Focus On Patient Compliance To Boost Pharma Sales…And More…

Posted on May 20, 2019 by Tapan Ray

One high-impact area in the healthcare space that often finds its place in the backseat is – patient noncompliance. A term that is commonly used in regard to ‘a patient who does not take a prescribed medication or follow a prescribed course of treatment.’ It comes with a steep price, for causing serious adverse impact not just on human health and health system, but also in the pharma business. Intriguingly, such incidents are still not scientifically monitored enough and vigorously acted upon, both globally and locally.

The World Health Organization (W.H.O) has also flagged it as a huge problem, as it reports, 10 percent to 25 percent of hospital and nursing home admissions result from patient noncompliance. Furthermore, about 50 percent of prescriptions filled for chronic diseases are not taken correctly, with 40 percent of patients not adhering to the treatment regimen.

In this article, just after giving a flavor to its financial cost to patients, I shall dwell mostly on its impact on the pharma players, as overcoming this important problem doesn’t generally fall in the area of strategic focus for most of them. Finally, I shall explore how drug manufacturers can translate this problem into an opportunity – as the third growth driver for business, creating a win-win situation for all.

Economic and health impact on patients:

Noncompliant patients suffering from both acute and chronic ailments, pay a heavy price, not just in terms of longer suffering arising out of complications, but also incurring significantly more health expenditure for treatment of the same diseases. According to IMS Institute for Healthcare Informatics, on average, less than 40 percent of patients around the world are fully complying with their treatment instructions.

Even in the Indian context, the problem is no different. Let me illustrate the point with the example of a chronic disease, such as Asthma. The article published on June 26, 2018 in ‘Lung India’ – the official publication of Indian Chest Society reported: “The mean annual direct costs among compliant and non-compliant patients were ₹14, 401 and ₹24, 407, respectively. Percentage of hospitalization was less among the compliant group (6 percent) when compared with noncompliant group (17 percent).”

The study concluded, asthma is not only associated with patient-specific impairment, but also creates a significant economic burden for the family and society. The major contributors to the burden are the medication cost and hospital admissions. Patient compliance with prescribed drugs can help keep asthma under control, thereby decreasing the economic burden and emergency hospital admissions – avoiding the economic risk from ill health with high out of pocket payments. Productivity loss is another under-appreciated source of economic loss contributing to indirect cost. The rising costs of investigations, interventions, and treatment of chronic diseases further complicate the problem.

Economic impact on pharma business:

According to November 16, 2016 report, published by Capgemini and HealthPrize Technologies, globally, annual pharmaceutical revenue losses had increased from USD 564 billion in 2012 to USD 637 billion due to non-adherence to medications for chronic conditions. This works out to 59 percent of the USD 1.1 trillion in total global pharmaceutical revenue in 2015.

The report highlights, besides medication nonadherence being a serious global health issue that needs to be addressed immediately, it also happens to be a critical business issue for pharmaceutical companies. Thus, it is the only area of their business where a sharp strategic focus “can generate significant top – and bottom-line growth, improve outcomes, and create substantial savings for the healthcare system – all at the same time.”

Major reasons for patient noncompliance:

Several reasons are commonly attributed to patient-noncompliance to medicines, such as:

Lack of knowledge of its health and economic impact
Importance of completing the full-course of the drug and dosage regimen for long-term remission, following immediate relief
Untoward side-effects and other inconvenience
Forgetting therapy because of preoccupation
Financial inability to complete the prescribed treatment regimen due to the high cost of drugs.

Nevertheless, the 9th Edition of Global Research Report by Capgemini Consulting underscores that reality is more complex. Patient adherence initiatives, if any, when undertaken, even by pharma companies, often lack a thorough understanding of the root causes of discontinuing treatment and failure to effectively engage patients with a holistic approach to the issue. It also emphasizes: “Individual tactics are tried by different brands and then discontinued as budgets and priorities shift, before their impact is known. Successes are seldom pulled through and expanded across the organization.”

Using it as the third major growth drivers for pharma:

The two primary factors that drug manufacturers are leveraging to boost growth of the organization are:

A. New product introduction – gradually extending to line extensions and new indications. One such illustration is the cholesterol-fighting drugLipitor of Pfizer. The lifetime sales of this brand as of the end third quarter 2017 generated a stunning USD 150.1 billion of business for the company. Incidentally, Lipitor patent expired in 2011. There are many similar examples, including Humira of AbbVie.

B. Regular and hefty price increases for already marketed products, for various reasons, but almost regularly. According to this 2019 report, percentage price increases, on a huge base, of some of the world’s top pharma brands were as follows:

AbbVie: Humira, a blockbuster drug with USD 15 billion in sales in the first 9 months of 2018: +6.2%
Allergan: Many of its brand-name drugs, including dry-eye medication Restasis: +9.5%
Biogen: Multiple sclerosis drug Tecfidera: + 6%
Bristol-Myers Squibb: Eliquis, a drug that prevents blood clots and is on pace for USD 6 billion in sales in 2018: + 6%
Eli Lilly: Type 2 diabetes medication Jardiance: + 6%

Many studies have captured the importance of regular price increase, as a key pharma strategy, not only to drive the internal growth, but also to keep their investors, as well as, the stock market on the right side. There are examples that for some of the top global pharma players, this strategy was directly responsible for 100 percent of earnings-per-share growth in 2016, and more than 20 percent of the revenue made in the first three quarters of 2018.

On the other hand, some top analysts’ findings highlight that drug companies serious strategic focus just on the issue of patient noncompliance with novel tactical measures, could fetch as much as a 30 percent increase in annual earnings per share for many players, even in India.

This brings up to the point – can strategic focus to minimize patient’s non-compliance, supported by adequate resources, be the third growth driver for drug companies?

Can focus on patient noncompliance be the third growth driver for pharma?

For a moment, leaving aside the above two primary growth drivers, if we look at the estimates, as quoted above, well over 50 percent to 60 percent of a brand’s potential sales is wasted due to patient noncompliance. Isn’t it huge? Can this be ignored? Obviously not. Instead, why not pharma converts this problem into an opportunity, with a sharp strategic focus, leveraging technology.

Translating this potential opportunity into reality is neither very easy nor is every company’s cup of tea. But the reward for the winners is indeed phenomenal. To chart on this frontier, one of the toughest barriers, besides a winner’s mindset, is getting access to credible and meaningful patient-data, for various reasons. On the other hand, it isn’t an insurmountable problem, either – especially, with today’s rapidly progressing technology.

Some companies have started the long march:

According to the review article, published in the New England Journal of Medicine: ‘The ability of physicians, to recognize non-adherence is poor, and interventions to improve adherence have had mixed results. Furthermore, successful interventions generally are substantially complex and costly.’

Realizing that it as a potential opportunity – disguised as a problem, several pharma players have started thinking about exploring this not much charted territory, confirm reports coming from different countries of the world. To give an illustration, November 22, 2016 edition of Fierce Pharma reported: ‘Pharma companies have more recently joined the conversation with partnerships and programs that include adherence aims.’

It is generally believed today that rapid ascendency of modern technology, and its strong influence on people, will help create a new awareness of its current adverse impact both on patients and the drug companies.

What else could be done in a much wider scale?

Digital interventions, such as smartphone apps, are becoming an increasingly common way to support medication adherence and self-management of chronic conditions. In this regard, the May 14, 2018 study titled, ‘Smartphone apps for improving medication adherence in hypertension: patients’ perspectives’, published in the journal of Patient Preference and Adherence, concluded as follows:

‘These data showed that patients can identify the benefits of a medication reminder and recognize that self-monitoring their blood pressure could be empowering, in terms of their understanding of the condition and interactions with their general practitioners.’ But some loose knots are still to be tightened.

Tightening the loose knots:

Having leveraged the state of the part digital technologies to tighten the loose knots in this area,a host of AI-enabled smartphone health and diagnostic apps, capturing patient compliance details, especially in chronic disease areas, are fast coming up. Most of these are being developed by large, small and medium sized non-pharma pure tech companies, including startups. For example, according to reports: ‘With the release of the Apple Health Record and Apple Watch with a single-lead ECG, it’s evident that Apple has officially entered the healthcare space.’

A good number of these apps have received even the US-FDA approval, such as: MyDose Coach - a reliable dose calculating app for type 2 diabetic patients who take insulin once-daily in concert with physician guided insulin recommendations. Or, GoSpiro – a home spirometer, to measure air output from the lungs for COPD patients and connects wirelessly to provide hospital-quality data regarding breathing.

That many non-pharma entities are trying to create a space for themselves in a high-tech, but non-drug treatment segment within the pharma space, has prompted, several drug manufacturers to rewrite their marketing playbook, incorporating this ‘new notation’.

