Tag Archives: COVID-19

The Economic Impact of Wearing Face Masks During COVID-19

COVID-19 is having a resurgence.

As of Friday, July 3, data from the Covid Tracking Project showed that the 7-day average number of daily new US cases rose to 47,244, a 37% increase relative to 34,476 the previous Friday. The percent of cases testing positive rose to 7.5% from 6.4% one week earlier.

Texas and Florida are particularly hard hit. Texas reported a 47% increase in hospitalizations Monday compared to a week ago while Florida posted a record high of nearly 11,500 cases on July 4.

To reduce the spread of COVID-19 public health experts and the CDC recommend “that people wear cloth face coverings in public settings when around people outside of their household, especially when other social distancing measures are difficult to maintain,”

Despite this, it is obvious that many individuals, particularly in Southern states are refusing to wear masks.

While driving to and from Tulsa, Oklahoma over the recent Father’s Day Weekend we were surprised that very few individuals were wearing masks in the convenience stores, gas stations and rest stops we entered. Similarly, my daughter related that during her recent drive from North Carolina through Tennessee, western Kentucky and southern Illinois to St. Louis almost no one was wearing masks indoors.

At the Trump rally in Tulsa perhaps 1 in 50 attendees were wearing masks inside the BOK Center.

What can we do to convince these non-mask-wearers (NWMs) to mask up?

A common reason cited for not wearing masks is that it represents an infringement on personal freedom. This concept prompted a tweet from the US Surgeon General 

Screen Shot 2020-07-07 at 7.09.19 AM

The infodemic of internet-based news, pseudoscience, and opinion that has sprung from the pandemic feeds into the failure to wear masks.

Kaiser Health News has pointed out that conflicting Covid-19 messages are creating confusion around public health and prevention. NewsGuard has identified 217 websites in Europe and the United States that publish “materially false” information about COVID-19.

Appeal to the Pocketbook

Perhaps an appeal to the pocketbook could convince the NMWs?

My financial advisor, Stuart Coats, sent out an email to clients over the July 4th weekend which included an excellent discussion which emphasized the economic and financial consequences of not wearing masks:

I can’t emphasize enough how the resurgence of COVID-19 in the US is a huge threat to our economic recovery. It only takes a single chart to demonstrate how inadequate our response has been. The chart below compares daily reported cases in the US (red line) to the European Union (blue line). Keep in mind the population of the EU is about one-third more than the US and the EU population density is three times that of the US. Our nation is richer than the EU and spends far more of GDP on healthcare and yet, while we were seeing about the same number of daily cases at the beginning of April, the EU proceeded to crush their new cases over about a month while we saw more of a plateau with downward drift over 2 months and then a massive spiking starting in the middle of June. As a result, many states are having to backpedal on their reopening plans and finally acknowledge the importance of wearing a mask.
EU vs US


A new study from the University of Washington’s Institute for Health Metrics and Evaluation projects that near-universal wearing of face masks could save 18,000 to 28,000 lives nationwide just by October 1. A recent report from Goldman Sachs suggests that a national mask mandate could partially substitute for renewed lockdowns in states with surging cases and prevent a 5% reduction in gross domestic product.

A recent survey done at the state level by data collection company Premise looked at the frequency of people always wearing a mask when going out. It found usage ranging from only 15% in Tennessee to 62% in Massachusetts. It is probably no coincidence that Tennessee is currently seeing a massive spike in cases to record-setting levels (now 10th worst state in the nation on a per capita basis) while Massachusetts which was once a national hotspot, now has a lower per capita rate of new cases than all but six other states.

It should be clear to all of us by now that wearing a mask is not only a neighborly thing to do, the life it could save could be your own or that of a relative or friend and wearing a mask is also good for jobs and for your portfolio value.

Stuart ends with a comparison of mask-wearing to the sacrifices our Founding Fathers made which I hope resonates with all liberty-loving Americans.

“If the signers of the Declaration were willing to mutually pledge to each other their lives, their fortune and their sacred honor, surely during a pandemic, we can manage the inconvenience of wearing a mask in public for the sake of our mutual health and economic well-being.”

Perhaps we can have the above sentence printed and displayed prominently in all public places where we can’t maintain social distancing. Will this appeal to economics overcome all the misinformation and misguidance that is out there?

Skeptically Yours,

-ACP

Can We Learn From History? The Tulsa Race Massacre, The Deadly Philadelphia Parade, and Covid-19

The skeptical cardiologist is in Broken Arrow, Oklahoma this Father’s Day weekend visiting Pops Pearson after a 2 week quarantine and a 6 hour drive. As fate would have it, we are not too far from the BOK Center in nearby Tulsa, where MAGA supporters have been queuing up since Thursday night in anticipation of President Trump’s campaign rally there today.

Tulsa’s local news has become national news as yesterday there were peaceful gatherings celebrating Juneteenth in the Tulsa Greenwood area and today it becomes the epicenter of Trump’s reelection campaign, and perhaps the epicenter of COVID-19 resurgence.

The Tulsa Race Massacre

Despite growing up in nearby Bartlesville and visiting Tulsa frequently over the years, until recently I was unaware of the horrible atrocities committed in the Greenwood area in 1921.

The New York Times yesterday published an article entitled “The Burning of Black Wall Street, Revisited” which provides details on what is now also termed the Tulsa Race Massacre.

” in the prosperous black district of Greenwood, white vigilantes systematically torched nearly 40 square blocks. Gone in the blink of an eye were more than 1,000 homes, a dozen churches, five hotels, 31 restaurants, four drugstores and eight doctors’ offices, as well as a public library and a hospital. As many as 9,000 black Tulsans were left homeless. Photographs from the period depict shellshocked survivors being marched at gunpoint to temporary concentration camps.

merlin_173450556_07b76edb-5f98-4116-80ed-e74cef4469bf-superJumbo

The Rally

For unclear reasons, Donald Trump has decided to have a campaign rally today about a mile from Greenwood, and in a state and city facing an uptick in COVID-19 cases.

