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Emerging Role of Digital Pathology in Cancer

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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 report estimated 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.

According to the article titled ‘Artificial intelligence is aiding pathologists’, published on September 02, 2017 by the ‘Digital Journal’, AI or machine learning is being increasingly used in ‘digital pathology’ for precision diagnosis of a disease.

One such use of AI in ‘digital pathology’ for cancer, is to recognize broad or specific patterns in a whole slide image to interpret the features in the cancerous tissues for accurate diagnosis of metastasis and recurrence, besides the stage or grade of cancer.

Preparation of samples for ‘digital pathology’ is very important, and the requirements may vary with different cancer types. Nonetheless, prescribed procedures for each need to be adhered to, meticulously, even in those areas where there is no qualified pathologist, and paramedics do this job. Hence, those personnel should be thoroughly trained and periodically refreshed by well qualified specialist trainers.

Digital pathology in India:

The article titled, ‘Telepathology at the doorstep of a village’, published by the Department of Atomic Energy in India that was last updated on December 14, 2017, aptly captures the scope of ‘digital pathology’ or ‘Telepathology’ in the country.

The authors recognized in the article, despite the high quality of expertise being available within the country, even for the treatment of cancer, it is not available or accessible to a large section of the population, more in the rural areas. On the other hand, super specialty health care facilities like, Tata Memorial Hospital (TMH) or All India Institute of Medical Science (AIIMS) cannot take the increasing patient load, beyond a point, due to various constraints.

Improving telecommunication infrastructure in the country, can be put to effective use for accurate diagnosis of cancer with ‘digital pathology’ or ‘tele-pathology’. Nevertheless, this application is currently operable mostly in those rural and semi urban areas, where a minimum standard of telecommunication infrastructure is available. However, the good news is, such areas are growing in India.

An interesting example is Barshi – a rural landscape in interior Maharashtra, located around 500 km away from Mumbai. Nargis Dutt Memorial Cancer Hospital (NDMCH) located in this hinterland, with Tata Memorial Hospital’s constant support and guidance, especially in ‘digital pathology’ has become an important cancer center. NDMCH now caters to a sizable population from a number of villages and towns surrounding it – in the districts of Solapur, Osmanabad and Latur.

A Government Press Release of October 19, 2016 states that AIIMS in Delhi has gone digital, becoming India’s first fully digital public e-hospital. More initiatives, such as these, in collaboration with rural health centers, and other related PPP initiatives, are expected to significantly improve access to ‘digital pathology’ to a large population, especially for early cancer detection in India.

More ‘Digital pathology’ initiatives are spreading roots in India, including the private business space. For example, according to a media report, Anand Diagnostic Laboratory in Bengaluru has become the first private diagnostic laboratory in the country to adopt the complete Roche Digital Pathology portfolio to provide better diagnostic insights for physicians and their patients.

“From simply remotely viewing patient slides, to consulting specialists real time within India or even through other parts of the world – the applications of digital pathology are endless” – commented the Managing Director, Roche Diagnostics India, while discussing the new technology at a meeting of pathologists in India.

Conclusion:

Against this backdrop, a wide-network of PPP initiatives of affordable ‘digital pathology’ would be a game changer, particularly for early detection of cancer.  With the incidence of cancer rising fast in India, and its effective management getting increasingly more complex – requiring prompt specialists’ intervention right from early diagnosis, such initiatives call for high priority.

A few green-shoots are already visible in this area, but quite sporadic in nature, though. Hoping that its pace of progress will soon gain momentum, the emerging role of digital pathology in cancer brings a fresh hope for survival with dignity to a large population of patients – if and when cancer poses to strike its deadly blow.

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 & Healthcare: Where The Healers Turn Looters?

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Two news reports of the last week, though no longer shocking, made me think exactly the same way as the headline of this article epitomizes.

These reports are not just two isolated instances, but an integral part of a similar chain of events that I partly addressed in one of my earlier blog posts titled, “Is The Core Purpose of Pharma Business Much Beyond Profit Making?” of November 10, 2014.

With the fist clenching media reports of just the last week, I shall try to dwell upon that in absence of good governance how two of the greatest healers and the medical care givers in the arena of healthcare – the doctors and the hospitals, are being increasingly perceived by the common citizens as nothing less than looters.

The doctors:

A November 21, 2014 report highlights that the Medical Council of India (MCI) has summoned over three hundred doctors from various parts of India, based on an anonymous complaint, for taking lakhs of rupees as bribes from an Ahmedabad based pharmaceutical company. All those 300 doctors have been told to bring copies of their Income Tax returns and bank statements.

