Could Vaccine Prevent Heart Attacks?

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.

Non-Communicable Diseases (NCD) are hitting the poor even harder, economically: a time to ponder and a time to act

November 11, 2010 edition of ‘The Lancet’ published an article titled, “Raising the priority of preventing chronic diseases: a political process”. The article enumerated the following:

“Chronic diseases, especially cardiovascular diseases, diabetes, cancer, and chronic obstructive respiratory diseases, are neglected globally despite growing awareness of the serious burden that they cause. Global and national policies have failed to stop, and in many cases have contributed to, the chronic disease pandemic. Low-cost and highly effective solutions for the prevention of chronic diseases are readily available; the failure to respond is now a political, rather than a technical issue.”

The situation is no different in India. The disease pattern in India is also showing a perceptible shift from age old ‘Infectious Diseases’ to ‘Non-infectious Chronic Illnesses’. As reported by IMS, incidence of chronic ailments in India has increased from 23 percent in 2005 to 26 percent in 2009. It has been estimated that chronic illnesses will be the leading cause of both morbidity and mortality by the next decade.

As a consequence of such findings healthcare needs and systems of the country should need to undergo a paradigm shift with the emergence of a carefully planned concept of ‘Preventive Healthcare’ in the country.

It is a myth that non-infectious illnesses are more prevalent in higher socio-economic strata:
There is a common perception that non-communicable diseases are more prevalent within higher socio-economic strata of the society, a national survey done in India shows that diseases related to misuse of alcohol and tobacco are higher in the poorest 20 percent quintile of our society.

Current healthcare system in India:

Currently the medical alleviation of the acute symptoms and the disease that a particular patient is suffering from is the key concern of all concerned starting from the doctor to the patient and his/her family. The process of the medical treatment revolves round symptom relief, diagnostic measures and appropriate treatment protocols and procedures conforming to the proper diagnosis of the ailments. While addressing the acute problems of the patients’ ailments is very important, proper assessment of the underlying diseases or evaluation of their risk factors do not get as much or no attention. As a result the important advice on preventive healthcare from the doctor properly highlighting its importance is not available to most of the patients.

Keeping such common practices in view and noting that ‘Preventive Healthcare’ is significantly different from ‘Curative Healthcare’, developing an appropriate protocol for ‘Preventive Healthcare’ has become the crying need of the hour.

‘Preventive Healthcare’ in India should be made mandatory:

The ‘Preventive Healthcare’ system in India is in its very nascent stage. If appropriate measures are taken in this area, like learning to reduce the impact of stress, avoiding sedentary life style, taking healthy diet, avoidance of tobacco and alcohol consumption, leading healthy sex life etc., it can in turn help the population to remain disease free and thereby to improve their respective work productivity in a very significant way.

Taking all these points into consideration, through policy initiative, The Medical Council of India (MCI) should make ‘Preventive Healthcare’ an integral part of each interaction of a patient with a doctor through appropriate regulations.

Chronic illnesses will significantly increase the disease burden of the country:

Many of the diseases like cancer, chronic respiratory disorders, cardiovascular, diabetes can be identified with preventable risk factors and. Therefore, such diseases can be prevented effectively, provided the healthcare policy of the country supports the ‘Disease Prevention’ process, program and initiatives through adequate resource allocation.

Role of a medical professional in customized ‘disease prevention plan’:

Role of medical professionals in the disease prevention process is also very important. The interaction of the patients with the doctors when they meet to address any ailment provides huge opportunity to the doctors to advice the patients about the ways of specific disease prevention, for which the individual patients have high exposure.

Need to raise general public and political awareness towards ‘Preventive Healthcare’:

Raising the level of awareness for ‘Preventive Healthcare’ is indeed very important. It requires a change in the mindset of the community in general together with healthcare policy makers, medical profession, employers, patients and their families.

National Non-Communicable Disease (NCD) prevention program of the government:

As per the Planning Commission, the government of India has reported to have initiated structured measures for the prevention of NCD, the main features of which are as follows:

“Health education for primary and secondary prevention of NCDs through mobilizing community action
• Development of treatment protocols for education and training of physicians in the prevention and management of NCDs
• Strengthening/creation of facilities for the diagnosis and treatment of CVD and stroke, and the establishment of referral linkages
• Promotion of the production of affordable drugs to combat diabetes, hypertension, and myocardial infarction
• Development and support of institutions for the rehabilitation of people with disabilities
• Research support for: Multispectral population-based interventions to reduce risk factors
• The role of nutrition and lifestyle-related factors
• The development of cost effective interventions at each level of care”

Conclusion:

Many diseases in India with proper ‘Disease Prevention’ measures can be effectively averted. Some common measures which can be easily practiced through community initiatives are maintenance of proper hygiene, sanitation, adequate physical activities, moderation in alcohol and tobacco consumption, healthy sexual activities, avoidance of unhealthy food etc.

To address this issue ‘The Lancet’ November 11, 2010, in the article, as mentioned above, prescribed three specific strategies as follows:

1. “Reframe the debate to emphasize the societal determinants of disease and the inter-relation between chronic disease, poverty, and development
2. Mobilize resources through a cooperative and inclusive approach to development and by equitably distributing resources on the basis of avoidable mortality
3. Build on emerging strategic and political opportunities, such as the World Health Assembly 2008—13 Action Plan and the high-level meeting of the UN General Assembly in 2011 on chronic disease”.

