Dwindling Drug Innovation: Declining Image: Unchanged Business And Advocacy Models

Posted on February 20, 2017 by Tapan Ray

A report of ‘The United States International Trade Commission (USITC)’ released on December 22, 2014 suggested, if tariffs and investment restrictions were fully eliminated, and standards of IP protection were made comparable to the U.S and Western European levels, American exports to India would rise by two-thirds.

A year later, on February 01, 2015 an interesting news article highlighted that the flashpoint of this issue “has clearly been pharmaceutical companies and their lobby group Pharmaceutical Research and Manufacturers of America (PhRMA), which have made some of the strongest representations to the US government against India’s IPR regime.” The same report also indicated that many other companies including the aircraft maker Boeing and the generic drug giant Abbott felt that India offered adequate IP protection and that they had not experienced major IP problems in the country.

The above stance of USITC continued echoing right from the beginning of this year. In January 2017, the CEO of US Biotechnology Innovation Organization (BIO) reportedly told our Prime Minister Narendra Modi, ‘if he follows western practices on intellectual property protection, his country would see a “tidal wave” of biotech industry investment.’

On February 08, 2017, when the fifth edition of ‘U.S. Chamber International IP Index’ report was released by the ‘Global Intellectual Property Center (GIPC)’, India featured in the 43^rd rank out of 45 countries. With this India remained virtually at the bottom of the IP index for the fourth year on the trot. The GIPC report underscored India’s “anaemic IPR policy”, Section 3.d of the Indian Patents Act, besides several others, as major market access barriers.

On February 14, 2017, another news article reported that America’s pharma sector has asked the US Trade Representative (USTR) to continue to keep India on its Priority Watch List (PWL), which includes countries that are alleged violators of US patent laws, claiming that the environment on the ground remains ‘challenging’ in India. Among the areas of concern for the US pharma companies operating in India, unpredictable IP environment, high tariffs and taxes on medicines, regulatory data protection failure, discriminatory and non-transparent market access policies and unpredictable environment for clinical research were listed among others.

With this backdrop, the key question that haunts many industry watchers, when the World Trade Organization (WTO) has no complaint with the Indian Patents Act 2005, and finds it TRIPS compliant, why are these reports coming from the United States consistently emphasizing that the current IP regime of the country is a key barrier to market access, especially for research-based pharma companies?

Is the core issue of the global pharma industry in India is predominantly not encouraging innovation well enough, or the dearth of inadequate Intellectual Property (IP) protection – or it is something beyond that, and is more fundamental in nature. In this article, I shall dwell in this area, first in the global perspective, and then zeroing-in to India.

A global perspective:

“The past 60 years have seen huge advances in many of the scientific, technological and managerial factors that should tend to raise the efficiency of commercial drug research and development (R&D). Yet the number of new drugs approved per billion US dollars spent on R&D has halved roughly every 9 years since 1950, falling around 80-fold in inflation-adjusted terms. There have been many proposed solutions to the problem of declining R&D efficiency. However, their apparent lack of impact so far and the contrast between improving inputs and declining output in terms of the number of new drugs make it sensible to ask whether the underlying problems have been correctly diagnosed,” articulated an important article published on March 01, 2012 in the Nature Reviews Drug Discovery.

This trend continues, virtually unchanged. R&D efficiency continues to remain a cause of great concern to the research-based global pharmaceutical companies. Accordingly, a 2016 report of the Deloitte Center for Health Solutions titled, ‘Measuring the return of pharmaceutical innovation’, among other findings, has captured the following:

Annual projected pharma R&D return declines to 3.7 percent from 10.1 percent in 2010
Peak sales per asset fall 11.4 percent year-on-year since 2010

What then is its basic solution?

When the right solution eludes:

In this scenario, when the right solution is still eluding, to record growth in corporate profit and earning to meet shareholders’ expectations, keeping the existing business model intact, the global research-based pharma companies have the following two limited options, which they are actively pursuing:

Take high price increases for the existing products
Launch the limited new products at a very high price

A report published in The First Word Pharma on October 06, 2015 quoting The Wall Street Journal (WSJ) vindicated exercising the first option. It reported that many drug makers have succeeded in increasing revenue on products despite a flat or declining demand by consistently increasing prices. An analysis revealed that revenue for the top 30 products in the United States zoomed by 61 percent over the past five years, three times the increase in the number of prescriptions sold over that period. While another report by Credit Suisse illustrated that 80 percent of the growth in net profit for the top 20 drug makers was attributable to price hikes.

To substantiate application of the second option, I quote from the CBS News, which on April 05, 2016 reported that an investigation into the cost of prescription drugs revealed huge price hikes over the past five years. Several brand name medications more than doubled in price. Again, on August 24, 2016, it gave a sense of this trend with the following examples, covering the launch price of innovative drug, and price increases of generic drugs:

Gilead fixed their new hepatitis C drug Sovaldi’s cost at US$ 900 – 1,000 per pill
Mylan Pharmaceuticals’ increased the cost of its anti-allergic drug EpiPen from about US$ 57 in 2007 to more than US$ 500 in 2016
Turing Pharmaceuticals increased the price of the anti-malaria drug Daraprim by 5,000 percent last year, charging US$ 750 per pill for a drug that used to cost US$ 13.50 per pill.

PhRMA – the often quoted trade association in America, representing the country’s leading pharma and bio-pharmaceutical research-based companies, reportedly said in a statement: “Focusing solely on the list prices of medicines is misleading because it ignores the significant discounts and rebates negotiated by insurers and pharmacy benefit managers.”

Even if, this argument is accepted as such, the tough impact of regular hefty drug price increases on the consumers is real, unquestionably.

The current business model leaves behind many patients:

The ‘Access to Medicine Index 2016’ report also finds that companies generally do not systematically target populations with the highest needs in their registration, pricing and licensing actions. Although, we continue to make progress toward major public health goals, such as, polio is close to being eradicated, as is guinea worm; more than 45 percent of people living with HIV/AIDS have access to ARVs; important vaccines for malaria and dengue fever are being implemented, still business models for providing healthcare are leaving many people behind. Globally, two billion people cannot access the medicines they need, most of whom live hand to mouth.

Particularly, the big global pharma companies, as the innovators and producers of life-saving medicines, need to act much earlier in the patients’ value chain. Without or inadequate action by these companies, alongside governments, NGOs and others, it will be impossible to bring modern medicine to everyone.

Public outrage over high drug prices:

Many studies indicate that the research-based global pharma and biotech companies, still strive hard to stick to their existing overall business models with a sharp focus on improving both the top and bottom lines of the business, though the R&D projects are becoming lesser and lesser productive. This prompts them resorting to hefty price increases, and introducing new products with high price. Fueled by this self-serving mindset, a simmering public outrage, globally, over high drug prices is fast catching up, further undermining the trust in the industry, as another report says.

No wonder why in the Gallup Poll of August 15, 2016, pharmaceutical industry featured just one above the bottom among the ‘Worst-Rated U.S. Business Sectors’. Moreover, even the Harris Poll released on January 17, 2017 found that 91 percent of U.S. consumers believe pharmaceutical and biotechnology companies put profits over patients.

The industry continues chasing rainbows:

In response to this mounting stakeholders’ criticism, arguably the richest pharma association in the world in its member subscriptions – PhRMA, reportedly launched a new ad campaign costing tens of millions of dollars on January 25, 2017. It aims to highlight innovation and scientific breakthroughs to change the public’s negative perception of the industry. This campaign will span across television, print, digital, and radio, the report elaborates.

Following is an example, as reported, listing three important and interesting comments on this campaign for pharma image revamp from some of those who matter:

Lawmaker Peter Welch, who chairs the House Democratic Caucus’ task force on drug pricing, said, “The issue here is not whether drugs have some benefits … The issue is whether pharma is going to be able to kill us with their pricing power or whether we will get transparency and competition.” He added, “The campaign is all about defending their pricing power and pushing their product.”

Similarly, another lawmaker Sen. Chuck Grassley (R-Iowa) said, “This is [PhRMA] trying to change the subject and to try and divert people’s attention away from drug pricing. Continuing to ignore drug pricing is probably not going to work.”

Ameet Sarpatwari, a drug pricing policy researcher at Harvard University said, “It’s really a matter of being tone deaf in terms of thinking somehow that this is going to change public perception”

Isn’t a great example of chasing rainbows by the industry association, in the number one pharma and biotech market of the world, instead of amending to the root cause of this burning issue?

The situation in India:

In this backdrop, amid a tough global situation, let me assess the related Indian scenario.

The research-based global pharma companies, apparently want to introduce the whole range of their patented products at a high price and in a monopolistic situation in India too, for much higher growth in revenue and profits. Thus, they are consistently pushing hard, with all guns blazing, for major changes in the Indian Patents Act 2005, which would involve jettisoning many patients’ health interest related safeguard conditions enshrined in the Act, such as Section 3.d that restricts ever-greening of patents, and introducing several other tougher IP measures, such as data exclusivity under the garb of imaginary patient safety issues with generic drugs.

They don’t seem to like price control of essential drugs in India, either. While intensely lobbying for it, the lobbyists vehemently argue in favor of the absurd, which is the affordability of medicines does not help to increase drug access to all those who need these most, even when on the ground, the out of pocket expenses for drugs in the country is as high as around 65 percent and universal health care does exist in the country, much to the dismay of many.

It has now been generally established by many global experts, including our own National Pharmaceutical Pricing Authority (NPPA) that market competition does not necessarily bring down drug prices, including for generics, quite unlike many other industries, but various pressure groups, including the media, can catalyze it, and quite effectively. What has happened recently with the cardiac stents price in the country, is just an example.

Is the devil in the traditional pharma business model?

An article titled, “How Pharma Can Fix Its Reputation and Its Business at the Same Time”, published on February 03, 2017 in The Harvard Business Review, emphatically states: “It’s a fact that the current business model of pharma companies is not working efficiently.” It suggests, besides enhancing the current unenviable public image of the industry, expanding access to medicines will help pharma companies enhance shareholder value. The success of a new business model depends on both the willingness and the ability of pharmaceutical companies to fully integrate access to medicine into their business strategies, the article emphasizes.

