From the President of Rezilir Health:
While staying home has been crucial these past few months to help in slowing the spread of Covid-19, your health needs still exist. As things begin to open and we attempt to return to a somewhat normal life, Rezilir Health remains a place of healing and hope. Our practice is committed to keeping you safe. We continue following strict guidelines from the CDC (Center for Disease Control) and are taking all necessary precautions. Additionally, if you are more comfortable staying at home and scheduling a telemedicine appointment via our virtual platform, we are happy to arrange that. Your health and well being are important to us. Please know that the Rezilir team is here for you and available should you need assistance.
In good health,
Tammy Motola, President/Co-Founder
October 22, 2020
Second Wave in Europe
Global metrics collected by the Financial Times shows that the “second wave” of infections has occurred in Europe with deaths rising, albeit significantly lower than the first wave in the spring.
Meanwhile, the CDC excess deaths data for the US is showing that the peak in excess deaths on August 1st was about 50% less than the initial peak on April 11th. Since then excess deaths have been on the relative decline, despite higher cases.
The CDC data shows that in Florida the peak in deaths was August 1st and the trend has been on the decline ever since. Currently, excess deaths are at the same rate above the baseline as the flu season from 2018.
Peer-reviewed data has shown that the relative mortality rate for Covid has decreased dramatically due to progress in medical care. The big question that is not answered in the statistics is what is the morbidity from complications of Covid – “Long Covid.” More on that to come in a future post
September 28, 2020
POST EXPOSURE TO COVID-19
The COVID-19 pandemic is causing global attention to fatigue that occurs after viral illnesses. Patients recovering from COVID-19 are reporting unresolved symptoms characteristic of ME/CFS and are calling themselves “long haulers.” 1 This attention to ME is long overdue as it has been a poorly recognized but common issue. ME/CFS (Chronic Fatigue Syndrome) affects an estimated 836,000 to 2.5 million Americans. According to the U.S. Clinician Coalition, a group of clinician experts in ME/CFS, an estimated 84 to 91 percent of patients have not yet been diagnosed. ME/CFS affects 3 times as many women as men and reported in patients younger than age 10 and older than age 70. The onset of the illness peaks between ages 11-19 and 30-39 years old. At least 25% of patients are bedbound or housebound and up to 75% are unable to work or attend school. Symptoms can persist for years, and patients may never regain their pre-disease functioning. ME/CFS costs the US $17 to $24 billion annually in lost productivity and direct medical costs.11
The first time someone may become concerned with ME/CFS is when they notice extreme fatigue and malaise after any physical or mental activity, even after their routine exercise. An individual can also notice that recovery after any exertion takes longer, and night sleep does not provide the usual refreshment, or there is significant difficulty falling asleep. The persistent or relapsing debilitating fatigue and post exertional malaise in ME/CFS usually do not resolve with rest and is severe enough to impair everyday daily activity in comparison to the individual’s pre-illness activity level. Frequently, a patient may remember the episode of infectious illness, such as mononucleosis or flu (or now potentially COVID-19), from which they “have never recovered.” The onset of ME/CFS is often abrupt. Moderate to severe fatigue which is present at least 50% of the time is a key finding distinguishing ME/CFS from other causes of chronic fatigue.
If you or someone you know is currently suffering from symptoms of ME/CFS and are frustrated with your current care and have been told “there is nothing wrong with you,” at Rezilir, we will listen to your story.
- NIH Director’s Blog. (September 3, 2020). COVID-19 long haulers. https://directorsblog.nih.gov/tag/covid-long-haulers/
September 8, 2020
CDC data for the country are confirming improving Mortality CFR
The CDC made public all of its “caseline data” so it is possible to analyze data across the country for COVID cases in an integrated manner.
As a result, we are able to see the case fatality rates by week across the country for the first time. The mortality rates are steadily dropping in a steady manner, similar to what we saw in Florida specific data in June. It started at 8.7% in April and has now dropped to 1.7%, given that reported cases actually undermeasure real cases by 3-5x now, this means that the total actual mortality rate for COVID is likely less than 0.5%. This can be driven by a whole host of drivers including better care, higher testing frequency and changes in virus lethality. Do not over-interpret data after mid-July as the reporting may not be complete.
Importantly, mortality data across all age groups including the high-risk older adults shows similar large drops in mortality rates ranging from 50 to 66 percent.
People still need to be careful – focus on metabolic and immune health, social distance and wear a mask indoors — but the drops in mortality rates are welcome news!
Analyses and graphs done by Justin Hart. https://twitter.com/justin_hart/status/1302991924425449478/photo/1
August 26, 2020
Florida COVID Metrics Continue to Decline
This week’s dashboard for Florida shows continued reduction in Covid from the July peak
- 75% reduction of ER cases with COIVD (4.0k this week, peak was 16k)
- 66% reduction of new cases (27k this week, peak was 79k)
- 53% reduction of positivity rate (6.7% this week, peak was 14%)
The CDC Excess Data for the entire US now shows excess deaths above trend for August 8th at a level that hasn’t been seen since March 28th.
August 18, 2020
Florida COVID metrics are now on the backside of the curve
This week’s dashboard for Florida showed the following percentage reduction from the peak in July
- 70% reduction of ER cases with COIVD (4.8k this week, peak was 16k)
- 49% reduction of new cases (40k this week, peak was 79k)
- 33% reduction of positivity rate (9.3% this week, peak was 14%)
Death rates show a similar story but need to be viewed with the right analytical filter.
The rates reported by the media daily are distorting because it reflects data sorted by the date that it comes into the department of health. Backlogs of data can create spikes that are not due to health issues but reporting issues. The Florida community dashboard led Rebecca Jones has organized deaths into the date that the case was first reported. This allows us to track the impact of deaths with the same timeline as cases. The data shows that the peak day in Florida for Covid was July 9th through July 11th (death peak was July 9th , cases date was July 11th. ) Note below how the deaths by date reported creates large variability which can easily be misinterpreted by the public (or spun by the media).
The CDC Excess Data has Florida data through the week ending August 1st which shows a steep drop in excess deaths. The results now look similar to numbers in mid-June.
All of this data clearly shows that Florida is at the back end of the curve. The big question at this point is do cases head down towards zero (e.g., a “burn-out” of the virus) or will they plateau at a higher number? We will discuss this issue in a future post.
August 5, 2020
COVID Florida Data for the Month of July
We continue to tally the daily Florida state data on COVID as seen in our summary table below.
It is important to note that the state reports deaths when they receive them so deaths for a particular time reflect when they were reported not when they occurred. For example, deaths reported on a single day in July may include deaths from as long as 6 weeks before they were reported.
- Overall cases are 474k. Given overall Florida population of 21.9M this is a case rate of 2.1%. The critical assumption is how much are cases underreported? If the CDC estimate that cases underreported actual cases by as much as 10-fold up to 1 out of 5 residents in Florida have been exposed to Covid.
- The 25-34-year-old segment has the highest case rate of 3.4% and the 75-84-year-old segment has the lowest rate of 1.41% suggesting that strategies to protect older adults are working.
- Overall case fatality rates for Florida are now 1.48%, if the true case rate is 10x higher that mortality rate would be 0.14%.
- Mortality rates vary as much as 1000-fold by age group: 0.02% in ages 15-24 , 20% in ages 85 and older.
- Cases peaked in late July and we anticipate that Florida cases will be heading significantly down during August.
|FLORIDA AGE GROUP||COVID CASES||CASE RATE||HOSPITALIZATIONS||COVID DEATHS||Deaths / Cases|
July 27, 2020
Trend Slowly Turning in Florida
While the Florida weekly dashboard showed a 8% drop in cases on Sunday July 26th, the more sensitive indicator of ED visits with COVID like illness dropped substantially by more than 40% over the last 2 weeks. The positivity rate has dropped from a high of 15% to 12.5%.