Below is the most recent graph of cases from Tulsa County’s health department:

covid tulsa

As USA Today noted, the Governor of Oklahoma seems unaware of the recent rise in cases and is confident that Oklahoma has safely reopened.

Oklahoma cases of COVID-19 rose by 450 on Thursday, blowing past the record 259 daily cases reported on Wednesday, as the surge of infections continued ahead of a massive rally for President Donald Trump and demonstrations set for this weekend in Tulsa.The Oklahoma State Health Department’s daily update showed Oklahoma City added 80 cases and Tulsa added 82, as the state’s total rose to 9,354. There were two additional deaths, raising the total to 366. The figures were released not long after Gov. Kevin Stitt participated at a roundtable at the White House and told Trump that Oklahoma was “one of the first states that has safely and measurably reopened.” “Oklahoma is ready for your visit,” the governor said. “It’s going to be safe and everyone’s really really excited.”

An opinion piece in the Tulsa World suggests “No matter how you feel about it, Saturday’s rally in Tulsa matters to us all:”

“Trump’s rally has turned Tulsa into a giant medical experiment with tremendous political implications. At issue is whether 19,000 people can be packed into an arena for hours on end while thousands more mingle in streets and parks outside without spreading COVID-19 and multiplying the deaths and debilitating aftereffects.

If they can, the lid almost certainly will come off. Concerts and sports events — and political rallies — will be back in business, no matter what public health officials say.

But if they can’t, the lid is likely to come down hard.

For Trump, the rally could be a wash, just another event among many.

Or, if things go well — if the crowds are large and adoring, if the incalculables go in his favor, if there is no associated COVID-19 spike — it could launch him toward a second term.

But if things don’t go well — if an acceleration of COVID-19 is traced to the rally, if even two or three people who contract it die, if there is violence that adheres to the president — it could be a turning point in the other direction.”

The Deadliest Parade in American History

My wife has been reading John Barry’s “The Great Influenza: The Story of the Deadliest Pandemic in History” and has pointed out to me several times the significance of a parade that took place in Philadelphia in accelerating the transmission of the Spanish Flu.

Per Wikipedia the “Philadelphia Liberty Loans Parade” was a parade in Philadelphia, Pennsylvania, on September 28, 1918, organized to promote government bonds that helped pay for the needs of Allied troops in World War I. More than 200,000 Philadelphians attended the parade, which led to one of the largest outbreaks of the Spanish Flu in the United States. It has since been declared the “deadliest parade in American history.”

At the height of World War I, history’s most lethal influenza virus erupted in an army camp in Kansas, moved east with American troops, then exploded, killing as many as 100 million people worldwide. It killed more people in twenty-four months than AIDS killed in twenty-four years, more in a year than the Black Death killed in a century

Barry concludes, “The final lesson of 1918, a simple one yet one most difficult to execute, is that…those in authority must retain the public’s trust. The way to do that is to distort nothing, to put the best face on nothing, to try to manipulate no one. Lincoln said that first, and best. A leader must make whatever horror exists concrete. Only then will people be able to break it apart.”

Skeptically Yours,

-ACP

N.B. More history we should be aware of:

Per Wikipedia, “Broken Arrow’s name comes from an old Creek community in Alabama. Members of that community were expelled from Alabama by the United States government, along the Trail of Tears in the 1830s. The Creek founded a new community in the Indian Territory and named it after their old settlement in Alabama. The town’s Creek name was Rekackv (pronounced thlee-Kawtch-kuh), meaning broken arrow. The new Creek settlement was located several miles south of present-day downtown Broken Arrow.”

….and something that Trump’s Tulsa visit has brought to the forefront:

“Juneteeth commemorates the end of slavery in the United States, when Union troops at the end of the Civil War reached Galveston, Texas, on June 19, 1865, to inform African-Americans there of the Emancipation Proclamation, which had been issued two years before.”

 

Are Trump’s Problems with Walking, Drinking Water Due to Hydroxychloroquine? 

Chuck Dinerstein at the American Council on Science and Health has an intriguing hypothesis:

“This past weekend at West Point, President Trump had trouble drinking a glass of water and he displayed an unsteady gait when descending a ramp. It is possible these problems indicate some type of neuropathy. And while it’s unlikely, one potential cause is hydroxychloroquine.”

After describing Trump’s recent apparent physical problems he writes:

So now, we have issues with two sets of muscles: the legs and arms. It would be odd to have an injury that involved two areas not be reported, especially involving the president. The same holds for structural problems, and that moves neuropathy up the differential list. What could be the source of a new-onset neuropathy? I know little of the president’s medical status. That is, except for one, perhaps salient fact: he said he has been taking hydroxychloroquine.

Physicians have rightly been concerned about the cardiac effects of this medication on the heart’s rhythm. But hydroxychloroquine has some other, less frequently cited adverse effects. If you read the FDA required package insert under adverse effects, here is what you will find:

“Musculoskeletal and connective tissue disorders: Sensorimotor disorder, skeletal muscle myopathy or neuromyopathy leading to progressive weakness and atrophy of proximal muscle groups, depression of tendon reflexes and abnormal nerve conduction.” [Emphasis added]

Proximal muscles are those closest to our body, like the muscles of the upper arm that raise the arm and hand. Or the muscles of the thigh that are actively involved in all phases of walking. It is not an overly common adverse side effect. It is probably relatively rare, but a quick search uncovered a review of 10 cases of hydroxychloroquine associated neuromyopathy.

I’ve been focusing on the cardiac side effects of HCQ but there are others including retinal toxicity which are more frequent and which could contribute to uncertain gait or hand-eye incoordination.

Of course, this is complete speculation but it contributes to understanding and recognition of how known and unknown side effects of unproven medications (or supplements) can tip the benefit/risk ratio toward increased risk.

I particularly like Dinerstein’s last sentence:

Again, let me emphasize that I am not attempting to diagnose an illness without performing both a careful history or physical examination. I am trying to point out a fallacy in the therapeutic use of medications. as there is always a tradeoff between benefits and risk. Always. In reporting on the president’s decision to treat himself with hydroxychloroquine on May 18, the New York Times reported, “Mr. Trump continued, explaining that his decision to try the drug was based on one of his favorite refrains: ‘What do you have to lose?’”

