Tag Archives: Ray

Coronavirus Outbreak: Drug Shortage, Treatment And Unease – A Review

Posted on by
Reply

The Coronavirus outbreak has reached a “decisive point” and has “pandemic potential”, said the Director General of the World Health Organization (W.H.O), reportedly, on February 27, 2020, urging governments to act swiftly and aggressively to contain the virus. He further added, “We are actually in a very delicate situation in which the outbreak can go in any direction based on how we handle it.” Alerting all, he appealed, “this is not a time for fear. This is a time for taking action to prevent infection and save lives now.”

As on March 08, 2020 – 106,211 coronavirus cases (view by country) were reported globally, with 3,600 deaths and 60,197 patients recovered. Thus, the most relevant question now is the level of preparedness of each country, to prevent a possible epidemic, which may even strike at a humongous scale. This will be relevant for both, the countries already infected with a coronavirus – in a varying degree, as well as, those who are still out of it.

From the drug industry perspective, equally pertinent will be to assess on an ongoing basis its impact on the medical product supply-chain and further intensifying ongoing efforts to find the ‘magic bullet’ – an effective remedy, partly addressing the unease of all, on this score. In this article, I shall try to ferret out the current status on these points, based on available and contemporary data.

The impact assessment has commenced:

While on the current impact assessment, I shall restrict my discussion on the largest pharma and biological market of the world – the United States (US) and of course, our own – India, starting with the former. On February 14, 2020, the US released a statement of the Commissioner of Food and Drugs Administration titled, ‘FDA’s Actions in Response to 2019 Novel Coronavirus at Home and Abroad.’ Highlighting the proactive actions of the regulatory agency, the statement recorded:

“We are keenly aware that the outbreak will likely impact the medical product supply chain, including potential disruptions to supply or shortages of critical medical products in the U.S. We are not waiting for drug and device manufacturers to report shortages to us—we are proactively reaching out to manufacturers as part of our vigilant and forward-leaning approach to identifying potential disruptions or shortages.” Adding further, he revealed that the US-FDA is in touch with regulators globally and has added resources to quickly spot “potential disruptions or shortages.”

Whereas in India, the Chemicals and Fertilizers Ministry has also announced: “The Government of India is closely monitoring the supply of APIs/intermediates/Key starting materials (KSMs) which are imported from China and the effect of the outbreak of a novel coronavirus in China on their supply.”

The current status:

As this is an ongoing emergency exercise, on February 27, 2020, by another statement, the US-FDA reported the first shortage of a drug, without naming it, due to the COVID-19 outbreak. It identified about 20 other Active Pharmaceutical Ingredients (APIs) or finished drug formulations, which they source only from China. Since January 24, the US-FDA has, reportedly, been in touch with more than 180 manufacturers of human drugs to monitor the situation and take appropriate measures wherever necessary. However, the prices of some key ingredients have already started increasing.

Back home, on March 03, 2020, Reuters reported, the Indian Government has asked the Directorate General of Foreign Trade (DGFT) to restrict export of 26 APIs and other formulations, including Paracetamol, amid the recent coronavirus outbreak. Interestingly, these 26 active pharmaceutical ingredients (APIs) and medicines account for 10 percent of all Indian pharmaceutical exports and includes several antibiotics, such as tinidazole and erythromycin, the hormone progesterone and Vitamin B12, among others, as the report indicated.

It is unclear, though, how this restriction would impact the availability of these medicines in the countries that import from India, especially formulations, and also China. For example, in the United States, Indian imports, reportedly accounted for 24 percent of medicines and 31 percent of medicinal ingredients in 2018, according to the U.S. Food and Drug Administration. Be that as it may, it still remains a reality that China accounted for 67.56 per cent of India’s total imports of bulk drugs and drug intermediates at USD 2,405.42 million in 2018-19.

Prior to this import ban, a report of February 17, 2020 had flagged that paracetamol prices have shot up by 40 percent in the country, while the cost of azithromycin, an antibiotic used for treating a variety of bacterial infections, has risen by 70 percent. The Chairman of Zydus Cadila also expects: “The pharma industry could face shortages in finished drug formulations starting April if supplies aren’t restored by the first week of the next month,” as the news item highlighted.

No significant drug shortages reported, just yet:

From the above details, it appears, no significant drug shortages have been reported due to Coronavirus epidemics in China – not just yet. Moreover, the Minister of Chemicals and Fertilizers has also assured: ‘No shortage of drug ingredients for next 3 months.’ He further added: ‘All initiatives are being taken to ensure there is no impact of the disease in India.’

However, on March 03, 2020, W.H.O, reportedly has warned of a global shortage and price gouging for protective equipment to fight the fast-spreading coronavirus and asked companies and governments to increase production by 40 percent as the death toll from the respiratory illness mounted. Moody’s Investors Service also predicted, coronavirus outbreak may increase demand, but poses a risk of supply chain disruptions, especially for APIs and components for medical devices sourced from China.

In view of these cautionary notes, especially the health care and regulatory authorities, should continue keeping the eye on the ball. More importantly, commensurate and prompt interventions of the Government, based on real-time drug supply-chain monitoring, along with the trend of the disease spread, will play a critical role to tide over this crisis.

In search of the ‘Magic Bullet’: 

Encouragingly, on February 16, 2020, the National Medical Products Administration of China has approved the use of Favilavir, an anti-viral drug, for the treatment for coronavirus. The drug has reportedly shown efficacy in treating the disease with minimal side effects in a clinical trial involving 70 patients. The clinical trial is being conducted in Shenzhen, Guangdong province. Formerly known as Fapilavir, Favilavir was developed by Zhejiang Hisun Pharmaceutical of China. A large number of other promising R&D initiatives are being undertaken, in tandem, by brilliant scientific minds and entities to find an effective treatment for this viral disease. To give a feel of it, let me cite just a few examples, both global and local, as below.

Pfizer Inc. has announced that it has identified certain antiviral compounds, which were already in development, with potential to treat coronavirus-affected people. The company is currently engaged in screening the compounds. It is planning to initiate clinical studies on these compounds by year-end, following any positive results expected by this month end.

Several large and small pharma/biotech are now engaged in developing a vaccine or a treatment. Gilead has, reportedly, initiated two phase III studies in February 2020, to evaluate its antiviral candidate – remdesivir, as a treatment for Covid -19. Takeda is also exploring the potential to repurpose marketed products and molecules to potentially treat COVID-19, besides developing a plasma-derived therapy for the same. Pipeline candidates of other companies are in earlier stages of development, as reported.

Whereas in India, Serum Institute of India (SIL) is collaborating with Codagenix, a US-based biopharmaceutical company, to develop a coronavirus cure using a vaccine strain similar to the original virus. The vaccine is currently in the pre-clinical testing phase, while human trials are expected to commence in the next six months. SII is expected to launch the vaccine in the market by early 2022.

Zydus Cadila, as well, has launched a fast-tracked program to develop a vaccine for the novel coronavirus, adopting a two-pronged approach, a DNA based vaccine and a live attenuated recombinant measles virus vectored vaccine to combat the virus. These initiatives seem to be a medium to long-term shots – laudable, nonetheless. 

Current off-label drug treatment for coronavirus:

Some of the drugs, reportedly, being used in China to treat coronavirus include, AbbVie’s HIV drug, Kaletra and Roche’s arthritis drug – Tocilizumab (Actemra). However, none of these drug treatments have been authorized yet by drug regulators, to treat patients with coronavirus infection.

According to the Reuters report of March 04, 2020, China’s the National Health Commission, in its latest version of online treatment guidelines, has indicated Roche’s Tocilizumab for coronavirus patients who show serious lung damage and elevated level of a protein called Interleukin 6, which could indicate inflammation or immunological diseases.

However, there is no clinical trial evidence just yet that the drug will be effective on coronavirus patients and it has also not received approval from China’s National Medical Product Administration for use in coronavirus infections. Nonetheless, Chinese researchers recently registered a 3-month clinical trial for Actemra on 188 coronavirus patients. According to China’s clinical trials registration database, the period of trial is shown from February 10 to May 10. 

Is coronavirus becoming a community transmitted infection?

Even while grappling with an increasing number of COVID-19 positive patients, the Indian Government is showing a brave front, as it should. However, it has also confirmed “some cases of community transmission.” This unwelcome trend makes India the part of a small group of countries, including China, Japan, Italy and South Korea, where community transmission of the virus has taken place. This is a cause of an additional concern.

Although, there has been no significant drug shortages reported yet, shortages of  hand sanitizers,recommended for frequent use by the W.H.O and other competent bodies, as they can, reportedly kill Covid-19. Similarly, N95 masks useful to prevent the spread of the disease, have also disappeared, adding more fuel to fire, if not creating a panic-like situation, for many.