It’s real now…for some:

As the above Fierce Pharma article reported: ‘Pharma companies have more recently joined the conversation with partnerships and programs that include adherence aims; efforts from Verily and Sanofi and IBM and Novo Nordisk have recently made the news.’Further, on November 07, 2018, in another report it brings to the fore that Geisinger Health System has developed mobile apps to manage asthma with AstraZeneca, and a wearable app to manage pain with Purdue. It also joined forces with Merck to develop tools for patients and caregivers to improve care coordination and medication adherence.

Moreover, on February 09, 2019, Japanese drug major Astellas and WiserCare - a company that develops healthcare decision support solutions, announced a collaboration that includes improving patient adherence to care plans, and improve the overall care experience.

In tandem, concern on patients’ data privacy, may also now be addressed, possibly by making use of blockchain or similar technology for such initiatives, as I discussed earlier in this blog.

Conclusion:

‘Acquiring new customers is important, but retaining them accelerates profitable growth,’ is the theme of an article, published in Forbes on June 08, 2016. Therefore, just as any other business, this dictum applies to the pharma industry, as well, especially in context of patient noncompliance to medicines, with a clear strategic focus to minimize its impact on performance.

The major reasons for patient noncompliance ranges from ignorance of its adverse impact on health to side effects, forgetfulness and right up to inability to afford full-course of the prescribed drug treatment. Despite its continuity over decades, adversely impacting patients, health system and the pharma players, it won’t be prudent to infer that no attempt was being made in the past, to address this critical issue. Nevertheless, those measures have not worked, for many reasons, as we see today from various research studies in this area, even in the Indian context.

Once again, intervention of technology to make patients compliant to medicine, is showing promise for following it up more vigorously. That some global drug majors are entering into collaborative arrangements with non-pharma, technology companies of various sizes, sends a signal of the emergence of a third major growth driver for pharma, as discussed above.

This issue is so important, especially considering that the low hanging fruits of R&D have mostly been plucked, just as regular hefty increases of drug prices are meeting with tough resistance, squarely. In this scenario, a robust strategic focus on patient compliance would not only boost pharma sales but would also reduce the disease burden of a large section of people significantly. This will benefit all and harm – none.

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.

‘Digiceuticals’: A Force Multiplier to Contain Chronic Diseases

Posted on October 23, 2017 by Tapan Ray

There is a growing need for more effective prevention, treatment or management of many serious Noninfectious Chronic Diseases (NCDs), with greater safety and at a lesser cost. As a major step in this direction, ‘digiceuticals’ or ‘digital therapeutics’ are now drawing heightened interest from the medical and scientific communities.

‘Digiceuticals’ are basically custom made digital software working as drugs. These are presented mostly in the form of user-friendly smartphone apps for various disease conditions – both as stand-alone therapy, or to augment other treatment processes for better outcomes.

Increasing usage of digital technology enabled therapy for a gamut NCDs, prompts me to discuss in this article the relevance, scope, promise, and of course, the rationale behind the same. Its importance swells manifold when the risks of lifelong health hazards that such chronic disorders may pose are factored-in, alongside their overall socioeconomic impact.

Chronic diseases – the invisible global epidemic:

Chronic diseases, such as heart disease, stroke, chronic respiratory disorders and diabetes, including cancer, are by far the leading causes of death and disability worldwide. The World Health Organization (W.H.O) also reiterates that this invisible epidemic is spreading out globally – across every region and pervading all socioeconomic classes.

The mortality, morbidity and disability attributed to chronic diseases, as estimated by the W.H.O, is expected to rise to 73 percent of all deaths and 60 percent of the global burden of disease by 2020. Interestingly, 79 percent of the deaths attributed to chronic disorders occur in the developing countries, such as India.

Can chronic diseases be prevented?

W.H.O also emphasizes that four of the most prominent chronic disorders, namely cardiovascular (CVD), cancer, Chronic Obstructive Pulmonary Diseases (COPD), and Type 2 diabetes – are linked by common and preventable biological risk factors, notably high blood pressure, high blood cholesterol and overweight. Most importantly, these relate to major behavioral risk factors, like unhealthy diet, physical inactivity and tobacco use, among several others.

Awaits a radical change – from “Suppliers Push” to “Consumer Pull”:

In the above perspective, a series of well-integrated action related to several human behavioral factors, could help prevent many NCDs, effectively. A fundamental change in mindset of all concerned is critical to avert the merciless onslaught of this epidemic. This calls for a radical change in the existing process of addressing these disorders – from “Suppliers Push” to “Consumer Pull.”

The January 2017 White Paper titled, “Human-Centric Health: Behavior Change and the Prevention of Non- Communicable Diseases”, published by the World Economic Forum (WEF), drives home this point succinctly, as follows:

“Decreasing the burden of NCDs will require a transformation through which the threat of disease is recognized and addressed. The transformation should move us away from the present state of ‘supplier push’, which emphasizes expensive, capital-intensive, hospital-centric interventions that have so far produced disappointing results, to a system that relies on ‘consumer pull’. A consumer-focused system would recognize the principles of behavioral economics to encourage and enable people to adopt healthier behavior across all aspects of their lives. Individuals would be supported in this effort by a network of critical stakeholders ranging from government to private enterprise, from healthcare providers to payers, from the technology developers to local communities.”

NCDs are triggered by behavioral pattern and lifestyle:

Picking up the thread from here, I shall deliberate now, how the state of the art digital technology-developers are playing a stellar role in this space, with greater precision and more cost-effective way. This is because, many NCDs are triggered by consistent behavioral and lifestyle pattern of an individual. Consequently, continuously monitoring of desired changes in individual behavior, are expected to gradually become the first-line treatment to effectively address these conditions. Several published studies indicate that the process has started rolling, aided by smartphone based sophisticated digital tools – in many cases even without any expensive and lifelong medications.

The May 26, 2016 paper titled, “Clustering of Five Health-Related Behaviors for Chronic Disease Prevention Among Adults, United States, 2013”, captures a cluster of five health-related behaviors for chronic disease prevention as – never smoking, getting regular physical activity, consuming no alcohol or only moderate amounts, maintaining a normal body weight, and obtaining daily sufficient sleep. This article was published by the Centers of disease Control and Prevention of the United States.

Preventing chronic diseases with ‘digiceuticals’:

The April 7, 2017 article captioned, “Can ‘Digital Therapeutics’ Be as Good as Drugs?”, published by the MIT Technology Review, dwells on this area. The paper indicates an emerging belief among technology geeks that ‘digiceuticals’, or digital drugs will become ‘the third phase’ of medicine for many disease conditions, being the successor to the chemical and protein drugs that we have today, but without the billion-dollar cost of bringing one such drug to market. The core idea behind this new concept is to develop software that can improve a person’s health as much as a drug can, but without the same cost and side-effects, the author says.

An innovative new class of medicine:

The term digital therapeutics or ‘digiceuticals’, as many calls these, is considered as an innovative new class of medicine that gives participants access to the world’s most effective behavior therapies, enhanced with smart digital technology, and delivered directly to their front door. These can be used both as a replacing medicine, and also for enhancing efficacy of a medical treatment, as a situation would necessitate.

There doesn’t seem to be any clear-cut difference between these two – digital therapeutics and ‘digiceuticals’. Nonetheless, some do believe that there is a difference – quite akin to prescription medication versus nutritional supplements, with consequential differences in regulatory and other areas. Be that as it may, ‘digiceuticals’ when used for prevention, treatment or effective management of any chronic ailments would require to be scientifically evaluated just as any other drugs, devices and treatment processes.

The future of health care will be App-based:

Another article titled “Digital Therapeutics: The Future of Health Care Will Be App-Based”, published in Forbes on July 24, 2017, highlights how several digital technology companies are now focusing on the development of state of art smartphone app-based digital treatment programs that can be delivered at a massive scale and with a low cost to prevent progression of many debilitating NCDs, for a large population across the world, including India.

‘Digiceuticals’ versus other mobile wellness apps:

Unlike many smartphone based wellness apps to keep a regular tab on daily exercises, heart rates, calorie intakes, breathing, sleep pattern among several others; treatment processes with ‘digiceuticals’ are quite different. These softwares are tailor-made to prevent or treat specific chronic disorders, like diabetes, cardiovascular conditions, COPD, insomnia and chronic depression, to name a few. The trend is fast catching up along with an increasing general realization that the influence of individual behavior and lifestyle pattern is so crucial in the prevention, and also in arresting the progression of many debilitating NCDs.

The current status:

The latest scenario in this area has been well captured in several research studies. One such is the 2017 Report of Grand View Research, Inc., which articulated the following key findings:

The global ‘digiceuticals’ or digital therapeutics market size was estimated at USD1.7 Billion in 2016, which is expected to grow at 21.0 percent CAGR from 2017 to 2025.Diabetes is expected to gain the largest market share due to the increasing global prevalence, fueled by the preventive steps taken to reduce them.