A July 2015 paper of McKinsey & Company titled, “Pharma’s next challenge”, also reiterates that in the developed economies, market access is chiefly concerned with pricing, and with satisfying local conditions. Whereas, in the emerging markets, to overcome the barriers, pharma players need to shift the focus of their commercial models from marketing and sales to access, and from brand-by-brand access planning to integrated cross-brand planning.

In pursuit of a new model:

Based on the above premises, the search for a new pharma business model, especially for the research-based pharma companies, in my view, may broadly focus on the following areas:

Learn from innovation models of the IT industry: Win-Win collaborative innovation models, including ‘Open Source Drug Discovery’, if scaled up, could reduce the cost of innovation significantly and making the new innovative drugs generally affordable. Thus, larger volume sales may adequately offset a voluntary cut in the product margin, creating a multiplier effect.

Be a part of the solution and not the problem: Because of fiercely pushing the blatant self-serving agenda, inconveniencing many patients, the core mindset of the pharma industry is considered by many as an integral part of the main problem. While pharma industry, quite rightly, seek more market access, they need to act as a facilitator too, to improve general access to medicines, in various imaginative ways, which is, of course, possible. This will make the pharma industry to be a part of the solution to the national problem, over a period of time.

Walk the talk: While pharma industry speaks all right things, in terms of ethical conduct of business, at a time when both national and international media frequently expose their gross wrongdoings. This continues, unabated. Sales and marketing functions are indeed very important, but not at the cost of good corporate governance. I am aware, all compliance rules exist immaculately on paper for many companies, but the senior management officials should demonstrate that they walk the talk, giving exemplary punishment to the wrongdoers, including their peers.

Change the current advocacy model: The current advocacy model of the research-based pharma companies is too self-serving. For example, in India it mostly demands, which is bordering obsession, to change the IP laws of a sovereign country, when the World Trade Organization (WTO) has no problem with these, whatsoever. There is a need for them to demonstrate, sans any shade of arrogance, visible respect to any country’s general sentiment on its Patents Act, as it’s their own decision to operate in those countries. An imaginative win-win change in this area, would significantly help to create a strong bond and mutual respect with other important stakeholders.

Are senior citizens in pharma business a barrier to change?

A recent white paper of ‘Eye for Pharma’, says in its conclusion “many of those now running pharma organizations have come through the ‘golden age’ of pharma and so may be reluctant to change”. Does this issue need to be addressed first by the Independent Directors of the respective Boards of the pharma companies?

In conclusion:

Many questions do spring up while addressing this issue. One common belief is that, pharma industry, in general, is reluctant to change its traditional business model, beyond just tweaking, despite declining overall productivity and in its public image.

In advocacy initiatives, while drawing stakeholders’ attention to the core grievance agenda, though they try hard to project their business focus on patients, especially using the buzzwords, such as, ‘patient centric approach’ or ‘patient engagement’, among many others, has anything visibly changed, just yet?

As the business environment is getting tougher and consumer expectations are fast changing, drug innovation is also steadily dwindling, so is the declining industry image. However, pharma business and advocacy models continue to remain mostly unchanged. It remains intriguing, why are the ‘wise guys’ of pharma business still so deeply obsessed with chasing rainbows, with so much of zeal, hectic activity and money, while majority of patients keeps bearing the brunt?

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.

‘Digi Gaon’: Will It Augment Access To Affordable Health Care In India?

Posted on February 13, 2017 by Tapan Ray

In the Union Budget speech of 2017-18, Indian Finance Minister articulated his intent, among several others, to launch a new initiative named ‘Digi Gaon’, which would extend the broadband digital technology in rural India. Besides education and skills, ‘Digi Gaon’ would facilitate affordable access to e-healthcare in the in the hinterland of the country.

“Under the Bharat Net, optical fiber has been laid in 1,55,000 km. I have stepped up the allocation for Bharat Net projects to Rs 10,000 crore in 2017-18 and by the end of 2017-18, high speed broadband on optical fiber will be available in more than 1.5 lakh gram Panchayats with hotspots and access to digital services at low tariff,” the Finance Minister said.

“This will give a major fillip to mobilizing broadband and Digital India, for the benefit of people living in rural areas,” he further added.

Increased penetration of ‘Telemedicine’, per se, in the country has the potential to improving time, cost and the quality of access to affordable health care in rural India, as confirmed by several important studies.

A broad perspective:

A report of the World Health Organization (W.H.O), titled “Telemedicine – Opportunities and developments in the Member States”, states that the term ‘Telemedicine’, was coined in the 1970s, which literally means “healing at a distance”. It signifies the use of modern Information and Communication Technologies (ICTs), such as computers, the Internet, and cell phones, to improve patient outcomes by increasing access to care and medical information.

Recognizing that there is no one definitive definition of ‘Telemedicine’ – a 2007 W.H.O study, after reviewing 104 peer-reviewed definitions of this word, adopted the following broad description:

“The delivery of health care services, where distance is a critical factor, by all health care professionals using information and communication technologies for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and for the continuing education of health care providers, all in the interests of advancing the health of individuals and their communities”

‘Telemedicine’ in India:

Before I get into other relevant details in this area, let me briefly explore in which segments of the three important areas – Market, Services and Providers, ‘Telemedicine’ has already started working in India, though with a varying degree of success.

Market segments:

‘Telemedicine Market’ in India can broadly be segmented into nine key categories. A recent research report on “India E-Health Services Market Outlook to 2020” by Ken Research captures the top three of these segments as follows:

Tele-radiology: The top segment in India that involves the electronic transmission of radiographic images of patients, such as, X-Ray, CT scan or MRI from one location to another location for an expert interpretation by a radiologist sitting there to quickly facilitate appropriate treatment.

Tele-consultation: Ranked second in terms of revenue earning of the Indian telemedicine industry in 2015. It involves establishing a clear audio and video communication link between the patient and doctors of different disciplines, as required. Patients’ demand for online consultations with the doctors is fast increasing as it helps to get disease specific medical advice from the different experts located anywhere in the world.

Tele-ICU: Was ranked as the third largest segment. It involves the use of an off-site command center in which a critical care team (intensivists and critical care nurses) connects with patients in distant ICUs to exchange health information through real-time audio, visual, and electronic means.

The following are the other six segments, which I am presenting below with a brief definition of each, for convenience:

Tele-ophthalmology: It delivers eye care through digital medical equipment and on telecommunications technology platforms.

Tele-dermatology: It involves communication technology to connect patients with dermatologists to improve skin health. The technology allows the patient to be examined and even treated without making a physical trip to a dermatologist.

Tele-surgery: It is the ability for a doctor to help perform surgery on a patient even though they are not physically in the same location. It is a form of telepresence.

Tele-pathology: It involves the practice of pathology at a distance using telecommunications technology to facilitate the transfer of image-rich pathology data between distant locations for the purposes of diagnosis, education, and research.

Tele-psychiatry: it is the application of telemedicine to the specialty field of psychiatry. The term typically describes the delivery of psychiatric assessment and care through telecommunications technology, usually video-conferencing.

Tele-Home Care and Nursing: This is primarily meant for patients who prefer receiving various health care services at home, such as those suffering from serious chronic diseases, post-surgery, and to cater to the critical regular heath needs of elderly persons.

Service segments:

Similarly, various international literature has segmented the ‘Telemedicine services’ into two broad types, as hereunder:

Real Time telemedicine services: These services include telephonic call or video-conferencing where both the doctors and the patients need to be present at the same time, and real time interaction happens between them.

Store and Forward telemedicine services: These do not require both the doctor and the patient be present at the same time and transmission and assessment of the medical records can be done at any convenient time.

Types of Providers:

Ken Research Report categorized the ‘Telemedicine Providers’ available in India into the following three groups:

Private Hospitals, such as Apollo Tele Health Services, Narayana Health Telemedicine Centers and Aravind Eye Care and telemedicine centers of Medanta, besides others.

Government Hospitals and Medical Colleges, such as, AIIMS, SGPGI and several others have made alliances with various districts and sub-district hospitals of different states in India. Some States such as Punjab, Gujarat and Uttarakhand have adopted a PPP model.

NGO run centers, such as, World Health Partners are the largest NGO in India that has 1100 with a market share of 56.1 percent.

The critical barriers to overcome:

There are several critical barriers to the rapid penetration of ‘Telemedicine’ in India. However, in this article, I shall discuss only five of those, which India has not cared much to resolve over a long period, and need to be addressed, sooner than later:

Frugal broadband Internet network:

Probably realizing that this stark reality still exists, despite earlier initiatives of ‘Digital India’ slogan, the Finance Minister in his 2017-18 budget speech announced a fresh budget allocation for the new ‘Digi Gaon’ project.

An efficient broadband Internet is an absolute must for any efficient ‘Telemedicine’ project, as most of the applications of ‘Telemedicine’, as mentioned above, would work effectively only in that environment. In 2016, India’s broadband Internet penetration was an abysmal 7 percent, as reported in a white paper of the International Telecommunication Union (ITU), and quoted by the chairperson of the Telecom Regulatory Authority of India (TRAI).

High initial cost of setting up a telemedicine network:

The initial cost of setting up a viable ‘Telemedicine’ network, including training of personnel, developing user-friendly smartphone-based apps with state of the art technology, is high with low current Return on Investments (ROI).

Availability and training of personnel:

- At the village end: Availability of proper technician, other IT staff and qualified local doctors and their periodic training and performance assessment.

- At the consulting centers: Appropriate training, coordination with other relevant staff and administration as required for compliance and monitoring performance standard.

No legal framework governing Telemedicine in India:

At present, there is no legal framework in India governing Telemedicine of the country. The Government would need to urgently consider this issue, as it creates related facilities and infrastructure in the country.

Lack of revenue generating business models for sustainability:

In India, ‘Telemedicine’ is generally considered as a part of ‘social responsibility’ of public, private, large corporate hospitals and NGOs. In the some of the private hospitals it is alleged that the underlying objective is to raise the bed occupancy rate when the patients on ‘Telemedicine’ require hospitalization.

