for COVID-19 is truly better than receiving no treatment at all.

Clinical Protocols in Supermarkets

In the U.S. today, few of us are self sufficient. We do not make our own furniture, build our own homes, and, perhaps most importantly, we do not grow and raise our own food. In other words, without the support of a wide range of business, we simply would not survive.

While most of us may be able to shelter in place, complete isolation is impossible. At the very least, we must be able to have essential goods and services delivered to us. If the pipes burst, we have to call the plumber to avoid property damage and the growth of toxic mold. Many Americans, especially the elderly, take several kinds of prescription medications which have to be delivered or picked up at the pharmacy. And, of course, without groceries, almost all of us would eventually starve to death.

A small minority have the option of just staying at home and asking delivery people to set the parcels down on the doorstep and run. Even precautions this scrupulous, however, do not firmly guarantee that viruses have not hitched a ride on packages or produce, and the one minute spot we miss disinfecting may turn out to be the vector for transmission of COVID-19. Our basic dependence on others for the goods and services needed to exist in 2020 puts us all at risk.

The average individual, of course, will choose to go out and shop in person for food. So the most careful don full battle gear, others rely on general social distancing guidelines, while the contrarians throw caution to the wind and act as if it is all business as usual. At any rate, every human being must eat to stay alive, so out to the grocery stores we go in search of sustenance to get through the lockdown.

Unfortunately, everything ultimately depends on supermarkets using suitable practices to minimize risk, putting grocery store managers and employees in the impossible position of applying protocols for reducing the transmission of infectious disease—a task normally reserved for clinics and hospitals. Certainly larger chains employ health and safety experts who set broad corporate policies based on current information, but each individual store and its employees will inevitably vary in their ability, and willingness, to correctly follow the company guidelines.

Admittedly, even healthcare providers differ widely in their level of training and adherence to hygiene and safety practices, but some core concepts and methods are incorporated throughout healthcare. For example, the golden rule of universal precautions, where the only right assumption is that everyone, even without a diagnosis or any symptoms, should be treated as if he or she had a contagious disease, is known to almost every healthcare worker. On the other hand, for the general public—including grocery store cashiers, deli staff, and meat cutters—this precept of universal precautions is a novel idea that can be difficult to fully grasp. “You won’t get it from me…I’m not sick!” And no one, not even the store manager, is likely to be able to tell you whether the spray used on cart handles is a low, intermediate, or high level disinfectant.

As healthcare professionals roll their carts through the aisles and observe supermarket employees doing their best to climb the steep learning curve of working out how to minimize the risk of infectious disease, mistakes are all too obvious. Recognizing that store clerks cannot possibly adhere to clinical protocols in no way detracts from the great respect and admiration deserved by these employees who continue to serve the customers, despite the real risks. Instead, our intention is to raise the awareness that, whenever venturing out for crucial supplies, everyone needs to be personally responsible. We cannot depend solely on others to keep us safe and healthy through this crisis. Be smart and stay vigilant.

Explanation of the Obesity Paradox with Immunotherapy in Non-Small Cell Lung Cancer

In a December 26th article in JAMA Oncology, researchers reported that overweight patients who receive immunotherapy for NSCLC (non-small cell lung cancer) enjoy better overall survival rates than patients at a healthy weight. Survival rates for overweight patients were 19% better than those at normal BMI, while obese patients demonstrated a whopping 30% gain over those at a healthy weight. The investigators, from the Flinders Centre for Innovation in Cancer in Bedford Park, Australia, generally cited the “obesity paradox” but offered no specific explanation for the startling discrepancies.

From a TCM point-of-view, overweight and obese patients present a Chinese medical pattern of phlegm-damp accumulation. For anyone who reaches middle age, it is all too obvious that we gain weight more easily as we get older. According to Chinese medicine, it is the decline of qi which is responsible for this phenomenon. The five primary bodily functions of qi are movement, transformation, protection, containment, and warming. As the digestive movement and transformation mechanism weakens with age, unprocessed residue accumulates as dampness and phlegm—what is referred to in Western medicine as adipose tissue.

Following the Chinese medical syllogism, the overweight and obese patients observed in this study all present patterns of phlegm-damp accumulation with varying degrees of underlying spleen qi vacuity. The immunotherapeutic agent administered—unlike more traditional oncological care which directly destroys cancer cells—harnesses the innate power of the immune system to eradicate tumors. From a traditional Chinese medical perspective, we would describe this approach as using the body’s own qi to fight cancer. The fact that overweight and obese subjects survive longer is attributable to the fact that the treatment suitably fits their Chinese pattern, providing qi where qi is conspicuously absent.

Chinese medicine has long utilized the effective strategy of fu zheng or “supporting the right” to manage cancer cases. Like innovative Western medical immunotherapy, the Chinese approach works by helping the body to help itself and, in doing so, improves baseline energy levels and stimulates bodily function. One curious difference between traditional Chinese fu zheng treatments and the primary drug, atezolizumab, featured in this study: while Chinese treatment energizes tired patients, the immunotherapeutic agent often causes shortness of breath, poor appetite, and fatigue—all indications of qi vacuity. It would seem that while Chinese herbal formulas boost qi systemically, this new drug selectively enhances the movement and transformation actions of qi while depleting qi in its other forms and functions.