What indeed? It would be ironic that the drug President Trump described as a “game-changer” might instead turn out to be a “gait-changer.”

Skeptically Yours,

-ACP

FDA Withdraws Emergency Use Authorization for Hydoxychloroquine

A month ago the skeptical cardiologist detailed the potential for lethal cardiotoxicity of the antimalarial drug hydroxychloroquine  (HCQ) concluding:

  1. HCQ and chloroquine (CQ)  have associated and well-documented, albeit rare cases of potentially lethal cardiotoxicity.
  2. The benefit of these drugs in the treatment of coronavirus infection is currently unproven.
  3. Data from high-quality randomized trials of HCQ treatment in patients with coronavirus is needed before we can assess whether the drug benefits outweigh its risk in COVID-19 patients.

The drugs had been approved by the FDA for emergency use authorization (EUA),  many physicians and hospitals were using them for patients with COVID-19. Even more disturbing,, President Trump was enthusiastically promoting HCQ and revealed that he was taking it as a prophylaxis against COVID-19.

Intense demand for HCQ  led to a shortage for patients who needed it  for proven indications such as systemic lupus erythematosus.

Since I highlighted the drug’s cardiotoxicity a series of papers have either shown a lack of benefit or potential worsening of outcomes with these drugs. Recognizing this the FDA withdrew its EUA for HCQ and CQ yesterday.

On June 15, 2020, based on FDA’s continued review of the scientific evidence available for hydroxychloroquine sulfate (HCQ) and chloroquine phosphate (CQ) to treat COVID-19, FDA has determined that the statutory criteria for EUA as outlined in Section 564(c)(2) of the Food, Drug, and Cosmetic Act are no longer met.  Specifically, FDA has determined that CQ and HCQ are unlikely to be effective in treating COVID-19 for the authorized uses in the EUA. Additionally, in light of ongoing serious cardiac adverse events and other serious side effects, the known and potential benefits of CQ and HCQ no longer outweigh the known and potential risks for the authorized use. This warrants revocation of the EUA for HCQ and CQ for the treatment of COVID-19.

Fortunately, as more data became available over the last month hospitals which were previously routinely giving HCQ (and often azithromycin) dropped these drugs from their treatment protocols.

Hopefully, now we can get back to deliberately and scientifically validating the safety and efficacy of drugs for COVID-19. We still need more data from the dozens of ongoing randomized controlled trials (RCTs) on treatment.

Two large randomized controlled trials will be particularly helpful in determining the best treatment for SARS-CoV2 infection.

One of them, theRandomised Evaluation of COVid-19 thERapY (RECOVERY) Trial   published preliminary findings on 5 June 2020 showing a lack of benefit of HCQ.

In addition to HCQ, RECOVERY is analyzing treatment effects of the antivirals lopinavir-ritonavir, low-dose steroid therapy and interferon.

SOLIDARITY is an international clinical trial to help find an effective treatment for COVID-19, launched by the World Health Organization and partners.

 

The Solidarity Trial will compare four treatment options against the standard of care, to assess their relative effectiveness against COVID-19.

Until we get results from high-quality RCTs like these, the antimalarials  HCQ and CQ should not be utilized for either prevention of or treatment of COVID-19.

Skeptically Yours,

-ACP

Father’s Day Visits and Flying During Covid-19: What Activities Are Safe To Resume?

Since COVID-19 struck America, most of us have stopped lots of heretofore normal activities in an effort to limit the spread of SARS-CoV-2. The curve has been flattened in most states and now the burning questions relate to when we can get back to normality.

Health care facilities have made the decision to resume most elective diagnostic procedures and are gradually moving from telemedicine to real in-person office visits. Hair stylists have gone back to cutting and colorizing hair.

For most activities, however, the decision to resume normality remains intensely personal and complicated.

For example, the skeptical cardiologist really wants to visit his 94-year-old father on Father’s Day weekend.

Pops Pearson lives in Tulsa, Oklahoma some 400 miles away, and I haven’t seen him (excluding Facetime sightings) since Christmas of last year.

 

How do I balance the risk of giving him COVID-19 versus the benefit of us spending time together? Would the risk/benefit change in 3 to 12 months? In a year or two?

There is no CDC or state or WHO guidance on whether I should make this trip.  However, the NY Times published a piece today which sampled the opinion of 511 “epidemiologists,” which offers some perspective on when it is right to resume certain activities.

The majority of the 511 epidemiologists who responded to the survey felt comfortable currently bringing in the mail and getting a haircut.

Screen Shot 2020-06-09 at 6.05.26 AM

My wife (the ex-eternal fiancée) and I still put the mail in quarantine and treat all packages as potentially contaminated. The epidemiologists were split on visiting hair salons or barber shops with 41% comfortable now and 39% in 3 to 12 months.

We have acquired hair cutting equipment for her to use on me and home hair colorizing stuff (not for me) and neither of us has seen a barber for 3  months. We plan to continue that for the foreseeable future.

It is interesting that 60% of epidemiologists are comfortable seeing a doctor for a non-urgent appointment. My patients also seem comfortable now coming into the office. We take a lot of precautions, but ultimately exposure risk for both patients and physicians is higher than if they had both stayed at home.

Resuming Activities in 3 to 12 Months

The majority of epidemiologists felt comfortable resuming ten activities in 3 to 12 months although a substantial minority were OK with doing them now.

Screen Shot 2020-06-09 at 6.05.46 AM

Two of the activities above are relevant to my “Pops Pearson visitation” decision.

Only 20% of the respondents felt comfortable visiting an “elderly relative or friend in their home” now, but this increased to 41 % by 3 to 12 months. This surprised me and suggests that most Americans may not be going into their relatives’ homes and/or spending significant time with their elderly parents.

Similarly, only 20% of respondents would travel by airplane now, but 44% would in 3 to 12 months.

A substantial minority of the respondents felt they would not be comfortable visiting relatives in the home (39%) or flying (37%) until over a year from now.