Currently, there exists a dearth of revenue generating business models for ‘Telemedicine’ in India, taking it beyond the realm of just ‘social responsibility’, and enabling it to play an increasing role in the overall health care space for long-term sustainability, with a win-win outcome for both its investors and patients.

Thus, the Government would require playing the role of an enabler to encourage, attract and support more and more private players and startups coming up with sustainable commercial business models in this area. Simultaneously, it should also play an active role to help increase public awareness in ‘Telemedicine’, eliminating patient inhibition, enhancing competition and reducing patients’ cost for various services.

Is ‘Affordable health care’ a victim of circumstances?

India with its public spend as a percentage of GDP on health care being consistently one of the lowest in the world over a period of a very long time, despite being the fastest growing global economy, the importance of high penetration of ‘Telemedicine’ in the country assumes a high importance. More so, when grossly inadequate public health care facilities continue to pose serious health risks for many of the country’s population.

On the other hand, in Indian private health care space, including drugs and pharmaceuticals, where a sizeable section of global pharma players and their lobbyists are continually pushing hard, predominantly an Intellectual Property (IP) orientated blatant self-serving agenda. They want to sell more of high price monopoly products and services to earn more and more profit, depriving a huge majority of local patients. It’s happening, even when the image of the global pharma industry has plunged to a new low, and is still going south, despite tons of money allegedly being spent on lobbying of various nature, more than ever before.

No wonder, why the globally acclaimed doyen of the IT industry – Mr. Narayana Murthy also openly acknowledged this fact, suggesting some science and technology based remedial measures. While addressing the Bio Asia 2017 on February 08, 2017 in Hyderabad he said: “India has fallen behind in healthcare, but science and technology can indeed play a role in bridging the gaps. Science and technology can play a key role in diagnosis and management of disease, of mass application of drugs and availability of drugs on a scale and at an affordable cost,” as reported in the Economic Times.

Thus, sandwiched between either side, ‘Affordable health care’ continues to remain a major victim of the circumstances, and is desperately looking for a strong Government intervention, just as what’s now happening in several developed countries, including the United States.

Conclusion:

Although ‘Telemedicine’ is an important enabler and enhancer, I reckon, it’s not a panacea. It would never replace brick and mortar high quality generally affordable health care facilities, along with affordable modern life saving medicines, any time in the foreseeable future.

The announcement of ‘Digi Gaon’ to facilitate ‘Telemedicine’ in India, without a well-charted roadmap and overcoming its critical success barriers, is intriguing. Nevertheless, this initiative has an underlying potential to transform ‘Telemedicine’ into a robust revenue generating model, even at the village level entrepreneurship, with sharp application of creative minds.

It’s a matter of great concern that in the space of Governance in India, public health care is increasingly becoming more a subject of a general lip service, rather than immaculate execution of a robust, comprehensive, time-bound National Health Policy with assigned accountability for each project and backed by requisite budgetary allocation, both by the Central and the State Governments. Consequently, one would seldom witness any such well hyped announcements on various public health care projects seldom coming to fruition on the ground, as promised.

Even if the recently announced ‘Digi Gaon’ initiative is considered as a standalone project for greater access to ‘Telemedicine’ in the hinterland of the country, it is important to understand that, in the short term, investment in ‘Telemedicine’ won’t be a magic wand for India to demonstrate a commensurate increase in health outcomes, along with reaping its consequential economic benefits.

To succeed in this area, several critical barriers need to be effectively overcome, soon. This would help showcasing ‘Telemedicine’ as an integral part of everyday e-health care solution for many. Otherwise, the Government is likely to face enormous challenges to leverage the true potential of ‘Digi Gaon’ for alleviation of acute miseries caused by poor, or lack of access to affordable health care, especially in rural India.

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.

Union Budget 2017-18: ‘Modicare’ Remains A Pie In The Sky

Posted on February 6, 2017 by Tapan Ray

Universal Health Care (UHC), as narrated in the National Health Policy (NHP) 2015 (NHP 2015 Draft) of Narendra Modi Government, making health a ‘Fundamental Right’ for Indian citizens, was considered a profound step by many, both in its both content and intent.

Being enormously enthused with this development, in my article of April 06, 2015 in this blog, titled “Would Affordable ‘Modicare’ Remain Just A Pipe Dream In India?”, I also termed this new draft health policy as ‘Modicare’, just as a few others did. If implemented both in its letter and in spirit, NHP 2015 has the potential to overshadow even the ‘Obamacare’ of the United States, almost hands down. Although it’s an altogether different story that under the new President Donald Trump’s administration, this Act faces a real threat of extinction, at least, in its current Avatar.

Is health care also a serious political issue?

Prompted by what has been happening in the oldest democracy in the world, the above fundamental question does surface. Its answer could be both, ‘yes’ or ‘no’, depending on the voters’ awareness on the subject, and the importance attached to it for individual well-being, including work productivity.

However, in this article, to impress upon how important are the promises on health care to the common citizens in the oldest democracy, I shall draw two back to back examples of pre-election campaign promises related to universal health care in the Unites states, where the answer to the above question has been an emphatic ‘yes’. Thereafter, I would explore what is happening in India in this area to fathom what could its answer possibly be in the largest democracy of the world.

The United States:

On November 4, 2008, Senator Barack Obama of Illinois was elected as the president of the United States. Just in a year’s time ‘The Patient Protection and Affordable Care Act’ popularly known as ‘Obamacare’, was passed in the Senate on December 24, 2009, and passed in the house on March 21, 2010. It was signed into law by President Obama on March 23rd, 2010 and upheld in the supreme court on June 28, 2012.

By enacting this historic health care reform legislation, President Obama fulfilled his election campaign pledge to provide healthcare to all in the United States of America, almost immediately after coming to power.

Similarly, during his 2016 election campaign, Donald Trump pledged to repeal the ‘Affordable Care Act (Obamacare)’, if elected, calling it a “total disaster.” Accordingly, on January 20, 2017 – the same day of becoming the 45th president of the United States, in his first executive order, President Trump, told government agencies to scale back aspects of the Affordable Care Act – fulfilling his pledge to undo Barack Obama’s signature healthcare law that made medical services accessible to millions of Americans.

Whether, it is a good or bad decision may not be a point of discussion in this article, but so far as the pre-election pledge on health care reform is concerned, both the Presidents – Obama and Trump indeed ‘walked the talk’.

India:

Besides the above two examples, the general expectation of the stakeholders in India was that in the priority agenda of the new Government health care will feature much higher than ever before. This was because the main ruling party of the Government in power now had promised to deliver a robust healthcare reform in its Election Manifesto 2014, if it is voted to power. Let me just reproduce below some of those critical promises:

India needs a holistic health care system that is universally accessible, affordable, effective and drastically reduces the out of pocket spending on health.

The Party accords high priority to the health sector, which is crucial for securing the economy.

As NRHM has failed to meet the objectives, it will be radically reformed.

The overarching goal of health care would be to provide, ‘Health Assurance to all Indians and to reduce the out of pocket spending on health care’, with the help of state governments.

The current situation calls for radical reforms in the health care system with regards to national health care programs and delivery, medical education and training and financing of health care.

The manifesto then goes into the details of each reform areas, after stating, “the last health care policy dates back to 2002; India now needs a comprehensive health care policy to address the complex health care challenges, keeping in view the developments in the health care sector and the changing demographics. The party will initiate the New Health Policy.”

This expectation flickered yet again:

This expectation flickered yet again, when just on the eve of the 2017-18 Union Budget Session, no less than the President of India, honorable Pranab Mukherjee on the last Tuesday reportedly reiterated that his Government assures ‘Health care for all’.

It’s about three years since the new Government is firmly placed on the saddle, after being voted to power. Regrettably, much promised, the new and comprehensive health care policy of India is still not in place. Could it mean, unlike in the US, pre-election political pledges on health care is still not considered a top priority area for quick implementation either by the Indian voters or the winning political parties, post-election? Probably, it doesn’t also sound as vote catching as a plethora of other ‘developmental activities’, ‘Foreign Direct Investments (FDI)’ and ‘GDP growth’ do, for winning a national election in our soil.

In India, most of the population think or feel about medical treatment and prevention of diseases mostly when we ourselves, or our near and dear ones suffer from serious morbidity, or are almost in a dying condition from serious ailments. At that moment of truth, most of us face almost an insurmountable barrier to treatment access due to individual ‘affordability’ condition. In the absence of enough decent public health facilities, one is compelled to go for private medical services that cost a bomb, most of which being out of pocket. At other times, it does not seem to matter much to many, or becomes an integral part of a burning social, political or economic agenda. It has thus far remained a dormant need, which needs to be brought to open by creating greater awareness in ambitious India, even during and after bringing a Government to power.

The fastest growing nation incurs lowest public health expenditure:

Even post ‘Demonetization’ exercise in the country, India would continue to remain the fastest growing large country in the world. However, the Government allocates just around one percent of GDP on public healthcare expenditure, ranking among the lowest in the world, in this area. Regrettably, there does not seem to be an adequate realization both among the public, corporate head honchos, including a large section of the country’s highly partisan media that sans sharp focus on health care, this immaculate growth story can get adversely impacted, in the long run.

Incoherent union health budgets sans any report card on achievements:

Be that as it may, in this article, I shall present before you a snapshot of the health care budgetary measures announced by the Finance Minister in his Budget speech both in 2016-17 vis-a-vis in 2017-18. Thereafter, I would try to explore how incoherent these are, and without any comprehensive status report on time-bound set goals. This is important, as taxpayers hard earned money was spent on those ‘goodies’, probably to give an impression that health care has not been totally left out by the Government during its annual budgetary allocation.

To demonstrate how incoherent and ad hoc these health budgets are, let me place before you what were the key areas of Union Budgetary allocations in 2016-17. If I may refer to my article of March 07, 2016 in this Blog titled, “Healthcare: Unwrapping The Union Budget (2016-17)”, we shall find that the key features were as follows:

The previous Union Budget of 2016-17:

The Government will launch a new health protection scheme, which will provide health cover up to Rs. One lakh (Rs. 100,000) per family. For senior citizens, age 60 years and above, belonging to this category, an additional top-up package up to Rs. 30,000 will be provided.

