Tag Archives: non-communicable

Could Vaccine Prevent Heart Attacks?

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Could Vaccine Prevent Even Heart Attacks? The question may sound weird to many, but it really appears so, possibly reducing further need of several expensive medications for lifelong use. A good number of academic institutions, besides some biotechnology companies, are taking rapid strides in the newer areas of vaccine development to protect people from various non-infectious serious ailments, including some fatal disorders, such as heart attacks.

In this article, I shall deliberate on this area.

Picking up the thread:

One of the critically important preventive therapy to save millions of precious lives is – vaccination.  Way back in 1796, Edward Anthony Jenner not only discovered the process of vaccination, but also developed the world’s first smallpox vaccine to save mankind from this highly infectious and life-threatening disease. As per published data, prior to this discovery, the mortality rate for smallpox was as high as up to 35 percent.

Very appropriately, Jenner is often referred to as the “Father of Immunology”, whose pioneering work has saved more lives than the work of any other person, in that era. Later, in 1901 Emil Von Behring received the first Nobel Prize (ever) for discovering Diphtheria serum therapy for yet another highly infectious disease, affecting mostly infants and children.

Nevertheless, the pioneering work of Edward Anthony Jenner laid the primary substructure of immunology, which continued to be developed as a robust prophylactic measure against various types of, initially infectious and communicable diseases.

Expanded scope for vaccines:

Gradually, the global focus of vaccine development started expanding from prophylactic vaccination for communicable disease such as smallpox, diphtheria, malaria and pneumonia; to non-infectious disorders, like cancer, diabetes and atherosclerosis that often leads to heart attacks and strokes; including several therapeutic vaccines, especially for cancer. The list continues.

In other words, from inducing long-life immunity against exogenous or foreign antigens in infectious diseases caused by microorganisms, to inducing similar immune reaction against the body’s own molecules, which are responsible for precipitating seriously debilitating or life-threatening pathological changes. These include conditions, such as cardiovascular or metabolic disorders and many other chronic ailments, including various types of the deadly disease – cancer.

Would vaccines prevent even heart attacks?

Let me now get back to where I started from: Would vaccines prevent even heart attacks?

Medical experts often say, until a sudden heart attack occurs, patients with atherosclerosis may show no symptoms for decades. This epitomizes the seriousness of this disorder in human population.

Since long, atherosclerosis used to be considered as ‘a lipid-driven disease caused by the continuous accumulation of cholesterol in the arterial intima.’ However, that concept is changing now based on enough scientific evidences. These clearly indicate that ‘atherosclerosis is predominately a chronic low-grade inflammatory disease of the vessel wall with an interplay of humoral, cellular, and locally produced pro-inflammatory factors.’

Atherosclerosis is a chronic low-grade inflammatory disease:

In the above context, a recent research study has arrested the attention of many medical scientists, including several top cardiologists, across the world. This article, published on June 19, 2017, in the peer-reviewed European Heart Journal reported the development of a vaccine that induces an effective immune response in mice to significantly reduce plasma lipids, systemic and vascular inflammation, and atherosclerosis lesions in the aorta.

Leverages the immune system of the body:

In simple words, this cholesterol-lowering vaccine demonstrates how the immune system of the body can be leveraged to lower blood lipids, signaling a strong potential to make drugs, such as statins, possibly irrelevant.

This is the first intervention study based on a well-established, translational mouse model for hyperlipidemia and atherosclerosis. The research found, as compared with the control group, the vaccine reduced total and LDL cholesterol levels in the mice, as well as reduced signs of fatty build-up in the arteries.

Potentially an effective and economical approach:

The authors believe, the vaccine may represent an effective and economical approach, with higher patient compliance, in the treatment and prevention of similar cardiovascular pathologies. Taking the study to its next stage, they have already enrolled human volunteers to conduct the phase one study, for a detailed scientific assessment on how this vaccine will work for the patients suffering from similar disorders.

Another interesting development:

To give just a flavor of the progress of vaccine development in several areas of serious and life-threatening non-communicable diseases, I am quoting below the following interesting study:

June 1, 2016 issue of ‘The Independent’ reported that scientists of Johannes Gutenberg University in Germany have taken a “very positive step” towards creating a universal vaccine against cancer that makes the body’s immune system attack tumors as if they were a virus. The researchers had taken pieces of cancer’s genetic RNA code, put them into tiny nanoparticles of fat and then injected the mixture into the bloodstreams of three patients in the advanced stages of the disease. The patients’ immune systems responded by producing “killer” T-cells designed to attack cancer.

