Novartis hails digital strategy as profits hold up during pandemic

Novartis has said that its investment in digital technology has helped it to ride out the worst of the pandemic, although sales of some of its newly-launched products have been affected by a fall in prescriptions and hospital visits.

The big Swiss pharma still managed to grow sales in Q4 compared with the same period last year, with sales increasing a reported 3% to $12.8 billion and profits growing 2% to just over $3 billion.

Under the leadership of CEO Vas Narasimhan, who took over in 2018, the company has focused on using digital technology to engage with both patients and doctors.

In a conference call outlining the company’s Q4 figures, Narasimhan and his leadership team said that this approach had helped overcome some of the challenges laid down by the pandemic.

However, the company did caution that its predictions for 2021 were based on an understanding that prescription drugs sales in hospitals would start to return to normal in the second half of the year.

Marie-France Tschudin, president of Novartis’s pharmaceuticals business, said digital technology had helped to improve productivity and its interactions with doctors.

“The opportunity is to become more personalised,” said Tschudin.

The company used “quality digital content” when interacting with doctors to avoid face-to-face meetings to discuss new drugs – something that is becoming increasingly common in the industry during the pandemic.

In China, Novartis has been working with the internet multinational Tencent on an AI-enabled “digital nurse” to manage heart disease.

It also has a patient “onboarding portal” for those who are beginning a new course of Novartis drugs.

“Fully electronic initiations is one area where we can make advances,” Tschudin added.

The investment in technology has enabled the company to remotely monitor clinical trials in real time.

Tschudin said: “We have conducted tens of thousands of remote monitoring visits. That’s enabling us to manage the clinical trial impact.”

Some products have been affected, however. Sales of spinal muscular atrophy gene therapy Zolgensma have been hit because it requires a course of drugs to suppress the immune system before prescription.

Doctors have been unwilling to prescribe it because of the higher chances of catching the virus, said CEO Narasimhan.

Most other drugs prescribed in hospitals have also been affected along with anti-infectives because of a lower than expected incidence of flu during quarantine, he added.

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Unlocking the potential in rare disease research with decentralised trials

A survey by rare disease patient network Raremark found that 86% of the community members asked were interested in taking part in clinical trials. CEO Jeremy Edwards looks at how decentralised trial models can solve some of the challenges for clinical trial recruitment in rare disease.

With low and geographically dispersed patient populations in rare disease, deciding where best to place trial sites can be a headache for sponsors. Sites need to be close enough for travel, and the number of site visits and trial appointments must also be manageable for people living with the complications of having little-known and rarely-researched orphan diseases.

Decentralising trials, a topic revitalised by the COVID-19 pandemic, seems like a no-brainer, but would people with rare diseases be open to them? In fact, how do rare disease patients even feel about clinical trials? A survey of members of the Raremark community found that 86% of respondents were interested in taking part in a clinical trial now or in the future.  The people who took part were from across the world, living with hemophilia, idiopathic pulmonary fibrosis, myasthenia gravis, and sickle cell disease.

Research and development will always be important to rare disease patients

This finding may come as a surprise to anyone who read this CISCRP report last year. The report found that people’s willingness to take part in clinical trials in 2020 fell dramatically compared to previous years – however that survey was conducted with the wider public while the Raremark survey focused specifically on people with rare diseases.

Progress in research and development for better treatments will always be a priority for rare disease patients. There are around 7,000 known rare diseases and only a fraction of those have treatments available.

“For those participants that did not want to take part in a clinical trial, reasons given included not knowing where to start looking for information as well as the COVID-19 pandemic, hesitance about traveling and not wanting to disrupt their medication plans.”

Getting a diagnosis is not always easy; people have to battle many years because rare diseases are not as extensively researched or known about as more common ailments. Common experiences heard from people with rare diseases can be things like:

“It took me a full 10 years [to get a diagnosis]! I experienced my first symptoms when I was 12, they progressed at 13 and I got a correct diagnosis at 22.”

“No one ever knows what to do with you! It’s a pure guessing game!”

“Never heard of it before my mum was diagnosed, also nothing was actually explained to us, we found out most information on the internet!”

“I had to suffer hours of excruciating pain before I could be taken seriously.”

This illustrates the toll that having a rare disease can have on the individual and their family’s lives. This is a key reason why patients view the continued progress of research and development as important. For those participants that did not want to take part in a clinical trial, reasons given included not knowing where to start looking for information as well as the COVID-19 pandemic, hesitance about traveling and not wanting to disrupt their medication plans.

Positive patient feedback for decentralised trials

While the idea of decentralised and virtual trial methods – i.e. taking the trial to the patient, rather than the patient to the trial – has been a topic of interest for some time, COVID-19 has brought it to the forefront.

Investment into companies that offer decentralised and virtual trial solutions increased dramatically in 2020 and this is translating into practical discussions regarding the implementation of decentralised trials. With all of this in mind, Raremark was interested to learn what people with rare diseases think about them.

We asked people where they would prefer to receive their trial medication and monitoring appointments if they decided to take part in a clinical trial. 57% of participants said they would like to receive the trial medication through a mix of clinic, home, and nearby hospital visits, and 45% would like the same mix for how they are monitored during trials.

Only a few people surveyed said they wanted to have all their appointments only at the clinic or only at their home.

We also asked participants if they would have any concerns about taking part in a trial that would not require them to travel to the clinic for all their appointments – 87% of survey participants expressed no concerns about this approach to trials.

When asked about features of decentralised trial designs that people found most attractive, the top reasons given were the convenience of having more of the study take place at home and less time traveling, as well as the use of technology, both to communicate with research staff and to have their health monitored.

For the 13% of participants who did have some concerns about these types of trials, the reasons they gave for their reservations included possible adverse reactions to the drug, and not having specialists there to help them. A few others said they would struggle to comprehend all the trial literature on their own.

What does this mean for clinical trials in the future?

The COVID-19 pandemic has turned many aspects of clinical research upside down; however it will also be a powerful agent for change in the way the pharma industry conducts clinical trials. One of the barriers to uptake of virtual trials in the past has been the assumption that it requires a fully decentralised approach. We’re now seeing a shift in focus towards hybrid models where sponsors identify aspects of a trial that could be done virtually or at locations closer to patients’ homes.

Clearly, face-to-face visits will still be necessary, but through a decentralised approach these can be limited and balanced with home visits from nurses or by engaging local clinics and hospitals so some appointments can be conducted at the patient’s regular doctor’s office.

There are already tools available and more being developed that can help make decentralised trials a possibility, including software that capture patient consent easily, at home video consultation tools that make staying in contact with patients straightforward, apps for nurses to use when they’re making home visits, and even integrated wearable devices that collect the relevant data needed for a trial such as biomarker data, physical activity and motor symptoms.

Adopt a person-first approach to increase engagement and retention

The best way to keep people engaged in trials and reduce trial dropouts is taking a person-first, approach.

It is essential to remember that the people who take part in clinical trials may have jobs, work or childcare commitments, or the nature of their disease may mean certain tasks take priority over others.

To keep people living with rare diseases engaged, clinical trials must adapt to fit as seamlessly as possible into people’s lives. Decentralised and hybrid trial models can help by removing obstacles that people may find disruptive to their everyday life when taking part in a trial, such as the burden of traveling to trial sites multiple times.

Additionally, there are several ways to keep the people who opted to participate interested and engaged, whether a decentralised approach is adopted. These include access to information and keeping communication lines open before, during and after a trial.

Participants should always feel comfortable asking questions and voicing concerns, so it is important to use every opportunity to keep people informed and treat their time and commitment with respect.

A few simple ways to achieve this include:

  • Replying to patient emails and call-backs promptly – there’s nothing worse than spending lots of time looking for patients only to lose them because of a missed call
  • Catering for work schedules, planning calls and screening appointments accordingly – remember patients have lives too.
  • Addressing any anxieties patients and caregivers have, including coming off existing medication, as well as questions regarding the trial drug or the tests and procedures involved in the trial.

Conclusion

Shifting towards decentralised trial designs can help solve some of the challenges around recruiting patients for orphan drug trials. Designing trials where participants do not have to travel as often and where some appointments can be done virtually will make them more convenient and cause less disruption to people’s lives. Rare disease patients are open to these trial types but still need some in-person appointments, therefore a hybrid approach with a mix of in-person and virtual appointments is desirable.

Ultimately, by understanding the world that rare disease patients are living in and designing trials accordingly, sponsors can significantly improve clinical trial engagement and participation.

You can learn more about our findings and the opinions around clinical trials in rare disease here.

About the author

Jeremy Edwards is the CEO of Raremark. He has been focused on aiding the biopharmaceutical and health sciences industry in the development of key compounds and new therapies for over 25 years.  His background includes executive leadership positions across the clinical development continuum; from full-service CROs, to highly specialised imaging modalities, to niche patient-focused service providers.

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2021 – The healthcare changes here to stay

2020 was the year that changed everything, and as the new year begins many are wondering what awaits the world in 2021. Impetus Digital co-founder and CEO Natalie Yeadon reflects on the last 12 months and shares her views on the healthcare, research and digital changes that could be here to stay.

I think it is fair to say that 2020 will not be particularly missed by anyone. Many started the year with big plans, whether for overseas trips, weddings, or industry events, and then the unthinkable happened. While the world first heard of the novel coronavirus in late 2019, it was not until 11 March 2020 that it was declared a global pandemic and it finally sank in just how serious of a threat it was. But how will the world continue to change in 2021?

Major global events

COVID-19 has amplified many of the issues that society was already facing. Although the pandemic has largely taken the media’s focus away from the climate crisis, it has given us a preview of what is to come if we do not stop exploiting the planet and our wildlife. Indeed, 2020 brought new record forest fires and extreme weather events.

In addition, 2020 was the year where social justice (not least in the form of Black Lives Matter protests) was brought into focus. Racial discrimination and bias were also uncovered in healthcare, with stark differences in COVID-19 rates and mortality between different ethnicities in many countries.

COVID-19 has widened the already large class divides seen between white-collar and service workers, with the former typically having the option of working from home and taking the recommended social distancing precautions. Conversely, the latter group is largely being forced to carry on with their work with little protection and low compensation, if they even have a job to go to after many smaller businesses closed their doors.

Public health has been politicised

Somehow, in 2020, wearing a mask to prevent the spread of a highly contagious disease became a controversial and political issue. People were asked to stay home, watch Netflix, and bake sourdough bread to protect those who are vulnerable, yet photos of packed bars and sports stadiums soon emerged and anti-masking protests were held across the world.

Epidemiologists, researchers, and clinicians are now household names, with people like Dr Anthony Fauci and Sweden’s Anders Tegnell drawing their fair share of both praise and criticism domestically and internationally. Countries’ strategies to contain the spread of the virus have been debated and criticised, and it will likely be years before we will be able to say which approaches were “right” and “wrong”.

“On the upside, the pandemic has brought enhanced focus to mental health issues and innovative approaches on how to best address these. If we can keep the momentum going and retain this focus post-COVID, perhaps the stigma around mental health can be lifted and better treatment strategies can emerge”

Mental health focus

The secondary effects on mental health during the pandemic are vast. We are already seeing increased rates of depression and anxiety because of the pandemic, and there are no signs of this slowing down. Women are especially impacted, disproportionately having to take on childcare or home-schooling compared to their male counterparts.

On the upside, the pandemic has brought enhanced focus to these issues and innovative approaches on how to best address mental health. If we can keep the momentum going and retain this focus post-COVID, perhaps the stigma can be lifted and better treatment strategies can emerge.

United global research

Another positive note is that the pandemic has accelerated laboratory and clinical trial collaboration far beyond what has ever been seen before. From the onset of the pandemic, scientists have been openly sharing their data with investigators from other centres or countries. It has also shown that the time it takes to get a drug to market can be substantially reduced when there is enough funding and political will. How this will affect clinical trials and regulatory approvals in the future remains to be seen, but there is reason to be optimistic.

Healthcare goes virtual

Before 2020, telehealth appointments were few and far between, with many clinics not set up for these services. Since then, the growth of telemedicine has been exponential. Another aspect of healthcare that has had to adapt is the way we monitor chronic conditions. Older patients or those with co-morbidities are at higher risk of severe COVID-19, so frequent clinic visits for routine blood pressure measurements are not always feasible. As a result, we have seen a dramatic increase in the interest and uptake of remote monitoring devices such as wearables and mobile health apps. I predict that this is just the beginning of healthcare’s virtualisation and am excited to see what the new year has in store.

Remote work is the future

Another major change in 2020 was of course the sudden move to remote work. For many, it was a 180-degree shift from business as usual. Interestingly, in a Canadian survey, the majority of respondents (55%) expected at least some of the workforce to remain remote in a substantial way after the pandemic is over, while only 17% expected all staff to be onsite five days a week. Further, major companies like Twitter have announced that employees will be able to work from home permanently, signalling a clear change in the way that we do work. While not without challenges, I see remote work becoming a mainstay due to its greater flexibility and convenience for workers.

Virtual events are rapidly improving

Finally, the ways that pharmaceutical and scientific communities attend meetings and events completely changed in 2020. Virtual meetings such as advisory boards and steering committees were already popular before this year but were often accompanied by in-person meetings. We have now seen without a doubt that it is possible to meet the same objectives virtually, often more effectively and at a lower cost.

The biggest change, however, is the way we now attend larger events such as conferences, congresses, and medical education events. There is no shortage of online conference solutions available, but there is still much to improve on. For example, some aspects of in-person events are not always there or are poor substitutes for the real thing.

Ideally, virtual event platforms should be comprehensive so that everything you need is in the same place. The layout, branding, and inclusions should be completely customisable to your needs, and it should come with all aspects of in-person events such as networking, breakout workshops, exhibitor booths, and poster sessions. The good news is that these types of platforms are getting better by the day, and so are the virtual events that they host.

What have we learned from the last year?

The past 12 months have shown that firstly, we live in a highly polarised world where science and public health are up for debate. Secondly, crisis leads to innovation and finally digital health technologies are the future with remote work and virtual meetings here to stay.

Wishing you all a safe, happy, and healthy 2021.

About the author

Natalie YeadonNatalie Yeadon is the CEO and co-founder of Impetus Digital, where she helps life science clients virtualise their meetings and events and create authentic relationships with their customers.

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How UCLA Health incorporated telehealth into its triage protocol

In response to the spike in demand for virtual care services amid the Covid-19 pandemic, UCLA Health developed telehealth-specific triage protocols to ensure their patients are getting care through the appropriate medium — whether in person or via a video visit. Here’s how they did it.

2021 Outlook: The future for life sciences customer experience

Research from a large-scale survey of 1000+ senior pharma professionals has highlighted the divide between digitally adept companies and those that have been slow to adopt technologies. We look at how the customer experience is changing due to COVID-19.

Historically, pharma has lagged behind other industries in adopting digital solutions, but with COVID-19 catapulting the sector, and healthcare in general, into a new digital era, the landscape is changing significantly and rapidly. What will this transformation mean for pharma’s customer experience?

In an April survey conducted by Reuters and Omnipresence, 1,363 senior professionals mostly working in pharma (82.8%) in the EMEA region (73%) and biotech, medtech/device or consumer health companies reported on how life sciences organisations were adapting to the ‘new normal’.

With severe restrictions on face-to-face engagements during the pandemic, digital engagement has been one of the few ways companies have been able to connect with customers. Findings from the report highlighted an urgent need for investments in customer relationship management (CRM) capabilities.

A unified approach

According to Sanjay Virmani, CEO of Omnipresence, a key struggle for pharma companies comes from the lack of a common data model, preventing them from having a connected and holistic view of the individuals they’re trying to engage with.

“When an organisation looks at an HCP or customer, are they a marketing customer, a medical affairs customer, a sales customer?”

“If different departments are not coordinated, how can the customer get all the information they need with the proper context? And if the company does not provide that seamless experience, the customer has to glue it together themself or not get it” – Sanjay Virmani

“It is not as if companies have not invested in the infrastructure and are not generating this data. The problem may be that there is no unification that is so essential to going in that agile, omnichannel direction.”

Unified platforms that can pull in data from multiple digital channels can help create a better customer experience according to Virmani. “There is a need to reinvest in the technology stack to be able to drive unification, but there is also a need to reinvent the cultural stack so that different departments are working in a coordinated manner,” he said.

“If different departments are not coordinated, how can the customer get all the information they need with the proper context? And if the company does not provide that seamless experience, the customer has to glue it together themself or not get it.”

In the report, 70% of respondents said they needed better ability to surface customer insights from various channels into digital workflows/CRM. 75% said they needed a more agile method to ingest and consolidate insights across channels and 65% said their CRM needed to improve the method and quality of data collection.

Pharma is also failing to utilise engagement tools, such as chatbots, even though many sectors are using them on some level. According to a report by Juniper Research, the banking sector is expected to automate up to 90% of customer interactions using chatbots by 2022.

“About 40% [of respondents] were not doing that at scale across multiple countries, regions, languages, and products,” said Virmani.

Hybrid strategies that enable companies to have the flexibility to shift between virtual and in-person engagement are likely to be where the industry is heading, Herman De Prins, chief information officer at UCB, explained, adding: “I don’t think we will have complete virtual HCP engagement post-pandemic. We already saw this in the first few months of the pandemic; there was an immediate move towards complete virtual HCP engagement, but once the pandemic restrictions were slightly loosened, we saw face-to-face coming back relatively strong. We do believe that remote engagements will continue — but they will be a hybrid engagement and not a purely virtual one.”

This survey also showed how companies were putting specific strategies in place to improve HCP engagement through modern digital channels, that were considered “non-traditional” pre-pandemic. 73.6% of respondents said they expected the use of social media to engage with HCPs to increase over the next 12 months. However, the transition to digital commercial operations has proved challenging for some companies with 32.3% of respondents saying their organisation did not have the commercial data and analytics capabilities to support digitisation of sales and marketing operations and 28.6% stating their organisation did not have the right technology/platform/channel capabilities to support the digitisation of sales and marketing including virtual sales capabilities.

CRM is only a minor part in the broader omnichannel approach. Changing only the CRM would achieve nothing but spend more money. What is truly needed is a deep change in the analytical and go-to market approaches and optimising the new channels” – Florent Edouard 

Florent Edouard, SVP, global head of commercial excellence at Grünenthal Group, commented: “The 60% or so who think they are ready for complete digitisation of sales and marketing operations say so because they have not truly tried it.

“This is probably the most challenging part of the digital transformation, as we need to acquire skills such as advanced analytics that we currently do not have, turn our customer model fully around, and implement tools that are able to create sophisticated AI-powered models that can manipulate billions of data points. Very few companies are equipped to do that in their commercial entities.”

Time for change

Commercial teams should now address the gaps they have in data and analytics and accelerate the adoption of omnichannel capabilities. While CRM was traditionally built for a time where there were only one or two channels, it is now becoming a thing of the past.

Omnichannel approaches that allow bi-directional engagement on all modern channels provide a seamless and individualised customer experience that will soon become the ‘better normal’.  Key benefits could be medical chatbots answering simple dosing questions, HCPs triggering inbound virtual meeting requests and ensuring compliant social media engagement from field teams to HCPs.

But what exactly does this mean for life sciences companies? “This means we need much better CRM capabilities than pre-pandemic. That does not mean these capabilities are not available. It just means they have not been exploited” said De Prins.

Organisations have started to recognise the urgency, with 79.7% of survey respondents stating the pandemic will influence priorities towards investments in customer experience.

“CRM is only a minor part in the broader omnichannel approach,” said Edouard. “Changing only the CRM would achieve nothing but spend more money. What is truly needed is a deep change in the analytical and go-to market approaches and optimising the new channels.”

Virmani agreed that the pandemic has made the need for better insights and analytics from CRMs and other CX systems much clearer and more urgent. “There will be a greater emphasis on the connected customer journey. Many companies are already thinking about customer experience as a competitive edge.”

Maximising the best management of customer experiences is one of the essential strategies that pharma companies can take to stand out from the competition. Indeed, companies that will triumph in the post COVID-19 world are the ones that continue to allocate resources, execute omnichannel development, remove silos and move towards a more unified and agile digital approach.

As the pandemic continues to accelerate the pace of digital change around healthcare, organisations need to grasp the opportunities this shift presents to make far-reaching improvements to their customer experience.

Check out the full report: COVID-19: Accelerating Digital Transformation in Life Sciences

Download the executive summary: COVID-19: A Pulse of the Life Sciences Industry

About Omnipresence

Omnipresence Logo

Omnipresence is a unified and intelligent customer experience management platform (CXM) for healthcare and life sciences organisations with CRM, omnichannel engagement, advanced analytics, and AI capabilities in a single platform.

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Nine for 2021: The COVID-19 legacy

In the first of a two part series, IQVIA’s Sarah Rickwood covers nine key trends and events that will affect the global healthcare and pharmaceutical industries in 2021.

One bright spot in an otherwise dreadful year: the pharmaceutical industry has discovered it can do things it never dreamed possible. Anyone who proposed that a novel, deadly virus would spread, with a vaccine developed demonstrating 95% efficacy, and approved for patients in less than a year would have been scoffed at.

If they had also predicted that the second person to receive the vaccine out of trial would be a gentleman named William Shakespeare, they would certainly have been dismissed as a fantasist. Yet these things have happened. The pharmaceutical industry has been through extraordinary times, and responded magnificently.

2021 will of course be a year of aftermath as the world resolves the COVID-19 infection crisis. It will also be a year of challenge, because the healthcare system crisis and the economic crisis triggered by the COVID-19 infection crisis will last longer than the infection crisis which caused them. It will also be a year of opportunity: trends which existed pre-COVID-19 have been accelerated by the changes wrought by the pandemic, and events and trends unaffected by COVID-19 will come to fruition in 2021.

“This may mean a change in patient journeys to pharmacotherapy becoming longer and more complex, but also occurring in different settings”

With the roll out of vaccination across population tiers, starting with the most vulnerable, there will be a progressive reduction in social distancing and pandemic imposed restrictions, but since vaccination will necessarily take time and different countries will move at different rates, it is unrealistic to expect that the restrictions of 2020 will rapidly disappear.

The crises that the pandemic has triggered will also become much more apparent in 2021 as the infection crisis recedes. These are the crisis of healthcare system capacity and non COVID-19 patient backlog, and the economic crisis, still largely to come in impact, which will constrain healthcare spend, both public and private, across countries and have knock-on impacts for medicines spend. These crises will provide the backdrop to both 2021 and the years beyond, and the nine trends that we will discuss must, of course, be viewed in their context, but we will focus on trends of opportunity and positive change for healthcare and the pharmaceutical industry.

Healthcare systems reconfigure

Around the world, the infection crisis put healthcare systems into shock. The prospect of overwhelming hospital ICU capacity was the primary driver of lockdowns, as governments sought to “flatten the curve” and manage infections. Certain countries were also forced to respond by building new capacity-dedicated facilities for severe COVID-19 patients, like the largely unused “Nightingale” hospitals in the UK.