To reinvigorate the supply of generic drugs 3,000 stores under Prime Minister’s Jan Aushadhi Yojana will be opened during 2016-17.

Starting a ‘National Dialysis Services Program’ to provide dialysis services in all district hospitals. The funds were to be made available through PPP mode under the National Health Mission. To reduce the cost, the budget proposed exemption of certain parts of dialysis equipment from basic customs duty, excise/CVD and SAD.

I am not sure how many stakeholders, if any, are aware of the exact status report on those proposals of the last year’s Union Budget allocation for health care. If that’s the prevailing situation, we now get another small bundle of different sets of ‘goodies’ in the Union Budget 2017-18, as follows:

Current Union Budget of 2017-18:

Even in the absence of a comprehensive National Health Policy, there are many other health related critical issues that may eventually impede the GDP growth rate of the country. A few examples of which are as follows:

The estimated premature deaths caused by cardiac ailments, stroke and diabetes, reportedly, will result in a loss of national income of over US$ 250 billion in the coming decade,

Mental health becoming a silent epidemic, affecting around 13 percent of the population and just 10 percent of them getting treatment,

Millions of families are unable to get access to secondary and tertiary care services for diagnosis and treatment of serious diseases, such as cancer, as they cannot afford private facilities, which gets compounded as India records one of the highest out-of-pocket health expenditure in the world, higher than even many lower income, lower-middle income, as well as the middle-income countries.

Nevertheless, the Union Finance Minister in his 2017-18 budget proposal announced a strong resolve for elimination of:

Kala-azar or Leishmaniasis and filaria by 2017
Leprosy by 2018
Measles by 2020
Tuberculosis by 2025

Unquestionably, these are grossly inadequate, especially, in young and ambitious India. Moreover, very people industry watchers would know whether the deadline set for each is achievable, and a periodic report card on the same will be made public or not.

Similarly, the government’s determination to reduce Infant Mortality Rate (IMR) to 28 by 2019 (39 in 2014) and Maternal Mortality Rate (MMR) to 100 in 2020 (167 in 2011-13) is also praiseworthy. However, both these, including tuberculosis prevention, diagnosis and treatment interventions, were a part of the Millennium Development Goals (MDGs) for India. These are an ongoing exercise set out in the Millennium Declaration in 2000. Moreover, why annual budgetary allocation only for those two now, out of 8 MDG goals?

A few other equally ad hoc health care measures, probably picked up at random, and announced by the Union Finance Minister in his February 01, 2017 budget speech were the following:

Rs 6,000 financial aid for pregnant women to cover hospital admission, vaccination and nutritional food.

Two new All India Institute of Medical Sciences (AIIMS) at Jharkhand and Gujarat.

1.5 lakh health sub centers to be converted to Health Wellness Centers

Amendment of the Drugs and Cosmetics Rules to ensure availability of drugs at reasonable prices and promote the use of generic medicines

New rules for regulating medical devices to be formulated, which will be internationally harmonized and attract investment into this sector

Structural reforms in the medical practice and education.

For senior citizens, Aadhar based Smart Cards containing their health details. A beginning will be made through a pilot in 15 districts during 2017-18.

By all these, the government has proposed 27.7 percent increase in allocation for Ministry of Health and Family Welfare to Rs.47, 352.51 Crore in the latest budget from Rs 37,061.55 Crore in 2016-17, on the current abysmally low base of around 1 percent of GDP. A sizeable chunk of this budget is expected to go towards setting up of two new AIIMS and for conversion of 1.5 lakh health sub centers to Health Wellness Centers. The National Health Mission (NHM) for the entire nation, which the Government earlier said is not working, receives an increase of Rs. 3,000 Crore. According to media reports, the Public Health Foundation of India (PHFI) also considers this budget allocation as a frugal one.

Besides the general expectation for the beginning of a Universal Health Care (UHC) regime in India, pharma industry had generally expected the following immediate term relief, which also found no mention in the budget:

Corporate tax cut
Extension of time line for weighted deductions of R&D expenditure and adding filing fees and clinical trial expenses under the exemption.
Rationalization in excise duty for APIs to bring it on par with formulations.
Changes to excise duty due to impending implementation of goods and service tax (GST) Withdrawal of service tax on health insurance
Exemption of input service tax on support services

Conclusion:

The reason why I brought ‘Modicare’ in my budget discussion is that it needs well-articulated budgetary allocation, even for just the beginning of its implementation, besides having a robust policy in place. Even on the eve of the 2017-18 Union Budget Session, no less than the President of India had reiterated that his Government assures ‘health care for all’ – further rekindling this hope.

In the absence of a well-charted pathway for public health care in India, no wonder that this budget, in my opinion, demonstrates a clear lack of direction, incoherent and inconsistent, just as the previous ones.

I hasten to add that the Government’s focus on rural infrastructure and development, providing financial benefit to farmers, help building affordable houses, creating new jobs, ensuring ease of doing business, putting more disposable income in the hands of the people are well appreciated. However, none can possibly refute the dictum, especially in the young and highly ambitious India that: “It takes a healthy nation to build a wealthy nation”.

The bottom line, therefore, is, the fastest growing nation of the world continues to feel wise and smart with its lowest expenditure on public health. It also leaves a general impression that the Government has removed from its list of priority all the pledges made on health care, before, during and after having a firm grip on the leash of power. Consequently, this has made ‘Modicare’ no more than a pie in the sky, as it were, for many, even after years of sustenance of an indomitable hope of it coming to fruition.

By: Tapan J. Ray

How Cost-Effective Are New Cancer Drugs?

Posted on January 30, 2017 by Tapan Ray

The main reason why cancer is so serious a disease, is the ability of the malignant cells to spread in the body, both locally by moving into nearby normal tissue, and regionally to nearby lymph nodes, tissues, or organs, affecting even the distant parts of the body. When this happens, doctors term it as metastatic or stage IV (four) cancer.

Although most patients with metastatic tumors would eventually die of cancer, the treatment with various types of anticancer drugs, could help prolong life, in varying degree. No wonder, many new anticancer drugs now obtain regulatory approval based on their effectiveness on metastatic cancer patients. Consequently, it has now become almost a routine to administer newer anticancer drugs to patients with early stage of disease, after they have undergone surgery or radiotherapy.

But, these lifesaving drugs are expensive – very expensive! For example, a newer anticancer treatment is often priced at US$ 100,000 or more per patient, which, obviously, a large majority of the population can’t just afford.

Are these new drugs cost-effective?

To put in simple words, cost effectiveness of a drug is generally ‘expressed in terms of a ratio where the denominator is a gain in health from a measure (years of life, premature births averted, sight-years gained) and the numerator is the cost associated with the health gain.’

From this perspective, a January 2015 research study titled, “Pricing In The Market For Anticancer Drugs”, published by the National Bureau Of Economic Research of the United States observed that anticancer drugs like bevacizumab (US$ 50,000 per treatment episode) and ipilimumab (US$120,000 per episode) have fueled the perception that the launch prices of anticancer drugs are fast increasing over time.

To evaluate the pricing trend of these drugs, the researchers used an original dataset of 58 anticancer drugs, approved between 1995 and 2013, and found that launch-prices, adjusted for inflation and drugs’ survival benefits, increased by 10 percent, or about US$ 8,500, per year. This study was restricted to drugs administered with the primary intent of extending survival time for cancer patients and drugs for which survival benefits have been estimated in trials or modeling studies. The researchers did not consider drugs administered to treat pain or drugs that are administered to alleviate the side effects of cancer treatments.

The paper concluded, as compared to the older ones, newer anticancer treatments, generally, are less cost-effective. Despite this fact, the prices of these drugs are rising faster than their overall effectiveness.

How much do these drugs cost to prolong a year of life for cancer patients?

Another paper, titled “Cancer Drugs Aren’t As Cost-Effective As They Used To Be”, published in the Forbes magazine on September 30, 2015, expressed serious concern on the declining cost-effectiveness of new anticancer drugs. The author termed this trend as unacceptable, and more disturbing when providing just a year of life to cancer patients costs around US$ 350,000 to even US$ 800,000. High prices should reflect large benefits, and we need to demand value out of medical interventions – he recommended.

Do the claims of efficacy also reflect the real-world effectiveness?

Providing an answer to this question, a very recent article titled, “Assessment of Overall Survival, Quality of Life, and Safety Benefits Associated With New Cancer Medicines”, published in the well reputed medical journal ‘JAMA Oncology’ on December 29, 2016, concluded as follows:

“Although innovation in the oncology drug market has contributed to improvements in therapy, the magnitude and dimension of clinical benefits vary widely, and there may be reasons to doubt that claims of efficacy reflect real-world effectiveness exactly.”

As stated above, this conclusion was drawn by the researchers after a detail study on the overall survival, quality of life, and safety benefits of recently licensed cancer medicines, as there was a dearth of evidence on the impact of newly licensed cancer medicines.

The authors analyzed in detail health technology assessment reports of 62 cancer drugs approved in the United States and Europe between 2003 and 2013, and found that these were associated with increased overall survival by an average of 3.43 months between 2003 and 2013. Following is a summary of the detail findings:

43 percent increased overall survival by 3 months or longer
11 percent by less than 3 months
30 percent was not associated with any increase in overall survival, which means almost one third of these drugs lacked evidence to suggest their increased survival rate when compared to alternative treatments
Most new cancer drugs, though improved quality of life, were associated with reduced patient safety

The researchers expect this study to support clinical practice, and promote value-based decision-making in the cancer drug treatment, besides assessing their cost-effectiveness.

Some overseas Cancer Institutes protested:

In 2012, doctors at the Memorial Sloan-Kettering Cancer Center reportedly announced through ‘The New York Times’ that their hospital would not be using Zaltrap, a newly patented colorectal cancer drug at that time, from Sanofi. This action of the Sloan-Kettering doctors compelled Sanofi to cut the price of Zaltrap by half.

Unlike India, where prices of even cancer drugs do not seem to be a great issue with the medical profession, just yet, the top cancer specialists of the American Society of Clinical Oncology are reportedly working out a framework for rating and selecting cancer drugs not only for their benefits and side effects, but prices as well.

