“A vaccine that nobody wants to take is not very useful.”
If there were a safe and effective vaccine against COVID, why wouldn’t people take it? After all, the virus has claimed 200,000 American lives, shut down schools and businesses and affected almost every aspect of our lives. The fact that scientists have been able to develop vaccine candidates in mere months after sequencing SARS-CoV-2’s genetic code is nothing short of a medical marvel. However, our country’s hyper-polarizing climate has thrust the rapid vaccine progress into the political ring, resulting in rising public distrust.
There’s a reason progress on the vaccine has been so fast. The Trump administration implemented “Operation Warp Speed” (OWS) five months ago, which aims to produce 300 million doses of vaccines by January 2021 with an approved budget of $10 billion.
So far, OWS results seem promising. There are nine vaccines in phase 3 trials, the final phase before submitting for FDA approval. For details on how clinical trial phases work click here. Frontrunners include Moderna and Pfizer, which use inactivated coronavirus fragments to induce an immune response, and AstraZeneca, which uses an adenovirus to carry coronavirus genes into cells, provoking an immune response.
Even with promising results, the public remains nervous. A new Kaiser Family Foundation (KFF) poll showed 62% expressing concern that political pressure from Trump would force the FDA to approve a vaccine without ensuring safety and efficacy. Less than half (46%) would get vaccinated if a vaccine were approved by the FDA before the election. Another poll from STAT echoed the KFF poll, with 78% worried that vaccine approval is driven by politics more than science.
The integrity of the FDA has been put in question, catching the ire of administration, scientists and the American public. On one hand, Trump has claimed an FDA ‘deep state’ that is committed to thwart his reelection by delaying a vaccine until after the election. On the other hand, scientists and the public are increasingly skeptical of the FDA, as the agency pushed out Emergency Use Authorization (EUA) for hydroxychloroquine after Trump touted it. The EUA was later rescinded.
More recently, the day after Trump called convalescent plasma a “medical breakthrough” the FDA gave plasma an EUA. It was promptly pointed out that misleading statistics overdramatized plasma’s benefit and the statement was later rescinded… via Twitter.
The mounting criticism of the FDA being controlled by the White House reached such a fever pitch that last week, in an opinion column in USA Today, eight career scientist at the FDA made a pledge that their work would continue unimpeded and independent of political influence. They stated “if the agency’s credibility is lost because of real or perceived interference, people will not rely on the agency’s safety warnings” and later adding “We and our career staff do the best by public health when we are the decision makers, arriving at those decisions based on our unbiased evaluation of the scientific evidence.”
Big Pharma is far from exempt. Many scientists say these vaccine makers need to be more transparent about how vaccine trials are run and reporting adverse events. In normal circumstances, drug companies hold clinical trial results precious in order to guard intellectual property and maintain competitive advantage. However, critics say that American taxpayers are entitled to know the details since the federal government has spent nearly $10 billion as part of OWS.
The most recent example of transparency (or perhaps lack thereof) is the incidence of a rare but lethal spinal inflammatory disorder called transverse myelitis in AstraZeneca’s Phase 3 trial, which immediately halted the trial. Trial shutdowns are common, and perhaps this instance demonstrates that drug companies are willing to slow down warp speed for the sake of patient safety. However, many are upset is that the shutdown was announced in a closed private meeting with investors and was actually leaked by STAT News.
Despite our best efforts, SARS-CoV-2 has endured long enough to welcome influenza’s 2020-2021 campaign and there is rising concern that even a mild flu season could overload hospital systems already dealing with COVID-19.
This so-called “twindemic,” while sounding alarmist yet with rational undertones, can be attenuated by the simple preventive measure of vaccination.
To put this in perspective, influenza is historically one of the top 10 leading causes of death in the United States annually. The 2019-2020 flu season was mild, yet resulted in 740,000 hospitalizations and up to 62,000 deaths nationwide, 4,500 of which were in Virginia. The most recent severe flu season was 2017-18 with 810,000 hospitalizations, and the CDC estimates that vaccination prevented 7.1 million illnesses, 3.7 million medical visits, 109,000 hospitalizations, and 8,000 deaths. Even though influenza has become normalized and even trivialized to the public, the ramifications of the virus on our healthcare system are significant and we are fortunate to have vaccines that work.
Most individuals who get the flu recover without serious complications. However, pregnant women, elderly, very young and anybody with certain chronic medical conditions are more susceptible to hospitalization and death if infected. While there are no reported cases of simultaneous influenza and COVID infection, it is reasonable to infer that the consequences would be dire.
Vaccination is proven to reduce prevalence of influenza and mitigate symptoms, leading to less outpatient visits, hospitalizations and intensive care admissions. By comparison, COVID has no vaccine and has claimed more than 183,000 lives nationwide and in Arlington has resulted in 460 hospitalizations and 140 deaths in just a few months. COVID rates have trended downward in Arlington, but anything that could spike COVID or flu cases such as not-so-socially-distant maskless gatherings, rallies, protests and crowded bars could unfavorably tip the scales and overwhelm the healthcare system.