All countries also created capacity within the existing hospital provision by cancelling elective surgeries and non-urgent hospital treatment. Where treatment continued, such as in cancer cases, it was where possible, shifted to a homecare setting, creating a rapid and substantial shift of care from hospital and into primary care and homecare. Primary care itself saw significant reconfiguration- for many patients, routine consultations became virtual- although not necessarily all digital or telemedicine as might be conceived by innovators.

Healthcare systems ended 2020 in a very different place to where they were in 2019, with hospital capacity (and hospital finances) challenges. These changes are likely to reduce only slowly in the Vaccine+ environment, and will not be entirely reversed.

For pharmaceutical companies there are a number of implications. As face to face visits with healthcare professionals declined, so did new diagnoses and new treatment starts, and also evaluations of current patients and switching of treatments. This has built a backlog of non COVID-19 patients in the system, patients who have either not seen treatment, or whose treatment has been delayed or sub-optimal. It varies by country and by therapy area, but is pervasively present, and its consequences play out both now and long into the future. In the near term, launch products, which rely for establishment on new and switch patient opportunities, have, with a few notable exceptions, had a dreadful year.

In the long term, the health impact of delayed or absent treatment for patients could play out as more severe or advanced disease presentation, higher co-morbidities and even earlier deaths. It will take a decade to fully evaluate the true impact.

For pharmaceutical companies, this may mean a change in patient journeys to pharmacotherapy becoming longer and more complex, but also occurring in different settings. Products which allowed patients to self-administer had a differential advantage which was quite variable before- in some cases it was an obvious advantage, in others the institutional inertia which promoted administration in facilities was slow to change. Now, the playing field is very clearly slanted toward self-administration as a consistently attractive advantage, with oral treatments (such as the oral migraine agents) clear winners.

Expect to see self-administration and oral presentations become a bigger factor in health technology assessment in the future.

The non COVID-19 patient backlog

The non COVID-19 patient backlog which has built across conditions and countries is something addressed in another in-depth article for pharmaphorum.

Throughout 2020, IQVIA data, both secondary and primary research pointed to often substantial share of non-COVID-19 patients receiving no, or suboptimal treatment. An IQVIA survey to Neurology, Cardiology, Rheumatology, Dermatology and Ophthalmologists in June 2020 across the lead five European countries showed an average of 30% of patients either “no shows” or still waiting for treatment that was delayed. IQVIA’s survey of oncologists and haematologists in the top 5 European countries on their experience of treating their cancer patients before and during the pandemic showed specialists reported their patient caseload fell to 41 patients a week (from 77/week pre-pandemic) at the height of the first wave of the pandemic. The June period, which coincided with lows of infection numbers in these countries, was little improved, at 50 patients/week, and as countries faced the second wave of infection in October, the number of patients reported seen per week had fallen back again, to 45.

“The real impact on submissions and approvals will be in 2021 and beyond, when the pandemic’s true impact on clinical trials becomes apparent”

In 2021, and beyond, addressing the patient backlog (and the consequences of failing to do so) will be an increasingly prominent healthcare topic, as the health impact for untreated, disengaged and sub-optimally treated patients becomes apparent. This will become especially acute with the COVID-19 vaccination roll-out, as this will engage health systems in a vaccination roll-out of unprecedented scale, whilst progressively removing the obstacles to re-engaging with care. We expect there will be a need for public information campaigns to encourage people to come forward for diagnosis and treatment of non-acute conditions which may simply have been tolerated during the pandemic.

The focus is likely to be on people who may have chronic, primary care treatable conditions, such as hypertension, dyslipidaemia, or early type II diabetes. There are also clear concerns, and some hard evidence, that mental health conditions have risen in number and existing conditions been exacerbated during the lockdown, most worryingly, among the healthcare professionals who are so vital to post-pandemic recovery.

In 2021, the pharmaceutical industry must play its role in supporting post-pandemic healthcare system recovery, creating specific plans against this issue, tailored to country and therapy area.

The post pandemic launch

A key commercial concern in the early days of the pandemic was the impact that it might have on innovative launch. Bringing the newest pharmacotherapies to market could be affected at multiple  levels – the approvals of new products by regulators, the availability of products in the commercial supply chain, access to new medicines evaluated and granted by payers, and then finally, the uptake and use of the product to its full potential.

New product approvals do not seem to have been adversely affected by the pandemic – as at the time of writing, the FDA has approved 48 novel drugs in 2020, matching the 48 medicines defined in the same way in 2019. The latest 2020 approval was Orladeyo for hereditary angioedema on 4 December, so there is potential for 2020’s approvals to exceed those of 2019. The EMA’s new medicines evaluation process seems similarly unaffected in 2020. This is encouraging but not unexpected; products approved in 2020 completed their trials and submitted their marketing authorisation applications prior to the pandemic. The real impact on submissions and approvals will be in 2021 and beyond, when the pandemic’s true impact on clinical trials becomes apparent.

Actual availability of approved medicines, as measured by IQVIA’s MIDAS data, is similarly unaffected in the US. In Europe the picture is more mixed- despite the single source of approvals from the EMA (including for the UK as 2020 is a transitional year). Actual availability of new medicines varies by country and falls below historical averages to August in Spain, and to a lesser extent the UK.

In Europe, health technology assessment (HTA) and payers granting access to products pose an additional barrier to launch uptake – so far IQVIA analysis of HTA concludes that whilst the pandemic had some impact on the volume of HTA activity, it has not yet changed the proportion of assessments that are positive or negative.

Ultimately, the real question is whether pandemic and post pandemic launches will fulfil their clinical and commercial potential. Global data on 2020 launch sales so far shows a challenging picture: a small number of launches have done well, solely because of their US sales. These strong launches include three with MIDAS sales of over $100m to August 2020, Ubrelvy and Nurtec, oral migraine agents both launched in February 2020 so prior to the first infection wave in the US, and Tepezza, the first and only approved treatment for the serious and rare condition, Thyroid Eye Disease (TED). The only other launch with significant global sales (again, from US sales) is a triple negative breast cancer treatment, Trodelvy. This and the remainder of the top 10 products by sales to August 2020 have made an average of $15m in global sales, as opposed to $33m for products of the same ranking in 2019.

2021 will therefore be a crunch year for post pandemic launch potential – focus will be on whether 2020 launches can accelerate sales and reach their expected pre-pandemic potential, and whether 2021 launches will experience the same challenges as those in 2020, given the environment will not be “pre pandemic” normal.

Price and value battleground

One key factor affecting innovative launch performance in 2021 will be the economic environment and healthcare system funding. Country GDPs fell an unprecedented amount in 2020, and whilst bounce back is inevitable in 2021 as lockdowns ease, the sums spent on managing the pandemic are huge, and economies are being re-shaped with unemployment sharply on the rise.

Healthcare and pharmaceutical industries generally weather economic downturns well, but there are features of this downturn which suggest particular challenge. The first is the combination of economic challenge with direct healthcare system challenge- stretched resources and the backlog of non COVID-19 patients. The second is the significantly reduced ability of healthcare systems to realise savings from existing pharmaceutical products going off patent. In 2009, $183m of global market value was due to go off patent in the next five years, in 2019, it was $200m. Similar gross figures, but the 2009 figure accounted for 30% of global market value, and 89% of the patent loss was small molecules. In 2019, the share of the market about to lose exclusivity has dropped to 19%, of which 44% is biologics.

From 2021 onwards, healthcare systems are going to be under considerably enhanced pressure to realise greater savings from biosimilars than ever before. Even if they do, however, their savings will be lower. They will need to control medicines spend elsewhere, and that means raising the bar for market access for innovation. We have already seen that the small number of pharmaceutical launches that did well in 2020 did so in the US market and represented either greater convenience and patient self-administration, or because they were unequivocally major steps forward for high unmet need patients.

Is it likely that in the price and value battleground, the distinction between winners and losers becomes much sharper in 2021, with evidence of clear, distinctive benefit more important than ever before. It is also possible that 2021 will see Europe start to fall back as the second market block for early launch return for innovative products, after the US.

Although separate to COVID-19, the UK’s departure from the EU takes it out of the EMA approval regime to become a clearly separate entity to the EU block. The market access lever is more heavily applied in Europe than the US. China and Japan, on the other hand, have come through the pandemic less heavily affected, and China is now approving innovative agents at historically unprecedented levels. Whilst the US will remain paramount for innovative launch, the East is on the rise.

Home healthcare and digital patients

While the technologies (and indeed the logic for) more home healthcare delivery and greater digital engagement existing prior to the pandemic, adoption has most certainly been accelerated vastly by it. 2021 will be the year where we understand where the new equilibrium will establish.

For example, in the US, weekly telehealth medical claims were up +800%, pre-pandemic vs Nov 2020, and building on its Mar 2020 capacity-increasing responses to COVID-19, in November the US CMS introduced the “Acute Hospital Care at Home” programme. However, on the other hand, some US private insurers have begun to roll back exemptions from out-of-pocket costs for non-COVID-19 related telehealth in response to high demand.

Self-administration & novel dosing regimes which free patient from clinic visits were definitely in the news in 2020. Merck, Sharpe and Dohme gained approval to halve its cancer immunotherapy (Keytruda) regimen to once per six weeks, reducing clinical visits by half with novel dosing, for example. Again, 2020 may have represented an acceleration of a pre-pandemic trend; IQVIA MIDAS data suggests spending CAGR 2015-20 for therapies suitable for self-administration was 13%, vs 7% for therapies which require hospital administration.

It’s not, of course, just self-administered pharmaceuticals which enable home healthcare – digital technologies enable home healthcare by allowing diagnosis, monitoring and patient engagement to happen at home. For example, UCB-Medisafe’s epilepsy portfolio digital companion will support patient engagement, and another US innovation, FDA approved platform including biosensor wearables and AI analytics powers Biofourmis’ [email protected] platform which has been rolled out nationally to help facilitate CMS’ “Acute Hospital Care at Home” program.

In the second article of “nine for 2021” we will look at the issues in 2021 which will directly impact pharma, including the permanent changes in pharma’s customer engagement model, the implications of a geographic re-balancing towards the East, CNS as the new value growth area for the 2020s, and the new biologics environment as biosimilars accelerate.

About the author

Sarah RickwoodSarah Rickwood has 26 years’ experience as a consultant to the pharmaceutical industry, having worked in Accenture’s pharmaceutical strategy practice prior to joining IQVIA. She has wide experience of international pharmaceutical industry issues, having worked for most of the world’s leading pharmaceutical companies on issues in the US, Europe, Japan and leading emerging markets, and is now vice president, European thought leadership at IQVIA, a team she has run for eight years.

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How Big Data will accelerate the future of digital medicine in 2021

The pandemic has shed light on inefficiencies in healthcare systems, and provided an opportunity to adjust how we manage care in the future. Jennifer Haas, executive vice president of Noteworth, shares her 2021 predictions surrounding the future of telehealth and big data. 

Healthcare providers are grappling with the task of scaling digital care delivery operations for ambulatory patients in response to the cost dynamics of effectively treating large populations with limited resources, especially in a post-COVID-19 world. At the heart of this challenge is how to secure, aggregate, analyse, and action the data necessary to make proactive patient care decisions and diagnoses.

In the coming year, there will be a renewed focus on healthcare providers needing to shift their business models to highlight the new need to make healthcare accessible and effective, regardless of geography, location, and mobility.

This will need to be done while also engaging and empowering patients in their own wellness. A recent report highlighted that over 40% of US adults had delayed seeing a doctor during the pandemic. Powering digital medicine platforms with big data and IoT devices ensures clinicians receive access to the entire scope of a patient’s health information while reducing the need for in-person visits and improving patient outcomes.

The ability to use big data in healthcare through digital medicine will prove to be invaluable for healthcare organisations as they work through the pandemic and the new world it has created. Having access to relevant data through digital medicine is helpful because it provides more opportunities for proactive intervention and a more accurate view of the patients’ health with consolidated real-time information.

“Another key benefit to big data incorporated into digital medicine platforms is the healthcare providers’ ability to connect with healthcare apps to track and monitor patient health”

When it comes to digital medicine, big data can improve communication and strengthen relationships between patients and their various healthcare providers.  This is largely because the use of digital medicine platforms feel much more comfortable and personalised for many patients. It not only allows them to take a more active approach in their own healthcare, but gives them access to their clinicians more freely and frequently.  It also allows the care team to be much more connected to the patients’ day to day progress and highlights potential intervention needs before they become critical.  Risk modeling and stratification will continue to evolve, allowing clinicians to collaborate with AI and Big Data to make more accurate predictions of where a patient’s health is trending.

One of the focuses of digital medicine is remote patient monitoring. This technology is especially helpful during the current pandemic as it gives providers the information needed in order to track the patient’s health statuses and react quickly when a patient has an urgent need for proactive care. Remote patient monitoring can alert patients and their healthcare teams when intervention, including seeking in-person medical attention on a scheduled or emergency basis, is needed. Having this data is vital to the future of how patients and their healthcare providers work together. By combining the power of big data within healthcare, digital medicine platforms can help reduce the number of unnecessary visits patients take to the doctor or hospital and alert providers, caregivers, and patients when their status requires in-person care.

Another key benefit to big data incorporated into digital medicine platforms is the healthcare providers’ ability to connect with healthcare apps to track and monitor patient health. As we see within numerous apps or smartphones, they allow users to track health factors such as physical activity, heart rate, breathing rate, and diet. These data points can be transmitted directly to a doctor and be factored into any treatment decisions. Being able to bring this data together creates more insight into a patient’s preventive and personalised care.

The benefits of big data analytics range across the board in healthcare. Most, if not all, healthcare sectors stand to benefit from the implementation of big data analytics within digital medicine. The providers (hospitals or private practices) will be able to provide better care to their patients to make more accurate data-driven decisions more efficiently.  The biggest winner will be the patients themselves who can utilise telemedicine and remote patient monitoring to their advantage in order to enjoy more flexible and convenient access to care which in turn helps them to live healthier lives.

The COVID-19 pandemic has pushed the once-niche telemedicine industry into the mainstream, creating a lasting shift in care delivery. In 2021 and beyond, we will see the healthcare industry shift even more towards digital medicine, specifically AI and risk stratification modeling.

If 2020 has taught the healthcare industry anything, it is that patients want choices and control over their own healthcare.  Healthcare providers and insurers need to listen. Leveraging digital medicine platforms allows providers the ability to draw on the desire for personalized, proactive care by utilising actionable data to proactively monitor a patient’s health status between visits while driving down care costs and improving patient outcomes.

About the author 

Jennifer Haas is executive vice president of sales for Noteworth, where she leads sales, channel partnerships, business development, marketing and social media including profit and loss management.

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How Cerner plans to bolster rural hospitals’ telehealth efforts amid the pandemic and beyond

In a wide-ranging interview with MedCity News, Cerner CommunityWorks President Mitchell Clark discussed the healthcare challenges facing rural communities amid the Covid-19 pandemic and the company’s new free offering that aims to support rural telehealth.

Moderna and BioNTech – who are they?

Moderna and BioNTech, two rising stars in biotech, were in the limelight this year with their pioneering mRNA vaccines against COVID-19. Just who are these companies and who is behind them, asks Richard Staines.

A year ago, the names Moderna and BioNTech were known mainly to those who followed biotech and pharma dealings.

But the tragic events of 2020 have meant these companies have become household names as their trailblazing mRNA vaccines became the first to be approved by regulators against the COVID-19 scourge.

Compared with many of the established names in pharma these companies are young upstarts but they have managed to achieve what other big names in the industry have failed to do and harness the power of mRNA to make medicine.

Their technology is based on synthetic messenger RNA – short for ribose nucleic acid – which is a short transcript of a longer DNA code.

As it’s just a messenger molecule, it does not affect the body’s own genetic code when it is injected as a vaccine – but what it does do is instruct cells to code for copies of a certain protein.

In this case that is the “spike” protein seen on the surface of the coronavirus that it uses to invade host cells.

The body produces antibodies against the protein, which neutralise the virus in the event of an infection.

It’s a revolutionary approach that allowed the vaccine to be made within a few days of the SARS-CoV-2 genetic code becoming available – what’s taken months are the rigorous clinical trials that proved the vaccines were safe and effective.

There has been considerable anxiety over whether using such an untried technology would be the best approach against COVID-19.

What the companies have now proved is that the technology can be used to make safe and effective vaccines in record time.

The companies are based on opposite sides of the Atlantic – Moderna was founded in Massachusetts in 2010 under the name ModeRNA Therapeutics by a team of investors two years after BioNTech began operating from a small lab in Mainz, Germany.

But both drew on the mRNA technology developed by Katalin Kariko from the University of Pennsylvania and her collaborator Drew Weissman, an immunologist from Boston University.

Together the pair had managed to find a way to get the human body to accept strands of mRNA without an immune reaction, by tinkering with the chemical make-up of the molecule.

It was a landmark discovery that meant a technology once derided as being a pipe dream could have applications in the real world as a medicinal therapy.

Moderna’s founders were led by Derrick Rossi, a post doctorate fellow from Stanford University who championed the technology to a team from Flagship Ventures, a Massachusetts firm founded and run by Noubar Afeyan.

CEO Stephane Bancel was hired the following year from France’s bioMerieux and Moderna went on to raise more than $2.6 billion in a series of private funding rounds, while fiercely guarding any details about the technology it was developing.

This changed in 2018 when Moderna went public with what was at that time the largest IPO in biotech history.

The launch raised $500m from investors using what is arguably the slickest stock market ticker out there – MRNA.

Its portfolio of products was broad – including a drug being developed with AstraZeneca for cardiovascular diseases, a cancer immunotherapy and a potential Zika vaccine.

“I was intrigued by the personalities of the founders. They are very good doctors, scientists and entrepreneurs. Whatever they were beginning they did it with the end in mind.”

While Moderna blazed its investment trail and tried to find ways to make sure its mRNA vaccines did not produce dangerous immune reactions, a small biotech called BioNTech had licensed in the technology from Kariko and Weissman.

Run by husband-and-wife team Ugur Sahin and his wife Ozlem Tureci, BioNTech wanted to use the technology to create individualised cancer therapies.

Matthias Kromayer, a general partner at the German investment fund MIG that helped found BioNTech in 2008, said he first met the pair 15 years ago and was immediately intrigued.

He told pharmaphorum: “They are very good doctors, scientists and entrepreneurs. Whatever they were beginning they did it with the end in mind.”

The company began to strike several deals with big pharma companies to develop cancer drugs and in 2013 hired Kariko, who had spent years working on mRNA at Penn, to oversee the mRNA work as senior vice president.

Fast-forward to the beginning of 2020 and the companies realised that they would have to quickly change their research priorities to vaccine development as the coronavirus pandemic began to emerge in China.

Kromayer said the risks and opportunities to take on the coronavirus vaccine challenge were huge for BioNTech, which only went public on the Nasdaq at the end of 2019.

He said: “It was a risk – if (the vaccine) had failed it would have shed negative light on mRNA tech. But it was a once in a lifetime opportunity.”

But according to Kromayer the BioNTech team were confident that mRNA was the solution to the coronavirus problem, as mRNA sequences can be generated in such a short amount of time.

“You can manufacture mRNA vaccine overnight and still it is stable,” said Kromayer.

The rest is history – Pfizer stepped in and licensed the technology, choosing the most promising of four potential mRNA vaccines from BioNTech.

Both Moderna and Pfizer’s shots aced the quickly convened clinical trials and became the first vaccines to make it to market less than a year after the pandemic began.

Thanks to the innovation there are hopes that peoples’ lives may return to normal as 2021 progresses but according to Kromayer this is just the tip of the iceberg for mRNA therapeutics.

The founders of both Moderna and BioNTech realised early on that this is far more than just a vaccine and could be used to tackle diseases that have proved impossible to tackle with the previous generations of medical technology.

Rossi, who left Moderna in 2014 had initially thought it could be used to reprogramme cells to act like stem cells but realised its potential after a bruising encounter with Robert Langer, the legendary MIT scientist and entrepreneur.

According to Kromayer potential uses include pre-emptive vaccines for diseases such as Parkinson’s as well as to create personalised cancer therapies.

Kromayer concluded: “The message is that mRNA based medicines are not just here to serve as vaccines it is much, much, more. This will revolutionise medicine over the next 10-15 years in areas we do not even imagine.”

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Oregon Health & Science University, GE set up state’s first virtual ICU program

The academic medical center collaborated with GE Healthcare to set up the first virtual intensive care unit program in the state, which will help the organization extend its critical care expertise across rural areas and manage bed capacity amid climbing Covid-19 cases.

Fine-tuning telehealth, addressing mental health take precedence for providers in 2021

Telemedicine

As 2020 draws to a close, healthcare providers are strategizing for the new year and the new normal. Providers will need to retool their telehealth efforts and prepare to meet a burgeoning mental crisis, among other issues.

Pandemic has little impact on pharma’s reputation, says report

The pandemic has had very little positive impact on the public’s perceptions of pharma although the industry has fared much better than politicians, according to a report.

According to the report from Takeda UK, only 17% of respondents said their impression of pharmaceutical companies had improved, based on how the industry had reacted to the coronavirus pandemic over the previous six months.

Findings were based on the report entitled Pharma: Repurposed? where Takeda commissioned Ipsos MORI to conduct online interviews among adults aged 16-75 from the UK.

In all, 1,104 interviews were conducted in October 2020.

Aside from the 17% who said their impression of pharma companies had improved during the pandemic, 54% said their impression had stayed the same and 16% said their impression had got worse.

Less than half of respondents trust the pharma industry to act in the best interest of society, while 82% of respondents trust healthcare professionals to act in society’s best interest.

The pandemic has had a positive impact on UK adults’ perceptions of healthcare professionals, with 44% of respondents saying their impression had improved.

In contrast, UK adults’ impression of politicians is markedly worse, with 51% of respondents saying their opinion of government ministers had worsened over the last six months.

When asked to give an opinion on a range of organisations and roles, just 38% of those interviewed had a favourable opinion of pharma companies.

Over a third of respondents had neither a favourable or unfavourable view of the pharma sector, suggesting the industry needed to engage more with the public on its role and activities.

Healthcare professionals were highly regarded by 74% of those interviewed as well as healthcare charities and scientists within the pharma industry (53%) were well regarded.

Total unfavourable views of government ministers stood at 55% and other politicians at 54%.

Jon Neal, managing director for UK and Ireland at Takeda, said: “The pharmaceutical industry has faced several reputational challenges over the years. However, perhaps now more than ever, the development of new treatments relies on cross-sector collaborations and public trust and willingness to engage with the sector.

“Therefore, we need to address perceptions of the industry to improve the future of healthcare and ultimately save lives.

“We hope this report will lead to further discussion about how the industry can convey a stronger purpose to build trust with both patients and other healthcare organisations.”