Conclusion:

Most global drug players with a business focus on branded – patented drugs, are not expected to fight with the supply disruptions. As reported, ‘Several top drugmakers – including Pfizer, Johnson & Johnson, Bayer, Merck KGaA and Roche—recently confirmed to FiercePharma that they have stock policies in place to minimize the impact.”

But, for the generic drug industry the disruption in the supply chain may have a snowballing effect. For example, as the March 03, 2020 edition of the New York Times (NYT) reported – supply chain disruption in sourcing some APIs from China is being felt most acutely in India, as the Government decided to stop exporting 26 drugs, most of them antibiotics, without explicit government permission. The same article also highlighted the possible multiplier effect of this development with its observation: “That’s a problem for the rest of the world, which relies on India’s drug makers for much of its supply of generic drugs. India exported about $19 billions of drugs last year and accounted for about one-fifth of the world’s exports of generics by volume”, it added.

As on date, there is no known cure for coronavirus infection. The magic-bullet has yet to be found out. However, over 80 clinical trials has, reportedly, been launched to test coronavirus treatments. This includes, repurposing older drugs, as well. Recently, only Favilavir, an anti-viral drug, has been approved for treatment for coronavirus by the National Medical Products Administration of China.

Coming back to the unease of many in India, the country’s perennial shortages of doctors, paramedical staff, hospital beds, adequate quarantine facility for a large number of patients and fragile public healthcare delivery system, still pose a humongous challenge in this crisis. More so, when just in the last week, U.S. intelligence sources, reportedly, told Reuters that ‘India’s available countermeasures and the potential for the virus to spread its dense population was a focus of serious concern.’

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.

UCPMP: Vacillating Between ‘The Perfect’ And ‘The Real’ World?

Posted on by
Reply

In the ‘perfect world’ one takes ‘perfect decisions’, while in the ‘real world’ one takes a ‘real decision’ – as the saying goes. In tandem, a raging debate continues on what is ‘perfect’ and what is ‘real’, in the world we live in today. This may cause a dilemma to many, which seems to be all pervasive today. Understandably, many critical industry practices and processes are also a part of this quagmire. The pharma industry, the world over, including India, is no exception, where such dilemma and debates span across virtually all the business domains of the industry.

However, in this article, I shall focus only on one specific issue – alleged pharma marketing malpractices that continue unabated, regardless of severe punitive measures in many cases, from several parts of the world. Has it then become a universal ‘culture’ in this area? For greater clarity, let me start the ball rolling by trying to understand the line that differentiates ‘the perfect world’ norms from ‘the real world’ ones.

Understanding the ‘line’ between the ‘Perfect World’ and the ‘Real World’:

I reckon, in ‘the perfect world’ people develop ideal values, ethical standards and practices. The social, business and economic environments also encourage and promote an uncompromising value system that culminates into perfect and desirable behavioral traits for all. Consequently, there are no grey areas in the ethics and value judgement, especially regarding what is ‘right’ and what is ‘wrong’.

Whereas, in ‘real world’, the surrounding social, business and economic environment usually encourages and promotes self-serving interests, mostly from the shelter of ‘perfect world,’ as we shall see later. There also appears to be a flexibility in the overall value system – drawn around different guidelines, for preferred behavior and practices in most spheres of life. Consequently, one can spot many grey areas in that space, which are subject to different interpretation by different people. ‘Exceptions’ to the preferred behavior are also many.

As construed by many, one contemporary and broad example could perhaps be, the ethics, values and governance – enshrined in the Indian Constitution, arguably belong to the ‘perfect world.’ The same for ‘the real world’ is, what the majority of the population, including those who are governing the country demonstrate through words, deeds and action on the ground.

Living in ‘the real world’ – most expect others to practice ‘the perfect world’ norms:

Although, most people, including several different entities, actually prefer to live in ‘the real world,’ following commensurate practices and exceptions – generally expect others to practice ‘the perfect world’ norms – following commensurate ethics and values. Governments usually, try to exhibit that they want all citizens to be in ‘the perfect world’. However, under pressure of different nature, their policy enforcement arms keep maintain the status-quo of ‘the real world.’

Let me illustrate this point from the Indian perspective, with some recent examples related to the prevailing Uniform Code of Pharmaceutical Marketing Practices (UCPMP) in the country. Here itself, we shall find, even the Government machinery vacillating between the both worlds.

Government vacillating between ‘both worlds’:

A recent media report related to the ongoing allegation on pharma marketing malpractices in India raised a controversy. It reported, on January 13, 2020 – ‘PM Modi warns pharma companies not to bribe doctors with women, foreign trips and gadgets,’ during his meeting with the senior officials from top drug-makers. This move was, reportedly, triggered by the report of “Support for Advocacy and Training to Health (SATHI)” – an NGO.

Prior to this, on May 03, 2018, it was also widely reported, “Prime Minister Narendra Modi recently opened a Pandora’s box by condemning the allopathic doctors of the country during an interaction called ‘Bharat ki Baat, Sab ke Saath’ with the diaspora in London. The PM condemned the Indian doctors on charges of corruption and malpractice. He emphasized on the doctor-industry nexus and shared concerns on the fallout of such a relationship.”

The above statements, as reported, reflect deep anguish of the Prime Minister for violation of ethics and values in pharma marketing practices – as expected in the ‘Perfect World.’ Following this outburst at the top echelon of the country’s governance hierarchy, the logical general expectation is, commensurate action by the Department of Pharmaceuticals (DoP), at least, to contain those contentious practices.

But, the Government seems to be vacillating: 

Instead, just after a few weeks from what was quoted in the above January 2020 report – on February 09, 2020 another media report highlighted something that confirms vacillation of the Indian Government from ‘the perfect world’ to ‘the real world’, albeit too frequently, on this issue.

Despite UCPMP being in force for all drug companies to abide by, voluntarily, since January 2015, the situation in this area hasn’t improved a bit, which the DoP also seems to be well aware of. The obvious question, therefore, that follows: Is the DoP on the same page as PM Modi?

Interestingly, despite the PM’s assertion in this regard, the DoP Secretary, reportedly, kept playing the same old tune even after 5 years of the UCPMP’s unsuccessful implementation. He again repeated: “We have strictly instructed all the stakeholders to follow the code voluntarily. If not complied seriously, the department will bring in stricter regulations at the time to come and also think about making it mandatory for effective compliance.” This threat, from the ‘perfect world’ perspective, continues with the ‘real world’ understanding for action.

The possible reason for the above vacillation:

Many consider, intense lobbying by the pharma associations as the possible reason for vacillation of the Government. This is vindicated by another report of January 17, 2020 that claimed, a powerful Indian industry association has sought multiple tweaks in the current UCPMP – meant for voluntary implementation by the drug industry in India. Two of these, among several others, were reported as follows:

  • Relaxed rules for the distribution of free samples.
  • Permission for doctors to work at pharmaceutical companies.

As reported, this proposal of the industry has been floated among pharmaceutical companies, for comments. ‘Once approved by all member companies, it will be sent to Department of Pharmaceuticals secretary P.D. Vaghela.’ However, it appears, there doesn’t seem to be anything new in it, as news archives reveal, similar proposals were submitted by the Indian drug industry associations, in the past, as well.

At this stage, let me hasten to add that the above January 2020 report, quoting the Indian PM’s anguish, was denied by a domestic industry association by a statement.

The first report was denied – albeit vaguely – by an industry association:

Curiously, the January 2020 report was denied by the domestic Industry Association - Indian Pharmaceutical Alliance (IPA) by releasing a statement. It said, the meeting convened by the Prime Minister Narendra Modi with the healthcare industry on January 01, 2020 was to discuss future road map for growth of the industry.

It further emphasized, the focus of the discussion was to promote research and development, build an innovation ecosystem, improve access to high-quality medicine and strengthen global competitiveness of the industry. The purpose was to take the industry to the next level and leverage opportunities going forward in the pharmaceutical sector. “There was no discussion on uniform code of pharmaceutical marketing practice in the meeting,” the statement added.

However, this statement appears rather vague to many, as it doesn’t emphatically deny that the PM did not say or mean those words, regardless of the context. Neither, the PMO, reportedly, has done so, as yet.

Probably because of this reason, another news article reported on January 15, 2020 that the Indian Medical Association, the country’s largest body of doctors, urged Prime Minister Narendra Modi to “prove, deny, or apologize (for)” the purported statement attributed to him asking pharmaceutical companies ‘not to bribe doctors with foreign trips, gadgets and women.’ I am still not aware of any response from the PMO on the same. Hence, some people find the industry association’s statement, especially considering the core issue under discussion today, albeit vague.

