Monthly Archives: May 2020

Covid-19: Will Pharma Deliver What It Can Do The Best, Soon?

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The news of a bright possibility of finding magic bullets to significantly tame, if not totally annihilate Covid-19, is coming almost every passing day. As expected, these are being initiated mostly by drug companies, alongside various academia, located in several countries of the world, including India. It rekindles hope to return to some kind of normalcy in daily life, work and business.

However, the hype created around each of these, either too early or based on some anecdotal reports, apparently driven by the desire for a windfall commercial gain, may be counterproductive. That some remedial measures to tackle the notorious virus will come very soon, could influence a number of decisions of those who are engaged in managing the situation.

The pressing need to restart the economic activity – come what may, even before the first wave of Covid-19 subsides in a developing country like, India, comes along with a strong storm signal. Balancing life with livelihood has never been so difficult ever. In tandem, it poses a great challenge also for the pharma industry to demonstrate what it stands for the society, such as:

  • Bringing scientifically proven, safe and effective drugs and vaccine, in a specified timeframe falling close to the realm of a genuine possibility.
  • Making these drugs and vaccines available, at an affordable price and accessible to all, globally.

In this article, I shall focus on the relevance of these two critical expectations of all, where, incidentally, pharma is expected to do and deliver the very best – particularly against the prevailing and near-chaotic scenario. Let me begin with the first point first.

A great challenge:

Understandably, the above task is not a piece of cake due to many reasons. For example, according to a leading pharma trade association in the United States, ‘On average, it takes at least ten years for a new medicine to complete the journey from initial discovery to the marketplace, with clinical trials alone taking six to seven years on average.’

Thus, logically, a new drug molecule for Covid-19 can’t possibly be expected, by any stretch of imagination, within the next 12 to 18 months. What one can possibly expect for the same is, repurposing older drugs for the same. Quite logically, steps are being taken in this direction. However, even for such drugs, a clinical trial would take ‘six to seven years on average.’ Considering the urgency to combat the Covid-19 pandemic, can a fair clinical trial be completed in the next 12 to 18 months?

Therefore, the challenge in hand for the drug companies, even considering a super fast-track regulatory assessment and approval in 12 to 18 months, appear a pretty tough proposition. The challenge gets more complex, if Covid-19 starts changing.

A new issue is unraveling:  

Recently, a new dimension got added to the mounting challenge of coming out with an effective drug or vaccine to fight Covid-19 pandemic, as evident from the Bloomberg article of May 20, 2020. It carries a headline ‘China’s New Outbreak Shows Signs the Virus Could Be Changing.’

It reported, Chinese doctors are seeing the Coronavirus manifest differently among patients in the new cluster of cases of their northern provinces of Jilin and Heilongjiang, compared to the original outbreak in Wuhan. Apparently, it indicates that the pathogen may be changing in unknown ways, complicating efforts to manage the infection. Although, more details need to be unraveled in this area, this incident could flag a fresh uncertainty over the virus mutation that may hinder current efforts of developing safe and effective drugs and vaccine for Covid-19.

Still no available drugs and vaccine for Covid-19 with proven clinical efficacy:

‘The Lancet’ article of April 02, 2020 – ‘‘Global coalition to accelerate COVID-19 clinical research in resource-limited settings’ has also emphasized the above point. It reiterated, there is still no available vaccine against Covid-19 infections and no drug with proven clinical efficacy, although there are several candidates that might be effective in prevention or treatment.

As of March 24, 2020, there were 332 COVID-19 related clinical trials, 188 of which were open for recruitment and 146 trials are preparing to recruit. These clinical trials were either planned or being carried out, mostly in China, South Korea, Europe and North America. However, not many trials were planned in south and southeast Asia, Africa, and central and South America at that time, the article pointed out. But the hype for the availability of drugs continues to reverberate, generally in the media reports. Nevertheless, the work is still in progress.

Some unproven hype as on date?

Despite so much of publicity on availability of drugs for the treatment and prevention of Covid-10, starting from Chloroquine and Hydroxychloroquine, which the US President Donald Trump called a “game changer” for Coronavirus – right up to Remdesivir, none has demonstrated scientifically proven clinical efficacy, as yet.

For example, the latest clinical trial results for Covid-19 on 15000 people, published in The Lancet on May 22, 2014 found, hydroxychloroquine and chloroquine did not benefit patients with the Coronavirus, either alone or in combination with an antibiotic. Moreover, the drugs caused an increased risk of cardiac arrhythmia. Earlier,  ‘The BMJ’ article of May 14, 2020 also found that the administration of hydroxychloroquine did not result in a significantly higher probability of negative conversion than standard care alone in mild to moderate Covid-19 infections. This study also noted, adverse events with the recipients of hydroxychloroquine were higher than non-recipients.