In a 2015 paper, a group of cancer specialists from Mayo Clinic also articulated, that the oft-repeated arguments of price controls stifle innovation are not good enough to justify unusually high prices of these drugs. Their solution for this problem includes value-based pricing and NICE like body of the United Kingdom.

This Interesting Video from Mayo Clinic justifies the argument.

Was it a tongue-in-cheek action from India?

On March 9, 2012, India did send a signal to global pharma players on its apparent unhappiness of astronomical pricing of patented new cancer drugs in the country. The then Indian Patent Controller General, on that day, issued the first ever Compulsory License (CL) to a domestic drug manufacturer Natco, allowing it to sell a generic equivalent of a kidney cancer treatment drug from Bayer – Nexavar, at a small fraction of the originator’s price.

However, nothing has changed significantly since then on the ground for cancer drugs in the country. Hence, many construe the above action of the Government no more than mere tokenism.

In this context, it won’t be out of place recapitulating an article, published in a global business magazine on December 5, 2013 that quoted Marijn Dekkers, the then CEO of Bayer AG as follows:

“Bayer didn’t develop its cancer drug, Nexavar (sorafenib) for India, but for Western Patients that can afford it.”

Whether, CL is the right approach to resolve allegedly ‘profiteering mindset’ at the cost of human lives, is a different subject of discussion.

VBP concept is gaining ground:

The concept of ‘Value-Based Pricing (VBP)’, has started gaining ground in the developed markets of the world, prompting the pharmaceutical companies generate requisite ‘health outcome’ data using similar or equivalent products.

Cost of incremental value that a product delivers over the existing ones, is of key significance, and should always be the order of the day. Some independent organizations such as, the National Institute for Health and Clinical Excellence (NICE) in the UK have taken a leading role in this area.

Intriguingly, in India, public health related issues, however pressing these are, still do not seem to arrest much attention of the government to provide significant relief to a large majority of population in the country.

Conclusion:

Warren Buffet – the financial investor of global repute once said, “Price is what you pay. Value is what you get.” Unfortunately, this dictum is not applicable to the consumers of high priced life-saving drugs, such as, for cancer.

Prices of new drugs for the treatment of life-threatening ailments, such as cancer, are increasingly becoming unsustainable, across the world, and more in India. As articulated by the American Society of Clinical Oncology in 2014, this is mainly because their prices are disconnected from the actual therapeutic value of products.

Currently, a sizable number of poor and even middle-income patients, who spend their entire life’s saving for treatment of a disease like cancer, have been virtually priced out of the patented new cancer drugs market.

The plight of such patients is worse in India, and would continue to be so, especially when no trace of Universal Health Care/Coverage (UHC) is currently visible anywhere near the healthcare horizon of the country.

By: Tapan J. Ray

Dry New Antibiotic Pipeline: Increasing Incidence Of Deadly Antibiotic Resistance

Posted on January 23, 2017 by Tapan Ray

On January 13, 2017, ‘The Telegraph’ quoting the ‘Centers for Disease Control and Prevention (CDC)’ reported that a woman in Nevada was killed by a superbug that proved resistant to every antibiotic available in the United States (US). She was in her 70s, and had recently returned to the US after an extended visit to India. The CDC found her blood containing ‘New Delhi metallo-beta-lactamase (NDM)’ – an enzyme that was first detected in India, makes bacteria resistant to many antibiotics. Nevertheless, this is just not a solitary example. It’s fast giving rise to a snowballing effect.

The magnitude of this problem has now assumed a global dimension. A May 2016 review of ‘Antimicrobial Resistance (AMR)’ estimates: ‘By 2050, 10 million lives a year and a cumulative 100 trillion USD of economic output is at risk due to the rise of drug – resistant infections, if we do not find proactive solutions now to slow down the rise of drug resistance. Even today, 700,000 people die of resistant infections every year.

According to the World Health Organization (W.H.O), AMR is the ability of a microorganism (like bacteria, viruses, and some parasites) to stop an antimicrobial (such as antibiotics, antivirals and antimalarials) from working against it. Consequently, standard treatments become ineffective, infections persist and may spread to others.

As antibiotics are a special category of antimicrobial drugs that underpin modern medicine as we know it: if they lose their effectiveness, key medical procedures (such as gut surgery, caesarean sections, joint replacements, and treatments that depress the immune system, such as chemotherapy for cancer) could become too dangerous to perform. Most of the direct and much of the indirect impact of AMR will fall on low and middle-income countries – the above review reiterates.

The first global report on AMR:

Not so long ago, In 2014, the first global report on AMR, published by the W.H.O reiterated that this scary scenario is no longer a prediction for the future. It is happening right now, and is not a country specific issue, but a global concern that is jeopardizing global health security.

“Hundreds of thousands of antibiotic-resistant infections and tens of thousands of related deaths go uncounted each year. But even if they were closely tracked, the lack of new drugs to meet the rising tide of resistance means the toll will only mount,” Reported Reuters in another article titled “Stronger superbugs and no new drugs to fight them”, on December 15, 2016.

Thus, there isn’t even an iota of doubt now that in the battle against bacterial infections, drug-resistant superbugs are fast emerging as one of the deadliest issues in the health care space, across the world, including India.

Interestingly, no one knows who will fall victim of this scary scenario and when. Neither can one eliminate this risk completely, even in the developed world. Only painstaking medical research, sans sole focus on creamy bottom-line, and with the application of cutting edge technology, can help overcome this fast-growing health menace to mankind.

“It’s all about the bottom line”:

Quoting a biochemistry professor at Indiana University, Bloomington, the above article reported, in 1980, 36 large American and European pharmaceutical companies were involved in research into new antibiotics. This number currently reduces to just four: Novartis AG, Merck & Co, GlaxoSmithKline Plc and Sanofi SA.

The May 2016 Data Table of ‘The Pew Charitable Trust’ indicates, as of March 2016, an estimated 37 new antibiotics with the potential to treat serious bacterial infections are in clinical development for the U.S. market. It is worth noting, the success rate of clinical drug development is low. Historical data show that, generally, only 1 in 5 infectious disease products that enter human testing (phase 1 clinical trial) will be approved for patients.

Moreover, most of these new antibiotics are based on existing drugs. Although, this approach is cheaper and easier to develop a new antibiotic, as compared to new classes of drugs, bacteria may rather quickly succeed in developing resistance to them.

It keeps happening, primarily because the return on investment for antibiotics, which are typically prescribed for a short period of 7 to 14 days, is much lower than the new drugs used for virtually a life treatment of chronic conditions, such as hypertension, hyperlipidemia, or diabetes.

Consequently, most of the constituents of Big Pharma have virtually fled the antibiotic business, as the new drug development ball game today “is all about the bottom line”, the article quoted.

Antibiotic resistance in India:

As W.H.O articulates in its above report, AMR poses a greater challenge in the developing nations, such as India, where the burden of infectious disease is high and health care spending is too low. The problem assumes a more critical dimension in India, that records among the highest bacterial disease burden in the world, with antibiotics playing a critical role in limiting morbidity and mortality.

The 2015 multi-country survey of the W.H.O unveiled a widespread public misunderstanding about antibiotic usage and resistance in India. Some of the major highlights are as follows:

Three quarters (75 percent) of respondents think, incorrectly, that colds and flu can be treated with antibiotics, and only 58 percent know that they should stop taking antibiotics only when they finish the course as directed.

More than three quarters (76 percent) of respondents report having taken antibiotics within the past 6 months; 90 percent say they were prescribed or provided by a doctor or nurse.

While 75 percent agree that antibiotic resistance is one of the biggest problems in the world, 72 percent of respondents believe experts will solve the problem before it becomes too serious.

Nowhere AMR is as stark as in India:

Another article published in the ‘PLOS Medicine’ on March 2, 2016, is quite in tune with the above W.H.O report. It also reiterates that antibiotic resistance is a global public health threat, but nowhere is it as stark as in India. The crude infectious disease mortality rate in India today is 416.75 per 100,000 persons and is twice the rate prevailing in the United States when antibiotics were introduced (roughly 200 per 100,000 persons).

It also captures the following burning issues in this area:

Antibiotic use is a major driver of resistance. In 2010, India was the world’s largest consumer for human health.

Access to antibiotics is rising, which portends well for the large proportion of India’s population that thus far had poor access to these life-saving drugs.

The convergence of factors such as poor public health infrastructure, rising incomes, a high burden of disease, and cheap, unregulated sales of antibiotics have created ideal conditions for a rapid rise in resistant infections in India.

Over-the-counter, nonprescription sales of carbapenems in India are among the highest in the world, and contribute to growing carbapenem resistance among gram-negative organisms.

Improving regulations of drug production and sales, better managing physician compensation, and encouraging behavior change among doctors and patients, are of immediate priority.

More serious than local perception:

The new report released by the Center for Disease Dynamics, Economics & Policy (CDDEP) in September 2015, has flagged an alarming trend of bacterial resistance to last-resort antibiotics that can lead to life-threatening infections across the world.

While the developed countries still use far more antibiotics per capita, high AMR rates in the developing nations, such as India, Kenya and Vietnam send a strong warning signal to the world.

For example, in India, 57 per cent of the infections caused by Klebsiella pneumoniae, a deadly superbug found in hospitals, were found to be resistant to one type of last-resort drug in 2014 – an increase from 29 per cent in 2008. It is worth noting that these drugs, known as carbapenems, are still effective against Klebsiellainfections in 90 per cent of cases in the U.S, and over 95 per cent in Europe.

A new class of antibiotics discovered with iChip technology:

The good news is, as reported in the June 18, 2015 issue of the Journal of Antimicrobial Chemotherapy, scientists could produce a new class of antibiotic, named Teixobactin, from a hitherto undescribed soil microorganism (provisionally named Eleftheria terrae). It was isolated with a new tool – the iChip, that allowed the environmental bacterium to grow and for the antibiotic it produced to be isolated and subsequently identified.

Working together with collaborators at the University of Central Florida and the Hong Kong Polytechnic University, a research team of Hong Kong University (HKU) has successfully synthesized this ‘game-changing’ antibiotic that can kill a wide range of bacteria seemingly without developing resistance.