Some key findings on UCPMP:

Be that as it may, as I indicated in one of my previous articles in this blog, a survey report by Ernst and Young titled, “Pharmaceutical marketing: ethical and responsible conduct”, was released in September 2011 on the UCMP and MCI guidelines. It highlighted some of the following points:

  • More than 50 percent of the respondents are of the opinion that the UCPMP may lead to manipulation in recording of actual sampling activity.
  • Over 50 percent of the respondents indicated that the effectiveness of the code would be very low in the absence of legislative support provided to the UCPMP committee.
  • 90 percent of the respondents felt that pharma companies in India should focus on building a robust internal control system to ensure compliance with the UCPMP.
  • 72 percent of the respondents felt that the MCI did not stringently enforce its medical ethics guidelines.
  • Just 36 percent of the respondents felt that the MCI’s guidelines would have an impact on the overall sales of pharma companies.

Although, this report may be a bit dated, its key findings don’t seem to have changed much as on date. It is also worth noting that there are umpteen examples of similar malpractices in the pharma industry, globally.

Conclusion:

“Compared to a strictly controlled manufacturing environment, the marketing environment for the pharmaceutical industry in India is less regulated, but will move towards greater regulation in times to come”, predicted ‘The Global Guide to Pharma Marketing Codes,’ a few years ago. The situation remains unchanged.

Alongside controversy over pharma firms allegedly ‘bribing’ medical professionals, the Alliance of Doctors for Ethical Healthcare (ADEH), a network of doctors from across the country has demanded that the UCPMP framed five years ago be made mandatory, as another media report highlighted on January 21, 2020.

But the reality is, the Government wants the drug industry to follow ‘the perfect world’ ethics and values in marketing practices to safeguard patients all round interest. Whereas, the drug industry wants the policy makers to appreciate the business compulsions of ‘the real world’ and introduce exceptions to the rules.

Both the stances are unlikely to meet a common ground, because general population expects the Government to adhere to ethics and values of ‘the perfect world’, in health care. Whereas, in public, pharma industry leaders often take vows of practicing so, but seem to act differently in ‘the real world’ situation, expanding the credibility gap.

In the perceivable future, it appears unlikely that the Government’s ‘perfect world’ expectations, and the ‘real world’ actions of most pharma players will be in sync with each other. Unless, of course, either the Government moves away from ‘the real world’ marketing ethics and values – safeguarding patient interest, to meet ‘real world’ expectations of the industry, or make pharma players to fall in line with ‘the perfect world’ expectance, by making the UCPMP mandatory.

Is the question, therefore, how to take a ‘perfect world’ decision for the people’s health interest, in the ‘real world’ of the pharma industry? Till this issue is resolved, UCPMP will continue to exist, but no more than a ‘toothless tiger’, as it were.

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.

 

 

India’s Preparedness Against Biological Threats

Posted on by
Reply

Recent Coronavirus outbreak poses a ‘very grave threat to the rest of the world’ – the head of the World Health Organization (WHO), reportedly said on February 11, 2020. Earlier, on January 28, 2020, it had changed the viruses’ risk-status from ‘moderate’ to ‘high’. As it creates a havoc in China, Coronavirus has recorded a limited spread in India, besides France, Canada, US, Japan, Thailand, Sri Lanka. This article will explore how prepared is India to tackle any similar biological threat to protect its citizens from a possible health catastrophe.

Let me begin by assessing pros and cons of the current initiatives of the Indian Government, both at the Center, as well as, in the States, in this regard.

The pros and cons:

Some of the ‘pros’, that the Ministry of Health and Family Welfare promptly initiated are as follows:

  • Updated Travel advisory for travelers visiting China. 
  • Discharge policy for suspected or confirmed novel Coronavirus (2019-nCoV) cases.
  • Guidelines on Clinical management of Severe Acute Respiratory Illness (SARI) in suspect/confirmed 2019-nCoV cases.
  • Guidance on surveillance for human infection with 2019-nCoV.
  • Guidelines for ‘Infection Prevention and Control in Healthcare Facilities’.
  • Guidance for sample collection, packaging and transportation for 2019-nCov.

The above steps are as commendable as some other prompt initiatives of the Ministry to stop Coronavirus from entering the country, such as leveraging technology for both thermal and symptomatic screening, especially at the high-risk airports.

However, according to global experts – India, along with several other countries are still ill prepared to face biological threats of a magnitude that we are now witnessing in China. On the other hand, according to February 12, 2020 publication of The World Economic Forum, there about a dozen of countries in the world who are best prepared for meeting similar health emergencies.

Similar calamity was predicted two years back by W.H.O: 

Interestingly, a similar situation was predicted by none other than Tedros Adhanom, Director General of the World Health Organization and was reported on February 15, 2018. He then said, “We have a problem. A serious one. At any moment, a life-threatening global pandemic could spring up and wipe out a significant amount of human life on this planet. The death toll would be catastrophic. One disease could see as many as 100 million dead.”

“This is not some future nightmare scenario,” he added. “This is what happened exactly 100 years ago during the Spanish flu epidemic.” Again: “A devastating epidemic could start in any country at any time and kill millions of people because we are still not prepared. The world remains vulnerable.”Explaining the reason for the same, the Director General pinpointed: “The threat of a global pandemic comes from our apathy, from our staunch refusal to act to save ourselves — a refusal that finds its heart in our indifference and our greed.”

Now, when the world is grappling with the menace of Coronavirus – may not be at the predicted global scale yet, those comments haunt us again. It flags each country’s preparedness to deal with such pandemic, as and when it strikes, unannounced.

‘Countries best prepared for health emergencies’ – and India:

The February 12, 2020 publication of The World Economic Forum, as indicated above, highlights several important realities of this subject. Let me quote below just two of these, which, I reckon, are the most profound:

  • National health security is fundamentally weak around the world, and none is fully prepared to handle such an outbreak.
  • Global biological risks are in many cases growing faster than governments and science can keep up.

Acknowledging these facts, based on the Global Health Security Index, the most prepared ones for epidemics or pandemics of all types were listed among 195 countries surveyed. Measured on a scale from 0-100, the US ranks as the “most prepared” nation (scoring 83.5). Next comes UK (77.9), the Netherlands (75.6), Australia (75.5) and Canada (75.3) featuring behind it.

Thailand and South Korea are the only countries outside of the West that rank in this category. China, the most populated country in the world – which is also at the center of the Coronavirus outbreak – is in 51st place, scoring 48.2. And, India, the second most populated country ranks 57 with a score of 46.5. The obvious question that comes up: Why India ranks so low in the Global Health Security Index, among 195 countries?

Knowing the risk – not enough, building capability is a must:

The above details will give a sense of risk exposure to pandemic or epidemic, like Coronavirus, for a country. As the experts point out, just knowing the level of risk exposures, is far from enough. Each Government has a fundamental duty to build capabilities for protecting its people from the disastrous consequences of any possible biological threat, as and when it strikes. This will call for taking quantifiable financial and other measures to fill the existing gaps in the epidemic and pandemic preparedness, as captured in many studies. 

India’s budgetary allocation for health remains frugal:

It gets reflected even in the Union Budget 2020-21for the health care sector. Although, the total allocation for the sector was about 10 percent higher from the year ago. The increase seems negligible, considering consumer price index inflation was 7.5 percent in December 2019, as analyzed by the publication Down to Earth on February 02, 2020.

The report said, over 50 percent of the increase will go into offsetting inflation and we don’t seem to be anywhere near achieving the target of allocating 2.5 percent GDP to health by 2025, as envisaged by even the current government.

More relevant to this discussion, the allocation towards schemes dealing with communicable diseases, in general, has remained unchanged, especially when ‘Indians are getting sick mostly due to infections’, according to NSSO study, as reported on November 25, 2019.

India’s ability to contain epidemic is much less than China:

In a relative yardstick, China, reportedly, has built a better health care infrastructure than India to respond to various health related needs of the country’s population, including emergency situation, such as Coronavirus. Some of the key reasons, for example, are as follows:

  • While India shows one of the lowest government-spend on public health care, as a percentage of GDP, and the lowest per capita health spend, China spends 5.6 times more. 
  • When Indians met more than 62 percent of their health expenses from their personal savings, as ‘out-of-pocket expenses’, the same is 54 per cent in China.
  • India’s ability to quarantine a large number of infected people is much limited as compared to China.
  • Health service delivery system, especially for over 70 percent of the rural population of India, lack adequate scientific and skilled manpower, alongside necessary emergency equipment to provide care to a large number of patients at the same time, if epidemics strike.
  • Around 74 percent of health care professionals happen to be concentrated in urban areas, catering to just a third of Indian population, leaving rural areas under-served, according to a KPMG report. Alongside, the country is 81 percent short of specialists at rural community health centers (CHCs).

Conclusion:

The recent Coronavirus outbreak sends a strong signal to public health authorities, across the world, about the task-cut out for them to catch the early signs of possible epidemics. Many countries, especially India, have much ground to cover to ensure the right level of preparedness in countering such unannounced biological threats.