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Healthcare’s COVID-19 backlog: how pharma can help

IQVIA’s Sarah Rickwood explores how pharma can help healthcare systems address treatment backlogs caused by the COVID-19 pandemic.

As lockdowns started in the West during March 2020, there was, inevitably, much punditry on exit scenarios – for economies, populations, and healthcare systems. Considerable time was devoted to the discussion of V- , U- and L-shaped recoveries.

As we cope with second waves of COVID-19 infections, it is probably fair to say most early pundits were over-optimistic on the length of time the crisis would take to resolve. The pandemic’s aftermath is looking to stretch into the first half of the 2020s. One of the most far reaching impacts will be from the backlog of non-COVID-19 patients who have seen diagnosis and treatment delayed, slowed or even missed and cancelled. For many patients the consequences will be devastating.

With the first wave of lockdowns, treatment backlogs were inevitable due to physical distancing requirements and a pivot to focus on COVID-19. The most immediate impact was cancellation of elective surgeries and other procedures, and the movement of healthcare professional/patient consultations to virtual platforms.

A study in the British Journal of Surgery estimated that globally, 28 million procedures would be cancelled or postponed during the peak 12 weeks of COVID-19 disruption. The same study also made an important prediction: even if all countries increased their normal surgical volume by 20% after the pandemic, it would take a median of 45 weeks to clear the backlog of operations resulting from the 12 weeks of the first wave of disruption.

It is pretty clear that healthcare systems are unlikely to be currently at 120% of their pre-COVID-19 capacity for elective surgeries. In all likelihood, as Europe and the US are in the throes of a second wave of COVID-19 infection, the specific backlog of elective surgery will take longer than predicted to address. Even past the second wave, as vaccines become available, healthcare systems will not return rapidly to pre-pandemic capacities, let alone deliver more than that capacity. The conclusion is that backlog clearance will extend into 2021.

“It is pretty clear that healthcare systems are unlikely to be currently at 120% of their pre-COVID-19 capacity for elective surgeries. In all likelihood, as Europe and the US are in the throes of a second wave of COVID-19 infection, the specific backlog of elective surgery will take longer than predicted to address”

Elective surgery, is, of course at one end of the spectrum of medical conditions with respect to disruptability by the pandemic – by definition they are optional (although if surgeries are postponed, they may become less optional over time), and necessitating visits to a health facility, which may not be possible if there is an infection risk, or that facility has been repurposed for COVID patients. Patients with other conditions, especially cancers, cannot wait.

It is clear that delay in referrals, diagnosis and treatment can mean the difference between treating a cancer that is early stage and therefore often curable to one that is late stage and could result in early death. In an August 2020 paper in the Lancet Oncology, the authors noted that referrals via the 2-week-wait urgent pathway for suspected cancer in England were reported to have decreased by 84%.

The authors used data on cancer patients treated in the English NHS to model the impacts of lockdown induced delays in diagnosis and treatment, and concluded, “Delays in presentation via the 2-week-wait pathway over a 3-month lockdown period (with an average presentational delay of 2 months per patient) would result in 181 additional lives and 3,316 life-years lost as a result of a backlog of referrals of 25%, 361 additional lives and 6,632 life-years lost for a 50% backlog of referrals, and 542 additional lives and 9,948 life-years lost for a 75% backlog in referrals.” The 2-week-wait pathway refers to the request from a General Practitioner in England for an urgent referral to a specialist of a patient exhibiting symptoms which could be cancer.

IQVIA has been conducting a survey of oncologists and haematologists on their experience of treating their cancer patients before and during the pandemic. So far, the study has undertaken three waves of research, covering hundreds of oncologists/haematologists across the five major European countries.

The cancer specialists interviewed reported that, on average, they were seeing 77 patients a week prior to the pandemic. This fell to 41 patients a week at the height of the first wave of the pandemic. The June period, which coincided with lows of infection numbers in these countries, was little improved, at 50 patients/week, and as countries faced the second wave of infection in October, the number of patients reported seen per week had fallen back again, to 45. This pattern was seen across the five countries.

Graphic 1

Because of the lockdown, it is not surprising, but very worrying, that cancer specialists reported delays in diagnoses, surgeries and chemotherapy during each of the three waves of interviews. Graphic 2 details the average percentage of specialists reporting each type of delay across the five countries. It is notable that the percentage of specialist reporting delays, which had dropped during the June infection low, rose once again when the second wave was being faced during October.

Graphic 2

In summary, we have evidence that cancer specialists are reporting delays to patient diagnosis and treatment for cancers across the major five European countries, delays that are continuing past the first waves of the pandemic and into the second, and there are models which suggest that significant increases in mortality and years of life lost will be a consequence of such delays. Treatment backlogs caused by the pandemic are real, will have serious consequences for patients, and will take significant time to resolve.

I’ve picked for discussion two areas, elective surgery and cancer treatment, where patients need to visit health facilities, and in the case of cancers, treatment delays have serious consequences. Not all diseases or conditions are so far along these axes – many chronic conditions can be managed to a very large extent remotely, and for some conditions delays to treatment, even quite lengthy ones, may not have an immediate adverse effect.

Many chronic conditions, such as diabetes, hypertension, dyslipidaemia are also highly prevalent. The impacts of the pandemic backlog on treatment outcomes for these diseases will be played out over years to come, and IQVIA’s longitudinal patient data is already showing decreases in treatment changes (new and switch prescriptions) in relation to key chronic conditions such as diabetes.

“Pharmaceutical companies will undoubtedly place more emphasis on developing treatments that can be home administered and self-administered in the future, and payers and health technology assessors may well value those attributes more highly”

The treatment backlog caused by the COVID-19 pandemic matters – to individual patients, to public health systems, and to the pharmaceutical companies developing treatments which patients may now not be receiving as and when they should for optimal treatment. Pharmaceutical companies cannot address this challenge alone. But they can help, and we are starting to see how.

The first step to addressing the backlog is through raising awareness, with health policy makers and with patients. For patients highlighting the importance of seeking treatment, but without generating unnecessary anxiety and health system pressure, is a sensitive task to be done in close collaboration with health systems. Companies need to acknowledge the pressures that healthcare professionals are under and identify where and how they can alleviate pressures and help doctors to help their patients.

Second, as health systems emerge from the pandemic and vaccines are rolled out (and mass vaccinations will also place pressure on health system and some individual doctor’s time), they will need better data and insight on patient journey bottlenecks, on healthcare system capacity stresses and on the services required to remove barriers to effective treatment.

Finally, pharmaceutical companies should play their role in seizing the opportunity to learn and future-proof healthcare delivery against future pandemics. The pandemic highlighted the value of treatments which patients can self-administer, and in many cases there’s been big swings to treatments which can be taken at home – a movement from warfarin, which requires clinic visits, to Direct Oral Anticoagulants (DOACs or NOACs), which do not, for example, in anti-thrombotic treatment. Pharmaceutical companies will undoubtedly place more emphasis on developing treatments that can be home administered and self-administered in the future, and payers and health technology assessors may well value those attributes more highly.

Graphic 3

The pharmaceutical industry has risen magnificently to the challenge of COVID-19, in terms of treatment and vaccine development. As the virus is defeated and infection rates fall during 2021, pharma’s next challenge will become increasingly apparent – to help address the other public health crisis of the treatment backlog precipitated by the pandemic. The solutions that pharmaceutical companies can bring to address this, and the relationships that they can forge consequently, will shape the pharmaceutical industry’s role in healthcare systems for the remainder of the 2020s.

About the Author

Sarah RickwoodSarah Rickwood has 26 years’ experience as a consultant to the pharmaceutical industry, having worked in Accenture’s pharmaceutical strategy practice prior to joining IQVIA. She has wide experience of international pharmaceutical industry issues, having worked for most of the world’s leading pharmaceutical companies on issues in the US, Europe, Japan and leading emerging markets, and is now vice president, European thought leadership at IQVIA, a team she has run for eight years.

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Regeneron’s COVID-19 antibody cocktail gets US emergency licence

Regeneron’s antibody cocktail is the latest COVID-19 drug to receive Emergency Use Authorization in the US, becoming the first therapy of this kind to become available.

The cocktail of casirivimab and imdevimab is still being investigated in trials but the FDA has enough data to grant a temporary licence while the pandemic continues.

Formerly known as REGN-COV2 or REGEN-COV2, the cocktail can be used for mild to moderate COVID-19 in adults and children at least 12 years of age and weighing at least 40 kg.

Doctors now have another option to choose from to combat the disease, following EUAs for drugs such as Eli Lilly’s baricitinib and Gilead’s Veklury (remdesivir).

To be eligible for Regeneron’s combination, patients must have received positive results of direct SARS-CoV-2 viral testing and be considered at high risk for progressing to severe COVID-19 and/or hospitalisation.

Clinical evidence from Regeneron’s outpatient trial suggests that monoclonal antibodies such as casirivimab and imdevimab have the greatest benefit when given early after diagnosis and in patients who have not yet mounted their own immune response or who have high viral load.

As part of the Operation Warp Speed project to rapidly develop therapies and vaccines against the disease, the US government and Regeneron a supply agreement for the cocktail, which was famously used to treat president Donald Trump after he became infected.

Regeneron will coordinate with state authorities to allocate the cocktail on a weekly basis, based on prevalence of the disease in each state.

The first 300 doses will be provided at no cost to patients, although hospitals and clinics may add their own fees.

AmerisourceBergen will be the first national distributor to begin delivering the therapy.

Earlier this month, Regeneron had to modify a trial protocol for the therapy after independent safety experts said it should not be given to high-risk patients after an undisclosed safety issue emerged in testing.

In late October, Eli Lilly said it wouldn’t resume a trial of its rival antibody therapy in hospitalised patients after National Institutes of Health researchers said it wouldn’t help.

AstraZeneca is developing a long-acting antibody therapy combination in the US and other countries to prevent infection happening and as a therapy for those already infected.

Regeneron’s antibodies were designed to combat SARS-CoV-02 using the company’s proprietary genetically modified mice, which have been engineered to have a human immune system.

The antibodies bind non-competitively to the virus’s spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population.

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How a clinical command center helped Tampa General Hospital save $40M

The Florida-based hospital worked with GE Healthcare to open a command center last year to manage clinical care operations. According to the hospital, the center has helped it save $40 million and manage patient flow and bed capacity amid the Covid-19 pandemic.

Viruses on Motorcycles

By ANISH KOKA

The most recent fiction dressed up as science about COVID comes to us courtesy of a viral Washington Post article.  “How the Sturgis Motorcycle Rally may have spread coronavirus across the Upper Midwest” screams the headline.   The charge made is that “within weeks” of the gathering that drew nearly half a million visitors the Dakota’s and adjacent states are experiencing a surge of COVID cases.  

The Sturgis Rally happens to be a popular motorcycle rally held in Sturgis, South Dakota every August that created much consternation this year because it wasn’t cancelled even as the country was in the throes of a pandemic.  While some of the week long event is held outdoors, attendees filled bars and tattoo parlors,(and that too without masks!), much to the shock and chagrin of the virtuous members of society successfully able to navigate life via zoom, amazon prime, and ubereats.

This particular Washington Post article’s sole source of data comes from a non-profit tech organization called The Center For New Data that attempted to use cellphone data to attempt to track spread of the virus from the Sturgis rally.  Unfortunately, tracking viral spread using cellphone mobility data is about as hard as it seems.  The post article references only 11,000 people that were able to be tracked out of a total of almost 500,000 visitors, and isn’t able to assess mask wearing, or attempts at social distancing. How many bars are there to stuff into in Sturgis anyway?? And so it isn’t surprising that even in an article designed to please a certain politic, this particular sentence appears:

“But precisely how that outbreak unfolded remains shrouded in uncertainty.”

The other striking feature of the article is the timing of this ptome to journalistic excellence. The article is published in the latter half of October precisely because South Dakota is documenting its highest numbers of new cases now.  It doesn’t seem to matter that the Sturgis Rally was held in early August, more than 2 months prior to the recent spike in cases. The Post article spends the majority of its time meandering through a few anecdotes from rally attendees who have finally seen the error in their ways, but provide no other data points to substantiate the condescension of the blue-checkmark twitterati that were all too happy to amplify the article.

In fairness, this isn’t the first time a scarlet C has been attempted to be hung on Republican Governor of South Dakota, and the band of deplorables she leads.  The unabashed Trump supporting Governor has had the conventional public health experts on mute for much of the pandemic.  The South Dakotan approach has emphasized private personal responsibility and was one of only eight states to eschew stay-at-home, or safer-at-home orders.  The really annoying aspect of this approach to public health autocrats was that it seemed to work really well, as new COVID cases leading up to the Sturgis rally numbered in the 5o’s and 60’s per day while other, admittedly larger states, had outbreaks in the tens of thousands per day.

The current attempts to tie increasing cases to a gathering that took place months earlier is squarely in the realm of politics, not science.  After almost eight long months the citizens of the globe are weary, and are restarting life out of necessity.  Schools are opening, traffic into cities is building, and grandparents are hugging their grandkids again.  Tracking spread of the virus as this happens is simply a reflection of the social interactions that have come to define life.  Testing for COVID is ubiquitous enough at this point to have largely become a meaningless exercise used primarily to support shoddy scholarship that generates a clickbait headline.  If it was politically expedient to connect France’s recent spike in COVID case to the Sturgis Rally, some ‘researcher’ would find a way to make science say it was so.

An earlier, more scholarly attempt to make the Sturgis Rally the nation’s largest super-spreading event provides a particularly good example of how science bends to politics.   In September, economists tried to use another cellphone dataset to show that counties across the nation that contributed more travelers to the Sturgis Rally saw a much higher rise in COVID cases than those that sent relatively few travelers.  A closer read of the paper finds the wheels start coming off this particularly poorly constructed narrative almost immediately.  One would think that researchers intent on demonstrating a COVID apocalypse triggered by a mass gathering would use deaths, but instead COVID cases are used.  The authors explain that their reason for using cases is because of the relatively low level of mortality since the Sturgis event.  At the time the article was published September 2nd, there had been one recorded death since the rally. 

It is true that South Dakotans appear to obey the natural laws of viral spread.  As people gather and socialize doing the things they value, whether that be at motorcycle rallies or the local Target, cases rise.  Two weeks after the Sturgis rally, South Dakota goes from seeing fewer than a 100 new cases per day to almost 400 new cases per day.

To put these numbers into context, one need only look at the rise in cases in California, Washington and Florida, all seemingly quiet until a few weeks after massive gatherings in major cities during the Memorial Day Weekend.

Fascinatingly the same researchers confident about the link between national superspreading and the Sturgis Rally also found no link between widespread Memorial day protests and a spike in cases 2 weeks later. 

The data in early September, almost one month after the Sturgis Rally actually suggests S. Dakotans had a reasonably small uptick in cases that was already beginning to dissipate according to the snapshot available from the South Dakota COVID dashboard.

And its not just PCR positivity, even the weekly influenza like illness reporting trends year-over-year, shows no significant spike compared to prior years.

The danger of superspreader events is that they create a conflagration that overwhelms hospitals, yet the hospital occupancy data In South Dakota shows almost 50% of regular hospital beds, and 36% of ICU beds were empty one month after the Sturgis Rally.

The real meat in this scholarly work, of course, is the proposition that Sturgis spread the virus far and wide.  The paper sought to demonstrate this by by showing counties across the country that contributed a high number of attendees to the Sturgis Rally saw higher rates of COVID spread in the weeks that followed. 

The following national map shows the counties that were noted to contribute a high number of travelers to the sturgis rally.  The deepest blue are high inflow counties, that were found to have an increase in cases between 6-12% after the Sturgis Rally.  Conversely, low inflow counties appeared to have no increase in new COVID cases.

This would appear to be concerning, visual evidence of COVID spread directly as a result of the Sturgis rally, until one actually uses the nice map to take a look at outbreaks in high inflow counties.  Here is one of the graphs of COVID cases in the deep blue high inflow Weld County, Colorado.  Even an electron microscope wouldn’t be able to manufacture a meaningful spike three weeks after the Sturgis even in early August..

Weld County, Colorado

The next high inflow county of interest is the home of Las Vegas, which also shows absolutely no visual evidence of chaos unleashed after the August gathering. The spike in cases here instead seems to time out well with casino openings in mid June.

Clark County, Nevada

Campbell County, Wyoming, another high inflow county, is perhaps more promising for the Sturgis superspreader narrative on first glance.  There appears to be a spike in cases about 2 weeks after Sturgis, but a closer look at the y-axis shows the spike in cases was 8 new cases in one day.  Not 80, not 8000, but eight cases.

Campbell County, Wyoming

But as cases rise across the nation in October in multiple disparate states, somehow the edifying narrative the Washington Post and other social media influencers are latching onto is that the Sturgis rally was the unique event that set fire to the midwest. Never mind that non-contiguous Alaska and Sturgis-adjacent North Dakota have new case/hospitalization peaks that appear to mirror each other by both accelerating in October, well after one would expect Sturgis to be responsible. 

Alaska

North Dakota

On the other hand, Hawaii appears to have some cause to blame its epidemic on the irresponsible Dakotans from Sturgis based on the timing of its new case and hospitalization peaks.  It’s just too bad motorcycle traffic between Hawaii and South Dakota is of the non-existent variety.

Even casual observers at this point should realize that Science is in the process of being shaped by politics. Perhaps this has always been so, and it just took COVID to make the contortions transparent.  Nonetheless, we live in a world where the answers are known before the research begins and the headlines are written before journalists put pen to paper.  This goes well beyond the garden variety cherry picking of research that is the hallmark of all debates, whether they be scientific or political.  This is utilizing the research enterprise to manufacture science that suits a particular politic. And so we get a particular focus on Sturgis two whole months after the event because the point is to shame deplorables in states with Republican leadership 3 weeks before a Presidential election.  In this brave new world, the science tells us that massive Memorial Day protests don’t trigger viral outbreaks, but motorcycle rallies in South Dakota do.  “Science” careens towards science fiction. 

Anish Koka is a cardiologist in Philadelphia.  He is co-host of the Accad & Koka report.  Follow him on twitter @anish_koka.

The Story of an American Mask Distributor

By SAURABH JHA

Seven weeks before President Trump declared COVID-19 a federal emergency heralding the economic lockdown, Jesse’s customers began cutting their orders. Jesse sells garments and cotton, imported predominantly from India, to wholesalers and retailers, big and small, in malls across the North East corridor.  His business had a good January. December was like any December. But February was different.  His customers, reassuring him that it wasn’t personal, were predicting a falling demand for their products because of COVID-19. They may be over reacting, but better shortage than glut, they felt.

Jesse, who has no medical background, had heard of a virus which quarantined cruise ships, but nothing seemed foreboding back in February. He had tuned out the President, who was being his usual clownish self. It was business as usual in Manhattan, where he lives. He received reassuring messages from public health figures about the novel coronavirus. New York City’s mayor was particularly upbeat, urging New Yorkers to mingle with even more vigor.

Jesse didn’t know how to reassure his customers. A week later, more customers cancelled their orders. By middle of February, the orders halved. Being a businessman, not philosopher, it mattered not to him why his customers had seemingly overestimated COVID-19’s threat. What mattered is that they had. Since his business operated on small margins, the reverberations could be substantial. The first order of the day was reducing the output of his factory in India which was running on all cylinders.

The second order of the day was survival. If his customers’ fears came true, his business would be destroyed. Jesse had no qualms accepting government bailout. But this was long before the federal government announced relief for businesses. The virus had yet to strike Italy. COVID-19, like Chengiz Khan, seemed to prefer the eastern perimeters of the Silk Road.

In his culture, Jesse Singh is an American Sikh hailing from the Punjab – there’s a simple rule. When customers don’t want a certain product, find something else to sell. His family motto is that you should love the act of selling, not the product being sold (the motto sounds better when said by a Punjabi in Punjabi).  

Another Punjabi rule, technically not a rule but part of their cultural RNA, is that Punjabis don’t sit idle. During the partition of the subcontinent, thousands of Sikhs arrived at Delhi train station hungry, battered, penniless, and homeless, after losing their homes and families to the mobs. After feeling sorry for themselves for a couple of days, they started selling tea and biscuits on the railway platforms.

If the panic from coronavirus could shut old businesses it surely could open new ones, Jesse thought. A soaring demand for personal protective equipment (PPE) seemed obvious. Since N-95 supply was regulated, he threw his weight behind surgical masks, believing that they’d be demanded by healthcare workers and eventually the general public. He decided to import a small batch on a trial basis.

Had Jesse searched PubMed for high quality evidence for the efficacy of masks, he might have found a Cochrane review which concluded that there was no evidence that masks reduced the spread of respiratory infections. Were he fluent in evidence-based medicine, he might have been despondent that no randomized controlled trial, adequately powered for hard outcomes, showed that masks work.

Were he on medical Twitter, he’d have read unambiguous messages from thought leaders that the public shouldn’t wear masks because they don’t work. Had he consulted medical experts, he might have seen a PowerPoint explaining the nuances of contact and aerosolized spread of viruses. He has never heard of the Peltzman effect – the phenomenon where people engage in riskier behavior when safety measures are enacted – an argument used by very clever people against universal masks.

Had Jesse been more informed in February, he might have binned his new business venture for want of effectiveness, but his blissful ignorance of statistics and experts allowed him to hone his business instincts. He had to choose between manufacturers in India or China. He was familiar with India but trusted China with quality. Jesse promptly flew to China to scout manufacturers of masks in Shanghai, Shenzhen, and Wuhan. The Chinese, who had by then successfully controlled their epidemic, had a whiff of the rising demand for masks. But it was early days and it was by no means certain that COVID-19 would become a global tour de force.

Jesse’s immediate concern was quality. An experienced distributor, he knew quality often outlived price. He knew even less about masks than he knew about viruses. He used SGS, a third party company, to check their quality. From twenty manufacturers that he initially scouted, he chose five.

In late February, a week after visiting China, his intuitions were verified. His customers, the same retailers selling clothes in malls, who’d buy cotton from him, asked him for masks. Jesse didn’t formally advertise his services or promote masks’ efficacy. There were no billboards on freeways picturing him with masks. He used his network on his smart phone. His customers knew he was pivoting to masks. They trusted him with cotton. They’d trust him with masks.

Word spread in the malls in the Tristate area about the mask distributor. New customers, such as McDonalds, began approaching him. Businesses bought masks in bulk not to comply with government mandates – there weren’t any, this was even before the lockdown, but to protect their employees in the only way they thought they could. Business leaders felt their employees needed masks to continue economic activity safely in a pandemic.

His first batch of 250, 000 masks was devoured instantly. By the end of March, Jesse was importing twenty million masks a week. By middle of April, in thick of the carnage in New York City, he finally began getting orders from hospitals and nursing homes.

The “landing costs” for an importer – the costs of getting masks to the local warehouse – includes manufacturing costs, truck and air delivery costs, and the tariff, pegged at 7 % – there was no clemency from economic protectionism in the pandemic. Jesse runs a business not charity but he was uncomfortable eking a margin off the imports. How does one profit from human misery?

