Emerging Role of Digital Pathology in Cancer

Emerging Role of Digital Pathology in Cancer

Dear readers, an unlocked door awaiting all of us with tons of opportunities as we log out of  2017 and log in to 2018. Let’s grab those, bringing changes and smile  in many lives. Happy New Year

Cancer is now a leading cause of death worldwide. Every year, across the world 8.2 million people die from cancer. As the World Health Organization (W.H.O) estimates, deaths from this deadly disease will continue to rise, reaching over 13.1 million in 2030.

W.H.O flags that two-thirds of these deaths occur in low and middle-income countries. More than 50 percent of cancer deaths could have been prevented through awareness campaigns, or could have been effectively addressed through expert screening, early diagnosis and affordable treatment.

From this perspective, ‘digital pathology’ offers an immense potential to make a significant difference in the lives of many, who are either high risk individuals, or actually suffering from life threatening ailments. In this article, I shall try to illustrate the above point, in simple language, citing the emerging role of ‘digital pathology’ in cancer, as an example.

Incidence of cancer in India:

W.H.O reports that presently in India, cancer is a major cause of morbidity and mortality. This is vindicated by the 2016 Press Release of the Indian Council of Medical Research (ICMR) stating that, the total number of new cancer cases was expected to be around 1.45 million  in 2016, and the figure is likely to reach nearly 1.73 million new cases in 2020.

ICMR expected over 736,000 people to succumb to the disease in 2016 while the figure was estimated to shoot up to 880,000 by 2020. The data also revealed that only 12.5 percent of patients come for treatment in early stages of the disease. Another reportestimated that around 2.5 million individuals in India are living with the cancer.

Launch of cancer screening program:

Realizing the increasing incidence of cancer, ‘the National Program for the Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS)’ was initiated in 100 districts in 2010, and expanded to about 468 districts in 2012, in tandem with other Non Communicable Diseases (NCDs).

After further review, the Government informed the Indian Parliament on April 01, 2017 about the launch of universal screening of diabetes, hypertension and cancer in 2100 districts, which would be extended across the country. Accordingly, ‘Operational Guidelines for Non-Communicable Diseases’ were worked out and made public.

A large number of cancer cases remain undetected:

It is worth noting, India is still among one those countries where a large number of cancer cases remain undetected or under-diagnosed. The country continues to grapple with a huge dearth of specialists in this area. These include not just cancer specialists, which reportedly is just 1 over 2000 cancer patients, but qualified pathologists, as well. This stark reality assumes greater importance, as early diagnosis with precision is the key to successful treatment of cancer.

It’s more in rural India:

Availability and access to affordable cancer diagnostic facilities, are indeed a major issue much more in rural areas – the home of over 70 percent of the Indian population. Consequently, its late detection, together with low awareness level for disease prevention, is considered to be the major factors attributing to relatively higher cancer mortality rate in the country.

The intensity of this problem increases manifold and gets more complex, due to various other geographic and logistical constraints. This situation makes high-technology based medical interventions a necessity to save many lives.

A unique public-private partnership initiative:

Interestingly, some developed countries are also trying to address the core issue of increasing access to affordable cancer diagnosis and treatment to all.  An example of which can be drawn from the United Kingdom (UK), where one of finest Universal Health Care (UHC) system exists, for a long time.

On December 06, 2017, by a media release Roche Diagnostics announced a groundbreaking partnership discussions with the UK Government to transform cancer testing in patients.’ It said that the current shortage of pathologists and geographic constraints can make it difficult or longer for an expert to provide an opinion on a cancer patient case, where ‘digital pathology’ can play a crucial life-saving role.

Roche Diagnostics articulated that once important patient-cases are made available digitally, experts from any location can review them without delay. This would lead to availability of more equal access to experts to provide a timely and accurate diagnosis for cancer patients. It further said, making more information available electronically opens possibilities for the discovery of new treatments and the development of Artificial Intelligence algorithms in pathology diagnosis.

