Pharma To Facilitate Self-Managing Chronic Diseases For Better Outcomes?

“India’s burden of non-communicable disease (NCD) is escalating, but still the country does not have sufficiently detailed data on NCDs for research and policy purposes.” This was captured in a recent study, titled “India’s escalating burden of non-communicable diseases,” published in The Lancet Global Health on October 03, 2018. Thus, many experts are pondering, how to contain this menace and lower the disease burden of NCDs, in this situation. One of the ways to address this issue is exploring some unconventional ways.

As several studies have established, improving ‘self-management’ of chronic diseases by patients, after proper diagnosis and a treatment plan being in place, is one of the pillars to lower the disease burden. One such study is titled, ‘Patients’ knowledge of their chronic disease,’ appeared on June 2013 – Vol 42 (6) issue in the journal of afp – Australian Family Physician. The paper highlights that effective tools, policies and other measures to help self-management, would facilitate the process. These arecritical not just for better outcomes, but also to reduce the overall treatment cost.

In a similar context, another recent article, titled ‘Why Apps for Managing Chronic Disease Haven’t Been Widely Used, and How to Fix It,’ published in The Harvard Business Review (HBR) on April 04, 2018 made an interesting observation. The authors wondered: “In an era where nearly, every consumer good and service — from books and groceries to babysitting and shared rides — can be purchased through an electronic transaction on a mobile device, it seems reasonable to think that more and more of our health care can also be managed using apps on mobile devices.”

This article will dwell in this area, based on several interesting and credible research findings. Nevertheless, to give a proper perspective, I shall start with a brief outline on the incidence of chronic diseases in India.

Increasing incidence of chronic diseases in India:

There are several recent reports confirming the ascending trend of non-infectious chronic diseases in India, two of which are as follows:

The National Health profile 2018, published by the Ministry of Health also records that between 1990 and 2016 the disease burden due to:

  • Communicable, maternal, neonatal, and nutritional diseases, as measured using Disability-adjusted life years (DALYs), dropped from 61 per cent to 33 per cent.
  • Noncommunicable diseases increased from 30 per cent to 55 per cent.
  • The epidemiological transition varies widely among Indian states: 48 percent to 75 percent for non-communicable diseases, 14 percent to 43 percent related to infectious and associated diseases; and 9 percent to 14 percent associated with injuries.

Alongside, the above article of The Lancet Global Health also underscores the following takeaways from its comprehensive analyses of NCDs in the Indian situation:

  • The three leading causes of mortality—cardiovascular diseases, respiratory diseases, and diabetes.
  • In absolute terms, these three diseases together kill around 4 million Indians annually (as in 2016).
  • Most of these deaths are premature, occurring among Indians aged 30–70 years, representing some of the world’s largest health losses, with enormous policy ramifications.
  • India’s Ministry of Health and Family Welfare is making efforts to establish policies and intervention strategies for prevention and control NCDs. For example, the National Program for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke, launched in 2010, and the National Program for Health Care of Elderly, launched in 2010–11, the article noted.

As none of the measures taken so far could create an appreciable impact, India needs to come up with a major intervention to tackle this escalating health issue, the article concluded. In my view, optimal use of modern technology in the self-management of such virtually lifelong diseases, can be a great enabler for patients to bring down the disease treatment and management cost, significantly. Let me hasten to add again, the question of self-management comes only after a proper medical diagnosis and a prescribed treatment plan for the same being in place.

The key benefits of self-management and the unmet need:

The key benefits of effective self-management of chronic diseases are many. However, the following four clearly stands out:

  • Improves Patients’ quality of life significantly.
  • Arrests progression of the ailment – containing associated disease related complications.
  • Substantially reduces the interval and number of follow-up visits with doctors.
  • Thus, reduces the disease burden appreciably.

Curiously, most traditional pharma companies are yet to take any major step to address, at least, the above four critical areas. They don’t seem to go beyond the conventional methods of disease related advices. Whereas, the crucial need to fetch a behavioral change in patients for participative self-management of NCDs, keeps lingering.

A number of research studies have also confirmed that ‘mobile health applications are promising tools for improving outcomes in patients suffering from various chronic conditions.’ One of these studies titled, ‘Smartphone app in self-management of chronic low back pain: a randomized controlled trial’, was published in the November 27, 2018 issue of the European Spine Journal.

Sensing an unmet need in this area, besides a large number of brilliant tech startups, many large and pure technology companies, such as Apple and Google have already entered this fray.

 A recent example:

Let me cite a recent example to drive home the above point. On December 12, 2018, CNBC featured an article carrying the headline ‘Apple now has dozens of doctors on staff, showing it’s serious about health tech.’ Some of the key points of this article are as follows:

  • The number of doctors on staff is an indication that Apple is serious about helping customers manage diseases, and not just wellness or fitness.
  • Doctors can also help Apple guide the medical community on how to use Apple’s new health technologies and to deflect criticism and also to win approval among doctors who fear liability and are already overburdened by technology.
  • Many of these doctors are also still continuing to see patients. That might also give Apple an edge by emphasizing the patient experience.

