All the decisions we can’t see

Let’s be honest, January was a bad month for healthcare news coming out of China.

For starters, at the end of December, a Chinese court sentenced He Jiankui to three years in prison for operating an illegal medical practice, which includes using a fake ethical review certificate and misleading participants about a study’s risks, and also violating an ethics guidance from 2003 that barred the reproductive use of research embryos.

You may remember Dr Jiankui as the individual who made the world’s first genetically edited babies by recruiting couples in which the man was HIV positive but the woman was not, as part of an effort to create embryos with a genetic mutation that made the couples’ offspring protected from the virus.

Esteemed bioethicists and scholars, such as Josephine Johnston from the Hastings Center that produces books, articles and other publications on ethical questions in medicine, science and technology that help inform policy, practice and public understanding, as well as Robin Lovell-Badge, a stem cell biologist at the Francis Crick Institute, have both acknowledged that He Jiankui’s work straddled a line that might have got them in hot water in both the US and the UK.

In fact, Lovell-Badge said in a statement distributed by the United Kingdom’s Science Media Centre that “both prison and a fine would have been the likely penalties if someone had done what [He Jiankui] did in the UK”.

And then, in early January, China informed the world about a deadly new coronavirus that has been causing severe respiratory illness and death among its citizens.

As of 6 February, in China there were over 28,000 confirmed cases and 565 people have died there; in addition there were more than 220 confirmed cases outside China and there has been one death in the Philippines.

On 26 January, the New York Times wrote: ‘The outbreak has drawn fresh attention to China’s animal markets, where the sale of exotic wildlife has been linked to epidemiological risks. The Wuhan virus is believed to have spread from one such market in the city. The SARS outbreak nearly two decades ago was also traced back to the wildlife trade.’

These two scenarios highlight an important aspect of public health and health policy: complex decisions that require almost real-time response are only as good as the information upon which those decisions are based.

In the case of He Jiankui, many countries have policies and laws in place against germline gene editing. But because the court proceedings, documentation and testimony in this case have not been made public, it is impossible to know the details surrounding the events that may have facilitated this ‘rogue scientist’s’ behaviour.

And because we don’t have those details, implementing new health policy to prevent recurrences of this situation remains difficult. Not impossible, but difficult. Some will argue that US and UK laws are expansive enough and the penalties imposing enough on their own merits that we need not fret about a single scientist’s actions in a universally agreed upon opaque scientific ecosystem.

Others will argue that the scientific community’s overwhelmingly negative response and outrage will discourage this from happening again. I disagree.

And in the coronavirus situation, the same New York Times article went on to say: ‘Conclusive evidence about how this outbreak started is lacking. Although officials in Wuhan first traced it to a seafood market, some who have fallen ill never visited the market.

‘Researchers have also offered disparate explanations about which animals may have transmitted the virus to humans. China’s record doesn’t help. During the SARS epidemic in 2002 and 2003, officials covered up the extent of the crisis, delaying the response. The Chinese government has promised far more transparency this time, and the World Health Organization (WHO) has praised its cooperation with scientists.’

I’m sure we all feel better that a non-partisan agency like the WHO has authenticated the cooperation of the Chinese scientific community in 2020 but the issue is far more complex.

We need to understand the larger social and cultural issues that may be driving the underlying causes of these deadly illnesses. And in order to do that, the Chinese government’s openness to the rest of the world’s questions and, ultimately, its willingness to revise public policy to reflect a greater harmonisation for global public health will be put to the test.

This is not a ‘China’ issue. It’s a transparency issue. Whether it’s the reporting of a measles outbreak in America or the promulgation of information on Ebola cases in West Africa, we are all responsible because the world needs more transparency.

January was a bad month for healthcare in China

This article was originally published here.

Someone like you

It is not entirely uncommon for consumer- packaged goods companies or luxury retailers to pay Facebook, YouTube or Instagram ‘stars’ to endorse and use their brands. Typically, this individual has the profile of a customer that the manufacturer or retailer wishes to target, with one mandatory characteristic: tens of thousands (if not more) of followers on social media.

In healthcare, this trend has started to gain significant traction over the last few years. These individuals – patient influencers as they are known – are becoming more and more ubiquitous. Most of the mainstream information on the role of patient influencers focuses on the inherent conflicts of interest, whether this activity transgresses the tight rules around direct-to-consumer advertising and, pragmatically, where we can find such people. Rarely do we discuss the policy/public health and behavioural implications of this growing trend.

