Tag Archives: Infections

Taming Two Critical Covid Uncertainties For Pharma’s Sustainable Growth

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The reasons behind a great urgency of the Governments, besides high expectations of the general public, to have the ‘ultimate solution’ very soon, against the ongoing pandemic, are understandable. However, various media-hyped narratives on their clinical trials, and timeframe for expected launch – ranging from November this year to anytime in 2021, are making many experts to raise eyebrows on the scientific processes followed for Covid vaccine development.

Exact answers to the ultimate efficacy standard, safety profile and dates of their availability to the entire population, are still not clear – not even to many domain experts. Besides, two other critical and fundamental questions in India, are related to huge financial resources and other wherewithal, such as, countrywide stringent cold-chain logistics network, required to achieve this goal.

While effective, safe and high-quality vaccines, as and when these will come, will be pivotal to contain the alarming spread of Covid-19 – and that too in a wave after wave manner. Alongside, the intense search for effective anti-Covid medicines are also expected to come to fruition. Doctors will then have in their arsenals a number of highly effective alternatives, that can predictably cure individuals, when infected by this lethal virus.

It causes a great concern when someone asks, when will those days of great relief to all come? For, those days may or may not be very soon – could well be for an indefinite period. No one seems to know the answer, yet.

Until then, pharma companies can’t afford to remain in a ‘quick-fix mode’ to address the problems related to Covid related market and consumer mindset changes. Choosing this path could eventually prove to be very costly, especially for the lost time in leveraging some key opportunities. Moving in that direction, would entail rebuilding the organization by creating a new work-culture – a mindset to be all-time ready for any disruptive changes in business. Most importantly, if or as and when it comes, the organization should not get as overwhelmed, as is happening during the current global pandemic.

In this article, I shall deliberate the following two critical and interrelated Covid-19 issues:

  • The uncertainty in achieving what everybody is expecting to get right away – getting a preventive vaccine or a cure for the infected patients.
  • Inordinate delay in getting prompt medical care by many patients for non-Covid related serious ailments, leading to complexity of the disease. How long this situation will continue still remains uncertain.

As things stand today, these uncertainties could continue for an indefinite period, making some of the Covid related changes irreversible. Thus, my aim will be, first to recap where we are today with these niggles. And then, focusing on the crucial need to pave a balanced pathway – uncharted by anyone, for destination success – in the new world order. Let me begin with the first issue first.

The uncertainty in achieving what everybody is expecting:

Although, some Covid vaccines, reportedly, will be ready by early 2021, uncertainties and delays are still anticipated on the way. Some the reasons may include the following:

  • A critical challenge: About 5.6 billion people worldwide would need to be immune in order to end the pandemic (NEJM). Thus, vaccination process may take years to achieve the coverage necessary for everyone to be protected.
  • Huge investment required: India would need to invest between Rs 3,000 -5,000 crore to create additional facilities for making a huge number of vaccines, required for the Indian population. Currently no one has the capacity to manufacture it for 1.3 billion Indian populations. Moreover, vaccine alone is not the solution to the COVID-19 problem, according to experts.
  • High vaccine cost in India: As these vaccines come from a very difficult platform its cost is going to be significantly higher than many other vaccines, so there is going to be a requirement to think about how we are going to fund this.
  • Coronavirus mutating, potentially evolving: As reported on September 24, 2020, Covid’s continual mutation may make it increasingly contagious. The study says, it’s possible that when our population-level immunity gets high, this Coronavirus will find ways to get around our immunity.
  • The logistical challenge of a lifetime: Getting billions of doses of COVID-19 vaccines around the world quickly, would require 15,000 flights and 15 million cooling boxes. Stringent temperature control requirements for the vaccine supply chain must not be compromised at any point, not even in rural India. It’s worth noting, some of these vaccines may need to be kept at temperatures as low as -80 degrees Celsius. Currently, even in the developed world, the most efficient medical supply chain conventionally distributes vaccines at +2–8°C.
  • Vaccines may not provide complete protection: If COVID-19 re-infections are common, “vaccines might not completely protect against the virus” and would instead require a design similar to seasonal flu shots to protect from new variants. Interestingly. India may, reportedly, approve covid-19 vaccines that show 50 percent efficacy in clinical trials.

Converting problems into opportunities:

Such uncertainties may not only aggravate people’s overall health risks, but also their exposure to Covid infection. Drug companies, drug authorities and various Governments have been working hard on these issues. However, as flagged earlier, amid this health crisis, there is also another growing concern of a very serious nature. It pertains to many people delaying their non-Covid related medical care and medical interventions, for various reasons.

Pharmaceutical companies can convert this problem into a golden business opportunity with ‘patient-centric’ innovative strategies having a cutting-edge, and from a number of platforms. Let me illustrate this point with an interesting example of an initiative taken by a global pharma major, in this area.