The line between profiting and price gouging isn’t as blunt as their moral distinction. Adam Smith’s invisible hand, which is elegant, subtle, and self-effacing can, in a blink, become Gordon Gekko’s visible middle finger, which is brutish, ostentatious, and unrepentant. It was one thing making money off McDonalds. But his new customers were nursing homes, with vulnerable elderly. Jesse consulted his community’s elders to assuage his moral discomfort.

Trade assumes a high moral position amongst Sikhs because they believe that the buying and selling of goods benefits both buyers and sellers. Money is only a medium of exchange; means rather than an end. Trade is “changa”, meaning a good thing or, to borrow a fancy economic term, “Pareto efficient”, win-win for all.

Nothing is immoral in selling or responding to demand in a pandemic, Jesse was reassured. So long as Jesse charged what he and his buyers thought reasonable, profiting wasn’t immoral, his elders said. It’d be immoral hording masks for rainier days, i.e. not fulfilling the present demand but waiting for customers to get more desperate to make more profit. Ironically, many hospitals rationed PPE in case the pandemic got worse, creating real shortages to combat hypothetical shortages.

In March, the landing cost of a mask was 38 cents, comprising manufacturing cost of 32 cents. Heeding his elders’ advice of not price gouging, Jesse’s margin was only 2 cents. He capped margins at 10 %. In the open market, the price of masks varied, and some distributors made margins of 60 % in the peak of the pandemic.

Jesse is an intermediary, a match maker, between buyers (businesses and hospitals in the US) and sellers (manufacturers in China). His services aren’t indispensable but valuable to both parties, because he saves them the time they would have spent looking for each other, and the information costs. He’s an information concentrator. He’s to mask manufacturers what Grub Hub is to restaurants.

The Chinese had no interest in price gouging either. They wanted to sell masks as cheaply as possible. They were willing to scale production but the demand had to come first. As the demand rose, the manufacturers produced more masks, and through economies of scale the marginal cost fell, and a month later, the cost of manufacturing a mask had fallen from 32 cents to 8 cents per mask. The quality remained unchanged.

Jesse never exceeded his religious ceiling of 10 % margin on the landing costs. By late May, when the WHO still had to change its stance on universal masks, and Jesse was selling over ten million masks a week, mask prices fell by 75 %. By then the masks were so cheap that you could buy forty for the price of a pumpkin spice latte at Starbucks.

The graphs in economic textbooks showing supply running heel-on-toes on demand simplifies reality. Demand doesn’t talk directly to supply.  The Chinese manufacturers weren’t responding to real-time demand as much as the expectation of future demand. Distributors like Jesse signal to the manufacturers when to ramp up production. Without intermediaries, economies of scale may never be realized because manufacturers, fearing making too many, may make too few to scale. Manufacturing costs don’t fluctuate like the stock market. Once manufacturing becomes cheaper, it remains cheap for some time.

Masks have become culturally iconic and politically toxic, symbols of community, of being our “brother’s keeper”, a proof of selflessness. Wear the mask for others not for yourself is the rallying motto. Masks, like taxes, have become objects of right wing resistance. Instead of the Gladstone flag’s inscription, “don’t tread on me”, the new slogan for small government conservatives is “don’t mask on me.” Mask defiance has caricatured libertarianism, which has taken more beating in this pandemic than any other ideology.

Masks are an effigy also of American technocratic incompetence. The early objections to masks were grounded in empiricism, real empiricism –  notably that the evidence was lacking that masks reduce viral exposure, and perhaps might even increase transmissibility. Iconoclastic mathematician and trader, Nassim Nicholas Taleb calls the mask debate naïve empiricism, because purveyors of such empiricism not only ignore power laws – where errors accrue asymmetrically, but invert the burden-of-proof – i.e. they answer the wrong question incorrectly.

Recently, Dr. Anthony Fauci, head of the COVID-19 taskforce and leading infectious disease expert, admitted that he downplayed masks’ efficacy early in the pandemic because he feared the public would hoard masks leading to shortage for healthcare workers. His concerns weren’t unfounded. The public had already displayed a sudden, insatiable appetite for hand sanitizers and demonstrated they could do a run on toilet paper, too.

Dr. Fauci is an honorable man. I’m not using Mark Anthony’s tone in his encomium for Brutus. I sincerely mean it. His admission takes incredible intellectual honesty and courage, particularly in the midst of a politicized pandemic, where Potomac sharks pounce on every syllable he utters. Yet, it’s hard not ruing an opportunity potentially foregone to have saved both lives and the economy.

Incompetence can’t explain why a $3.6 trillion industry, never short of drug eluting stents or CT scans, feared a mask shortage for its workers. There must be something more, something which F.A. Hayek understood, a phenomenon we ignore because we can’t control. By the time a hospital’s multidisciplinary “Mask Purchasing Committee” might have met on Zoom to discuss the economic models of cost-effectiveness of purchasing excess masks in a pandemic, Jesse was half way around the world knocking on Chinese manufacturers’ doors. Hayek’s intuition, that dispersed knowledge was, in the net, superior to centralized knowledge, may apply to supply chains, too.

When mighty American institutions failed one by one in this pandemic, the Americans failed to turn to their mightiest institution – the markets. So caught were they lamenting an imminently lamentable federal response, so frustrated were they by their leader, an Emperor Nero on Hydroxychloroquine, that they forgot about doers like the God-fearing Jesse Singh. So focused were they on their weaknesses, that the Americans forgot their strength.

Markets aren’t the panacea for many things in healthcare, such as ventilators, even if the moonraker, Elon Musk, once offered to build them. But markets are capable of supplying cheap items whose use follows the power law. In bazaars in India surgical masks sell for four cents. Each mask is washed and rinsed and used for a week! Alas, we focused on sophisticated ventilators not cheap masks.  How cheaply might ventilators have been avoided?  Musk was ridiculed for naively suggesting that he could solve the ventilator shortage. The joke was actually on us.    

In the 2005 Tsunami in the Indian Ocean, coastal animals fled to safety well before the tidal waves emerged. They sensed calamity. The market sensed an impending calamity in February, even as the WHO struggled to grade COVID-19’s threat, and many American experts remained anchored on the seasonal flu. J.M. Keynes, Hayek’s intellectual adversity, wrote about the importance of animal spirits – or consumer confidence – for the economy. The market began closing well before the technocrats recommended that they be closed. The market predicted the experts’ expertise.

Jesse doesn’t care about the politicization of masks. He doesn’t ask if masks work. He’s masked not to sell them but because he must be masked. If there was little demand for masks, he’d have sold something else in this pandemic. As to his being right about its demand, he defers credit.

“Jo Wahe Guru ki marzi”, he says. It’s all up to God.

Saurabh Jha is a radiologist who wears a mask in the dark room but has no masks to sell. If you need masks, e-mail [email protected]

[Podcast] How Cleveland Clinic Helps Employers Create a Safer Workplace During COVID-19

Photo of James Merlino, MD

Dr. Jim Merlino, Chief Clinical Transformation Officer, Cleveland Clinic

Despite having entered the US eight months ago, COVID-19 remains a topic enshrouded in confusion, conflicting information, hyperbole, and even conspiracy theories. Everyone, informed or not, seems to have an opinion about the coronavirus pandemic.

Fortunately, health systems, hospitals, and medical providers are  uniquely qualified to fill the educational void and assert a leadership position within their communities. 

In this week’s podcast, my friend and frequent guest, Dr. Jim Merlino shares how Cleveland Clinic’s free advisory service, COVID-19: Creating a Safe Workplace, helps employers and employees, “return to work, safely and confidently during the coronavirus pandemic.” 

Listen to the podcast or read the transcript to discover:

  • Why educating the public is such a vital responsibility for providers to embrace
  • How Cleveland Clinic was able to leverage its expertise and preparation for COVID-19 into an effective educational program for employers
  • Why executive leadership is essential for larger missions like these
  • Surprising new insights about how the coronavirus spreads
  • How large and small institutions can take similar leadership positions within their communities

Finally, please help educate the public by sharing COVID-19: Creating a Safe Workplace website with employers, patients, coworkers, colleagues, friends, family, and social media. 

Other streaming services: This and other episodes of the Healthcare Success podcast are also available…
iTunes | Spotify | iHeartRadio | Google Play | Pod Bean | Tunein | Radio Public | Stitcher


Podcast Transcript

Note: The following ‘How Cleveland Clinic Helps Employers Create a Safer Workplace During COVID-19′ podcast transcript is computer generated and edited for clarity.

Stewart Gandolf, MBA:
Hi everybody, Stewart Gandolf here with another podcast featuring absolutely one of my favorite guests and personal friend, Dr. Jim Merlino. He is Chief Clinical Transformation Officer with Cleveland Clinic, now back at the Clinic after some excellent time with Press Ganey. Welcome Jim, first of all.

Dr. Jim Merlino:
Thanks Stewart. Always great to talk with you.

Stewart Gandolf, MBA:
In preparation for this meeting, we spent some time talking about, catching up how the world is very different than the last time Jim and I spoke. Last time we talked was pre COVID, pre Jim moving over to Cleveland Clinic. Things have changed quite a bit since then, obviously. And I think today we’re going to talk about a topic that I think is really, really important, which is getting the word out, leveraging the pulpit of healthcare providers. As the most trusted people in America, doctors, hospitals, health systems have a unique opportunity to educate the public. And I was talking offline with Jim prior to doing this, how during the very, very early days of the pandemic, some of our blog posts were about this topic. Back when everything was absolutely uncertain, and the world was going crazy. Our firm went virtual about a week or two ahead of everybody else, right about the same time that Stanford went virtual, before it became mandatory.

Stewart Gandolf, MBA:
I was telling Jim, we have some friends that sent us predictions on what this pandemic was going to look like. So we went virtual really mostly for public good at that stage, even though some of my employees thought I was crazy, and we spent a lot of time writing in our blogs of how you can, as a provider, be part of the solution, get the word out. Can you post on social media? Can you talk to your patients? Can you send emails? How can you be a voice? And that was before any of this stuff had widely happened within our surrounding communities. We just had a sense there’d be a need for authoritative information to supplement what’s happening in the more official channels.

Stewart Gandolf, MBA:
So anyway, Jim and I were talking about this and in true fashion with Cleveland Clinic, with the leadership role that the clinic takes in terms of public health, began an advisory service. And so that’s what we’re going to talk about today. And Jim, I’d love to hear from you, how this all began, the mission. This is your format. Let’s just talk. Tell me about the advisory service and maybe the history of it to start.

Dr. Jim Merlino:
Sure Stewart. Well, again, it’s really great to be doing a podcast with you again, and I really always enjoy our conversations and the insights that you bring to the industry through your work as well. It’s interesting. Healthcare obviously is on the front lines with the pandemic response and taking care of people who are affected by COVID. But we actually, I think, have a bigger responsibility and that is to help society reactivate and also function safely in the era of COVID because we clearly are in an environment now where COVID is with us. Whether you believe it or not, it’s here. It’s not going away until there’s a treatment or an effective vaccine. It’s just going to be a part of what we do.

Dr. Jim Merlino:
I think one of the things that we’ve learned in healthcare, and it’s not just true for Cleveland Clinic, it’s true for healthcare across the world, is that we understand how to keep people safe. And for the most part, I think healthcare has done that and you see different statistics on healthcare worker infectivity, but there are a lot of organizations across the country that have kept their workers safe. We had over 1100 caregivers infected with COVID. We’re confident, because of the contact tracing that we’ve put in place, that we can say we don’t believe any of those caregivers received COVID from taking care of a COVID positive patient, but that’s not without effort. It’s because of the safety measures that we’ve put in place, the teams of people that we’ve had together since the beginning of this pandemic that have really studied these issues and really debated about what are the best things that we need to do, or the safest things that we need to do.

Dr. Jim Merlino:
So with all of that in mind and understanding that the tsunami was coming towards us very quickly, we did a lot of preparation. We were very fortunate, in Northeast Ohio, that the tsunami didn’t hit us like it did in other parts of the country like New York or Washington. But nevertheless, we did see COVID, we did take care of a lot of patients, we’re still taking care of a lot of patients, but we learned a lot.

Dr. Jim Merlino:
And as we saw that the tsunami wasn’t going to hit us as hard as we thought it was going to, we were able to now take the information that we’d prepared for our organization and actually retune it or reformat it so that we could push it out to the public; to businesses, to churches, to educational institutions, so that others could use it. We started getting a lot of incoming early from different businesses and other organizations that needed help, and we wanted to be helpful. Cleveland Clinic has four cares, care for community, care for organization, care for caregivers and care for patients, and we very much see this as part of our responsibility to help care for the community.

Dr. Jim Merlino:
And I’ll just add one more thing, and that is that it’s interesting that if you think about managing diseases, for most diseases, we’ve had decades to study them. For COVID, everything we know about this disease has really come in the last six months or less, and we’re learning new things every day. We’re clarifying things every day. And so the most important resource that we’ve been able to provide to partners outside of healthcare is really interpreting what’s going on and translating that information to what they do every day so they can keep their employees, their customers safe. It’s been interesting work. It’s been fascinating to be a part of, it’s been an honor to be a part of it, to help others. We think it’s really meaningful and impactful.

Stewart Gandolf, MBA:
The Cleveland Clinic, as I mentioned earlier, the idea of being in your community, a thought leader, a healthcare thought leader, and Cleveland Clinic clearly does that not just in its community, but from a world scope. Is that part of the clinic’s DNA? How has that evolved, this idea of we’re trying to be something more than just the provider? We want to really be a thought leader. How did that evolve and how does that sustain?

Dr. Jim Merlino:
Cleveland Clinic has always prided itself on being an organization that’s innovative and trying to do things that benefit others, and that’s just part of our DNA. We’re actually coming up on a 100 year anniversary this year. It’s interesting the last pandemic was 100 years ago. We’re 100 years old, but it is really in our DNA, and it’s also part of the focus of our CEO, Dr. Tom Mihaljevic. He believes that we should be doing things as much as we can to really push hard and trying to figure out ways to evolve healthcare. And I think the work we’re doing with COVID response is part of that. And again, we don’t have the license on best practices. I think one of the benefits of COVID, if there’s any benefit, because there aren’t many for sure, is how people have worked together across the country. Other healthcare organizations across the world have come together to share information. And what we’ve been able to do is really just help package that so that we can help others understand what to do and be safe.

Dr. Jim Merlino:
It is interesting, one thing about the Cleveland Clinic, one of the things I think that makes the Cleveland Clinic unique, there’s a lot, I’m certainly biased, is that we have a network of hospitals and healthcare institutions across the world. And what was striking about COVID … And we were meeting every day. During the heart of the pandemic, we were meeting twice a day, and all of our sites were dialed in. It was the ability to learn from each other. So a truly integrated network where you’re getting information from Abu Dhabi, you’re getting information from London, from Florida, from Las Vegas, from Toronto, and all of that’s feeding into your decision making. And what was most fascinating is everybody was experiencing this a little differently. So for instance, our operations overseas was able to give us some early warning into some of the things that they were seeing and also how they were responding to it, and that directly impacted our responses in the States, both in Cleveland and Florida. So it was a very interesting time to be a part of such an important integrated delivery system.

Stewart Gandolf, MBA:
Jim that totally makes sense. I feel like obviously Cleveland Clinic has some amazing resources with multiple locations and a hundred year history and an incredible medical team and support teams. At the level of maybe a community hospital or a group practice or any level, but let’s maybe take a step, just one step down, a single hospital or a couple of hospitals, or just a large group, what would be important if they too feel like, “Okay, we’re not Cleveland Clinic. We can’t be, but we want to be that kind of a thought leader here in Topeka or Poughkeepsie or wherever.” What kind of recommendations, before we get into the specifics of your advisory service, but what have you learned they can use to … What would be the couple of things that you’d really want to have in place so that yes, raise your hand, be a colleague with us, help us get the word out. What kinds of things do you think would be important for that?

Dr. Jim Merlino:
I don’t think you have to be Cleveland Clinic to be helpful to your community. I think if you likely look across the nation and talk to healthcare providers in other systems, I’ve certainly talked to many of my colleagues around the country. For the most part, we’re all coordinating. We’re all driving the same things. When we think about changing a policy, for instance, around visitors, we reach out to our colleagues, my friends. I reach out to my colleagues, reach out to their friends. We really are trying to bring information together. I think that’s probably true for a lot of providers.

Dr. Jim Merlino:
But what I would say to smaller organizations, regardless of where they are and whether they’re a hospital or a practice, or a couple doc or a provider group that’s providing care, you know what to do. Likely you’ve been delivering care in COVID, and the information that you have available to you, how you think about this, the clarity that you bring to that process will be helpful to partners that are in your community, because this is complicated and it really requires a thoughtful approach to keep people safe, but an approach we know we can do.

Dr. Jim Merlino:
And I think that what I would say to anybody that’s listening that may be practicing in a smaller environment is talk to people in your community and ask them how you can be helpful, ask them how you can translate what’s going on around COVID to impact how they can keep themselves, their employees and their customers safe. They need us. They don’t just need us to take care of sick people. They need us to provide guidance. And this is such an opportunity for healthcare in the United States and across the world to really step into a role, to do much more than we’ve probably done in the past, relative to things going on in the community.

Stewart Gandolf, MBA:
You mentioned your CEO, and that’s so often the case, the idea of … Because I could see how you’re a busy hospital located in whichever town you are and you may not have the resources, but I think it’s more than just resources. It’s more of your vision of how you fit in the community because it’d be really easy and certainly forgivable. We’re just treating patients here. We don’t have time to do this high fluid and visionary stuff. We just have to take care of patients and I totally get it. But I guess it comes down to maybe the vision of the CEO and the leadership of what role, maybe a larger role than just treating patients. Does that makes sense Jim?

Dr. Jim Merlino:
Absolutely, and it also comes to getting back to the role of your hospital. If you think about the history of healthcare in the United States and how it evolved, a big part of it was community centric and most hospitals are community hospitals. And they were formed by municipalities coming together, putting money in to build a hospital to take care of people in the community. So it really is getting back to the roots. I remember one of my first roles in healthcare, I was a board member in a community hospital in the city that I grew up in, actually where I was born. And it was a hospital that was built in early sixties by seven communities coming together. One donated the land, everybody threw in some money and before you know it, you had a hospital. And today, that’s part of a big healthcare system in Cleveland. It’s doing amazing stuff, but that’s what we’re about in healthcare. So taking care of our neighbors, caring for the sick, but also providing information to the community on how to stay healthy, which is just, when you think about it, that’s noble.

Stewart Gandolf, MBA:
We’ve talked about in some of the other relevant webinars and podcasts I’ve been doing surrounding this topic. If you haven’t, first of all, it’s for the good, to get the word out, but also that’s the primary reason. We’re in this for healthcare. We’re in this to serve our community. But from a business standpoint too, it’s to take the leadership because if there’s a void in the marketplace to be a positive force, we’re not doing it for that, but that’s a good thing too. We want to be more than just that big building that people fear or may have had … Everybody has their own relationship with the community hospital. They’ve typically been part of the community for years, but to be that kind of thought leader, I think is important. And all the things we’ve talked about in the past like, and I’m going to dive into the advisory service in a moment here, but the social media, the emails, and talking to patients, the safety videos, showing them how you care, showing them how the heroes, the everyday stories, showing them how they’re going to be safe are all important.

Stewart Gandolf, MBA:
So from there, I’d love to segue to more about the advisor service. Tell me about how do you deliver it and what is it? How much does it cost, if anything? How do they deliver it? What the purpose is, all that. I’m fascinated.

Dr. Jim Merlino:
Thanks for asking. We are too in terms of how quickly it’s really grown into something. And first of all, it’s free so that makes it easy for people to consider it.

Stewart Gandolf, MBA:
You did it!

Dr. Jim Merlino:
Exactly.

Stewart Gandolf, MBA:
All of our listeners need to write this down, they can just write this down. Free is good. So yeah.

Dr. Jim Merlino:
Free is good. Well sometimes free is not good. You always wonder what the intent is or if there is something behind the curtain, but no, this is free. And it hasn’t costed us much because we really just take in what we do every day for our caregivers and repackaged it so it’s a little easier for people who are not in medicine to understand. So we have a website that on that website, we have multiple industry playbooks that we’ve assembled that break down in simple terms how to think about keeping people safe. So there’s one for restaurants, for instance, manufacturing, office environment. They’re on the website. They’re all free. They’re all downloadable. They’re all easy to read. They all have a basic template that talks about the basics of COVID and safety, and then that portion that deals with the specific environment. They’re not that long.

Dr. Jim Merlino:
We built a playbook around how to better communicate with people, your employees, customers during this time, how to communicate with empathy because certainly, healthcare workers aren’t the only ones that are being stressed. Everybody’s being stressed on something so we thought that would be important. We do weekly webinars with our experts. So infectious disease, epidemiology, testing, HR to provide insight, to help employers, organizations keep their employees mentally fit and exercising their minds and healthy at home. We have a long running list of frequently asked questions that are posted as new information becomes available. Again, translated into simple terms, what do you do if somebody in your office tests positive for COVID? What do you do if somebody has symptoms? What do you do if somebody has a family member? What do you do if somebody gets exposed? Again, it’s just breaking down on all the things that people worry about. And all of that’s on the website, which I’ll share with you. It’s clevelandclinic.org/covid19atwork. Once again, clevelandclinic.org/covid19atwork.

Dr. Jim Merlino:
And what’s interesting about the material and the reaction to it, as I said earlier, is that it’s been a service because people just want to know what is going on, what the information they need to be concerned about really is. Cutting through the media, the conflicting news reports, the things they read, and then translating it into what to do. And that’s been very rewarding because I think that’s the clarity that we’ve been able to bring in. And frankly Stewart, as you would suspect, in some cases we just don’t know and we say it, but everything is guided by CDC guidance, what the scientific evidence is demonstrating. And then if there’s no gold standard to go to, it’s the best clinical judgment based on a pool of experts. I’ll give you one example that’s very public, which is our relationship with United Airlines.

Dr. Jim Merlino:
So Cleveland Clinic’s had a long relationship with United and it’s been our corporate partner. And during the worst part of the pandemic, the darkest days of the pandemic when New York City was being clobbered, we sent a team of physicians and nurses to help out, and United was kind enough to fly them there and fly them back. And we got into a discussion about what they needed because they were asking, “We’re trying to figure out how to keep people safe while flying, how to keep our people safe. Would you be able to provide some input to us?” And then we said, “Absolutely. We’re here. Let’s talk about it.”

Dr. Jim Merlino:
And so, and again, sharing with permission and we started going through the material and they were very sophisticated. As you would expect, it’s a big company, the airlines. When it comes to safety, they all talk to each other. They think about this all the time. They’re very sophisticated and they had a lot of great material and we provided input based on what we saw as the science around what they were doing. They adapted some things that we suggested that they didn’t think about. They changed some things that they probably didn’t need to do. But that, I think, has probably made flying safer.