In truth, we have known about influencers for years. Malcolm Gladwell described them in his landmark book, The Tipping Point: How Little Things Can Make a Big Difference, published in 2000. Gladwell introduced us to ‘connectors’ and ‘mavens’. Connectors are, well, in the habit of connecting people. However, it is not only the simple act of connecting that is of importance but, as Gladwell states, the sheer number of connections that these individuals can bring together. Mavens, in contrast, are not about people and connections. Mavens share knowledge and spread information. So, in essence, patient influencers are part connector and part maven, which is what makes them incredibly valuable to the pharmaceutical companies that are now paying such influencers to share their experiences about products and raise awareness about disease states.

But there is one other factor that makes these influencers incredibly persuasive and valuable beyond the fact that they know a lot of people and are good at sharing information: they look like us. If not physically, then emotionally and experientially. The academic literature has reinforced what we already knew intuitively, which is that we feel more closely aligned to people who are similar to us and that, more likely than not, we are predisposed to find such people credible.

It is this hallmark of having ‘walked a mile in your shoes’ that draws us to these patient influencers. They know what we are feeling, what we have gone through and what is around the corner. They are connectors and mavens. But they are also part prophet and part therapist.

So, with this backdrop as our foundation, what about the policy and/or public health implications of this trend? Well, let’s look at two aspects of this. Firstly, the ability of patient influencers to aggregate the opinions and experiences of patients and potential patients is tantalising. We may soon have incredibly rich insights into traditional ‘black box’ topics as a result of these patient influencers and their networks. Imagine being able to better understand if ‘redness on the skin’ is an injection site reaction, described in (almost) real time. Or being able to ascertain patient compliance to therapy. Or comprehend the packaging and design of your pill bottle or blister pack. While there are challenges with such ‘social listening’ platforms, such as the inability to distinguish between ambiguous or ill-defined terminology, the artificial intelligence and deep learning algorithms being developed may soon get us there.

The second insight from this growing trend of using patient influencers is that we may drive unnecessary healthcare utilisation. One of the best public databases in the US for looking at the online habits of patients, the Health Information and National Trends Survey (HINTS), demonstrates that people are increasingly using the internet to seek health information and that they are increasingly comfortable with it as their first option for potential answers. In other words, for those who are undiagnosed, we may be driving people to their primary care providers needlessly, seeking diagnosis of symptoms. And for those who are already diagnosed, we may be driving these patients to seek more expensive treatment options as they see patient influencers with their same illness using treatment modalities that provide high quality of life and wonder ‘what about me?’

Barring a major regulatory or legal barrier, it seems reasonable to believe that patient influencers are here to stay. While sharing disease and product information, connecting patients with each other and generally providing an avenue for patients to not feel alone are all incredibly important features of this growing trend, perhaps its best application will be to demonstrate impactful public health and policy implications.

Patient Influencers are becoming ubiquitous. Should we care?

This article was originally published here.

Warren Buffet’s Greatest Healthcare Lesson

Predicting rain doesn’t count. Building arks does. Buffett wrote this in a Berkshire Hathaway shareholder report from 2001 to explain the big mistake he made that year.

In Buffett’s estimation, Berkshire Hathaway had a terrible year, which was further compounded by the tragic events of September 11th, 2001. Buffett was explaining that he had actually predicted many of the market events that happened before that fateful day, but he “didn’t convert thought to action” as he wrote, thus violating the Noah rule (the rain came
as he expected but he hadn’t built an ark).

The essence of Noah’s rule is that we need to inject some sort of Bayesian practicality into how we think, plan and execute things. You are all vaguely familiar with Bayes’ Theorem – or at least its basic precept – which is that the probability of an event occurring is based on prior knowledge of variables and factors related to that event.

So, in everyday terms, the probability that my flight will leave on time is a function of which day of the week it is, where I am going, which airport I am flying out of and the weather, just to name a few factors. I know this because I have flown thousands of times. In other words, I am using my prior knowledge of factors and variables related to flight departures to help me understand the probability of my flight, on this particular day, actually leaving on time.

Simple, yes?

But nothing in public health is simple. And the COVID-19 pandemic has undoubtedly (re)focused our attention on one of the great, unintentional health lessons of our time. Yes, Bill Gates warned us about the threat of a viral pandemic in his March 2015 TED talk.