So in addition to hand washing, facemasks and social distancing, we should add getting the flu vaccine to the list of things we can do to help during the pandemic. Seems simple enough, but proactive flu fighting presents a few big challenges.
Only 47% of Americans got the flu vaccine last year. CDC Director Robert Redfield stated in a recent WebMD interview that his goal for the upcoming flu season is 65%, and he plans to accomplish that by expediting vaccine availability (they have been available since mid August), increasing vaccine production to nearly 200 million (up from 85 million last year), and having the CDC purchase 10 million doses (up from 500,000) to give to uninsured adults.
Fourteen years of school and training is needed to become a physician specializing in infectious disease. Yet when it comes to novel treatment for COVID-19, a former crack addict who has made millions selling pillows has as powerful a voice as a doctor.
The race for a cure presents both opportunities and challenges to how we evaluate novel treatments and we are witnessing how drug approval can go awry during a pandemic. As a doctor, it is frustrating and concerning to see so many Americans place their trust in politicians and entrepreneurs over evidence-based medicine. It leaves me wondering if the role of a physician, and science in general, is devalued.
In this case, without adequate scientific backing, President Trump expressed enthusiasm for the Food and Drug Administration (FDA) to approve an experimental botanical extract called oleandrin as a cure to COVID-19. MyPillow CEO Mike Lindell has been the biggest champion for oleandrin, stating “It’s an absolute miracle. I take it every day. I don’t get the virus. I have at least 50 to a 100 of my friends and family. Some that got it, and in two days they’re fine.” No, you’re not reading The Onion or watching a late-night infomercial starting with “from the maker of MyPillow…”
Turns out that Andrew Whitney, executive of oleandrin drug maker Phoenix Biotechnology, enlisted outspoken Trump donor Lindell, who also has financial stake in the company, to speed up approval. Lindell then got HUD Secretary Ben Carson aboard and arranged for a private meeting with Trump in July to tout how oleandrin can cure COVID.
In addition to anecdotal stories, Lindell and Whitney reference a study that suggested oleandrin can inhibit SARS-CoV-2 replication in monkey kidney cells in vitro. However, the study was not peer reviewed, not tested on humans and one of the authors was previously a chairman of Phoenix Biotechnology’s scientific advisory board. To date, there is no peer-reviewed randomized control trial in humans showing efficacy of oleandrin against COVID-19 — it could in fact be lethal — yet members of the administration want it thrust to the masses. Perhaps more concerning than the paucity of science is how easy it was for Lindell to push this product at the highest level.
We have seen this tactic before, in which entrepreneurs push unproven products as if it were a Shark Tank sales pitch in hopes that Trump will urge FDA Commissioner Stephen Hahn to expedite approval. For example, in March, Trump personally urged Hahn to authorize hydroxychloroquine for emergency treatment. The FDA obliged but later rescinded authorization after it was deemed ineffective and could actually cause serious heart arrhythmias.
The summer heat has arrived and despite holding our collective breath, the coronavirus has not miraculously disappeared. In persevering through a shutdown, a three-phase reopening, and now an emergency ordinance to limit sidewalk traffic, we have learned that we are resilient — but the cracks are starting to show in our population’s mental health.
In fact, nearly 30 percent of Americans are experiencing symptoms of clinical depression as of late July, compared to 6.6 percent last year based on a recent National Center for Health Statistics and Census Bureau’s Household Pulse Survey. The numbers for anxiety closely mirror with 36 percent compared to 8.2 percent last year. The number of online mental health screenings has increased 400 percent. Perhaps the most alarming — albeit uncited — statistic comes from CDC director Robert Redfield, who stated that there have been far greater suicides and drug overdoses than COVID deaths among young people since the lockdown.
I have experienced this upward trend firsthand. There has been a doubling of old and new patients coming into the clinic for ketamine infusions, a relatively new FDA-approved modality used for treatment of depression and anxiety. The most commonly cited reasons I hear include: fear of getting sick, grief from sick loved ones, financial distress, loss of job, loss of community, home-life stress, and reduced access to healthcare. There is also something I call “COVID fatigue”, which is over-saturation of COVID coverage in the news and social media and includes the accompanying stress of teasing out fact from fiction. I realize the irony as I contribute another COVID article to the milieu.
How do you know if you are having depressive symptoms? The challenge is that depression and anxiety are on a spectrum, and sometimes it’s hard to pinpoint if it’s just a “bad day” or something more insidious. However, if feelings such as persistent sadness, emptiness, irritability, guilt, pessimism and emotional distancing occur for weeks and adversely affect sleep, appetite and work, then you may be dealing with pandemic-induced depression or anxiety.
There are measures you can take if you suspect you are depressed or anxious. If the symptoms are severe and debilitating, then contact your mental health professional. If suicidal, check yourself in to the hospital or at the very least call the National Suicide Prevention Lifeline at 1-800-273-8255 or text HELLO to 741741 for the Crisis Text Line.
Here are some additional preventative measures.
Keep a schedule — This is game-changing if you have been laid off or need to take care of children. Interestingly, keeping a schedule for children has been shown to prevent childhood mood disturbances–particularly germane given full distance learning for Arlington Public Schools this fall. Creating goals that can be reasonably accomplished, such as reading a book or daily neighborhood walk, can boost dopamine in the brain and increased motivation and sense of accomplishment.
