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Drug Quality Imbroglio And ‘Culture of Bending Rules’ in India

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“Bottle Of Lies Exposes The Dark Side Of The Generic-Drug Boom” – re-emphasized the book, released in May 2019.  This confirms, the raging debate on the questionable quality of many generic drugs manufactured in India and involving several top domestic pharma companies, is a never-ending one. Numerous articles also ascribe many different reasons to this saga, leaving an overall impression – as if, blindfolded persons are trying to describe an elephant, touching and feeling different parts of the animal’s body, each at a time.

Let me illustrate the point with the Bloomberg article of January 31, 2019. It reported, “Culture of ‘Bending Rules’ in India Challenges U.S. Drug Agency.” And further commented: ‘The FDA confronts creative improvisation in the world’s largest generic-drug exporter.’ Curiously, according to the above report it seems to be a general belief among many, even within India.

This article will take into account the above apprehension – specifically raised against Indian drug manufacturers of both branded and non-branded generics. Accordingly, my focus will be on just three points – as possible causative factors for this critical issue:

  • Is it an India specific concern – thus related to ‘Indian cultural mindset’? or it’s a global issue, involving both Indian multinational drug manufacturers.
  • Is it a systematic attempt to create a perception bias against low-cost generic drugs, worldwide?
  • Are generic drug makers resorting to such unacceptable shortcuts due to increasing margin pressure?

Having deliberated these points, I shall try to outline a set possible remedial measures to address this issue in a holistic way, ensuring a win-win outcome. Let me first explore, whether or not this issue is specific to India, involving Indian drug manufacturers.

Is the issue India specific?

Is the issue of questionable quality of generic drugs, irrespective of whether they carry a brand name or not restricted to the shores of India? One can find its answer in the same report, as quoted above. A yearlong investigation by Bloomberg News into the generic-drug industry concluded, ‘FDA inspections at factories from West Virginia to China have found reason to doubt the data meant to prove drugs are safe and effective.’

One possible reason for such perception could be, since India is predominantly a branded generic market, voices decrying ‘questionable’ safety and efficacy of cheaper non-branded generic drugs, are too loud. Nevertheless, amidst all this, who’s who of branded generic manufacturers continue getting caught on the wrong foot by overseas regulators in the quality quagmire. Ironically, multinationals are also included in it.

Multinationals are also included in such quality quagmire:

There are several examples of non-compliance to requisite drug quality standards by multinational drug companies. Let me illustrate the point with an example that involves a top global pharma player.

The March 04, 2019 ‘Warning Letter’ of US-FDA for the Irungattukottai (Tamil Nadu) plant of Pfizer in India, clearly said: “Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture.”

This is not a solitary example of Pfizer’s generic hospital injectables manufactured in this plant. According to a media report dated July 17, 2018, twice before US-FDA had cited manufacturing and testing issues in this facility, containing 11 observations of the regulator, such as, workers “manipulated test sample weights to obtain passing results” for both batches of raw materials and finished product. It is a different matter that the company, later on, decided to close this plant for commercial reasons. Be that as it may, negative perception of generic drug quality is indeed an issue that needs to be addressed without further delay, holistically.

Studies have captured negative perception of generic drugs:

That this is a perception, has been well – elucidated along with its implications, in several studies. A few of which are as below:

A BMJ article concluded: “A significant proportion of doctors, pharmacists and lay people hold negative perceptions of generic medicines. It is likely these attitudes present barriers to the wider use of generics.” It further added, “Negative perceptions of medicine quality along with other drivers contribute towards choosing more expensive medicines in the private sector.”

Endorsing this point, yet another BMJ article inferred: “Negative perceptions of generic medicines and preferential promotion of branded medicines over generics by pharmaceutical companies could influence prescriber behavior and affect trust in healthcare provided in public services. To succeed, access to medicine programs need to systematically invest in information on the quality of medicines and develop strategies to build trust in healthcare offered in government health services.”