Dr. Jim Merlino:
And what’s interesting about flying right now is so certainly airline travel has significantly decreased, but planes never stopped flying and they didn’t put in the safety precautions. And yet, we don’t yet think we have a confirmed case of, there may be one we don’t know of, but we haven’t traced the case of COVID through airline transmissions. It’s probably coming as community spread increases and flying increases. But I think right now, we feel comfortable that we haven’t seen it. But the interesting thing is that, relative to United, is they were the first airline to mandate masks, and that was one piece of advice that we had given them, and they were very, very aggressive about it. They said, “Okay. If you tell us that that’s important, we will do it and we will enforce it.” And as you know now, all the airlines are doing it.

Dr. Jim Merlino:
So I think that’s a good partnership because the last thing I would say, and then I’ll shut up, is that it’s not just what the businesses or the hospitals need to be doing to keep us safe. This is a social contract. We have to be doing things to keep ourselves safe. If we go onto an airplane, we should need to wear a mask. We shouldn’t refuse to do that. We shouldn’t protest like, “We don’t have to do that.” No, you need to do that. That’s your responsibility. When you go to an environment where you’re working, like a hospital, where we know we can keep you safe. When you go home, you have to think about how to continue to keep you safe.

Dr. Jim Merlino:
I have a colleague, Dr. Steve Gordon, he’s our chair of infectious disease. He’s internationally renowned. He says, “Listen, COVID gets in healthcare, for healthcare workers, COVID gets into the back door, which is they come to work, they have all the precautions, they’re safe. They go home, they do something they shouldn’t have done. They drop their guard, they get infected.” That’s the backdoor and that’s the thing we have to close by being very mindful. We all have a role. COVID doesn’t discriminate and everybody in the world right now, everyone, and think about that. Everyone in the world is susceptible to it. So we all have a responsibility in this. We’re all in it together.

Stewart Gandolf, MBA:
It’s fascinating when I think about that and it’s interesting too, because the idea of airplanes, and I didn’t know that. I didn’t know there’s no documented cases for airlines having COVID. So there’s so much fear out there, misinformation and what I really like about the idea that you guys are doing this is beyond it’s helping me us all safer, but curating it, helping people understand what’s real, what’s not, how do you do that? Is there any secret to that? Because that’s very … Just that one little anecdote I think is really important.

Dr. Jim Merlino:
We have a big team and we talk about things, and so I’ll give you an example. During the heart of the pandemic, one of the biggest concerns … Well, during the start of the pandemic. We’re in the heart of the pandemic. There was a big concern about PPE, personal protective equipment. One of the top concerns was we’re going to run out. The tsunami is coming, we’re going to run out and what are we going to do? But yet you can’t ration it because you can’t cut corners. You can’t say to people, “You don’t need it there,” or, “Don’t use it this way.” It just wasn’t an option. So we had a team of people, of about 10 people, probably a little more, that really were meeting every day to talk about how do you manage PPE? What’s the best way to do it? How do you account for supply chain issues? How do you model out how much you have, and what’s your run rate on PPE?

Dr. Jim Merlino:
But it’s a statement of how experts come together to really tackle the smallest of problems that are really huge problems. That’s been our approach for everything, is we’ve had teams of professionals that are really experts in this space that have worked on these issues.

Dr. Jim Merlino:
Is my dog barking?

Stewart Gandolf, MBA:
That’s part of COVID. It’s perfectly OK to have dogs barking!

Dr. Jim Merlino:
Einstein my labradoodle.

Stewart Gandolf, MBA:
Oh my gosh. When we go offline, I’ll put my camera so you can see my dog. I have a labradoodle too. He’s enormous.

Dr. Jim Merlino:
Oh, I have a miniature. Oh yeah! We got to do it!

Stewart Gandolf, MBA:
Going back to the curation and United in that, again, thought leadership, I fly on a different airline. I have about three million miles. As you know, I travel a lot as you do too. And at the beginning of the pandemic, there was news reports about them being very spotty with requiring masks. So they lost me for a long time because I’m not getting on a plane if this has become a political statement with the person sitting next to me. I want to be safe and that whole idea of we’re all responsible, I think is really important. And it’s great that you guys are doing that. I think also, I want to ask about this. You mentioned restaurants and I don’t know if you guys do bars, but even offices. So this is very real to me today.

Stewart Gandolf, MBA:
So literally last night, I mentioned we went virtual earlier and I’ve just been very conservative about this. And people who know me know I’m not doing this from a fear standpoint, I’m doing it from a public health standpoint. So we shut down early, not because I was paranoid about getting COVID, but more you don’t know who you’re impacting. And I have a bunch of a team and it turned out actually we could have had a near miss with COVID had we stayed open very much longer, which I won’t go into.

Stewart Gandolf, MBA:
What kind of response have you gotten? Because I know from our standpoint, that’s going to be fantastically helpful to have an authority because again, we’re not experts at this. Yeah, I market healthcare, doesn’t mean I’m a doctor. It doesn’t mean I don’t have any expertise in COVID. I read a lot, but I don’t feel comfortable with my employees safety and their relatives’ safety by making these decisions. So by guiding, having a sense of trusted authority to go to makes me feel a whole lot better. I don’t know if you have anything to add to that, and certainly what kind of reaction have you gotten from doing this?

Dr. Jim Merlino:
A good reaction. I think one of the biggest concerns of patients is coming back to healthcare for elective procedures or not urgent procedures is will they be safe? And the answer is yes, they will be. And I think that that’s the same thing that employees want to know coming back to work or staying working. Will they be safe? And the answer is, yes, you will. However, and it’s a but, and that is you have to follow the rules. You have to be thoughtful. When your employer executes on a mask policy, you should follow the rules and wear the mask. When you have the ability to sanitize your hands, you should sanitize your hands.

Dr. Jim Merlino:
Look, the way we talk about these protections, these layers of protection, is that there’s something called the Swiss cheese model. In safety science for the military, for the airlines or healthcare, we assume that events are trying to hurt people and we enact barriers, and each barrier is like a piece of Swiss cheese. It blocks some things, but it has holes and it lets some things through. But the more pieces of Swiss cheese, the more barriers you line up, the better protective screen you can build to prevent those things from hurting people. And so when we think about precautions that employers put together; masking, social distancing, hand-washing, disinfecting commonly touched surfaces, education about how to keep yourself safe at home. None of those are perfect. Some are better than others, but collectively, they create a pretty strong barrier.

Dr. Jim Merlino:
And again, going back to healthcare experience, we know that we can keep people safe if they follow the rules and they have to be mindful about it. Again, I think the message is that if we do the right thing and we execute on what we know works, we can keep people safe and that should be the message. But again, part of that message needs to be that you have a responsibility as well. So when you leave the workplace, you want to be concerned about what you’re doing, who you’re interacting with, how you’re behaving, because you want to keep yourself safe at home as equally as much as you want to keep yourself safe at work.

Stewart Gandolf, MBA:
My wife went through a procedure right when things started to open up again and I told her, “Hey, this is a window. It’s probably going to bad again pretty quickly. Jump on now.” So she got her elective procedure done whenever that was. And so she went through it and it was amazing. They really had thought it through the whole, from the start to finish, how they greeted her in the parking lot, how they did all the way through. And then my wife said, “But the one thing is one nurse looked down and said, “This mask is just stupid. We don’t really need this.” And so that one, and fortunately, she kept her mask on, but obviously, didn’t have total buy in at an individual level. And that’s really what this requires, is a bunch of individuals doing stuff right, and even it’s … Maybe I’ll just argue, okay, you don’t believe it, but just suspend disbelief for me. Would you please? Because at the end of the day, that’s what we need.

Stewart Gandolf, MBA:
And I think the other point that you bring up is the importance of responsibility because, okay, great. This is so insightful to me, the idea of, okay, we have all this PPE. Who thought that your most dangerous experiences are not at the hospital, it’s when you go home? If you’re not being careful? Is that what you’re saying essentially, that the most dangerous part of your day, if you were treating COVID patients, is if you’re going home and being irresponsible?

Dr. Jim Merlino:
Well, I think that the biggest opening for risk is that. I wouldn’t say it’s the most dangerous. If you’re an ICU physician or a nurse taking care of COVID positive patients, that’s dangerous work. But I think if you’re following the precautions and you’re using them, you can keep yourself safe. So you have to be very mindful about that. It’s no different than any other environment where the risk of getting hurt is real if you’re not following safety precautions.

Dr. Jim Merlino:
But the need to be paying attention to safety doesn’t stop when you leave. And you don’t need to wear an N95 mask and gown at home, but you do need to be thinking about potential exposure opportunities, who you’re communicating with, making sure you’re avoiding large groups, quarantining yourself if you’re exposed to somebody. So that continuum of safety really stretches everywhere, not just where you’re working, regardless of what you do for a living.

Stewart Gandolf, MBA:
As we come into the home stretch here, I’d love to get any final comments you have, but I guess maybe starting with that would be to give you a place to start is what is the advice you would give to pastor of a church or the owner of a bar, or an office? All of us say to you with exasperation, “Dr. Merlino, I’m a pastor. I don’t know anything about this stuff.” What would you tell them? Obviously go to your side, but what’s maybe the philosophy or?

Dr. Jim Merlino:
I think the philosophy is to be cautiously optimistic. Number one, we will get through this. It’s not going to be without costs and it’s not going to be easy, but we will get through this. And I think it’s really important that as my boss, Dr. Tom Mihaljevic says, you have to keep perspective because we will get through this. The second thing I would say is to educate yourself and learn as much as you can. Pay attention to sites that are reputable. Don’t make your decisions based on what you’re hearing or what you’re reading on news outlets. Pay attention to medical sites and use that as your guidance. And stay up to date because the information changes. We’ve evolved a lot of our thinking on COVID. When the pandemic first started here in the United States, my wife and I were wiping down our groceries. You don’t need to do that.

Dr. Jim Merlino:
So pay attention to what’s changing and use common sense and be diligent about the procedures. A mask needs to cover your nose and mouth. It can’t just cover your mouth. It can’t be worn at your neck. It has to be worn the right way. You have to have precautions in place, or I’m sorry, protocols in place to think about what you do if somebody gets COVID in the workplace. Don’t wait for it to happen. Plan ahead. So those are the things that I would tell businesses. Those are the things that I tell businesses.

Stewart Gandolf, MBA:
There’s been times where I’ve been in situations here in California, which was at the beginning, was in the leadership position. Now, not so much, where nobody’s wearing a mask and it’s even me knowing what I know, there’s that social pressure to not wear a mask and I wear it anyway. And so I think that’s important to recognize there’ll be times that are probably challenging and do what the experts telling you. Not just because everybody else is not wearing it does not mean, “Well, they’re doing it.” It’s not safe.

Dr. Jim Merlino:
That’s right.

Stewart Gandolf, MBA:
Because that’s really what I think happens. They just said, “Well, nobody’s doing it. I guess it’s okay. It’s a sunny day and nobody’s sick.” And on the other hand, to not freak out and not be paralyzed because we have to go through life. And it sounds like, which is very heartening to hear the optimism in there that there are ways to get through this. And if we’re following the basics and I love, again, the Swiss cheese model, because that’s where I think … Maybe my last comment and then if you have anything else you can add up is perfection is the enemy of good. So in this case, if you’re thinking it’s just overwhelming. If I want to be 100% safe, I’d be lying in the sun, by myself with an N95 mask on, with the wind blowing at 100 miles an hour. It’s like, well, so then if you’re paralyzed and you’re afraid to do anything.

Stewart Gandolf, MBA:
But maybe the odds are, and maybe you can tell me this clinically, all right, if you’re having dinner outside, you’re six feet away or 10 feet away, it becomes like you overreact and just don’t have life and it becomes undoable. Do you have any comments on that? Because it feels like that’s where people get into trouble. They either, well, this is just too hard, they do nothing, or they end up with no health issues because they’re trying to do absolute perfection, which is maybe not as necessary. Any comment on that?

Dr. Jim Merlino:
Yeah. It’s like people who have obsessive compulsive disorder. People who suffer from that, they have to do specifically sometimes over and over again. That’s not what this is about. This is about really just understanding what are the few things that are capable of keeping you safe when they’re done together and just being vigilant about it. You can go to a restaurant that’s appropriately set up for social distancing and where people are wearing masks. You can sit at the table with your spouse and take your masks off if servers are masked. Those things are safe. I’ve done it. I’ve flown. My wife and I flew to Florida the first two weeks of July and we wore our masks. Everybody on the plane had a mask on. We went out to eat but we went out to eat in restaurants that we knew were following the precautions. And we were very, very careful about observing our environment because we weren’t going to walk into a situation that would put us at risk.

Dr. Jim Merlino:
But the point is you can do things. You don’t have to live in a bubble. You just have to be vigilant. And I would add, one of my closing comments would be the biggest thing we worry about in healthcare with any safety precaution or process is fatigue. People forgetting it, or people getting comfortable with it. We have to be mindful. We have to stay vigilant because that’s how we’ll keep ourselves safe. So we can’t relax our guard, so to speak, as we’re continuing to live with this pandemic.

Stewart Gandolf, MBA:
That totally makes sense, and for obviously the vast majority of our audience here is in health care. They live this every day and hopefully, some of those insights will help you communicate with your patients or your constituents and your employees too. We haven’t talked about this, and maybe just a second before we close here, your own employees at the hospital, they’re still people too and there probably is still some fear there. So any comments to the providers that are listening here or one final comments of how to get the word out to employees or to your patients?

Dr. Jim Merlino:
Well, to the providers, thank you, because I know that everyone in the provider space is working very hard to do the right thing, to keep themselves safe, to take care of patients, and it’s hard, so thank you. Again, I think it just comes back to emphasizing safety. We have to keep talking about it. We have to remind people about it. We have to reinforce it. That’s the message.

Stewart Gandolf, MBA:
Very good. Jim, as always, it’s been fun and fantastic talking to you, insightful. Love your thought leadership, love what you and your team are doing. Thank you.

Dr. Jim Merlino:
My pleasure. Thank you, Stewart. It’s always great to talk with you about these issues.

The post [Podcast] How Cleveland Clinic Helps Employers Create a Safer Workplace During COVID-19 appeared first on Healthcare Success.

PharmaShots ViewPoints: Revised approach for First Aid during and after the Catastrophic Pandemic – Safe and Saving

The SARS CoV-2 or COVID-19 pandemic has changed human life permanently. Hence, a few critical areas need revisiting in light of these changes to set a “new normal” for them. One of such areas is first aid. Correctly given first aid helps victim of an emergency episode of a disease or an accident prevents damage and thereby disabilities and often saves life.  While the post-pandemic world changes the social behavior, diseases and emergencies continue to influence the human life in the same way. In fact, with less visits to hospital and significant healthcare resource consumed by the pandemic, need for first aid is enhanced. However, the nature of infection of SARS CoV-2 requires revisit the first aid practice to ensure safety of both, the rescuer and the victim.

There are multiple advisories and instructions issued by authorities on this matter, including National Safety Council of America, American Red Cross, St. John Ambulance, St. Andrew First aid, European Resuscitation Council, etc. On the other side, there is a debate about whether CPR is safe during the SARS CoV-2 global outbreak, also known as COVID 19 Pandemic. However, most of these literature focuses on Cardiopulmonary resuscitation (CPR) and a few on psychological first aid, which may not be enough in the current situation of a highly spreading contagion.

Hence, this article discusses about top 10 changes in the first aid practice in the local context.

1  Be more prepared

1.1  Keep yourself informed and updated

SARS CoV2 infection and multiple unidentified risks, which the authorities are publishing time to time. A first aider must remain updated about risks, treatment, first aid approach, advisory and instructions by referring to websites and news feed. In addition to the national emergency helpline numbers, there may be some helplines for COVID-19. One important aspect that may go unnoticed is changes of emergency contacts.

1.2 Carry and use Personal Protection Equipment (PPE) where possible

A First aider is at a high risk of exposure to coronavirus infection. Hence, it is important to use PPE. However, if PPE is not available, it is advised to use full sleeves apron or an additional over cloth (like a shirt or jacket over already worn clothes).

1.3  Carry extra gloves, extra mask, fluid resistance Mask/towel

A first aider willing to serve during the pandemic situation should try to carry multiple PPE. At least, should carry multiple gloves and masks, especially the fluid resistant masks or clothes. 

1.4 Use disinfectant spray, a spray of disinfectant mouthwash

Disinfection is the key of prevention of coronavirus infection. Hence, even for personal hygiene use of sanitation production is strongly recommended. Hence, along with hand sanitizers it is important for first aiders to carry and use spray sanitizers and the mouth sanitizers.

2   Changes in First aid infrastructure and equipment availability

2.1  Changes in the composition of the first aid box in vehicles etc.

A new first aid box must include some additional material beyond the routine equipment and materials. These new additions are – PPE Kit, Masks (minimum 2), Gloves (minimum 4 pairs), face shields, disinfectant spray, mouth disinfectant, sealable bag, fluid resistant clothes and plastic sheets, women-sanitary pad or absorbent diapers and bag valve mask breather.  In addition, it is advised to keep touchless thermometer and SPO2 sensor in the First Aid box.

2.2  Oxygen cylinders to be made available at all establishments like ATM, Bank, community places

Like the fire extinguishers are placed in all notified places such as banks, vehicles running on gas, ATM rooms, community centers, offices, there must be a provision of placing oxygen cylinders with disposable masks.

2.3 AED or mechanical CPR equipment to be available in public places

For Cardiac Arrest AED is an important therapy. However, there is some level of risk attached to it.

3 Reframe risk assessment

The lay rescuer / trained non-medical first aiders are usually the first level persons to reach the casualty. Hence, the first aider must suspect every case as a SARS (Corona infections of all types) case unless confirmed otherwise. First change is to start with assessment of  level of COVID Risk of the area.  Applications like goggle maps are useful often. Some countries practice placing signage to indicate risk zones. In addition, the pandemic calls for a multilevel additional assessment to check for COVID-19.  Especially, the first aider must assess the risks of cross contamination, like if there are some body discharges around or on clothes of the casualty including spits, sputum, saliva, blood, vomitus etc.

In addition to risks also need to check for resources like first aid box, resuscitation machines, oxygen cylinder etc. Their appropriate use will help maintain safety.

4 Unlearn and Relearn First Aid skills

First aiders are traditionally trained to assess surrounding, casualty etc. However, SARS COV2 is a contact-spread infection. Hence, the first-aiders need to avoid a few important first aid techniques consciously, that deemed best suite before set up of the pandemic.

4.1  Staying Safe while giving first aid during the pandemic

While we discussed multiple changes so far, there are several personal responses, which are important to remember and execute at all times. Few of them are a repetition of what is stated already

  1. Tell the crowd to maintain social distancing or to completely disperse.
    1. Use enough protection. If there is PPE kit, use, if not, use apron, overcoat or plastic sheet to cover the first aider
    2. Minimize provider exposure, Do not touch a wound or any of the body fluids, exposed dressings, pads, etc. Also, do not touch anything that is meant to touch patient’s sensitive areas esp. face, wounds, etc.
    3. Sanitize hands and face of rescuer and first aider before checking for eyes, tongue, and breathing 
    4. Disinfect immediately before and after the procedure

4.2   Changes in the casualty assessment and response

  1. Do not touch any part and surroundings of a casualty with bare hands.
    1. Do not check to breathe by placing an ear near the nose to avoid close proximity. Instead, use trusted mobile apps to monitor vitals like SPO2, Blood pressure, Heart rate, and respiratory rate, except when cardiac arrest is suspected.  
    1. Use of Shepherd (Figure 3), Sylvester (Figure 1), Holgar-Nelson methods (Figure 2) where possible than using mouth to mouth or mouth to nose ventilation except for cardiac arrest.
    1. In case of conditions like epileptic seizures, cover the patient’s body first before holding the limbs or provide disposable soft support to avoid injury. In both these conditions, avoiding exposure to anybody’s fluids is extremely important. 
Source: https://lorenamontes1234.wordpress.com/2013/07/02/health-product-review-other-methods-of-artificial-respiration/

4.3   Differences in methods of carrying

Usually, when a first aider carries a casualty, in any position (fireman’s lift or back-mount) carrier’s face is exposed to risk. Hence, it is important to over the casualty correctly with a fluid resistant clothes or plastic sheets etc. and use face shield to minimize exposure. In two or more persons carry (stretcher, fore and aft etc.) the risk to carrier is relatively less. However, in this case, for security of the casualty from exposure to external droplets, it is important to cover the casualty properly.

5 Safe Disposal of all exposed material

Safe disposal of all exposed material is now a part of first aid. While earlier it was fair to dispose the bio-waste into safe trash, now the definition has included many critical aspects All exposed material and not just bio-waste, including PPE, Masks, kit materials like cotton, dressing, overclothing must be removed immediately after first aid, disinfected, and store in a sealed disposable bag before handing them over to biohazard disposal team. No material to be left unattended even after disinfection. The clothing must be laundered immediately if possible. The area of the casualty must be correctly disinfected after removal of the casualty.

6 Safe Cardiopulmonary Resuscitation  (CPR)

Source: https://www.jaypeedigital.com/book/9788184484403/chapter/ch6

6.1  Hands-only CPR continuous compressions at a rate of at least 100–120 min

Hands only CPR is chest compression at rate of 100 – 120 chest compressions per minute with inspection of airway and as needed extension of neck every minute. The C-A-B steps should be followed as otherwise, but Mouth to mouth ventilation to be avoided unless extremely necessary. Sylvester method may be used  in stead of mouth-to mouth / nose ventilation.

Fig 1: https://www.slideshare.net/rajendra9a/artificial-respiration-66248377

6.2   Use water absorbent, fluid-resistant mask

If mouth-to-mouth respiration is inevitable, water absorbent, fluid resistant mask or cloth in multiple folds for both rescuer as well as for the casualty must be used. The mouth and face of both the rescuer and the casualty must be sanitized with spray disinfectant.

7. Safe Road management of accidents, injury, wound, and blood handling

7.1  Care of wounds and bleeding

First aid for bleeding continues in the same hierarchy with elevation with direct pressure, pressure points and tunicates as first, second and third line of treatment. However, it is important to continue keeping complete aseptic precautions while handling the wound. No wound should be touched with open hands. There should not be any pre-exposed dressing for the wounds including open fractures. All rescuers must wear mast and gloves at all times and all other persons must stand at least 2 meters away from the casualty. The safe disposal and post-removal sanitation must be practiced. 

7.2   Care for Close fractures

There is no difference in handling the close fractures. However, the sanitation and safe disposal with social distancing must be practiced.