Capacity building for prevention, early detection, taking medical countermeasures – to contain the fast spread of the deadly organisms, and effective treatment response at the earliest, is the need of the hour. India also needs to develop capabilities for rapid development of drugs and vaccines in such a situation, fighting against time. Quoting the National Institute of Virology, some recent reports indicate that India’s scientific expertise and manpower aren’t enough, just yet, to deal with similar crises.

India’s public healthcare system and its delivery mechanism are still not robust enough either to keep in quarantine or in providing effective treatment and care for a large number of patients during any epidemic situation.

Against this perspective, I reckon, India is still grossly underprepared to face any biological threat, if it strikes with all its might. In that sense, the scary Coronavirus episode may be construed as yet another wake-up call to break the perceived slumber of the Government, if not apathy, as it were.

Thus, the question that surfaces: Shouldn’t the country, at least now, deploy enough resources to protect its citizens from any possible biological threats and aggression, just as it does, to provide safety, security and well-being of the population against any other external or internal threats?

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.

An Essential ‘Acrobatic Feat’ Remains Relevant Even In Digital Pharma World

Posted on by
Reply

“A manager must, so to speak, keep his nose to the grindstone while lifting his eyes to the hills — quite an acrobatic feat!” This profound statement was articulated by the Management Guru of all-time – Peter F. Drucker, in his book named “The Practice of Management.” This book was published probably before many management experts of today were even born – in 1954. This epic quote of Drucker is in context of the critical requirement to harmonize management decisions affecting the short and the long-term strategic business goals.

While looking at the pharma industry from the above perspective, one may often find, the quality-time spent, especially by its marketers, on ‘lifting their eyes to the hills’ – looking for the early signals on critical changes in future success requirement – is often minimal. Most seem comfortable in ‘keeping their nose to the grindstone’ to deliver the short-term objectives, with a belief that the future brand success factors will replicate the present ones. Thus, honing the current strategies would automatically ensure achieving the long-term requirements.

This prompts a question, should pharma marketers predominantly concentrate on sharpening their traditional marketing tools for near-term excellence or reach out much beyond that? Today’s article will deliberate on this subject, in the context of changing market dynamics and consumer expectations in the today’s world.

Are the brand success parameters changing?

Scores of data-based assessments of progressive changes in the customer value trend, highlight significant shifts from the past, necessitating an overhaul of the value delivery parameters and the system – not just honing. More often than not, such reconditioning could even be disruptive in nature – as may happen with the change to a well-integrated digital marketing system.

For example, until recently pharma brands used to be differentiated primarily based on its intrinsic key features and benefits, like efficacy and speed of recovery, safety and side-effects profile, ease of compliance and nature of drug interactions during concomitant use and more. Today, the parameters of brand differentiation have gone much beyond that, which could have been captured by an astute marketer while ‘lifting his eyes to the hills’, alongside ‘keeping his nose to the grindstone.’

The evolving parameters of brand-differentiation are not just restricted to the features and benefits, but call for unique customer value creation – such as providing a unique treatment experience to patients – understanding their needs, expectations and preferences. This, in turn, change the traditional pharma marketing ball game, as the success ingredients are so different.

Capturing, conceptualizing and delivering customer value, following the traditional pharma marketing tools and processes will increasingly be a daunting task. New digital tools and platforms – well-integrated into the evolving pharma marketing processes, would be necessary to win customers’ share of mind, more effectively than ever before. Nevertheless, value delivery still remains at the core of the pharma marketing system.

Value delivery still remains at the core – with significant changes: 

Value delivery will always remain the core purpose, and a constant factor in pharma marketing initiatives. It was so in the past, is at present, and will continue to be in the future, regardless of changes in the market and customer dynamics.

Nonetheless, what is construed as ‘value’ to capture a sizeable share of consumers’ mind has changed. Traditionally, it has been mostly intrinsic to the organization, revolving around the product features and benefits, as stated earlier. But, today, it is getting more focused on the extrinsic factor – related to the customers.

Thus, creating a unique experience for them with the brand has become the new challenge of change to pharma marketers for performance excellence, as I discussed in one of my recent articles. Consequently, providing this external and well-researched ‘customer-centric value’ has become the new brand differentiator.

While ‘lifting eyes to the hills’, some interesting findings:

Among many others, Decision Support Group (DCG), as well, while ‘lifting their eyes to the hills,’ well-captured the emerging consumer expectations in health care through a detailed study. This was published as ‘Cybercitizen Health Infographic’ on October 27, 2015. Let me paraphrase below some of the important findings of this study:

  • As customers are expecting pharma to provide best-in-class patient experience and associated services in the disease treatment process, marketers need to differentiate brands through these parameters.
  • 59 percent of health care consumers expect brand experiences and services beyond what the physical brand offers.
  • Only 8 percent of the respondents said pharma companies are providing a better customer experience than 2 years ago, while 30 percent said so for doctors, and 21 percent regarding pharmacists.
  • 40 percent of the consumers who value experience as much as drug effectiveness, would pay a little more for a drug or a health procedure.

How is this extrinsic value measured?

As confirmed by several studies, going beyond what a physical pharma brand would offer, the customers, including individuals who pay from the pocket for a disease treatment, measure the value of a drug today differently. It is now predominately by outcomes, the patients’ overall experience during the treatment, and overall – cost-effectiveness of the entire process, and not just the medicine.

Thus, the pharma market is sending a clear signal to the marketers to ‘shape up’ accordingly, soon and start with measuring care by outcomes – going beyond the product features and benefits – just as patients would do. If not, there could be a strong possibility of being ‘shipped out’, as the marketing productivity could head south, with more capable professionals filling up the void.

Commensurate changes in marketing success measurement:

The emerging changes in measuring ‘marketing success’ were aptly demonstrated in the article, ‘Redefining Value: What Value-Based Care Means for Pharma’, published by the Intouch Solutions on July 07, 2016.

It said: ‘Once, success simply meant a “blockbuster” – a drug that sold enough.’ However, this paradigm is shifting. Soon, it will be measured by the value of outcomes with the brand – the positive impact that it creates on the patient’s health, leaving behind a unique treatment experience.

To be successful with the brand, the marketer will, therefore, need to create a genuine, credible and powerful data-based outcome story. It should effectively demonstrate how the unique brand value offerings, supported by services can make it possible. The services may include, among others:

  • Supporting patients in managing their condition as part of their life.
  • Educating patients and helping them feel empowered in the treatment decision making process.
  • Helping patient access to medication.
  • Assisting patients in developing and maintaining a healthy lifestyle.

For many pharma marketers this exercise will involve a strategic shift in their thinking process. Embracing a fundamental change in the way they have been practicing traditional pharma marketing all these years.

Are some of these changes disruptive in nature?

Several of the aforesaid changes may appear disruptive to many, causing a discomfort of moving out of their comfort zones. Some may even try to wish it away, and continue practicing the traditional pathways as long as these help achieving some results. But, not certainly for a long while. In which case, it will be akin to delaying a greater disruption before ultimately getting caught off-guard.

Dr. Vas Narasimhan, Chief Executive of the Swiss pharmaceutical giant Novartis, puts it nicely. He advised, ‘the key to surviving disruption is understanding that a leader needs to be prepared to embrace it – even if that means willfully disrupting yourself.’

However, the good news is, digital transformation of a business makes embracing this change less difficult. Which is why, a number of companies are trying to seriously engage in digital marketing. Let me hasten to add, the ‘digital transformation process’, regardless of promises that many self-styled experts would make, is tough. It makes the organization chart an uncharted frontier and starts from the very top.

Digital transformation follows an arduous path, starting from the very top: 

There are many descriptions of the ‘digital transformation process’. However, the one that appealed to me is the one that comes from the Agile Elephant. It describes the process as follows:

‘Digital transformation is the process of shifting your organization from a legacy approach to new ways of working and thinking using digital, social, mobile and emerging technologies.  It involves a change in leadership, different thinking, the encouragement of innovation and new business models, incorporating digitization of assets and an increased use of technology to improve the experience of your organization’s employees, customers, suppliers, partners and stakeholders.’

The recent examples in this regard that come at the top of my mind, include:

Does digital marketing transform the brand value delivery process? 

Digital marketing facilitates the new and extrinsic brand value delivery process, as the use of this technology is all pervasive in our everyday life. Interestingly, almost all businesses, mostly in the organized sectors and technology startups, are trying to leverage digital technology to create sets of differential customer values.

And then integrating those to the core marketing strategy, for effective delivery of a crafted solution to the patients’ comprehensive needs, will be a challenging task. Moving in this direction, besides creating interactive websites, many drug players are using a number of digital tools, including social media sites, to start with. These are all serving as integrated digital marketing platforms to engage with targeted customers.

It’s apparently a foregone conclusion today that ‘the traditional one-way relationship in our health care system, will soon change to two-way relationship.’ Where interactive digital marketing, social media and other similar platforms, will facilitate building such relationship for a meaningful exchange of information with the target groups, transforming in the healthcare landscape.