The adoption of digital therapeutics offers a reduction in healthcare cost associated with many NCDs, and are thus being used on an increasing scale. Digital tracking, continuous monitoring of various health parameters, management of physical activity and controlling eating habits are some of the important factors expected to propel the market growth.

Ascending trend of its usage for prevention of a wide range of NCDs would further add to the growth momentum. Patients accounted for the largest market share in the end-user segment owing to user-friendly interface and cost-effective management of many NCDs.

The North American region accounted for the highest revenue owing to technological advancement and health care expenditure to curb rise in a number of chronic diseases.

The Asia Pacific region is expected to garner considerable growth during the forecast period owing to increasing adoption of advanced healthcare technologies and rise in the number of NCDs.

The latest development in India:

A similar initiative, though, as augmentation of physician intervention in patients with Type 2 diabetes for better treatment outcomes, has recently been reported by the Press Trust of India (PTI) on June 13, 2017.

The abstract of the report, among other points, says that an Indian digital diabetes leader has announced “the results from a pilot designed to evaluate the feasibility and scalability of an artificial intelligence-led lifestyle intervention to improve self-management of people living with type 2 diabetes as a supporting tool to existing care in India…. The pilot results suggest that continuity of care between physician appointments for people with type 2 diabetes can be achieved with positive outcomes in a clinically significant, scalable and affordable way through this program. Participants that completed the pilot on average dropped their average blood sugar levels (HbA1c) by 0.59%. Amongst the participants that completed and dropped their HbA1c, the average observed was even higher at 1.04%. In addition, the participants showed a daily active usage of 78% for the duration of the 16-week program.”

This is indeed a laudable initiative by an Indian digital tech company. More such ventures are expected to be forthcoming, taking rapid strides in India. Keeping pace with these developments, “digiceuticals,” I reckon, will spread its wings faster to play a crucial role in preventing, if not treating and managing several serious NCDs – and in most cases without even swallowing any pill.

Conclusion:

The key concept behind ‘digiceuticals’ or digital therapeutics is to exert a strong influence on individual behavior and lifestyle pattern, which are crucial both in prevention, and in controlling the progression of many NCDs. The desired level of change in behavior and lifestyle of individuals can be achieved through custom-made digital software. These are expected to deliver the same, or even better results in such disease conditions, at a much lesser cost, sans any serious side effects.

The ball has already started rolling with considerable success and a discernible promise in this direction. However, accelerating its speed further, and ultimately flooring the gas pedal, would depend on how all concerned stakeholders’, especially the technology experts, doctors, pharma industry, and other health care providers work in-sync with each other, leveraging the true potential of ‘digiceuticals’.

The rapid pace of progress in this endeavor will be a force multiplier in arresting the fast spreading ‘invisible epidemic’, as it were, of many serious chronic diseases or disorders, in a much better and cost-effective way than ever before.

By: Tapan J. Ray

Dawns A New Era: Regenerative Medicine For Degenerative Disease

Posted on July 17, 2017 by Tapan Ray

Could breakthrough innovation in ‘Regenerative Medicine’ significantly reduce the need of expensive lifelong medications, or even make the use of some important medical devices less relevant, or even help avoiding expensive and risky surgical interventions? The common answer to these critical questions is now getting clearer, in tandem with the rapid progress of the science of ‘Regenerative Medicine.’

On June 13, 2017, Nature Biomedical Engineering published an interesting an article titled, “3D-printed vascular networks direct therapeutic angiogenesis in ischemia.” In simple words, these 3D-Printed patches are going to usher in a highly innovative way to treat ischemic diseases, in the future. As the researchers highlighted, arterial bypass grafts are currently considered as the gold standard for the treatment of end-stage ischemic disease, though many patients are unable to tolerate the cardiovascular stress of arterial surgery. The researchers found that implantation of 3D-printed grafts containing endothelial-cell-lined lumens, induces spontaneous and geometrically guided generation of collateral circulation in ischemic settings.

In rodent models of hind limb ischemia and myocardial infarction, these scientists successfully demonstrated that the vascular patches rescue perfusion of distal tissues, preventing capillary loss, muscle atrophy and loss of function.

In this article, I shall deliberate on the importance of this discovery, and its overall future implications on a broader perspective.

Regenerative medicine:

Here comes the basic question – What is ‘Regenerative Medicine’?

It is defined as a highly innovative branch of medicine that develops implementable methods to regrow, repair or replace damaged or diseased cells, organs or tissues. According to RegerativeMedicine.net following are illustrations of some conditions or diseases that regenerative medicine has the potential to cure, and what their current state of treatment looks like in in the American perspective:

Heart valves- 250,000 patients receive heart valves, at a cost of US$27 billion annually
Heart disease and Stroke- 950,00 people die of heart disease or stroke, at a cost of US$ 351 billion annually
Diabetes- 17 million patients have diabetes, at a cost of US$ 132 billion annually

I discussed in this blog, the subject of ‘3D Printing in health care’ on January 11, 2016. Hence, won’t dwell on that subject here

Ischemia, and the relevance of the above discovery:

Ischemia, as many would know, is a condition that restricts adequate flow of blood in some parts of our body, which over a period, may narrow, harden or even block the important blood vessels, much often resulting in stroke, heart attack or other related life-threatening vascular disorders.

Currently, ischemic heart conditions are usually treated either with blood thinning drugs, or blood vessel relaxants. In more serious stages of this condition, doctors prefer angioplasty or other surgical interventions, such as coronary artery bypass.

In this broad perspective, the relevance of the above discovery in addressing various debilitating or life- threatening ischemic conditions, is profound. Its novelty lies in the ability of the scientists making a 3D-printed patch that can be infused with cells to help grow healthy new blood vessels.

An emerging medical space:

The science of ‘Regenerative Medicine’ is increasingly being considered as an emerging medical space aimed at the treatment of those diseases that are usually classified as degenerative, incurable and irreversible. As it appears today, this science has the potential to unfold a new paradigm in this space, where patients can expect cure for many serious ailments, such as, spinal injuries, heart disease, Parkinson’s, Alzheimer’s disease and even diabetes, besides many others.

One more recent pursuit in this much uncharted frontier was reported in the British news daily – ‘The Telegraph’ on February 21, 2017, revealing the outcome of a path-breaking medical study for freezing the progression of a crippling ailment called Multiple Sclerosis (MS). This research followed a unique Stem Cell (SC) transplantation process, and is regarded as the largest long-term follow-up of SC transplantation treatment study of MS in regenerative medicine.

This study, spearheaded by Imperial College London, established that 46 per cent of patients who underwent the treatment did not suffer a worsening of their condition for five years. The process works by destroying the immune cells responsible for attacking the nervous system. This is indeed a very significant development in the space of medical research.

The treatment, called autologous hematopoietic stem cell transplantation (AHSCT), was given to patients with advanced forms of MS who had failed to respond to other medications. However, the researchers noted that the nature of the treatment, which involves aggressive chemotherapy, carried “significant risks”.

As many would know, MS is caused by the immune system malfunctioning and mistakenly attacking nerve cells in the brain and spinal cord, leading to problems with movement, vision, balance and speech. It’s a lifelong condition and often causes serious disability, with no cure still in sight. The disease is most commonly diagnosed in people in their 20s and 30s, although it can develop at any age.

A potential game changer:

According to California Institute for Regenerative Medicine (CIRM), this procedure has a game changing potential for successful use:

To replace neurons damaged by spinal cord injury, stroke, Alzheimer’s disease, Parkinson’s disease or other neurological problems

To produce insulin that could treat people with diabetes, and heart muscle cells that could repair damage after a heart attack, or

To replace virtually any tissue or organ that is injured or diseased

Research on “Regenerative Medicine’ signals a new hope:

Following are examples of just a few more promising developments, indicating that research in ‘Regenerative Medicine’ is taking rapid strides, signaling a new hope:

- A cure for Type 1 diabetes:

According to an international report on October 9, 2014, for the first time after 23 years of research, Harvard University has been able to manufacture millions of beta cells required for transplantation. It could mean a cure for diabetes, and the end of daily insulin injections for patients living with Type 1 diabetes. Although, just around 10 per cent of all diabetes is Type 1, it is the most common type of childhood diabetes.

The report indicated, the stem cell-derived beta cells are presently undergoing trials in animal models, including non-human primates, where they are still producing insulin after several months.

Another report of April 2014 indicates that for the first time, scientists have successfully replaced the damaged DNA of a type 1 diabetes sufferer with the healthy genetic material of an infant donor. When these cells are injected back into the diabetic patient, it is expected that they will begin to produce insulin on their own.

- Restoring vision in macular degeneration:

Yet another study published in ‘The Lancet’ in October 2014 stated that scientists in the United States have announced that single transplant of stem cells has helped restore the sight of patients suffering from incurable forms of blindness due to Age-related Macular Degeneration (AMD). Currently no effective treatments exist for this eye disorder, which can cause complete blindness due to the loss of light-receiving photoreceptor cells in the retina.

