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The Safety of Covid-19 Vaccines

By: David P. Lind

The Safety of Covid-19 Vaccines

The U.S. public’s views and attitudes on the available Covid-19 vaccines can vary widely, which is a consistent finding from the Kaiser Family Foundation. The differences by age, ethnicity, politics and location can be very striking. Any hesitancy toward accepting the vaccine largely boils down to trusting that the vaccines are safe. But this rather tenuous faith in the available Covid-19 vaccines is no different than historical attitudes about vaccines from yesteryear.

With almost one-third of Americans having received at least the first Covid-19 vaccine dosage, what do we really know about the safety of the vaccines?

ANSWER: The preliminary findings appear to be very encouraging, even to those who may have personal doubts.

According to the Centers for Disease Control (CDC) on March 13, there have been 529,301 deaths from Covid-19 out of 29,113,651 total known cases. That is 1 death for every 55.0 cases.

Also reported on the CDC website (March 13), “Over 92 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020, through March 8, 2021. During this time, the Vaccine Adverse Event Reporting System (VAERS) received 1,637 reports of death among people who received a COVID-19 vaccine.” 

The number of vaccination deaths (1,637) – out of 92 million vaccinations given – results in 1 death for every 56,200 vaccinations. 

Given this data, the risk of you dying from Covid-19 if you become infected is 1,022 times greater than the risk of you dying from being vaccinated. 

Regarding Covid-19 risks versus vaccine risks, Dr. Robert E. Oshel, former Associate Director for Research and Disputes for the National Practitioner Data Bank, said it quite well:

Only if you are virtually certain that you could never be exposed to Covid-19 and become infected would it be safer not to be vaccinated. I don’t think that (this data) is particularly disturbing.  In fact, that seems pretty safe to me in comparison to the risk from Covid-19. I’d rather take the vaccine risk instead of the risk of getting Covid-19 and its serious complications or death.  I’d also prefer taking that small personal risk over the possibility of becoming infected and passing the virus on to others and potentially causing their deaths.

The effectiveness data for the Pfizer, Moderna, and Johnson & Johnson vaccines appear to clearly outweigh their risks. Of course, if you have certain medical risks, it is always advisable to consult with your physician about your particular medical situation.

Through March 12, the number of administered vaccines in the U.S. was 101,128,005 – which includes both first and second doses. Below is the breakdown by vaccine type:

Source: Centers for Disease Control – March 13, 2021

New data from the CDC suggests that Americans have been remarkably vigilant about getting their second Covid-19 shot.

Any hesitancy that I may have had about Covid-19 vaccines are now a thing of the past.

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Disparate Views on Patient Safety Progress

By: David P. Lind

Patient Safety Progress - a Matter of Perspective When it comes to patient safety progress in the U.S., are we better off today than we were 17 years ago, when the Institute of Medicine’s seminal report “To Err is Human” was published?

Depending on the source (and their particular perspective), the answer to this question can vary widely.

As outlined in our ‘Silently Harmed’ white papers, the measurement of medical errors within hospitals is, quite frankly, abysmal. However, there are pockets of success – such as infection rates – that have dropped in hospitals. This past December, the Agency for Healthcare Research and Quality (AHRQ) issued findings that indicate decreases in infections, medicine reactions as well as other complications from 2010 to 2014 that have resulted in 2.1 million fewer incidents of harm – and 87,000 fewer fatalities.

In Iowa, an editorial by Dr. Tom Evans in the Des Moines Register acknowledged that preventable medical errors do exist – but that “significant improvements” have been made over the past 10 years. Further, data suggests that adverse drug events were virtually eliminated (99.9 percent), pressure ulcers were reduced by 89.4 percent, central line-associated infections decreased 34.7 percent along with many other improvements that were made in less than four years. These “downright impressive” results brought an avoidance of 3,310 adverse events, 15,603 fewer days in the hospital, and more than $50 million in cost savings.

Such public messages appear to be a good start, but make no mistake, we should refrain from performing a celebratory dance in the end-zone as if a game-deciding touchdown was scored. Continuing our football analogy, some notable national experts may suggest that the ball has advanced only a few yards, but far shy of reaching a new set of downs.

The fact is, when it comes to actually reporting adverse events, we don’t know what we don’t know. In other words, we can only measure what is being reported.

A recent report from Leapfrog Group and Castlight Health finds that computer systems in hospitals fail to flag 13 percent of potentially fatal mistakes, while about 40 percent of the most common medication errors were not caught when tested. In 2014 alone, the Centers for Disease Control and Prevention (CDC) indicates that a life-threatening bacterial infection, called Clostridium difficile (C. diff) has sickened over 100,000 American hospital patients. The CDC reports this particular infection has increased by four percent between 2013 and 2014, while other research suggests that 450,000 people, both inside and outside of U.S. hospitals, are affected by this infection each year, resulting in 29,000 fatalities.

