Internal Review Boards & Patient Harm

Internal Review Boards & Patient Harm

During the COVID-19 Pandemic internal review boards (IRB) were scrutinized for delaying potential treatments and vaccines to fight the coronavirus that causes COVID. IRBs exist to ensure that scientific research doesn’t harm patients. Throughout the history of science, many dubious science experiments have been carried out by less than fully considerate scientists. An IRB is a useful tool to ensure that researchers have real reasons to conduct experiments that may cause some type of physical or psychological harm to participants, and to ensure that researchers do as much as possible to mitigate those harms and adequately address the safety and needs of subjects before, during, and after an experiment.
However, in recent years many researchers have argued that IRBs have become too risk averse and too restrictive. Rather than purely focusing on the safety and health of research participants, IRBs have been criticized as protecting the brand of the research institution, meaning that some valuable and worthy science is denied funding or approval because it sounds weird and if it doesn’t go well could reflect poorly on the academic standing of the institution that approved the study. Additionally, well meaning IRBs can cause extensive delays, as each study is reviewed, debated, and approved or denied. Studies that are denied may have to make adjustments to methodology and approaches, and re-deigning studies can add additional time to actually get the study up and running. For many research studies this may be more of an inconvenience for the researcher than anything else, but during the COVID-19 pandemic, these delays have been sharply criticized.
COVID moves fast, and a delay of one month for a study that could prove to be life saving means that more people would die than would have died if the study had not been delayed. This means that in the interest of promoting safety, an IRB can create a delay that harms life. Mary Roach wrote about these concerns years before the pandemic in her book Gulp, “rather than protecting patients, IRBs – with their delays and prodigious paperwork – can put them in harms way.” If checking the right boxes on the right forms and submitting the right paperwork at the right time is more important than the actual research, we could see delays that hold back treatments, preventative vaccinations, and cures for deadly diseases.
The Pandemic has shown us how serious these delays can be. IRBs may have to be rethought and restructured so that in times of emergency we can move quicker while still addressing patient safety. For science where time is important and risk is inherent in the study, we may have to develop a new review or oversight body beyond the traditional IRB structure to ensure that we don’t harm patients while trying to protect them.
Mary Roach on Reincarnation in India

Mary Roach on Reincarnation in India

In the book Spook, Mary Roach writes, “People don’t seem to approach life with the same terrified, risk-aversive tenacity that we do. I’m beginning to understand why, religious doctrine aside, the concept of reincarnation might be so popular here. Rural India seems like a place where life is taken away too easily – accidents, childhood diseases, poverty, murder. If you’ll be back for another go, why get too worked up about the leaving?” Roach is joking of course, but this quote comes at the end of a lengthy description of dangers and risks that she experienced in India that we would find appalling in the United States. Her travels to India brought her face to face with cyclists moving through heavy traffic and breathing diesel smog. She was afraid of large trucks overflowing with potatoes and cauliflower that threatened to spill over onto the vehicle she was riding in. And she was also afraid for the lives of more than one woman riding precariously on the back of a fast moving Vespa.
While the quote is funny, it does get at some interesting ways of thinking about life, death, and how we go about our days. I’m not sure how much of our differences in risk tolerance in the United States versus India comes down to beliefs in reincarnation, but I can see how ideas of reincarnation would be comforting in a dangerous society. I don’t know if reincarnation would be enough to create a moral hazard scenario where people were intentionally negligent about safety because they expected to come back in another life, but I’m sure there is some impact that could be studied.
The quote from Roach also seems to suggest that Americans value our lives differently than individuals in India. She highlights how risk averse Americans tend to be, referring to how much we go out of our way to ensure everything we interact with is safe, and how we try to limit risk in everything from roller coasters to strollers. I think that what is likely going on is a difference in culture that stretches back years and is fraught with technological limitations and differences in population density. I am currently listening to an audiobook with an author who interviewed friends from her childhood in rural Ohio in the 1960’s and 70’s. Her dad was a doctor, and she notes how many individuals, including children, died in accidents involving farming equipment. Today we have adopted technology within everything we do, allowing us to make the world safer. Risk stands out more than in the 1960’s and 70’s when we didn’t have the technology to make everything as safe as we can now. Perhaps the difference that Roach noted, that she jokingly attributed to belief in reincarnation, is simply due to limitations in technology and a need to earn money.
Nudges for Unrealistic Optimism

Nudges for Unrealistic Optimism

Our society makes fun of the unrealistic optimist all the time, but the reality is that most of us are unreasonably optimistic in many aspects of our life. We might not all believe that we are going to receive a financial windfall this month, that our favorite sports team will go from losing almost all their games last year to the championship this year, or that everyone in our family will suddenly be happy, but we still manage to be more optimistic about most things than is reasonable.