To recreate a type of cell in the retina that supports those photoreceptors, the new treatment uses stem cells derived from embryos that are only a few days old and have the ability to develop into any kind of tissue in the body. However, the transplants have proved controversial because they use stem cells derived from spare human embryos left over from IVF treatment.

- A cure for heart failure:

One more international report of May 01, 2014 states, by injecting human stem cells into the organs of macaque monkeys, scientists have been able to regenerate their damaged hearts by up to 40 per cent in just a few weeks. Thus, it appears now that a cure for heart failure could be just a few years away and would mean that even people who are “bed-bound” with heart failure could be “up and about” again within a few weeks.

As on date, the heart muscle cannot be repaired, making people with severe heart failure necessarily wait for a heart transplant, provided the patients are willing, and can afford so.

Conclusion:

There is a host of diseases, including several chronic ailments, such as diabetes, heart conditions, rheumatoid arthritis, or some types of cancer, which can’t be reversed, however, could be managed with a lifelong treatment. For most of these diseases, ‘Regenerative Medicine’ has the potential to be a game changer by transforming many lives.

Moreover, ‘Regenerative Medicine’ is expected not just to bring down the cost of health care and the disease burden significantly, but would also help increasing the economic productivity of a nation considerably.

Currently, medical research of the highest order in this area, has mostly been conducted by various academia of global repute, along with a few in the industry. It should soon involve, besides patients, several industries, including pharmaceuticals and biotech sectors, in a big way.

Nevertheless, this emerging trend sends a clear signal that to treat various chronic, incurable, irreversible and seriously debilitating degenerative diseases ‘Regenerative Medicine’ is now poised to take a giant leap in the health care space. In that process, it would possibly help healing various ailments in a more meaningful, providing a cure for many chronic diseases that was a badly missing piece in the medical science, so far.

Thus, ‘Regenerative Medicines’ to treat many ‘Degenerative Diseases’ signal a great potential to give an altogether new shape and dimension to the future of global health care. It is also expected to ensure lesser lifelong usage of expensive drugs, setting a new normal to bring back the patients’ lives back to the pre-disease state.

By: Tapan J. Ray

Disruptive Digital Innovation To Reduce Medication Need?

Posted on May 1, 2017 by Tapan Ray

Application of digital technology in various spheres of not just business, but in our individual day to life also, promises a disruptive change for the better, from the traditional way of doing things and achieving goals – freeing a lot of precious time for us to do much more, and even faster. An impending tsunami of this digital revolution, as it were, is now all pervasive, with various digital application platforms becoming increasingly more cost effective, quite in tandem with the fast pace of cutting-edge innovation. This is so different from what is generally witnessed in the pharma business.

Interestingly, despite high demand for cost effective health care from all over the world, not much progress in this area is still visible within this industry, in general, and particularly in the pharma business. Various reasons may be attributed to this apathy, which I shall not venture to go into, today.

On the other hand, sniffing a huge opportunity in this largely vacant space, many tech giants and startups are investing heavily to make health care of people easier, and at the same time reap a rich harvest, far outpacing the big pharma players.

As I connect the different dots on world-class digital initiatives in the health space, a clear trend emerges on the global scenario. The way Internet revolution, to start with, followed by smartphones and many other wireless digital services is changing the rhythm of life for many making it much easier, is just amazing. These include a plethora of everyday ‘must-do’ and several other functions, such as, precise need-based information gathering, online banking, tax-filing, shopping, payment, social networking, cloud computing and storage, besides a gamut of other digital services.

Similar disruptive digital innovations are expected in the health care space too, involving many long-awaited patient-centric areas, such as, significant reduction in the cost of medication. I discussed a similar issue in one of my earlier articles, published in this blog. However, today, I shall focus on this specific area, in view of its possible huge impact on the traditional pharma business model.

May reduce need of medication:

That tech startups are developing digital tools that reduce the need of medication, was very recently reported in an article titled, ‘Digital disruptors take big pharma beyond the pill’ published in the Financial Times on April 24, 2017. For example, a California-based startup, has reportedly come out with a digital device, smaller than an iPhone and fitted with a cellular chip, that can keep instant and accurate track of blood sugar levels. If the readings fall in the danger zone, an appropriate text message will be automatically generated for the person, such as – “drink two glasses of water and walk for 15 minutes”. The individual can also seek further help over the telephone from a trained coach – a highly-qualified dietitian for further guidance, the article highlights.

The whiz kid developers of wearable digital devices and apps are now intently working on many innovative health care solutions. Many of these can help early disease detection, and chart the risk profile of persons prone to various ailments, based on an enormous amount of well researched scientific data, significantly reducing the need of medication through effective disease prevention and management protocols. For example, there are umpteen evidences, demonstrating that specific moderate physical exercises help control diabetes just as well as medication, when detected early.

Thus, I reckon, such wearable digital devices and apps carry a huge promise to detect many diseases like, diabetes at its very onset or even before, and influence the person to take the necessary measures. In case of diabetes, it could be like, walking a certain distance every day, along with regular dietary advices from a remote center. Won’t such digital interventions work out far cheaper and convenient than lifelong visits to physicians and administration of anti-diabetic drugs?

The notes of the pharma business playbook need to be rewritten?

Let me quickly elaborate this point with an example of a common chronic ailment, say, diabetes. For effective management of this disease, global pharma players prefer to focus on better and better antidiabetic drug development, and after that spend a fortune towards their effective sales and marketing for generating enough prescription demand. Branded generic manufacturers are no different. This is important for all of them as most patients will have to administer the medicines for chronic ailments for a lifetime, incurring significant recurrent expenses for effective disease control. The first access point of such disease management has always been a doctor, initially for diagnosis and then for lifelong treatment.

Disruptive digital innovation could change the first point of intervention from the doctors to various digital apps or devices. These digital tools would be able to check and capture the person concerned predisposition to chronic diseases like, hypertension and diabetes, besides many other serious ailments, including possible cancer. When detected early, primary disease management advice would be available to patients from the app or the device itself, such as, the above-mentioned device for diabetes. If the preventive practices can manage the disease, and keep it under control, there won’t be any serious need to visit a doctor or pop a pill, thus, avoiding any need of active medication.

In that sense, as the above FT article has articulated, ‘rather than buying a pill, people might buy an overall solution for diabetes’ can’t be more relevant. When it happens, it will have a multiplier effect, possibly impacting the volume of consumption of medicines, just as what disease prevention initiatives do. Consequently, the notes of the pharma business playbook may have to be rewritten with right proactive measures.

As reported, the good news is, at least a couple of global pharma players have started fathoming its impact. This is apparent from Sanofi’s collaboration on digital devices and patient support for diabetics, and to some extent with Pfizer on immuno-oncology, using expertise in data analytics to identify new drug targets.

The key players in this ‘healthcare value chain’:

When the digital health care revolution will invade the current space of traditional-health care, it will create both the winners and losers. This was clearly highlighted in an article titled, ‘A digital revolution in healthcare is speeding up’, published by ‘The Economist’ on March 02, 2017.

From this article, it appears, when viewed in the Indian context that primarily two groups of players are currently ‘fighting a war for control’ of this ‘healthcare value chain’, as follows:

Traditional innovators: These are pharma companies, hospitals and medical-technology companies, such as, Siemens, GE and Phillips.

Technology insurgents: These include Microsoft, Apple, Google, and a host of hungry digital entrepreneurs and startups – creating apps, predictive-diagnostics systems and new devices.

Where is the threat to traditional pharma innovators?

This emerging trend could pose a threat to traditional innovators as the individual and collective knowledge base gets wider and wider – the above article envisages. With the medical records getting increasingly digitized with new kinds of patient data available from genomic sequencing, sensors and even from social media, the Government, including many individuals and groups, can now get a much better insight into which treatments work better with avoidable costs, on a value-based yardstick. For example, if digital apps and wearable devices are found even equally effective as drugs, with the least cost, to effectively manage the menace of diabetes in the country, notwithstanding any strong ‘fear arising’ counter propaganda, as we often read and here and there, those will increasingly gain better acceptance from all concerned.

The moot question, therefore, arises, would the drug companies lose significantly to the emerging digital players in the health care arena, such as, Microsoft, Apple and Google?

Tech giants are moving faster:

In several disease areas like, cancer and diabetes, the tech giants are taking longer and bigger strides than the traditional pharma innovators. For example:

Microsoft has vowed to “solve the problem of cancer” within a decade by using groundbreaking computer science to crack the code of diseased cells so that they can be reprogrammed back to a healthy state.

Apple has a secret team working on the holy grail for treating diabetes. The Company has a secret group of biomedical engineers developing sensors to monitor blood sugar levels. This initiative was initially envisioned by Steve Jobs before his death. If successful, the advance could help millions of diabetes patients and turn devices, like Apple Watch, into a must-have.