July 20, 2020
A Picture is Worth a Thousand Words
Below are two graphs of Covid Cases and Deaths in the United States and Florida. We have used 7-day averages in New Covid Cases and Deaths from Covid to smooth out the weekly reporting issues.
Skeptics have been saying over the last 2 months that deaths will follow cases “in two weeks.”
This clearly is not the case.
What is clear from the US data that since early June the virus has become significantly less lethal. Less cases are being hospitalized – the percent of cases being hospitalized has dropped from 12% in May to 3.2% in July. The case fatality rate has dropped from 5.6% in May to 1.2% in July. This is likely due to a combination of a younger population and improved treatment. The average new daily deaths in July has dropped to 680 a day less than half the deaths in May.
|Average New Daily Cases||Positivity Rate||Average New Daily Hospitalizations||Average New Daily Deaths||% of Cases Hospitalized||Deaths / Hospitalizations||Deaths / Case|
Of course, everyone should still focus on prevention, especially given higher numbers of cases. Hand washing, masks indoors and social distancing. There are still significant risks that transmission can happen from the younger population to the older population.
However, the decreased death rate needs to be taken into account by any future public health strategies that contemplate increasing lockdowns.
Sources: Covidtracking.com, downloaded data from US and Florida July 18, 2020
July 15, 2020
The Current Truth : Mid-July Covid Numbers for Florida
The mid-month numbers for Florida are available today. Here are the comparisons between the last half of June and the first half of July
- Cases went from 75k to 149k almost double.
- Deaths went up, but the case fatality rate decreased further, now down to 0.68%.
- Hospitalizations went up, but the hospitalization rate decreased further, now down to 3.2%
- ICU availability is 11%
- Positivity rate for the first half jumped up from 14% to 19% when looking at all cases (including repeat testing), confirming that higher cases are not due to more testing. A better metric for positivity rate is the rate for new cases only, that number has averaged 14.2%. There are some indications over the last few days that this number is starting to go down but not enough to call a trend.
|Jul 1 – Jul 15||149,376||790,958||4,780||1,022||18.9%||3.2%||0.68%|
|June 16 – June 30||75,108||514,811||2,581||574||14.6%||3.4%||0.76%|
|June 1 – June 15||21,163||408,835||1,845||496||5.2%||8.7%||2.34%|
|May 16 – May 31||12,953||412,512||2,460||543||3.1%||19.0%||4.19%|
|May 1 – May 15||9,520||226,432||2,198||701||4.2%||23.1%||7.36%|
|April 16- April 30||11,179||168,896||2,451||681||6.6%||21.9%||6.09%|
|April 1 – April 15||16,173||152,886||2,521||532||10.6%||15.6%||3.29%|
|March 1 – March 31||6,338||60,597||823||77||10.5%||13.0%||1.21%|
July 12, 2020
Beneath the Headlines: Covid & Florida
The Orlando sentinel headline today reads “Florida breaks state, US record with 15k Covid coronavirus cases reported in a single day, an all-time high for a state”. Let’s take that headline and unpack that further.
As I have said previously, it is nearly impossible for the public to get a true understanding of what is happening with Covid by relying on the media with their focus on headlines and the popular narrative.
We analyzed publicly available data through the Florida Department of Health and the Covid Tracker project to look at aggregate data trends which are summarized in my extensive blog. For all of the facts and data, please click here.
In Florida, the data is taking us in two different directions:
- Cases are significantly increasing and may reflect a reality where the rates are even higher: 7-10%+ if we look at antibodies and 10-30% if we assume that the T- cell immune response is similar to Sweden.
- Death rates and hospitalizations are plummeting which is welcome news. If current trends hold excess death rates from Covid will likely contribute to less than 6% of total expected deaths by the end of the year.
Don’t just look at the headlines — think for yourself!
June 22, 2020
Florida & COVID: What Now?
In Florida, the rate of COVID is surging since the beginning of June. What are the facts on the virus?
Current cases are 4,061 on 6/19 compared to 1,029 on 6/7 a four-fold increase. The increases in cases are real and cannot be attributed to higher testing alone. The number of people tested has increased modestly (23%) 34,392 on 6/19 compared to 27,935 on 6/7. The positivity rate for new cases has nearly tripled, 12.36% positive on 6/19 compared to 3.85% on 6/7. This number had been trending down for most of May and represents a concerning reversal.
Hospitalizations are staying the same if not declining. Hospitalization and mortality rates remain concentrated in individuals 65 and over. 19% of the cases are in patients 65 and older, but those patients constitute 86% of the deaths. If we consider that elective surgery cases are now happening and are getting counted as COVID hospitalizations, the trend is likely declining.
This phenomenon of higher case rates but lower death rates is not being seen in other countries besides the United States. As a result, there isn’t an immediate, obvious answer, but there are three potential explanations:
- Younger people are getting the virus at a higher rate as older people appropriately take more precautionary measures. Nationally, the data shows that people 50 and over show a strong decrease in test positivity from April to June, with a reduction of 25% to 4-5% over that period of time. The average age of the person who is testing positive for the virus is trending downwards in Florida, it is now 32 for example in Broward County.
- Treatment in the hospital continues to improve. Remdesivir and dexamethasone are now two effective treatments supported by the literature which is likely reducing mortality rates. ICU and ventilator capacity are not an issue in Florida
- The virus may be getting less deadly. This has been hypothesized by Italian researchers but not confirmed.
In conclusion, although the surging case rates in Florida is getting the headlines, a deeper analysis of the data shows good news with death rates and no changes with hospitalizations. That being said, surging case rates in Florida call for a relook at a more targeted strategy at reducing transmission.
What does a targeted strategy look like?
The US public is losing appetite for draconian lockdown measures since the effects of shutting down the economy seems to cause as much health issues as COVID itself. Measures to reduce the transmission of the virus need to be more precise. Fortunately, we have much better information in June than we did in February when this first started. For example, there has been a comprehensive review of the effects of worldwide lockdowns in Nature.
A targeted strategy could include the following:
- Track new metrics. Because the death rates are going down, it will be critical for us to be able to follow death rates and hospitalizations as the major metric of success rather than just cases alone. We also need to develop a COVID complication metric as it is likely that there will be significant cases of chronic fatigue and other post-viral complications in young patients even if they are not hospitalized.
- Enforce indoor wearing of masks. Unfortunately, the wearing of a mask has become polarized. The messaging on this has whipsawed back and forth as experts attempted to create a particular response in the public rather than just presenting the facts. In my view, the wearing of a mask indoors is the most effective and practical intervention to reduce transmission. Japan for example, has been able to control COVID primarily through this policy without less of a lockdown. Cloth masks are not nearly as effective as N95 but far, far better than nothing. They are an act of altruism; you are protecting others from yourself. There needs to be a focus across the state on wearing masks indoors.
- Allow outdoor activities since outdoor transmission of the virus is much harder than indoor transmission. As a result, it should be ok to keep the parks and the beaches open. Outdoor restaurant seating doesn’t create a problem. It should also be fine to not wear a mask if you are by yourself or social distancing from other people. In the case of outdoor crowds, Initial data from outdoor gatherings (e.g., Arkansas pools) and outdoor protests does not point to outdoor activities as a major vector of transmission.
- Selectively tighten high-risk indoor activities. Indoor transmission is the major vector. You do not need to shut down the entire economy to be able to effectively reduce the transmission of the virus. Areas in Florida that need to be managed more effectively include:
- Bars – the business model around most bars (alcohol, mingling, reduced social inhibition) directly contradicts appropriate strategies. Shutting down the bars and keeping restaurants open would be an appropriate targeted response.
- Elevators – in most elevators, it is impossible to manage social distancing appropriately unless deliberate attempts are made to reduce capacity in elevators (e.g., no more than 2 people who don’t know each other).