The government should spearhead the paradigm shift towards this direction with appropriate regulation, generating increased societal and political awareness within the country and through mobilization of adequate resources. All these will ultimately help us to translate the well-known dictum into reality, ‘prevention is better than cure’.

Otherwise, especially the poorer section of the society will continue to get caught in the vicious cycle of debt and illness, seriously jeopardizing the economic progress of the country.

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.

 

National Non-Communicable Disease (NCD) prevention program of the government needs a new thrust to contain the burden of disease in India.

The disease pattern in India is showing a perceptible shift from the age old ‘Infectious Diseases’ to ‘Non-infectious Chronic Illnesses’. As reported by IMS, incidence of chronic ailments in India has increased from 23 percent in 2005 to 26 percent in 2009. It is estimated that chronic illnesses will be the leading cause of both morbidity and mortality by the next decade.As a consequence of such changing disease pattern, healthcare needs and related systems of the country should undergo a paradigm shift together with the emergence of a carefully planned concept of ‘Preventive Healthcare’ for the entire population of the nation.
It is a myth that non-infectious illnesses are more prevalent in higher socio-economic strata:

There is a common perception that non-communicable diseases are more prevalent within higher socio-economic strata of the society. However, a national survey done in India shows that diseases related to misuse of alcohol and tobacco are higher in the poorest 20 percent quintile of our society.

Current healthcare system in India:

Currently with appropriate disease treatment measures, alleviation of acute symptoms of the disease that a particular patient is suffering from, is the key concern of all concerned starting from the doctors to the patients and their family. The process of the medical intervention revolves round treatment protocols and procedures based on the diagnosis of the current ailments and not so much on preventive measures for other underlying diseases, except with the use of vaccines for some specific diseases.

Developing a protocol for ‘Preventive Healthcare’ for non-communicable diseases is very important:

In the above process, while addressing the acute problems of the patients’ current ailments is very important, proper risk assessment of other underlying diseases, if any, which the patient could suffer from in future, for various reasons, do not attract any organized attention. As a result the important advice on preventive healthcare from the doctors, properly highlighting its importance, is not available to most of the patients to enable them to significantly reduce, if not eliminate, their future burden of disease.

Keeping such common practices in view and noting that ‘Preventive Healthcare’ is significantly different from ‘Curative Healthcare’, developing an appropriate protocol for ‘Preventive Healthcare’ has become a crying need of the hour.

‘Preventive Healthcare’ in India should attract high priority of the healthcare policy makers with a care vigil on its effective implementation at the ground level:

All said and done, the ‘Preventive Healthcare’ system in India is in its very nascent stage. If appropriate measures are taken in this area, like learning to reduce the impact of mental and physical stress, avoiding sedentary life style, taking healthy diet, avoidance of tobacco and alcohol consumption, leading healthy sex life etc., it can in turn immensely help the population to remain disease free and healthy, thereby contributing to improvement of their respective work productivity in a very substantial way.

The Medical Council of India should also step in:

Thus the role of medical professionals in the disease prevention process is also very important. The interaction of the patients with the doctors when they meet to address any ailment provides huge opportunity to the doctors to advise those patients about various measures of underlying disease prevention, for which different patients have different types of exposures.

Keeping all these points in view, through regulatory initiatives, the Medical Council of India (MCI) should consider making ‘Preventive Healthcare’ an integral part of each interaction of a patient with a doctor.

Include the civil society in the healthcare improvement process of the nation:

The risk factors of many of the diseases like, cancer, chronic respiratory disorders, cardiovascular, diabetes, and hypertension can be identified well in advance and appropriately assessed. Therefore, such diseases can be prevented effectively, to a great extent, provided the healthcare policy of the country supports the ‘Disease Prevention’ process, program and initiatives through adequate resource allocation, improving awareness of the civil society and above all including them in this healthcare improvement process of the nation.

Need to raise general awareness towards ‘Preventive Healthcare’:

Raising the level of awareness of ‘Preventive Healthcare’ is indeed very important. It requires a change in the mindset of the community in general, together with the healthcare policy makers, medical profession, employers, patients and their families.

National Non-Communicable Disease (NCD) prevention program of the government:

As per the planning commission, the government of India has initiated the following structured measures for the prevention of NCD:

• “Health education for primary and secondary prevention of NCDs through mobilizing community action;
• Development of treatment protocols for education and training of physicians in the prevention and management of NCDs:
• Strengthening/creation of facilities for the diagnosis and treatment of CVD and stroke, and the establishment of referral linkages;
• Promotion of the production of affordable drugs to combat diabetes, hypertension, and myocardial infarction;
• Development and support of institutions for the rehabilitation of people with disabilities;
• Research support for: Multispectral population-based interventions to reduce risk factors;
• The role of nutrition and lifestyle-related factors;
• The development of cost effective interventions at each level of care”.

Conclusion:

Many diseases in India, with proper ‘Disease Prevention’ measures can be effectively averted. It is worth repeating that some common measures which can be easily practiced through community initiatives are maintenance of proper hygiene, sanitation, adequate physical activities, moderation in alcohol and tobacco consumption, healthy sexual activities, avoidance of unhealthy food etc.

Besides, the government should spearhead the paradigm change towards ‘Preventive healthcare’ by including the civil society as a part of this process along with appropriate regulations wherever necessary, generating increased awareness within all concerned and through mobilization of adequate resources. All these will ultimately help all of us to translate the well-known dictum into reality, ‘Prevention is better than cure’.

By Tapan 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.