Verily – the life sciences arm of Google’s parent company Alphabet, has been working on a “smart” glucose-sensing contact lens with Novartis for several years, to detect blood glucose levels through tears, without drawing any blood. However, Novartis has since, reportedly, abandoned its 2016 goal to start testing the autofocus contact lens on people, though it said the groundbreaking product it is “progressing steadily.” It has been widely reported that this could probably be due to the reason that Novartis is possibly mulling to sale its eye care division Alcon.

Calico, which is also owned by Google’s parent company Alphabet, has US$ 1.5 billion in funding to carry out studies in mice, yeast, worms and African naked mole rats for understanding the ageing process, and how to slow it, reports MIT Technology Review.

No wonder, why an article published in Forbes magazine, published on April 15, 2017 considered these tech giants as ‘The Next Big Pharma’. It said, ‘if the innovations of Google and Apple are another wake-up call for the life science industry, which oftentimes has relied on the snooze function of line extensions and extended-release drugs as the source of income and innovation.’

In conclusion:

An effective disease treatment solution based on different digital platforms has a key financial advantage, as well. This is because the process of generation of huge amounts of credible scientific data, through large pre-clinical and clinical trials, establishing the efficacy and safety of new drugs on humans for regulatory approval, is immensely expensive, as compared to the digital ones. Intriguingly, no global pharma player does not seem to have launched any significant digital health care solution for patients to reduce the overall cost of disease burden, be it prevention or management.

In that context, it’s encouraging to note the profound comment of the Chief Operating Officer – Jeff Williams of Apple Inc., made during a radio show – ‘Conversations on Health Care’, as reported by ‘appleinsider.com’ on January 06, 2016. During the interaction, Williams reiterated that the rapid progress of technology in this direction is very real, as ‘Apple’ and other smartphone health app developers are stretching the commoditization of computer technology to serve health sciences. In not so distant future, with relatively inexpensive smartphones and supporting health apps – the doctors and researchers can deliver better standards of living, even in severely under-served areas like Africa, where there are only 55 trained specialists in autism.

Thus, it now looks reasonably certain to me that disruptive digital innovation on various chronic health care solutions is ultimately going to reduce the need of medication for many patients, across the world, including India, significantly.

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.

A Patient-Centric State Initiative To Revolutionize Disease Treatment

Posted on February 9, 2015 by Tapan Ray

In his State of the Union address, just before the recent visit to India in January 2015, President Barack Obama articulated the need to develop “Precision Medicine” in his country – a bold, giant and perhaps unprecedented State initiative to remarkably improve effectiveness of disease treatment.

To set the ball rolling, in his budget proposal for the year 2016, President Obama earmarked an amount of US$ 215 million for this purpose. This includes an allocation of US$130 million for the National Institutes of Health (NIH) to create a national research database of about a million American volunteers by studying their genetics together with other relevant factors, such as the environments they live in and the microbes that live in their bodies.

‘Precision Medicine’ initiative is similar to path breaking 13-year and US$3 billion Human Genome Project, that has formed the bedrock of modern genomics, President Obama said. He also expressed hope that the private healthcare sector too, including universities and foundations, will get involved to “lay the foundation” for this new initiative of the Government for the interest of patients.

Why is this approach so relevant in today’s healthcare?

In an article published in the ‘British Medical Journal (BMJ) in October 2012, Richard Smith - an editor of BMJ until 2004 and a Director of the United Health Group’s chronic disease initiative wrote:

“Doctors know that many of the patients they treat with drugs will not benefit. Many patients know that too.”

Dr. Smith also emphasized, for centuries medicine classified diseases by what could be seen, felt, and smelt. Thereafter, medical scientists in this area started defining diseases anatomically, physiologically, and biochemically. Even today, this is by and large the paradigm where most medicines fall.

Smith underscored, because of imprecise diagnosis the treatment also becomes haphazard. There is big variation in how individuals respond to drugs and yet that variation is not usually recorded. The regulators approve drugs based on their average performance even today.

The White House release also reiterates, most medical treatments have been designed for the “average patient.” This “one-size-fits-all-approach,” treatments can be very successful for some patients but not for others.

This calls for broadening the scope of disease treatment – from the conventional and error-prone ‘Disease Oriented’ approach, to relatively more unconventional and better targeted with greater value – ‘Patient-Centric’ ones, wherever needed.

Two current trends:

To address this key deficiency in the effective treatment of several dreaded diseases for many patients, following two are the current trends, as stated by William Pao, M.D., Ph.D., who led Roche’s Oncology Discovery & Translational Area research unit since May 2014:

We now know that on a molecular level every cancer is different – not only between different tumors, but even between different areas within a single tumor! This means that we need to match the right drug to the patient who we know will respond best to the drug, at the right time during the course of treatment.

Patients will have their tumors profiled not only for genetic drivers, but also for predictive immunotherapy markers at different time points in their course of treatment.

Personalized and Precision Medicine:

The above trends in the endeavor of making treatments more patient specific – thus more effective, have thrown open scientific discourse and intense research on ‘Personalized’ and ‘Precision’ medicines.

As Pfizer has described in its website:

Personalized Medicine is a unique approach to medical practice in which the individual aspects of a patient are directly considered to guide treatment planning, including his or her genetic make-up, key biomarkers, prior treatment history, environmental factors and behavioral preferences. This approach can be used to optimize pharmaceutical treatments and overall care.

Whereas, Precision Medicine is an approach to discovering and developing medicines and vaccines that deliver superior outcomes for patients, by integrating clinical and molecular information to understand the biological basis of disease. Precision medicine is the biopharmaceutical research and development paradigm that will help enable more patient-centered clinical practice, including treatment decision-making based on genetic information – an emerging standard now often described as “personalized medicine”.

As President Obama said while announcing the proposal on January 30, 2015, ‘Precision Medicine’ promises delivery of the right treatment at the right time, every time, to the right person.

He also said that the new effort will “bring us closer to curing diseases like cancer and diabetes…and give all of us access to the personalized information we need to keep ourselves and our families healthier.”

‘Precision Medicines’ Dominate Oncology segment:

In the European Society for Medical Oncology (ESMO) 2014 Congress, pharma majors reported their latest advances on precision medicines in the cancer care. Bristol-Myers Squibb, Roche, AstraZeneca, GlaxoSmithKline (GSK), and Merck & Co. were among the companies presented updates of their most promising cancer drugs closer to this area.

According to a large pharma lobby group in the United States – The Pharmaceutical Research and Manufacturers of America (PhRMA):

“Recent advances in diseases such as cancer and cystic fibrosis are delivering on the promise of targeted treatments, and between 12 and 50 percent of all compounds currently being researched by the industry are potential personalized medicines. These advances hold great promise in improving patient outcomes and controlling costs by targeting the right medicines to the right patients.”

‘DCAT Connect’ Report of September 2014 also indicates significant increase in ‘Precision Medicines’ in the pipelines of the leading global pharma companies, which is a key change over the past decade.

In 2013, targeted therapies increased their share of the global oncology market, accounting for 46 percent of total sales, up from 11 percent a decade ago. According to IMS Institute for Healthcare Informatics, the global oncology drug market reached US$ 91 billion in 2013 with CAGR of 5.4 percent from 2008 to 2013.

Taking note of this trend, it appears that in the near future ‘Precision Medicines’ would possibly be the most promising class in the treatment of cancer, particularly in breast cancer, lung cancer and certain types of leukemia. This is mainly because medical scientists are already quite acquainted with the molecular signatures of different types of cancer related tumors.

Medical scientists and researchers are also working on ‘Precision Medicines’ to more effectively address many other diseases, such as, diabetes, cardiovascular and ailments related to several types of infections.

Increasing potential:

Realization of the potential of ‘Precision Medicines’ to improve care and speed the development of new treatments has just only begun to be tapped.

In recent times, scientists and researchers have accelerated efforts to understand more about biomarkers for this purpose. A study conducted by the German Association of Research-Based Pharmaceutical Companies (vfa) indicates that more than 20 percent of clinical trials carried out since 2005 focused not just on agents, but also on biomarkers. Before 1990, only one in twenty clinical trials addressed biomarkers.

According to another report, last year, 20 percent of all new drug approvals in the United States were for “Precision Medicine” treatments. This vindicates, yet again, the immense potential to turn genetic discoveries into innovative disease treatments for patients.

A bold state sponsored research initiative:

State funded, ‘Precision Medicine’ initiative is a bold new step of the American Government to revolutionize improvement in healthcare and treating disease. It is expected to pioneer a new model of patient-powered research that promises to accelerate biomedical discoveries and provide clinicians with new tools, knowledge, and therapies to select which treatments will work best for which patients.