- Large public gatherings indoors. Super-spreader events, seem to be the major accelerator of transmission, where 20% of cases are driving 80% of transmissions. A global database has been constructed of these “super-spreader” events that accelerate transmission of the virus. 97% of these events happened indoors, with the vast majority of them occurring where people were confined together for prolonged periods of time. Given these findings, having a capacity limit on indoor public gatherings is common sense. If there is an important reason to have a public gathering, put it outside and have everyone wear masks.
Yours in health,
Dr. Craig Tanio
June 10, 2020
Science, Lockdowns and Hypocrisy
Whether to have a lockdown or not is not a scientific question.
It is a political one.
That truth has been tremendously obscured in this pandemic for months but became crystal clear over last weekend.
There was a dramatic shift in the tone of public health leaders about the relative dangers of COVID and crowds. Multiple public health “experts” were quoted on the record as saying that their public health concerns about transmission of COVID were trumped by their public health concerns about racism and the need for protest. Any example of this was the following tweet from Jennifer Nuzzo, Dr. PH at Johns Hopkins
“We should always evaluate the risks and benefits to control the virus. In this moment, the public health risks of not protesting to demand an end to systemic racism greatly exceed the harms of the virus.”
This tone of the public health “experts” was quite different a month ago. For example, Arthur Caplan, an ethicist was quoted as saying that: “Lockdown protesters have a moral duty to forgo medical care in favor of those who followed the rules.”
Of course, the scientific truth is that the virus does not care about who is protesting and for what cause. Nothing had changed except the politics of who was protesting. The hypocrisy of many experts was clear – they were trying to frame their assessment of politics, risks, and tradeoffs of lockdowns as science when in fact it was their individual opinion and assessment.
There is nothing wrong with individual opinion and assessment – that is the domain of policy and opinion pages. The New England Journal of Medicine has run a policy and perspectives section for decades. Their viewpoint is quite similar to the New York Times Editorial page and for a long period of time it was clearly understood that those perspectives and editorials were quite different than the science parts of the journal.
We need to have a real dialogue on the science, policy and viability of lockdowns. Questions about lockdown policy will only increase in the next few weeks as we will almost assuredly get a bump in infections from large protests as well as the shift in movement from phase 1 to phase 2 in many states. There is a high probability of a “second wave” of infection in the fall, similar to what happened in the Spanish Flu in 1918. What would this dialogue involve? Here are some thoughts:
Acknowledgement about policy
- There is no perfect answer
- We need to make real and explicit tradeoffs. We make tradeoffs all the time. An example is the speed limit. If you drive 100 miles an hour, you are much likely to get in an accident than 10 miles an hour. As a society, we set speed limits with a clear understanding that some people will die in motor vehicle accidents.
Political and policy tradeoffs
- What is the degree of medical harm that is occurring from the economic damage inflicted by lockdowns? What is the risk of mental health, addiction, and domestic violence to name a few?
- How does that compare to the degree of medical benefit from a lockdown?
- What infringement on our civil liberties should we be willing to tolerate in the name of public health?
- What does it mean to be an “essential business”? What values are involved? Why are liquor stores essential and churches are not?
- How can we increase the precautions and testing in the nursing home industry which are causing 50% of the deaths?
- What are the facts in our specific geographic area? How can we tailor our policy to meet our specific community?
Scientific facts to incorporate into policy
- The virus is less fatal than we initially thought (see last week’s blog) and there are clear groups that are higher risk
- Most deaths are concentrated in nursing homes, the elderly, and patients with high morbidity
- Masks are helpful in reducing transmission
- Social distancing and hand washing are helpful in reducing transmission
- The virus is much less transmissible outside
- The virus is causing chronic illness in a subset of people including the young, which is not dissimilar to viral sequelae seen in other viral infections such as myalgic encephalomyelitis
Open scientific questions to consider
- Is medical treatment changing and improving outcomes in Covid? Is the virus changing? Is the combination of the two leading to reduced mortality from Covid?
- Should we be advocating for additional preventive interventions? Does having a healthy immune system (e.g. normal levels of Vitamin D) help to prevent Covid complications?
- How much real data is there to support the “six feet” distancing recommendations? Would a close radius e.g., 4 feet allow businesses to become more viable?
Here’s to an open dialogue about these issues and the tradeoffs involved.
Yours in health, Craig
May 31, 2020
Science, the Media & COVID Avoid the Popular Narrative; Think for Yourself
In the opening lecture of my first day in medical school at the University of California San Francisco in 1984 we were told the following
“50% of what you will learn in medical school over the next four years is false. The problem is we don’t know which 50%”
And this has played out in my medical career. Areas that have dramatically changed include:
• Change of HIV from an incurable disease to a chronic disease controlled by treatment
• Cure of Hepatitis C and Peptic Ulcer Disease with antibiotics
• Acknowledgment that Alzheimer’s can be prevented and delayed with appropriate lifestyle interventions
With COIVD-19, the changes in medical data has been dramatically accelerated with insights changing on a weekly basis. Multiple factors have been at play including that this was a new virus, that initial data from China was most likely incomplete and inaccurate, and that the entire scientific community has been working to solve this problem.
Changes in the case fatality rate are a good specific example with COVID. Most models were relying on initial data from China that was leading scientists to estimate that the case fatality rate could be as high as 1 to 5%. Since those estimates in February, our estimates of the case fatality rate has been reduced by a factor of 10 to 100-fold. In addition, it has also become clear that age is a major variable in who is at risk. The table below shows the CDC’s most likely estimates for the case fatality rate for people with COVID and symptoms as of May 30, 2020:
|Age||Case Fatality Rate||Survival Rate|
We could write a few “good news” headlines from this data
• “CDC says 99.95% of younger adults who get a COVID infection survive”
• “CDC case fatality rate estimates are reduced more than 10-fold from initial February estimates”
How many of those headlines have you seen?
Very few to none. And why not?
I believe one of the major reasons is because rapidly changing science data does not fit neatly into “overarching media narratives” that have become part of journalism in 2020. Journalists like to stick to a point of view and then organize all of their stories and information around that point of view.
If we are to really understand the truth with scientific data, we need to avoid the popular narratives and think for ourselves. An astute reader needs to understand the following:
• Initial scientific data is rarely clear-cut. In today’s day and age, media stories should always provide links to the data so that the reader can check the original sources themselves if they want.
• The “experts” are often wrong. It is easy for journalists to go to their “expert source” and present those viewpoints as the truth and start to build a “narrative.”
• Facts will change. The late economist John Maynard Keynes was known for saying: “When the facts change, I change my mind. What do you do sir?”
• Science advances only by proving hypotheses false. The philosopher Karl Popper proposed this view of science a century ago and it has held firm. A good example this is the pharmaceutical pipeline – for every 1 drug approved by the FDA there more than 6 failed candidates. However, each of those drug candidates had compelling data that warranted significant investment in the phase I clinical stage. It took research, time, and money to prove that the initial hypotheses were false.
One of the benefits of today’s internet is that it is possible to get multiple viewpoints and data so that readers can make up their own mind. A serious threat and danger to this is the emergence of social media “fact-checking or banning of alternative viewpoints.” For example, the CEO of YouTube has posted a policy stating that any viewpoints on COVID contrary to the WHO viewpoint will be banned. Which viewpoint? The one today or a few months ago? These efforts at censorship are inherently against the scientific method and should be condemned.
Dr. Craig Tanio
May 12, 2020
Protecting the Vulnerable: The 80/20 Rule and COVID
The 80/20 rule was originally coined by Vilfredo Pareto an Italian economist. He famously said that for many events, 80% of the effects are driven by 20% of the causes. And while the numbers 80/20 may not always hold, this principle of cause and effect shows up in many complex systems and events.
We can clearly see this with COVID.