On the other hand, in India, as reported on May 23, 2020, the Union Health Ministry has issued an advisory expanding the pool of people to be given the anti-malarial drug hydroxychloroquine (HCQ) as a prophylactic to prevent them from contracting the infection.

Similarly, even Gilead had stated in its Press Release of April 29, 2020: ‘Remdesivir is not yet licensed or approved anywhere globally and has not yet been demonstrated to be safe or effective for the treatment of COVID-19,’ besides some  initial success reports. Notably, in India, Union Health Ministry has also recommended the use of anti-HIV drug combinations Lopinavir and Ritonavir for high-risk group patients, although there is no proven clinical evidence for its efficacy and safety in Covid-19 patients, if not against the use of this combination therapy.

Commercial activity progresses even before evidence-based regulatory approval:

Although, a single clinically proven drug is yet to come out, commercial activities for some of these drugs – in a near desperate situation – based apparently on hype created, including by the US President, have progressed or progressing. This had happened for hydroxychloroquine and has now started happening for remdesivir.

Almost every passing day one finds yet another repurposed drug being put on clinical trial by a different company, probably for similar reasons. There is nothing wrong on that, but which drugs work and which do not, must be evaluated in a more cohesive manner and sooner.

The good news is, the World Health Organization (WHO), which is concerned with recommendations for ‘administering unproven treatments to patients with COVID-19 or people self-medicating with them,’ has announced the “Solidarity” clinical trial for the new Coronavirus treatments. This is an international clinical trial, aimed at the scientific assessment of 4 treatment options to slow the disease progression or improve survival rate for COVID-19 patients.

Otherwise, a strong desire for people to survive – ‘somehow’, will prevail in this desperate situation, over what these medicines can actually deliver. Even drug companies never experienced in the past or even could even envisage such a pandemic at this humongous global scale.

A similar scenario is witnessed with some major vaccine development initiatives. For example, stock markets soared with the early signs of viral immune response of the much publicized experimental Covid-19 vaccine being developed by Moderna Inc. However, a few days later, after ‘parsing the data to gauge the company’s chances of success’ by the analysts, it was reported: ‘It’s too soon to assume success for Moderna Inc’s COVID-19 vaccine.’ Curiously, it continues to happen in the early days with almost all such well publicized initiatives. Nonetheless, the pursuit to find out safe, effective and clinically proven drugs and vaccine continues.

Which is why, bringing scientifically proven safe and effective drugs and vaccine sans the early hype, in a specified time, falling close to the realm of a genuine possibility, becomes a key deliverable of pharma players, in this situation. That said, it brings me to the second point where pharma and biotech companies are widely expected to meet the other expectations of all – making these drugs and vaccines available, affordable and accessible to all, globally.

Making Covid-19 drugs and vaccines available, affordable and accessible to all, globally:

Again, this seems to be an equally tough call for most drug players, as has been happening, generally. But Covid-19 drugs and vaccines are just not for saving life, these are also intimately related directly to the livelihood of a very large global population, especially in the developing nations, like India. Therefore, ‘Coronavirus vaccine should be for everyone, not just those who can afford it,’ as articulated in the article, published in the STAT news on March 05, 2020.

This apprehension arises among many in the United States, as well. Mainly because, as reported in the above article, vaccine coming out of the two vaccine development projects funded by the U.S. government, one by Sanofi and another by Johnson & Johnson, may not be affordable to all Americans.

Further, quite a number of countries in the world lack resources, infrastructure, and health care personnel to detect the virus and prevent it from spreading quickly and easily among populations. In which case, without drugs and vaccines, the number of cases is likely to grow exponentially, putting stress on already burdened health care workers and facilities. Consequently, it will make harder to provide timely care for those who are ill. Thus, vaccines will be an important tool for preventing such a catastrophe.

For those with resources – ‘rich countries and rich people,’ a Covid-19 vaccine will certainly be valuable to save lives. However, for most people in all countries, including India, it may be essential for the livelihood, as well. Without it, they will suffer disproportionately and unnecessarily, the article concluded. Thus, in this hour of multiple crisis of global dimension, the drug players are expected to come forward, making these drugs and vaccines available, affordable and accessible to all, globally – a task where they can deliver the best, compared to others.

Conclusion:

Amid ‘Lockdown.4’ in India, as on May 24, 2020 morning, the recorded Coronavirus cases have mounted to 131,920 with 3,869 deaths. By the way, on the same day, the most populated country in the world – China, where Covid-19 struck first in December 2019, records 82,974 cases with 4634 deaths, so far.