7.3  Other bleeding

For visible / diagnosed internal bleeding ice-cold water bath or ice-pack must be applied in as is conditions. In case of vomiting of blood the patient should be given ice-cold water to drink. In vaginal bleeding, the patient should be given comfortable sitting position with pad. However, the most important aspect is anything that is provided to the patient, must be sanitized at all levels and all the immediate handlers must sanitize their hands well. All the discharges must be well disinfected as soon as possible.

8  Safe first aid for respiratory conditions

Fig 3: https://www.flickr.com/photos/[email protected]/20402935893

8.1        Infectious and acute respiratory conditions

In case of acute respiratory conditions, risk if SARS COV-2 is the highest. Hence, the patient must be asked to wear double mask, face shield and disinfect his clothes, hands and face. The rescuer must wear PPE before handling the patient. If there is breathlessness, patient must be made to sit on a chair with head rested on back with extension. If oxygen cylinder is available, patient must be given oxygen to breath. COVID 19 helpline must be immediately called for further help. The rescuer must follow the diagnosis of the patient. If the patient is tested positive or is a suspect of coronavirus infection, the rescuer must go for isolation and testing.

8.2   Acute Exacerbation of Asthma

In case of acute exacerbation of asthma, the patient should be given moral support, with some instructions from the social distance, unless the patient looks to have an emergency need. In emergency need, the patient should be given bronchodilator and comfortable position with moral support. All the procedure must be with minimum PPE (Gloves, mast and face shield) and after handling the patient and his belonging, hands must be sanitized with change of gloves.

9   Safe First Aid in shock, stroke, heart attack

First aid approach for critical conditions like shock, stroke and Heart attack is changed to include disinfection and PPE use and social distancing before start of the first aid. While all these three are emergency situation, all three are extremely susceptible to infection of SARS CoV-2 Infection. Hence, the patient requires more than usual care to avoid cross contamination. Hence, the first most important step (may be even before first aider prepares with PPE, the crowd must be pushed back more than 3 meters and with the help of a reliable assistant (family member, PPE / safety gear wearing security guard or a person from forces etc.) the area around must be disinfected).

Another critically important point in all these three conditions is that the patient must not be given mask to wear (in fact, this makes the patient more vulnerable to infection). Use of a transparent face-shield is highly recommended. If the patient is conscious or in stupor, patients hands and face must be immediately sanitized. Critical points of changes in the first aid include:

9.1   Changes in shock first aid approach

  1. While giving heal-low position to the patient, place a clean paper / plastic sheet under to avoid contamination from down.
  2. While loosening the clothes, start immediately after sanitizing hands. Follow sequence Face, Head, chest, waist, feet.
  3. While providing a patient a warm cover, use a fresh disposable sheet below the cover and disinfect the warm cover with a spray disinfectant
  4. Rest head tilted on side on an absorbent pad (sanitary pad in women hygiene or absorbent diaper is the best)

9.2   Changes in the approach for stroke first aid

  1. If there is any active bleeding, vomiting, plasma or nasal discharge, wipe it only with the absorbent pad or a fresh absorbent cotton.
  2. If CPR is needed, use low pressure oxygen or bag valve mask breather instead of other artificial method. If heart function is normal and the patient can be laid down, use chest compressions for breathing. Avoid moving limbs, especially if they are week.
  3. Do not give anything including blood pressure lowering drugs orally. Rather reach the nearest medical center.

9.3  Changes in approach for heart attack first aid

  1. The first aid for heart attack remains grossly the same, with a few precautions to avoid cross infection.
  2. There is a high possibility that the low oxygen saturation mimics symptoms of heart attack. Hence, it is important to have all safety precautions

10    Psychological first aid

Psychological first aid is an emerging technique, which has immense importance in the current pandemic situation. There is an increasing number of psychological casualties due to fear, anxiety, or depression due to many reasons including loss of wedges, increasing incidence of stress-related complex, etc.  There is a good informative article by  George S. Everly, Jr. on this topic. That must be read and comprehended.  A solution like digital pet could be a good option.


Refrences

[i] First Aid Technical Bulletins

[ii] Coronavirus (COVID-19): Prevention & Safety Information for Students

[iii] Covid-19: advice for first aiders

[iv] How to Perform CPR During the Coronavirus crisis

[v] European Resuscitation Council COVID-19 Guidelines

[vi] Psychological First Aid

[vii] Exploring new frontiers in mental health care with digital technologies 

Dr. Ashish Indani

Dr. Ashish Indani is a physician and currently working for Tata Consultancy Services as a domain consultant for Life Sciences Platforms. He holds a long experience in conducting first aid training.

Related Post: PharmaShots ViewPoints: The New Normal and Covid-19 Vaccine Development

How to Pandemic-Proof Our Healthcare Payment System

By AISHA PITTMAN, MPH and SETH EDWARDS, MHA

The pandemic has focused many policymakers’ attention  on strategies to make the healthcare system better. The obvious answer is one that we know is efficacious, if perhaps not the sexiest: value-based care.

The current healthcare payment system – built around the fee-for-service (FFS) model in which healthcare providers are reimbursed for the quantity versus quality of care – required $175 billion in bailouts and temporary modifications to remain whole during the crisis, a stance that’s unsustainable for both providers and payers.

The Centers for Medicare & Medicaid Services (CMS) admitted as much with its renewed national commitment to value-based care in late June: The movement to value is happening now.

The worth of value-based care models has long been detailed, from more coordinated care to lower costs. In fact, a recent survey by Premier Inc. found that healthcare providers in alternative payment models (APMs) were better positioned to respond to COVID-19 and support reopening plans through the rapid deployment of telehealth, care management and data analytics. These are the types of population health capabilities the industry must focus on spreading – and incenting – in the near future.

Value-based care could have kept providers’ finances off  life support.

In stark contrast to those in FFS, providers in value-based payment models such as global budgets and capitated arrangements faced fewer hurdles in the initial pandemic response. Participating in the most advanced type of APM, these providers were able to rely on existing capabilities to meet patient needs. Their revenue streams remained consistent, unlike providers in FFS or even APMs built on the FFS chassis such as the Medicare Shared Savings Program.

If all payments to healthcare providers were in global budgets or capitation, the response to the first wave of COVID-19 would have differed immensely. A consistent budget for an aligned population would have had more consistent revenue and been able to truly focus on shifting care delivery to meet pandemic-related needs. Perhaps more providers would have had population health capabilities in place, reducing the need for rapid expansion and investment.

Congressional stimulus could have been limited to increased spending directly related to COVID-19, such as testing costs and research into treatments. With more flexibilities inherently built into global budget and capitated arrangements, Congress and the Department of Health and Human Services would have spent less effort on designing and implementing temporary regulatory flexibilities.

Providers are beginning to consider how other payment arrangements may better serve them. Fourteen percent of respondents in Premier’s April survey of APM participants indicate they are considering renegotiating payer contracts.

So, how do we get to a new healthcare payment system?

While we have made gains in the movement to value, progress toward the most advanced models has been slow. Providers with local community ties and direct interactions with patients are best suited to manage the risk and health of populations. To speed the progression from no or low risk to advanced risk models, several changes are needed.

  1. Continue incenting providers to move to advanced APMs. 

    The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) correctly incented the movement to advanced APMs, providing a 5 percent bonus to providers who have a significant volume of payment through an advanced APM. But five years later we have not achieved the movement to value for which we once hoped. A slow rollout of new models and a low bar for performance under the Merit-Based Incentive Payment System have made it easier for providers to remain in FFS rather than moving to APMs. 

    With a renewed focus on value, we need to revisit the incentives. Congress should give CMS authority to shift the payment thresholds that providers must meet to qualify for a bonus. Both the lack of availability of advanced APMs and the structure of advanced APMs will make it increasingly difficult for providers to meet the threshold. The COVID-19 pandemic may exacerbate this issue, as the dip in in-office services could change attribution, and an increase in telehealth may impair providers’ ability to meet the thresholds. Additionally, Congress should extend the advanced APM bonuses, which are set to expires in 2024 (payment year 2022).

  1. Set a clear timeline for a transition to APMs. 

    Uncertainty remains in the movement to value. A 2019 Premier survey illuminated how the transition to risk-based contracting has been slow and market-dependent, with fewer than one in five respondents having more than half of their population covered by Medicare FFS, risk-based arrangements, and only 5 percent of respondents expecting to have more than 80 percent of their population in risk-based arrangements over the next five years. Medicare has led the charge in creating new models; however, the COVID-19 pandemic has stalled some progress, with no opportunity for new MSSP entrants in 2021 and insufficient direction from CMS to date on the future of Direct Contracting. 

    A vision for the transition from FFS to APMs is imperative so that providers can determine their approaches (i.e., models, arrangements) to prepare for a payment environment that is almost entirely value-based. 

  2. Enhanced flexibility in existing and new APMs. 

    Many of the regulatory flexibilities introduced during COVID-19 that providers would like to see made permanent have not historically been allowed in FFS due to concerns of cost, fraud or abuse. Some of these flexibilities (e.g., telehealth) have been tested in APM models but with more restrictions than allowed during the public health emergency. The fact that these models proved effective at the onset of the pandemic – in effect, during the worst of circumstances – shows that they should certainly be allowed as providers settle into a new normal. 

    When providers are required to manage to a budget while maintaining or improving quality, they will ensure patients are getting the right care in the right setting at the right time. Current models built on a FFS chassis maintain a lot of FFS requirements, yet expect providers to truly innovate care. In order to significantly shift care and address high-priority issues such as social determinants of health, providers need far more flexibility than currently allowed.

  3. Ensure adequate reimbursement in APMs. 

    Reimbursement inadequacy surfaced as the most significant barrier to APM adoption in the same2019 survey referenced above. The current benchmarking approach in ACO models creates a race to the bottom whereby providers must lower costs year over year to remain successful. For those who have made significant gains over past years, it becomes increasingly difficult to meet new benchmarks. New benchmark approaches should consider how to avoid penalizing those in low-cost regions or providers who are dominant in the market. Premier has long advocated for the Rural ACO Improvement Act (S. 2648)/Accountable Care in Rural America Act (HR 5212) to accommodate these improvements. 

    Beyond this fix, payment models need to be structured to assure their own longevity. Rather than increasing discounts each year, CMS should consider when it’s appropriate to cease discounts (e.g., after a certain level of cost reduction) or completely eliminate discounts (e.g., models directed toward rural providers). Additionally, payment methodologies must also account for the clinical risk of the population by removing caps on risk score increases for populations that become more complex over time.

  4. Ensure a level playing field for all providers. 

    High performers should be encouraged to participate in models regardless of provider type. Current CMS models, however, disadvantage certain provider types (e.g., MSSP high-revenue ACOs, a proxy for hospital-led ACOs, are forced to take on risk faster than others) or new entrants (in Direct Contracting, new entrants receive a more favorable benchmark than others). These efforts to advantage one type of provider over another create market distortions and encourage competitors to take steps to game the system. 

When put to the test, the current payment structures failed to serve healthcare providers or patients.

As public health needs place greater pressure on the healthcare system, providers must consider how they can morph their FFS-based operational and payment models. The changes outlined above will ensure providers can steadily and successfully progress into advanced risk models that better insulate their revenue, while raising the quality of care. History shows that when providers have a clear plan for moving to new models, they work aggressively to succeed rapidly advance to the risk-bearing echelon.

Key to igniting this movement is revisiting the incentives, which begins with Congress authorizing CMS to increase the availability and structure of advanced APMs so that providers accept the payment thresholds as accessible. The most effective way to drive high-quality, cost-effective care is with incentives that motivate all the providers across a system to collaborate, innovate and deliver.

Aisha Pittman, MPHis vice president of policy at Premier Inc. She leads Premier’s advocacy efforts on provider reimbursement, including quality measurement and alternative payment models.

Seth Edwards, MHA, is vice president of strategy, innovation and population health at Premier Inc. and has expertise in healthcare policy and strategy implementation.

Mental health platform helps students facing exam results during pandemic

The UK digital mental health support platform Kooth has joined with five of the UK’s well known Instagram influencers to launch a campaign to help students deal with the pressures of exam results season.

The campaign encourages the hundreds of thousands of students waiting to receive their exam results, to stay mentally strong and know they have access to support, if needed.

Kooth has launched the campaign called #PositiveFutures, which will last from 10th to 20th August ahead of an exam results fortnight made more stressful because of the pandemic.

To help get this vital message across, Kooth have partnered with five social media stars: BBC Radio 1Xtra Talks host Reece Parkinson, sustainable living ethical fashion blogger Mikaela Loach  currently studying medicine at Edinburgh University, model and soon to be student Louis Hopgood (@louishopgood_), freelance writer and LGBTQ+ Activist Ben Pechey (benpechey) and West End performer Grace Mouat.

The five influencers will be sharing their mental health stories, personal experiences and tips for surviving and thriving during this stressful period.

Recent data from Kooth has shown that young people are already experiencing rising levels of anxiety and stress.

Levels of presenting problems linked to ‘school/college issues’ rose by 246.4%  and levels of anxiety and stress have increased by 53% compared to the previous year.

As most exams have been cancelled marks this year are awarded against expected outcomes with grades being standardised by exam boards and Ofqual, the exams regulator.

But there are concerns the system won’t take into account rapid improvement made this year and fears that the proposed system to grade A-levels and GCSEs could disadvantage BAME students and those from poorer backgrounds.

There has already been controversy in Scotland, where thousands of school pupils received worse than expected results after the country’s exam body lowered 125,000 estimated grades after exams were cancelled because of the COVID-19 pandemic.

The Scottish Qualifications Authority worked out National exam results using estimates made by teachers, based on the pupil’s performance over the last school year.

The BBC reported that SQA figures showed that pupils from the most deprived backgrounds saw grades reduced by 15.2 percentage points, compared to only 6. 9 percentage points from the wealthiest pupils.

A “deluge” of appeals is expected amid accusations that the SQA had been tougher on those from deprived backgrounds, although the SQA said its moderation process ensured “fairness to all learners.”

Loach said in the Instagram campaign: “You are not defined by any result that you get.”

“Everything will be fine, I promise you,” Pechey added in the campaign.

Kooth, accredited by the British Association for Counselling and Psychotherapy and commissioned by the NHS, is available to over five million children and young people from 11-25 years of age.

It is commissioned in 85% of the NHS’s clinical commissioning group areas across the country and has a fully safeguarded and pre-moderated community with a library of peer and professional created content, alongside access to experienced online counsellors.

 

 

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COVID herd immunity: At hand or forever elusive?

By MICHEL ACCAD, MD

With cases of COVID-19 either disappeared or rapidly diminishing from places like Wuhan, Italy, New York, and Sweden, many voices are speculating that herd immunity may have been reached in those areas and that it may be at hand in the remaining parts of the world that are still struggling with the pandemic.  Lockdowns should end—or may not have been needed to begin with, they conclude. Adding plausibility to their speculation is the discovery of biological evidence suggesting that prior exposure to other coronaviruses may confer some degree of immunity against SARS-CoV2, an immunity not apparent on the basis of antibody seroprevalence studies.

Opposing those viewpoints are those who dismiss the recent immunological claims and insist that rates of infections are far below those expected to confer immunity on a community. They believe that the main reason for the declining numbers are the behavioral changes that have occurred either under force of government edict or, in the case of Sweden, more voluntarily. What’s more, they remind us that the Spanish flu pandemic of 1918-1919 occurred in 3 distinct waves. In the summer of 1918 influenza seemed overcome until a second wave hit in the fall. Herd immunity could not possibly have accounted for the end of the first wave.

The alarmists may have a point.  However, recent history offers a more instructive example.

Until early 2015, epidemiologists considered Mongolia to be exemplary in how it kept measles under control. In the mid-1990s, the country instituted a robust vaccination program with low incidences of outbreaks, even by the standards of developed countries. In the early 2000s, it adopted a 2-step MMR immunization schedule and, after 2005, its vaccination rates were upwards of 95%. From 2011 through 2014, not a single case of the virus was recorded, leading the WHO to declare measles “eradicated” from Mongolia in November 2014.  

On March 18, 2015, however, a measles case occurred in the capital Ulaanbaatar, featuring a viral genotype similar to that of an outbreak in neighboring China. Within days, numerous other cases arose, marking the beginning of a multifocal epidemic across the country. A first wave of infections lasted until July and another one, begun in the fall of 2015, lasted until the spring of 2016. Taken together the outbreaks caused nearly 54,000 cases of measles and 140 deaths despite implementation of a program of supplemental immunizations instituted in the middle of 2015. Most of those affected were children less than 1 year of age who had not yet received any immunization, but 6% of the victims had received one or even 2 shots.  

What does this unfortunate event tell us about herd immunity?  A review paper titled “Herd Immunity: A Rough Guide,” written by Fine, Eames, and Heymann and published in 2011, gives important insights on the topic.

Herd immunity holds that if a sufficient number of people are immune to a contagious disease, then this immunity protects those who would otherwise be susceptible to it. The idea was first proposed in the 1930s when epidemiologists noted that the occurrence or disappearance of epidemics of common respiratory viruses, such as measles, mumps, or chickenpox, correlated with the presence or absence of a critical mass of immune individuals within a community. 

The widespread introduction of vaccines in the 20th century confirmed many examples of herd immunity, which occurs when an immune individual interferes with the chain of transmission of the contagious agent. Vaccination campaigns spurred the development of theoretical models to estimate “thresholds” of herd immunity based on estimates of transmissibility factor, or the famous R0. It is from such models a herd immunity threshold (HIT) estimates are derived and a HIT range of 50-80% has been proposed for COVID-19. In other words, models predict that 50-80% of the population must be infected and develop immunity to COVID-19 before the phenomenon of herd immunity can take effect.

Fine et al. describe in some detail the highly complex social and biological factors that bear on the modeling of herd immunity, and they warn against placing too much confidence in HIT estimates.  Despite growth in understanding and despite refinement in theoretical models, they believe that we ought to remain circumspect when considering the question of thresholds in practical terms: 

Managers [of vaccination programs] must be wary of target thresholds for vaccination, insofar as thresholds are based on assumptions that greatly simplify the complexity of actual populations. In most circumstances, the sensible public health practice is to aim for 100% coverage, with all the doses recommended, recognizing that 100% is never achievable, hoping to reach whatever is the ‘‘real’’ herd immunity threshold in the population concerned (emphasis mine).

The measles outbreak in Mongolia vindicates their cautionary advice. One might have felt justified into thinking that Mongolia possessed herd immunity on the eve of March 18, 2015 only to realize the next day that it didn’t. 

On reflection, the reason for the difficulty is simple. To be immune is a “negative” concept.  It cannot be positively established by empirical observation. It is only the opposite that can be demonstrated, i.e., that a person is infected. Of course, when knowledge about a particular infection is solid and biological markers of immunity are robust, the presumption of immunity can be made with more confidence, but it remains a presumption.  

Where does that leave us as far as COVID-19 lockdowns are concerned?  

Those who oppose lockdowns should be glad to see that Sweden and many other places may soon be “COVID-free.”  But invoking herd immunity as an explanation, persuasive as the biology may be, could be premature.  Arguments against lockdowns should look elsewhere for their grounding.

Conversely, opponents of lockdowns cannot be so sure that herd immunity has not occurred in some places.  Our understanding of the immunology and transmissibility of SARS-Cov2 is sufficiently sparse to allow very wide confidence intervals around any point estimate of herd immunity thresholds. The optimists could very well be right.

One last point.  At the end of their article, Fine et al. point out that most vaccination programs aim not to eradicate infectious disease but to reduce disease to a level that is “tolerable.” In a sense, then, our societal attitudes towards disease and death bear importantly on whether we perceive that herd immunity has been reached.

But in an age when health has been declared a common good and medicine has become irredeemably politicized, any case and any death can be deemed “intolerable” or weaponized for political aims.  That, more than anything else, may be what makes herd immunity particularly elusive.

Michel Accad is a cardiologist based in San Francisco and host of the podcast, The Accad & Koka ReportThis post originally appeared on his blog, Alert and Oriented here.

Influential MPs ‘astonished’ at UK government’s delayed pandemic response

As the UK’s economy is hit by its worst contraction for 41 years, an influential committee of MPs has blasted the government’s failure to plan for the economic impact of a pandemic and stock up on protective equipment for health staff.

The Commons Public Accounts Committee (PAC) said in a report that it was “astonished” that the government had failed to consider the economic impact of a pandemic, even though this had been identified for years as a “top risk” by officials.

Issues such as shortages of personal protective equipment (PPE) will be considered in detail in a separate report – but the PAC identified “fundamental flaws” in the government’s central procurement.

Getting enough PPE for 58,000 separate sites including hospitals and care was always going to be difficult, but the government failed to stock up in advance despite a pandemic being identified as the government’s top “non-malicious” risk.

According to the PAC the Cabinet Office claims it never ran out of PPE centrally, but there were local shortages of equipment, particularly aprons.

The report said: “It matters very little that the government had enough PPE centrally if these vital goods and equipment are not getting to those who need them locally. The Department of Health and Social Care was not focused enough on the challenge of how to identify need in the care sector and ensure supply of PPE.”

This lack of preparedness also resulted in the government paying higher unit costs, which would have been lessened had the government stocked on PPE sooner or had UK-based supply options.

The government has been criticised elsewhere for its reliance on “just in time” contracts with suppliers of PPE, which failed to produce the necessary equipment in the early days of the pandemic as global demand soared.

However the PAC added that it gave the government credit for moving fast to deliver £120 billion in support for the health and social care sector.

One size fits all

The PAC also criticised the government’s “one size fits all” approach where sectors of the economy have been left without the “bespoke” economic support they need.

One of the committee’s main criticisms was the length of time it took for the government to come up with plans to support businesses and individuals.

While the first case of coronavirus was confirmed on 31 January, it took until the budget on 11 March for the government to announce plans.

It was a further week before it became clear to the treasury that a furlough scheme would be needed, and further delays to a scheme for the self-employed, which had to be designed from scratch.

Looking forward the PAC is concerned that lessons have not been learned ahead of a potential second spike in infections.

“It is not clear that the government is undertaking the necessary preparatory work for a second peak of infections,” the PAC said in its report.

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Collective State Action Is Needed to Fight This Pandemic Right Now

By KEN TERRY

As COVID-19 cases soar across the country, the federal government has lost control of the situation. Amid the Trump Administration’s happy talk and outright dismissal of the crisis, the U.S. is experiencing a forest fire of contagion and hospitalizations, and an upsurge in COVID-related deaths has already begun.

Other countries like Taiwan, South Korea, Germany, Australia and New Zealand have controlled their outbreaks, which is why their COVID-19 infections and deaths have been minimal or trending downward in recent months. To replicate those nations’ strategies of testing, contact tracing and quarantining, the U.S. Congress would have to appropriate about $43.5 billion, according to one estimate. But as we know, Senate Republicans won’t pass such a bill without Donald Trump’s prior approval—and that’s unlikely as long as his main focus is on reopening the economy.