Just a year ago, in September 2013, the Chief Vigilance Commissioner reportedly received a letter alleging that doctors were taking bribes from Pharma companies. The complaint was forwarded to the Health ministry. The MCI took over the case in December 2013 and formed a subcommittee to investigate the doctors.

The complaint details that the Ahmedabad-based pharma company has been paying to the doctors not just huge cash, but also gifting them cars and flats, besides sponsoring foreign trips for the family.

In return, the involved doctors are allegedly prescribing that Ahmedabad based pharma company’s products that are priced 15 to 30 percent higher than those of well-established other pharma players.

In addition, according to reports, the doctors would also air on the Television sets placed at their respective clinics, advertisements of the pharma company products against hefty cash or equivalent in kind.

Although, the allegations of unholy nexus between pharma players and the doctors are continuity of a good old saga, the risk taking incentives that it provides to the wrong doers are very significant. The anonymous letter alleged that the concerned pharma company’s profit zoomed from zero to Rs. 400 Crore in a period of just 5 years.

According to available reports, the MCI has already questioned 166 doctors, out of which 7 are senior doctors from Maharashtra, including 3 physicians from Mumbai.

The hospital:

Another report on the subject that appeared yesterday is related to overcharging for an oncology medicine of Novartis – Sandostatin LAR, over the last nine months by the well-known Tata Memorial Hospital of Mumbai.

According to the report, even when Novartis revised the price of Sandostatin LAR from Rs. 65,499 for a 20mg vial to Rs 32,000 during Oct-Dec 2013 and the chemists in the hospital’s vicinity were selling the same vial for Rs 32,000, Tata Memorial continued to sell it at Rs 48,296.

The report also states that patients could have saved much more, if the hospital had prescribed an Octreotide generic of the same strength, Octride Depot 20mg by Sun Pharma with an MRP of Rs 17,800 is sold at Tata Memorial for Rs 12,157, instead of Sandostatin LAR 20mg.

However, the newspaper claims, “DNA was the first to report about the price disparity at the hospital on Nov 5. Tata Memorial Hospital has decided to reimburse cancer patients who were overcharged for a Novartis-branded oncology medicine over the last nine months.”

Interestingly, we get to know only about a few of such instances, only when these are reported either anonymously or by some employees or through rare impartial investigative journalism of international standard.

Treatment of dreaded diseases like Cancer also not spared:

The above hospital case assumes immense importance, as it is related to a dreaded disease and an expensive cancer drug. In real every day life, many such cases of various hues and colors are taking place in India incognito, at the cost of patients.

A scary scenario:

According to the ‘Fact-Sheet 2014′ of the World Health Organization (WHO), cancer cases would rise from 14 million in 2012 to 22 million within the next two decades. It is, therefore, no wonder that cancers figured among the leading causes of over 8.2 million deaths in 2012, worldwide.

A reflection of this scary scenario can also be visualized while analyzing the growth trend of various therapy segments of the global pharmaceutical market.

A recent report of ‘Evaluate Pharma (EP)’ has estimated that the worldwide sales of prescription drugs would reach US$ 1,017 Bn. by 2020 with a Compounded Annual Growth Rate (CAGR) of 5.1 percent between 2013 and 2020.

Interestingly, oncology is set to record the highest sales growth among the major therapy categories with a CAGR of 11.2 percent during this period, accounting for US$ 153.4 Bn. of the global pharmaceutical sales.

High incidence of cancer in India:

A major report published in ‘The Lancet Oncology’ states that in India, around 1 million new cancer cases are diagnosed each year, which is estimated to reach 1.7 million in 2035.

The report also highlights, though deaths from cancer are currently 600,000 -700,000 annually, it is expected to increase to around 1.2 million during this period.

The Lancet Oncology study showed, while incidence of cancer in the Indian population is only about a quarter of that in the United States or Europe, mortality rates among those diagnosed with the disease are much higher.

Experts do indicate that one of the main barriers of cancer care is its high treatment cost that is out of reach for millions of Indians.

Breast cancer is the most common type of cancer, accounting for over 1 in 5 of all deaths from cancer in women, while 40 percent of cancer cases in the country are attributable to tobacco.

Cancer drug price – a global issue to address:

As the targeted therapies have significantly increased their share of global oncology sales, from 11 percent a decade ago to 46 percent last year, increasingly, both the Governments and the payers, almost all over the world, have started feeling quite uncomfortable with the rapidly ascending drug price trend.

In the top cancer markets of the world, such as, the United States and Europe, both the respective governments and also the private insurers have now started playing hardball with the cancer drugs manufacturers.

There are several instances in the developed markets, where the stakeholders, such as, National Institute for Health and Care Excellence (NICE) of the United Kingdom and American Society of Clinical Oncology (ASCO) are expressing their concerns about manufacturers’ charging astronomical prices, even for small improvements in the survival time.

