Worsening Health Effect Of Climate Change In India: A Perspective

At present, out of the top five most pressing global and local environmental challenges, ‘Climate Change’ features at the top.

It has been broadly defined as, “a change in global or regional climate patterns, in particular a change apparent from the mid to late 20th century onwards and attributed largely to the increased levels of atmospheric carbon dioxide produced by the use of fossil fuels.” 

The impact of Climate Change’ is so profound that, if not addressed immediately, it would most likely to cause extinction of human life from the planet Earth and that too in the most agonizing and painful way, lasting over a long period of time.

The Paris Summit and its objectives: 

To effectively address the ‘Climate Change’ issue, nearly 150 world leaders of 196 countries, including Prime Minister Modi, deliberated in the Paris summit earlier in December 2015. Their representatives and negotiators ultimately succeeded, at the fag end of the ‘Paris Summit’ to arrive at a global consensus for inking a new ‘Climate Change’ agreement.

Prior to this, a report titled, “Paris 2015: Getting a global agreement on climate change”, published in August, 2014 by the Green Alliance Trust, United Kingdom stated that the agreement, expected to be signed in this Paris summit should ensure a meaningful united global action on climate change, covering the following key points:

  • A strong legal framework and clear rules
  • A central role for equity
  • A long term approach
  • Public finance for adaptation and the low carbon transition
  • A framework for action on deforestation and land use

Experts opined that a strong deal will make a significant difference to the ability of individual countries to tackle climate change by ensuring the following:

  • Give a clear signal to business for desired environmental protection and pollution control
  • Guide investment toward low carbon outcomes
  • Create a simpler, more predictable framework for companies operating in different countries
  • Help meeting international development aims, which are at increasing risk from rising global temperatures.
  • Help reducing poverty
  • Help improving health and building security
  • Fetch huge benefits to the natural environment by helping to avoid biodiversity loss and the degradation of ecosystems upon which the existence of human life depends

India’s position on ‘Climate Change’:

India’s position on ‘Climate Change’ has been clear and is well captured in Prime Minister Modi’s reiteration in the Paris summit as follows:

“Climate change is not of our making. It is the result of global warming that came from an industrial age powered by fossil fuel. Yet, we face its consequences today, and that is why the outcome in Paris is so important and we are here today. We want the world to act with urgency. Agreement must lead us to restore balance between humanity and nature. We want a comprehensive equitable and durable agreement in Paris.”

Worsening health effect:

‘Climate Change’ could even drive the human race to extinction in its final outcome. Meanwhile, besides its devastated environmental impact on the planet Earth, it would gradually but surely worsen human health conditions.

In this article, I shall focus only on human health perspective on ‘Climate Change’. 

Direct and indirect health impact:

I would classify the adverse impact of ‘Climate Change’ on health basically into two categories:

- Indirect

- Direct

Indirect impact: 

Many of the indirect health impact events of ‘Climate Change’ either go unnoticed or are still considered as an ‘Act of God’. Although this issue relates to our ultimate survival, even today in India not many debates are taking place on the subject, mostly in the Television Channels. This amazing medium continues to remain obsessed with competitive high decibel shouting and slanging matches to strengthen the viewers’ appetite, even more, mostly on trivial sensationalism.

Fortunately, global awareness of the disastrous impact of ‘Climate Change’ is increasing, slowly but surely. 

I shall give below just a few examples of indirect health impact of this change:

- Extreme weather events, such as floods, droughts, tsunamis, heat-waves and other disasters would keep increasing the mortality rate. Many experts attribute the cause of the recent deluge in Chennai to ‘Climate Change’, though there are other view points too. 

- Extreme weather conditions have also started causing frequent crop failures, especially in the developing world like India. As a result, many people go hungry and children suffer from malnourishment, mostly in rural areas, precipitating adverse health consequences.

- The impact of all these on mental health is also at times devastating and should in no way be ignored. Frequent incidences of farmers’ suicide in India due to crop failures could possibly be due to their deteriorating mental health, which needs to be studied in detail.

Direct impact:

According to ‘Big Picture’ – a free and impartial educational resource that explores the innovations and implications of cutting-edge science, rising temperatures and pollution levels may act together to directly worsen various health conditions, a few examples are as follows:

- Researches say, air temperature is more likely to affect cardiovascular function, when ozone levels are high, including the heart’s electrical activity and airflow into the lungs.

- A recent review has established that air pollution sets off nearly as many heart attacks as physical exertion, alcohol or coffee. Belgian researchers examined 36 studies conducted in various countries between January 1960 and January 2010 to examine the percentage of heart attacks attributable to the common risk factors and found that air pollution increased a person’s heart attack risk by 5 percent.