I have periodically heard that patient safety experts in academia are not living in reality, as they tend to use their own theoretical acumen and measurements that seldom match up with the ‘real world’ of care delivery. Perhaps this may be true in some cases, but many of these same ‘academia’ experts also practice medicine for a living and have a great deal of passion to ‘simply do the right thing.’ They avoid projecting a false sense of security that our care is safer than it really is. Doing so can be disingenuous – if not grossly misleading.

A short list of highly-accomplished individuals that are on the forefront of patient safety in the U.S. and worldwide include: Dr. Ashish Jha, Harvard School of Public Health; Dr. Martin Makary, Johns Hopkins University; Dr. Peter Pronovost, Johns Hopkins; Dr. Atul Gawande, surgeon at Brigham and Women’s Hospital (Boston); Dr. Lucian Leape (retired from Harvard); Dr. Robert Wachter, UCSF Medical Center; etc. This list is long and impressive. They are not fearful about holding up the mirror to other clinicians and provider systems and challenging them to measurably improve their outcomes based on what is most important to patients.

On March 23, ProPublica held a webcast forum to discuss the value of the Surgeon Scorecard that became available to the public in 2015. Given the lack of specific risk-adjusted data we have on individual clinicians, it was interesting to hear arguments on both sides about the evolution of clinician scorecards available for public use. Toward the conclusion of the forum discussion, Dr. Jha was asked to summarize the progress of patient safety since the IOM report went public 17 years ago. This particular comment was quite revealing:

But at the end of the day, are we measurably and meaningfully safer today than we were 17 years ago? Personally, I would argue the data suggests we are not. We are not meaningfully safer than we were.

Again, time to ‘huddle-up’ and find new ways to advance the ball down the field. Let’s hope that a celebration will eventually take place in our collective future!

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Tepid Improvement in Patient Safety Progress
But Massive Savings Are Possible

By: David P. Lind

Healthcare Cost Savings - Tip of the IcebergAs our healthcare delivery system evolves, we must reach beyond the endless discussion and distractions over who pays and how much. The cost, compliance, coverage and political discussions are no doubt important, but these are inextricably linked to the safety outcomes of medical care we expect to receive – but, in too many cases, do not.

The patient safety dialogue has been buried from the general public under many other pressing national concerns:  the general economy, global terrorist activities, general elections later this year, immigration, Middle East unrest, gun control – as well as countless other issues.

In addition to covering more Americans, the premise of the Affordable Care Act (ACA) was to initiate new care delivery models that would eventually make healthcare more affordable and achieve better outcomes. The hope is that our healthcare ‘system’ is now on the path to recovery – we just need to give the initiatives time to work.

But is it really that simple?

If the Centers for Disease Control (CDC) were to include preventable medical errors in hospitals as a category, it would be the third leading cause of death in the U.S. – behind heart disease and cancer. Quite simply, the numbers for those seriously and fatally injured are massive. National estimates indicate that between 6.6 million to 11.5 million patients are seriously harmed in our hospitals – EACH YEAR. For those fatally harmed, the annual estimated range is 98,000 to 440,000 deaths.

Are improvements being made, and if so, by how much? The short answer is Yes, but…

The federal Agency for Healthcare Research and Quality (AHRQ) released a report in late 2015 indicating that hospitals have averted many types of preventable injuries (such as infections and medicine reactions) during the period 2011 – 2014, using 2010 as the base year. During this four-year period, officials examined 30,000 medical cases and, from this, extrapolated the number of complications that were possibly avoided. The cumulative results appear to be downright impressive: 2.1 million fewer incidents of harm, 87,000 fewer deaths and about $20 billion in healthcare savings.

No doubt, this is encouraging news. On the surface, the general public (and media) appear to have only tepid concerns about patient safety issues, most likely because the federal government, hospitals, grant-receiving medical provider collaborations, academia and other organizations are “all over” this national problem.

But these improvements only represent the proverbial ‘tip of the iceberg.’

Even Dr. Richard Kronick, director of the AHRQ, commented that these findings have yet to be fully understood and improvements most likely came from “low-hanging fruit.” In other words, these are the relatively easy problems. Problems in the past that should’ve been averted in the first place, but were not.

Loaded with curiosity, I decided to compare these improvements to national estimates of medical errors to understand how much progress was really made during this four-year period. Using the conservative estimate of 6.6 million patients harmed annually in hospitals, the 2.1 million averted conditions reported by AHRQ during the cumulative four-year period equates to an eight percent improvement. By using the high-end estimate of 11.5 million harmed patients annually, this reported improvement is under five percent. Keep in mind, that 2.1 million was a cumulative amount over four years, while the 11.5 million is EACH year.

As for preventable hospital fatalities, using the conservative 98,000 annual estimate that came from the Institute of Medicine in 1999 (which is now widely considered as being grossly low), about 22 percent of fatalities were averted. The high-end 440K estimate translates to a five percent fatality aversion.