And yes, every G7 nation has a ‘pandemic preparedness playbook’ that they constantly review and pass on to new incoming administrations. And, of course, we have brilliant scientists working in research laboratories. Yet here we are in this apocalyptic world of 2020 at the mercy of this virus.

The cold, hard truth is that we didn’t build our ark. The original SARS virus in 2002 was a rain warning. And so was H1N1. And MERS. And Zika. And Ebola.

Every virologist in the world who has spent any amount of time studying zoonotic diseases has been sounding the alarm bells for decades. They have been predicting the rain. And it wasn’t just rain – it was rain in biblical proportions, they told us. We nodded. We said we understood. But we didn’t.

Now the time for predictions is over. Now is the time that we really need to get down to the business of building arks. Do we really need to predict that there is going to be another pandemic in 20 or 30 years? Let’s plan to do something about it based on our knowledge of prior events related to this pandemic.

If it happens (which is likely), we’re ready. If it doesn’t, no harm done. Let’s stop with predicting whether some misinformation or disinformation is going to break down the trust in the dozens of vaccines that are sure to arrive and let’s assume it’s going to happen based on what we know about both anti-vaxxers and social media misinformation in the 21st century.

Let’s build an ark for that right now. If it happens (which is likely), we’re ready. If it doesn’t happen, it doesn’t happen. Either way, we’ve got the ark built for that scenario. Let’s stop predicting that developing the vaccine is hard but that manufacturing and distributing it is going to be even harder.

If we know that we need everything from glass vials, to a cold chain strategy to enough needles and syringes, let’s get on it. Now. Today. Build the ark. Appropriate the government funding. Get the private sector involved. Do whatever is needed.

For too long we have been great at predicting what can and will happen in public health. But we have failed miserably at building the ark. We have surrounded ourselves with sacred cows and cocooned ourselves in obvious echo chambers.

The solutions to public health’s biggest problems, to be sure, are more complex than an aphorism from 20 years ago buried in the pages of some shareholder’s report.

We need disciples committed to the cause. We need money. We need political will. We need luck, patience and hard work. We need to be bold and take risks. But most of all, we need to learn to live with the rain.

He told us about it almost two decades ago – we didn’t pay attention

This article was originally published here.

In Plain Sight

I knew I would write this first column of 2021 on this topic as far back as April or May of 2020.

The second week in December – as I wrote my monthly column – was the week we, in North America, would wait for Time magazine’s proclamation of its Person of the Year. And in the spring of 2020, it seemed obvious that the winner of this award would be related to this virus in some way.

Then the George Floyd incident occurred, and its aftermath ruptured us. And before that we had lost Kobe Bryant, a worldwide sporting icon. And I reminded myself that at that point there was still a US election to happen in the coming months.

Doubt began to creep into my mind. But I remained steadfast in my belief: it had to be healthcare’s time to shine. Look, it’s not a Nobel Prize by any stretch of the imagination.

The Queen certainly isn’t going to be knighting anyone over it. You won’t even get into the Guinness Book of World Records. And there’s probably an entire generation of people who haven’t even heard of the award.

Or worse yet, have heard of it and don’t care about it. But in this annus horribilis it could have helped provide some small recognition. It could have been a meaningful symbol of the sacrifices and contributions made.

Amid all the misinformation and disinformation about science, it might have recalibrated people’s thinking about one of our most venerable institutions.

In previous years the award has gone to ‘science’. In 1960, the award went to the collective referred to as ‘US Scientists’ and
in 1996 Dr David Ho won the award for his pioneering work in AIDS research.

As recently as 2014, the award went to the ‘Ebola Fighters’, a sure nod to pandemic response. There’s nothing wrong with Joe Biden and Kamala Harris as the chosen winners. But, in this year and at this time, this was not the right choice.

The award is widely acknowledged as being designed for ‘a person, a group, an idea, or an object that for better or for worse has done the most to influence the events of the year’. In this year it had to be related to healthcare.

There was no other choice. Full stop. Let us count the ways we could have recognised healthcare with this award. The researchers who raced to sequence the virus’ genome.

The Chinese ophthalmologist who tried to warn his colleagues about this novel pneumonia in December 2019. Every single healthcare worker who treated patients, put themselves in harm’s way, were infected and/ or died from this scourge.