As the White House release reiterates, most medical treatments have been designed for the “average patient.” As a result of this, “one-size-fits-all-approach” treatments can be very successful for some patients but not for others. This is changing with the emergence of ‘Precision Medicine’, an innovative approach to disease prevention and treatment that takes into account individual differences in people’s genes, environments, and lifestyles.

In this process, ‘Precision Medicine’ gives clinicians tools to better understand the complex mechanisms underlying a patient’s health, disease, or condition, and to better predict which treatments will be most effective.

Opposite view:

In an op-ed titled, ‘Moonshot’ Medicine Will Let Us Down, published recently in The New York Times, the author argued with his differing viewpoints.

I am quoting below three of those arguments:

“For most common diseases, hundreds of genetic risk variants with small effects have been identified, and it is hard to develop a clear picture of who is really at risk for what. This was actually one of the major and unexpected findings of the Human Genome Project. In the 1990s and early 2000s, it was thought that a few genetic variants would be found to account for a lot of disease risk. But for widespread diseases like diabetes, heart disease and most cancers, no clear genetic story has emerged for a vast majority of cases.”

“Another unexpected finding of the Human Genome Project was the problem of ‘missing heritability.’ While the statistics suggest that there is a genetic explanation for common conditions and diseases running in families or populations, it turns out that the information on genetic variants doesn’t explain that increased risk.”

“The idea behind the “war on cancer” was that a deep understanding of the basic biology of cancer would let us develop targeted therapies and cure the disease. Unfortunately, although we know far more today than we did 40-plus years ago, the statistics on cancer deaths have remained incredibly stubborn.”

I am sure, you will analyze the above points with the facts that you have at your disposal on this subject to arrive at a logical conclusion.

Current Applications:

Though these are still early days, initial benefits of ‘Precision Medicines’ have been reported in many areas, such as:

Genetic analysis of patients dealing with blood clots: Since 2007, the U.S. Food and Drug Administration has been recommending genotyping for all patients being assessed for therapy involving Warfarin.

Colorectal cancer: For colon cancer patients, the biomarker that predicts how a tumor will respond to certain drugs is a protein encoded by the KRAS gene, which can now be determined through a simple test.

Breast cancer: Women with breast tumors can now be effectively screened to determine which receptors their tumor cells contain.

Cystic fibrosis: In America, patients with a rare form of cystic fibrosis now can choose a drug designed specifically to target the genetic defect causing their illness. Specialized medical centers, such as “individualized medicine centers” at the Mayo Clinic, are also available to the patients for effective treatment.

Ethical issues:

While following this pursuit of excellence of the genetic scientists in the realm of disease treatment, some experts have reportedly raised flags of caution. They strongly feel that DNA code sequencing brings to light a “very real privacy concerns” of individuals.

GeneWatch UK is an organization that investigates how genetic science and technologies will impact on our food, health, agriculture, environment and society. They have been strongly arguing, if genome sequencing is extended to entire population, individuals and their relatives could then be identified and tracked by matching their DNA with the genome stored in the respective health records. This move, as contemplated by them, could “wipe out privacy” with an impact on the society.

Thus, the ethical and social issues in the development of ‘Precision Medicine’ primarily in the area of genetic testing need to be effectively addressed, sooner.

Conclusion:

The quest for moving away from conventional and error-prone ‘Disease Oriented Treatment’ paving the way for unconventional and value added individual patient-specific ones, may soon come to fruition.

Advances in ‘Precision Medicine’ have already led to powerful new discoveries and several new treatments that are tailored to specific characteristics of individuals, such as a person’s genetic makeup, or the genetic profile of an individual’s tumor. This is leading to a transformation in the way the world can treat diseases such as cancer.

Patients with breast, lung, and colorectal cancers, melanomas and leukemia, for instance, should be provided with facilities in specialist hospitals to undergo molecular testing as a part of patient care, enabling physicians to select treatments that improve chances of survival and reduce exposure to adverse effects.

Although, the potential for precision medicine to improve care and speed the development of new treatments has only just begun to be tapped, some skeptics do say that tailoring medical treatments to individual characteristics of each patient is both overly optimistic and cost-prohibitive.

Be that as it may, in the balance of probability the benefits of prudent use of ‘Precision Medicine’ far outweigh the concerns expressed. This evolving new paradigm would help saving not just significant expenses, but also precious time that is usually spent on ‘trial-and-error treatments’, by enabling clinicians to determine quickly which therapies are most likely to succeed.

Though lot many grounds would still need to be covered in this area, the State sponsored ‘Precision Medicine’ initiative of America to revolutionize disease treatment, in my view, is indeed a laudable one, every way.

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.

Would ‘Regenerative Medicine’ Shape The Future Of Global Healthcare?

Posted on December 22, 2014 by Tapan Ray

Just the last week, on December 19, 2014, international media broke the news of regulatory approval of the first stem cell treatment by the European Medicines Agency (EMA).

The Agency reportedly has recommended an Orphan Drug – Holoclar of the Italian pharmaceutical company Chiesi Farmaceutici S.p.A for the treatment of moderate-to-severe Limbal Stem Cell Deficiency (LSCD) caused due to physical or chemical burns to the eyes in adults. LSCD can lead to blindness, where Holocar works in around 80 percent of cases.

The EMA decision to approve Holoclar will now be sent to the European Commission for market authorization.

As reported, this new generation treatment takes a small sample of the patients’ healthy cornea, removes the stem cells and grows them until there are sufficient numbers to put back into the eye. The cells themselves then repair the damage.

Experts consider this development as very significant step forward, as stem-cell therapies are now being tried mostly in the laboratory environment and clinical trials.

Treatment with Stem Cells – A new paradigm:

A stem cell is defined as an undifferentiated cell of a multicellular organism that is capable of giving rise to indefinitely more cells of the same type, and from which certain other kinds of cell arise by differentiation.

Stem cells are, therefore, immature cells that can be induced to transform into tissue or organ-specific cells and are classified as per their source, such as Embryonic Stem Cells (ES) from early human embryos, fetal stem cells from aborted fetus; adult stem cells from tissues, skin and bone marrow; cord blood cells from umbilical cord and even fatty tissues.

In human developmental biology, extensive scientific research over many years has led to the discovery of human stem cells.

Regenerative Medicine:

This terminology is generally used for new medical advances in which an understanding of the human genome allows the use of the body’s own mechanism to heal it. This may include new pharmaceuticals and the ability to create new cells that could be implanted into patients to replace diseased or missing tissues.

The science of ‘Regenerative Medicine’ is increasingly being considered as an emerging medical space aimed at the treatment of those diseases that are usually classified as degenerative, incurable and irreversible. As it appears today, this science would unfold a new paradigm, where patients can expect cure for many serious ailments, such as, spinal injuries, heart disease, Parkinson’s, Alzheimer’s disease and even diabetes, besides many others.

Some promising developments:

Besides the recently EMA approved new treatment, as mentioned above, examples of just a few more promising developments in research with the stem cells, are as follows:

- Possible cure for Type 1 diabetes:

According to an international report of October 9, 2014, for the first time, after 23 years of research, Harvard University has been able to manufacture millions of beta cells required for transplantation. It could mean a cure for diabetes and the end of daily insulin injections for patients living with Type 1 diabetes. Around 10 per cent of all diabetes is Type 1, but it is the most common type of childhood diabetes.

The report indicated, the stem cell-derived beta cells are presently undergoing trials in animal models, including non-human primates, where they are still producing insulin after several months.

- Transplant of embryonic human stem cells on patients with macular degeneration partially restored vision:

Another study published in ‘The Lancet’ in October 2014 stated that scientists in the United States have announced that single transplant of stem cells has helped restore the sight of patients suffering from incurable forms of blindness due to Age-related Macular Degeneration (AMD). Currently no effective treatments exist for this eye disorder, which can cause complete blindness due to the loss of light-receiving photoreceptor cells in the retina.

- A cure for heart failure could be just a few years away:

Yet another international report of May 01, 2014 states, by injecting human stem cells into the organs of macaque monkeys, scientists have been able to regenerate their damaged hearts by up to 40 per cent in just a few weeks. Thus, it appears now that a cure for heart failure could be just a few years away and would mean that even people who are “bed-bound” with heart failure could be “up and about” again within a few weeks.

As on date, the heart muscle cannot be repaired, making people with severe heart failure necessarily wait for heart transplant. Of course, if the patients are willing and can afford so.

Debate around stem cell research:

Like many other research areas involving biological science, a raging debate has also commenced globally on several sociopolitical, cultural and ethical issues involving the use of stem cells as therapy.

Many clinical research related issues too are now surfacing on the use of human embryos, manipulations and modifications in stem cells research.

Apprehension of misuse, especially through cloning, had prompted many governments, India included, to ban reproductive cloning, keeping therapeutic cloning open for research.