A Public-Private-Partnership (PPP) approach, such as the above can add greater efficiency, especially in tissue pathology services – including the expensive ones, to deliver faster and more accurate test results across the health care space, even in India. It goes without saying, such a PPP initiative has to be fleshed out with considerable details to unleash its true potential.

Thus, ‘digital pathology’, I reckon, has the potential to play a path-breaking role in providing access to affordable and early diagnosis of cancer to a large number patients, even in remote places, leading to better outcomes.

The scope of ‘digital pathology’:

It now brings us to the question of: what exactly is ‘digital pathology’? In simple term, ‘digital pathology’ involves remotely examining the whole slide digital imaging of original pathological slides of a patient, virtually in real time, from anywhere in the world to properly diagnose a disease. In case of cancer, these are digital image of original blood and tissue slides of patients, examined by experts with the application of special ‘digital pathology’ software and hardware, from a distant specialty hospital or laboratory.…Continue reading…

Health Care in India And ‘Development For All’ Intent

Health Care in India And ‘Development For All’ Intent

Posted on December 25, 2017

‘Development for All’ has become a buzzword, especially in the political arena of India, and is being used frequently during all recent elections as no one can deny its crucial importance in a country like ours.

Nonetheless, some do feel that there should be greater clarity on what all it encompasses. There is no scope for assumption, either, that it definitely covers the economic growth of the nation. But, does it include health care for all, as well? This is a relevant question, since health care plays a crucial role in maintaining high growth of Gross Domestic Product (GDP) by any country, over a long period of time.

The ideal answer to this question would, of course, be an emphatic ‘yes’? However, on the ground is it really so? I explored that subject in my article published in this Blog on November 06, 2017 titled, ‘Healthcare in India And Hierarchy of Needs’.

In this article, I shall focus on health care and the ‘Development for All’ agenda of the Government, as witnessed by many in recent elections. Let me illustrate the point using one of the most recent state assembly elections as an example – Gujarat Assembly election of December 2017. I am citing this example, because it generated so much excitement among many, across the country, for different reasons, though.

Who is responsible for public health care in India?

A recent submission made on the floor of Parliament by the Government, explains the point unambiguously. It goes, as hereunder:

“Public health is a state subject. Under the National Health Mission, support is being provided to States/UTs to strengthen their health care systems to provide accessible, affordable and quality health care to all the citizens. Moving towards Universal Health Coverage wherein people are able to use quality health services that they need without suffering financial hardship is a key goal of 12th Plan.” This is what the Minister of State, Health and Family Welfare, reiterated in the Lok Sabha, just about a year ago, on November 25, 2016.

Since, public health is predominantly a state subject, and so important for each individual, besides being one of the key indicators for long-term socioeconomic progress of a country and, one expects health care to be a key issue during the state Assembly elections. This is necessary to maintain the pace of development in this area, be it a state or the country.

Intriguingly, it appears to have no more than a ‘me-too’ reference in the election manifestos of political parties.

Does health care scenario in a state matter?

Now, zeroing on to Gujarat election as an example, the media report of March, 2017highlighted, gradually reducing budget allocation percentage of health care in Gujarat. It elaborated, the State has reduced its budgetary allocation for health care from 5.59 percent of the total budget in 2015-16 to 5.40 percent of the revised budget of 2016-17, and now to 5.06 percent in 2017-18.

Consequently, the health care budget and spending on the proportion to the Gross State Domestic Product (GSDP) is going down year after year. Whereas, globally, the percentage of GSDP spent on health and education is considered a key parameter of human development, the report states.

According to a report of the Observer Research Foundation dated December 06, 2017, Gujarat still has a high dependency to the private sector for both outpatient (84.9 percent cases) and also the inpatient (73.8 percent cases). As a result, the out of pocket spending on health care of the state stands at 63.7 percent. This makes Gujarat climbing up the ladder of per capita income, while slipping down the slope of health and social indicators,” the article states.

Just as what happens in all other Indian states, the recent state assembly elections offered an opportunity for the political leadership, cutting across the party line, for a significant course correction. Making health and nutrition one of the top priority focus areas, would have also ensured sustain economic development for Gujarat, in a more inclusive manner, for a long time to come.