Teixobactin has activity against Gram-positive (but not Gram-negative) organisms and mycobacteria and a novel mode of action inhibiting peptidoglycan biosynthesis. Teixobactin, a still-experimental drug that may herald a new era of antibiotic discovery. However, there are no guarantees that it will be able to reach the market post regulatory acid tests, though the use of the iChip will hopefully result in the discovery of further potential new antibiotics.

Country specific frugal innovation is also necessary:

Alongside, various academic initiatives in search of new, path breaking antibiotics, frugal innovation in various countries to address the local issues in this area, could also play a very significant role to contain this menace.

In this context, I shall quote from the example of a small country, such as Singapore, which is contributing significantly to medical research and development in this area.

An article published in a new daily of Singapore – ‘Today’, on December 29, 2016, highlighted that drug-resistant superbugs have become one of the most pressing problems in the healthcare space of even one of the cleanest cities of the world.

Driven by the need to find a more suitable alternative, researchers at the Institute of Bioengineering and Nanotechnology (IBN) of Singapore, have developed a new material that can kill E coli bacteria within seconds. E coli is a type of bacteria found in the intestines of humans and animals, and some strains can cause severe diarrhea, abdominal pain and fever.

The article, reported that the novel synthetic material, known as imidazolium oligomers, can kill 99.7 percent of the bacteria within 30 seconds, more rapidly than any existing antimicrobial product on the market, such as hand wash or surface sprays. Existing products take minutes to hours to kill the bacteria. It was also tested and found to be effective against other common strains of antibiotic-resistant bacteria and fungi, such as Staphylococcus aureus, Pseudomonas aeruginosa and Candida albicans. It has been licensed by a multinational firm for commercial development in October.

If Singapore can take its own initiatives in this crucial health care space, why can’t India?

Conclusion:

Strict enforcement of the existing regulations of the medical sector, particularly in the prescription of medicines, is of crucial importance. Lack of knowledge among medical practitioners, as well as public on rational use of antibiotics, aggravates the issue.

Notwithstanding fast drying-up of global research pipeline for new antibiotics due to several reasons, India needs to address this fast escalating life-threatening problem through various other practical means. One such could be, putting in place a comprehensive National Action Plan for AMR, quite in line with the Global one, which the W.H.O has already recommended.

This critical issue gets further compounded, as a very significant part of an out-of-pocket expenditure on health care is on medicines, and longer treatment with ineffective drugs and/or second line expensive antibiotics, are pushing the treatment costs higher. On the other side, higher priced drug regimens are less likely to be adhered to, which again contributes to the AMR.

“This situation needs to be interrupted and reversed, not only for safeguarding people’s health, but also for providing protection against health care costs and people going into poverty,” advises the premier World Health body.

Finally, it is important for all to bear in mind, no one knows who will fall victim of this scary scenario and when. So, a decisive action from all concerned can’t wait any longer.

By: Tapan J. Ray

Mental Health Problem: A Growing Concern In The Healthcare Space Of India

Posted on January 16, 2017 by Tapan Ray

A thud!

Something fell from high above!

In no time, a bright young life of just a 32-year-old highly accomplished professional – a widely admired soul, vanished in the thin year, for good, mostly unnoticed in the quiet neighborhood, initially.

The news was more than a shock to my family. It engulfed me by the fire of impotent rage against this cruel play of destiny, where nothing can be undone, just nothing!

What prompted this so bright, successful, hugely promising and an ever-helpful-to-all guy doing what he did? No one could ferret out the answer, just yet, and possibly would never be.

Medical literatures have now established a close relationship between depression and its possible lethal outcome – suicide. Using literature data, one can estimate that 60 to 70 percent of the subjects attempting suicide were suffering from depression of various kinds. Was this young man too silently suffering from this undiagnosed and untreated mental illness?

In this article, I shall dwell on this important aspect of overall health care in India.

Depression ranks 4th in the 10 leading causes of the global burden of disease:

The World Health Organization (W.H.O) underlines: “Major depression is now the leading cause of disability globally and ranks fourth in the ten leading causes of the global burden of disease. If projections are correct, within the next 20 years, depression will have the dubious distinction of becoming the second cause of the global disease burden. Globally, 70 million people suffer from alcohol dependence. About 50 million have epilepsy; another 24 million have schizophrenia. A million people commit suicide every year. Between ten and 20 million people attempt it.”

A recent study:

Currently in India, millions of people with mental illnesses continue to remain untreated. This is vindicated by a chain of recent research studies titled, “China-India Mental Health Alliance Series”, published in ‘The Lancet’ on May 18, 2016.

The studies highlighted that: “China and India, which together contain 37 percent of the world’s population, are both undergoing rapid social changes. Because mental disorders account for a high proportion of morbidity, detailed knowledge of the mental health status of the populations in these two countries, and the evidence-base regarding the treatment of those disorders, are of paramount concern.”

“In China, mental, neurological and substance use disorders accounted for 7 percent of all (years of healthy life of the whole population) in 1990, rising to 11 percent by 2013. Similarly, in India, the proportion of all burden explained by mental, neurological, and substance use disorders rose from 3 percent in 1990 to 6 percent in 2013,” the researchers highlighted.

Greater concern in India:

In 2013, 36 million years of healthy life were lost to mental illness in China, and 31 million in India. The new research estimates that by 2025, though 36.9m years of healthy life will be lost to mental illness in China (10 percent increase), it will be 38.1m in India (23 percent increase). Anxiety and depression are the most common mental health problems among working age adults between 20 and 69 years.

Similarly, dementia is emerging as a growing mental health issue for both countries. However, from 2015 to 2025, it is estimated that the number of healthy years lost due to dementia will increase by 82 percent in India against 56 percent in China.

Interestingly, in August 2016, replying to a debate on the ‘Mental Health Care Bill’ in the Parliament, the Union Health Minister Mr. J. P. Nadda said, around 6-7 per cent of Indian population suffered from mental illnesses, while 1-2 per cent suffer from acute mental disease.

This means, over 70 million people are affected by mental illness in India, which has a close association with the rate of suicides, cardiovascular disorders, and loss of a significant number of productive days. It is estimated that around 50 percent of people with severe mental disease and around 90 percent of those with less severe symptoms, remain untreated in the country.

Depression, reportedly, the most prevalent form of mental illness that affects almost 3 to 5 percent of urban population living in cities, such as, Mumbai or Delhi. Around 30 percent of them are severely neurotic.

Alzheimer’s disease was reported to be the most common of severe disorders (54 percent) followed by vascular dementia (39 percent).

Another Government statistics indicate that 20 percent of Indians reportedly need counselling at some point of their lives. One per cent of the population suffers from serious mental health disorders, while 5-10 percent of Indians suffer from moderate disorders.

Another recent study:

Another recent report published in ‘The Lancet Psychiatry’ on 12 August 2016, captured the following details for India, in this area:

Very few population-representative data were found for mental disorders, with an average coverage of just 1 percent of the country’s population.

Major depressive disorder, anxiety disorder, and alcohol dependence were the most common mental, neurological, and substance abuse disorders, for men.

For women, anxiety disorder, major depressive disorder, and dysthymia were most common.

Human and financial resources for mental health are grossly inadequate with less than 1 percent of the national health care budget allocated to mental health in India.

Improvement of coverage will need to address both supply-side barriers and demand-side barriers related to stigma and varying explanatory models of mental disorders.

An associate professor of psychiatry at New Delhi’s All India Institute of Medical Sciences (AIIMS), reportedly said, there is just one psychiatrist for every 400,000 Indians. Apparently, he also said that there are only about 4,000 psychiatrists, 1,000 psychologists and 3,000 social workers in the entire country of over 1.2 billion people. Only 1,022 college seats for mental health professionals are set aside in India.

Or, in other words, a huge dearth of trained mental health professionals, coupled with low public investments, and fueled by high associated stigma, continue to compel many Indian populations lose many years of their lives to the illness.

Role of traditional medicines:

The study also suggests that traditional medicine practitioners, who are so common in India, “may be trained to recognize and refer patients who are at risk to themselves and others, or to advise patients against stopping their medication. Nevertheless, the authors do call for more research in this area to understand the effectiveness and potential risks of traditional medicines in the treatment and management of mental health.

Associated stigma:

It’s worth repeating, unlike many developed countries of the world, there is still a stigma associated with mental health problems in India. There are several instances of its adverse impact, not just on the social level, but also on the employment opportunities. These issues compound the treatment problem, making their public interaction too very weird at times, further increasing social polarization and inequalities.

Not a personal failure:

As the World Health Organization (W.H.O) articulates: “Mental illness is not a personal failure. It doesn’t happen only to other people. We all remember a time not too long ago when we couldn’t openly speak about cancer. That was a family secret. Today, many of us still do not want to talk about AIDS. These barriers are gradually being broken down.”

The Mental Health Care Bill:

The long-awaited ‘Mental Health Care Bill’, which after an extensive consultation process, is now awaiting the lawmakers’ formal approval for its enactment as law. The Bill, was passed by the Rajya Sabha on August 8, 2016, and is expected to be discussed in the Lok Sabha, probably in this budget session. It was first introduced on August 19, 2013, the Rajya Sabha Standing Committee report was submitted on November 20, 2013.

The bill reportedly redefines mental illness to better understand various conditions that are persistent among the population. It states that mental illness is a ‘substantial disorder of thinking, mood, perception, orientation or memory that grossly impairs judgement, behavior, capacity to recognize reality or ability to meet the ordinary demands of life’. Mental conditions related to alcohol or drug abuse are also included in the definition.

The Bill basically aims at protecting the rights of persons with mental illness and promote their access to mental health care.

One of the major highlights of the bill is decriminalization of attempt to suicide, as it states that the person attempting suicide will be presumed to be ‘under severe stress’ unless otherwise proven, and is not punishable. This move is commendable, ‘as it takes away the burden of implicating a mentally ill person in a crime that he or she had no sane control over.’ The W.H.O report on suicides (2000-2012) puts India right on top of the list in Southeast Asia. It says, the average suicide rate in India is 10.9 for every 100,00 people.