 

Most people believe they are better than average drivers, even though by definition half the people in a population must be above and half the people below average. Most of us probably think we will get a promotion or raise sometime sooner rather than later, and most of us probably think we will live to be 100 and won’t get cancer, go bald, or be in a serious car crash (after all, we are all above average drivers right?).

 

Our overconfidence is often necessary for daily life. If you are in sales, you need to be unrealistically optimistic that you are going to get a big sale, or you won’t continue to pick up the phone for cold calls. We would all prefer the surgeon who is more on the overconfident side than the surgeon who doubts their ability and asks us if we finalized our will before going into the operating room. And even just for going to the store, doing a favor for a neighbor, or paying for sports tickets, overconfidence is a feature, not a bug, of our thinking. But still, there are times where overconfidence can be a problem.

 

2020 is an excellent example. If we all think I’m not going to catch COVID, then we are less likely to take precautions and are more likely to actually catch the disease. This is where helpful nudges can come into play.

 

In Nudge, Cass Sunstein and Richard Thaler write, “If people are running risks because of unrealistic optimism, they might be able to benefit from a nudge. In fact, we have already mentioned one possibility: if people are reminded of a bad event, they may not continue to be so optimistic.”

 

Reminding people of others who have caught COVID might help encourage people to take appropriate safety precautions. Reminding a person trying to trade stocks of previous poor decisions might encourage them to make better investment choices then trying their hand at day trading. A quick pop-up from a website blocker might encourage someone not to risk checking social media while they are supposed to be working, saving them from the one time their supervisor walks by while they are scrolling through someone’s profile. Overconfidence may be necessary for us, but it can lead to risky behavior and can have serious downfalls. If slight nudges can help push people away from catastrophic consequences from unrealistic optimism, then they should be employed.
Taboo Tradeoffs

Taboo Tradeoffs

A taboo tradeoff occurs when we are faced with the dilemma of exchanging something that we are not supposed to give up for money, food, or other resources. Our time, attention, energy, and sometimes even our happiness are perfectly legitimate to trade, but things like health and safety generally are not. We are expected to exchange our time, attention, and physical labor for money, but we are not expected to exchange our personal health for money. When I first read about taboo tradeoffs in Daniel Kahneman’s book Thinking Fast and Slow, the year was 2019, and we had not yet entered into a period of time defined by a global pandemic where people began to challenge the taboo against trading health and safety for entertainment, for trials for COVID-19 cures, and to signal their political allegiance.

 

In the book, Kahneman suggests that holding to hard rules against taboo tradeoffs actually makes us all worse off in the end. “The taboo tradeoff against accepting any increase in risk is not an efficient way to use the safety budget,” he writes. Kahneman’s point is that we can spend huge amounts of resources to ensure that there is absolutely no risk to ourselves, our children, or to others, but that we would be better off allocating those resources in a different way. I think Kahneman is correct, but I think that his message has the potential to be read very differently in 2020, and deserves more careful and nuanced discussion.

 

“The intense aversion to trading increased risk for some other advantage plays out on a grand scale in the laws and regulations governing risk.” The important point to note is that complete security and safety comes at a cost of other advantages. The advantage to driving to a football game is that we get to enjoy watching live sports, the risk is that we could be in a serious traffic accident. The advantage of using bug spray is that we kill the creepy crawlies in the dark corners of the garage, the risk is that we (or a child or pet) could accidently ingest the poison. The safest things to do would be to watch the game on TV and to use a broom and boot to kill the bugs, but if we avoid the risk then we give up the advantages of seeing live sports and using efficient pest control products.