That apart, Covid-19 is a very special situation for all countries, probably more than what happened during the 1918 Spanish flu pandemic, for several reasons. Comparing these two pandemics, especially during the lockdown period, has been common. Due to this pandemic, as many as 675,000 people, reportedly died only in America, many of them were previously healthy young adults. Almost similar situation is on the horizon with the Covid-19 pandemic.

Agreed, that the overall healthcare infrastructure and global scientific resources to combat these two pandemics may not be comparable. But even in the context of the 21st century, this is a very critical global situation, for both – saving life and also the livelihood. Thus, for pharma and biotech companies ‘this is not a time to make money’, as the chief executive officer of Serum Institute of India, which is helping produce a vaccine for Covid-19 developed by Oxford, puts it succinctly. Be that as it may, the answer to the two questions that I started with, still remains elusive.

By: Tapan J. Ray    

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Come Covid-19 Drug And Vaccine, Pharma Will Get Back To The Traditional Mode

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‘Corona will remain a part of our lives for a long time. But at the same time, we cannot allow this to happen that our lives will be confined only around the corona. We would wear masks, follow two yards distance and pursue our goals. Therefore, the fourth phase of lockdown, lockdown 4, will be completely redesigned, with new rules,’ said the Prime Minster of India, during his televised address to the nation on May 12, 2020.

Many countries around the world, have already decided to move ahead, phasing out Covid-19 lockdowns cautiously, in a manner that each country will deem appropriate. Alongside, in line with many other industries, several pharmaceutical companies seem to have also started accepting this new reality. For example, Novartis, which reportedly, started digitizing its sales and marketing even before the COVID-19 pandemic, has hit the fast forward button.

This is evident from what Novartis said: “We were already on a journey in terms of our commercial model where digital and other channels and virtual detailing were becoming a bigger part of our mix.” The Company is planning an omnichannel digital launch for its latest new product – Tabrecta for metastatic lung cancer. This was prompted by the very sensitive situation that the world is going through ‘and the extra burden that’s put-on physicians and patients” as the pandemic continues - the company clarified.

This leads to the key question, are most companies on the same wavelength as Novartis, in this area? Or, a large majority of drug players, is still nurturing the hope that prescription demand generation activity from doctors and hospitals will soon return to the traditional mode of what was prevailing during pre-Covid-19 pandemic days? This flows from an age-old experience – a large number of sales or medical representatives have always spearheaded the demand generation mechanism for any patented or brand-generic medicine.

Still, for many it is difficult to even think of any quantum shift in this space, as the traditional core mechanism continues, despite so much hype of digitalizing pharma operations. Whereas, several others do feel, at least, a Covid-19 vaccine or a drug for its effective treatment, which, apparently, are almost knocking at the door, will bring the current situation back to the previous normal. Will vaccine or an effective drug be a panacea to win the war of Covid-19 pandemic, decisively? In this article, I shall dwell on this subject. To set the ball rolling, let us fathom whether or not coming out with a safe and effective Covid-19 vaccine, in a jiffy, is rather a certainty.

Is Covid-19 vaccine a certainty?

No doubt, a large majority of people believe, a vaccine to prevent COVID-19 is perhaps the best hope for ending the pandemic, as Mayo Clinic has also said so. However, it also records the following major apprehensions or challenges in developing a COVID-19 vaccine, based on the research data:

  • Ensuring vaccine safety
  • Providing long-term protection
  • Protecting older people

On May 12, 2020, at the US Senate hearing about the path forward from pandemic lockdowns in the United States, NIAID director Anthony Fauci also said, there’s “no guarantee” any of the vaccines in testing will be effective, though based on his knowledge of other viruses, he is “cautiously optimistic.” Thus, projections about how COVID-19 will play out, are still mostly speculative.

Why ‘projections about how COVID-19 will play out are still speculative’?

A recent article – ‘How the COVID-19 Pandemic Could End,’ published in the ‘Scientific American,’ also commented so. It said, the end game will most likely involve a mix of everything that checked past pandemics:

  • Continued social-control measures to buy time,
  • New antiviral medications to ease symptoms,
  • And a vaccine.

Citing the famous example of the H1N1 influenza outbreak of 1918–1919, it said, doctors and public health officials had far fewer weapons than they do today. Thus, the effectiveness of control measures, such as school closures depended on how early and decisively, they were implemented. Over two years and three waves, the pandemic infected 500 million and killed between 50 million and 100 million. It ended only as natural infections conferred immunity on those who recovered.

Which is why, as on date the pursuit to achieve all three goals as mentioned above, would likely to continue. That said, a safe an effective Covid-19 vaccine will be the most preferred way to stop rapid transmission of the Coronavirus outbreak. However, this comes with a critical caveat.