However, arriving at a broader consensus in this area does not seem to be an insurmountable problem, in any case, as things stand today.

Research on stem cells and regenerative medicine in India:

Though it may sound almost unbelievable, India is now considered to be in the forefront of stem cells research and its use in a limited manner.

Indian Government under Indian Council for Medical Research (ICMR) and the Department of Biotechnology (DBT) has already set up a number of stem cell research institutions across the country. These institutions have already commenced valuable research in this area. DBT had granted more than Rs 300 Crore over the previous five years to be used in basic and applied research in stem cell technology.

According to one August 2014 report from ‘Business Insider’, several stem cells research initiatives are ongoing both in public and the private sectors in India.

A few examples, as reported, are as follows:

Public initiatives:

The National Centre for Cell Research (NCCR), Pune, has worked on stem cell trans differentiation into pancreatic islets.

Research at All India Institute of Medical Science (AIIMS) and Postgraduate Institute of Medical Education & Research (PGIMER), is ongoing on retinal degeneration and stroke.

National Institute of Immunohematology (NIIH) has been able to differentiate umbilical cord-derived mesenchymal stem cells into cardiomyocytes or cardiac muscles.

The National Centre for Biological Sciences (NCBS) in Bangalore, part of the Tata Institute of Fundamental Research, also works closely with the government on stem cells research.

The Government of India had set up The Centre for Stem Cell Research (CSCR) in 2008 in collaboration with Christian Medical College, Vellore, with the intention of using stem cell science for understanding human diseases and development of stem cell-based therapies. Interestingly, it also runs a training program for scientists and students of stem cell research. CSCR will also carry out clinical trials with stem cells produced under current good manufacturing practice (GMP) conditions.

Private initiatives:

Reliance Life Sciences obtained permission to use on large-scale stem cells sourced from the patient’s body for therapy.

The LV Prasad Eye Institute, Hyderabad, has developed corneal limbal stem cells.

Sankara Nethralaya Stem Cell Research Center, Chennai, is working on retinal and corneal stem cell application and immunoregulatory properties of stem cells.

Hospitals such as Dr KM Cherian’s research facility in Medville have used stem cells from bone marrow to help regenerate the heart.

Besides, Indian rules and law permit the usage of one’s own banked stem cells. Several storage facilities such as Life Cell, Reliance Life Sciences, Cryobanks International and Stemade for dental stem cell storage have also come up.

Stem cells research guidelines in India:

In India, ICMR-DBT Guidelines for Stem Cell Research are in place. These guidelines have been laid down to ensure that research with human stem cells is conducted in a responsible and ethically sensitive manner and complies with all regulatory requirements pertaining to biomedical research in general and stem cell research in particular.

Since it is a rapidly evolving field of science, the recommendations may change with time.

All types of research and clinical trials in stem cells would require to be registered with and obtain prior permission and approval of the National Apex Committee (NAC) and the Institutional Committee (IC-SCRT) for Stem Cell Research.

It is notably important that the guidelines categorically states that only stem cell research, basic and translational, is permitted but not therapy.

NAC- IC-SCRT permits therapy usage in patients only through approved and fully monitored clinical trials. Stem cells cannot be used as therapy without appropriate regulatory approvals in India.

Conclusion:

Currently, most treatments for non-infectious chronic ailments only delay the disease progression and associated complications. There is virtually no cure for most of these diseases, which include, spinal injuries, heart diseases, Parkinson’s, Alzheimer’s disease or even hypertension, asthma or diabetes.

Regenerative Medicine would not just bring down the cost of healthcare and the disease burden significantly, but would also help increasing the economic productivity of a nation considerably.

Currently, medical research of the highest order in this area is mostly being conducted by various academia of global repute along with the industry. This emerging trend sends a clear signal that ‘Regenerative Medicine’ is now strongly poised to give an altogether new shape to the future of global healthcare, adding unique dimensions.

Consequential paradigm shift in the field of healthcare, I reckon, would herald the dawn of a brand new era, setting in place a whole new commercial ball game, the like of which the world has never witnessed, ever before.

By: Tapan J. Ray

Cheaper Drugs: Happy Patients: Angry Industry

Posted on July 21, 2014 by Tapan Ray

Recent price reductions of a number of cardiovascular and diabetes drugs falling outside the National List of Essential Medicines 2011 (NLEM 2011), have attracted fury of the pharma industry . By a notification dated July 10, 2014, the National Pharmaceutical Pricing Authority (NPPA) has invoked Para 19 of the DPCO 2013 for these price changes, the implications of which would indeed be far reaching.

NPPA has now decided to examine inter-brand price variation for single ingredient formulations in eight therapeutic groups, which, besides cardiovascular and diabetic drugs, would include, anti-cancer, HIV/AIDS, anti-TB, anti-malaria, anti-asthmatic and immunological (sera/vaccines). In these therapy areas, the Maximum Retail Price (MRP) of the brand(s) exceeding 25 per cent of the simple average price of all in the same molecular category having 1 percent or above market share, would be capped at the 25 per cent level.

Pharma industry, in general, feels that this ‘unwelcoming decision’ of the NPPA, which allegedly goes beyond the scope and spirit of DPCO 2013, would invite great uncertainty in its business environment.

On the other hand, many consider this price reduction as a ‘Good Omen’ for millions of patients suffering from related life-long ailments. They argue, the purpose of this ‘Bitter Pill” of the NPPA, is to send a clear message to the pharma industry to shape-up with responsible drug pricing.

The new Minister’s recent statement:

It may not be a bad idea to take into consideration the above notification of the NPPA in the light of what the new minister of Chemicals and Fertilizers – Mr. Ananth Kumar said on May 28, 2014. According to media report, the Minister expressed his intent as follows:

“… As far as branded medicines of multinational pharmaceutical companies are concerned, we will talk to all of them and try to bring down prices of essential drugs for poor by 25-40 per cent… The pharmaceutical industry is very important for the health of the country, he added…our main mission will be to ensure the availability of all necessary medicines at affordable prices, especially for poor across the country.”

It is, therefore, quite possible that the NPPA’s decision on price reduction of cardiovascular and diabetes drugs has the Minister’s concurrence.

Industry’s key concern:

This recent decision of the NPPA has reportedly angered the industry, as the Drug Price Control Order 2013 (DPCO 2013) clearly articulates two basic criteria for drug price control in India, as follows:

1. Span of price control:

This was re-defined (from DPCO 1995) on the ‘essentiality criteria’ of the drugs, which in turn is based on the National List of Essential Medicines 2011 (NLEM 2011)

2. Methodology of price control:

This was re-defined (from DPCO 1995) with a clear departure from ‘Cost-Based Price Control’ to the ‘Market-Based Price Control’.

The industry alleges violation of these criteria for the recently announced price reduction of a number of diabetic and cardiovascular drugs, as those do not fall under NLEM 2011.

Price variation is of no-use to patients for prescription drugs:

As the prices of non-scheduled formulations are not fixed by the NPPA, which can virtually be launched at any price to the market, there has been a huge variation of prices between the branded generics within the same chemical entity/entities. Following is a quick example:

Molecule	Disease	MRP of Lowest Price Brand	MRP of Highest Price Brand
Telmisartan 10’s	Hypertension	Rs. 25	Rs. 385
Glimeperide 10’s	Diabetes	Rs. 40	Rs. 133 (Brand Leader)

From this chart, one may be able to fathom some basis in the NPPA’s argument that similar price variations in many branded-generics are of no-consequence for prescription drugs, as doctors decide the medicines that a patient would take. If doctors were influenced to prescribe high priced medicines, the patients would require paying more for those drugs, further increasing their Out of Pocket (OoP) expenses. It is also not uncommon that highest price brands are category-leaders too, as indicated in the table above.

Key lacunae in DPCO 2013:

As highlighted in my earlier blog post titled “Is The New ’Market Based Pricing Model’ Fundamentally Flawed?”, even besides that specific drawback in the methodology of price control in DPCO 2013, NLEM 2011 does not also cover a wide range of essential drugs.

NLEM 2011 does not cover many combinations of TB drugs, a large number of important drugs for diabetes and hypertension, which I shall deliberate in just a bit.

Many other critical life saving medicines, such as, anti-cancer drugs, expensive antibiotics and products needed for organ transplantation have been left out of price control. In fact, the prices of a number of these drugs have reportedly gone up after the notification of DPCO 2013.

The government has now reportedly admitted in an affidavit filed before the Supreme Court that the market value and share of medicines covered by new DPCO 2013, as ‘Essential Drugs’, is a meager 18 per cent of the Indian Pharmaceutical Market (IPM).

As a result, DPCO 2013 based on NLEM 2011 undermines the entire objective of making essential drugs affordable to all.

All these lacunae in the current DPCO 2013 calls for a major revision of NLEM 2011. The Union Health Ministry has reportedly initiated steps to revise the list considering the existing market conditions and usage of drugs by the patients.