Every volunteer in the global Pfizer, Moderna, AstraZeneca and J&J trials. Every volunteer in all the other trials that I don’t have the room to mention. Anthony Fauci’s unwavering commitment to setting the record straight at every turn.

And for every other ‘Anthony Fauci’ in every other country in the world. Every public health official in every small town who tried to enforce rules to protect their citizens.

Every epidemiologist who pored over data and ran model after model to help us understand the numbers. To the World Health Organization employees and staff who have broken themselves trying to coordinate a response.

To the Bill and Melinda Gates foundation and every other single foundation across the globe that has tried to raise money and ensure an equitable distribution of these vaccines.

Every bench researcher who spent countless hours trying to find a cure. Every member of the fragile healthcare supply chain family that had a hand in procuring vials, swabs and needles. Every company in every country that converted its manufacturing floor to make face masks or produce hand sanitiser.

Every laboratory technician who ran PCR test results by the millions to get us results as fast as possible. To all the contact tracers who tried to help governments understand community spread.

Every recovered patient who donated blood for convalescent plasma. Every patient who fought valiantly and helped us learn about how to better treat this disease through its fighting spirit. And every victim.

I know Time’s Person of the Year award is not that meaningful anymore. But it could have been, just one more time. Instead, this year’s award has become a simple and sad reminder of something even more simple and sad: we have stopped caring about and recognising the contributions of science.

The obvious choice was in plain sight.

I usually wouldn’t care about pop culture awards – this time is different.

This article was originally published here.

Dear Joe

Dear Joe,

Congratulations on winning the recent US Presidential Election. Now the work begins. You have tremendous challenges on the domestic front, with foreign policy and with an economy that is staggering. Your country is divided. Schools are closing. People are dying.

But the health of your citizens and a single-minded focus on the healthcare system is the only way out. You are no stranger to the importance of individual health. You suffer from asthma and have undergone two surgeries for intracranial aneurysms and a pulmonary embolism. So,
you know that if you have your health, nothing else matters.

And if you don’t have your health, nothing else matters. You also most certainly know about the gravity of a strong US healthcare system since you were part of the administration that crafted the Affordable Care Act in 2010.

The importance of protecting pre-existing conditions and expanding access to affordable health insurance. You have spoken about a new ‘public option’ and tax credits to help working class families along with the elimination of surprise medical billing. You have promised to reverse the US administration’s withdrawal from the World Health Organization. Your goals are high. And your aim is far. Bravo.

But COVID-19 is the problem. It is here today. And it is not going anywhere soon. How you deal with it is the singular answer to how everything else goes in 2021.

While PPE procurement may seem like a conversation from a different time, reports suggest that this is still a problem. Ensuring that healthcare and frontline workers can safely do their jobs is paramount to dealing with the virus in the here and now.

Vaccines are coming. Preparing the supply chain and understanding the logistics of getting these vaccines to the people is a gargantuan task. You have selected amazing people for your taskforce. But you must also use the collective experience of other countries that have rolled out complex, large-scale public health vaccination programmes.

Vaccines are great. Vaccinations are better. The sad truth is that many Americans have expressed a distrust in science and in the development
of these vaccines. Experts have stated that, in order for the economy and the workplace to return to normal, at least 70% of society needs to get vaccinated in order for herd immunity to take effect.

Having enough doses to make this happen does not appear to be an issue based on long-term manufacturing projections that we have been given. But after a full year of anti-science rhetoric and deception in your country, the messaging and education campaign will be more important than the logistics and supply chain discussions. Take my word for it.

And here’s a suggestion for the key messaging elements of your campaign to the American people: Trust and Two. In order to establish trust in the vaccines, your administration must put epidemiologists and doctors at the forefront to share information and data with the general public.

The Food and Drug Administration (FDA) and Centers for Disease Control (CDC) must be part of this campaign, after being sidelined for the past year, or used exclusively as vehicles to misinform and confuse. You must have independent scientists and form review committees to validate the information that is shared with the American public.

And you must have a plan to work with local leaders in communities of colour and with visible minorities who, for too long, have been on the fringes of healthcare communication and who have become understandably leery.

Two. This key element of the messaging campaign should not be overlooked. Pfizer’s vaccine requires two shots, three weeks apart. Moderna’s vaccine requires two shots, four weeks apart. And AstraZeneca’s vaccine is being studied in a protocol where two shots are given one month apart. You see why ‘two’ is important?