Some key transformation areas with the digital marketing system:

As Agile Elephant puts it, the following are a few examples of key healthcare transformation areas with digital marketing:

  • The efficacy of treatment will be transparent with cost-effective data-based outcomes story.
  • Data transparency will follow data visualization enhancing how patient data is communicated to them, or how certain medications and treatments are affecting different areas of the physiological system.
  • Patients will be empowered to play an active role in their health care.
  • Patients disease treatment experience could be optimized across multiple touchpoints’.

Conclusion:

Currently, it appears, most pharma marketers ‘keep their nose to the grindstone’ to continue honing the traditional processes of brand marketing with an expectation for better return. However, if they could find time for ‘lifting eyes to the hills’ with all seriousness, they will be able to sense a shifting paradigm with a new set of marketing success factors. If not done even now, it could perhaps be too late to make amends for business sustainability.

Many may get carried away by the hype of digitalization as a panacea, but this is just a facilitating technology – to be in sync with, among others, the evolving values of pharma customers, through innovative value delivery systems. Regardless of digitalization all around us, the name of the game that differentiate men from the boys in this game, remains – generation of cutting-edge ideas. Only this can transform – effective delivery of differentiated ‘customer value’ into business excellence.

Interestingly, to accomplish this objective meaningfully, the aforesaid ‘acrobatic feat’, as enunciated by Peter Drucker in 1954, remains relevant and essential for pharma marketers, just as all other managers, even in the digital pharma world.

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.

Criticality of Drug Quality In The Moment Of Truth

Posted on by
Reply

When global health emergencies strike unannounced – in the scale and magnitude of new coronavirus, it shakes the health care system of all countries, in varying degree though, irrespective of the robustness of the economy. In such situation, the robustness of health care infrastructure, stringent manufacturing quality standards, operational flexibility for seamless sourcing of all drug ingredients in the required quantities, besides speed and agility of the delivery system – are put to the acid test.

Anytime readiness to effectively neutralize this crisis is of utmost importance. Accordingly, the key national goal should be to create a robust ‘whole’ that is much more than the sum total of each of each of the above factors – a sturdy ‘drug security system’ for the country. The most populous country of the world – China may have succeeded in building a 1,600-bed hospital coronavirus hospital in just 10 days, completing on February 05, 20120. But it is still looking for necessary drugs from other countries, such as the United States.

Curiously, China hasn’t yet disclosed its reason. More so, when the country is the top global supplier of Active Pharmaceutical Ingredients (API), including antiretroviral (ARV) drugs, along with India, according to the World Health Organization (W.H.O). This draws many to look at the general apprehension on the questionable quality of drugs that China, allegedly, produces. But, could this be the reason?

Nevertheless, regardless of inquisitiveness to know the reason, the question mark on its drug quality remains. And this is also not the risk-taking time for any nation, as it could possibly endanger lives of scores of the impacted population. The criticality of drug quality in ‘The Moment of Truth,’ such as, the new coronavirus emergency, can only be wished away at one’s own peril.

On the other hand, the confidence expressed in India, as we shall see below, in ‘drug security’, just based on adequate ARV drug availability appears to be coming from a different plane, although the drug quality issue is exactly the same in India, if not more concerning. From the above perspective, my today’s article will focus on this subject, purely based on available data, starting with the request of the Chinese authorities for ARV drugs from the United States.

Chinese request for ARV drugs:

‘U.S. Drugmakers Ship Therapies to China, Seeking to Treat Coronavirus – AbbVie, Gilead, others respond to Chinese authorities’ requests for antiviral drugs to test effectiveness against deadly respiratory illness.’ This was reported by The Wall Street Journal (WSJ) on January 27, 2020. It goes without saying that these antiviral drugs also include Anti-Retrovirals (ARVs).

AbbVie Inc. and Johnson & Johnson  are among the drug makers that have begun shipping drugs approved to treat HIV, while Gilead Sciences Inc. is exploring whether it should send an antiviral therapy it is developing.

It isn’t known whether the drugs would be able to help contain the explosion of respiratory virus infections sweeping the country or provide relief to infected patients. Chinese authorities have requested the shipments to test the drugs’ effectiveness in containing the new coronavirus, the report added.

An intriguing difference between India and China:

Interestingly, China is looking for sourcing some of these ARV drugs from the United States and not from India, either – one of the top producers of these drugs, as W.H.O reported.

In contrast, according to an Indian report of February 04, 2020: ‘Leading domestic drug companies have said they are ready with supply of anti-retrovirals (ARVs) that seem to work in treating the novel coronavirus (2019-nCoV).’

As I said earlier, although, China hasn’t yet specified the reasons behind their decision on ARV drug import from the United States, but could it have any link on the internal general apprehension of these drugs quality, safety and effectiveness?

Acknowledging for a moment that this is global allegation on Chinese drugs, in general. So is regarding India, as we shall see below. Then where does India stand on this score, especially in view of the confidence with ARV drugs, as exhibited in the above media report from India? That said, the logical question that surfaces now – why is the request for ARV drugs?

Why ARV drugs?

Although W.H.O said that there is ‘No known effective treatments’ for new coronavirus, as yet, various reports do indicate the use of ARV drugs in the treatment of 2019-nCoV:

  • A combination of flu and HIV medications are helping treat severe cases of the new coronavirus in Thailand.
  • Chinese health officials are already administering the HIV and flu drugs to fight the coronavirus, but the combination of the three together in a cocktail seemed to improve the treatment.

The Scientist, on February 02, 2020 reported that large doses of the flu drug oseltamivir combined with HIV drugs lopinavir and ritonavir, reportedly, improved the conditions of several patients in Bangkok, Thailand.

Global dependence on Chinese and Indian generic drugs:

About 80 percent of the Active Pharmaceutical Ingredients (APIs), including many ARVs, which are used for manufacturing of drug formulations in the United States are said to come from China and other countries like India. This appeared in the article titled, ‘U.S. Dependence on Pharmaceutical Products From China,’ published by the Council on Foreign Relations (CFR) on August 14, 2019.

India’s dependence on Chinese APIs:

Latest statistics from Directorate General of Commercial Intelligence and Statistics tabled in the Parliament show that in 2017-18, Indian imports of APIs and drug intermediates from China increased to 68.36 per cent. The same at 67.56 per cent in 2018-19, still remained the largest share in total Indian imports, with the overall India’s dependence on imports going up by 23 per cent from 2016-17 to 2018-19.

As reported in the media on November 22, 2019, India’s national strategies, such as, “2015 – Year of Active Pharmaceutical Ingredients” or ‘Make in India’ campaign, to promote indigenous means of production continue to be relegated on paper. Even, the current National Security Advisor had warned that Chinese dependence on API can be a national security threat.

According to the Department of Pharmaceuticals (DoP), Chinese API imports are due to economic considerations, which are essentially cheaper and more cost-effective for the Indian drug manufacturers, the above report highlighted.

Against this backdrop, the above local media report indicating, leading domestic drug companies are ready to supply anti-retrovirals (ARVs), may invite more questions than answers. Added to this come the critical quality issues with drugs manufactured in China and India.

Quality issues with Chinese drugs:

Credible documents highlight, as China’s pharmaceutical industry is not effectively regulated by the Chinese government, its regulatory apparatus is inadequately resourced to oversee thousands of Chinese drug manufacturers. Even if Beijing made such oversight a greater priority. This has resulted in significant drug safety scandals.

Although, the drug quality related concerns seem to be even more related to India, the drug industry of the country, reportedly, remains in a denial over most of such charges involving drug-quality.

India tops with the most quality related FDA warning letters in 2019:

The author of the above article reiterates, ‘Americans are expecting India, which supplies a significant percentage of the finished drug supply in the U.S., to get its act together to improve the quality of the medicines it makes, I am afraid they will be waiting a long time for that to happen. The only solution is for American lawmakers to enact new regulations focused on holding those who intentionally put public health at risk to account.’

To avoid ‘your-opinion-versus-my-opinion’ type of a debate with this article, let us look at some hard facts. These are from the ‘warning letters’ on drug quality, issued to various pharma companies, across the world, by the USFDA’s Center for Drug Evaluation and Research (CDER). The details were well captured in an article, titled ‘The country with the most FDA warning letters in 2019,’ published by Pharma Manufacturing on January 20, 2020.

Some key CDER findings:

As I consider, the top three CDER findings may be summarized as follows:

  • In 2019, CDER issued dozens warning letters for manufacturing issues to pharma companies outside the U.S. One country in particular – India – received the highest number of letters.
  • CDER’s office of Manufacturing Quality Letters issued 43 letters to companies outside of the U.S. Of those letters:

-   20 were aimed at facilities in India.

-   With 11, China received the second most manufacturing quality warning letters.

-   The rest of the letters were distributed among plants in Europe, Costa Rica, Singapore, Turkey and others.