We discussed in our last post that the elderly are uniquely vulnerable to COVID. Patients over the age of 80 being up to 12 x more vulnerable. The New York Times today reported on the percentage of deaths that are being driven by nursing home residents. Their findings:
- Across the country, nursing home residents are 11% of the cases and 33% of the deaths
- In many states (Maryland, Virginia, Delaware, Pennsylvania), nursing home residents constitute over 50% of the cases
- In states where deaths are lower, there are almost assuredly reporting issues (e.g., New York). Because of the reporting issues the exact numbers are not clear, but other analyses of the data has shown almost 40-50% of cases nationwide driven by nursing homes.
So let’s call it the 50/10 rule instead of 80/20.
Policies have almost assuredly exacerbated this problem including:
- Discharging nursing home patients out of the hospital back into the nursing home (driven by reimbursement reasons)
- California, New York and New Jersey had policies requiring nursing home patients to accept COVID positive patients upon discharge. This is the equivalent of throwing a match onto kindling.
- Not testing all residents and workers within a nursing home
It would not take much time to test everyone in a nursing home! The CDC estimates that there are 1.7M beds in the country. Current US testing capacity is about 250k a day and projected to double shortly. Testing workers in the nursing home
Whatever your politics, focusing public health efforts on the most vulnerable is evidence-based. It is easier to do, and it would get maximum results. It just makes sense.
May 11, 2020
Which populations are the most vulnerable to COVID?
The largest study of mortality risk for COVID was released today from the UK. It looked at over 17 million patients and 5600 in hospital deaths. It starts to give us a much more granular look at what factors contribute to a higher risk of dying for COVID. Some of these risk factors have not been well-characterized prior to this study.
Highest risk factors
- Age is the highest risk factor with risk increasing significantly with every 10-year bracket over the age of 59. Patients 60-70 have 2x risk, Patients 70-80 have 4.7x risk. Patients over the age of 80 have a 12x higher risk.
- Organ transplant and recent malignancy have a 5x higher risk
- Diabetes and obesity had a stepwise risk, the worse the condition the higher the risk up to 2.4x higher risk
- Stroke/dementia (1.79x) and other neurologic risks (2.5) were in a similar category
Important risk factors
- Socioeconomic deprivation had a stepwise risk up to 1.75 x
- Asian (1.6x), African (1.7x), male (2x), chronic liver disease (1.6x)
Modest risk factors
- Rheumatoid arthritis/lupus / psoriasis had a slight increase in risk (1.2) the same as asthma (1.25) and chronic heart disease (1.2)
- Hypertension was not a risk
- Current smokers had reduced risk (0.8) – now seen in multiple studies, ex-smokers had a higher risk (1.25x)
This should really help provide more clarity as to which populations should be considered vulnerable. The risk factors are multiplicative in that a person’s total risk is the product of all of their risk factors.
See the picture below for more details
We will certainly use this data going forward to counsel patients about their individual risk in connection with COVID-19.
May 6, 2020
Vaccines, Treatments and Global Impact
Promising Vaccine News. The most important news from last week was an announcement by the Jenner Institute in Oxford that their vaccine for COVID had been shown to be effective in rhesus monkeys. They have a head start on other groups as their vaccine template has been shown to be safe in humans from prior studies. As a result, they can launch to clinical trials in humans in May with a timetable that could create initial supply by September if there is emergency approval from regulators. A lot needs to go right but this is the first really good news that we have heard. We will closely track other vaccine developments including work on an RNA based vaccine.
Remdesivir – Due to new information and studies that came out last week the FDA did approve Remdesivir under an emergency use authorization for use for patients with low oxygen saturations (<94%), mechanical ventilation or extracorporeal membrane oxygenation. As we predicted a couple of weeks ago, the FDA did not wait for placebo-controlled studies. There were multiple studies over the last few weeks showing conflicting results but at this time it does look like Remdesivir is reducing the length of stay in the hospital and improving the time to recovery by a modest amount. It is not an option for patients outside of the hospital. Gilead will be donating supplies of Remdesivir rather than charging for it at present.
What is the true impact of COVID across the globe? The Financial Times has started to track the increase in death rates in countries across the globe compared to historical death rates. Their conclusion is that the death rate across the globe is likely undercounted by 60%. This is a very accurate and legitimate way to keep track of the likely impact of the pandemic across the globe.
A week later, the NY Times did an analysis for states that used a similar methodology. This analysis provides extraordinary clarity on the different impacts COVID is having across the US. For the period of March 15 – May 2nd, New York City experienced 23,000 excess deaths. In comparison, the 3 most populous states — California experienced 1,100 excess deaths, Florida experienced 400 excess deaths and Texas experienced 60 excess deaths.
Since most of the national media is New York based, it is no wonder that their tone reflects the experience in New York City, while people who are living in Texas may be wondering what the fuss is all about.
There is one caveat to tracking excess deaths that will become more relevant over the next few months. If deaths start to occur secondary to economic issues (e.g. suicide, substance abuse, domestic violence) those are not direct impacts of COVID but indirect impacts. The medical impact of a global recession should not be underestimated.
4. Keeping track of other treatments. The Milken Institute has developed this very useful real-time update on all treatments being explored by the scientific community for COVID. An extraordinary amount of work is being done in a coordinated manner by scientists across the globe. We are confident that some of this work will start to pay off in a way that will help people.
April 27, 2020
Relevant New Information
Here’s a summary of relevant new information on COVID-19
- Hospital Capacity: A month ago, there looked to be a vast potential mismatch between hospital supply, ventilator supply and coronavirus patients. Now much of the hospital system in the country is idle and shutdown. Going forward, it is unlikely that there would be ventilator shortages in any part of the country even in a second wave of infections of Covid-19.
- Prevalence: There have been a number of studies this last week looking at the overall prevalence of coronavirus in the population varying from 14% in New York to 6% in Miami. It is not enough to create “herd immunity” but sufficient to reinforce our discussion a few weeks ago that most patients with coronavirus are asymptomatic.
- Treatment: Not a good week for treatment. Data on hydroxychloroquine from a VA study came back negative although there were issues with the timing of treatment and bias in the nontreated cohort. The WHO leaked data on Remdesivir that was negative and then withdrew the posting of the study. Cardiac complications from hydroxychloroquine are becoming noticeable in sick hospitalized patients making it less likely that it will be an effective in-patient treatment if started late.
- Transmission: Data keeps coming in that suggests that the major mode of transmission is indoors in crowded spaces. For example, eating outside in a restaurant looks like a potential option according to this study.
- Who is getting sick? By far the 2 segments of the populations that are getting sick are patients with a chronic condition (e.g., diabetes) and older adults. Because the prevalence rate is higher, the fatality rate of people who catch the virus is much lower (at this point likely less than 1%).
- When is the vaccine coming? No time soon. Best guess is 12 to 18 months, but there are scenarios where a vaccine is not created.
- Is this a local or national issue? The medical spread of the virus is absolutely a local issue. A look at the Hopkins map shows that the concentration of virus varies tremendously across the country county by county.
- How should I think about the number of deaths to date? Most of the deaths have been concentrated in the urban areas of New York and New Jersey with 54k deaths to date in the United States on April 26th. As a comparison, there were 69k deaths mainly in rural areas from the opioid epidemic in 2019 according to the CDC.
- Can we “contain” the virus? The big challenge is that there is a high amount of asymptomatic patients who are actively shedding the virus. This makes containment highly challenging for an entire population unless there is a country high sheltered from the rest of the world such as New Zealand. It may be possible to keep the virus away from a targeted set of people for a short period of time, such as NBA players in a playoff season – but only with multiple rounds of high volume testing and prevention.
- Are antibody tests for COVID-19 accurate? Not yet. If the prevalence of the disease is low and sensitivity and specificity is not high enough, then there will still be false negatives and false positives. I suspect that “version 2.0” of these tests will have high enough sensitivity and specificity but false negatives and positives will be an issue for the immediate time being.