 

Kahneman notes that when we make these decisions, we often make them based on a fear of regret more than out of altruistic concerns for our own health and safety or for the health and safety of others. If you traded some level of risk of your child’s safety, and they died, you would feel immense regret and shame, and so you avoid the taboo tradeoff to prevent your own shame. When this plays out across society in millions of large and small examples, we end up in a collectively risk averse paralysis, and society gives up huge advantages because there is a possibility of risk for some individuals.

 

To address the current global state of affairs, I think Kahneman would recognize the risk of COVID-19 and would not encourage us to trade our health and safety (and the health and safety of others) for the enjoyment of a birthday party, holiday meal, or other type of gathering without wearing masks and taking other precautions.  Throughout the book Kahneman highlights the difficulties and challenges of thinking through risk. He addresses the many biases that play into how we behave and how we understand the world. He demonstrates the difficulties we have in thinking statistically and understanding complex probabilities. The takeaway from Kahneman in regard to the taboo tradeoff is that there is a level at which our efforts of safety are outpaced by the advantages we could attain by giving up some of our safety. It isn’t necessarily on each of us individually to try to decide exactly what level of risk society should accept. It is up to the experts who can engage their System 2 brain and evaluate their biases to help the rest of us better understand and conceptualize risk. We might be able to do some things understanding that there is a level of risk we take when engaging in society in 2020, but adequate precautions can still mitigate that risk, and still help us maintain a reasonable balance of safety tradeoffs while enjoying our lives.
Outlier Wellness

Outlier Wellness

“Only a handful of outlier health problems are preventable in any real sense,” writes Dave Chase in his book The Opioid Crisis Wake-Up Call, “about seven percent, according to my colleague, Al Lewis.”

 

My last post was about the cost of outliers, how just a small percentage of patients account for a huge percentage of overall healthcare spending in the United States. We know that there are a few unlucky individuals whose healthcare is incredbily costly, yet they are not the first people we think of when we think about excessive healthcare spending in the United States. As a result, we fail to truly understand the weaknesses of our healthcare system and how our healthcare dollars are actually being spent. We introduce programs that don’t actually address the real problems in escalating healthcare costs.

 

This is where the ideas about and problems with wellness programs begin. Chase continues, “While the notion of workplace wellness and prevention was a noble idea, we now know that company after company is spending a huge amount of plan dollars and resources trying to do something that can’t be done.”

 

The idea of workplace wellness programs is to encourage healthy living habits and lifestyles of employees. Since our employers are usually paying a lot for our healthcare coverage and sometimes directly for our healthcare, anything employers can do that makes employees more healthy, outside of the healthcare space, will reduce the healthcare costs and needs of employees, generating a return on investment in the long run.

 

Unfortunately, the people who cost the most, who really drive incredibly high healthcare spending in the United States, don’t suffer from conditions that can be addressed through workplace wellness programs. Your plan to encourage workers to walk more, to buy foam rollers for the office, and to reward employees who count calories is not going to prevent an employee from being diagnosed with a congenital heart arrhythmia, won’t stop a rare blood disorder, and isn’t going to prevent any other unpredictable obscure disease from costing thousands or millions of dollars for your health plan.

 

What is worse, wellness programs usually just encourage those who are already living healthy lifestyles to flaunt how healthy their lifestyle already is. You likely won’t reach or encourage the employee who has a second job someplace else, the single mom with two kids who is just  trying to get dinner on the plate each night, or the employee who has been discouraged and dejected their whole life. An Apple Watch or an iPad isn’t going to solve the problem of a long commute, an unsafe neighborhood, or past trauma. We spend a lot of money on wellness plans that don’t address the real upstream social determinants of health for many employees, and can’t possibly address the health problems of the most expensive outliers in our healthcare system. The idea of workplace wellness programs has the right spirit, but the truth is these interventions need to happen at a much larger level than what the employer can really address.
Healthcare Safety and Data

Hospital Safety & Data

One problem with healthcare in the United States is that consumers don’t control their data and the information about them. Even the employers of healthcare consumers, who are paying for the services provided to patients and often responsible for whether patients have healthcare coverage at all, don’t have access to any of the healthcare data of the employees they pay to cover. Healthcare information is protected by providers and guarded by insurers.