- Higher temperatures may also make the body more sensitive to toxins, such as ozone.   

- Studies show allergies are on the rise in developed countries, including the United States, which could partly be rising carbon dioxide levels and warming temperatures. 

- A number of notorious diseases, such as, malaria and cholera, thrive with the increase in temperature and rainfall. To give an example, the mosquitos that carry the malaria parasites grow rapidly in hot and humid conditions. The increasing prevalence of such weather conditions in climate change is likely to spread these diseases in a much wider population.

Is there any upside for ‘Climate Change’? 

Available information also points out towards some possible, but limited benefits for ‘Climate Change’, as follows: 

- Reduced risk of dying of the elderly persons from extreme cold in the winters of the temperate countries.

- Longer summers in those countries are likely to improve agricultural yields of the farmers.

Let me hasten to add, all these upsides, if at all, may not help the developing and poorer nations of the planet Earth, as such climatic conditions are mostly prevalent in the developed nations of the world.

Need for further research:

A report titled, “A Human Health Perspective On Climate Change”, published on April 22, 2010 by ‘Environmental Health Perspectives’ and the ‘National Institute of Environmental Health Sciences’, identified the following major research areas that need to be further explored and understood in the ‘Climate Change’ perspective:

The above outcome of the study is exactly in the expected line, which was “to identify research needs for all aspects of the research-to-decision making pathway that will help us understand and mitigate the health effects of climate change, as well as ensure that we choose the healthiest and most efficient approaches to climate change adaptation.”

How can we all contribute individually?

On this subject, by a release on November 26, 2011, ‘The National Aeronautics and Space Administration (NASA)’ of the United States recommended some very easy to follow steps for all of us.

It said, each individual can help in this matter by using less energy and water. For example, one may consider turning off lights and TVs when one leaves a room. Turn off the water, when brushing teeth.

It suggests, another way to help is by learning about Earth and its climate. The more we know about how Earth’s climate works, the more we shall be able to help solve problems related to climate change and that is also the purpose of this article.

In addition, besides many others, we may consider lesser use of our private cars and more of available public transports. Smokers may consider to quit smoking. We can also help by planting trees, which absorb carbon dioxide from the atmosphere.

India’s high stake:

A December 9, 2015 article published in ‘The New York Times’, titled “For Indians, Smog and Poverty Are Higher Priorities Than Talks in Paris” reiterated as follows:

At the climate talks in Paris, “few countries have so much at stake as India. For the last month, the front pages of major newspapers have been dominated by one environmental crisis after another: City-dwellers are up in arms about hazardous levels of air pollution, which has already damaged the lungs of about half of Delhi’s schoolchildren. And last month brought torrential rains and flooding in the southern city of Chennai, evoking the erratic weather that climate experts warn about.”

India’s consistent stand in various ‘Climate Change’ talks is drawing a fine balance between rapid development of the nation, with commensurate new job creation and health safety & environment. However, the apprehension that is being expressed now by many, whether that is feasible on the ground at all, for holistic measures in the right direction, with the adequate funds flow for the same.

Thus, the key concern of the Indian negotiators was, signing of any global agreement to support a strong climate regime, without requisite funding, could seriously impede India’s economic growth and development agenda. The developing nations, such as India, therefore, expect adequate and committed funding from the developed nations for generation of clean energy to drive inclusive economic prosperity of the respective emerging economies.

Developed nations still not quite on the same page?

The developed nations, even in the final text of the deal, do not seem to be quite on the same page, with firm financial commitments. As a result, a ‘Tug of War’ of objectives, as it were, surfaced in the final negotiation process – mainly between sustained economic development and stringent global measures with fund commitment to contain possible extinction of the human race in the world.

The impact of an effective implementation of the agreement is expected to last almost in perpetuity.

Conclusion:                                                                              

Finally, on the last Saturday, December 12, 2015 a new global deal to address the pressing issue of ‘Climate Change’, was agreed in Paris. Unquestionably, this is a critical step forward for all countries to save the planet Earth.

Intriguingly, the deal still does not provide for a binding commitment towards adequate funding by the developed countries, which is so essential for the developing nations to adopt clean and renewable energy to contain the devastating impact of the ‘Climate Change’.

Although, the agreement does talk about funding of US$ 100 billion a year from 2020 to 2025, this is not the legally binding part of the deal, as many people had expected.