Would the entire population need to be vaccinated?

Experts believe, unless a vaccine is administered to all of the world’s eight billion inhabitants who are not currently sick or recovered, COVID-19 is likely to become endemic. It will circulate and make people sick seasonally—sometimes very sick. But if the virus stays in the human population long enough, it will start to infect children, showing mild symptoms.

In that process, children appear less likely to develop severe disease if they get re-infected as adults.  Thus, the combination of vaccination and natural immunity will protect many of us. ‘The Coronavirus, like most viruses, will live on—but not as a planetary plague,’ the ‘Scientific American,’ article concluded.

Covid-19 end game to involve a mix of those that checked past pandemics:

Let us now look at the possible mix of the Covid-19 end game, which were involved in checking the past pandemics, one by one:

Continued social-control measures to buy time:

The social control measures would include compliance with the prescribed social distancing norms, in tandem with aggressive testing for the infected individuals, isolating them, and quarantining their contacts. These measures were well tested in the past epidemics and useful if followed well, by all.

Therefore, from the pharma industry perspective, getting back to the traditional ‘pre Covid-19 mode’ of prescription demand generation mechanism, will indeed be challenging for most drug players.

Availability of well-tested antiviral medications to ease Covid-19 symptoms:

So far, there is no scientifically and well-tested medications for the treatment of Covid-19. However, many different medications are under clinical trials in various parts of the world. So far, most hyped among them appears to be remdesivir, an experimental antiviral developed by Gilead for the treatment of Ebola.

However, the clinical study result of ‘Remdesivir in adults with severe COVID-19,’ published in The Lancet on April 29, 2020 found that the dose regimen of intravenous remdesivir used in the study, was adequately tolerated, but did not provide significant clinical or antiviral effects in seriously ill patients with COVID-19.

The World Health Organization (WHO) also, reportedly, announced a large global trial, called ‘Solidarity’, to find out whether any of those drugs can treat infections with the Covid-19. In India, several drug companies are also testing the water, with their shortlisted drugs, such as, Zydus Cadila want to test a form of interferon, usually used against hepatitis B and C, as a potential treatment for COVID-19. More trials on remdesivir are ongoing, let us keep our fingers crossed.

Interestingly, Gilead has, reportedly, signed nonexclusive licensing agreements with five Indian generic drug makers – Cipla, Mylan, Ferozsons Laboratories, Hetero Labs and Jubilant Lifesciences,  to produce COVID-19 therapy remdesivir for low- and lower-middle income countries. Under the agreements, Gilead will share its manufacturing know-how with them to help gear up remdesivir local production. Moreover, each of these companies will be allowed to set the price for its own generic version of the drug.

In any case, scientifically proven safety and efficacy of any drug or vaccine for the prevention or treatment of Covid-19, is yet to be known. Hence, for all individuals, strict compliance with social distancing measures is the only way to avoid this highly contagious infection. The same is also applicable to doctors and sales representatives while working in the field, at least, till an effective Covid-19 vaccine or drug comes.

Affordability and access to Covid-19 drug and vaccine:  

Assuming that a safe, effective and clinically proven vaccine or a drug for Covid-19 will be available sooner than what experts anticipate now, yet another critical issue needs to be resolved, soon. This is related to their affordability and access, to contain the mortality and morbidity of the disease, for a vast majority of the population, especially in the developing nations, like India.

Even Gavi noted: ‘In the race to produce a safe and effective vaccine against the COVID-19 virus, one of the many challenges will be the cost of developing the vaccine and eventually getting it to the vast number of people worldwide who will need it.’ However, it is generally anticipated that ‘COVID-19 vaccine or a drug may end up costing people a small fortune.’ Another article also echoed the same sentiment by saying, ‘Covid-19 treatments won’t work if people can’t afford them.

However, India’s Serum Institute based at Pune, has announced that it is ready for 20-40 million vaccine shots at Rs 1,000/dose, by September-October 2020. The company is ‘’putting its weight behind an Oxford University-led consortium, which announced the start of human clinical trials on April 23 and is one of the first such projects to get underway globally.’

At the same time, another report emphasized: “Even after India approves the Coronavirus vaccine, it might not be possible to produce more than 10-20 million doses in the first year,” again raising the availability and access issue for a Covid-19 vaccine, as and when available in India.

Conclusion:

As on May 17, 2020 morning, the recorded Coronavirus cases continue to climb sharply to 90,927 with 2,872 deaths.. Moreover, on May 13, 2020, the world Health organization has also warned that “this virus may become just another endemic virus in our communities, and this virus may never go away.” Thus, the world has to live with it. By the way, the accuracy of many Covid-19 test kits has also been widely questioned. This reportedly includes speedy Abbott test, as well.