 

A troubling result is that consumers and employers often don’t know much about the quality of care provided at a hospital or from a given provider, and don’t know about the safety record of providers and hospitals. Outcome measures are sometimes protected by law, and are other times hidden behind complex systems that prevent employers and consumers from finding and understanding the information.

 

Dave Chase compares the problem this creates to airline travel in his book The Opioid Crisis Wake-Up Call, “No corporate travel department would allow an employee to fly on an airline that suppressed its safety records (even if the FAA allowed it). In the same way, it’s unconscionable to blindly send an employee to a hospital with little or no information on its safety record. If the hospital suppresses that information, go elsewhere and tell your employees why.”

 

There are many ways in which we treat the healthcare system differently than other sectors for no apparent reason. I wrote about the way we don’t consider healthcare broker’s conflicts of interest in the same way we consider financial adviser’s conflicts of interest. In a similar example as above, we heavily scrutinize any spending by employees for lunches or hotel stays on trips, but we don’t apply the same scrutiny to hospital billing. Our failure to consider safety the way we would for employee travel, even though many employers spend more on their employees healthcare than on their travel, is a failure of how we think about the system.

 

I think that Robin Hanson and Kevin Simler explain a little of why this is in their book The Elephant in the Brain. We don’t know what medical care is effective and we don’t know which systems and providers are safe, but we do know when someone took time off work for care. We can signal our support for that individual with cards, balloons, and messages about how much we value them and hope they recover quickly. Much of our healthcare system and how we treat it is based on signaling. Accessing care shows others that we have resources and powerful allies who care about us. We also use healthcare to signal to others how much we care about them and what a valuable ally we would be to them. The result is costly, in terms of dollars and health and safety problems.

 

We have to get beyond this signaling mindset and approach to healthcare if we want to rein in prices and have a safe and effective system. If we want our healthcare to be sustainable for the long run, it can’t be built around signaling, but must actually be built around effective solutions. Employers have an important role to play by demanding the information they need to be accountable in providing valuable health benefits to employees. Hospitals, providers, and insurance companies can’t continue to monopolize and hide patient data, preventing employers and patients from making smart and economical healthcare decisions.

Start High School After 8 A.M.

I’m a super early morning person and I have been since high school, but I was definitely a bit of an anomaly in high school and throughout college. Most high school students, not necessarily through their own poor decision-making or bad habits, go to sleep a lot later at night and don’t wake up very early. It is a pattern that is made fun of in families and in popular culture, but it is a pattern that seems to be pretty stable and should be considered when we think about designing a school system for teenage children that maximizes their educational opportunities and efficiency.

 

This is an argument that Dan Pink presents in his book When. In most places in the United States, my hometown of Reno being one of them, our high school students have the earliest start time. Middle school students head to school next, and our elementary age children start school the latest. This allows us to have three different bus schedules that pick up the oldest kids in the early morning, then get the next youngest group, and finally get the little guys. What we prioritize is an efficient bus schedule that feels safe for our youngest kids, not necessarily our kids learning.

 

The problem with this schedule is that it is a bit backwards for our oldest and youngest children. Our younger kids tend to wake up a little sooner and would actually do better than our teenagers with starting school early in the morning. Teenagers need just as much sleep as kindergartners, but rarely get enough. Moving school back for them would actually help them get more sleep and be better students. Their learning would improve, their driving would be safer, and hopefully outcomes for our high school students would be better in the long run.

 

Pink references a study of start times for schools writing, “one study examined three years of data on 9,000 students from eight high schools in Minnesota, Colorado, and Wyoming that had changed their schedules to begin school after 8:35 a.m. At these schools, attendance rose and tardiness declined. Students earned higher grades in core subject areas of math, English, science and social studies and improved their performance on state and national standardized tests. At one school, the number of car crashes for teen drivers fell by 70 percent after it pushed its start time from 7:35 a.m. to 8:55 a.m.”

