The OK for Patients’ Return to Healthcare Needs Clear Signals From Trusted Sources

COVID-19 was a shock to the system unlike anything that had been anticipated. Even prior to the shutdown, health-perceptive people were starting to avoid public venues and there were declines in the numbers of people going out to eat at restaurants, to public functions, visiting with friends and also going to the doctor’s offices.

When it comes to healthcare, that has translated into multiple stress points to our system of care spanning both health and economics with people avoiding care for both their chronic and acute medical needs. Medical personnel themselves have been consumed by COVID-19 duties to care for patients and many have themselves fallen ill. Many medical and dental practices have shut down or have reduced greatly the number of patients being seen and then, only under specific circumstances. That means that not only will there be a backlog of patients, but they will be coming in for care when they have progressed in their illness or made its treatment more complex. Moreover, they may have lost their insurance. The interruption of services has brought financial peril to practices, particularly small ones. Cracks that existed in the healthcare system prior to COVID-19 have widened while new ones have appeared. As with all venues – work, restaurants and healthcare, a return is going to be premised on multiple factors, but many of which will rely on communications.

My colleagues at FleishmanHillard’s TRUE Global Intelligence – the in-house research arm – fielded an online survey of 600 adults in the U.S. aged 30-75 on May 4-5 to provide insights into the perceived risk people have of returning to healthcare offices and moreover, what will make them feel safe.

What they found was that concern is widespread, far-reaching and multi-faceted. Overall nearly forty percent of consumers surveyed felt either “not very safe” or “not at all safe” in going to a dentist and nearly 1 in 3 (28 percent) stated that they did not feel very safe or not at all safe in a physician visit. Moreover, 41 percent stated that they would not feel very safe or not at all safe in going to a hospital for a diagnostic test, while even greater numbers stated they would not feel secure in going for elective surgery either as an outpatient or inpatient. Women felt a greater sense of unease than men by far in each of these categories, and naturally because of the risk of co-morbidities with COVID-19, the older a person was, the less inclined one was to feel safe. Overall, only one-third felt that it would be considered safe to visit their physician in the coming months. You can view and download the complete survey report here.

Concerns were not limited to the physical premises, but also centered on ancillary issues. For example, 69 percent of respondents said they were either “extremely concerned”, “very concerned” or “moderately concerned” about someone not being able to attend a procedure with them, or to be able to stay with them during recovery. Additionally, 58 percent were concerned that they would not be able to have someone to take care of them once they were home, and nearly half feared not being able to find someone to take them to and from a procedure – sentiments that were particularly concerning to younger consumers.

What will it take to be ok? The bottom line for consumers (80 percent) was that there needed to be some clear way of communicating the parameters of safety in a healthcare setting, but consumers are guarded about the motivation behind those communications, with 63 percent worried that a drive to get patients to return may be driven by financial reasons. They overwhelmingly (88 percent) expressed a desire for clear and simple communications about safety in returning to the healthcare setting but 80 percent feel that there currently are no clear signs.

Clear communications on this front will not be easy. The survey revealed that one of the most reassuring messages to patients was that healthcare staff are being routinely tested for COVID-19. But the real challenge is that as people seek certainty and security, the solid facts about COVID-19 are still being discovered. And no one entity is in charge of the message complicated further by a politicization of the issue. The survey also revealed that the voice of the physician is more important than that of elected officials or governmental bodies.

In short, it is likely to be communications from healthcare providers – both individual practices and large institutions, medical societies and perhaps ultimately those without a direct financial interest – such as patient organizations – that may ultimately shape perceptions about that risk. That makes this more of a grassroots effort than communications that comes from the top-down. That, in turn, means that efforts may vary regionally and even by locale. Above all, it will be essential to strike the right balance of message with the appropriate messengers and the correct times. And above all, it will be a process, not an event.

Photo by Martha Dominguez de Gouveia on Unsplash

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The Pharmaceutical-Biotech-Devices Industries Face a New World Post-Pandemic

There is going to be a time in the not too distant future, when the fuller picture of the healthcare impacts of COVID-19 come into sharper focus. When that happens, it is not likely to be pretty. In large part, this is because a very large portion of the population has moved into a state of unemployment. With that reality come a labyrinth of consequences that alter the healthcare landscape on a seismic scale, particularly in the United States where access to healthcare relies largely on being employed. For the pharmaceutical, biotech and device industries, this impacts everything from from philanthropy, to sales force mindset and approach, to the development of strategic partnerships. There are going to have to be changes. And moreover, there are likely to be new expectations.