Two shots. Not one. An individual gets immunity with two shots and only with two shots. Research has shown that other immunisation programmes are plagued by patients who initiate but do not complete a vaccine series. This could be the biggest hidden issue with the COVID-19 vaccines and it is not being forcefully messaged or communicated.

Call it compliance. Or adherence. Or whatever you wish to call it. The key is that ‘two’ will be the most important number of 2021. You have been dealt an exceedingly difficult hand, with the outgoing administration effectively relinquishing any action on controlling COVID-19, which has allowed the infection to run rampant to the tune of one million cases per week.

Good luck. The world is rooting for you and your administration.

An open letter to the incoming President of the United States on COVID-19 messaging priorities

This article was originally published here.

Be Careful What You Wish For

Other than hoping that SARS-CoV-2, the virus that causes COVID-19, would just disappear or that we could all collectively skip the year 2020, the two most common yearnings I hear, see and read about in relation to COVID-19 are: let me get the virus and get it over with, and let’s hurry up and get a vaccine out there like some other countries are doing (I’m looking at you, China and Russia).

On the subject of hoping one gets the virus so that one can ‘get it over with’, where to begin? How about with the fact that
there are no clear and universal predictive factors that can tell us who is going to get severe disease and who is going to get mild disease.

We know that underlying health conditions, those that are elderly and those that are immunocompromised are at the highest risk of bad outcomes. But we should not confuse those who are at highest risk of bad outcomes as being those who are the only people at risk of bad outcomes. As the evidence emerges from around the world, we continue to observe younger people contracting the virus, suffering serious illness, requiring hospitalisation and dying.

But let’s suppose in our wish to get the virus and get it over with, we could be granted a mild case of COVID-19. Even then, we would be misguided. We now know that there are thousands of people who have contracted mild COVID-19, never having been hospitalised, never having suffered the typical symptoms and eventually having tested negative but these individuals continue to report troubling long-term effects including neurological deficit, fibromyalgia and mind-numbing fatigue.

And don’t fall for the invincibility bias that once you’ve contracted COVID-19, you can’t get it again (that has been disproven) or that if you do get it again, it will be really mild (we don’t have enough evidence to say that at this stage). And without a doubt, the other reason you don’t want to wish for COVID-19 is that even if you didn’t get a serious case, even if you didn’t have any long-term effects, and even if you don’t get a second infection (or a very mild one), you might infect someone else who might not be so lucky.

Let’s turn to the vaccine wish. There are more than 50 vaccine candidates in various stages of clinical trial development. And by the sounds of it, we might need every one of them in order to somehow vaccinate close to eight billion people.

However, some countries like China and Russia have gone ahead and started to roll out large vaccination programmes, despite the fact that phase 3 efficacy and safety results from their vaccine candidates have not been analysed. This has prompted some in Western European and North American circles to wish for something similar.

Let’s be clear about the pitfalls here. By accelerating the approval and distribution of vaccine candidates where a full read-out and understanding of the efficacy and safety results has not occurred, we run the risk of harming a lot of people. Remember that we’re giving vaccines to healthy people. Let’s also be clear that when vaccine trials pause (see AstraZeneca and Johnson & Johnson) due to adverse events, this is a good thing.

As I and others have opined previously, it demonstrates that the system of checks and balances is working and that we are adhering to strict principles that govern how clinical trials ought to be conducted. So wishing for an accelerated approval, given the trade-off required on safety and efficacy, is simply a bad idea.

But another reason you don’t want to wish for an accelerated vaccine is a much more subtle and nuanced justification. Frankly, the optics of it are horrible. Yes, you heard me. We need to convince people that a vaccine is safe and that it has been properly vetted and studied if we’re going to get uptake. And if we’re going to control this virus so that we can all go back to living normally, we’re definitely going to need uptake. Massive uptake. Like 70% of the population uptake.

The psychology of this point is, I’m sure, not lost on the reader. We have seen some Western governments promise vaccines on a certain date which has generated raised eyebrows from people who are used to the slow, methodical nature of these sorts of things.

That a vaccine to control a novel disease we had never even heard of 11 months ago might take about a year and a half to produce is strangely comforting. Anything else is not. As we approach the end of this annus horribilis, we must ground our wishes, hopes and prayers in a reality that reflects what we are actually seeing and not what we want to see.

Ten months into this pandemic, it seems a lot of people are hoping for some strange thing

This article was originally published here.