 

I understand that we don’t want to encourage teenagers to stay up all night on phones and computers, and I recognize that many people would be afraid that pushing the start of school back would do just that, but as it is now, we force teenagers into settings that are not conducive to learning. We make them start school early, prevent them from getting enough sleep, and put them in dangerous situations due to fatigue. What our current system reveals is that we value efficient bus schedules and perhaps a feeling of safety for our smallest kids over the actual learning that is supposed to take place in school. Perhaps it is fine to express our values this way, but we should take a critical look at the learning taking place in our schools and make sure that we are ok with the values we prioritize when it comes to our children’s school schedules. Making a switch would likely help our students learn more and save lives, two outcomes that should be high priorities for society and our education systems.

The Safety Myth

I have heard people, television show hosts, and family members make the argument that black communities are not over policed or over arrested because black people support the levels of policing that take place in their communities. I have heard the argument that confederate symbols really are not a problem because a famous black celebrity or athlete said they have never been bothered by them. I have heard the argument that black people want police protection and safety, so we should not be critical of our police who arrest black people in our ghettos and low income neighborhoods.

In his book Between the World and Me, Ta-Nehisi Coats looks at this argument and is able to break down some of the thinking taking place. He writes, “according to this theory “safety” was a higher value than justice, perhaps the highest value.” Arguments to preserve our policing and arguments that discrimination and inequalities arise because they are what poor and minority communities want misplace the importance justice in our system.

Arguing against safety is difficult. It is hard to say that being safe and protected in your home or neighborhood is not something you want. Everyone would like to have a police force that could be relied upon given the dangers of society, but when  that police force is part of a system that does not provide equal justice, then there are problems in relying on them for protections, crime prevention, and security.

Coats continues and writes about his childhood and walking to school in Baltimore, “What I would not have given, back in Baltimore, for a line of officers, agents of my country and my community, patrolling my route to school! There were no such officers, and whenever I saw the police it meant that something had already gone wrong.” What Coats shows here is that our system was not forward thinking for black communities, but reactive to problems and crimes. Rather than operating in a system meant to reduce and limit dangers, the police reacted to dangerous incidents. Coats says that things had already gone wrong when the police arrived, but I think it is reasonable to say that things had already gone wrong when restrictive housing policies and racial segregation moved wealthier white people to suburbs, created inner city ghettos, and restricted poor minorities to less healthy environmental living spaces. If we valued justice more than our personal safety, we wound not just arrest black people and claim that our unequal justice system was justified by poor communities’ desires for protection from crime.

An Artifact of the Media

In his book The Most Good You Can Do, Princeton professor Peter Singer introduces the idea that the world is improving and becoming a less dangerous place as we become more globalized, and as effective altruists and average citizens make greater efforts to help those who are the most disadvantaged.  Singer states, “If the world seems to be a more violent and dangerous place than ever before, however, this impression is an artifact of the media.” I strongly agree with Singer’s statement and believe that in many ways our world is an improved place, even though that idea is not presented to us by our politicians and national media.

 

Despite claims that we need to make America great again and that daily life in the United States is in danger, many people face few risks of even being moderately uncomfortable.  For me, remembering how challenging life is for those in third world countries helps provide me a better perspective of where I am, and how sever my struggles are relative to others.  Singer would argue that effective altruists are able to live their lives with greater happiness because they are able to recognize this fact and take steps to reduce their own needs while using their resources to help others.  When you can avoid fear, jealousy, and gluttony in the United States, you are able to live quite comfortably without being pressured by the negatives in capitalism. You are then able to use capitalism to your advantage by not consuming and spending more, but by consuming less and donating more in an effort to assist those who need it most.

 

Singer presents information in his book which backs up his claim that the world is slowly improving. He cites statistics from UNICEF that he included in a book written in 2009 which showed that nearly 10 million children were dying from avoidable causes related to poverty each year. The most recent statistic available from UNICEF as Singer completed The Most Good You Can Do in 2015 showed that 6.3 million children were dying from poverty related avoidable causes.  The reduced child mortality rates gave Singer hope, and to him served as proof that we were getting to a world with less suffering and unnecessary death.  Singer did not assert that effective altruists or any specific program was the reason for the reduced death rate, but he presented the information as a ray of light in the face of the doom and gloom of our national media.  We are bombarded with negativity every time we turn on the TV or pull up social media, but Singer argues that this negativity is created by our media consuming habits which dial in on the negative and tragic.  Our perception of the world has become worse and worse as we have taken major steps to shape the world into a better place.