In my view, if there is just one statesman who could be singled out for taking exemplary initiative to make the deal come through, it would be President Barack Obama of the United States. He spoke several times to the heads of the several developing nations, including India, China and Brazil, many times to iron out the differences till the last moment, for this key global issue – indeed a statesman par excellence, at least to me.

Be that as it may, the deal has now been inked, Indian Government also has expressed its satisfaction and happiness with the final text of the agreement. Still, a key question haunts: Would it produce the desired results, as expected? Well, that depends on how effectively and time bound manner the global commitments get translated into reality, with required fund flowing smoothly, to contain environmental disasters, leading to natural calamities and jeopardizing human health-safety.

Let’s all keep our finger crossed, as the saying goes, “The proof of the pudding is in the eating.”

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.

Biologic Medicine: Ushers in a different ‘Mega Race’ for inorganic growth

During the last several years the success of biologics compared to conventional small-molecule drugs to meet the unmet needs of patients, is gradually but surely changing the area of focus of pharmaceutical R&D altogether, making the biotech companies interesting targets for M&A. Over a period of so many years, the small-molecule blockbuster drugs business model made pharmaceuticals a high-margin industry. However, it now appears that the low hanging fruits to make blockbuster drugs have mostly been plucked.

These low hanging fruits involved therapy areas like, anti-ulcerants, anti-lipids, anti-diabetics, cardiovascular, anti-psychotic etc. and their many variants, which were relatively easy R&D targets to manage chronic ailments. Hereafter, the chances of successfully developing drugs for cure of these chronic ailments, with value addition, would indeed be a very tough call.

Deploying expensive resources towards finding a cure for so called ‘chronic diseases’ may also not promise a strong commercial incentive, as the treatment for ulcer, lipid disorders, diabetics, hypertension etc. are currently continues lifelong for a patient and a cure will limit the treatment to a short to medium term period.

Greater promise in biologics:

On the other hand, the bottom-line impact of a successful R&D outcome with safer and effective drugs to treat intractable ailments like,various types of cancer and blood disorders, auto-immune and Central Nervous System (CNS) related diseases, neurological disorders such as Parkinson’s, Myasthenia gravis, Multiple Sclerosis, Alzheimer’s diseases etc., will be huge. It is believed that well targeted drugs of biologic origin could well be successful treatment for such intractable diseases.

The golden opportunity of meeting the unmet needs of the patients with effective biologics, especially in high-growth therapeutics, as mentioned above, has given the M&A activities in the pharma-biotech space an unprecedented thrust.

Biologic versus conventional drugs:

Biologics Conventional and NME drugs
Large molecules (>5000 molecular weight) Small molecules (~500 molecular weight)
Bio-technologically produced or isolated from living sources Chemically synthesized
Complex structure/mixtures (tertiary structure, glycosylated) Simple well-defined structure
High target specificity Less target specificity
Generally parenteral administration (e.g., intravenous) Oral administration possible (pills)

(Source: MoneyTreeTM Report. PWC, 2009)

According to IMS, Biologics contribute around 17% of global pharmaceutical sales and generated a revenue of US$120 billion MAT March 2009. As we see today, gradually more and more global pharmaceutical companies, who used to spend around 15% to 20% of their annual sales in R&D, are channelizing a large part of the same to effectively compete in a fast evolving market of biologics through mainly M&A route. This is also driven by their strategic intent to make good the loss in income from the blockbuster drugs going off patent and at the same time fast dwindling R&D pipeline.

A shift from small molecule based blockbuster model to a biologics-based blockbuster one:

Frost & Sullivan forecasts a shift from small molecules-based blockbuster model to a biologics-based blockbuster one for the global pharmaceutical majors, just as biologics like Enbrel ,Remicade, Avastin, Rituxan and Humira, as mentioned below, have already proved to be money spinners.

The top 10 global brands in 2009:

Rank Product Chemical/Biologic Global Sales US$ Mn
1 Lipitior Chemical 12,511
2 Plavix Chemical 9,492
3. Seretide/Advair Chemical 7,791
4. Enbrel Biologic 6,295
5. Diovan Chemical 6,013
6. Remicade Biologic 5,924
7. Avastin Biologic 5,744
8. Rituxan Biologic 5,620
9. Humira Biologic 5,559
10. Seroquel Chemical 5,121

(Source: EvaluatePharma)

Faster growth of biologics attracting attention of large pharma players:

Currently, faster growth of biologics as compared to conventional new chemical entities is driven by novel technologies and highly targeted approach, the final outcome of which is being more widely accepted by both physicians and patients. The large global pharmaceutical companies are realizing it pretty fast. The type and quality of their recent acquisitions, vindicate this point.