Of the other activities on the above list, I am uncomfortable right now with all except a “hike or picnic outdoors with friends.”  We have had close friends over to our house for outdoor socially distanced gatherings, two at a time. We have gone for bike rides with friends outdoors.

I’m not sure when I will feel comfortable attending an indoor dinner party, exercising at a gym, or eating at a dine-in restaurant.

To Visit Or Not To Visit?

After much discussion with family and rumination,  I have decided to drive to Tulsa and stay with Pops Pearson for Father’s Day.

The decision to drive was an easy one. Although we usually choose the one-hour SouthWest Airlines flight from St. Louis to Tulsa we still consider flying a  COVID-19 a high-risk activity. The airlines have made considerable strides in reducing the possibility of transmission in flight, but we still hear that it is not mandatory for fliers to wear masks.

The CDC website confirms that flying increases the risk of contracting COVID-19:

” Air travel requires spending time in security lines and airport terminals, which can bring you in close contact with other people and frequently touched surfaces. Most viruses and other germs do not spread easily on flights because of how air circulates and is filtered on airplanes. However, social distancing is difficult on crowded flights, and you may have to sit near others (within 6 feet), sometimes for hours. This may increase your risk for exposure to the virus that causes COVID-19.”

For those of you with more distant relatives, the decision to fly or drive is more complicated. I know that when we visit my wife’s relatives in Wilmington, NC in August  (which will be a 14 hour drive) we are still planning on driving.

To minimize the risk of me transmitting coronavirus to my dad, I have put myself in a modified quarantine. I will be conducting office visits by telemedicine and one of my partners has kindly offered to cover my hospital patients during this time. In the two weeks leading up to the visit, I and my wife have agreed to avoid any activities which might increase our risk of exposure to SARS-CoV-2.

Resuming Activities in > 1 year

When will it be safe to attend a large wedding or funeral service, go to church or attend a baseball game? Definitely not now.

Of note, the majority of epidemiologists did not respond to this survey and were uncomfortable making such predictions:

About 6,000 epidemiologists were invited to participate in the survey, which was circulated to the membership of the Society for Epidemiologic Research and to individual scientists. Some said they were uncomfortable making predictions based on time because they didn’t want to guess the timing of certain treatments or infection data. “Our concern is that your multiple choice options are based only on calendar time,” 301 epidemiologists wrote in a letter. “This limits our ability to provide our expert opinions about when we will feel safe enough to stop social distancing ourselves.”

I, too, am uncomfortable making predictions and doling out advice on behaviour during COVID-19. There is much uncertainty as evidenced by the reluctance of 90% of scientists to answer this survey.  The pace at which important data emerges is dizzying. For many personal decisions like mine, we must make critical decisions based on imperfect guidance.

Epidemiologically Yours,

-ACP

AstraZeneca’s COVID-19 Vaccine Enters Phase 2/3 Clinical Trial |

From the Website FierceBiotech comes some good news in the battle against COVID-19


Researchers at the University of Oxford have begun enrolling subjects in a phase 2/3 clinical trial of AstraZeneca-partnered COVID-19 vaccine AZD1222. The next stage of the program, which follows a 1,000-subject phase 1, is set to enroll 10,260 people in the U.K. to generate results to support the first shipments to customers in September.AZD1222, the recombinant adenovirus vaccine that originated in Oxford, entered the clinic shortly after Moderna’s candidate. The initiation of the phase 1 trial marked the start of a large, significantly truncated development program plotted out by researchers at the University of Oxford, who have talked up the prospect of making the vaccine available in September.Work toward that goal is advancing apace on multiple fronts. On the R&D side, the University of Oxford said Friday that it has begun enrolling participants in the phase 2 portion of the program.The phase 2 will relax the exclusion criteria used in the phase 1, notably by enrolling a small number of children aged 5 to 12 years and adults aged 56 years and older. One cohort will enroll adults aged over 70 years, a demographic that is particularly at risk from the coronavirus. By expanding the age range, the researchers aim to understand how immune response varies across demographics.Once the vaccine moves into phase 3, the researchers will limit enrollment to people age 18 years and older. Adult participants in the phase 2 and 3 trials will be randomized to receive one or two doses of AZD1222 or a vaccine against meningococcal bacteria that will serve as the control. The use of an active vaccine as a control is intended to ensure participants are unable to tell whether they received AZD1222 based on side effects such as soreness at the injection site. In the absence of such effects across both groups, participants could determine whether they had received the vaccine and make behavioral changes that skew the results of the study. Investigators plan to administer the vaccines to participants in the next stage of the study across May and June. Subjects will then attend follow-up visits to provide blood samples that will show whether their immune system has responded to the virus. The researchers will also ask some participants to log any symptoms they feel in the week after vaccination.Those measures will provide an early look at the safety and immunogenicity of the vaccine, but it will take longer to gauge whether the shot can prevent people from becoming infected with the coronavirus. The researchers are trying to accelerate that process by enrolling healthcare workers and other people who are more likely to be exposed to the virus. Depending on the extent to which SARS-CoV-2 is present in the U.K., it is expected to take two to six months for enough infections to happen to show whether the vaccine is working.Neither the university nor AstraZeneca are hanging around to see if that is the case before preparing for widespread use of the vaccine. The phase 2/3 trial is getting underway despite the university being yet to share phase 1 data, and AstraZeneca is already racing to equip itself to ship 1 billion doses.

Source: AstraZeneca’s COVID-19 vaccine enters phase 2/3 clinical trial | FierceBiotech

I’ve got my fingers crossed that it will be effective and safe and we could potentially have a vaccine by September.

Skeptically (but occasionally optimistically) Yours

-ACP

Telemedicine Visits: Are They Right For You During and Beyond COVID-19?

The skeptical cardiologist, like most physicians in America, began converting scheduled in-person office visits to “telemedicine” visits in late March when it became clear that  COVID-19 was spreading rapidly.

It made no sense at that time to bring patients into our office for regular visits who were vulnerable and high risk, exposing them to physicians and staff who might have asymptomatic COVID-19 and vice versa.