In this scenario, people may have to necessary live with social distancing norms and the practice of wearing a mask outside the home, always. Besides, the template for relief from Covid-19 becomes more complex, particularly considering availability, affordability and access to a safe and effective drug or vaccine in India, as and when these will come. Taking these together, the end game for Covid-19 in the foreseeable future, becomes anybody’s guess.

Coming back to the pharma industry, curiously, some people are still hoping for ‘business as usual’ in the traditional pre-Covid-19 mode, although the writing on the wall is increasingly getting clearer. The only alternative that people can possibly follow under the circumstances, is strict compliance to social distancing norms, which pharma companies, doctors, healthcare consumers and others would also require to adhere to, with as much earnest. Thus, envisaging a return to pre-Covid-19 prescription generation mode, may not be prudent choice, anymore.

By: Tapan J. Ray   

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Changing Doctors’ Practice Dynamics With Covid-19 And Beyond

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Unexpectedly, the answer to an onerous question surfaced just around a year’s time. In my article on this blog, written on April 08, 2019, I raised a question – “Would ‘Connected Healthcare’ Catch Pharma Players Off-Guard?” Interestingly, an unexpected and abrupt turn of events in the global healthcare space, including India, triggered by Covid-19 pandemic, signals an early dawn of an evolving reality, related to ‘Connected Healthcare’, in India.

Never ever, I reckon, the Government realized so well that continuation with a fragile public healthcare infrastructure is self-defeating for the country. Allocation of financial resources, at least 2.5 percent of the country’s GDP, for its rejuvenation – powered by AI-based modern digital technology, would help avoid overburden on the healthcare system. This will mean, saving more lives and also a significant reduction of morbidity, especially in a situation, like Covid-19 pandemic. Good health can propel good economy, more effectively.

That’s why, ‘connected healthcare’ – by effectively linking requisite ingredients of all health-related information that medical professionals and the patients would need, appears to be the new reality. This process is being facilitated by rapid acceleration of usage of various digital platforms, by both healthcare consumers and providers. Thus, it is becoming increasing clear now that leveraging digital technology with innovative mindset and a fresh pair of eyes, will be the way forward, in India, as well. It seems very likely, when considered from two angles:

  • What several research data reveals about an increase in usage of digital platforms by healthcare consumers and providers, before and during Covid-19 pandemic. Especially because, this struggle appears to be for a long haul.
  • Most countries are currently struggling to navigate through highly contagious Covid-19 outbreak and simultaneously trying to chart a workable pathway for avoiding similar eventualities in the future.

In this article, I shall try to focus on Covid-19 induced changes in doctors’ practice dynamics – based on research studies, while revisiting the subject on ‘connected healthcare,’ and its relevance now – also in the years ahead.

Research studies capture a new and growing awareness: 

The recent findings from the “Digital Doctor 2020” survey, which is a ‘21-country study of Doctors’ perspectives on digital and connected health, highlight some interesting points. This study was conducted just before the global outbreak of Coronavirus. Some of its findings were also deliberated inan article published in the PharmExec.com on April 23, 2020. The paper is titled, ‘How Prepared Were Physicians for the COVID-19 Digital Upswing? Some of the key points, as reported, are worth noting:

  • Although, the awareness of drug prescribers of different digital technologies related to healthcare is high, how these technologies work in healthcare was unknown to many doctors at the time of the Digital Doctor 2020 survey. It came out that clear benefit statements, will be welcomed when there is such a steep learning curve.
  • Regardless of face-to-face interactions still remaining preferred choice before the pandemic, online channels are on the rise and accelerating with COVID-19 lockdown.
  • Benefits of using connected health devices for patient management and treatment are widely recognized and is believed to play a key role in the future. The respondents agree, even their patients are now more interested in their own health data, as they are gaining control over their weight, diet and physical activities.

Highlighting that their research data over the last few weeks showing increasing usage of digital solution to respond and adapt to the new realities of Covid-19 pandemic, the author of the article concluded: ‘For a long time, digital solutions have often been considered an option; now they have become a necessity.’ To understand the emerging scenario, let us now look at the preferred communication channels of the doctors – pre-Covid-19 outbreak. 

Preferred channels of doctors pre-Covid-19 outbreak:

According to the Ipsos survey of pre-Covid-19 outbreak, face-to-face communication with Medical Representatives (MR) used to be the most favored channel of the doctors, as follows:

Channel Med. Rep Speaker Program Conf. E-detail Journal Ads Med. Liaison E-mail Direct mail Pharma website
Pref. % 35.2 11.7 10.0 8.4 8.4 8.8 8.4 5.0 4.1

However, on April 14, 2020, Ipsos shared the results of their interim research conducted, together with M360, among doctors, conducted during Coronavirus outbreak. The preliminary findings indicate, Covid-19 will permanently alter physician practice dynamics. A clear shift in the engagement model with them – away from in-person detailing, throws several significant questions on the traditional physician engagement template of the pharma players.