- What are the goalposts of public health policy? A month ago, when social distancing started the public health goalposts were clearly defined “Avoid overwhelming hospitals and overwhelming ventilator capacity.” This made sense given our knowledge of the virus at the time, the situation in Italy, and that models were showing that many areas could have been overwhelmed.
The public health goalposts have morphed in some circles from “avoid overwhelming hospitals” to “avoid catching coronavirus”. If that is the target, this policy goal is not possible without prolonged social distancing lasting for months. Because if the strategy is initially successful it will need to continue until there is a vaccine.
If the goalpost is “protect vulnerable populations from infection” then a different targeted strategy around high-risk elderly patients and high-risk patients with chronic conditions may be in order. An immediate priority would be to protect patients in nursing homes and assisted living. The next priority would be to determine specific high-risk patients within the list of patients with chronic conditions that would allow a more precise targeting strategy.
Dr. Craig Tanio
April 19, 2020
Is Remdesivir a possible solution?
Strong but not conclusive scientific signals on the effect of Remdesivir in hospitalized COVID-10 patients Remdesivir is an antiviral made by Gilead, the pharmaceutical company that has successfully developed antivirals for Hepatitis C among other diseases. It is a parenteral agent, meaning it is given by intravenous solution.
A study came out this week in the New England Journal of Medicine that shows that Remdesivir appears to have a large positive effect in the hospital setting. 61 patients were provided Remdesivir on a compassion-use basis, open label basis. 53 patients had data that could be analyzed.
- 68% of patients had documented clinical improvement.
- For the very sick patients that were on mechanical ventilation there was a 18% fatality. Historical controls in China and other countries showed > 50% fatality.
- The mortality rate of patients who weren’t on mechanical ventilation was 5%.
- 3 out of 4 patients who receiving ECMO (extracorporeal membrane oxygenation) stopped receiving it; a very large signal that something is occurring.
Gilead is actively collecting data on Remdesivir in 2 major studies :
- A severe Covid-19 study that includes 2,400 participants from all over the world.
- Its moderate Covid-19 study includes 1,600 patients also all over the world.
The trial is investigating five- and 10-day treatment courses of Remdesivir. The primary goal is a statistical comparison of patient improvement between the two treatment arms. Improvement is measured using a seven-point numerical scale that encompasses death (at worst) and discharge from the hospital (best outcome), with various degrees of supplemental oxygen and intubation in between. There are no placebo arms in either of the studies which would readily be possible (e.g. IV bags of placebo).
Conventional wisdom is that if these trials show positive results it will likely lead to fast approvals by the FDA and other regulatory agencies and become the first approved treatment against the disease. It is unclear whether the FDA will require a placebo arm before approving the drug. The future debate on the need for placebo arms before approval will be enlightening.
We should consider the data this week as a strong but not conclusive scientific signal that Remdesivir could work as a treatment for hospitalized patients with COVID-19. More data is rapidly coming.
1. Grein J, Ohmagari N, Shin D. Compassion Use of Remdesivir for Patients with Severe Covid-10. NEJM 2020 April 10. DOI: 10.1056/NEJMoa2007016
April 16, 2020
How can we manage the virus AFTER we flatten the curve? PROPHYLAXIS
Effective prophylaxis for COVID-19 simply put would be a game-changer.
Prophylaxis is the use of medication to prevent or reduce the chance of the infection ever occurring. It has been used in infections ranging from malaria to HIV.
There are two types of strategies: pre-exposure and post-exposure. Pre-exposure treatment is usually done on an ongoing basis. Post-exposure prophylaxis is usually done after a specific event (e.g., health care workers exposed to a large amount of virus in the ICU).
There are 12 active clinical trial studies currently on clinicaltrials.gov looking at hydroxychloroquine (HOCQ) prophylaxis. It’s parent Chloroquine, has a long track record of 50 years of being effective for prophylaxis for malaria. There are no other drugs being actively studied for prophylaxis at this point for COVID.
An example of the 12 studies is a randomized study looking at 3000 healthcare workers and first responders in the Henry Ford Health System and in a separate study for healthcare workers run by the University of Minnesota. The dose of HOCQ prophylaxis in these 2 studies ranges from:
- Once a week intervention 400mg a week Twice a week intervention 400 mg
- Twice a week
- Daily intervention 400 mg a day
Another research approach that might get us insights quicker on HOCQ prophylaxis is the use of big data. There is a natural prophylaxis strategy already occurring in the population – the patients who are already taking HOCQ because of lupus. Researchers are actively using pharmaceutical databases and insurance claims to follow outcomes in these patients and compare them to controls to see if COVID-19 infections are less in patients on HOCQ compared to controls. These studies can be done quickly, and we will keep close track in the next 30 to 60 days to see the preliminary results.
We naturally focus on the medical issues of COVID-19 rather than the economic and policy issues. However, we did want to point the reader to a good bipartisan economic and policy working paper authored by Avik Roy, Bob Kocher and others that is being continually updated with new evidence and policy ideas. Importantly it discusses both optimistic scenarios and pessimistic scenarios, which is critical in this time of uncertainty.
Please stay tuned,
Dr. Craig Tanio
April 15, 2020
How can we manage the virus AFTER we flatten the curve
By now, most people know what it means to “flatten the curve” through social isolation, masks and hand washing. The next logical question is what will it take for us to get out of lockdowns across the country? The answer will be driven by a mixture of science and policy. In the next few blogs, I will discuss a number of factors on the science that will drive this answer. We will frame this as a set of the right questions since the answers will likely evolve as we get more data.
How infectious are asymptomatic people?
What has been worrying epidemiologists is that asymptomatic people are driving the virus. A recent article in Science describes what might have occurred in China. An epidemiologic model shows that a large percentage (86%) of COVID-19 infections in China were in undocumented patients, people who had little symptoms to no symptoms. Even though those people had only 55% of the transmission rate of documented patients, a large proportion (79%) of the spread was mediated through undocumented patients because of their grater numb The reason for this may be that COVID attaches to ACE2 receptors in the throat and as a result, the virus is present in throat secretions, not just the lung.
There are several implications if this is true:
- Healthcare workers will need to have universal precautions, every health care worker with a mask (something we already do at Rezilir)
- We need to have dramatic and repeated testing to “box in the virus”, not just test those with significant symptoms.
- Even more contact workers are needed to follow-up with patients of who have tested positive.
It is assumed that the virus will infect a very high amount of the population. Some models show up to 50-75%, based on what has happened in prior flu epidemics, which creates what is called “herd immunity” that prevents the virus from spreading further.
5 recent studies show similar numbers all below 20%:
- Germany – a study that sampled 1000 residents in the town of Gangelt showed that 14 percent of the population had antibodies to COVID, 2 percent showing active infection and a total of 15 percent of people who had been infected with the virus.
- Diamond Princess – This was the ship that was quarantined on February 3rd when a passenger boarded the ship on January 20th and stayed on the ship for 5 days and spread the virus. All of the 3711 passengers were tested, ultimately 17 percent of them turned out to be infected
- China – A study of 391 people and 1286 of their close contacts in Shenzen, China who shared a household with someone who had been infected showed that 15 percent of the close contacts were infected.
- NYC – Universal screening of 215 women admitted for delivery at Columbia Presbyterian showed a 15.4% infection rate. Of the 15.4% who were infected 13.9% had no symptoms and 1.9% had symptoms.
- Iceland – A study in the New England Journal of Medicine on 4/14/20 screened 6 percent of the entire population and 13.3% had positive results for infections with COVID-19. Interestingly the percentage of infected participants that was determined through population screening remained stable.
These studies are among the first to understand what percentage of the population is infected. It’s hard to know how to interpret them yet – it could mean that fewer people will ultimately get infected. Or that in all of these situations, the virus could have spread further without isolation strategies. If it is the former scenario, the implication would be profound. So we will keep a close eye out for further studies including those of US hospital workers to see if there are situations where the percentage of the exposed population gets above 20%.