What we are witnessing, instead:

The ‘best’ intent of a political party on any area of governance, if it comes to power, generally gets reflected in the respective election manifestos. From that perspective, let’s take a quick look at the key promises on health care, made in the respective election manifestos of the two principal political parties, on the eve of December 2017Gujarat election. I found these, as follows:…Continue reading…

SCM: Embracing Technology for Patients’ Safety

SCM: Embracing Technology for Patients’ Safety

Supply Chain Management (SCM) in the pharma industry is generally perceived as a logistic function, just in most other industries, involving the distribution of medicines from manufacturing plants, right up to pharma distributors. Thereafter, it becomes the responsibility of the respective distributors to reach these to the wholesalers, who cater to the needs and demand of retail chemists.

In tandem, pharma SCM is also playing a key role in reducing overall cost of drugs, improving the profit margin, and to some extent their affordability to a larger number of patients. This process involves efficient procurement of right products of the right quality, transporting them in the right condition, delivering them at the right location in right time, with optimal inventory carrying cost.

That said, today’s reality demands the SCM to cover much larger space. This calls for taking in its fold even those critical parameters that go beyond the realm of business performance – protecting the health and safety interests of patients, effectively. In that sense, SCM plays a pivotal role pharma business operation, having a potential to make a profound impact in the lives of many, quietly.

Coming out of the cocoon of narrowly defined distribution or logistic functions, pharma SCM, in many countries, has started rediscovering itself, as a multi-dimensional and multi-factorial business necessity, keeping patients within its core focus area, always.

I wrote on ‘The importance of Supply Chain Integrity’ and ‘Maximizing value of a new product launch with an innovative Supply Chain Management System’ in this blog on November 29, 2010 and August 30, 2010, respectively. Thus, in this article, I shall dwell on the role of pharma SCM in ensuring patients’ health and safety, embracing modern technology.

Current concerns:

Gradual transformation of SCM with high-tech interventions is visible now, but in a sporadic way. Speedy development initiatives in this area need to be more inclusive, everywhere. This is a paramount requirement of the pharma business, that has been prompted by serious breaches in the SCM process, affecting patients’ health, safety and security, besides impacting the brand image.

Manifestations of these get reflected in the instances like, availability of substandard and counterfeit drugs, or large product recalls, or quality issues with APIs and excipients escaping SCM scrutiny.

W.H.O says, it’s now all-pervasive:

The availability of substandard and falsified medical products, although is a menace to the society, seems to be all pervasive. The November 2017, Fact Sheet of the World Health Organization (W.H.O) recognizes this fact. The paper categorically states that no country has remained untouched by this issue – from North America and Europe to sub-Saharan Africa, South East Asia, and Latin America. Thus, this hazard, once considered a problem limited to developing and low-income countries, is no longer so.

The leading factors: ‘poor governance and weak technical capacity’:

The W.H.O study titled “Public health and socioeconomic impact of substandard and falsified medical products” released in November 2017 invited rather embarrassing media headlines, such as “India among countries where 10% of drugs are substandard.” Some of the most common medicines consumed in India, such as Combiflam and D-Cold were also found as sub-standard by Central Drugs Standard Control Organization (CDSCO) – as this news item reports.

Commenting on the possible reasons for this menace, W.H.O underscored that such substandard and falsified medical products are most likely to reach patients in 3 important situations. These are, constrained access to high quality and safe medical products, poor governance, and weak technical capacity.

The most important and viable option to effectively address this drug-safety threats is innovative applications of state of the art technology platforms. Many pharma players, are gradually realizing it through experience. Quite in unison, various Governments, India included, are also contemplating to follow the same path. Some nations are enacting robust laws for strict compliance of the remedial measures, as charted out by the respective drug authorities.

Harnessing technology as an enabler:

I reckon, harnessing modern technology will facilitate putting in place a robust ‘Track and Trace’ in the SCM, through product ‘serialization’, to effectively address this menace. As many would know, pharma serialization broadly means that each medicinal product pack will carry a Unique Identifier (UID), that can be tracked and traced till the same reaches the end-user …Continue reading…