It also signals another fundamental change in the physicians’ practice dynamics, as Covid-19 seems to have changed practicality of having face-to-face communication between the representatives and doctors, as before. This situation makes ‘connected healthcare’ a reality – as we move deeper into the everyday- evolving scenario.

Some unexpected and significant changes surfaced in a month: 

The above research also flagged, the following two important changes, among several others, triggered by the Coronavirus outbreak:

  • The mean number of sales representative visits dropped from 15.7 before the Coronavirus outbreak to 1.3 in just the following month, during the pandemic 
  • Overall preference and effectiveness of e-detailing also improved, significantly, where any non-personal communication and interaction with drug companies, either through sales representatives or by others, were considered as e-detailing. 

This brings me back to the question, how are doctors feeling about this never before shift in their practice dynamics?

How are doctors feeling about a never before shift in their practice dynamics?

The ongoing research on this critical area captures a new reality, where many doctors, especially those who are not directly engaged in combating the Covid-19 pandemic, are clearly feeling a shift in their practice dynamics. Curiously, the new feeling of a shift also includes, the way these doctors interact with different drug companies, mostly through their Medical Representatives.

These inklings of the doctors are expected to get translated into some fundamental changes in the real-life situation, as we all sail through the life-changing time caused by Covid-19. Especially, considering the requirements of a new normal – social distancing, wearing a mask always while on outdoor, and several other norms as prescribed from time to time.

‘Connected healthcare,’ is expected to take its place on the center stage:

In this situation, ‘connected healthcare,’ which used to be more discussed than practiced, is expected to take its place on the center stage. It is necessary in the present situation for remote consultations, primarily for chronic ailments – for effective disease management and treatment. More so, as in the current situation individual health awareness of a large population, even in India, is increasing with an accelerated speed, perhaps more than ever before.

Thus, this is the right time to focus on ‘connected healthcare’, powered by AI-based digital technology. It has immense potential to help the Indian population getting immediate medical attention at a lower cost, with an improved access, for all. Though these are early days, it appears the ball has started rolling in the right direction, as the recent draft guidelines of the Indian Council of Medical Research (ICMR) indicates: ‘Patient can WhatsApp, SMS or email consent for Covid-19 clinical trials.’

Conclusion:

Still today, there is no sign of even temporary flattening the disease progression curve in India. As on May 10, 2020 morning, the recorded Coronavirus cases continue to climb sharply to 62,939 with 2,109 deaths, which is rising in India faster than most other countries. On May 07, 2020, AIIMS director again warned that Covid-19 pandemic is yet to peak in the country. “According to modeling data and the way our cases are increasing, it is likely that peak can come in June and July,” he added.

But is it getting worse? Despite stringent lockdown, there has been a surge in cases, which can also be attributed to higher levels of testing. However, from a doubling rate of 11.5 days on May 3, it has shortened to 10.3 days, which means that cases are doubling in quicker time. Each set of 10,000 cases is now increasing at a more rapid pace than the preceding set, highlighted an editorial of a leading news daily.

With a vaccine still elusive, the government had been banking mostly on the lockdown to break the chain of transmission of the virus. Meanwhile, the World Health Organization (WHO) has said: ‘Deliberately infecting healthy people with Coronavirus may speed Covid vaccine studies,’ reflecting more uncertainties in this area. It is also not likely that the country will cease to have any problems with its fragile public healthcare infrastructure and delivery system, even after flattening the disease progression curve.

Along with many other Covid-19 induced life-impacting changes, doctors’ practice dynamics are also expected to undergo a metamorphosis, lasting for an indefinite period. Consequently, I reckon, it’s about time, even for the pharma industry to voluntarily adopt ‘connected healthcare’ as a future way of life. One can get a glimpse of it in the Covid-19 clinical trial draft guidelines of the ICMR. Nonetheless, ‘connected healthcare’ comes with a clear signal of reducing the cost of healthcare and improved patient access, having the potential to effectively mitigate a sizeable part of the precipitated healthcare crisis, caused by Coronavirus.

By: Tapan J. Ray   

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Pharma Sales Post Covid-19 Lockdown

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Disruptions from Covid-19 pandemic have caused limited access to physicians for Pfizer’s marketing and sales teams have had. If ‘the novel Coronavirus pandemic hamstringing the company’s sales team,’ there could be a slowdown in new prescriptions and a sales hit in the second quarter, said the global CEO of Pfizer, on April 28, 2020. He further said, ‘new prescriptions for a range of its products will decline as patients continue avoiding in-office physician visits.’