Again, in a separate survey of over 2700 physicians on perceptions of generic drugs, more than 23 percent of respondents expressed negative perceptions about their efficacy and nearly 50 percent. reported negative perceptions of generic drug quality. In the same survey, patients also expressed concerns that the lower cost of generics is associated with reduced medication quality.

Although, the above survey was conducted in the United States, the current situation in India, I reckon, is no different, but with one caveat. Here, preferential promotion of branded generic medicines over cheaper non-branded equivalents, by the respective drug manufacturers, could significantly influence prescriber behavior. Therefore, the question that follows: Is this perception-creation based on facts?

Is the negative perception fact-based?

Although, even the US-FDA clearly states that: ‘A generic medicine works in the same way and provides the same clinical benefit as its brand-name version”, I did try to find some conclusive evidence depicting brand name drugs are superior to their cheaper generic equivalents. While doing literature searches, two types of results emerged – there are studies that do not find any significant difference between generic drugs and their branded equivalents. At the same time, a few other studies do suggest that there is a difference between these two, but admitting that these studies are not conclusive. Let me give below examples of each.

No quality difference found between generic drugs and the branded variants: 

I shall quote here three studies, out of which one is India specific. The analysis reported in the above BMJ article, found that ‘the generic and branded variants of the medicines tested were of comparable quality.’

Another study, published by PLOS Medicine on March 13, 2019 also said, “In this study of 8 drug products conducted using 2 large US commercial insurance databases, we observed that use of generics provided comparable clinical outcomes as the brand products.”

An India specific researchon the same also reported, most generic and branded drug users believed that their drugs were effective in controlling their ailments with no significant difference in reported adverse effects and drug adherence.

Slightly different results were also reported with generics, but not conclusive:

One such study questioned, whether generic drugs are truly equivalent to the brand-name versions.This article was published on January 2019 by Harvard Health Publishing with the title, “Do generic drugs compromise on quality?”

This article quoted a Canadian study, published in the October 2017 issue of ‘Circulation: Cardiovascular Quality and Outcomes’, which found that patients who took generic versions of three different blood pressure medications in the months after the generic drugs became available saw increased rates of drug-related side effects.

Was it due to a perception bias?

To ascertain whether or not there is a perception bias, let us look into the following details of the same study along with its conclusion.

In this study, the researchers ‘looked at the numbers of emergency room visits and hospitalizations for 136,177 individuals ages 66 and over (60% of them women) who used any of three blood pressure medications: losartan (U.S. brand name Cozaar), valsartan (Diovan), and candesartan (Atacand). The investigators examined data for the periods 24 months before and 12 months after the generic versions of these medications went on the market. And found that before the generic versions became available, about one in 10 people taking the blood pressure drugs had to go to the emergency room or be hospitalized each month. In the month after each of the generics went into use, the rates of these adverse events went up: 8% for losartan, almost 12% for valsartan, and 14% for candesartan.’ The study authors commented, this might suggest performance differences between the brand-name and generic drugs.

However, analyzing this study, the Harvard article suggested further probe on the question: Did it result from quality problems with the generic versions of these medications or were there other factors that occurred in this time frame?

Another research, aimed at finding, whether patients are more adherent to generic statins than brand-name statins (lovastatin, pravastatin, or simvastatin) and whether greater adherence improves health outcomes, also concluded, “An 8% reduction in the rate of the clinical outcome was observed among patients in the generic group versus those in the brand-name group.” This also wasn’t a conclusive one, either.

Nevertheless, the key point of a ‘perception bias’, is captured in a separate study, where the researchers did find higher rates of psychiatric hospitalization for patients taking generic and AG escitalopram and sertraline, compared with those who initiated the brand-name product. Importantly, they noted that these outcomes were likely due to either residual confounding or generic perception bias.

No quality difference also found between branded and non-branded generics in India:

There are studies, which captured no quality difference between branded generics and non-branded generics in the country. One such India specific study concluded: “Quality of branded-generics is same as for their branded version. The study highlights the need to modify the drug price policy, regulate the markups in the generic supply chain, conduct and widely publicize the quality testing of generics for awareness of all stakeholders.”