  • The data from CDER shows that India has the poorest rate of FDA inspections with acceptable outcomes (83 percent) — much lower than China (90 percent) and the U.S. (93 percent).

Conclusion:

Today, a host of effective drugs and vaccines are available to treat a number of both non-infectious and infectious ailments, including many life-threatening viral diseases. However, the effectiveness of these medicines in treating such diseases, as well as many other illnesses, gets significantly compromised by questionable quality and distribution of these medicinal products. Even way back, a similar concern was deliberated in an article captioned, ‘Substandard drugs: a potential crisis for public health’, published in the British Journal of Clinical Pharmacology (BJCP), on November 29, 2013..

It may ordinarily remain undetected, sans stringent and wide-scale regulatory scrutiny. Additionally, a number of involved countries still remain in a denial mode. It’s also a fact, several governments may not have wherewithal for the same, particularly when the manufacturing units are too many, such as in China and India.

However, when a critical national health emergency strikes, unannounced, like the new coronavirus, the moment of truth dawns. Obviously, the national governments would want to be risk averse and prefer sourcing the best of drugs, to rapidly contain the spread of the disease, saving more lives. It’s not difficult to fathom, either, any country is unlikely to admit this reality, in public, even while taking measures for the same.

China’s sourcing of ARV and other drugs from the United States may or may not be due to the drug quality reasons. Nonetheless, I reckon, the criticality of drug quality issues can possibly be best realized, mostly when the ‘Moment of Truth’ arrives. Unannounced! Just like a bolt from the blue!

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.

China Coronavirus And API Sourcing – A Threat… Or An Opportunity For India?

Posted on by
Reply

‘2015 – Year of Active Pharmaceutical Ingredients’ (API), announced the Government of India by a Press Release on February 25, 2015. This came after ascertaining that over-dependence on imports of bulk drugs or API, especially from China, is detrimental to India’s health interest. This decision was also in sync with the freshly announced, and well-publicized government objective regarding ‘Make in India’.

Two years down the line, on July 15, 2017, eHEALTH publication also deliberated on this issue in an article – ‘Why over dependence on APIs imported from China is harmful for India?’ It reiterated, India has proven capabilities in the generic drug formulations, but over dependence on China for sourcing – 70-75 per cent of APIs does not augur well for the Indian pharmaceutical sector. Because, as any interruption in supply from China can badly impact the sector, jeopardizing the health of millions of people, not just in India, but across the world, as well.

The reason for Indian drug formulation makers depending on China-supplied APIs, is mainly for its low cost, and not for any technological other reason, the article said. Regardless of the India’s announcement – ‘2015 as the year of API’, the API industry continued to struggle without much tangible support. Despite a lot of decisions still being in the pipeline, let me hasten to add, some inconclusive signs of early recovery have been captured in this space by some recent studies.

With the outbreak of the recent ‘coronavirus’ menace, the moment of truth has arrived in the country. On the one hand, it is posing a threat to the country’s API sourcing, on the other it could throw open a door of opportunity for Indian API manufacturers, as the Chinese API prices would start climbing up. But the question is, in which way it would evolve? In this article, I shall focus on this aspect of the new coronavirus menace, starting with a brief description of the background.

China coronavirus – when the alarm bell rang: 

According to the World Health Organization (WHO), on December 31, 2019, it was alerted to several cases of pneumonia in Wuhan City, Hubei Province of China. The virus did not match any other known virus, raising a great concern. No one knows how it affects people who are sick with it – how they can be treated, and what the countries can do to respond. One week later, on 7 January, Chinese authorities confirmed that they had identified a new virus.

What it does?

This new virus is a coronavirus, which is a large family of viruses that cause illnesses ranging from the common cold to more severe diseases, such as Severe Acute Respiratory Syndrome, such as SARS and MERS.

Since the virus, reportedly was first detected in Wuhan in people who had visited a local seafood and animal market, it is likely to have transmitted from an animal to humans. Nevertheless, several known coronaviruses are known to be circulating in animals that have not yet infected humans. The new coronavirus has been named novel coronavirus (2019-nCoV) and is the seventh coronavirus known to affect humans.

W.H.O has been working with Chinese authorities and global experts to learn more about it. However, because this is a coronavirus, which usually causes respiratory illness, the world body has circulated advice to people on how to protect themselves and those around them from getting the disease.

The damage, thus far:

Bloomberg on February 02, 2020 reported the death toll from the coronavirus outbreak has risen to 305, with 14,555 confirmed cases worldwide.  The first death outside of China took place in the Philippines on February 01. Alarmingly, 2019-nCoV infections have also spread to at least 15 other countries. These numbers keep increasing.

Nearer home, India, on January 30, 2020, also announced its first case. “One positive case of Novel Coronavirus – a student studying in Wuhan University — has been reported from Kerala,” said a statement released by the Health Ministry. On February 02, 2020, Reuters reported the second case of coronavirus in Kerala.

This scenario prompted the World Health Organization (WHO) to meet again on the last Thursday and declare the new coronavirus an international public health emergency.

The impact on the pharma industry:

Responding to the criticality of this situation, health authorities across the world are trying to put in place effective ways to overcome this crisis. In the healthcare space, medical scientists are ‘racing to develop a vaccine to protect people from the virus.’ One lab in California, reportedly. has plans for a potential vaccine to enter human trials by June or July this year.

Alongside, many are wondering about the looming threat that it poses on the API sourcing from China by the global pharmaceutical industry, including India. However, as I said earlier, some Indian experts, are also sensing an opportunity for country’s API manufacturers to fill the possible void, as it gets created.

API sourcing concern:

An exclusive survey conducted by Kemiex, titled ‘Coronavirus impact analysis for APIs, feed and food additives,’ among 97 life sciences professionals, published by them on January 20, 2020, reports some interesting findings. Some of the key ones are, as follows:

  • 85 percent experts foresee API and other ingredient supply disruptions, with 35 percent expecting a high and 50 percent envisaging a low impact.
  • Orders planned for the 1st quarter with delivery in 2nd quarter are expected to be mostly affected, while disruptions might continue a quarter. Only a minority believes the disruptions will last until year end or beyond 2020.
  • The biggest impact is expected from extended Chinese New Year holidays and delayed production start.
  • A first impact analysis based on preliminary information shows that only selected products such as amino acids (taurine…), certain vitamins and other APIs and additives could be affected.
  • European and other suppliers report readiness and stocks to secure delivery to end users during interruptions in China, or some of its districts. respectively.

However, other reports also underscore, with the proliferation of the new coronavirus the incidences of confirmed infection with clear symptoms and deaths are also expected to increase. This may lead the Chinese government to extend lock down several commercially important parts of the country. Which, in turn, could impact, among others, manufacturing and shipments of API and pharma ingredients for several months.

Some green shoots are now visible in India?

Quoting a JM Financial analysis, some media reports predicted, a worsening coronavirus crisis may benefit Indian API manufacturers, as it observed some green shoots in the Indian API manufacturing space. Analyzing the stocks of six local API manufacturers – Galaxy Surfactants Ltd., Fine Organic Industries Ltd., Navin Fluorine International Ltd., SRF Ltd., PI Industries Ltd. and UPL Ltd., it found that the stocks of these companies have beaten the market trend in recent years. They observed, the robust growth of these companies was fueled by end-user industries, and exports to China – which has closed many chemical facilities on environmental concerns.

Moreover, the increase in overall API demand – caused by shortages triggered by a serious disruption of API production in China’s Hubei province, and restriction of movement within China, is likely to drive the prices up with the spread of the epidemic. The cumulative impact of all this, would possibly help the Indian bulk drug manufacturers, significantly, helping India to tide over the API sourcing crisis.

Conclusion:

‘Scientists are racing to develop a coronavirus vaccine, but it could take years to reach the market,’ as media reports highlight. Meanwhile, researchers are, reportedly, also looking at ways of quickly repurposing existing antiviral drugs to see whether any might work against the new coronavirus.

The serious health menace caused by the new coronavirus that prompted the W.H.O to signal it as a global emergency, has also raised a serious concern on API sourcing. This is because, around 80 percent of the API used by drug formulation manufacturers is sourced from China.

Looking only at this aspect of the issue, and also from the Indian perspective, the point to ponder – is it all threat? Or a veiled opportunity worth cashing-on to neutralize, at least, a part of the API sourcing threat?

Against the backdrop of the Indian Government’s announcements, such as, ‘2015 – Year of Active Pharmaceutical Ingredients’ (API), alongside the well-publicized ‘Make in India’ campaign, and some recently reported green shoots in this area – the expectation of an ‘opportunity in waiting’, could well be a reality. Who knows? But, a lurking apprehension still lingers!

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.

What Pays More: Creating ‘Innovative ‘Customer Experience’ Or ‘Innovative Drugs’?