Pfizer is not only the company facing such situation. In fact, the entire pharma industry is encountering a tough headwind for the same reason. However, being very specific on the quantum of sales hit – on the same day, ‘Merck, with a heavy presence in physician-administered drugs’, predicted an adverse impact of US$ 2.1Billion on sales, from COVID-19.

Physical absence of, virtually the entire pharma field force in the field for strict compliance of social distancing during the lockdown period, causing a crippling effect on the new prescription demand generation activity. This possibility was hardly imagined by anyone in the industry. Which is why, the current situation is too challenging for pharma sales and marketing leadership teams to respond, with a sustainable strategic approach. Moreover, most of them don’t yet seem to be accustomed with charting any pivotal demand generation activity, sans field force.

Further, the meaning of ‘Patient-Centricity’ in the post lockdown period – still maintaining ‘social distancing’ norms, is expected to undergo considerable changes. This may include development of newer health care practices for many customers, which they started practicing during the lockdown period. However, no one can exactly predict, as on date, whether such changes will continue for a long term, as we move on. In this article, I shall deliberate on a likely scenario in the pharma selling space post Covid-19 outbreak, based on research studies. This is primarily because Covid-19 could be with us for a long time.

Covid-19 could be with us for a long time:

As reported, on the day 35 into the world’s largest lockdown, India, reportedly, was failing to see an easing of new cases similar to what hot spots such as Spain and Italy have recently experienced with more intensive Covid-19 outbreaks. Even today, the scale and duration of the pandemic are very uncertain, so will be the necessity of maintaining social or physical distancing guidelines. This possibility gets vindicated by what the Director General of the World Organization said on April 22, 2020: ‘Make no mistake: we have a long way to go. This virus will be with us for a long time.’ Thus, shutdowns in different forms, is expected to continue for some time in India.

‘Covid-19 pandemic to last for minimum two years’ with its consequent fallout also on the pharma industry:I

Interestingly, ‘India began its containment measures on March 25, when its outbreak showed only 564 cases.’ As on May 03, 2020, the recorded Coronavirus cases in India have sharply climbed to 39,980 and 1,323 deaths. India is now expected to prepare exiting the 54-day lockdown in phases from May 17, 2020, with a few limited relaxations even before that date. However, as the BBC news of April 9, 2020 also points out, the country may not afford to lift the lockdown totally – everywhere, for everyone and for all the time, anytime soon, for obvious reasons.

The April 30, 2020 report from the Center for Infectious Disease Research and Policy at the University of Minnesota, confirms this situation. It says: ‘The Coronavirus pandemic is likely to last as long as two years and won’t be controlled until about two-thirds of the world’s population is immune.’ This is because of the ability to spread from asymptomatic people, which is harder to control than influenza, the cause of most pandemics in recent history. Thus, the Coronavirus pandemic is likely to continue in waves that could last beyond 2022, the authors said.

Many countries around the world are already facing similar issues for exiting Covid-19 lockdown. It has been observed that easing the lockdown is a tricky policy choice, as it triggers a fresh wave of infection, as recently happened in advanced countries, such as, Singapore and several other nations.

It is, therefore, clear now that shutdowns need to continue in different forms in India as different waves of Covid-19 infections strike, in tandem with scaling up of requisite testing and health infrastructure to manage those outbreaks, effectively.  Consequently, its impact on the pharma industry is likely to continue with its unforeseen fallout, prompting the same old question, yet again, why the oldest commercial model remains pivotal in the pharma industry.

The oldest commercial model remains pivotal in the pharma industry:

About a couple of years ago from now, an interesting article of IQVIA, titled, ‘Channel Preference Versus Promotional Reality,’ highlighted an important fact. It said, one of the oldest commercial models of using medical or sales representatives to generate product demand through personal communication with each doctor, and other key stakeholders, is still practiced in the pharma industry, both as a primary medium and also to communicate the message.

The same model continues in the pharma industry, regardless of several fundamental challenges in the business environment. Curiously, erosion of similar models in many other industries, such as financial and other services, in favor of various highly effective contemporary platforms, is clearly visible. Some of these fundamental challenges involve an increasing number of both, the healthcare professionals and also patients they treat, moving online.

This has been happening since some time – long before Covid-19 outbreak. Today, many patients want contemporary information on the disease-treatment process, available alternatives and the cost involved with each. These patients also want to communicate with their peers on the disease for the same reasons, before they take a final decision on what exactly they would like to follow. A similar trend is visible, at a much larger scale, with medical professionals, including top drug prescribers.