Thus, so far, we have seen in this article that concern on quality of generic drugs is neither India specific, nor is it related to ‘Indian cultural mindset.’ And this is, undoubtedly, a global issue, involving both Indian and multinational drug manufacturers. There are also ample evidences available that a systematic attempt is being made to create a perception bias against low-cost generic drugs, worldwide. Let us now look at the third possible causative factor, as I listed above.

Is it due to margin pressure on generic drugs?

The answer to this question was deliberated in an article titled, ‘Generic drug makers feel pinch as prices crumble,’ published in the Financial Times on August 17, 2017. Quoting a top global financial analyst, it reported – global generic drug industry, where Indian manufacturers are major players,has maintained roughly 30 per cent operating margins over a long period of time, with improvements year on year. But, since last few years, there has been a margin degradation, which may possibly further go down – even lower than what it is today.

The article further highlighted, a round of consolidation among their main customers in the US: the wholesalers, have escalated the problem.  Many of these groups have clubbed together to form “mega buyers”, known as general purchasing organizations, that can command large discounts. Moreover, for the US market, another area of ‘concern’ is that the US-FDA has identified boosting competition in the generics market as one of its main priorities. As this reform opens up, it could squeeze the generic drug margins further.

Many envisage that intense cost cutting measures, could have transgressed in the drug quality assurance area, aggravating this issue. Although, it needs to be verified through credible studies, curiously, some signs of improvement in this area has recently been reported.

That said, there appears to be a strange coincidence between recent reports on Indian drug makers showing improvement in USFDA inspection outcomes and attempts to increase generic drug companies and some of their top executives slapped with price-fixing lawsuits in the U.S.This needs to be studied further.

The way forward:

The negative perception of generic drugs, in general, and non-branded generic drugs, in particular, is most likely a well-crafted business issue, rather than a genuine patient safety concern. It calls for an immediate two-pronged approach:

  • Vigorous awareness and educational campaigns on safety and efficacy of generic drugs targeted to patients, medical and paramedical professionals.
  • New regulatory measures, especially the following five:

- No pricing pressure or price control in any form of generic drugs

- Abolish brand names for generic drugs

- Make generic prescription compulsory to boost intense competition and thereby     reducing the price.

- Restrict the number of ingredients in FDC not more than two or three

- Make Uniform Code of Pharmaceutical Marketing Practices (UCPMP) mandatory.

Conclusion:

Thus, the questionable quality of generic drugs is not an India specific concern and involves both Indian multinational drug manufacturers. This is also evident from the analysis, as quoted above, that underscores, ‘FDA inspections at factories from West Virginia to China have found reason to doubt the data meant to prove drugs are safe and effective.’ Many studies have revealed that there is a systematic attempt to create a perception bias against low-cost generic drugs, worldwide.

A sequence of remedial measures, as described above, also include fostering competition, instead of introducing government controls on prices of generic drugs with stringent regulatory oversight being in place.

Thus, the so called ‘belief’ that the ‘culture of bending Rules’ is culpable for dubious generic drug quality in India, is more akin to a strong perception, prevailing in India, rather than based on any scientific analysis related to this issue. This ought to change with a well-coordinated intervention – for patients’ health interest sake.

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.

Is Pharma Communication In Sync With Doctors’ Expectations?

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Not many pharma companies, especially in India, undertake any ongoing data-based analysis to gain insight on expectations and change in behavioral pattern of their customers, particularly doctors and patients. Many developments are taken as obvious, such as, when busy practitioners don’t want to give much time to a medical rep for brand detailing, if not any time, common spontaneous inference remains – ‘they are too busy.’ These responses are mostly without any data backup. Thus, meaningful efforts in finding ‘productive alternatives’ continue to remain elusive.

As making personal calls to some top medical practitioners becoming increasingly difficult, non-personal outreach for them tend to significantly go up. It often happens without any quantifiable assessment of how each of these targeted doctors is responding to even the non-personal outreach of the company.