This vaccine was found to be effective in fighting “aggressively growing” tumors in mice. At the same time, such vaccines are fast and inexpensive to produce, and virtually any tumor antigen (a protein attacked by the immune system) can be encoded by RNA, the report said.

How expensive are the R&D costs for vaccines?

In this context, an important related question may well be raised: How expensive are the R&D costs for vaccines? According to a paper published by the US National Library of Medicine and National Institute of Health (NIH):

“A vaccine candidate entering pre-clinical development in 2011 would be expected to achieve licensure in 2022; all costs are reported in 2022 Canadian dollars (CAD). After applying a 9 percent cost of capital, the capitalized total R&D expenditure amounts to $ 474.88 million CAD.” 

Some key issues and challenges:

Scientific breakthroughs in genetics and biotechnological research, supported by state of art tools related to information technology, a wide range of vaccine development initiatives, targeting both in infectious and non-infectious diseases, are making rapid progress. However, as I had said before, there are some key issues and challenges that need to be addressed, simultaneously. A few examples of which are as follows:

  • Actual cost of vaccines goes much beyond their R&D expenses. This is mainly because of dedicated and highly specialized manufacturing facilities required for their mass-scale production, and then for the distribution of the same, mostly using cold-chains.
  • Around 60 percent of the production costs of vaccines are fixed in nature (National Health Policy Forum. 25. January 2006:14). Thus, such products will need to have a decent market size to be profitable.
  • Unlike many other medications for chronic ailments, which need to be taken for a long duration, vaccines are administered for a limited number of times, restricting their business potential.

Full neutralization of this cost before keeping a modest margin, could make such high-end vaccines relatively expensive for patients, without adequate financial incentives from the Government.

In conclusion:

The discovery of the interesting vaccine to prevent both fatal and non-fatal heart attacks followed an interesting path, and took a long time of around one and a half decade to go for the phase I human trial. Putting together the facts from the available scientific literatures, the long and arduous path of this journey may be, I reckon, summed up, as follows:

An article published by the Harvard Stem Cell Institute (HSCI) on June 9, 2014 first reported that it’s plausible to prevent heart attacks with vaccination. Nonetheless, it all started even much before that, when in 2003, a group of researchers in France studying families with very high cholesterol levels and very early heart attacks, discovered a specific cholesterol regulator. Mutations in the related gene seemed to be responsible for very high cholesterol levels, and early heart attacks. Further research on the subject continued thereafter, based on this novel finding.

Thereafter, in 2014, HSCI scientists collaborating with researchers at the University of Pennsylvania developed a “genome editing” approach for permanently reducing cholesterol levels in mice with a single injection, potentially reducing heart attack risk by up to 90 percent, reported this Harvard article. ‘Circulation Research’ – a journal of the American Heart Association, published the study online on June 10, 2014.

Currently, in mid 2017, from the article published in the peer-reviewed ‘European Heart Journal’ we get to know that development of a vaccine that can prevent heart attacks is going for phase I clinical trial, following several well-tested and scientific evidence based promises.

The outcome of the final phases of this study will now be keenly followed by the experts. Others will optimistically wait for the D-day – virtually the dawn of a new paradigm of preventing heart attacks through vaccination, well before it can result into any fatal or crippling consequences.

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.

MDGs Break Ground For SDGs: Is India Poised To Achieve The Health Goals?

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The Millennium Development Goals (MDGs) were placed in the pages of history amid several other remarkable global initiatives of the United Nations (UN), as the timeframe for achievement of these targets got over in 2015.

In 2000, the leaders of 189 countries signed this historic millennium declaration at the United Nations Millennium Summit for improving the lives of the world’s poorest people. Eight MDGs, were agreed upon by its members, each one supported by 21 specific, measurable targets and more than 60 indicators with clear deadlines, as a concerted global movement in this direction. The eight goals spanned across the areas of poverty alleviation, providing universal primary education, ensuring gender equality, preventing child mortality, meeting maternal health needs, protecting the environment and entering various global partnerships, with a target achievement date of 2015.

Did the glass remain ‘half-full’ or ‘half-empty’?

At the end of 2015 the UN reportedly called the MDGs ‘the most successful anti-poverty movement in history’. However, it could probably be a matter of looking at this glass either as ‘half-full’ or ‘half-empty’.

An interesting article published in the international daily ‘The Guardian’ on July 06, 2015, highlighted some hits and misses of MDGs from the global perspective.