Invocation of a ‘Safeguard Provision’ in DPCO 2013:

Probably anticipating this scenario, a key safeguard provision was included in Para 19 of DPCO 2013, which reads as follows:

“Fixation of ceiling price of a drug under certain circumstances:

Notwithstanding anything contained in this order, the Government may, in case of extra-ordinary circumstances, if it considers necessary so to do in public interest, fix the ceiling price or retail price of any Drug for such period, as it may deem fit and where the ceiling price or retail price of the drug is already fixed and notified, the Government may allow an increase or decrease in the ceiling price or the retail price, as the case may be, irrespective of annual wholesale price index for that year.”

It now appears, NPPA could realize the key limitations of DPCO 2013, which was put in place rather hastily, in course of its implementation for over one year. Consequently, the patients’ long standing plight with high drug costs for many common life style diseases that are not featuring in NLEM 2011, prompted the the drug regulator in its above notification to bring 108 non-scheduled formulation packs of diabetic, cardiac and other drugs under Para 19 of DPCO 2013, catalyzing an outcry within the pharmaceutical industry in India. Out of these 108 formulation packs, 50 come under anti-diabetic and cardiovascular medicines.

Many important drugs are outside NLEM 2011:

Following is an example of the important cardiovascular and anti-diabetic drugs, which are not featuring in the NLEM 2011 and have now been brought under Para 19 of DPCO 2013:

Sitagliptin, Voglibose, Acarbose, Metformin hcl, Ambrisentan, Amlodipine, Atenolol, Atorvastatin, Bisoprolol, Bosentan, Gliclazide, Glimepiride, Miglitol, Repaglinide, Pioglitazone, Carvedilol, Clopidogrel, Coumarin, Diltiazem, Dobutamine, Enalapril, Rosuvastatin, Simvastatin, Telmisartan, Terazosin, Torasemide, Trimetazidine and Valsartan, Enoxaparin, Eplerenone, Esatenolol, Fenofibrate, Heparin, Indapamide, Irbesartan, Isosorbide, Ivabradine, Labetalol, Levocarnitine, Lisinopril, Metolazone, Metoprolol, Nebivolol, Nicorandil, Nitroglycerin, Olmesartan, Prasugrel, Prazosin, Propranolol, Ramipril.

More reasons for industry outcry:

As reported in the media, the industry outcry reportedly highlights, besides what I have cited above, the following:

The price control order under Para 19 has been notified without any prior consultation with the industry.

The manner and method in which this unilateral decision has been taken is untenable.

The NPPA’s reasoning, about exploitative pricing by the industry as the reason for such a move, is incorrect given that every product category (in consideration) has approximately 30-70 brand options across price ranges for physicians and patients to choose from. The premise that products are not accessible due to affordability is misplaced. (The above table explains this point).

Disease environment was same when the government had cleared the policy and no “extraordinary circumstance” has emerged since then for the regulator to invoke Para 19 in public interest.

NPPA has exceeded its brief and gone into policy-making.

NPPA’s rationale for invoking Para 19 of DPCO 2013:

On the other hand, following reasons were cited by the NPPA for taking this decision:

The aim of DPCO 2013 is to ensure that essential drugs are available to all at affordable prices. The Supreme Court of India vide its Order dated November 12, 2002 in SLP no. 3668/2003 have directed the Government to ensure that essential and life saving drugs do not fall outside the ambit of price control, which has the force of law.

The Ministry of Chemicals and Fertilizers has delegated the powers in respect of specified paragraphs of the DPCO 2013, including paragraph 19, to be exercised by the NPPA on behalf of the Central Government in public interest.

There exist huge inter-brand price differences in branded-generics, which is indicative of a severe market failure as different brands of the same drug formulation identical to each other vary disproportionately in terms of price.

The different brands of the same drug formulation may sometimes differ in terms of binders, fillers, dyes, preservatives, coating agents, and dissolution agents, but these differences are not significant in terms of therapeutic value.

The main reason for market failure is that the demand for medicines is largely prescription driven and the patient has very little choice in this regard.

Market failure alone may not constitute sufficient grounds for Government intervention, but when such failure is considered in the context of the essential role that pharmaceuticals play in the area of public health, such intervention becomes necessary. This assumes greater significance, especially when exploitative pricing makes medicines unaffordable and beyond the reach of most, putting huge financial burden in terms of out-of-pocket expenditure on healthcare.

There is very high incidence of diabetes in the country, which affects around 61 million persons and the figure is expected to cross 100 million by 2030 as per the projection of the International Diabetes Federation; and it is estimated that every year nearly 1 million people in the country die due to diabetes and hypertension.

The drug regulator categorically mentions that In accordance with the guidelines issued by the NPPA, after approval of the ‘Competent Authority’, these price fixations of non-scheduled formulations under Para 19 of DPCO 2013 have been made.

Constituents of the same Ministry with conflicting view points:

Though both NPPA and the Department of Pharmaceuticals (DoP) come under Mr. Ananth Kumar, the new Minister of Chemicals and Fertilizers, both these constituents seem to have conflicting views on this important issue.

The pharma industry reportedly has sought the DoP’s intervention in this matter. The DoP, in turn, is learnt to have requested for the opinion of the Ministry of Law on using ‘Para 19′ provision in favor of public interest by the NPPA, invoking the power assigned to the drug regulator.

Another route for the industry is to legally challenge the said notification of the NPPA. However, one should keep in mind that a PIL is still pending before the Supreme Court questioning the validity DPCO 2013.

The arguments for and against:

Taking all the above points into consideration, the following two important areas of debate have now emerged on this NPPA notification, both in favor and also against:

A. Nothing has materially changed since DPCO 2013 was put in place:

Industry sources highlight that he following two points, that triggered NPPA’s invoking Para 19, have been there for a long time, including the period when the National Pharmaceutical Pricing Policy 2012 (NPPP 2012) was formulated:

- Huge price differences among various branded generics of the same molecule

- Cardiovascular ailments and diabetes have assumed endemic proportion

The other group counters that, if mistakes were made while formulating the NPPP 2012 because of intense pressure from vested interests in the erstwhile regime, why corrective actions can’t be taken now?

B. NPPA has exceeded its brief:

Industry sources question, how could NPPA possibly issue such notification of price reduction for non-scheduled formulations, as it is not a policy maker?

Others counter with equal zest: Of course NPPA is not a policy maker, it is a drug price regulator… And as a price regulator, it has implemented Para 19 of DPCO 2013 in the right earnest with the requisite powers conferred on it.

The impact:

According to published data, after the latest price revisions of diabetic and cardiovascular drugs, around 21 per cent of the anti-diabetic drug market faces the ceiling price, while the total market of cardiovascular medicines under price control is now estimated at around 58 per cent, with an overall adverse impact of reportedly Rs 550 Crore on the Indian Pharmaceutical Market. Overall price reduction for these two categories would range between 5 and 35 per cent, the average being around 12 per cent.

MNCs seem to have been hit harder:

An additional bad news for the MNCs is that the scope of Para 19 has now gone beyond the generic space and included even patented product.

For the first time a patented product Sitagliptin has been brought under the purview of Drug price Control order. This decision could give an unprecedented handle to the NPPA to regulate prices of even patented drugs through invocation of Para 19 of DPCO 2013 in future. Moreover, many high-priced branded generics of MNCs are brand leaders too. Thus, in a relative yardstick, invocation of Para 19 would hit the MNCs harder, creating an uncertainty in their business environment.

Conclusion:

Drug prices are cheapest in India in dollar terms, claims the pharma industry. Does this claim hold much water? May be not, because it should be realistically seen in terms of Purchasing Power Parity (PPP) and Per Capita Income in India. In that sense many would argue that drug prices in India, on the contrary, are not cheaper at all.

Moreover, it is important to take into cognizance the huge inter-brand price differences in branded-generics due to a flawed system, as patients have no role to play in choosing a drug (within the same molecule) that they would need to buy. It is the doctor who is the sole prescription decision maker, where price, per se, may not play a very significant role.

In a situation like this, despite the anger of the industry, many would ponder whether or not NPPA’s engagement and reasoning, on behalf of the Government, to bring some sense in the madness of drug pricing in India be just wished away?

Cheaper medicines in general and generic drugs in particular, would always make the patients and the payor happy, leaving the industry mostly angry.

Keenly observing the recent series of events and taking note of a number of highly credible viewpoints, besides a couple of seemingly spoon-fed, ill-informed and run-of-the mill type editorials, this is about time for the stakeholders to judge without any bias what is right for the country, its people and of course the business to work out a win-win solution, dousing the likes of ‘Fire in The Blood‘, once and for all.

By: Tapan J. Ray

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

Posted on January 9, 2012 by Tapan Ray

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

PILMAN

A Tapan Ray Website

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