We can hope that electoral victory by the Democrats in November will change this equation, but Joe Biden won’t take office until January if he wins. Meanwhile, the coronavirus is chewing up America. We can’t afford to wait six months to blunt the impact of this horrible disease. However, there is a solution that doesn’t depend on federal leadership: states can form compacts that would form the basis for collective action to get us out of the trap we’re in.

Interstate compacts are very common in the U.S. Various pacts cover everything from clean water and clean air to medical licensure, mental health and interstate transportation. For example, under the Middle-Atlantic Forest Fire Protection Compact, which includes Ohio, West Virginia, Virginia, Pennsylvania, New Jersey, Delaware, and Maryland, member states assist one another in fire prevention and suppression and firefighter training.

Altogether, there are more than 200 active interstate compacts. Twenty-two of them are national in scope and more than 30 are regional.

Article 1 of the U.S. Constitution specifically allows states to enter into multistate agreements for their common benefit. Congress doesn’t have to approve interstate compacts unless they would increase the states’ political power in a manner that would encroach upon the federal government’s power.

Such is not the case with the coronavirus crisis. If states joined together to fight the pandemic, they’d be fulfilling their mandate to protect the public health. While it might be argued that the federal government should be coordinating these efforts, collective state action would not trespass on that authority if Washington shirked its duty, as it is doing today.

New York Governor Andrew Cuomo pointed to the need for this collective action after New York’s COVID-19 crisis had passed its peak. Acknowledging that his state didn’t require as many ventilators as initially projected, Cuomo in mid-April said he was sending 100 of the machines in the New York stockpile to Michigan, 100 to New Jersey and 50 to Maryland. 

Now some other states are in crisis. Hospitals in Texas, Arizona, Florida and California are running out of ICU capacity as their COVID case counts continue to rise. Across the country, desperate measures are being considered or carried out, including triaging patients by their likelihood of survival. In the richest nation on earth, with one of the most extensive healthcare infrastructures, the idea of having to leaving some patients out in the cold is beyond crazy.

There are workarounds, of course. Some hospital wards can be repurposed as ICUs. Field hospitals can be set up in convention centers and parks, as they were in New York City. But all of this takes time. In the short term, neighboring states could enter compacts that obligate their hospitals to take some of the overflow of COVID patients if other states run out of ICU space. They could share ventilators and PPE, instead of bidding against each other for the equipment. States with lower rates of COVID infection could encourage some of their health workers to travel to more hard-hit states, as some clinicians did when New York was in need.

Beyond fighting the pandemic in hospitals, compact member states could also form learning collaboratives to find out which approaches to mask-wearing, social distancing, contact tracing and quarantining work the best. Moreover, they could pool their resources to scale up the requisite number of tests, as suggested in a recent New York Times op-ed.

If compact members wanted to go further, they could agree to require the wearing of masks in public places and/or follow the guidelines of the White House Coronavirus Task Force on reopening their economies. States that refused would be excluded from compacts that might help them cope with the pandemic.

All state governors are facing a common challenge—which is why they should cooperate with each other, regardless of their political philosophy. Those that reopened their economies too early have learned a painful lesson. Some of these states have had to pause their reopening schedules or are on the verge of new lockdowns. Whether or not their governors have recognized their earlier mistakes is open to question. Still, it’s clear that the only way to reopen successfully is to contain COVID-19 and maintain social distancing until a vaccine is available.

Interstate compacts are not a panacea. For one thing, the Senate has not taken up the House-passed Heroes Act, which includes emergency funding of state and local governments, and it’s unclear whether those funds will be included in the compromise package being worked out. Without this money, the states would be unable to meet their obligations under compacts. Also, the compacts would be only a partial substitute for a rational, comprehensive national policy to combat COVID-19. For starters, the federal government’s help is still needed to provide adequate supplies of equipment for testing and treatment of patients and protection of clinicians.

For now, however, collective state action is desperately needed so that the states most badly hit by this pandemic can receive timely aid from the other United States.

Ken Terry is a journalist and author who has covered health care for more than 25 years. His latest book, Physician-Led Health Care Reform: A New Approach to Medicare for All, will be published this month by the American Association for Physician Leadership.

Will the Drug Repurposing Industry Boom due to the Pandemic?

Since, the outbreak of novel coronavirus, drug repurposing has become one of the core research strategies for finding a treatment. Several clinical studies for the already approved drugs, have been registered in order to identify cure for the novel coronavirus infection. It is known that on an average, it takes around 12 to 15 years to develop and commercialize a novel drug product, involving high financial investments. On the other hand, drug repurposing has become an integral part of the pharma and the healthcare sector globally. This is due to the fact that drug repurposing offers costs and time related benefits in early stages of development. Presently, drug repurposing is one of the viable options for the pharma industry to win against the pandemic. This pandemic has led increased interest in this domain.

What is the role of drug repurposing service providers?

Many start-ups, mid-sized and well-established players are primarily focusing on collaborating together so as to minimize the workload on the big firms for the development and the commercialization of a drug in lesser time. Several number of service providers, including contract research organizations (CROs), claim to provide the necessary support to drug developers in identifying / predicting prospective drug candidates for repurposing. Such companies offer a variety of services, encompassing both drug discovery operations and consultancy requirements. In fact, many of such players claim to have developed proprietary platforms based on advanced technologies, such as big data analysis, artificial intelligence (AI) and real-world evidence, in order to facilitate drug repurposing related decision-making.

Will the Drug Repurposing Industry Boom due to the Pandemic?

Since 2011, the drug repurposing domain has become an attractive alternative to the slow pace traditional drug discovery and development process. There are few notable examples that could quote the success of this methodology such as Pfizer’s Sildenafil and Grunenthal’s Thalidomide. Sildenafil was originally developed to treat coronary artery disease in 1980. But in the year 1998, it became a blockbuster due to its new use in treating erectile dysfunction.

What are the recent initiatives undertaken in the field of drug repurposing, to combat COVID-19?

In the past few months, several drug repurposing service providers have undertaken various collaborative initiatives, to develop vaccines / biologics as the potential therapeutic against COVID-19. For instance, in April 2020, SOM Biotech partnered with Ewha Womans University to identify targets against coronavirus by using SOM Biotech’s technology. Some of the prominent examples of approved drugs that are being evaluated to treat COVID- include chloroquine / hydroxychloroquine (anti-malarial drug) and remdesivir (initially developed to treat hepatitis C). Due to the rapid advances in the field of biology, genomics and bioinformatics, drug repurposing strategy has been actively engaged in finding ways for combating rare diseases in recent years. It is expected that the process of identifying new uses for existing drugs will continue to gain popularity in the near future as well. Thus, greatly helping the progress of the medical and the healthcare sector

Visit this link for more Insights.

Roots Analysis – Pharmaceutical, Biotechnology and Medical Devices.

You may also be interested in the following titles:

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THCB Gang Episode 17, LIVE 7/9 1PM PT/4PM ET

Episode 17 of “The THCB Gang” was live-streamed on Thursday, July 9th! Watch it below!

Joining me were some of our regulars: patient advocate Grace Cordovano (@GraceCordovano), health economist Jane Sarasohn-Kahn (@healthythinker), WTF Health Host Jessica DaMassa (@jessdamassa), and guests: Tina Park, partner at Diagram (@diagramoffice) & Shannon Brownlee, Senior VP at the Lown Institute (@ShannonBrownlee). The conversation focused on asynchronous care, the gap between patients & technology, and the Supreme Court ruling on employers’ ability to limit women’s access to birth control coverage. It was a great and engaging conversation with some of the top health care experts in the field.

If you’d rather listen, the audio is preserved as a weekly podcast available on our iTunes & Spotify channels — Zoya Khan

COVID-19 Q & A with Animal-Borne Disease Detective Daniel Streicker

TEDMED Speaker Daniel Streicker provided some great insights about bats and pandemics in his 2018 TalkWhat vaccinating vampire bats can teach us about pandemics” and TEDMED blog post. Learn about this Animal-Borne Disease Detective’s perspective on COVID-19 in our Q & A below.

TEDMED: What do we know about the origin of COVID-19? Which theories stand strong in your mind?

Daniel Streicker: We know that SARS-CoV-2 (the virus that causes COVID-19) most likely originated from a non-human animal, but exactly which animal and how it managed to make the jump to people largely remains a mystery. The virus genome is most closely related to viruses that are known to circulate in Old World bats in the family Rhinolophidae (horseshoe bats). That points to bats in this same group as the origin, but the viruses we know about aren’t a perfect genetic match to SARS-CoV-2. In fact, there are few decades worth of transmission separating the previously known viruses from the virus that is now circulating in humans. That gap could be filled by another bat virus that we don’t know about (there are likely many undiscovered coronaviruses in bats). Alternately, a historical bat virus might have jumped into and evolved in some ‘intermediate’ host prior to infecting humans. We don’t know exactly what triggered the shift to humans, but finding the animal source would provide viral clues. Researchers are now trying to use knowledge of the biology of the virus to work out candidate animals to survey.

TM: What should we be weary of to prevent another bat initiated outbreak?

DS: Like all animals, bats host diverse viruses, some of which are able to infect humans. Consequently the main thing we can do is limit the opportunities that viruses have to spread between species. In some cases, there are practical solutions like limiting the trafficking and consumption of wildlife or improving handling and animal housing standards. However, when there are indirect routes of infection between animals and people such as through the shared environment, through arthropod vectors (ticks, mosquitoes) or through domestic animals, prevention will be challenging without larger scale changes in human societies, such as changing farming practices, land use, and resource extraction practices. COVID-19 is not the first and it is not likely to be the last disease outbreak that originates from bats.

TM: Are there ways to take precautions against animal to human transmission for new diseases? Or is it inevitable?

DS: Unfortunately, some amount of animal to human transmission is inevitable. The positive side is that with each epidemic we gain new knowledge and technologies that let us respond faster. It also puts one more high-risk virus on our radar which might be prevented from re-emerging in the future. We can also do more now than ever before to prepare. The more we understand the routes through which animal viruses emerge, the more we can develop broad-acting precautionary measures to reduce the risk. For example, limiting human-wildlife interaction in high risk situations. However, we also have new tools that are allowing viruses to be discovered at unprecedented rates. More comprehensive knowledge of viral diversity can accelerate investigations into the origins of novel viruses that appear in humans. This cataloging of viruses is also a first step towards evaluating risk prior to emergence in humans, though we still need better ways to narrow the list of viruses that are worth preemptively investigating.

TM: Was there anyway for the world to anticipate this virus? What additional complications arise given that this is a novel virus?

DS: We couldn’t have predicted this exact virus, but given that the SARS outbreak of 2002-2003 was caused by a very similar virus (taxonomically the same species as the virus that causes COVID-19), it is really not a surprise. In the wake of SARS, a great deal of surveillance was undertaken to discover and characterize coronaviruses in wild animals, and numerous scientists provided persuasive evidence that these kinds of viruses were circulating in bats and posed a threat to human health. Why more effort was not put into developing vaccines and antivirals for humans is perplexing.

TM: Once we understand the source of COVID-19, and eventually develop a vaccine, should efforts be put into tracking and vaccinating the source animal – as you suggested for rabies in vampire bats?

DS: If this is a virus that is transmitted in nature by a wide variety of bat species, vaccination would be challenging. If emergence in humans turns out to be the consequence of a rare evolutionary change in an intermediate host, vaccinating that host could be practical. On the other hand, it could be that transmission in the intermediate host was short lived and it has now gone extinct from animals. In that case re-emergence would be relatively unlikely even without human intervention. The bottom line is that we need to know the steps that the virus took between bat and human to know where the most effective interventions should be targeted.

The post COVID-19 Q & A with Animal-Borne Disease Detective Daniel Streicker appeared first on TEDMED Blog.

Q & A with Anupam B. Jena

2020 TEDMED Speaker Anupam B. Jena shares the power of creative observations in his Talk The profound difference between seeing and looking.” In response to his Talk and his segment on TED Radio Hour, TEDMED spoke with Anupam about observing the changing world during COVID-19.

TEDMED: Given the rise of COVID-19, what questions that are “hidden in plain sight” have you been most intrigued by?

Anupam B. Jena: I’ve been intrigued by a few questions. In some respects, the COVID-19 pandemic is The Great Natural Experiment. Medical procedures, including screening tests for cancer, have been deferred. Can this inform as to how necessary those tests really were by studying the impact of those delays on patient outcomes? For some procedures, like cardiac bypass surgery in patients with severe heart disease, we’ll be able to better understand in a large-scale way what the impact of several month delays are on outcomes. The list is endless. I also wonder about the impact of forcing people to stay close together for longer periods of time than they do normally. There’s already evidence of domestic strain. It may also be the case that in families that have at least one smoking member, second hand smoke exposure (especially among kids) could rise. Remember, kids normally spend their days at school not all day at home. I mentioned in my NPR TED Radio Hour episode that I thought that outcomes of individuals with alcohol dependence might worsen because of the stress of pandemic and the lack of availability of resources like AA for those who use it.

TM: How do you balance correlations and coincidences? How do you differentiate the two if the observed event is a unique instance?

ABJ: My main approach, and that of economists, is only to take seriously those correlations that arise from individuals being exposed to an event for an essentially random reason. If we want to study the impact of the malaria drug hydroxychloroquine on COVID-19 outcomes – something that’s been in the news – what you quickly see is that patients who receive the drug tend to be different, on average, than those who do not. They are often sicker. A simple comparison may falsely lead you to conclude that the drug harms people. In the end, it may, but the right approach is to find people who were otherwise similar but by chance were exposed to the group. For example, patients who happened to be hospitalized after President Trump’s advocacy of the drug may be more likely to have been prescribed it. That might serve as a natural experiment because patients hospitalized before and after that first presidential announcement obviously were unaware that announcement was going to occur.

TM: How might the current pandemic inspire creative thinking and macro-level change to the US health system?

ABJ: The current pandemic has forced a lot of people who don’t think about health care issues to now put those issues front and center in their mind. Having talked a lot to people recently who are completely removed from health care, the ideas they come up with about testing, about the impacts of social distancing on their lives, etc., are fascinating. In many instances, what they are describing are the outcomes of this huge experiment but they just aren’t thinking about it in that way.

TM: Do you consider this pandemic a natural experiment?

ABJ: Yes and No. A natural experiment has to satisfy an important criteria – the impact of the event, in this case the pandemic, has to exact its effect on people’s lives in a single way, otherwise it becomes difficult to study. For example, suppose we find that the pandemic led people to not fill prescriptions for their essential medications and we wanted to use that transient disruption to study the ‘effect’ that medicines have on health outcomes in a real world setting. It is true that the medication disruption was caused by an unforeseen event, the pandemic. But if people’s health worsens, was it because of the lack of medication use or because of the stress and other changes to life induced by the pandemic. In that example, the natural experiment assumption fails.

TM: While everyone is looking at the health care system being overloaded, what are you seeing in the world of health?

ABJ: I am struck by the resilience of health care systems and health care professionals. In my own health care system, which is not alone, the organization is taking active steps to improve housing, social distancing measures, and testing in hard hit, historically underserved areas. That doesn’t help their ‘bottom line’ and as an economist who first thinks of the non-altruistic reasons that individuals and organizations do what they do, it highlights what we can do together when we have incredibly challenging problems to solve. At the end, the pandemic will take fewer lives than heart disease and cancer. It would if we were able to dedicate this amount of effort to reducing the burden of those diseases, the impacts to society would be large.

TM: Where do you anticipate seeing the most unexpected change in creative thinking?

ABJ: There has been a huge increase in interdisciplinary thinking around the pandemic. For example, economists are weighing in on issues that epidemiologists have studied for decades, in some cases offering new insights and in other cases re-discovering the wheel. A tangible area of interdisciplinary work is estimating the effectiveness of policies to stem the tide of the pandemic. At their core, these are statistical or econometric issues – what was the observed effect of a policy on disease spread, using state-to-state or county-to-county variation in the timing of policy implementation – not issues that are best addressed by mathematical epidemiologic models.

The post Q & A with Anupam B. Jena appeared first on TEDMED Blog.

Q&A with Peter Piot about COVID-19

At TEDMED’s gathering in Boston, we had the opportunity to interview on stage the world’s top virologist, Peter Piot. In plain English, Peter provided solid scientific knowledge about COVID-19 and how to cope with it. Short answers, clear explanations.

Based on that live interview here is a written Q & A supporting the responses to 100 questions on COVID-19 with Peter Piot. We hope that you will find this additional content helpful and that you will share the video Q & A and this blog post with your friends and family.


1. TEDMED: Let’s start with the basics. What is a virus?

A virus is a very tiny particle of RNA or DNA genetic code protected by an outer protein wrapper.

2. TEDMED: How common are viruses?

Viruses are everywhere. It’s amazing to realize that if you add them all up, all the viruses in the world weigh more than all the living matter in the world — including all of the plants, animals and bacteria. 10% of the human genome is derived from virus DNA. The Earth truly is a “virus planet!”

3. TEDMED: Why is it so hard to stop a virus from spreading?

Because virus particles are so incredibly small, billions can float on tiny droplets in the air from just one cough.

4. TEDMED: Exactly how small is a virus?

Tiny. Even with a regular microscope, you can’t see a virus. 100 million viral particles of the novel coronavirus, can fit on a pinhead. That’s how incredibly small they are.

5. TEDMED: What do virus particles do?

Virus particles try to insert themselves into living cells in order to multiply, infect other cells and other hosts.

6. TEDMED: Why do viruses try to get into living cells?

It’s how viruses “reproduce.” Viruses act like parasites. They hijack living cells in order to force each cell to make more viruses. When a cell is hijacked, the virus sends out hundreds or thousands of copies of itself. It often kills the hijacked cell as a result.

7. TEDMED: What does it mean to be infected with the new coronavirus, which scientists have designated “SARS-CoV2”?

It means that SARS-CoV2 has started reproducing in your body.

8. TEDMED: What is the difference between SARS-CoV2 and COVID-19?

SARS-CoV2 is the virus; COVID-19 is the disease which that virus spreads.

9. TEDMED: Is it easy for a virus to get into a living cell?

This depends in the first place whether the cell has the right receptor for the particular virus, just as a key needs a specific keyhole to work. Most viruses are blocked by our immune system or because we don’t have the right receptors for the virus to enter the cell. Thus, 99% of them are harmless to humans.

10. TEDMED: How many kinds of viruses exist, and how many of them are harmful to humans?

Of the millions of types of viruses, only a few hundred are known to harm humans. New viruses emerge all the time. Most are harmless.

11. TEDMED: On average, how many particles of the virus does it take to infect you?

We really don’t know yet for SARS-CoV2. It usually takes very little.

12. TEDMED: What does it look like?

SARS-CoV2 looks like a tiny strand of spaghetti, wound up in a ball and packed inside a shell made of protein. The shell has spikes that stick out and make it look like the corona from the sun. This family of viruses all have a similar appearance; they all look like a corona.

13. TEDMED: How many different coronaviruses affect humans?

There are 7 coronaviruses that have human-to-human transmission. 4 generate a mild cold. But 3 of them can be deadly, including the viruses that cause SARS and MERS, and now the new coronavirus, SARS-CoV2.

14. TEDMED: Why is it called the “novel” coronavirus?

Novel just means it is new to humans, meaning that this specific virus is one that we’ve never seen before. Our immune system has been evolving for 2 million years. But since our bodies have never seen this virus before, there has been no opportunity for humans to develop immunity. That lack of immunity, combined with the virus’s ability to spread easily and its relative lethality, is why the arrival of SARS-CoV2 is so disturbing.

15. TEDMED: How often does a novel virus emerge that we need to care about?

It’s rare… but it happens. Examples include the viruses that cause diseases such as HIV, SARS, MERS and a few others. It will happen again. The emergence of a novel virus is a very big problem … if it can easily spread among people and if it is harmful.

16. TEDMED: How easily does the new virus spread?

SARS-CoV2 spreads fairly easily from person to person, through coughs and touch. It is a “respiratory transmitted” virus.

17. TEDMED: Is there any other way that the virus spreads?

Recent reports indicate that it may also spread via fecal and urine contamination, but that requires confirmation.

18. TEDMED: How is this new virus different from the earlier known coronaviruses that spread SARS or MERS?

SARS-CoV2 is different in 4 critical ways: First, many infected people have no symptoms for days, so they can unknowingly infect others, and we don’t know who to isolate. This is very worrisome because SARS-CoV2 is highly infectious. Second, 80% of the time, COVID-19 is a mild disease that feels like a minor cold or cough, so we don’t isolate ourselves, and infect others. Third, the symptoms are easily confused with the flu, so many people think they have the flu and don’t consider other possibilities. Fourth, and perhaps most importantly, the virus is very easy to spread from human-to-human because in the early stages it is concentrated in the upper throat. The throat is full of viral particles so when we cough or sneeze, billions of these particles can be expelled and transmitted to another person.

19. TEDMED: I thought the virus leads to pneumonia? How is the throat involved?

The disease often starts in the throat (which is why tests often take a swab from the throat) and then as it progresses it moves down to the lungs and becomes a lower respiratory infection.

20. TEDMED: I hear the word “asymptomatic” used a lot. What does it mean?

It simply means having no symptoms.

21. TEDMED: Are you saying that someone can be infected with the new virus and never show symptoms at all?

Unfortunately, yes. Many infected people do not show any symptoms for the first few days and then a mild cough or low fever shows up. This is the opposite of SARS, where you had clear symptoms for a few days but were only contagious when sick.

22. TEDMED: If you have no symptoms, can you still infect other people?

Unfortunately, yes. And that makes it much more difficult to slow the spread.

23. TEDMED: How likely is it that scientists will develop a vaccine to prevent people from getting infected?

It is reasonably likely, but there are no guarantees that we will even have a vaccine. Failure is possible. For example, we’ve been searching for an HIV vaccine for 35 years and we still don’t have one. I’m optimistic that we will develop a vaccine for SARS-CoV2, but we will have to extensively test it for efficacy and safety — which takes a lot of people and time.

24. TEDMED: Assuming that a vaccine for coronavirus is possible and further assuming that it will be discovered fairly quickly, how long before we have a vaccine that we can start to inject into millions of people?

We will have vaccine “candidates” in a month or two. But because of the need for extensive testing to prove it protects and is safe, it will be at least a year before we have a vaccine we can inject into people that is approved by a major regulatory agency. In fact, 18 to 24 months is more likely by the time we scale it up to millions of doses, and that is optimistic.

25. TEDMED: Why will it take so long to develop a vaccine if this is an emergency?

It’s not necessarily vaccine discovery that takes so long, but vaccine testing. Once a “candidate” vaccine exists in the lab, a series of clinical trials are needed, first on animals and then on successively larger groups of people.

26. TEDMED: Have we made progress already?

The good news is that only weeks after the discovery and isolation of SARS-CoV2, which occurred in early January of 2020, vaccine development started immediately. Funding has been allocated by many governments and many companies and scientists around the world are working on it with great urgency.

27. TEDMED: Are scientists in these countries cooperating, or are they competing with each other?

A bit of both, and that is not a bad thing. But international cooperation has generally been good. That’s encouraging.