That this is happening, was captured in a world-wide survey by ZS Associates in 2016. It highlighted: ‘The number of digital and non-personal contacts that the pharmaceutical industry now has with physicians exceeded its number of sales rep visits to doctor offices.’ It is worth repeating, this finding comes from a global survey.

Lack of insight in this area, could give rise to an avoidable disconnect between many pharma company’s core communication strategy, and what individual doctors would like to hear from them and in what way. Unless this issue is addressed sooner, it could be a strong invisible barrier to brands’ success, if not the image, too. Thus, in this article, I shall explore its implication, the key factors driving this trend, and most importantly, how to bridge this gap. Let me start with the well-established trend of increasing volume of non-personal contacts and hasten to add, by ‘non-personal’ I mean situations where a person is not physically present.

Increasing volume of non- personal outreach:  

In these days, personal interaction of medical reps with doctors, despite being traditionally important, is just one of the many channels for delivering requisite content to them. With increasing difficulty in getting top prescribers’ time, for effective brand detailing, many more non-personal channels are fast opening up.

Today, even in the Indian context, more than half of the total outreach volume of many drug companies, especially to such prescribers, are taking place through non-personal promotions. These include activities, such as:

  • Both, general and personalized e-mails
  • Mobile alerts to achieve various different objectives
  • E-detailing
  • Continuing Medical Education (CME)
  • Speaker program with associated arrangements and fees
  • Sponsoring medical events, seminars, symposia
  • Advertising in medical journals

Whereas, a little less than 50 percent of the total outreach by volume, still take place through in-person interactions with medical reps for brand detailing, as studies indicate. Interestingly, for known products, such contacts are often no more than just brand reminders.

The productivity of such calls needs to be measured and quantified, just as what is required for various non-personal channels, including digital – the contact volume of which is fast increasing for several companies. Curiously, despite this prevailing scenario and in some cases, a declining performance trend notwithstanding, higher promotional budgets continue to be available, based on hope and supported by optimistic forecasts.

The key reason attributed to this trend:

The article titled ‘What healthcare professionals want from pharma’, published in Pharma IQ on April 23, 2019 wrote about a key research finding on this subject. It emphasized, ‘only 46 percent of physicians worldwide are “accessible”- defined as meeting with a pharma sales rep in 70 percent of requests in the past year – a figure that has declined from 78 percent in 2008.’

On the same issue, the survey brought out two other important points:

  • 38 percent of physicians restricted MR access, and
  • 18 percent of physicians “severely’’ restricted MR access

The question that follows is, how much doctors’ time is taken by non-personal communication?

Doctors’ time taken by non-personal communication:

The above article also found: ‘These doctors estimate they receive more than 2,800 contacts from pharma reps each year via digital and non-personal marketing channel – contacts that consume an estimated 84 hours per year, or two full work weeks of their time.’ This level of “white noise” makes it imperative to rethink strategies for reaching prescribers, the article added.

What do doctors do with non-personal communication?

In this situation, understanding when doctors open doors to MRs, read promotional emails, commit to speaker events, and engage with other sales and marketing channels could be the difference between gaining market share by delivering a strong customer experience and failing to keep pace with a competitor. This was one of the key findings of ZS Associate’s 2017 Access Monitor study.

Thus, gaining insight on individual customer behavior for personalized customer engagement, would help create a cutting-edge competitive advantage for pharma players. With this acuity, astute pharma marketers would require prioritizing their focus on communication channels and platforms – alongside resource allocation for each.

Current resource allocation:

As reported in the above survey by ZS Associates, while marketing executives and doctors notice the increase in non-personal communications, pharma players, in general continue to allocate around 88 percent of their total sales and marketing budget to the sales force. This is despite non-personal communications – including digital, now comprising 53 percent of the total marketing outreach, as captured in this worldwide survey.

The survey findings do raise a point of caution as it says: ‘If pharma companies continue to increase investment in less expensive digital communications without considering customer preferences, physicians may feel overwhelmed and eventually ignore them.’ Thus, it will be important for drug companies understand doctors’ expectations in this area.