Here are just a few realities:

  • We will be sicker. First of all, people have put off care across therapeutic categories, in many cases likely exacerbating their existing conditions. In addition, illness that may have been prevented through early detection and treatment will not have been. Icing on this particular cake is that everyone is stressed resulting in substantial acute mental health needs – and we don’t really have a good mental health system of care in this country. In fact, we don’t even have a system.
  • We will be poorer. Just when we need access to the healthcare system more urgently, more broadly, and with more needs, as a result of unemployment we will have less ability to do so. Insurance that was employer dependent will have evaporated for many, savings will be consumed and with a resulting increase in indigence (which means food and nutrition insecurity), there will likely be a huge and unprecedented migration onto Medicaid.
  • We will have fewer options. Healthcare practitioners have taken it on the jaw and a number of practices as well as institutions, such as rural hospitals, may be in shorter supply. In addition, healthcare workers have been on the front lines and many have been stricken and died. And there will be those who will not want to continue in their profession given this experience and the new demands placed on them in a post-COVID world. Some will just understandably burn out. That means that even for those lucky enough to retain their insurance, the options at hand for accessing medical care may be far less than they were before.
  • We will be more on our own. Non-profit patient support organizations provide a great deal of support for all types of patients. During the early days of the AIDS epidemic these organizations filled the many holes that were in the system of care providing everything from counseling to food support to dentistry to name a few in a long list. There exist a multitude of patient organizations providing support and advocacy for their constituent groups. They are all charitable entities that rely on donations. With so many fewer people employed, donations will be much more competitive and in much less supply. They are going to need help to survive.

Naturally it is not up to the pharmaceutical, biotech and device sector to solve all of these problems, but there may be a very real expectation that they are huge part of the solution in areas where they have the ability to make the greatest impact.

In September 2019, a Gallup poll was released that showed that the pharmaceutical industry had hit rock bottom when compared to other sectors, with a positive rating of just 27 percent of the population and a negative rating of 58 percent. Now, as we universally experience a pandemic that has threatened our health and our wealth, attitudes may be shifting. Some have speculated that this crisis presents industry with an opportunity to change public perception. This was evidenced in a analysis conducted by my colleagues at True Global Intelligence, the in-house research practice of FleishmanHillard. In a survey of over 6500 people conducted globally in six markets, people were asked how important various entities were in responding to the pandemic. Pharmaceutical companies had the second highest ranking (93 percent of respondents), just behind the role of national government, ahead of local government, employers and well ahead of other major corporations.

In other words, there is a great expectation of industry. Fulfilling it may mean adopting new approaches to supporting health care professionals as they grapple with the pent up medical demand for non-COVID conditions. It will likely require a more holistic relationship between providers and companies through their sales force; the development of new and expanded patient assistance programs to address the needs of the newly indigent and those lacking insurance; providing beefed up support for patient organizations seeing to the ancillary needs of their constituents, and more. It requires proactive planning now, not reactive patchwork later.

There are going to be a lot of pieces to pick up and put back together. From adversity there is always present opportunity. This is not just a medical crisis, it is a humanitarian one. And unlike the AIDS pandemic that was horrific but narrow in scope, this one touches every single person in critical ways. That means an approach in a post-pandemic world must also be humanitarian and must be comprehensive. People expect the pharmaceutical, biotech and device industries to step up and bring this pandemic to its knees with treatments, vaccines and tests (antibody and viral presence), but the expectation is not likely to stop there. When everything else is somewhat broken, the industry will likely still be standing tall. The future perception of the industry may hinge more on its presence in the aftermath of COVID-19 in helping shape a new and better environment than it will be by innovation expressed during the pandemic that eventually may bring an end to it.

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The Language of “Recovery” in the Age of COVID-19

There have been many parallels drawn between this pandemic and the AIDS pandemic that began in 1981. And in fact while many obvious differences exist there are many valid comparisons. Moreover, there are some common threads that run through crises involving a communicable disease and here were a few from this writer back in February 2020. But as many turn their attention to a “recovery” phase for this pandemic, there are also some lessons learned from the experience of HIV/AIDS that might be applicable today.