Healthcare customers’ increasing digital preference was captured well before the Covid-19 outbreak:

The rise of digital communication as a global phenomenon, was deliberated in the June 04, 2019 ‘Whitepaper’ of IQVIA, titled ‘The Power of Remote Personal Interactions.’ It captured an increasing digital preference of healthcare customers much before Covid-19 outbreak. For example, according to IQVIA Channel Dynamics data1, there was a 26 percent decline in total contact minutes for face-to-face detailing in Europe, since 2011.

Another 2018 IQVIA survey reported, 65 percent to 85 percent of representatives were saying that access to physicians is becoming harder. The paper also indicated that the rise of digital and multichannel communication with healthcare professionals has been far from uniform across countries, with Japan leading the world, followed by the United States.

India is an emerging power in the digital space, today. Thus, I reckon, it has immense opportunity to leverage digital platforms in healthcare, especially to effectively address the current void in the demand generation activity of drug companies. The key question that needs to be answered: Are pharma customers developing new habits during, at least, the 54-day national lockdown period?

‘It takes about 18 days to 254 days for people to form a new habit’:

According to a study, titled ‘How are habits formed: Modelling habit formation in the real world,’ published on July 16, 2009, in the European Journal of Social Psychology, it takes anywhere from 18 days to 254 days for people to form a new habit. Thus, changing preferences of many healthcare consumers, including doctors and patients, at least, in the 40-day period of national lockdown in India, may trigger a change in habits of many patients. This change may further evolve over a period a time.

Such changes would demand a new and comprehensive ‘Patient-Centric’ approach from pharma players, as well, having a clear insight on the dynamics of the changes. Gaining data-based insight on the same, pharma sales and marketing leadership would need to develop a grand strategy to deliver ‘patient-group’ specific desired outcomes. One of these approaches could be, triggering non-personal sales promotion on digital platforms.

Triggering non-personal sales promotion on digital platforms:

Dealing with future uncertainty calls for non-conventional and innovative strategies, such as, generating brand prescription effectively even without personal promotion. Thus, to tide over the current crisis, triggering non-personal sales promotion on digital platforms, appears to be the name of the game. In a 2018 IQVIA survey, looking at the multi-channel landscape in life sciences, 54 percent of the 250 respondents from pharma and biotech were found already using virtual interactions, such as e-Detailing, or were planning to assess the approach.

What is required now is to rejuvenate the initiative, with a sense of great urgency. Covid-19 pandemic has the possibility and potential to expedite a strong pull in this direction, responding to a new ‘customer-centric’ approach, as prompted by the evolving scenario, triggered during the 54-day long stringent lockdown period. This is especially considering the fact that it takes about 18 days to 254 days for people to form a new habit.

Further, as Bloomberg reported on May 02, 2020, “coming up with a vaccine to halt Covid-19, in a matter of months isn’t the only colossal challenge. The next big test: getting billions of doses to every corner of the world at a time when countries increasingly are putting their own interests first,” which may take quite time.

Conclusion:

One thing for sure, the sudden outbreak of Covid-19 pandemic has made all ongoing and robust strategic business plans somewhat topsy-turvy. Most pharma companies were compelled to floor the break-pedal of several business operations, including prescription demand generation activity of field sales forces, during the lockdown period.

At this time, many healthcare consumers, including patients, tried various remote access digital platforms to continue with their treatment or for a new treatment of common ailments, besides procurement of medicines. Two primary drivers, in combination with each other, prompted those individuals to try out the digital mode. One, of course, the stringent lockdown norms, and the other being the fear of contracting Covid-19 infection, if the prescribed personal distancing standards are breached – just in case.

This position may lead to two possibilities – one, involving the patients and the doctors and the other, involving field staff/doctors/hospitals/retailers, etc. During, at least, the 54-day long lockdown period, if not even beyond May 17, 2020 – those patients may develop a sense of convenience with the digital platforms. This may lead to a new habit forming, which has the potential to create a snowballing effect on others – through word-of-mouth communication. The process may signal a shift on what ‘Patient-Centricity’ currently means to the pharma players.

The other one, I reckon, involves with the continuation of strict social or physical distancing norms for an indefinite period. This could seriously limit field-staff movement and meeting with the doctors, hospitals/retailers, besides many others, and more importantly would lead to a significant escalation of cost per call. The question, therefore, is: Will pharma selling remain as before, post Covid-19 lockdown? Most probably not. If so, a new task is cut out, especially for the Indian pharma leadership team, to chart a new ‘Patient-Centric’ digital pathway, in pursuit of sustainable business excellence.

By: Tapan J. Ray   

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.