Pharma – doctor communication: Expectations and gaps: 

On the doctors’ front, there are two important developments that pharma marketers should take note of:

  • Core expectation of doctors is much clearer now:  As one of the above studies clearly indicate, the core expectation of all practicing doctors, from both personal and non-personal contacts with the drug companies, is to get the ‘news that they can use’, in their respective medical practices.
  • Availability of multiple expert sources/channels to fetch relevant medical information: The reality today is, medical representatives are no longer the only credible source for many busy practitioners to get useful medical information, not just for the molecule, but also for specific brands. ‘And with more choices, physicians increasingly prefer to learn about products on their own terms,’ as the above worldwide survey points out.

Hence, there exists a gap between how and what type of content busy practitioners expect from pharma companies and how and what the drug companies actually deliver to them. There isn’t an iota of doubt that this gap has to be bridged for making sales and marketing efforts more productive.

It demandsa deep insight into the way doctors gather medical information – based on real-time data analysis. This is critical, considering the role it plays for success in generating increased brand prescription support.

Acquiring insight into the way doctors gather medical information:

There are four key elements, I reckon, to acquiring insight into the way doctors gather medical information:

  • What each high-value medical practitioner considers as ‘the news that he/she can use’ in their practice, which would also help a company to generate increasing brand prescription support? Its answer should be the key driver for targeted content development.
  • How a doctor would prefer to receive it – as a personal or non-personal communication?
  • What would be each such doctor’s most preferred channel or platform to receive this message?
  • How to create an effective and measurable synergy between personal and non-personal communication for each important prescriber?

As too-much, too-frequent and too-many types of communication may often be counterproductive, delivering the right content, on the right platform, through the right channel for each top prescribers, would likely to pave the way for success in this effort.

Real-time monitoring to increase the strike rate is important:

This is relevant for both personal and non-personal communication and would include several areas, such as, after getting appointment of a top specialist, with great difficulty, what results follow after the interview concludes. Or after sending important and even personalized emails, how to monitor whether doctors are opening those, reading and acting upon, as intended.

This is no rocket science. There are ample mechanisms to make it happen. However, it is important to decide first, which of these means would suit a particular company the most, for effective implementation. That said, leveraging modern technology and constantly updating it, is the only way forward, for sure. While the task is difficult, but is certainly achievable – with the optimal mix of right resources and perseverance.

Conclusion:

When the expectation is, to build a strong pharma brand with a long-term success record, the only tool is effective communication of brand-value to target customers – in the right way, leading to tangible value creation for all. The source of communication being respective drug companies, one can be sure that it will be relayed to targeted receivers, such as doctors, patients and other stakeholders. However, none can be too sure whether the receiver will be willing to receive it the way it was planned by the source – and through the same channels.

Like many other industries, pharma customers are also becoming more selective in receiving, accepting and acting on medical communications, according to individual expectations and preferences. Several research studies have confirmed this emerging trend. Simultaneously, it is also getting revealed that most communication of a large number of drug companies are not quite in sync with doctors’ expectations. As a result, return per dollar/rupee spent on such communication is fast declining.

Thus, it’s time for a significant course correction – with a sense of urgency, as discussed above. No doubt, all pharma players have a strategy in place to make their brand communication effective. Nevertheless, what they should also focus on, is to align their communication with doctors’ expectations.

It is, therefore, imperative that pharma communication is made in sync with doctors’ expectations – not based on a couple of interviews with them, as it were, but by analyzing a massive pool of credible data, leveraging modern technology. Otherwise, high value prescribers may keep considering reps visit as ‘noise’ and remain indifferent to such outreach.

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.

Would ‘Connected Healthcare’ Catch Pharma Players Off-Guard?

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Rapid advancement of medical science is making several life-threatening diseases easily preventable, curable and manageable. For some conditions, such as, peptic ulcer even surgical interventions are no longer necessary. This results in the expansion of preventive and primary-care segments, with equal speed. Simultaneously, increasing complexity of many diseases, late stage disease detection, and better identification of rare diseases, are broadening the specialty hospital segment, as well.

On the other hand, the general mindset of people is also changing as fast. They dare to chart in the cyberspace, seek for more health-information, prefer participative care, expect a speedy treatment process – delivering better outcomes.