Posted on by
Reply

More innovative a drug is, the better is its business success rate. This was the general perception of around 92 percent pharma professionals in the past three years. Whereas the fact is: ‘Having the best product doesn’t guarantee sales anymore’. This was established by a research study of the ‘Bain & Company’ - covering multiple therapeutic areas, and was published on October 14, 2019.

It showed, when physicians prescribe a drug – its efficacy, safety and side-effect profile initially account for only 50 percent to 60 percent of the physician’s choice, with a declining trend over time. Interestingly, the other 40 percent to 50 percent of it, is based on a range of ‘physician and patient experience factors’, which pharma players need to target in innovative ways to differentiate their brands.

Many pharma companies are now experiencing the harsh reality that more innovative drugs, backed by traditional sales and marketing support are not yielding desirable financial returns. Head scratching has already started among astute pharma professionals to understand its reason for remedial measures. Thus, the number of executives who agreed with the above ‘Bain & Co’ study that: ‘Having the best product doesn’t guarantee sales anymore,’ increased to almost fourfold – from 8 percent to 28 percent in the next three years.

Thus, in this article, I shall explore whether innovation in creating a ‘unique patient experience’ during a disease treatment process, is as important, if not more than a ‘new drug innovation’. Curiously, high failure rate of most pharma players to innovate in this area, isn’t discussed as much as high failure rates in the development of innovative new drugs.

‘Customer service’ innovation – high failure rate – falling short of expectations:

Again, another article - ‘How Agile Is Powering Healthcare Innovation,’ published by ‘Bain & Company’ on June 20, 2019, brought out some interesting points related to this area. Let me quote a few of which as follows:

  • 65 percent of ‘customer-service innovation’ fall short of expectations of the target group.
  • The number of health care executives recognizing the need to respond quickly to changing customer-needs, has increased from 38 percent in the past three years to 60 percent for the next 3 years. But, most of them ‘lack the methodology, and even the language to implement it in practice.’
  • ‘Having the best product doesn’t guarantee sales anymore.’ Thus, healthcare companies face growing pressure to innovate in providing unique ‘customer experience’.
  • The critical point to note, customer needs evolve continuously, and leading companies respond rapidly with innovative new solutions catering to changing market demand.

As the core purpose of working for ‘customer-service innovation’ is linked with creating ‘brand loyalty’, let’s have a quick recap on ‘brand loyalty’ really means for pharmaceutical products, in today’s context.

‘Brand loyalty’ for pharmaceutical products in modern times:

There are many similar definitions of ‘brand loyalty’ for a pharmaceutical product. The research article – ‘Brand Loyalty as a Strategy for the Competition with Generic Drugs: Physicians Perspective,’ published in the Journal of Developing Drugs, on August 30, 2016, defined ‘brand loyalty,’ and articulated its advantages.‘ I am paraphrasing a few of which, as below:

  • The extent of the faithfulness to a particular brand, which is a major indicator of a long-term financial performance of companies.
  • The main advantages of brand loyalty can be defined as greater sales and revenue, a substantial entry barrier to competitors, increase in a company’s ability to respond to competitive threats and lower consumer price sensitivity.
  • ‘Brand loyalty’ can protect against price competition, including branded generics, as it gives confidence to physicians on the perceived effectiveness and safety of a brand – which they usually won’t be willing to compromise with for lower prices.

This brings us to a key question. Are traditional pharma methods of creating ‘brand loyalty’ getting replaced by the key consideration of creating a ‘unique customer experience’?

Creating ‘brand loyalty’ through ‘patient loyalty’ – a new equation:

It’s a fact today that traditional pharma methods of creating ‘brand loyalty’ is getting replaced by the key consideration of creating a ‘unique customer experience.’ This, in turn, is increasing the need of building ‘patient loyalty’, both for a pharma brand, as well as respective companies offering these brands. This is a new equation, where offering a ‘unique treatment experience’ to patients assumes a critical role more than ever before. This needs to be clearly understood by today’s pharma marketer, without any ambiguity.

In traditional pharma marketing, physicians remain, virtually, the sole focus of the branding exercise, as they appear to be the only decision makers of writing a brand prescription. Patients, in general, hardly used to have any role to play in that process. In this scenario, brand loyalty for the doctors – assuming the absence of any malpractices, is primarily driven by the following three much known factors:

  • Physicians’ unprejudiced buying-in a brand’s value offerings
  • Evaluation of opinion leaders and the doctors’ professional counterparts,
  • Quality of disease treatment outcomes.

Nevertheless, before getting into this area, let’s have a quick look at the primary drivers that pharma marketers have been using to boost financial performance of a brand.

Traditional sales boosters of a pharma brand:

The primary drivers that pharma marketers have been using to boost financial performance of a brand can broadly be classified as follows:

  • Multiple ways are followed to make important doctors write more prescriptions,
  • Increase the drug price, whenever an opportunity arises.

These factors still remain important, but aren’t just enough to deliver sustainable performance over a period of time. Thus, a new dimension needs to be added to it.

Add a new dimension to create brand and corporate loyalty:

With the emergence of increasingly more informed and demanding patients, there is a need to create a ‘loyal patient population’, by offering them primarily a ‘unique treatment experience’. And this is the new dimension.

For this purpose, off-the cuff approaches or strategies based on mere gut-feelings are unlikely to work. As I indicated in one of my articles, marketers need to acquire deep insights on their customers to make sales and marketing decisions more informed, than what it is today. Currently available state of the art technology can be a great enabler to facilitate this process.

This is easier said than done, because answering the question – how does a drug company create ‘brand loyalty’, is indeed a tough call. Nonetheless, many different industries have realized, since long, that offering a ‘unique customer experience’, is critical to create a pool of ‘loyal customers’.

I also had written earlier, pharma is still a late learner in accepting various new normal, in a holistic way. Accepting this reality, a sharp focus on creating ‘brand loyal doctors’ in various innovative ways, I reckon, will serve this purpose well. It’s only recently, a few companies have started working to offer such ‘experience’ to patients in the disease treatment process - end-to-end. Ironically, a large majority of them prefer to talk about it more than actually translating the same into reality.

Benefits of ‘brand loyalty’ through ‘unique customer experience’:

There are several advantages of building pharma ‘brand loyalty’ by offering ‘unique customer experience, without diluting the focus on ‘increasing prescription generation through doctors’. The benefits, I reckon, include, both new – innovative products and also branded generics. Let me give below one example of each:

  • Innovative new-products – positive word-of-mouth promotion: Satisfied patients having ‘unique end-to-end treatment experience’ with a new, innovative brand, are very likely to share it with others. This may be done by using different modes of communication, including various social-media platforms. This, in turn, may help both – add to take-off speed – post launch and create a snowballing impact on the brand adoption thereafter.
  • Branded generics – extend the product life cycle and increase growth: Patients who are loyal to a particular branded version of a generic molecule, are quite likely to refuse any change to a cheaper equivalent, even if recommended by the physician. Moreover, they will advocate for this brand to others, using different communication platforms, as indicated above. Continuation of this process will extend the life cycle of the branded-generic, with increasing growth and market share.

Conclusion:

Now, it’s time to get back to what we started with - What pays more: Creating ‘Innovative ‘Customer Experience’ Or ‘Innovative Drug?’ From the above perspective, it emerges that bringing innovative product to markets is, of course important. However, to ensure its sustainable financial success, other innovations, such as creating ‘a unique end-to-end patient experience’ with the brand, in all probability, would weigh more. This is an area which did not receive much attention for a long time, moving beyond the creation of increasing numbers of ‘brand loyal’ doctors, for business success.

Today, increasing consumerism in the health care space, besides pricing pressure, unfavorable perception and sinking image of the industry, is creating a strong headwind – impeding desirable growth of many pharma players. Such a challenging business scenario has prompted a few of them to innovate in designing a differentiated ‘customer experience’ – in a true sense.

Although, a large number of companies are talking about it, most are mere lip-services – a ground-swell in this area is yet to take place. The industry priority, in general, still weighs heavily in developing innovative products, and creating ‘brand loyal’ doctors, rather than cultivating ‘brand loyal patients’, alongside.

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.

Any Threat To Current Commercial Model Of ‘Gene Therapy’?

Posted on by
Reply

Wish All My Readers A Very Happy, Healthy, Peaceful and Prosperous 2020

 

One of the most complex areas in disease management, is the ailments related to genetic disorders. As these were incurable, over the last four decades, medical researchers are engaged in understanding the complex and intricate process to modify human DNA, using viruses for treatment. This painstaking initiative led to the evolution of ‘gene therapy’ which, according to Mayo Clinic, ‘involves altering the genes inside human body’s cells in an effort to treat or stop the disease.’ In that process, ‘gene therapy’ replaces a faulty gene or adds a new gene, to cure a disease or improve the human body’s ability to safely and effectively treat dreaded ailments, such as cancer, cystic fibrosis, heart disease, diabetes, hemophilia and AIDS, it further added.