A pace setting initiative:

On September 22, 2020, Fierce Pharma reported, ‘J&J wants everyone to know that taking care of their health can’t wait—even during a pandemic.’ This effort is based on the findings of a recent Harris Poll commissioned by them. This study revealed, the COVID-19 pandemic has caused many Americans (68 percent) to delay healthcare treatment. It ranges from standard routine exams to important elective surgeries to ER visits – with physicians sharing concerns about the long-term impact of patients delaying care. The situation is expected to be no different in other countries of the world, including India.

Based on this finding Johnson & Johnson (J&J) have recently launched a US-based online initiative, aimed at giving both patients and physicians information and resources about health care options. This unique campaign has been named – “My Health Can’t Wait”.

By a statement J&J announced: “As the largest healthcare company in the world, we are committed to helping people live their healthiest lives, which means getting the care they need, when they need it.” It added: “Through My Health Can’t Wait, we hope to provide patients and healthcare providers with resources to help stay connected and prioritize their health care, both during this pandemic and in the future.” The point, especially take note of is, ‘both during this pandemic and in the future.’ This part of the above sentence of J&J, echoes the well-known management dictum – converting problem into opportunities, I add, even during the Covid pandemic.

I hope, many pharma players may also wish to pursue similar direction, responding to their own specific needs. But, not just to keep the head above water, in combating this unprecedented health crisis, but with a long-term strategic perspective – to rebuild the organization – for business excellence the new normal.

The concept reverberates:

I find the concept of ‘rebuilding the organization now, for business excellence the new normal’, reverberating in several expert voices. For example, The McKinsey ‘Briefing Note’ of September 16, 2020 – ‘COVID-19 and the great reset.’ It said: ‘The world anxiously awaits an effective COVID-19 vaccine that can be readily distributed. Until then, the priority is to re-energize organizations—to act rather than react. Even as the uncertainties of the COVID-19 crisis multiply, the goal must be to rebuild for the longer term.’

The authors emphasized, ‘a crisis has a way of bringing things to a head.’ Many believe, the coming months might be the best opportunity in memory for healthcare companies to pursue exponential innovation. This, according to McKinsey, ‘could create an additional $400 billion in value by 2025. And now is the time to claim the hundreds of billions of dollars that could be saved through productivity gains.’

Thus, I reckon, apart from creating a great business compulsion of working harder to neutralize the short-term operational constraints, Covid pandemic also provides a unique opportunity to pharma leadership. It gives a space for them for thinking long-term, and from a strategic perspective. The aim is to rebuild the organization, placing it at a higher trajectory for success, in an uncharted frontier, thus far.

Conclusion:

Meanwhile, as on September 27, 2020 morning, India had recorded a staggering figure of 5,992,532 of Coronavirus cases with 94,534 deaths. The virus’s unprecedented onslaught on the country still continues, unabated. Be that as it may, coming back to where I started from, I reckon, pharma companies, in general, could play a stellar role in converting the dual problems of uncertainties into a number of opportunities. In that process, they can create a win-win situation for all, in the health care space.

The uncertainties related to scientifically proven, safe and effective Covid drugs and vaccines will, hopefully, be addressed – sometime, by the scientists and medical researchers. However, as the above McKinsey paper wrote: ‘Until then, the priority is to re-energize organizations – to act rather than react. Even as the uncertainties of the COVID-19 crisis multiply, the goal must be to rebuild for the longer term.’ Thus, the second issue, needs to be creatively leveraged mostly by individual drug players, starting from now.

From this perspective, pharma leadership, will need to commit quality time of thinking people, supported by adequate resources, for conceiving and effectively implementing a ‘patient-centric’ strategy, that patients will fall for in the new normal. That being done, the top honchos, will require to roll up their sleeves to prioritize primary, secondary and tertiary action areas.

Instead of trying to do a little bit of everything, in all possible areas of Covid related changes in the market dynamics, ‘primary action areas’ ought to be the starting point, deploying all resources. And then, expand to the ‘secondary’ and ‘tertiary’ ones, in a well-calibrated manner. Evaluation of results and tightening the strategic loose knots, if any, should be an ongoing process. If implementation of the process requires handholding, so be it. Because, taming these two critical Covid related uncertainties, is intimately related to a sustainable growth for the pharma companies.

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.

 

Infections may cause NCDs like, diabetes and cancer: Ongoing scientific quest to decipher the mystery

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To create a positive health impact on the lives of billions of people, the United Nations (UN) on September 19, 2011 unanimously adopted a ‘Political Declaration’ on ‘Non Communicable Diseases (NCDs)’.  In the years ahead, this path-breaking initiative on NCDs, with global commitment, is expected to make a huge difference in the lives of many, across the world.

NCDs have now been identified as a key healthcare challenge of this century and include ailments like, cardiovascular, chronic pulmonary diseases, diabetes, arthritis and cancer. In the developing countries, over 80% of all deaths are related to NCDs.

There are times when NCDs raise issues related to social justice and human rights. For example, in a country like India where out of pocket expenses towards healthcare is around 80%, a major illness like cancer even in a middle income group family, can drive the entire household to huge socioeconomic hardship.