Following examples would give an idea of global sensitivity in this area:

After rejecting Roche’s breast cancer drug Kadcyla as too expensive, NICE reportedly articulated in its statement: “A breast cancer treatment that can cost more than US$151,000 per patient is not effective enough to justify the price the NHS is being asked to pay.”

In October 2012, three doctors at Memorial Sloan-Kettering Cancer Center announced in the New York Times that their hospital wouldn’t be using Zaltrap. These oncologists did not consider the drug worth its price. They questioned, why prescribe the far more expensive Zaltrap? Almost immediately thereafter, coming under intense stakeholder pressure Sanofi reportedly announced 50 percent off on Zaltrap price.

Similarly, ASCO in the United States has reportedly launched an initiative to rate cancer drugs not just on their efficacy and side effects, but prices as well.

Developments in India:

India has already demonstrated its initial concern on this critical issue by granting Compulsory License (CL) to the local player Natco to formulate the generic version of Bayer’s kidney cancer drug Nexavar and make it available to the patients at a fraction of the originator’s price. As rumors are doing the rounds, probably some more patented cancer drugs would come under Government scrutiny to achieve the same end goal.

I indicated in my earlier blog post that the National Pharmaceutical Pricing Authority (NPPA) of India by its notification dated July 10, 2014 has decided to bring, among others, some anticancer drugs too, not featuring in the National List of Essential Medicines 2011 (NLEM 2011), under price control. These prices have already in force.

Not too long ago, the Indian government reportedly contemplated to allow production of cheaper generic versions of breast cancer drug Herceptin in India. Roche – the originator of the drug ultimately surrendered its patent rights in 2013, apprehending that it would lose a legal contest in Indian courts, according to media reports.

Biocon and Mylan thereafter came out with biosimilar version of Herceptin in the country with around 40 percent lesser price.Herceptin,

Hence, affordable pricing of cancer drugs would continue to remain a key pressure point, as it just happened yet again.

The government to intervene again:

According to a media report of the last week, the new government in India is planning to control prices of anti-cancer drugs to address this critical issue.

As the current National List of Essential Medicines (NLEM) does not include many important anti-cancer medication, Tata Memorial Centre of Mumbai has recommended to the government that oncology drugs, such as Trastuzumab, Erlotinib, Irinotecan, Lenalidomide, Capecitabine, All Trans Retinoic Acid (ATRA), Bendamustine, Rituximab, Temozolomide (TMZ), Zoledronic acid, Megestrol acetate and Letrozole, should be added to the NLEM.

As a first step towards this direction the National Pharmaceutical Pricing Authority (NPPA) has invited comments on the same from the pharmaceutical industry and other stakeholders to bring these drugs under price control.

Quoting NPPA the report states, “the recommendations are based on factors such as the ability of the drug to improve the overall survival chances of the patient. The other factors include higher priority to drugs that have the potential to cure a fraction of patients versus those that have been proven to only prolong lives; the number of patients potentially impacted in India based on data from population based cancer registries of the National Cancer Registry Program; the non-availability of alternative medications of the same or other pharmacological class that can act as a reasonable ‘substitute’; and price of the drug to patients and the differential in price between various brands.”

Although this is a welcome move to most of the patients, the pharma industry would certainly not be happy with this development, because of very obvious reasons and is expected to strongly oppose this initiative of the government. Let us wait and watch how this scenario unfolds further.

Conclusion:

In pursuit of the Eldorado to generate more and more wealth, shorn of least concerns for majority of patients, quite a few companies are not sparing even the dreaded diseases, such as cancer, pushing many patients to abject poverty, if not untimely death.

Increasingly, many healthcare players across the world are reportedly being forced to pay heavily for ‘unethical behavior and business practices’ by the respective governments. Unfortunately, no such steps are being taken in India, not just yet.

At least on paper, for errant doctors and hospitals there is MCI to take prompt remedial measures. For implementation of Drug Price Control Order (DPCO) there is NPPA, though effectiveness of these two seemingly powerful bodies are far from the expectations of the stakeholders, occasional reported jingoism notwithstanding.

Currently in India, there are no legally binding ‘codes of pharma marketing practices’ in place. Even the Department of Pharmaceutical does not seem to have any legal jurisdiction for taking penal action against the errant pharma players for marketing malpractices or misdemeanor.

In this chaotic scenario, is it not quite challenging to fathom how would the government possibly discourage any healthcare or pharma player from turning looter instead of playing the expected role of a healer, ensuring beyond doubt that there is no wolf in sheep’s clothing?

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.