28. TEDMED: Can’t we develop a vaccine faster?

Unfortunately, there are no shortcuts. The human body’s immune system is complex and unpredictable. Viral mutations may occur. Children are different from adults. Women may respond differently than men. We need to be sure that any vaccine is 100% safe for everyone who gets it. To accomplish that, we need to test drugs and vaccines at various doses on a wide range of healthy human volunteers under carefully measured conditions.

29. TEDMED: How deadly is the new virus?

Most scientists believe that it kills 1% to 2% of all the people who become infected. The WHO currently reports a higher figure of more than 3%, but that estimate is likely to come down as they figure out how to count many unreported or mild cases. Mortality is clearly higher in older people and those with underlying conditions.

30. TEDMED: Is the average death rate the figure to focus on?

Not really. You can drown in an “average” of 3 inches of water. A better way to understand the risks is recognizing that it can be deadly for certain groups of people and much less so for other groups — with a wide range of outcomes.

31. TEDMED: So what are the numbers and checkpoints to focus on?

80% of the time it’s a mild disease, but in 20% of cases it becomes more severe, with the worst cases reporting high fever or shortness of breath. As a result some people require hospitalization, and some will need intensive care to survive through a few critical days when their lungs are extensively infected.

32. TEDMED: Which groups of people are most at danger here?

First of all, older people like me: I’m 71. The older you are, the higher your risk. Also at greater risk are people with underlying diseases such as diabetes, chronic obstructive lung disease and pulmonary disease or cardiovascular disease or immune deficiencies.

33. TEDMED: How much danger do these high-risk groups face?

Their mortality rate can be as high as 10% or even 15%. And, your risk increases when you have more health conditions. The scientific data about all of this is regularly updated on the web.

34. TEDMED: So your risk increases significantly if you have other conditions, such as diabetes. Why?

Because your immune system reacts poorly to any infectious virus, but particularly to this one.

35. TEDMED: It seems that generally speaking, children and young people are only mildly affected, if at all. Is that true?

This is what it looks like, but as with so many other issues on COVID-19, this requires confirmation.

36. TEDMED: If true, why would SARS-CoV2 affect older people much more, but not younger people and children?

We actually don’t know. It’s going to be a while before we figure it out.

37. TEDMED: Anything else unusual?

You can infect other people even if you are totally asymptomatic and feeling fine. That’s unusual, though it can also happen with HIV infection.

38. TEDMED: We often hear COVID-19 compared to the seasonal flu. What’s the right way to frame this comparison? For example, are the seasonal flu and coronavirus equally dangerous?

The seasonal flu typically infects up to 30 million people a year in the U.S., and fewer than 1/10th of 1% of the infected group will die – but that is still a big number. Worldwide, in an average year, a total of 300,000 people die from seasonal flu. But, on an average basis, the new coronavirus is 10–20 times more deadly, and in contrast to influenza, we cannot protect ourselves through vaccination.

39. TEDMED: Does the new virus spread as easily as the flu?

The new virus appears to spread as easily as the flu.

40. TEDMED: Continuing with the comparison of flu and COVID-19, what about causes? Is the flu also caused by a virus?

Yes. Flu is caused by the influenza virus. But the influenza virus and coronavirus are very different. A flu shot doesn’t help you with the new coronavirus, but it greatly reduces your risk of flu. The common cold, for which there is no vaccine or cure, is often caused by another type of tiny virus called a rhinovirus, and occasionally another coronavirus.

41. TEDMED: How does the infection progress when the new coronavirus gets a foothold in your body?

It usually starts with a cough. Then a low fever. Then the low fever turns into a high fever and you get shortness of breath.

42. TEDMED: At what point is good medical care the difference between life and death?

It is usually when your fever is very high and your lungs are compromised so that you are short of breath or you need help to breathe.

43. TEDMED: How is the new virus different from a disease such as the measles, mumps or chicken pox?

SARS-CoV2 is currently far less infectious and dangerous but there is still a lot we don’t know about it. The other diseases are well understood.

44. TEDMED: If the new coronavirus is less dangerous than other viruses, why are many people so afraid of it?

Because new things that can kill us or cause us to be sick, make us very nervous. But accurate knowledge is the antidote to fear, so here in the U.S., I urge you to pay attention to CDC.gov. In other countries go your national health ministry or WHO websites.

45. TEDMED: How often should people check the CDC or WHO websites, or the website of their national health ministry?

We continuously update our knowledge as we learn more about the new virus, so these sites should be checked frequently.

46. TEDMED: Has mankind ever wiped out a virus completely?

Yes. Smallpox, which used to kill millions of people. And, we’re very close with polio thanks to the Gates Foundation and many governments around the world such as the U.S. Let’s not forget what a terrible plague that was in the world.

47. TEDMED: How does the new virus get to new places around the world?

By road, air and sea. Viruses travel by airplane nowadays. Some of the passengers may carry SARS-CoV2.

48. TEDMED: So, every international airport is a welcome mat for the new virus?

The reality is that SARS-CoV2 is already firmly present in most countries, including in the U.S., and far from any major international airport.

49. TEDMED: Since the epidemic began in China, do visitors from that country represent the biggest danger of importing coronavirus into the U.S.?

Since the new virus emerged in China in 2019, 20 million people have come into the U.S. from countries all over the world. The U.S. stopped most direct flights from China 4 weeks ago, but it did not prevent entry of the virus. Now cases of COVID-19 in China are often imported from other countries as the epidemic in China appears to be declining for the time being.

50. TEDMED: In other words, major airports are all you need to guarantee that any country will have the virus everywhere in less than 3 months.

Yes. I think you say in America, “The horse has left the barn.” This is not a reason to completely stop all travel.

51. TEDMED: Why might a country like Japan close its schools?

Other countries such as Italy and France are doing the same. It’s because scientists don’t know how much of the spread is accelerated by children who are carriers. Japan is trying very hard to slow the spread. Children generally pass along viruses quickly since they don’t wash their hands or practice much personal hygiene. They play a big role in how the flu spreads which is why many countries have been closing schools in affected areas.

52. TEDMED: If I get infected, are there drugs I can take to make the virus less severe, or make it go away entirely?

No drugs have yet been proven effective as a treatment or what doctors call a “therapy.” A lot of different drugs are being tested in clinical trials, so hopefully that will change for the better soon.

53. TEDMED: How likely are we to come up with new therapeutic drugs, and how soon?

I’m quite confident that probably in a matter of a couple of months, we are very likely to find “off-label” uses of current drugs that help treat an infected person. In other words, we’ll have a new use for existing drugs that were originally used against other viral infections such as HIV. It will take time and a lot of real tests to be sure though. New therapeutic drugs are being tested in clinical trials, particularly in China, but also elsewhere. It looks promising.

54. TEDMED: What about antibiotics? Everybody always turns to them in a crisis.

This is a new virus, not a bacteria. Antibiotics work against bacteria but they do not work against viruses. They may be helpful in hospital usage with secondary infections that are bacterial, but antibiotics have no effect at all on the new virus itself.

55. TEDMED: What about all kinds of new cures and therapies and treatments I’ve heard about on the Internet?

There are going to be endless false claims. Only when you read about it on multiple reliable websites, can you feel confident there is real science. But most of what you hear will be total rubbish, so be very careful, and don’t spread unconfirmed rumors.

56. TEDMED: How about masks? Are those blue surgical masks or an N95 facemask useful?

Masks have very limited value except in certain specific circumstances. For example, depending on the type of N95 mask, just under 50% of inbound virus particles will be filtered out, but they may reduce spread from airborne droplets.

57. TEDMED: What are the advantages of masks when used properly and who should wear masks?

The best masks, carefully fitted and worn properly, slow down the spread FROM sick people coughing. Meaning, the mask is not to protect you from other people; it is to protect other people from you. It is a courtesy to others to wear a mask when you get what you think is a cold, and you start coughing. Masks have an additional benefit: they make it less likely that you will touch your mouth, so it becomes less likely that if you have the virus on your hands, you will transfer it into your body. Masks provide benefits for healthcare workers. If you work in a health- care setting or in elder care, masks are mandatory.

58. TEDMED: Is there anything I can do to prevent from becoming infected in a global pandemic outbreak?

Washing hands frequently, not touching your face, coughing and sneezing in your elbow or a paper handkerchief, not shaking hands or hugging all reduce your risk. If you are sick, stay home and consult with a doctor over the phone to see what to do next, and wear a mask when seeing other people.

59. TEDMED: What does “mitigation” mean? I hear scientists using that word a lot.

Mitigation means slowing the spread of the virus, and attempting to limit its effects on public health services, public life and the economy. Until there’s a vaccine, what we can do is slow it down. That is really important.

I hear scientists using that word a lot. Mitigation means slowing the spread of the virus, and attempting to limit its effects on public health services, public life and the economy. Until there’s a vaccine, what we can do is slow it down. That is really important.

60. TEDMED: What other ways can we slow down the spread of the virus?

Good hygiene and common courtesy can slow down the spread. In addition, “social distancing” measures — such as working from home, not taking a plane, closing schools, and banning major gatherings — will help slow the spread of SARS-CoV2.

61. TEDMED: Do different viruses spread more easily than others?

Yes. Measles is the worst. You can get measles by walking into an empty room that an infected person left 2 hours earlier! That’s why we have measles outbreaks when vaccination rates go down. It’s a very tough disease. The common cold spreads fairly easily. HIV is much harder to spread, and yet we’ve had 32 million deaths.

62. TEDMED: What will it take to stop this virus?

Nobody really knows for sure, but China has shown that it is possible to stop the spread significantly. A vaccine may be necessary to fully eliminate SARS-CoV2.

63. TEDMED: How long will it take for the new virus to spread through a population the size of the United States?

Left to spread with normal measures of good hygiene, SARS-CoV2 appears to double its infected population about every week. That means it will go from 50 people who are infected to 1 million people infected in about 14 weeks. That’s the simple arithmetic of contagion. Of course, we can do things to slow it down.

64. TEDMED: How effective is good hygiene in slowing down the spread of coronavirus? Do the numbers of infected people decrease noticeably if people follow the guidelines?

The numbers change based on how careful people are, and even small changes are important to avoid stressing the healthcare system more than absolutely necessary.

65. TEDMED: Can a few thousand cases be hidden among our population? How would that be possible?

Every year, there are millions of flu cases. This year, some of these cases are actually COVID-19. In addition, many infected persons show no symptoms or very mild symptoms, so they are hiding in plain sight.

66. TEDMED: Exactly what does it mean to test positive?

It means that a sensitive test has detected that the virus is present in fluids from that person.

67. TEDMED: Should everyone be tested as quickly as possible?

Testing for COVID-19 should be much more widely available because we still don’t know enough about who is infected, and how the virus spreads in the community. We need far more testing to learn important data.

68. TEDMED: Why has South Korea set up a system of “drive-through” testing?

South Korea has drive-through testing because they are trying very hard to slow the outbreak by finding every infected person as fast as they can.

69. TEDMED: What is the main symptom that people should be on the lookout for?

Coughing is the #1 symptom.

70. TEDMED: Is fever a good way to identify infected people?

A high fever may be cause for concern and is worth getting medical attention. But screening for fever alone, at an airport or checkpoint for example, lets a lot of infected people pass.

71. TEDMED: What percentage of the people who tested positive in Chinese hospitals arrived without a fever?

About 30% of Chinese coronavirus patients had no fever when they arrived at the hospital.

72. TEDMED: Is the new virus likely to come back to a country again once it peaks and the number of new cases drops off?

SARS-CoV2 is likely to never leave us without the same effort that eliminated smallpox and has almost eliminated polio.

73. TEDMED: Meaning, the only way to beat the new coronavirus in the long term is global population-wide vaccinations?

We really don’t know. Population-based measures may work, but a vaccine may be necessary and is probably viable as long as the virus stays stable and does not mutate too much.

74. TEDMED: Might the new virus “burn out” like other viruses have seemed to do?

We don’t know, but it is unlikely. SARS-CoV2 is already too well established around the world. This is no longer just a Chinese issue; there are probably hundreds of thousands of people infected but not yet tested — not only in China but in close to 100 other countries. SARS-CoV2, like the influenza virus that causes the seasonal flu, will likely be with us for a long, long time.

75. TEDMED: Will the new virus come back in waves or cycles, and if so, when?

Again, we don’t know, but it is a very important question. Probably, although at this early stage, nothing is sure. The 1918 pandemic flu circled the world in 3 waves. The new virus may have a second wave in China with the reopening of schools and factories. But until we see what actually happens, we don’t know how SARS- CoV2 will behave.

76. TEDMED: If we get a “lucky” break or two in the coming months, what does being “lucky” look like?

Warm weather may slow down the spread, although we don’t have any evidence yet that this is the case. Singapore, which has 120 cases already, and has one of the best COVID-19 control programs in the world, is just 70 miles from the equator — so at least in that case, a warm climate has not stopped the virus from spreading. It’s possible that SARS-CoV2 could steadily mutate into a less dangerous form so that fewer people die from it, as happened before with the swine flu in 2009. But I wouldn’t count on it. Quickly finding an effective drug therapy or cocktail of drugs would be excellent news. That’s about it for luck.

77. TEDMED: Do people who are at high risk for COVID-19 have the same chance of dying everywhere?

Unfortunately, your risk of death depends a lot on where you are in the world. If you need and get cared for in a well-equipped modern hospital, which we hope is accessible to lots of people, the death rate will be far lower because of intensive care respirators and fewer secondary infections.

78. TEDMED: How do I know if I’m going to be in the mild group or the one that needs hospitalization?

You don’t know for sure, but being over 70 or having a chronic condition increases your risk of severe illness, and even death. We can only speak in terms of probabilities, because we don’t yet know enough about COVID-19.

79. TEDMED: Should I be worried that I’m going to get COVID-19? How worried are you, Peter?

If you’re not at high risk, I wouldn’t worry too much, but I would do everything I can to avoid becoming infected as you don’t know individual outcomes. Everyone is eventually going to be at risk for acquiring this infection in the next few years, just as no one avoids the common cold or the flu over time. So all of us should be ready to stay home at the first signs.

80. TEDMED: What do you mean everyone is going to be at risk for getting the virus?

I mean that all humans spend time with other humans, so we are all connected — and biology is relentless. However, I would take sensible precautions and, at the same time, not worry obsessively. That isn’t helpful.

81. TEDMED: If everyone is going to get the new virus, why try to avoid getting it?

If I get the virus immediately, then I can be done with it and move on. We want to slow down the infection, which means slow down the number of new cases and total cases, so our hospitals can handle the most affected patients without getting overwhelmed or turning away patients with other types of illnesses that require immediate attention.

82. TEDMED: It appears that after people recover from the new virus, they may still be contagious. Is that true?

We don’t know, although it appears that may be the case for a while after recovery. We are not totally sure. More research is needed.

83. TEDMED: Once you get the virus, are you then permanently immune to getting it again, like with measles or mumps?

Here again, we don’t know the answer to that important question yet.

84. TEDMED: Obviously, permanent immunity against COVID-19 would be important for individuals who came through one bout of the disease. Is such immunity also important for society as a whole? Why?

This question is extremely important for the vaccine development, because vaccines rely on the ability of our body to mount a protective immune response and on a stable virus. And obviously the number of people susceptible to becoming infected would gradually decrease over time.

85. TEDMED: Is the new virus seasonal, like the flu?

We haven’t gone long enough to see if there is a seasonal mutation to SARS-CoV2, or how the trillions of new virus particles change as they pass through millions of people.

86. TEDMED: So this virus can mutate by itself into new forms with new symptoms?

We don’t know at all. If it does, new vaccines may be necessary to prevent the mutated version of SARS-CoV2 from spreading.

87. TEDMED: If the virus naturally mutates, does that mean it could become more deadly, and on the other hand, it could also become less deadly?

Yes, either one is possible. It’s a new virus, so we have no idea what the mutations will do.

88. TEDMED: If coronavirus becomes a threat that doesn’t go away, what does that mean for myself and my family?

It means we will all learn to deal with it, and make sure we are all adopting safe behaviors. We should be particularly mindful of the needs of older family members.

89. TEDMED: I heard the virus can live for 9 days on a countertop. Is that true?

It’s probable that SARS-CoV2 can stay viable on some surfaces for quite a while, but we don’t know for how long.

90. TEDMED: The greatest pandemic of modern times was the 1918 flu pandemic right at the end of World War I. In that pandemic, influenza simply mutated — it was not a new virus. How does SARS-CoV2 compare to that mutation?

SARS-CoV2 is just as contagious as the 1918 influenza pandemic and appears to be nearly as lethal, but time will tell. Remember, back in 1918 there was no medical system anything like what we have in the developed world, and there were no antibiotics to treat bacterial pneumonia, which was a major cause of death.

91. TEDMED: Is there any chance that this is one giant false alarm and that we’re going to look back this summer and say “wow, we all panicked over nothing!”?

No. COVID-19 is already in well over 100 countries and it’s highly contagious. Virtually every day there are more and more cases, in more countries. This is not a drill. It is the real thing.

92. TEDMED: It’s hard to believe that suddenly a truly new virus that mankind has never seen can infect millions of people. When is the last time that happened?

SARS and MERS were new — but they did not reach scale. HIV was new to the world and has infected 70 million people — of whom 32 million have died from the HIV Pandemic.

93. TEDMED: HIV affects poor countries much more than wealthier ones. Will that likely be true for the new virus?

Yes, absolutely. Wealthy countries such as the U.S. are going to have much lower death rates because of better hydration, supplemental breathing equipment, proper handling of infections, and the like. This is potentially a giant problem for low-resource countries that have poor health systems. Many countries in Africa will face enormous risks. When it reaches the most resource-challenged countries of the world, it’s very likely to be catastrophic.

94. TEDMED: It sounds like the bottom line is that you are not terribly optimistic.

In general, I’m definitely an optimist but at the same time, there is a lot to be very uncomfortable and nervous about. I understand people have fears, especially if they are in one or more of the high-risk groups. But there is also good news, because we are already seeing progress in global cooperation, especially in science and medicine. We are seeing more transparency among governments. The number of cases in China is currently rapidly declining, but that could change. And, we are seeing very rapid development of therapeutics, for example.

95. TEDMED: You also said there is a lot to be concerned about. What are your biggest worries for the new virus?

Poorly managed, the spread of coronavirus can quickly overload any country’s healthcare system and block people who really need all kinds of medical access. Another worry is that overreaction and fear can cripple a country’s economy, which causes another kind of suffering. So, this is a very tough trade-off.

96. TEDMED: And, what should we be psychologically prepared for?

We should be psychologically prepared to hear about lots of “new” cases being reported in every city in the U.S. that begins testing, as well as an increasing number of deaths, particularly among the elderly. In reality they are often not “new” cases; they are existing cases that have become visible for the first time.

97. TEDMED: What things are you encouraged about?

1. Modern biology is moving at breakneck speed. 2. In addition to the public health community worldwide, including the World Health Organization, Government leaders at the highest levels are focusing on the threat. 3. We isolated the virus in days and sequenced it quickly. 4. I am confident we will soon have a treatment. 5. We are hopefully going to have a vaccine. 6. This is truly the age of modern communication. That can help us, as long as we debunk fake and dangerous news.

98. TEDMED: How ready is the U.S. for this?

The U.S. has had ample time for a head start to prepare for this pandemic, and so have other high-income countries. We all benefitted from China’s unprecedented mass quarantines that slowed down the spread. The U.S. will handle the serious cases correctly from the start by being more prepared.

99. TEDMED: Who are you most worried about?

It’s the low-resource countries that I am very worried about. Each death is a tragedy. When we say that on average, 1% to 2% of infected people will die from coronavirus, that is a lot. After all, 1% of a million is 10,000 people, and it is the elderly I am very worried about. But 98%-99% of people won’t die from this. The seasonal flu kills tens of thousands of Americans every year and you don’t panic — even if we actually should take flu far more seriously and make sure we are all vaccinated against it every year. Just as we have learned to live with seasonal flu, I think we will need to learn how to go about our lives in a normal fashion, despite the presence of COVID-19, until an effective vaccine becomes available.

100. TEDMED: Are there more pandemics in our future?

Definitely yes. This is part of our human condition and of living on a “virus planet.” It is a never-ending battle. We need to improve our preparedness. That means committing ourselves to seriously invest in pandemic preparedness and building a global fire brigade, long before the house catches on fire next time.

Peter, all of us at TEDMED thank you very much for your insights on this worldwide challenge. The better informed we all are, the better opportunities we will have to slow the spread of this — or any other — pandemic, and eventually either cure it or prevent it.


ABOUT PETER PIOT

Peter Piot, co-discoverer of the Ebola virus, is the Director of The London School of Hygiene & Tropical Medicine, renowned for its research, postgraduate studies and continuing education in public and global health.

Described by the Financial Times as “one of the world’s most famous ‘virus hunters,’” Professor Piot co-discovered the Ebola virus in Zaire in 1976. From 1995–2008, as the founding Executive Director of UNAIDS and Under Secretary-General of the United Nations, he made UNAIDS the chief advocate for worldwide action against AIDS. He also served as an Associate Director of WHO’s Global Programme on AIDS.

Professor Piot has held important posts at the Institute of Tropical Medicine, Antwerp, the Free University of Brussels, the University of Nairobi, the University of Washington, the Ford Foundation, and the Bill & Melinda Gates Foundation. He was the Director of the Institute for Global Health at Imperial College, London, and held the chair “Knowledge against poverty” at the College de France. A Fellow of the Academy of Medical Sciences, he was elected a foreign member of the National Academy of Medicine of the U.S. National Academy of Sciences. He is also a member of the Academy of Sciences Leopoldina of Germany, the Académie Nationale de Médecine of France, and of the Royal Academy of Medicine of his native Belgium, and a fellow of the Royal College of Physicians.

He has received numerous scientific and civic awards including an honorary doctorate from seven universities, the Canada Gairdner Global Health Award, and Robert Koch Gold medal, (2015). He was a 2014 TIME Person of the Year (The Ebola Fighters), and received the Prince Mahidol Award for Public Health. In 2013 he was the laureate of the Hideyo Noguchi Africa Prize for Medical Research. He received the Thomas Parran Award from ASTDA, the Nelson Mandela Award for Health and Human Rights in 2001, the Frank A Calderone Prize in Public Health in 2003, and the Prix International INSERM, Paris, RSTMH Manson Medal, and Bloomberg Hopkins Award. He was knighted as a Baron in 1995 in his native Belgium, and awarded an Honorary Knighthood KCMG in 2016, and the Grand Cordon of the Order of the Rising Sun of Japan (2018). He has published over 600 scientific articles and 17 books, including his memoir ‘No Time to Lose’ in 2012 (WW Norton), translated into French, Dutch, Japanese and Korean, and ‘AIDS between science and politics’ in 2015 (Columbia University Press).

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