It begins with the very term – recovery. On the grand scale this word refers to the desire to address the economic impact that has been wrought by the pandemic and the necessary measures of social distancing to contain it. On a more individual level, recovery signifies getting our lives back – having people over, going out to a restaurant, receiving or giving a hug. For the former the yearning has led to policies put into motion that will relax containment measures, leveraging economic gain with potential human loss. For the latter, it may lead to easing up and going to get that haircut or have one’s nails done or getting that hug. For both, the outcome may be perilous. Time will tell.

Language is important. The word “recovery” sets up an expectation that things – business, the economy, our personal lives, will go back to “normal” or that there will be a “new normal” that is different – though undefined despite the fact that the term is increasingly used. There are many scenarios of what may happen with the COVID-19 pandemic, but one of them is that the recovery is represented less by a definite demarcation – a turning point or represented by straight lines – to one represented by wavy lines, where infection rates go up and down. In the absence of a vaccine, this scenario has a strong basis, perhaps particularly as social distancing is relaxed in a patchwork fashion across the nation. A “new-normal” could be a state of being where there is no new normal.

From 1981 through 1997, I worked in HIV/AIDS and in the early days of the 1980s was the Director of Legal Services at the Gay Men’s Health Crisis in New York City, providing legal support to people – helping battle insurance companies, devising immigration solutions, bringing discrimination actions and doing endless wills – many in hospital rooms suited up in protective garb of caps, gowns, and masks. Almost every day I got “RIP sheets” delivered to me naming my clients who had died. I had about 3000 clients at any given time and there were 3-4 names per sheet of paper. On some days, the RIP sheets ran 20 pages long. Many co-workers died; many friends died (once 2 in a day); my partner died. It would be many years before there was an effective treatment that would bring change. Every day represented a yearning for recovery – hopes that rested on the possibility of either a cure or a vaccine. It bears noting that we are still waiting for either one. And all that happened nearly forty years ago.

My point is this. Recovery experiences that are so life-changing is very subjective. It is not a blanket return to normal. Something you quickly learn going through this sort of thing is that it is not a crisis that comes and goes, it is bigger than a crisis. Tectonic plates shift. Things re-order. Recovery implies an ability to forget about what has happened and to move on. But in fact, when the magnitude of what you go through is so large, expansive and pervasive, you don’t forget, you learn to live with it. Or you don’t. It became a mantra of mine in those days. You don’t forget this, you learn to live with it. And that takes work.

And so in the context of today’s pandemic, what we are going through – economically, politically and personally – invites a sort of examination of our strengths on a very subjective level. A promise of “recovery” in the traditional sense is perhaps setting ourselves up for failure. Moreover, this does not happen from the top down. It cannot be ordered by policymakers, either those in government or those in corporations, organizations or other institutions. It is not directed, it is inspired. And it will have to come from within – from the people living in states, the people working in companies, and those serving in institutions. And forty years from now, it may well be those who discarded the notion of “recovery” in favor of concentrating on the ability to adapt who have a perspective that helped them survive.

Photo by Ezra Jeffrey-Comeau on Unsplash

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Impact of COVID-19 on FDA Enforcement and Approvals – Part 5 – FDA Provides Update to Shape Expectations on New Approvals

In response to written questions submitted last month regarding the potential for delays, FDA had stated that “CDER remains fully capable to continue daily activities, while responding to the public needs of the current COVID-19 outbreak.” In a subsequent blog posting this month, it was noted that FDA was devoting personnel to focus on COVID-19-related review efforts and that it was certainly possible that this might be a factor in delaying new approvals of non-COVID-19 medicines and devices. Yesterday FDA provided an update which affirms the possibility of delay. The fact that there was such an update would seem to indicate that the agency regards delays as increasing in likelihood.

Of note in yesterday’s statement the agency stated – With many staff working on COVID-19 activities, it is possible that we will not be able to sustain our current level of performance indefinitely. Our staffs are working at full capacity and we are striving to ensure that the drug programs continue to see minimal interruptions during this time. However, if there is an increase in drugs shortages and supply disruptions, we will be ready to reprioritize more of this work, as necessary.

And respecting devices, it seems to appear a little more certain that there will be delays: Additionally, with many staff in CDRH working on COVID-19 activities related to pre-Emergency Use Authorizations (pre-EUAs), EUAs, and Immediately In Effect (IIE) guidance documents, it is possible that we will not be able to sustain our current level of performance indefinitely. However, this will be assessed on an ongoing basis.