Telemedicine made a lot of sense. As eloquently expressed by Dr. Russel Libby:

With the evolving COVID-19 pandemic and its impact on access to medical care, there is no better time to help physicians navigate and implement telemedicine into their practices and enhance their ability to care for patients. Through telemedicine, we can triage patients and help avoid unnecessary visits to health care settings, thereby reducing exposure to the COVID-19 virus and helping to keep our front lines safe, ensuring they have the resources needed to take on this immense challenge. The tools and guidelines being created now are already helping many to use telemedicine and will continue to help define its role at this moment, and shape the future of physician practice.” 

I wrote a post on March 20 (but didn’t publish it for some reason) explaining this change to patients:

Because the virus can be spread from infected individuals before they have symptoms there is a risk that patients can be infected anytime they are out in public.
Infected patients can visit the doctor’s office without any symptoms and transmit the virus to health care workers and other patients.
The perfectly healthy person sitting near you  in the doctor’s waiting room could be infected.This means you should reserve  seeing in person a doctor for when it is absolutely necessary that you be examined.

Due to the above concerns, beginning yesterday I personally began contacting all patients on my office schedule for the day.  After having a conversation with them, if  they were doing well and could delay their visit, the appointment was canceled. I encourage all physicians and patients to do everything they can to minimize unnecessary health care visits. Stop elective surgeries and screening procedures. Stop routine check-up visits.


The Rise of Telemedicine

Fortunately, due to COVID-19 CMS changed its coverage policies for telemedicine and has been reimbursing visits done utilizing video connections as if these were office visits.

For those individuals who do not have the ability to connect via video means (including Face time, WebEx, Zoom,and  Doximity) we have been utilizing telephone only visits. CMS has also ramped up reimbursement for these interactions.

In addition, I can see new patients as a telemedicine visit since CMS announced waivers on old restrictions.

CMS also announced that “the requirement for physicians to hold a license in the state in which services are rendered is waived.”

Rules, coding, and reimbursement for billing are in flux right now but I have found CodingIntel.com to be a reliable source and this summary PDF from Woodcock and Associates to be unusually clear:

I’ve been trying to get my employers to utilize telehealth services for several years unsuccessfully. I think they make good sense for many patient situations, especially when combined with the kinds of remote patient monitoring (like Kardia Pro) have implemented with my patients.

Hopefully, now that telehealth has been expanded it will become the norm after COVID-19.

 


Telemedicine Visits Work For Many Patients

It’s been two months since we began utilizing telemedicine visits and we have successfully flattened the curve of the epidemic.

For the most part, I think the telemedicine visits have been successful in allowing me to check on the status of my patients and manage their cardiac conditions. We are typically able to get the patient to record a home blood pressure and heart rate. Many of my patients have home ECG devices (mostly Kardia) which allow us to monitor their cardiac rhythm

The video allows a rudimentary physical exam. I can tell how the patient is breathing, speaking, and answering questions. I can see any gross abnormalities of their head, neck, ears, and eyes.

One significant limitation is that  I cannot listen to their heart and lungs. In cases where patients are having difficulties that would best be assessed by a full physical exam or by an ECG  we have brought them into the office.


Reopening

On May 18 St. Louis City and County officials announced the reopening of certain businesses. Of note, hospitals and doctor’s offices weren’t mentioned in these announcements.

The CMS document on “Opening Up America Again” states:

Therefore, if states or regions have passed the Gating Criteria (symptoms, cases, and hospitals) announced on April 16, 2020, then they may proceed to Phase I. The Guidelines for Opening Up America Again can be found at the following link: https://www.whitehouse.gov/openingamerica/#criteria

Maximum use of all telehealth modalities is strongly encouraged.

In conversations with patients these last 2 months I have found that they have almost without exception been sheltering at home and practicing social distancing and have been very happy to conduct the visits using telemedicine.

Of course, some have elected to reschedule follow-up visits to a future time with the hope that COVID-19 will be less of an issue and these are the patients I’m not having conversations with.

In the next few weeks I will be personally contacting patients on my schedule and assessing their need and desire for an in-person office visit.

The guidance I have from CMS and from the leadership of my medical group is to continue primarily favoring telemedicine visits. However, if my patient has a strong preference for an in-person office visit or if I perceive that a physical examination, vital sign check, or ECG is essential for their proper care we will keep the in-person office visit.

I’d appreciate hearing all reader’s and patient’s thoughts on this topic so feel free to leave comments or email me at DRP@theskepticalcardiologist.com

Virtually Yours,

-ACP

Feature Image

LDN 1471: A Windblown Star Cavity
Image Credit: Hubble, NASA, ESA; Processing & License: Judy Schmidt

Asthma, Inhaled Steroids and Covid-19

If you, like the skeptical cardiologist, suffer from asthma you may be wondering if you are at a higher risk of contracting Covid-19 or developing more severe respiratory complications from the disease once infected.

There are 25 million asthma sufferers in the United States, about 8% of the population and many of us are using as primary treatment a combination of inhaled beta-agonists (for immediate relief) and inhaled corticosteroids (ICS) (for long-term conditioning of the lung).

How are these treatments influencing our risks during the Covid-19 pandemic?

A commentary published online in Lancet Respiratory medicine suggested that there is a lower prevalence of asthma in patients with Covid-19. However, the sum of evidence from this commentary and elsewhere is insufficient to say asthma is protective.

When there is an absence of evidence, as we saw with hypertension as a risk factor and hydroxychloroquine as a treatment, the tendency of journalists is to obtain a quote from a physician who has treated patients with Covid-19 to buttress a particular argument. Quotes which say something like “we don’t know” or “there is not enough evidence right now” are highly unlikely to be published whereas anecdotal speculation is always intriguing (but often misleading.). The New York Times published this quote on the topic:

“We’re not seeing a lot of patients with asthma,” said Dr. Bushra Mina, a pulmonary and critical care physician at Lenox Hill Hospital in New York City, which has treated more than 800 Covid cases. The more common risk factors, he added, are “morbid obesity, diabetes and chronic heart disease.”