Conclusion:

Mental health has now been included in the United Nation’s ‘Sustainable Development Goals (SDG)’ at its General Assembly in September 2015. It is very likely that SDGs addressing mental health issues will become a part of country development plans and of bilateral and multilateral development assistance. This could well mean that millions of people will finally receive much needed help in this area.

Zeroing-in to India, mental health problems have since been a low priority area in the public health narrative of the country. The health information system of the country does not prioritize mental health, either.

To address this growing concern, besides forthcoming enactment of ‘Mental Health Care Bill’, the much-awaited healthcare reform of the nation, should include a transparent policy framework for mental health. A substantial number of community health workers, including traditional medicine practitioners need to be trained to deliver basic mental health hygiene and care. More serious cases, in that process, should be referred to the qualified professionals.

Mental health problems are growing at a rapid pace in India, being a cause of great concern in the healthcare space in India. It deserves to be treated like any other serious physical illness or disease, in a systematic way, backed by adequate budgetary support for affordable treatment and counselling measures, wherever required.

By: Tapan J. Ray

Sharper Focus On Vaccine: A Huge Scope To Reduce Disease Burden In India

Posted on January 9, 2017 by Tapan Ray

Several international research studies have conclusively established that the aggressive application of nationally recommended prevention activities could significantly reduce the burden of disease in several areas. Immunization or vaccination program is one such critical areas.

Several ailments, which used to be so common all over the world, can now be effectively prevented through vaccination. The most common and serious vaccine-preventable diseases are: diphtheria, Haemophilus influenzae serotype b (Hib), hepatitis B and C, measles, meningitis, mumps, pertussis, poliomyelitis, rubella, tetanus, tuberculosis, rotavirus, pneumococcal disease and yellow fever. The list of the World Health Organization (WHO) indicates that vaccines are now available for 25 different diseases.

Thus, vaccination can save millions of lives and morbidity that such diseases still cause to a very large number of global population. Thanks to vaccines, two most scary diseases – small pox (totally) and polio (almost totally), have been eliminated from the world.

No doubt, why vaccination was voted as one of the four most important developments in medicine of the past 150 years, alongside sanitation, antibiotics and anesthesia by readers of the ‘British Medical Journal (BMJ)’ in 2007. It has been decisively proved that vaccines are one of the most successful and cost-effective public health interventions, which help preventing over 3 million deaths every year, throughout the world, topping the list in terms of lives saved.

In tandem, concerted efforts need to be made by both the industry and the Governments to improve affordable access to all these vaccines for a larger section of the population, especially in the developing world.

A crying need still exists:

Nevertheless, there is still a crying need for greater encouragement, more resource deployment and sharper focus towards newer vaccine development for many more dreaded and difficult diseases. One such area is malaria vaccine.

Some areas of new vaccine development:

Following is an example of some newer therapy areas where novel vaccines are now reportedly under development:

Malaria vaccine
Cancer vaccine
AIDS
Alzheimer’s disease

Malaria vaccine:

A July 24, 2015 article of the BBC News states, the ‘European Medicines Agency (EMA)’ gave a positive scientific opinion after assessing the safety and effectiveness of the first anti-malarial vaccine of the world – Mosquirix, developed by the British pharma major GlaxoSmithKline.

The vaccine reportedly targets the ‘P. falciparum’, the most prevalent malaria parasite and the deadlier of the two parasites that transmit the disease. At present, in the absence of any licensed vaccines for malaria, the main preventive measures to contain the spread of this parasitic disease are spraying of insecticides, use of other mosquito repellent and mosquito nets.

However, it was observed during its clinical trial that he best protection with this vaccine was achieved among children aged five to 17 months, receiving three doses of the vaccine a month apart, plus a booster dose at 20 months. In this group, cases of severe malaria were cut by a third over a four-year period, the report said.

Some concern was also expressed, as the effectiveness of the vaccine waned over time, making the booster shot essential, without which the vaccine did not cut the rate of severe malaria over the trial period. Moreover, the vaccine did not prove very effective in protecting young babies from severe malaria.

This caused a dilemma for the ‘World Health Organization (WHO)’. On the one hand, the stark reality of malaria killing around 584,000 people a year worldwide, and on the other, lack of conclusiveness in the overall results for this vaccine. Therefore, the world health body decided at that time to further consider about it, soon after the experts’ deliberation on whether to recommend it for children, among whom trials have yielded mixed results, gets completed.

The good news is, on November 18, 2016, Newsweek reported the announcement of the W.H.O, that Mosquirix will be piloted across sub-Saharan Africa in 2018, after a funding approval of US$ 15 million for this purpose.

Cancer vaccines:

According to the National Cancer Institute, which is a part of the National Institutes of Health (NIH) of the United States, cancer vaccines belong to a class of substances known as biological response modifiers. Biological response modifiers work by stimulating or restoring the immune system’s ability to fight infections and disease. There are two broad types of cancer vaccines:

Preventive (or prophylactic) vaccines, which are intended to prevent cancer from developing in healthy people.

- Persistent infections with high-risk human papillomavirus (HPV) types can cause cervical cancer, anal cancer, oropharyngeal cancer, and vaginal, vulvar, and penile cancers. Three vaccines are approved by the US Food and Drug Administration (FDA) to prevent HPV infection: Gardasil®, Gardasil 9®, and Cervarix®.

- Chronic Hepatitis B virus (HBV) infection can lead to liver cancer. The FDA has approved multiple vaccines that protect against HBV infection, such as, Engerix-B and Recombivax HB, which protect against HBV infection only.

Treatment (or therapeutic) vaccines, which are intended to treat an existing cancer by strengthening the body’s natural immune response against the cancer. Treatment vaccines are a form of immunotherapy.

- In April 2010, the USFDA approved the first cancer treatment vaccine. This vaccine, sipuleucel-T (Provenge®), is approved for use in some men with metastatic prostate cancer. It is designed to stimulate an immune response to prostatic acid phosphatase (PAP), an antigen that is found on most prostate cancer cells.

Another type of cancer vaccine is currently being developed, known as the Universal Cancer Vaccine.

Universal Cancer Vaccine, 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.

The 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.

The analysts forecast the global cancer vaccines market to grow at a CAGR of 27.24 percent over the period 2014-2019.

HIV/AIDS Vaccine:

The 21st International AIDS Conference (AIDS 2016) held in Durban, South Africa from July 18 to 22, 2016, revealed that a vaccine against HIV will be trialed in South Africa later in 2016, after meeting the criteria needed to prove it, could help fight the epidemic in Africa. A small trial, known as HVTN100, took place in South Africa in 2015 to test the safety and strength of immunity the vaccine could provide, ahead of any large-scale testing in affected populations.

This development reportedly has its origin in a large landmark 2009 trial of RV 144 vaccine in Thailand, demonstrating the proof of concept that a preventive vaccine with a risk reduction of 31 percent could effectively work. The trial was supported by the World Health Organization (WHO) and UNAIDS. The clinical trial participants who received Vacc-4x, reportedly “experienced a 70 percent viral load decrease relative to their level before starting Anti-Retroviral Therapy (ART), compared with no notable reduction among placebo recipients.”

Alzheimer’s disease vaccine:

A vaccine for Alzheimer’s disease could be trialed in human within the next 3-5 years, after researchers from the United States and Australia have uncovered a formulation that they say successfully targets brain proteins, which play a role in the development and progression of the disease, states a July 18, 2016 report published in the ‘Medical News Today (MNT)’.

This vaccine generates antibodies that target beta-amyloid and tau proteins in the brain – both of which are considered hallmarks of Alzheimer’s disease. In their study, the researchers found that the formulation was effective and well-tolerated in Alzheimer’s mouse models, with no reports of adverse reactions. The vaccine was also able to target the proteins in brain tissue from patients with Alzheimer’s.

Study co-author Prof. Michael Agadjanyan, Institute for Molecular Medicine, California said: “This study suggests that we can immunize patients at the early stages of AD (Alzheimer’s disease), or even healthy people at risk for AD, using our anti-amyloid-beta vaccine, and, if the disease progresses, then vaccinate with another anti-tau vaccine to increase effectiveness.”

If the vaccine continues to show success in these preclinical trials, the researchers envisage that they could be testing the vaccine in individuals at high risk for Alzheimer’s, or those in the early stages of the disease, within the next 3-5 years.

More details on vaccine development:

A 2012 report on vaccines, published by the Pharmaceutical Research and Manufacturers of America (PhRMA) give details of vaccines under development.

Vaccine requirements of the developing world:

Developing countries of the world are now demanding more of those vaccines, which no longer feature in the immunization schedules of the developed nations. Thus, to supply these vaccines at low cost will be a challenge, especially for the global vaccine manufacturers, unless the low margins get well compensated by high institutional demand.

Issues and challenges:

To produce a safe, effective and marketable vaccine, besides R&D costs, it takes reportedly around 12 to 15 years of painstaking research and development process.

Moreover, one will need to realize that the actual cost of vaccines will always go much beyond their R&D expenses. This is mainly because of dedicated and highly specialized manufacturing facilities required for mass-scale production of vaccines, 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.

Thus, the long lead time required for the ‘mind to market’ process for vaccine development together with high cost involved in their clinical trials/marketing approval process, special bulk/institutional purchase price and limited demand through retail outlets, restrict the research and development initiatives for vaccines, unlike many other pharmaceutical products.

Besides, even the newer vaccines will mostly be required for the diseases of the poor, like Malaria, Tuberculosis, HIV and ‘Non-Communicable Diseases (NCDs)’ in the developing countries, which may not necessarily guarantee a decent return on investments for vaccines, unlike many other newer drugs. Thus, the key issue for developing a right type of newer vaccine will continue to be a matter of pure economics.

India needs a vibrant vaccine business sector:

For a greater focus on all important disease prevention initiatives, there is a need to build a vibrant vaccine business sector in India. To achieve this objective the government should create an enabling ecosystem for the vaccine manufacturers and the academics to work in unison. At the same time, the state funded vaccine R&D centers should be encouraged to concentrate more on the relevant vaccine development projects, ensuring a decent return on their investments for long-term economic sustainability.