In the current environment, the only thing that can be said with certainty is that we are dealing with a great deal of uncertainty. The statement from FDA does not absolutely say that there will be delays, but that there are factors at play that make it more possible that there may be delays. It bears keeping in mind that not all new drug and new device applications are equal – in other words, while delays are possible and even probable, there are likely variables at play that will be highly influential on whether a particular application is delayed. But the communication from FDA underscores the possibility.

For the present it is a wait-and-see moment for each and every product in the pipeline. And in the longer term, to see what impact that this year will have on the future course of approvals as well as the standards by which products are reviewed.

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T-Minus COVID-19 – Impact of Pandemic on New Medicine Launches

As the coronavirus pandemic began to unfold, focus on the pharmaceutical and biotech sectors was on the most immediate and apparent concerns – the impact on the supply chain for drugs that are currently in the market and on the regulatory process for approving new ones. More distant in time, but also of extreme importance is the effect on the launch of new medicines that have been approved.

Drugs coming to market are important in several respects. First, they may represent advances in either safety or efficacy over previous treatments – or they can even be bringing new treatments in a category where there are very few or no viable treatment options. Second, they represent hope to patients whose needs are not being met in the current treatment environment. Third, they may have a financial impact for the company and they set shareholder expectations for return. Finally, they underscore the innovation of a company that is vital to its brand.

But a new drug launch in the time of COVID-19 comes with definite challenges. Recently in the U.S. Bristol Myers Squibb stated in its press release announcing FDA approval of the company’s treatment for multiple sclerosis that the commercial launch would be delayed due to the COVID-19 situation. And in Europe bluebird bio announced that it would delay the treatment of the first patient in Germany with its new approved gene therapy until the second half of 2020.

Why would COVID-19 affect a drug launch? Some of the factors involved include:

  • Risk Associated with Routine Medical Visits – There has been an observation that catheterization laboratories have seen a steep drop in utilization since the pandemic began, which could indicate that people are avoiding going to the doctor right now out of fear of contagion, even when experiencing something as serious as symptoms of a heart attack. In particular, patients who are older or who are experiencing a serious illness that might put them at increased risk may avoid going to the medical office for a routine visit. Since healthcare providers are the gatekeepers to prescriptions, it necessarily would impact uptake of any new medication.
  • Loss of Insurance – Millions of people are losing their jobs, and often with it, their access to health insurance not only for the care, but to cover the cost of new prescriptions. The magnitude of job loss is going to seriously impair the ability of people to access their existing medicines, much less be evaluated for new (and likely more expensive) treatments.
  • Concerns Related to Starting New or Switching Therapies Now – Switching a therapy to a new medicine, or starting any new medication, may require follow up evaluation. If people are avoiding non -urgent medical care based on fear of COVID-19 transmission, their desire to switch medications that might necessitate follow up is likely to dampen any desire to start a new therapy.
  • Physician Practices Under Stress – Many practitioners are on the front lines or are in institutions that are under siege, dealing with issues from the inherent lack of personal protective equipment to patient need to demands for tests that are not available. This is not to mention their own health status and those of their families. Many individual practices are not seeing patients.
  • Company Sales Forces Operating in Virtual Environment – Prescribers are introduced to new medicines and learn about their many aspects through visits from sales representatives. By necessity, these are occurring in a virtual environment, but it’s a conversion that will take time to establish itself, with the technical side being only part of the challenge. It is one thing to take a discussion of orders online, it is quite another to master the art of developing a relationship in a virtual setting.

While the challenges are many, there is one counterweight that may address some of what might otherwise impede access to care – the increasingly rapid facilitation of access to telemedicine. Every day the the impacts of the pandemic take on new aspects. And each day we are without a vaccine means these effects are going to linger. While telemedicine is not a panacea, it is one means of addressing the issue of access based on concerns that patients have for stepping into the healthcare environment. There is little question that the pandemic has motivated the healthcare system to turn to telemedicine as a solution and to have payers firm up efforts to reimburse for its use. Hopefully as we collectively travel through this new terrain, over time we will address the loss of access to healthcare due to financial constraints. There is no question that delay of new medicine launches for now may be a short-term necessity, but we are going to have to deal with the fact that we are in the midst of long-term problems to every aspect of the healthcare system on which we are going to rely.

Photo by Fusion Medical Animation on Unsplash

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