A major problem in sorting out asthma as an independent risk factor is that many papers are lumping all “chronic respiratory diseases” together which puts asthma in a bucket with chronic obstructive pulmonary disease (COPD) and interstitial lung disease like pulmonary fibrosis. There are striking differences in the demographics and prognosis of these diseases. For example, patients with COPD are older and much more likely to have smoked cigarettes, two factors clearly associated with Covid-19 risk.

In addition, asthma in older adults is highly associated with obesity, a well-recognized independent risk factor Covid-19 complications.

Among adults aged 60 and over, there was a significant trend of increasing asthma prevalence with weight status: 7.0% among normal weight adults; 9.1% among overweight adults; 11.6% among adults with obesity.

In addition, almost no data is available on asthma stratified by severity and treatment. The severe asthma patient who requires oral corticosteroids is markedly different from the mild asthmatic whose only treatment is intermittent inhaled beta-agonists.

These data, like the data on hypertension, should be taken with a grain of salt, but at a minimum, we can say there is no signal that asthma by itself increases the risk of Covid-19 infection.

Inhaled Corticosteroids and Covid-19

The authors* of the commentary in Lancet which implied asthma (and chronic respiratory disease) was protective against Covid-19 infection also concluded that

“the possibility that inhaled corticosteroids might prevent (at least partly) the development of symptomatic infection or severe presentation of COVID-19 cannot be ignored”

They cited some very preliminary data to support this contention:

in in-vitro models, inhaled corticosteroids alone or in combination with bronchodilators have been shown to suppress coronavirus replication and cytokine production. Low- quality evidence also exists from a case series in Japan, in which improvement was seen in three patients with COVID-19 requiring oxygen, but not ventilatory support,

Personally, I have always worried that my use of ICS put me at a higher risk of respiratory infections because corticosteroids are potent immunosuppressives, potentially lowering my immune response to bacterial, viral, or fungal infections. This 2019 meta-analysis in Infection found a 24% higher rate of upper respiratory tract infection in patients using ICS.

Due to these concerns, when the pandemic began I purposely cut back on my Advair usage. Fortunately, my asthma has been very mild since I started taking Dupixent for eczema 3 years ago. Since then, Dupixent has been approved for treatment of asthma. (By the way, although dupilumab is a targeted biologic therapy that inhibits signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), two key proteins that may play a central role in type 2 inflammation that underlies atopic dermatitis and several other allergic diseases we have no idea if it increases or decreases Covid-19 risks or complications.)

Does ICS usage increase or lower our risk of Covid-19 outcomes?

This figure from a review of the topic shows where in the process ICS could influence Covid-19, either increasing or decreasing risk of 1) initial infection 2) progression to pneumonia or 3) progression to ARDS and death once pneumonia is established.

F1.medium.gif

There are theoretical arguments to suggest the use of ICS could either improve or worsen all 3 stages.

The review of 59 publications on Covid-19 concluded:

Following examination of the full texts including translations of those in Chinese, no publications were identified as having data on prior ICS use in patients with SARS, MERS or COVID-19 infection. No data were available for either a qualitative or narrative answer to the review question.

The bottom line right now is that we don’t know if ICS use is an important risk factor in Covid-19 outcomes.

Should ICS Stay or Go

The recommendations of the CDC, and all pulmonary/asthma societies at this point is to stick to your current asthma action plan. If that includes taking an ICS, keep on taking it at current levels.

In fact, the AAAAI  and other major asthma or pulmonary organization emphasize that patients should remain on their current medications because experiencing an exacerbation event and the need for hospitalization, in those who become poorly controlled, could actually increase patient exposure and the risk of infection.

I’ve gone back to taking my ICS at pre-pandemic levels and I don’t consider that my asthma puts me at any higher risk during the pandemic.

Skeptically Yours,

-ACP

N.B. Common inhaled corticosteroids include:

  • Beclomethasone (QvarTM)
  • Budesonide (Pulmicort FlexhalerTM)
  • Ciclesonide (AlvescoTM)
  • Flunisolide (AerospanTM)
  • Fluticasone (Flovent Diskus TM, Flovent HFATM, Arnuity ElliptaTM)
  • Mometasone (AsmanexTM)

ICS are commonly combined with long-acting beta agonists.  The “purple circle” Advair is one such combination.

N.B. The authors of the Lancet commentary seem to have heavy ties to companies that stand to profit from sales of ICS

DMGH has received personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, Novartis, Pfizer, and Sanofi, and non-financial support from Boehringer Ingelheim and Novartis, outside of the submitted work. RF has received grants from GlaxoSmithKline and Menarini, outside of the submitted work. AA has received grants from AstraZeneca, GlaxoSmithKline, and Menarini, and personal fees from AstraZeneca, Chiesi, GlaxoSmithKline, and Menarini, outside of the submitted work. OS and JRB declare no competing interests

Here are the references they cited suggested ICS might be beneficial against coronavirus.

  1. Yamaya M, Nishimura H, Deng X, et al. Inhibitory effects of glycopyrronium, formoterol, and budesonide on coronavirus HCoV-229E replication and cytokine production by primary cultures of human nasal and tracheal epithelial cells. Respir Investig 2020; published online Feb 21. DOI:10.1016/j.resinv.2019.12.005.
  2. Matsuyama S, Kawase M, Nao N, et al. The inhaled corticosteroid ciclesonide blocks coronavirus RNA replication by targeting viral NSP15. bioRxiv 2020; published online March 12. DOI:10.1101/2020.03.11.987016 (preprint).
  3. Iwabuchi K, Yoshie K, Kurakami Y, Takahashi K, Kato Y. Morishima T. COVID-19. Three cases improved with inhaled ciclesonide in the early to middle stages of pneumonia. 2020. http://www.kansensho.or.jp/uploads/ files/topics/2019ncov/covid19_casereport_200310.pdf (accessed March 27, 2020; in Japanese).

 

Does Hypertension Put You at a Higher Risk for Infection or Death From Covid-19?

Early news reports of fatalities in China from coronavirus strongly implied that hypertension was an independent risk factor for severe disease and death.