Globally, several goals of the MDGs have not been made for various reasons. Focusing on health-related areas, I find, though the child mortality rate has reduced by more than half over the past two and a half decades from 90 to 43 deaths per 1,000 live births, its MDG target of an expected decline by two thirds could not be achieved.  Similarly, the global maternal mortality ratio despite falling by nearly half, was far short of its aim of a two-thirds reduction. Likewise, despite the reduction of the number of new HIV infections by around 40 percent between 2000 and 2013, its MDG goal of halting and beginning to reverse the spread of HIV/Aids by 2015 has not been met.

The overall status in India:

According to the United Nations in India, in the above focus areas, the country has made some progress in reducing its under-five mortality rate, which declined from 125 per 1,000 live births in 1990 to 49 per 1,000 live births in 2013; maternal mortality rate also declined from 437 per 100,000 live births in 1990-91 to 167 in 2009.

India recorded significant progress in reducing the prevalence of HIV and AIDS across different types of high-risk categories, with adult prevalence reducing from 0.45 percent in 2002 to 0.27 percent in 2011. However, a quarter of global TB cases still occur in India with nearly 2.2 million people are diagnosed with the disease annually, and an estimated 220,000 die as a result.

MDGs and India’s achievements:

Coming now to target versus achievements, the Millennium Development Goals India Country Report 2015 released by the Ministry of Statistics & Program Implementation (MoSPI) in February 2015, states that India had put considerable emphasis on all the MDGs with significant progress. Although the nation could meet targets of some of these well ahead of the 2015 deadline, overall, only six of the 18 targets adopted as part of the eight goals in 2000 have been fully met. However, according to another report brought out by the U.N. Economic and Social Commission for Asia and the Pacific, India has met only four of the eight MDGs.

As per Sample Registration System 2013, though the overall reduction of Under 5 Child Mortality Rate (U5MR) was nearly 60 percent happened during 1990 to 2013, India had missed this target.

Similar were the performances for a reduction in the Infant Mortality Rate (IMR) and the proportion of one year old children immunized against measles and improving the Maternal Morality Ratio (MMR). However, the prevalence of HIV among pregnant women aged 15-24 years showed a declining trend and incidence of Malaria also came down. Thus, it appears that the progress made and the achievements recorded in India against MDG targets are indeed a mixed bag.

The same question, therefore, logically follows for India too: Has the glass become ‘half-full’, or remained half-empty post MDG efforts?

MDGs break ground for ‘Sustainable Development Goals (SDGs)’:

The MDGs comprising of eight goals to eradicate extreme poverty, were indeed a laudable concerted global initiative of the United Nations. It could reportedly bring over a billion people out of extreme poverty. According to ‘United Nations (2015): The Millennium Development Goals Report’, during the period of 1990 to 2015, extreme poverty fell in developing countries from 47 to 14 percent. Similarly, the proportion of undernourished people fell by almost half, with almost similar decline in the child and maternal mortality rate. Nevertheless, communicable diseases, gender/income inequalities and striking disparities between rural and urban areas continued to persist with the world’s poor remaining overwhelmingly concentrated in several areas.

Thus, learning valuable lessons and significantly benefitting from them, MDGs broke ground for the next logical global initiative in this genre. As the time-frame for implementation of MDGs got over in 2015, the global leaders on the same platform of the United Nations followed it through with the newly developed ‘Sustainable Development Goals (SDGs)’ in the same year.

While aiming to make the outcomes of the new drive more sustainable with a focus on the environmental goals, SDGs did not altogether jettison some of the unfinished agenda of MDGs – mainly for continuity. Unlike MDGs, SDGs are targeted primarily to the developing, least developed and poorest countries. Nevertheless, all member countries of the UN require participating, fund and actively contribute in achieving SDGs targets, no matter how developed they are.

While MDGs had only 8 goals, 21 targets and 63 indicators, SDGs are a set of 17 goals and 169 targets that all 193 UN Member States, including India have committed to achieve between 2016 and 2030. Importantly, though MDG targets were adopted in 2002 and got over in 2015, its effective time span for achievement was of 25 years, as the baseline data used were for the year 1990 with some subsequent revisions. Whereas the baseline for SDGs starts from 2015 estimates, which may be revised to actual figures as and when these are made available.