NCDs are preventable:

According to the World Health Organization (WHO), adequate physical activity, healthy diet/nutrition and tobacco avoidance can prevent:

  • 80% of premature heart disease
  • 80% of type II diabetes
  • 40% of cancers

Currently, as we shall see below, immunization is also being considered as a preventive therapy for certain types of NCDs.

NCDs may be of infectious origin:

Dr. Bennett Lorber in his article titled, ‘Are All Diseases Infectious?’, published in the ‘Annals of Internal medicine’ wrote that many common NCDs like, cardiovascular, diabetes, peptic ulcer, arthritis and even certain types of cancer originate from infections by micro-organisms.

Mainly because of this reason and its consequent adverse socioeconomic impact, the low and middle income countries of the world will require controlling many types of infections, possibly through immunization, before they ultimately develop into NCDs.  Such measures, in turn, will help them reducing the risk factors of morbidity and mortality related to NCDs.

Infections and NCDs:

As indicated above by Dr. Bennett Lorber, following are some examples of reported relationship between infection and NCDs:

Reactive Arthritis:

Reactive arthritis or spondyloarthropathy has been known to follow intestinal infection with Salmonella typhimurium and Yersinia enterocolitica or urethral infection with Chlamydia trachomatis.

Scientists from the United Kingdom have already announced that they will soon begin human trial of an experimental rheumatoid arthritis vaccine.

Peptic Ulcer and Gastric Carcinoma:

Helicobacter pylori is known to cause of gastritis and peptic ulcer disease and is an important risk factor for gastric carcinoma.

Researchers at Rhode Island Hospital in collaboration with the University of Rhode Island and EpiVax Inc, have identified a potential vaccine to reduce colonization of Helicobacter pylori, which is known to cause peptic ulcer and gastric carcinoma.

Acute Renal Failure:

It was reported that about 10% of infected persons younger than 10 years of age develop hemolytic uremic syndrome, and as many as 75% of cases of the syndrome in the United States are complications of intestinal infection with E. coli.

Vasculitis:

The most common cause of vascular damage in secondary vasculitis is now considered to be related to different types of microorganisms. Patients were reported to have developed polyarteritis nodosa a few months after having hepatitis B infection.

It is widely reported that in the developed countries most common vasculitis is related to hepatitis B and C. However, in the developing world HIV related vasculitis appears to be  common.

Inflammatory Bowel Disease (IBS)/ Crohn’s Disease:

The precise etiology of Crohn’s Disease though remains to be conclusively deciphered, it is  believed by many researchers that the disease develops due to a reaction to a persistent intestinal infection in vascular endothelial cells.

Diabetes:

A good number of experts support a link between infection with enteroviruses in the pancreata and insulin-dependent diabetes mellitus.

To arrest or slow the autoimmune response that destroys insulin-producing cells in diabetes, it has been reported that the Diamyd vaccine, now in Phase III clinical trial in both USA and Europe, has shown very promising results.

Coronary Artery Disease:

A study published in the journal of ‘Clinical Infectious Disease’, Volume 40, Issue 8 ‘demonstrates a significant association between high titers to C. pneumoniae IgG and IgA and acute Myocardial Infarction (MI) in a cohort of young men and suggests that recent or chronic active infections could be associated with an increased risk for MI.’

In other studies also, patients with acute myocardial infarction were found to have elevated serum antibody levels to Chlamydia pneumoniae. This opens up possibility of preventing heart attacks with a vaccine.

Cancer:

The US FDA has already approved two types of vaccines for cancer prevention:

  • Vaccines against the hepatitis B virus, which can cause liver cancer.
  • Vaccines against human papillomavirus, which are responsible for about 70% of cervical cancers.

In addition, US FDA has also approved another cancer vaccine for metastatic prostate cancer.

A type of cancer known as Kaposi sarcoma is linked to an infectious agent found in patients with  acquired immune-deficiency syndrome. Scientists are in the process of developing treatment vaccines against many types of cancer.

Conclusions:

In the field of NCD, a not so widely publicized scientific revolution is in the making. Many well researched findings have, to a great extent, established that infectious agents could be the causative/precipitative or risk factors for NCDs like, chronic pulmonary and cardiovascular diseases, diabetes and cancer.

The moot question raised by Dr. Bennett Lorber earlier:  ‘Are all diseases infectious?’, is gradually getting answered through intensive scientific research. Otherwise, who would have thought, until recently, that vaccines could be developed for diabetes, certain types of cancer or even peptic ulcer?

Such path breaking scientific research findings are, in turn, creating a hope and opportunity for disease prevention through immunization for many NCDs, especially for the developing nations of the world.

It is very heartening to know that United Nations (UN) have taken note of these revolutionary developments in the ‘Non Communicable Disease’ space and are deliberating on the effective ways to combat NCDs caused by infections with the development and use of appropriate vaccines.

The entire world eagerly awaits more actionable outcome of the ongoing scientific quest to decipher the mystery related to many more NCDs to ensure better health of mankind of the Planet Earth.

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.