Connect with loved ones — Set time to reach out to close friends and family by phone, FaceTime or Zoom. Social connectedness is often overlooked, but is crucial in mental well-being.
Reevaluate mindset — While there are undoubtedly many negative things the pandemic has brought, it can be helpful to reframe your perspective and think of how the pandemic has been positive for you. For example, perhaps you have saved significant money from not traveling and dining out, or have gotten closer to family and friends. Doing this will also likely enhance your sense of gratitude once things normalize.
Utilize telemedicine — There is no need to feel medically stranded, as telemedicine use has increased out of necessity. Therapists and psychiatrists have pivoted to using it almost exclusively in many cases.
If your loved one is experiencing depression or anxiety, try to listen and validate the reasons for their feelings as opposed to trying to fix the situation. Let them know there is no weakness in seeking psychiatric help.
“Safer at Home” doesn’t necessarily mean it is safe to be home when it comes to mental health. However, unlike COVID-19, there are proven ways to help prevent and treat depression and anxiety, and success starts with recognition of symptoms and seeking appropriate help.
Dr. George C. Hwang, known to his patients as Dr. Chaucer, is a practicing anesthesiologist who also helps to run Mind Peace Clinics in Arlington. He has written for multiple journals, textbooks and medical news outlets, and has been living in Arlington for the past 15 years.
“It felt like they were tickling my brain.”
No, my patient wasn’t describing a complex neurosurgery. He was describing the 6-inch nasal swab used to sample his nose for COVID-19 testing, a common requirement before proceeding to surgery.
Virginia recently initiated Phase 3 reopening, and like the increasing sidewalk bustle on Wilson Boulevard, operating rooms have also been reinvigorated as elective surgeries are once again being performed. If you are like many Americans that have delayed care due to coronavirus, you may be wondering “Is it safe to have elective surgery during COVID?”
In fact, half of Americans postponed medical care due to COVID, and a third of those plan to get care in the next 3 months. Demand far exceeds supply, and some experts estimate an elective surgery backlog of up to 45 weeks in some hospitals. However, the solution isn’t as simple as booking as many elective surgeries as possible. Hospitals have to balance increasing surgery bookings to meet patient demand (and quite frankly, to stay financially afloat) while still saving capacity for a potential COVID surge. As ARLnow readers know, COVID numbers change rapidly, and presurgery protocols adapt to those fluctuations. So what can you do to proceed safely?
If you’re considering elective surgery, here are some questions you can ask your doctor that will help you make an informed decision.
How important is the surgery?
This is the single most important question. In an ideal world, patients should feel comfortable asking their surgeon and expect an honest, unbiased response. Elective does not mean “doesn’t need to be done” — it means surgery can be scheduled and oftentimes patient come from home. However, elective can become urgent, such as surgeries related to cancer treatment. I’ve seen this happen numerous times in the past several months. On the other hand, elective cases such as carpal tunnel release or cosmetics are rarely urgent.
In addition, your doctor should assess your personal risk based on your underlying health. For example, if you’ve had a recent heart attack, uncontrolled diabetes or severe lung disease, then your risk for needing the intensive care unit (ICU) after surgery is higher. Many ICUs, as seen in NYC and now Florida, need as many beds as possible during COVID spikes. In fact, some local hospitals utilize a risk-stratification calculator based on patient’s baseline health, and if the score is too high then surgery will be postponed. A high score means higher likelihood of needing that coveted ICU bed after surgery.
What is the hospital doing to make sure I don‘t get COVID?
Catching COVID while in the hospital may be the biggest source of anxiety for patients considering surgery. There are questions you can ask to assess how hospitals are reducing that risk, such as:
- Are there adequate personal protective equipment (PPE) like N95 respirators? Supply of PPE in Arlington has been good, and yes, the stories of reprocessing N95s are true.
- Are staff being screened or tested?
- What’s the protocol for COVID-positive surgery patients? Are they performed and recovered in dedicated rooms?
- Are patients being tested prior to surgery?
Do I need to get tested before surgery?
Most likely yes. There are many times I have seen patients arrive day of surgery after refusing testing, and consequently turned away. In Arlington, most operating rooms require a negative COVID test before surgery (some test day of surgery, others 3 days before). Patients are then advised to self-isolate leading up to surgery–an honor system. I’ve experienced a few speed bumps with this new workflow, most commonly delayed COVID test results. Hospitals have rapid one-hour tests, but those are ideally reserved for emergencies due to limited availability, though some use it for every elective case.
If the answer to these questions are reasonable, then elective surgery can be safe. Perhaps all this testing and precautions is overkill, but it seems healthcare associated transmission is controlled. Patients I’ve spoken to are reassured by all the measures taken to protect them before surgery, even if it means enduring a tickle in the nose.
Dr. George C. Hwang, known to his patients as Dr. Chaucer, is a practicing anesthesiologist and helps run Mind Peace Clinics in Arlington. He has written for multiple journals, textbooks and medical news outlets, and has been living in Arlington for the past 15 years.