Other questions that we need to answer in upcoming blogs are the following:
- Can prophylaxis be effective?
- How accurate are antibody tests?
- Will antibodies provide immunity?
- Can early treatment be effective?
Meanwhile, the team at Rezilir Health wish you and your loved ones health, strength and HOPE during this difficult time.
Dr. Craig Tanio
1. Li R, Pei S. Substantial undocumented infection facilitates the rapid dissemination of novel coronavirus (SARS-COV2) Science 16 Mar 2020, DOI: 10.1126/science.aab3221
2. Gudbartsson D. Helgason A. et al. Spread of SARS COV2 in the Icelandic Population. NEJM April 14 2020 DOI: 10:1056/NEJMoa2006100
April 10, 2020
VIP Is Being Studied in COVID-19 Trial
One thing that COVID-19 has in common with CIRS patients that we see at Rezilir Health is the major problems are caused by an overactive immune response, often known as the “cytokine storm.”
So it is not surprising that the FDA announced on March 29th that NeuroRx had received approval for an Investigational New Drug study to study IV Vasoactive Intestinal Peptide in COVID-19 patients on a ventilator. The VIP that they are studying is Aviptadil which is a patented synthetic form of Vasoactive Intestinal Polypeptide that has previously shown promise in treating ARDS (Big Pharma not Compounded).
As many of Rezilir patients know VIP, has been extraordinarily helpful to limit and to prevent the overactive immune and inflammatory response that happens in CIRS from Water Damaged Buildings. The biological analogies are quite promising, although getting the formal evidence is critical. Evidence is a must!
While no formal outcomes have been reported in the last 10 days, there are some informal results from the ICU that sound quite promising. More to come!
Have a continued joyous Passover and Easter Weekend
April 9, 2020
Model showing significant changes in peak
IHME Model showing significant changes in peak resource use
The Murray model is making significant adjustments daily in individual state projections so don’t just follow the media for what is happening nationally. Overall estimates of national ventilator needs have dropped significantly. As of today:
- Florida projections of peak resource is April 21st
- United Kingdom projections of resource is April 17th
- California projections of peak resource is April 13th
- National projections of peak resource use is April 11th
- New York projections of peak resource use is April 8th today
- Washington State projections of peak resource was April 2nd
Asian countries are showing some second bumps in cases, notably Singapore that has a very effective public health response. It announced that there were 142 new cases today and the reimposition of full lockdown.
Moving from a population-based containment model to a case-based containment model
As we move through the peak, there will be a vigorous national debate on how to restart the economy and still have an effective public health strategy.
The 25% sudden drop in economic output is unprecedented, it is larger than the Great Depression and comparable to war within a country. There is a considerable body of literature to show that unemployment and economic distress has its own impact on health outcomes that are considerable.
The critical question we will need to figure out in the next few weeks is how to move our public health strategy from a population-based containment model (e.g., same rules for everyone) to a case-based containment model (i.e., specific rules for those who are actively infected.) An approach that will preserve our civil liberties and privacy.
More on this to come but a couple of principles will be critical
- We need an effective IgG and IgM test to see whether citizens are actively infected or immune. Ideally this is a point of care, reliable and with rapid turnaround time.
- We need effective surveillance processes to find new infections. Digital apps will be critical. As a public service announcement please take a look at www.detectstudy.org for a research study by Scripps that is looking at how to use apps to best monitor health anonymously.
- We will need a significant deployment of newly trained caseworkers to follow-up newly infected individuals to trace contacts (new opportunities for those who are unemployed).
- We need to have rigorous self-isolation for citizens that are newly infected which is actively reinforced.
- Janlert U, Winefield AH, Hammarström A Length of unemployment and health-related outcomes: a life-course analysis. Eur J Public Health. 2015 Aug;25(4):662-7. doi: 10.1093/eurpub/cku186. Epub 2014 Nov 23.PMID: 25417939
April 7, 2020
PUBLIC HEALTH & COVID-19
If you are searching for data on how the epidemic is likely to evolve across the country and in your area, the most cited model is now “The Murray Model” run by Christopher Murray at the Institute for Health Care Metrics in Seattle, Washington. IHME has been the preeminent group in assembling massive global health datasets and has been doing this for over a decade. I worked with Chris 12 years ago when I was at McKinsey and Company as Chief Operating Officer of their Health Care Systems Institute and he was our adviser. Extraordinarily smart and insightful. That being said, lots of people in the media on both sides are having commentary on the accuracy of the model and it is changing day to day as the data evolves. Check it out.
Since the practices, principles and professionalism of public health are also front and center in the news, you may have become interested personally more interested in what public health is about. If you have extra time to spare in social isolation at home, take a look at this free Coursera course on Public Health sponsored by the Johns Hopkins School of Public Health, which starts today.
FLORIDA TREND IS DOWN
The overall Florida numbers went down for the second day in a row. Needs to be for fourteen days before we can really say the peak is gone, but a hopeful trend.
April 3, 2020
Update on Masks and Testing
The CDC finally announced today that everyone should wear a mask when outside. They recommended that people wear cloth or fabric face coverings which can be made at home when entering public spaces.
This is a good thing and a practical strategy.
News reports emphasized that this is to prevent those people who have the virus and might not know it from spreading the infection to others.
However, in our opinion the most important effect is the psychological effect of wearing a mask – it keeps the user and everyone else aware that we have to do our part to prevent the spread of disease. Experience in multiple countries is showing that when the population all wear masks the disease is spread slower. Our observation in South Florida is that less than 50% of the population were wearing masks. The wearing of masks will enforce other strategies further.
The prior recommendations to not wear masks, we believe was primarily based on a concern of affecting the supply of hospital grade masks for health care workers. This is a practical solution. Healthcare workers need the protection first.
Just keep in mind that a homemade mask does not provide full protection. But something is most assuredly better than nothing.
We are awaiting the availability of widespread IgG and IgM testing of the virus.
There have been a couple of stops and starts on FDA approval of testing. On Tuesday, it spread on social media that Bodysphere had received FDA approval for its test which turned out not to be the case. On Thursday, there was a valid announcement by Cellex, a company in the Research Triangle North Carolina on the FDA approval of their test for emergency use.
What you should know right now is that the antibody tests are different than the current PCR tests which tell us if someone is actively infected. What the IgG and IgM tests tell us the degree of a patient’s antibody response. IgM antibody indicates that it is a current infection; IgG infection importantly indicates the presence of immunity in the person.
The spread of antibody tests will be a gamechanger. When we can tell that patients are immune and when health care workers are immune, it will provide a significant step up in our ability to manage the infection in a more targeted way.
March 30, 2020
Testing, Masks and Current Outbreaks
Here is the newest update of highly relevant information on COVID-19 pandemic and perspectives on how we can all keep safe with COVID-19.
Please visit our website www.rezilirhealth.com daily for up to date information from Dr. Tanio.
The cheaper and more widespread testing can come the better. Multiple announcements happened over the last week on the availability of point of care testing within 15 minutes which promises to be a gamechanger. We need to distinguish between PCR based testing which can tell us who immediately is infectious, and IgG and IgM based testing which can tell us who is immune. But economics and innovation and working to get cost low and availability high. Things are changing quickly. We absolutely need to have the resources and change so that every citizen can get tested at the front line when we need it. We aren’t there yet, the technology is available and now we need to ramp up production.
Multiple country experiences – Hong Kong, Singapore, Czechoslovakia – are showing us that wearing masks in this outbreak is a sign of social altruism and effective social policy. Being kind to your neighbor is so critical as social policy and social cohesion. Much of the controversy around who should wear masks stemmed from the fact that health care masks were in shortage and experts wanted to allocate supply to health care workers. Well, people can still create homemade masks which can help to reduce at least 70% of spread if not more. 70% is far better than 0%! Even more importantly, wearing masks when you are outside of the home can help to keep everyone in the community aware that we all have to do our part to prevent the spread of this disease.