Bloomberg and many other seemingly reliable news sources relied on one Chinese doctor’s anecdotal statements along with a Lancet article to make this claim:

“A top Chinese intensive care doctor told Bloomberg that of 170 patients who died in January in Wuhan, nearly half had hypertension, and anecdotally he said that he and other doctors have noticed hypertension is prevalent in those who die.”

However the actual Lancet report on 191 patients published March 11, 2020 , entitled Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study did not find hypertension or heart disease to be an independent risk factor for severe respiratory disease or death.

Of the 191 patients, 137 were discharged and 54 died in hospital. 91 (48%) patients had a comorbidity, with hypertension being the most common (58 [30%] patients), followed by diabetes (36 [19%] patients) and coronary heart disease (15 [8%] patients).

Although patients with hypertension were more likely to die than those without hypertension this does not prove hypertension is an independent risk factor

Age was by far the most significant risk  factor and the older patients also had more hypertension. When all variables were factored into an analysis, hypertension and heart disease were not significantly related to death:

Multivariable regression showed increasing odds of in-hospital death associated with older age (odds ratio 1·10, 95% CI 1·03–1·17, per year increase; p=0·0043), higher Sequential Organ Failure Assessment (SOFA) score (5·65, 2·61–12·23; p<0·0001), and d-dimer greater than 1 μg/mL (18·42, 2·64–128·55; p=0·0033) on admission

Heart disease and hypertension were not significant factors after accounting for age.

Nephrology Journal Club (NephJC) has an excellent discussion (frequently updated and well-reference)  on this topic here. After looking at all current publications in this area they agree with me that the current data do not support the idea that hypertension is an independent risk factor for either getting SARS-CoV2 or having a more serious illness from it.

Among the patients with COVID-19, it seems the prevalence of prior h/o HT is higher in those who develop severe disease than those who do not. Same applies for development of ARDS or death – but mostly in unadjusted analysis. See table below for more. The last two rows are the best quality data so far, and suggest the association between COVID-19 severity and hypertension is attenuated after adjustment.

updated HT table.JPG

Sources: Guan et al, NEJM; Huang et al, Lancet; Wang et al, JAMA; Zhang et al, Allergy; Zhou et al, Lancet; Wu et al, JAMA IM; Italian report (PDF); Chen et al, BMJ; Shi et al, JAMA Cardiol; McMichael et al, NEJM; Guo et al, JAMA Cardiol; Bean et al, MedRxiv 2020; Petrilli et al, MedRXiv 2020

As can be seen, most of the studies except the last two, did not adjust for age. Even age-stratified association of hypertension would have been a more useful way to see these data to understand this issue a bit better. We hope more data in coming days will clarify this relationship. Unlike what we stated earlier, the Zhou et al study did not adjust for hypertension.

Source: AHA website , using NHANES data

Source: AHA website, using NHANES data

As can be seen above, hypertension in the general population closely associates with increasing age, hence any association with hypertension may merely represent confounding due to age, and should be interpreted after careful analysis.

The Question Is Definitively Answered

The speed at which data and studies are being published on Covid-19 is so rapid that a study has been published since I began writing this post which I feel definitively answers my title question.
Using observational data on 8910 hospitalized patients in 169 hospitals in Asia, Europe, and North America, investigators examined cardiovascular factors that were associated with in-hospital death.
Surprisingly, in this database, although the average age of the 515 nonsurvivors was 56 years versus 49 years for the 8195 survivors, there was no difference in the prevalence of hypertension. In fact survivors had a slightly higher prevalence of hypertension (26.4% versus 25.2%) despite being younger than the nonsurvivors.
A multivariable logistic-regression model identified age>65 years, coronary artery disease, heart failure, arrhythmia, COPD and current smoking as independently associated with in-hospital death.
nejmoa2007621_f1
Hypertension was not independently associated with in-hospital death.
Interestingly, patients receiving ACE inhibitors and statins were substantially less likely to die.
In Summary
  1. Hypertension does not put you at a higher risk of serious illness or death due to Covid-19.
  2. As discussed in previous posts (see here and here), there is no reason to stop taking your ACE inhibitor or angiotensin receptor blocker (ARB) blood pressure medication during this pandemic. (Also don’t start demanding you be put on an ACE inhibitor-the protective association seen in one study does not prove causality, we need randomized trials to show drugs safety and effectiveness!)
  3. Be very skeptical of early anecdotal reports and small trials rushed to publication (especially “preprints” which have not been peer-reviewed) during Covid-19. The poorly substantiated claims that hypertension was a major risk factor for death and that ACE inhibitors increased patient’s risk during Covid-19 have proven false. As better data emerges regarding hydroxychloroquine, despite enthusiastic anecdotal reports from some physicians, this drug has not been proven safe and/or effective for Covid-19 treatment.

Skeptically Yours,

-ACP

 

A Reliable Source for Reliable Sources During Covid-19

It is a daunting task tracking down reliable information during Covid-19. Misinformation tends to spread like …the coronavirus. The Baker institute Blog is providing excellent succinct summaries of reliable information and sources as the pandemic evolves.

The post below  originally appeared on the Baker Institute Blog April 20, 2020  and was  coauthored by Vivian Ho, Ph.D. (@healthecontx), James A. Baker III Institute Chair in Health Economics, Kirstin Matthews, Ph.D. (@stpolicy), Baker Institute  Fellow in Science and Technology Policy and Heidi Russell, M.D., Ph.D., Associate Professor, Department of Pediatrics, Baylor College of Medicine and Associate Director, Center for Medical Ethics and Health Policy, Baylor College of Medicine.


Having finished our fifth week in isolation, we are encouraged that the nation may have passed its peak date for the number of new cases and new deaths. We update you on efforts to identify treatments for the coronavirus, as well as policymakers’ discussions on when to reopen the economy, what that might look like, and where government funding should be directed. Previous issues are posted here.

Epidemiology and Treatment

Health experts warn us not to expect a single peak day in terms of new cases, deaths, or otherwise. Daily reports of new cases and deaths can fluctuate depending upon the availability of tests and delays in reporting. The New York Times’ juxtaposes a bar graph of the number of new cases by day with a line calculating the 7-day average of these numbers, indicating that the number of new cases has fallen to less than 30,000 per day. The 7-day average of new deaths also has begun to fall, to roughly 2,000 per day.