Several studies, e.g., one titled ‘Gene therapy on the move,’ published in the EMBO Molecular Medicine highlighted, the first gene therapy clinical trials were initiated more than two decades ago. However, initially many of these were impeded by the occurrence of severe side effects in a few treated patients. Nevertheless, over a period of time, ‘highly efficient gene targeting strategies and site-directed gene editing technologies have been developed and applied clinically.’ With over hundreds of clinical trials to date, gene therapy has moved from a vision to clinical reality – offering a powerful treatment option for the correction of monogenic disorders.

It is believed that in the new millennium, ‘gene therapy’ has emerged as one of biotech’s momentous success stories for curing many genetic disorders, which were once considered incurable. But, the cost of ‘gene therapy’ treatment is indeed jaw-dropping – ranging ‘from about US$ 500,000 to US$ 1.5m. And for treatment over a lifetime, some drugs can cost as much as US$ 750,000 in the first year, followed by US$ 375,000 a year after that – for life.

Since, I have already deliberated on ‘gene therapy’ price and associated moral dilemma that it causes, in this article, I shall focus on different concerns that could pose a threat to its ongoing commercial model. Nevertheless, let’s start with the current scenario on ‘gene therapy,’ for better understanding of the issue.

The current scenario:

According to McKinsey & Company’s October 2019 article - ‘Gene therapy coming of age’ - till 2019, the primary focus in development of ‘gene therapy’ has been on monogenic rare diseases with all currently approved therapeutics falling into this category. It is worth noting, rare diseases tend to have clear genomic targets, as well as, high unmet need in a very small patient population, who have generally been under-served by other, more traditional, therapeutic modalities (including monoclonal antibodies)—making them ideal targets for gene therapies.

More than 150 investigational new drug applications were filed for gene therapy in 2018 alone. With this in mind, McKinsey & Company expects this market to grow significantly, with ten to 20 cell and gene therapy approvals per year over the next five years.

Major ‘gene therapy’ launched:

If one takes a broad look at the ‘gene therapy’ treatments launched so far, which I have compiled from different sources, it may appear as follows.

Gene Therapy Company Country Launch Year Indication Price ($M) Current status
Glybera UniQure Europe(EMA) 2012 Pancreatitis caused by absence of a gene - lipoprotein lipase, affecting about 14 people per year in Europe 1.0 Withdrawn (unaffordable)
Strimvels GSK Europe (EMA) 2016 To treat ADA-SCID patients (rare disease) 0.665 Sold to Orchard Therapeutics. Only 5 patients were treated.
Kymriah(CAR-T therapy) Novartis USA 2017 Acute lymphoblastic leukemia 0.475
Yescarta(CAR-T therapy) Kite Pharma USA 2017 Diffuse large B-cell lymphoma 0.373 Gilead acquired Kite Pharma in August 2017 for 11.9 billion dollars
Luxturna  Spark   2017 Rare disease called RPE65 mutation-associated retinal dystrophy. 0.850 for both eyes Novartis is paying $105M up front for the ex-US rights.

The latest being Zolgensma of Novartis. It was approved by USFDA on May 24, 2019 for ‘patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene.’ It costs US$ 2.125 million in the US for a one-time treatment.

However, to get a better idea on the industry focus in this area, let us look at the current ‘gene therapy’ pipeline.

Current ‘gene therapy’ pipeline:

To fathom the extent of industry interest in ‘gene therapy’ let’s have a glance at the depth of its pipeline – both in terms of phase-wise clinical study, as well as therapy areas covered. This will help understand the concerns that could pose a threat to its ongoing commercial model.

Clinical Trial Phase Total by phase    Therapy Areas:HematologyOncologySensory OrgansInternal MedicinesOthers
I 574
II 520
III 205
Filed/Approved/Marketed 237
Total 1536

Adapted from: McKinsey article – ‘Gene therapy coming of age’, October 2019

Both large and small companies are entering into the fray:

Besides Novartis and GSK, as mentioned above, other Big Pharma constituents, such as Pfizer, Roche, Gilead and Bristol-Myers Squibb - are also putting their money in developing ‘gene therapy.’ This includes Mergers and Acquisitions too. For example:

Alongside, newer ‘gene therapy’ platforms continue to come up, many funded by venture capitals – further enriching the ‘gene therapy’ pipeline. In tandem, fresh concerns that could pose a serious threat to the ongoing commercial model of ‘gene therapy’ are also being realized. Mainly, the impact of the one-time or curative version of such avant-garde therapy on current pharma business models.

Also facilitates a giant leap towards personalized medicine:

‘Gene therapy’ is also believed to be a giant leap of medical science towards personalized medicine. This is because, in addition to repairing and replacing defective or missing genes of a human body, this therapy can use body’s own cellular immune system to treat the disease. This is because, CAR-T cell therapy can fall in the category of personalized medicine, where a patient’s T cells are changed in the laboratory, empowering them to attack cancer cells.

Concerns that could threaten its ongoing commercial model:

Despite its significant patient-value offerings with long-term benefits, ‘gene therapies’ that have been approved and are already in the market had to confront with tough unforeseen challenges, both from fresh regulatory questions - to therapy withdrawal for commercial reasons. These developments, coupled with a very low and difficult to identify patient population, and affordability related low market access, prompt the need of a transformed marketing model for novel ‘gene therapy.’ This is important for financial sustainability of current ‘gene therapies’ in most pharma markets, globally, including the United States.

Some critical areas:

An article on ‘gene therapy’ by the Managing Directors of L.E.K Consulting, published by Cell & Gene on May 16, 2019, also pointed to some of these critical areas. Even this paper articulated, the fundamental value proposition of ‘gene therapy’, its long-term efficacy with a single-dose treatment, gives rise to a number of unique challenges for its manufacturing companies. Let me paraphrase below just three of those, as I understand, to drive home this point.

Declining number of eligible patients for most doctors: 

The promise of a functional cure is expected to limit ‘gene therapies’ to a single dose per patient, in most cases. Thus, inability to re-treat would lead such therapies to deplete their addressable prevalent populations, for most doctors. This is primarily because, as the number of treated patient accumulates – the number of potential patients who could be treated in a given year is reduced. This leads to demand that would peak early before steadily declining. Once the prevalent population is depleted, the demand for a gene therapy would be driven by incident patients.

However, research has now been initiated targeting larger populations – e.g., those suffering from leukemia and lymphomas. But, the greatest revenue potential for ‘gene therapy’, is expected to be its success in delivering life-changing treatment outcomes in multiple myeloma. When such patients will get to experience better outcomes from cell and gene therapies, the incremental approach the industry has been taking in this area, will be more than justified.

Till then, it could pose a challenge to business sustainability:

As discussed, the ‘gene therapy’ sales curve with an early peak and then steady decline, caused by a depleted addressable patient population within a few years after launch, could pose a serious challenge to business sustainability. This would require launching, possibly another ‘gene therapy’ product before the revenue of the first ‘gene therapy’ starts waning. Consequently, the timing of its life cycle management efforts and subsequent launches would be a critical success factor.

Intricacy of market access dynamics:

Optimal market access of ‘gene therapy’ will call for working in unison with virtually all stakeholders, including regulators, governments, and at the same time, effectively disseminating the real-life treatment-success stories. However, both in the developed countries and also in the emerging markets, such as India, its treatment cost will continue to remain a key barrier, sans some disruptive pricing strategy.

How this tough task remains unresolved, can be sensed from the Wall Street Journal (WSJ) report of December 19, 2019 titled, ‘Novartis to Offer World’s Most Expensive Drug for Free Via Lottery.’ For this purpose, Novartis launched a lottery-style program to provide doses of its pricey gene therapy for Zolgensma, a one-shot ‘gene therapy’ cure, for free of charge. But, this approach drew criticism from patient groups that called it – an inappropriate way to distribute a lifesaving treatment aimed at babies for a deadly inherited disease whose victims cannot control their muscles. At a price of US$ 2.1 million, Zolgensma, is the world’s most expensive drug.

Conclusion:

As I discussed above, ‘gene therapy’, also known as ‘human gene transfer,’ has been one of biotech’s momentous success stories in the new millennium, paving the way for a cure of many genetic disorders – once considered incurable. However, the number of patients on ‘gene therapy’ remains small compared to other therapeutic regimens, mainly because of two factors. One – this therapy, mostly targets rare diseases, and the second – even among those small patient populations, only very few can afford such pricey therapy.

Nevertheless, current research in this complex area, is now targeting larger populations – suffering from leukemia, lymphomas and multiple myeloma. Success in these areas will open the door of significantly greater revenue potential for ‘gene therapy’ by delivering life-changing treatment outcomes. Till then, its current business model, I reckon, would continue to pose a high commercial risk to this venture.

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.