Health goals in SDG:

Health has a central place in SDG 3 to ‘ensure healthy lives and promote well-being for all, of all ages’. Briefly speaking, it commits itself to a global effort to eradicate epidemics of both communicable and non-communicable disease and strengthen health systems’ capacity, ensuring Universal Health Coverage (UHC), along with making medicines and vaccines affordable to all. In addition, SDG 3 clearly focuses on mental health issues with suicide being the second leading cause of death globally between the ages of 19 to 25. It also aims at reducing the numbers of deaths and illnesses caused by air, water, and soil pollution and contamination, significantly.

Towards further enhancing public policy efforts, SDG 3 emphasizes on strengthening the implementation of the WHO Framework Convention on Tobacco Control; supporting the research and development of vaccines and medicines; substantially increasing health financing; the recruitment, development, training, and retention of the health workforce; and strengthen early warning, risk reduction, and management of health risks. Besides, a few targets falling under other different goals are also linked to the health goal of SDG 3, in various ways.

SDG 3 targets:

According to the ‘Resolution adopted by the General Assembly on 25 September 2015’ on ‘Transforming our world: the 2030 Agenda for Sustainable Development’, SDG 3 lays down nine key targets, as follows, though a few of which overlap with the MDGs:

  • Reduce the global maternal mortality ratio to below 70/100,000.
  • Reduce neonatal mortality to below 12/1,000 and U5MR to below 25/1,000.
  • End the epidemics of AIDS, tuberculosis, malaria, and neglected tropical diseases and combat hepatitis, waterborne diseases, and other communicable diseases.
  • Reduce by one-third premature mortality from non-communicable diseases.
  • Strengthen the prevention and treatment of substance abuse.
  • Halve the number of global deaths and injuries from road traffic accidents (by 2020).
  • Ensure universal access to sexual and reproductive health care services.
  • Achieve universal health coverage.
  • Reduce the number of deaths and illnesses from hazardous chemicals and air, water, and soil pollution and contamination.

Is India poised for it now?

This is indeed a critical question. I guess, no one can just yet vouch, with a great degree of certainty, what exactly would India ultimately achieve against the SDG 3 targets. That said, I reckon, India has now all its success ingredients in place. Let me deliberate on just a few broad but very important ones out of all those, as hereunder:

  • With the announcement of the National Health Policy 2017 (NHP 2017) and commitment to the same by none other than Prime Minister Modi himself, focusing on public health has now been recognized as one of the critical ingredients for the future economic prosperity of India. Hence, there is a fair chance now that the nation’s public health expenditure as a percentage of GDP would be gradually raised from around 1.2 percent to 2.5 percent – expectedly by 2020, bringing health in the core development agenda of both the Central and the State Governments.
  • The unfinished task of achieving MDGs needs to be completed faster, driven by its ongoing momentum. The national and the respective States-specific goals, along with a clear roadmap to achieve the targets within the specified time-frame, outlining the success indicators for each deliverable, assigning accountability to designated individuals with a periodic review system for the same, needs to be put in place, soon, actively encouraged by the current national development oriented Union Government, if not initiated already.
  • The process of implementation of the Universal Health Coverage (UHC), as enunciated in the NHP 2017 should be hastened. This is necessary to bring the entire population, without any discrimination whatsoever, as the beneficiary of this movement.
  • Scaling up the capacity building process at a much faster pace for the entire public health infrastructure and service delivery systems, along with skill development programs need to be placed at the center stage of the public health agenda of India, to bring SDG 3 to fruition.
  • Strategic involvement of private players and the credible NGOs to achieve SDG 3 targets would help move faster to ultimately experience the sense of a great public health related achievement for all concerned within, and probably outside the country, as well.

In conclusion:

As MDGs break ground for SDGs, India seems to me quite poised to achieving its health goals.

Moving towards this direction will invite a sharp focus on addressing the  non-communicable diseases, as well, while accelerating the ongoing efforts on maternal and child health, and nutrition.

It goes without saying that meeting SDG 3 targets will require adequate public investments for health, besides a well-crafted and time-bound public health policy, charting a clear roadmap for the same. The current Union Government now appears to have committed to both, putting its National Health Policy 2017 in place.

Once these goals are attained, it will enable India to clearly ‘Ensure healthy lives and promote well-being for all, at all ages’. In that process, a new India will be created where all essential public health related needs and demands of all, irrespective of their socioeconomic status, will be expeditiously taken care of, delivering with precision high quality of products and services.

Hopefully, the transformed India would then demonstrate to the world, as someone had said before, it’s just not a matter of ‘more money for health, but also more health for money’.

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.