On Friday Worldometers estimated that 58,000 people in the U.S. have recovered from the coronavirus. Mark Lipsitch, an epidemiologist at Harvard University, provides a compelling case that most individuals who contracted the virus will have an immune response, some better than others. He suggests that the immune response will offer some protection over the medium term — at least a year — and then its effectiveness might decline. This view that contracting the virus yields only temporary immunity, is shared by other experts. Thus, treatments and a vaccine for COVID-19 are crucial in ultimately conquering this pandemic.

To date, researchers and drug companies have launched over 100 human experiments to identify treatments for the coronavirus. However, an article in the Washington Post warns that the lack of coordination across investigations could generate numerous small-scale trials with conflicting answers. For example, there are more than two dozen separate U.S. trials listed for the anti-malarial drug hydroxychloroquine. Some use the drug as a preventive, others as a treatment; some in combination with other drugs, and some with no comparison group. Information from multiple investigations is often better, but coordination across these studies could have yielded larger sample sizes and cleaner study designs, so that results could be used to prioritize treatments. Francis Collins, director of the National Institutes of Health has been working behind the scenes to launch an unprecedented public-private partnership to achieve better coordination.

In the scientific journal Immunity, researchers review the COVID-19/SARS-CoV-2 vaccine development and its challenges  In addition, the WHO cataloged a long list of potential candidates, and an article from “The Scientist” describes frontrunners that hoped to be tested this year, providing details on each vaccine’s approach to target the virus as well as preliminary evidence. Meanwhile, fake news regarding causes of and treatment for coronavirus are circulating through social media. The World Health Organization (WHO) has posted a series mythbuster infographics to dispel rumors such as one that 5G mobile networks spread COVID-19.

Policy Response

Public health experts continue to emphasize that passing the peak number of cases or deaths does not mean that the pandemic is over, and that we will need to maintain social distancing in one form or the other for months to come. More than a dozen states have extended stay-home orders past the White House deadline of April 30th. In the meantime, governors on the east and west coasts were reported last Monday to have formed pacts to decide when they would reopen their economies. Governors of Midwest states followed suit soon afterwards. These pacts will draw on facts and science to create plans to re-open each state in a way that limits new outbreaks of coronavirus. Among the steps are contact tracing, treatment and social distancing measures.

For example, last week we highlighted the recommendation for A National COVID-19 Surveillance System which included capacity to conduct 750,000 coronavirus tests per week. Unfortunately, most parts of the country report test supply shortages that remain “crippling.” Experts emphasize the need for contact tracers, to identify those who could have contracted the virus by coming into contact with someone who has tested positive for the virus. Policy makers are acting on that recommendation, with the C.D.C. planning to hire hundreds of contacts tracers and, it is in discussions to divert 25,000 Census Bureau workers to do contact tracing in the coming weeks and months. Experts suggest that employers can do their part to reduce the spread of coronavirus by offering screening at their place of business. Employers can help workers to safely self-isolate at home and work with local health authorities to improve contact tracing.

As TIME magazine stated, “Public health experts have savaged President Donald Trump’s decision to cut U.S. funding to the WHO.” Critics include U.N. Secretary General António Guterres and the editor-in-chief of the Lancet medical journal, who called the decision “a crime against humanity.” The administration is reportedly withholding funds, because the WHO failed to adequately investigate early information about the virus’s ability to spread between humans and for not criticizing China for its lack of transparency over the virus. This view is echoed in an article in The Atlantic, which points to structural problems at the WHO that make the organization vulnerable to misinformation and political influence, in this case by China. Nevertheless, the U.S. pays for about 22% of the WHO’s budget. Cutting funding for international public health initiatives in the midst of a crisis could have dire consequences for Americans in the future.

Health and Human Services is distributing the first $30 billion in emergency grants to hospitals and doctors from the CARES Act according to their historical share of revenue from the Medicare program for seniors — not according to their coronavirus burden. States lightly hit by the coronavirus, such as Minnesota, are getting more than $300,000 per COVID-19 case, while New York is receiving $12,000 per case. The HHS decision raises the prospects that hospitals in hard-hit areas will be weighing their financial health more heavily than patient well-being for each additional COVID-19 case that comes through their doors.

On the Medical Frontlines

Evidence of strain on the healthcare workforce continues to mount.  The Centers for Disease Control (CDC) published a report estimating at least 9,282 United States health care workers have been sickened by COVID-19, and at least 27 died.  This is likely an underestimate because of how local or state authorities report cases. The CDC concluded that approximately half of these providers were exposed in their workplace.  The worse outcomes were in the over 65 workforce, although death and critical illness occurred at all ages. The first installment of a bi-weekly survey of medical staff across the country was performed by MedPage Today.  The responses suggest that regional variation in the share of the healthcare workforce that is temporarily out, critically ill or dead because of COVID-19 lies between 1% and 20%.  The proportions are much higher in concentrated areas like New York.  For an in-depth account of healthcare workers who died from COVID-19, we applaud the stories found in Lost on the Frontline.

Healthcare workers are particularly at risk when performing nasal swabbing to test for the coronavirus, which requires the provider to stand directly in front of the person being tested. The swabbing generates a natural reflex to cough or sneeze, sending droplets into the air. To that end the first COVID-19 test of saliva was approved by the FDA this week.  This new test will allow patients to spit into a vial and hand it back to the health care worker. The test is not yet available in most health care organizations, and questions remain about its accuracy. But as these hurdles are overcome, this safer, simpler testing would also circumvent the shortage of nasal swabs that is hindering test availability across the country.

In the coming we week, hopefully new cases of the coronavirus and daily death toll continue to decline. We are most concerned about the continuing short supply of coronavirus tests. We hope that federal, state, and local governments aggressively pursue efforts to hire and train contact tracers throughout the country. Debate has begun on what role smartphone apps by Apple and Google could play in contact tracing, and we will follow that discussion closely. We also look forward to reviewing state governors’ developing plans to reopen their economies.


Still socially distanced but ever skeptically Yours,

-ACP