Employers must understand that by averting preventable injuries, the potential cost savings are enormous, dwarfing the $20 billion reported by AHRQ. The cost savings per hospital-acquired condition found in the AHRQ report is almost $9,500. If we use this number, the potential annual cost savings by having all 6.6 million preventable injuries averted would be $63 billion annually. Should 11.5 million preventable injuries be averted, the savings would be estimated around $109 billion annually. This savings would translate into a sizeable benefit to communities, employers, employees and taxpayers. But this projected savings does not even approach the social costs associated with preventable medical errors.

Yes, progress in patient safety improvement is inching forward. But to move the needle beyond this anemic pace, this issue must become a top priority for the general public to force the care delivery system to be more transparent, effective, efficient and, most importantly, safe.

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Confronting THE ‘Silent Killer’

By: David P. Lind

Silent Killer

Keeping silent. What IS the third leading cause of death in the U.S.?

The safety of the people shall be the highest law.
Marcus Tullius Cicero

A democratic society values freedom of speech, protection from harm and unjust imprisonment. Unfortunately, one of these values has been glaringly absent for some time.

While preparing this particular blog, I am reminded that countless towns, cities and states have silly, if not outrageous ordinances and laws. Take Iowa – some laws have been on the books for many years and are grossly outdated – most likely due to oversight or just plain laziness. For example:

  • A man with a moustache may never kiss a woman in public.
  • One-armed piano players must perform for free.
  • Kisses may last for no more than five minutes.
  • In Dubuque, any hotel in the city limits must have a water bucket and a hitching post in front of the building.
  • Marshalltown forbids horses to eat fire hydrants.

If these comical, yet ridiculous laws are still in existence (some are now repealed), can you imagine just how many ‘violations’ have occurred since they were implemented? Having such laws or ordinances legislated to control harmless acts within our towns and state borders are quite meaningless, don’t you think?

So then, why are we not concerned about having legitimate legislation that attempts to protect every patient from harm, even when the harm is mostly ‘silent’ and assumed to be unintended? Allow me to explain…

If the Centers for Disease Control (CDC) were to include preventable medical errors in hospitals as a category, it would be the third leading cause of death in the United States, behind heart disease and cancer. When it comes to reporting these mistakes around the country, however, doctors and nurses have been fired when they speak up. This code of silence is, to say the least, deafening. Medical errors, no doubt, have become THE ‘silent killer.’

In its 1999 “To Err Is Human” report, the Institute of Medicine (IOM) called for a nationwide, mandatory reporting system for state governments to collect standardized information about “adverse medical events” resulting in death and serious harm. Interestingly, this call for a national reporting system was not implemented.

However, as of November 2014, 27 states and the District of Columbia now have variations of authorized adverse event reporting systems. Oregon’s reporting system is voluntary. As of this January, Texas now reports such events. Many of Iowa’s neighboring states, such as Illinois, Minnesota and South Dakota have reporting requirements.

What about Iowa? Not much.

To improve the care we receive, we first must understand how prevalent this problem is in Iowa and elsewhere. In 2010, Harvard published a report in the New England Journal of Medicine indicating that about 25 percent of all patients are harmed by medical mistakes. In 2014, Massachusetts completed a survey of its residents and determined that 23 percent received medical errors.

So are preventable medical errors in Iowa similar to these alarming reports, or is care provided within our borders somehow insulated from the dismal results found elsewhere? That becomes the big question – we simply don’t know. In Iowa, we have no independent trusted source to publicly provide ongoing transparency about this ‘silent killer.’

A quote from noted cancer surgeon, Dr. Marty Makary, refers to the importance of openness and transparency – which easily applies to this particular subject matter:

“Health care costs are not going to be reigned by different ways of financing our system, but by making it more transparent so that patients can fix the system. I’m convinced that the government is not going to fix health care. And doctors are not going to fix health care. It’s going to be the patients.”

There are different ways to scale over this ‘Wall of Silence.’ Perhaps a good, first step may be to establish reporting requirements, much like the other 27 states are now doing. By taking this approach, health workers who desire to do the right thing by reporting errors can be protected from workplace retaliations. Another, more immediate strategy is to ask Iowans about their experiences – a simple process that establishes a baseline for later, more deliberate, actionable solutions to make safety-of-care a statewide priority. To ultimately improve patient safety and quality, public reporting and provider feedback is critical.

We must not tolerate secrecy and demand ‘sunlight’ within the medical care we receive. A preventable medical error becomes egregiously INTENTIONAL when nothing is done to prevent it from occurring again in the future. By staying quiet, opportunities to learn and improve the quality of care will be lost.

Now, well into the 21st Century, it is time to assess which laws best serve our citizens. Limiting a kiss to five minutes does not have the life-changing consequence when compared to addressing and eliminating THE ‘silent killer’ of our time.

Isn’t it time to take action? I welcome your thoughts on this very important issue.

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