Preventing outbreaks is a local, national and global issue:
Map data is rapidly showing us that the outbreak issue is a global issue, a national issue and most importantly a local issue. What happened in Lombardy, Italy is dramatically different than what happened in Rome, Italy. Queens and Brooklyn are the epicenter of the global outbreak, but data in New Orleans, as well as South Florida, are also concerning. In other parts of the country, the data is quite different.
The rapid increases and doubling in cases every 2-3 days shows that we have not leveled the curve yet. In some areas there are hints that social distancing is working but we still premature.
What is clear is that prevention strategies will have to dramatically vary by region of the country – at the state and county level.
Multiple companies are showing ingenuity and innovation on increasing the supply of ventilators and the supply chain is being ramped up. Specific individual regions are taking steps to create additional hospital ICU beds capacity is being created quickly.
THE CRITICAL TWO ISSUES: There are two issues that are critical for us to solve to effectively manage Covid-19 before we can get a vaccine which likely won’t happen for another 12 to 18 months.
Treating the Virus and reducing its complications
We need to effectively treat the complications from the virus – rate of hospitalization, rate of ICU admissions, and fatality rates. There are some early signs that certain countries have lower complication rates, e.g., German. If this rate can drop significantly in the next 3 months, it can save thousands of lives AND help the economy. The way this can happen is for the medical community to collectively work on helping patients recover once they are effective.
In this week, we have seen significant and rapid progress on this front.
1. Integrative treatments:
There is a good article that was published this week discussing how integrative treatments can support the immune system. As the authors point out “Unfortunately, no integrative measures have been validated in human trials as effective specifically for COVID-19. Notwithstanding, this is an opportune time to be proactive. Using available in-vitro evidence, an understanding of the virulence of COVID-19, as well as data from similar, but different, viruses, we offer the following strategies to consider. Again, we stress that these are supplemental considerations to the current recommendations that emphasize regular hand washing, physical distancing, stopping non-essential travel, and obtaining testing in the presence of symptoms”.
2. Chloroquine and Azithromycin.
There was updated data on the French nonrandomized observational trial of chloroquine and azithromycin. The author, Dr. Didier Raoult reports that in 80 in-patients receiving a combination of hydroxychloroquine and azithromycin, the team found a clinical improvement in all but one 86 year-old patient who died, and one 74-year old patient still in intensive care unit. Most of those patients were treated early in their course. The team also found that, by administering hydroxychloroquine combined with azithromycin, they were able to observe an improvement in all cases, except one. The team went on to say: “Thus, in addition to its direct therapeutic role, this association can play a role in controlling the disease epidemic by limiting the duration of virus shedding, which can last for several weeks in the absence of specific treatment. In our Institute, which contains 75 individual rooms for treating highly contagious patients, we currently have a turnover rate of 1/3 which allows us to receive a large number of these contagious patients with early discharge. Chloroquine and hydroxychloroquine are extremely well-known drugs which have already been prescribed to billions of people.” “In conclusion, we confirm the efficacy of hydroxychloroquine associated with azithromycin in the treatment of COVID-19 and its potential effectiveness in the early impairment of contagiousness. Given the urgent therapeutic need to manage this disease with effective and safe drugs and given the negligible cost of both hydroxychloroquine and azithromycin, we believe that other teams should urgently evaluate this therapeutic strategy both to avoid the spread of the disease and to treat patients before severe irreversible respiratory complications take hold.”
We await good randomized trials on this treatment which are critical to advancing the science. They must happen.
In a future post, we will discuss the ethics of treating patients without a randomized double bind clinical trial. Needless to say there was been huge variability in state leadership around hydroxychloroquine which has ranged from the governor of Michigan threatening doctors licenses if they prescribed hydroxychloroquine compared to the governor of Florida who made a deal with Teva Pharmaceuticals to provide compassionate use of the drug to local hospitals in South Florida.
3. Remdesivir. The next Remdesivir data should be due in mid-April from China. It is pharmaceutically designed to inhibit Ebola RNA-Dependent RNA polymerase, which is 96% identical to SARs-COV-1. The article below shows the biological data on how Remdesivir works against SARS-CoV-2 in cells.
The most important data we can watch over the next few weeks is whether the combination of all of these therapies can reduce the complication rate.
We will keep you posted. Keeping Healthcare Workers Healthy Our healthcare workers are doing heroic work in this pandemic. Doctors, nurses and staff are all working around the clock to help people. They are also incredibly vulnerable at this time. The shortage of Personal Protective Equipment (PPE) for medical personal has to be addressed more effectively in the weeks to come.
Convalescent serum could help people remain in the workforce as a form of prophylaxis. This is a treatment that has been around since the Spanish Flu pandemic in 1918. Antibodies that a patient has just created are gathered from the patient in “convalescent serum” which is then given to a patient who is fighting the disease. A study from China a few weeks ago that showed some preliminary results in five critically ill patients. In this preliminary uncontrolled case series of 5 critically ill patients with COVID-19 and ARDS, the administration of convalescent plasma containing neutralizing antibody was followed by improvement in their clinical status. This strategy was tested in the US at Houston Methodist in Texas over the weekend for the first time.
Clinical References 1. Alschuler, Weil et al. Integrative considerations during the COVID-19 pandemic https://doi.org/10.1016/j.explore.2020.03.007 2. Shen, Wang et al. Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma PMID: 32219428 DOI: 10.1001/jama.2020.4783
3. Wang, Chao et al. Remdesivir and chloroquine effectively inhibit the recently emerged novel coronavirus (2019-nCoV) in vitro PMID: 32020029 DOI: 10.1038/s41422-020-0282-0
Disclaimer: If you are not an active Rezilir patient, please disregard any medical advice contained within this document. This is for general informational purposes only and does not constitute the practice of medicine, nursing, or other professional healthcare services, including the giving of medical advice. No doctor/patient relationship is formed. The use of this information and the materials herein is at the user’s own risk. The content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Users should not disregard or delay in obtaining medical advice from any medical condition they have, and they should seek the assistance of their healthcare professionals for any such conditions.
March 23, 2020
Rezilir Health is Open
There was a fair amount of internet-related controversy on the overview of COVID-19 information we linked to on Saturday morning and by Sunday morning, Medium had taken the feed down. We will find a good general overview in a subsequent update.
PHARMACOLOGIC TREATMENT OPTIONS
- There are a number of US clinical trials that are emerging to study hydroxychloroquine. The first clinical trial is for medical professionals/workers (University of Minnesota sponsored) – send an email to firstname.lastname@example.org. The second study will be run by NY state for patients, further details are to come.
- The University of Washington added hydroxychloroquine to its internal treatment guidelines
- The Chinese studies have looked mainly at chloroquine. There is an in vitro study (Yao – see footnote) comparing the two showing that hydroxychloroquine can get better inhibitory studies. Clinically we consider both of these medications to be relatively equivalent.
- The French government is setting up a new trial to expand work on the abstract from France discussed earlier this week that showed a successful reduction in COVID 19 load with azithromycin and hydroxychloroquine.
- The NEJM study looked at Keletra (ritonavir/lopinavir) and concluded that the medication had no effect on survival. The quality of the study was good. More research needs to be done and will be done.
There are reports from Europe that NSAIDs may exacerbate virus progression. We are looking into this but in the meantime recommend Tylenol (Acetaminophen).
Angiotensin 2 Blockers
- Initial data is conflicting on whether ARBs could help or hurt patients; at this point, patients should remain on ARBs
The Japanese made flu drug was reported in the Guardian to be effective in reducing the duration of COVID-19 virus in patients and improve long conditions of those who received treatment. (Awaiting link to study) Tocilizumab an anti-inflammatory was reported by the Chinese to have improved results in an observational, non-randomized study.