Mega race for biologics and vaccines:

Driven by the above factor, in 2009 Pfizer acquired Wyeth for US $68 billion, Roche acquired Genentech for US $ 47 billion and Merck acquired Schering-Plough for US $ 41 billion. Only the above three M&A are valued more than US $ 150 billion and that too at a time of global financial meltdown.

Acquisition of Wyeth enabled Pfizer to expand its product-mix with vaccines, animal health and consumer products businesses and at the same time leveraging from Wyeth’s biologics capability.

Similarly, Merck got tempted to acquire Schering-Plough mainly because of latter’s rich R&D pipeline with biologics.

Roche, which was basically a pharmaceutical company, post-acquisition of Genentech, became a major bio-pharmaceutical company with a great promise to deliver in the years ahead.

Other M&As, which would signify a shift toward the growing space for biologics are the acquisition of MedImmune by AstraZeneca and Insmed by Merck and the recent bid of Sanofi-Aventis for Genzyme.

Faster growth of biologics:

As mentioned above, despite patent cliff, biologics continue to contribute better than small molecules to overall growth of the R&D based global pharmaceutical industry.  Most of these biologics are sourced either through acquisition or  collaborative arrangements.

Currently cash strapped biotech companies with molecules ready for human clinical trials or with target molecules in the well sought after growth areas like, monoclonal antibodies, vaccines, cell or gene therapies, therapeutic protein hormones, cytokines and tissue growth factors, etc. are becoming attractive acquisition targets, mainly by large pure pharmaceutical companies with deep pockets.

Another M&A model:

Besides mega race for mega acquisitions, on the other hand, relatively smaller pharmaceutical players have started acquiring venture-backed biotech companies to enrich their product pipelines with early-stage drugs at a much lesser cost. For example, with the acquisition of Calistoga for US $ 600 million and venture-backed Arresto Biosciences and CGI Pharmaceuticals, Gilead known for its HIV drugs, expanded into blood cancer, solid tumor and inflammatory diseases. In 2009 the same Gilead acquired CV Therapeutics for US $1.4billion to build a portfolio for cardiovascular drugs.

Smaller biotech companies, because of their current size do not get engaged in  very large deals, unlike the top pharma players, but make quick, decisive and usually successful deals.

Another commercial advantage for biologics – lesser generic competition :

After patent expiry of a New Chemical Entity (NCE), innovators’ brands become extremely vulnerable to cut throat generic competition with as much as 90% price erosion, as these small molecules are relatively easy to replicate by many generic manufacturers and the process of getting their regulatory approval is not as stringent as biosimilar drugs in most of the markets of the world.

On the other hand biologics, which involve difficult, complex and expensive biological processes for development together with stringent regulatory requirements for getting marketing approval of biosimilar drugs especially in the developed markets of the world like, EU and USA, offer some significant brand protection from generic competition for quite some time, even after patent expiry.

It is for this reason, brands like the following ones are expected to go strong for some more time to come, without any significant competition from biosimilar drugs:

Brand Company Launch date
Rituxan Roche/Biogen idec 1997
Herceptin Roche 1998
Remicade Centocor/J&J 1998
Enbrel Amgen/Pfizer 1998

Change of appetite:

In my view, the voracious appetite of large pharmaceutical companies for inorganic growth through mega M&As, will ultimately subside for various compelling reasons.  Instead, smaller biotech companies, especially with products in Phase I or II of clinical trials without further resource to take them to subsequent stages of development, will be prime targets for acquisition by the pharma majors at an attractive valuation.

Conclusion:

Although the large pharma majors are experimenting with pure biotech companies in terms of acquisitions and alliances, it will be interesting to see the long term ‘DNA Compatibility’ between these companies’ business models, organization and work/employee culture and market outlook to improve their overall global business performance, significantly. Only future will tell us whether or not just restructuring of the R&D set up of companies like, Pfizer, Merck, Roche and perhaps Sanofi-aventis at a later date, helps synergizing the overall R&D productivity of the merged companies.

In this context, Frost & Sullivan had commented: “Widely differing cultures at Roche and Genentech could make retaining top scientists a huge challenge. Roche is Swiss and a stickler for precision and time, while Genentech has a more ‘Californian attitude’ and is laid back and efficient in its work”.

Though the long-term overall financial impact of the ‘mega race for mega deals’, as mentioned above, is less clear to me, acquisition of biotech companies, especially well thought through smaller ones, seems to be a pretty smart move towards inorganic growth by the global innovator companies.

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.