Often, these stakeholders find it difficult to deploy sufficient fund to take their vaccine projects successfully through various stages of clinical development to obtain marketing approval from the drug regulator, while earning a decent return on investments. This critical issue needs to be urgently addressed by the Government to make the disease prevention initiatives in the country sustainable.

A possible threat to overcome:

As per reports, most Indian vaccine manufacturers get a major chunk of their sales revenue from exports to UN agencies, charitable organizations like, the Bill & Melinda Gates Foundation, GAVI, and other country-specific immunization programs.

The report predicts, the virtual monopoly that Indian vaccine manufacturers have enjoyed in these areas, will now be challenged by China, as for the first time in 2012, the Chinese national regulatory authority received ‘pre-qualification’ certification of WHO that allows it to approve locally manufactured vaccines to compete for UN tenders.

Conclusion:

Keeping this in perspective, vaccine related pragmatic policy measures need to be taken in the country for effective disease prevention, covering all recommended age groups, of course, with an equal focus on their effective implementation, without delay. Consequently, this will not only help reduce the disease burden in the country, but also provide the much-awaited growth momentum to the vaccine market in India.

Alongside, increasing number of modern imported vaccines coming in, would help India address one of its key healthcare concerns effectively, and in a holistic way.

It is about time to aggressively garner adequate resources to develop more modern vaccines in the country. In tandem, a rejuvenated thrust to effectively promote and implement vaccine awareness campaigns, would help immensely in the nation’s endeavor for disease prevention with vaccines, that offers a huge scope to reduce disease burden, for a healthier India.

By: Tapan J. Ray

Awaiting The Two To Tango: Pharma Innovation And Public Health Interest

Posted on January 2, 2017 by Tapan Ray

“The rewards for the breakthrough drug discovery must be substantial, but if prices are the only mechanism through which returns on research flow, affordability will be compromised,” articulated an article titled, ‘Pharmaceutical Policy Reform – Balancing Affordability with Incentives for Innovation’, published in The New England Journal of Medicine (NEJM) on February 25, 2016.

The article arrived at this conclusion, on the backdrop of the high prices of prescription drugs becoming an issue of paramount concern, not just in the United States, but across the world. This concern is so acute that it found its way into policy proposals from both the prime candidates, in the American Presidential election held on November 8, 2016.

Through last several decades, healthcare sector in general and particularly the pharmaceutical industry, witnessed many innovations that cure and effectively manage ailments to improve the general quality of life. It enormously impacted the lives of many in the developed countries, and a few others which offer high quality Universal Health Care in a comprehensive format, for all.

A trickle-down impact:

Nevertheless, even no more than its just a trickle-down impact, helped increase overall life expectancy of the population in many developing and poor countries, mostly driven by the expanding number of cheaper generic drugs, fueled by more treatment and disease management options.

The paper titled, ‘World Population Prospects – The 2015 Revision’ of the Department of Economic and Social Affairs, Population Division of the United Nations’ reported that the life expectancy at birth rose by 3 years between 2000-2005 and 2010-2015, that is from 67 to 70 years. All major areas shared in the life expectancy gains over this period, but the greatest increases were in Africa, where life expectancy rose by 6 years in the 2000s, after rising by only 2 years in the previous decade.

Similarly, the global life expectancy at birth is projected to rise from 70 years in 2010-2015 to 77 years in 2045- 2050 and to 83 years in 2095-2100. Africa is projected to gain about 19 years of life expectancy by the end of the century, reaching 70 years in 2045-2050 and 78 years in 2095-2100. Such increases are contingent on further reductions in the spread of HIV, and combating successfully other infectious as well as non-communicable diseases.

The availability of cheaper generics gave some respite:

Out of a total population of 7.3 billion, as the above report says, the World Bank estimated that in 2013, 767 million people still lived on less than US$ 1.90 a day. Unfortunately, despite the greater availability of a large variety of cheaper generic drugs, the basic health care remains elusive to hundreds of millions of people in the world.

What causes more concern is the fact that 6 percent of people in low and middle-income countries are tipped into or pushed further into extreme poverty because of health spending, as the June 12, 2015 report of the World Health Organization (W.H.O) and the World Bank highlights. W.H.O has estimated that over a billion population of the world still suffer from neglected tropical diseases.

How many people benefitted from pricey patented drugs?

Nevertheless, despite so much innovation in the pharma industry, access to these new drugs remains elusive to a large section of even some the most developed nations, such as the United States, as they can’t afford these high-priced drugs. The overall situation, in this regard, is going from bad to worse. For example, the March 16, 2015 study published in the Mayo Clinic Proceedings reveals that the average annual cost of cancer drugs increased from roughly US$ 10,000 prior to 2000 to an astounding over US$ 100,000 by 2012.

Further, an August 31, 2015 article published in the ‘Health Affairs’ also gave examples of Biogen Idec’s multiple sclerosis drug, Tecfidera, which costs US$ 54,900 per patient per year; hepatitis C cures from Gilead Sciences, with a sticker price of $84,000 per patient; and Orkambi, a cystic fibrosis drug from Vertex Pharmaceuticals approved this month, priced at a whopping US$ 259,000 per year. A Kaiser Health Tracking Poll last July 2015 found that 73 percent of Americans find the cost of drugs to be unreasonable, and most blamed drug manufacturers for setting prices too high, the article stated.

The health care scenario in India is no better:

A study conducted by the ‘National Sample Survey Organization (NSSO)’ from January to June 2014, which was the 71st round of the ‘National Sample Survey’, and published in the ‘Health in India’ report, narrates a very gloomy picture for India, especially for a clear majority of those who incur ‘out of pocket’ expenses on medicines. The report states, out of all health expenditure, 72 percent in rural and 68 percent in urban areas was for buying medicines for non-hospitalized treatment.

Thus, many patients cannot afford health services, even when these are needed the most. As many as 68 percent of patients in urban India and 57 percent in rural areas attributed “financial constraints” as the main reason to take treatment without any medical advice, the report adds.

In this situation, the challenges that the Governments and the civil society are facing in many developing, and to some extent even in some developed countries, though for different reasons, are multi-factorial. It has been well established that the humongous global health care challenges are mostly of economic origin.

Pharma innovation benefitted the developed countries more:

A study titled, ‘Pharmaceutical innovation and the burden of disease in developing and developed countries’ of Columbia University and National Bureau of Economic Research, to ascertain the relationship across diseases between pharmaceutical innovation and the burden of disease both in the developed and developing countries, reported that pharmaceutical innovation is positively related to the burden of disease in the developed countries but not so in the developing countries.

Making the two to tango:

These facts prompt the need to make the pharma innovation and public health interest to tango. Several suggestions have been made and initiatives taken in this direction. Some of which are as follows:

Responding to this need, in 2006 W.H.O created the ‘Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG)’. The primary focus of IGWG is on promoting sustainable, needs-driven pharmaceutical R&D for the diseases that disproportionately affect developing countries. One positive effect of this global debate is that some global pharmaceutical companies have initiated their R&D activities for neglected tropical diseases, such as, Malaria and Tuberculosis. Many charitable organizations like, Bill & Melinda Gates Foundation and Clinton Foundation, are allocating significant funds for this purpose.

A paper titled, “Optional reward for new drugs for developing countries” published by the Department of Economics, University of Calgary, Institute of Health Economics, proposed an optional reward fund for pharmaceutical innovation aimed at the developing world to the pharmaceutical companies, which would develop new drugs while ensuring their adequate access to the poor. The paper suggests that innovations with very high market value will use the existing patent system, as usual. However, the medicines with high therapeutic value but low market potential would be encouraged to opt for the optional reward system. It was proposed that the optional reward fund should be created by the governments of the developed countries and charitable institutions to ensure a novel way for access to innovative medicines by the poor.

‘Open Innovation’ or the ‘Open Source Drug Discovery (OSDD)’ is another model of discovering a New Chemical Entity (NCE) or a New Molecular Entity (NME). Imbibing ‘Open Innovation’ for commercial results in pharmaceuticals, just has what has happened to android smartphones, would encourage drug discovery initiatives, especially for the dreaded disease like cancer, to make these drugs affordable for a very large section of people across the globe. In this model, all data generated related to the discovery research will be available in the open for collaborative inputs. In ‘Open Innovation’, the key component is the supportive pathway of its information network, which is driven by three key parameters of open development, open access and open source. This concept was successfully used in the ‘Human Genome Project’ where many scientists, and microbiologists participated from across the world to sequence and understand the human genes. Currently, pharmaceutical R&D is a well-protected in-house initiative of innovator global companies to maximize commercial benefits. For this reason, only a limited number of scientists working for the respective innovator companies will have access to these projects. In India, the Council of Scientific and Industrial Research (CSIR) is the champion of the OSDD movement, locally. CSIR believes that for a developing country like India, OSDD will help the common man to meet his or her unmet medical needs in the areas of mainly neglected tropical diseases.

Conclusion:

Thus, the ongoing heated debate on Innovation, Intellectual Property Rights (IPR) and Public Health Interest is gathering steam all over the globe.

Argumentative Indians are also participating in this raging debate. I reckon rightly so, as India is not only the largest democracy of the world contributing 16.7 percent of the global population, it is also afflicted with 21 percent of the global burden of disease. Considering this, the reason for similar heated debate in our country is indeed no-brainer to anyone.

Many would possibly not disagree, both encouraging innovation and safeguarding the public health interest are equally important to any society, be it in the developed nations or developing countries. Nevertheless, some constituents of ‘Big Pharma’ and their trade association still highlight that ensuring access to high price innovative drugs is the responsibility of the respective Governments. Any other regulatory mechanism to bring down such prices will be construed as a barrier to encouraging, protecting and rewarding innovation.

Be that as it may, most other stakeholders, across the world, especially the patients, are awaiting these two goals to tango. From that point, I reckon, giving a quick shape to commercially well-tested initiatives, such as, ‘Open Innovation’ model could well be an important step to ensure access to innovative new medicines for a larger number of patients of the world, meeting their unmet medical needs with greater care.

By: Tapan J Ray

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A Tapan Ray Website

Tag Archives: Ray

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Sharper Focus On Vaccine: A Huge Scope To Reduce Disease Burden In India

Awaiting The Two To Tango: Pharma Innovation And Public Health Interest