One clear risk that is emerging across all age groups are co-morbidities – particularly insulin resistance, chronic inflammation, and immune issues. These are all issues we have tried to address. We remain optimistic that new therapeutic options will rapidly emerge to help patients and medical workers with treatment options for COVID-19.
Clinical Footnotes. 1. Yao et al 2020. In Vitro Antiviral Activity Hydroxychloroquine https://doi.org/10.1093/cid/ciaa237
2. Cao et al 2020 Lopinar-Ritonavir https://www.nejm.org/doi/full/10.1056/NEJMoa2001282?query=recirc_curatedRelated_article
Disclaimer: If you are not our patient, please disregard any medical advice contained within it. This is for general informational purposes only and does not constitute the practice of medicine, nursing, or other professional healthcare services, including the giving of medical advice. No doctor/patient relationship is formed. The use of this information and the materials herein is at the user’s own risk. The content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Users should not disregard or delay in obtaining medical advice from any medical condition they have, and they should seek the assistance of their healthcare professionals for any such conditions
March 21, 2020
Rezilir Health is Open
As most of our patients settle at home this weekend practicing social distancing, we believe it is very important to keep the right context and perspective on the information that you are getting on COVID-19. A couple of thoughts this Saturday morning:
1) Get the facts right. The facts keep changing daily and it is important that we all get the right facts without hysteria or bias. A very helpful analysis and summary of facts that not well appreciated in most newsfeeds is Aaron Ginn’s summary as of March 20, 2020. Everyone should take the time to look at the information and think for themselves.
The rapid increases in daily numbers (total cases expanding to 16k at an exponential rate), are in the context of massive increase in testing which distorts some of the numbers. Don’t panic about the new numbers until the data has a few days to settle.
2) Most cases of COVID-19 will be mild. The facts are that 80-85% of all cases will be mild and will not require a hospital visit; only 1% of everyone tested for COVID-19 in the US will have a severe case that will require a hospital visit. As we hear escalation in numbers, it is important that we keep this in mind.
3) Treatment data is starting come through.
We should expect a high volume of treatment data coming out weekly as the scientific community looks to develop effective treatment options for COVID-19.
There is a good summary article this week by Dr. Saddiqi at the Brigham on how to think through treatment protocols for Covid-19 that outlines progressive phases of the disease, a useful classification, the need to avoid the hyperinflammatory stage and potential therapies (with an emphasis on potential and yet unproven therapies). A very useful summary chart is listed below
Negative data came out on Thursday on a randomized trial in the New England Journal of Medicine on Lopinavir and Ritonavir. While the data was disappointing, it was high quality. the investigators appropriately prioritized speed and designed a trial that could rapidly produce an answer so that we have important insights from patients seen in January.
Early data on hydroxychloroquine coming out but it is early. Hydroxychloroquine (Plaquenil) made it to Trump’s press conference this week causing a run on prescriptions. Here are the facts. Because of the lack of effective alternatives and some promising non-randomized data, several countries have put hydroxychloroquine into their COVID-19 clinical therapeutic guidelines on Belgium and China. French investigators published an open-label non-randomized study this week that showed promising results including reduction of viral shedding. Hydroxychloroquine has been an effective agent for managing infections and inflammatory responses in several therapies ranging from autoimmune conditions and chronic infections with some in vitro data published to support dosing schedules. The data needs to be replicated with better randomization and controls and we look forward to seeing improved research coming out in the weeks to come. In the meantime, we will incorporate this into our clinical protocols always remembering to customize care for each particular clinical situation.
In good health,
Dr. Craig Tanio
2) Gautret et al. (2020) Hydroxychloroquine and azithromycin as a treatment of COVID‐19: results of an open‐label nonrandomized clinical trial.
International Journal of Antimicrobial Agents – In Press 17 March 2020 – DOI : 10.1016/j.ijantimicag.2020.105949
3) DOI: 10.5582/bst.2020.01047 5) https://www.ncbi.nlm.nih.gov/pubmed/32150618 DOI: 10.1093/cid/ciaa237
4) https://www.ncbi.nlm.nih.gov/pubmed/32150618 DOI: 10.1093/cid/ciaa237
March 19, 2020
Rezilir Health™ is Open
Rezilir Health is here for you.
Things are changing rapidly with the global COVID-19 pandemic. A couple of reflections and observations over the last few days are listed below.
The data on the extent of the pandemic is rapidly changing as the US starts to catch up with testing. Regardless of your politics, our country’s attitude is rapidly changing, and some effective action is starting to happen, hopefully it will be quick enough to slow the progression of the virus.
Cases in the US hit 7k more than 5x last week and remains on the exponential curve. https://coronavirus.jhu.edu/map.html
The Oxford data set will let you keep track of individual country trajectories to see when the US starts to slow down https://ourworldindata.org/coronavirus
The research is showing that most of the transmission is happening in the population driven by asymptomatic patients, many of them younger. We need everyone to act collectively to have more physical isolation so we can protect the most vulnerable in the population.
At Rezilir we are changing our processes so that patients who need to come into the clinic can feel like they are safe and at low risk of catching an infection. Everyone is wearing masks. It is slowly penetrating the US health care community that EVERYONE should wear some type of mask to slow down dose of transmission, even if it is a scarf or modest face mask.
There is a lot of collaborative work in the medical community on what treatments should be available if someone is diagnosed as having COVID-19. At present many of the European guidelines and the US UpToDate guidelines are including a treatment protocol that involves Plaquenil (hydroxychloroquine) a drug that we use for many of our Lyme patients. We will be incorporating this into our treatment protocols and can share additional information on these guidelines.
We have also been in collaboration with our other functional medicine colleagues on appropriate immune support protocols and have upgraded our onsite IV protocols. If you need additional Immune Support, please call, we can give you a protocol to have available including a “ramp-up” amount that you can advance to without needing to get an urgent package sent to you.
We are committed to helping you in any way we can! Please continue to reach out and let us know of your victories and concerns.
All the best,
Craig, Tammy and the Rezilir Team
March 17, 2020
Rezilir Health™ is open
In regards to the safety of our patients and the Rezilir Team, we are trying to convert all appointments to either a phone call or a doxy video appointment. As always, we do not accept walk-in appointments.
Currently, you still have the option to take your insurance-based labs to Quest or LabCorp. Be smart, make an appointment so your wait will be shorter. Wear a mask in the waiting room. Use your own pen while signing in. If you have disposable gloves, wear them to check-in at the kiosk if your lab is on a kiosk system. If you don’t have labs, use hand sanitizer immediately or if you have the availability, wash your hands for 20 seconds minimum immediately. Also, carry a paper towel with you to open any door you may need to walk through the lab.
If you need to come to the office for specialty labs, please arrive on time. Before entering our clinical space, your temperature will be taken and a screening process will occur. Once you have passed the screening process, you will be asked to use provided hand sanitizer when you arrive and be given a mask to wear.
Below is a chart of symptoms. Do not forget that we still are in the middle of cold and flu season and you can see that the symptoms can be similar, bot COVID-19 has far fewer symptoms. This list is not all-inclusive
|Muscle & body aches||X|
|Shortness of Breath||X|
If you develop Emergency Warning Signs for COVID-19 get medical attention immediately at the emergency room. Emergency warning signs include:
- Difficulty breathing or shortness of breath
- Persistent pain or pressure in the chest
- New confusion or inability to arouse
- Bluish lips or face
Please use reliable sources to get your information such as the CDC (https://www.cdc.gov/) or the WHO (https://www.who.int/). You can also contact your local Department of Health in your state. Local municipalities may have different protocols for testing and/or social gatherings.
We will be providing you with daily updates on COVID-19, please check back. If you have questions, please put them on the portal