This example demonstrates how detail are the plans of these tech companies for gaining a firm foothold in the healthcare space.

‘Effectiveness’ and ‘future scope’ of self-management of diseases:

The article titled, ‘Self-Management: A Comprehensive Approach to Management of Chronic Conditions,’ featured in the August 2014 edition of the American Journal of Public Health (AJPH) reiterated some important points. It established the relevance, future scope and effectiveness of self-management of chronic diseases, as follows:

  • As chronic conditions emerge as a major public health concern, self-management will continue to grow as a crucial approach to managing these conditions, preventing illness and promoting wellness.
  • Chronic disease conditions are generally slow in their progression and long in their duration. Thus, self-management can offer those living with these conditions, a means to maintain or even improve their capacity to live well, over the course of their lives.
  • Self-management intervention programs that address specific diseases are showing success across multiple chronic conditions.
  • These programs have particular value that represents an amalgamation of the goals of the patient, family, community, and the clinician with everyone working in partnership to best manage the individual’s illness while facilitating comprehensive care.
  • Self-management reaches beyond traditional illness management by incorporating the larger concept of prevention by emphasizing the notion that those who are chronically ill still have a need for preventive interventions to promote wellness and mitigate the further deterioration of health.
  • If one considers the nature of self-management in all its elements and practical characteristics, it is not only a logical approach to health and health care, but also an optimal way to address chronic conditions as a major issue in public health.

Inducing a behavioral change in chronic disorders with health apps:

For effective self-management of chronic diseases, there is a need to neutralize the negative influence of the individual’s behavioral traits. Research studies have also established that behavior-change-focused interventions play an important role in this effort.

However, not all patients take adequate care for such changes to take place. While the treating doctor may play an important role of a coach in this area, in reality, they usually don’t find enough time to spend on each patient with NCDs. The McKinsey & Company’s publication titled, ‘Changing patient behavior: the next frontier in health care value,’ also reiterates that to address the rising cost of chronic conditions, health systems must find effective ways to get people to adopt healthier behaviors.

As I mentioned before, this space has attracted active interest of many tech players in business expansion. More evidence-based health apps are being introduced to help drive patient-behavior change for effective self-management of chronic diseases. There are reported surveys on weight management aided by health apps, where ‘ninety-six percent of respondents agreed or strongly agreed that using a diet or nutrition app helped drive positive behavior change and healthy eating habits.’

In my article, titled ‘Prescription Digital Therapy Now A Reality,’ published in this blog on May 07, 2018, I mentioned that in September 2017, the first USFDA-cleared mobile app has been made available to patients. The app has both safety and efficacy label to help treat patients with ‘Substance Use Disorder’. Studies have established that it is two-times more effective than conventional in person therapy sessions.

More recently, in September 2018, Apple’s smart-watch version 4 included a US-FDA cleared electrocardiogram (ECG), officially classifying it as a medical device capable of alerting its user to abnormal heart rhythms. In the same context, US-FDA Commissioner Scott Gottlieb, M.D., said that digital advances, creating a new technological paradigm of health tools and health apps., are empowering consumers to take better informed decisions on their medical care and healthy living.

Conclusion:

It has been well-demonstrated by research studies that evidence-based health-apps for self-managing chronic diseases improve outcomes, remarkably. Consequently, this has triggered some critical activities by purely tech companies in the health care space, even in India. The primary driver being a strong consideration of this segment as an opportunity area to meet an unmet need, where most pharma players don’t seem to be doing enough, as on date.

Before it gets too late, there appears a need to take a serious note of this shifting paradigm. The awareness of which should then play a critical role in developing marketing strategies for brands used in NCDs. Otherwise, non-pharma tech companies will eventually dominate this segment, armed with a different genre of technological prowess that they possess.

The article titled, “Evidence-Based mHealth Chronic Disease Mobile App Intervention Design: Development of a Framework,” published inJan-Mar 2016 edition of the Journal of JPMIR Research Protocols, epitomizes it succinctly:

“Mobile health technology creates a shift in the paradigm of chronic disease management. It offers new possibilities to engage patients in self-management of their chronic diseases in ways that did not exist in the past. To maximize the potential of mHealth requires the integration of research and expertise from multiple disciplines including clinical, behavioral, data analytics, and technology to achieve patient engagement and health outcomes. This paradigm shift also triggers a need for new approaches to designing clinical and behavioral support for chronic disease management that can be implemented through existing health care services and programs.”

These developments send a strong signal for pharma to facilitate self-managing chronic diseases, soon enough, for better patient outcomes and, in tandem, creating a win-win situation for both.

By: Tapan J. Ray

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

 

 

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

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

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

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

NCDs are preventable:

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

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

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

NCDs may be of infectious origin:

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

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

Infections and NCDs:

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

Reactive Arthritis:

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

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

Peptic Ulcer and Gastric Carcinoma:

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

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

Acute Renal Failure:

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

Vasculitis:

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

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

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

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

Diabetes:

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

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

Coronary Artery Disease:

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

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

Cancer:

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

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

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

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

Conclusions:

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

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

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

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

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

By: Tapan J Ray

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