The cumulative impact of these are creating some brilliant sparks, confirming evolution of some disruptive health care business models. These are quite different from what we generally experience today.One such model is termed ‘connected healthcare.’ This is a unique business model, having potential to break the decades old status-quo – for the benefit of patients – closely involving doctors, pharma – medical device/diagnostic companies and of course the hospitals. In this article, I shall deliberate on ‘connected healthcare’ looking at its various aspects and examining whether pharma industry is ready for this change. Let me start this discussion with the role of Internet of Things (IoT), as an enabler for this process.

Internet of Things (IoT) – A great enabler for ‘connected health’:

‘Internet of Things (IoT)’ has opened new vistas of opportunities for providing healthcare with significantly better outcomes. According to Ecoconsultancy, by leveraging the IoT network, medical devices of everyday use can be made to collect, store and share invaluable medical data, providing a ‘connected healthcare’ system. Consequently, doctors, along with patients, can get speedy and deeper insights into symptoms and trends of diseases for prompt interventions, even from remote locations. The question that follows: what really is ‘connected health?’

‘Connected Health (cHealth)’ and a teething problem:

‘Connected health or (cHealth)’ refers to the process of empowering healthcare delivery through a system of connected and interrelated computing devices, mechanical and digital machines on an IoT network platform. It provides the ability for seamless data transfer and access between patients and providers, without requiring human-to-human interactions to improve both quality and outcomes of healthcare.

Two more articles, one titled ‘Connected health: How digital technology is transforming health and social care,’ and the other ‘Accelerating the adoption of connected health’, both published by Deloitte Center for Health Solutions also described ‘Connected health (cHealth)’quite eloquently.

One of the papers highlighted, being a technology driven network system, cHealth has its own teething problems. Some of its key reasons include: Many physicians ‘are often reluctant to engage with technology, partly due to the scale and pace of changes, and partly through lack of education and training, and concerns over liability and funding.’

Precise value offerings of a ‘Connected Health’ system:

The Accenture study titled, ‘Making the Case for Connected Health,’ established that ‘connected health’ approach creates value at three different levels, as follows:

  • Clinical efficacy and safety - Eliminating duplicate lab and radiology tests; improving patient safety through 24/7 access to comprehensive, legible medical records; and speeding up access to patient medical histories and vital information – the cost of treatment can be reduced, significantly.
  • Shared knowledge - Improves care quality, benefits with prompt safety alerts, such as drug interaction, enhances clinical decision-making through sophisticated tools along with evidence-based care protocols, and helps acquiring new capabilities in health care.
  • Care transformation - Advanced analytics help sharing clinical decision-making process, population health management, and facilitate building new care delivery models.

‘Connected health’ in managing chronic diseases:

‘Connected health’ is being practiced at different levels in many countries. These are particularly useful in treating or managing chronic ailments, such as cardiovascular (hypertension), metabolic (diabetes) disorders and COPD (Asthma).  Some examples are as follows:

Many hypertensive patients monitor their blood pressure and other related parameters, through self-operating digital instruments and devices. If the auto-flagged readings get transferred to the treating physicians through IoT system, physicians can promptly adjust the drug doses and offer other required advices over the same system online, and as and when required or periodically. This could avoid periodic personal visits to doctors for the similar purpose, saving time and money. At the same time, it ensures better quality of life through the desired level of disease management, always.

Similar results have been reported in the management of diabetes and Asthma with ‘connected health’ system.

 ‘Connected health’ in treating life-threatening diseases, like cancer:

The paper titled, ‘Smart technology helps improve outcomes for patients with head and neck cancer,’ published by the News Medical on May 17, 2018, which was also read at the June 2018 Annual Meeting of the American Society of Clinical Oncology (ASCO), highlights some interesting developments in this area. This federally funded, randomized clinical trial on 357 people receiving radiation for head and neck cancer, using mobile and sensor technology to remotely monitor patient symptoms, resulted in less severe symptoms related to both the cancer and its treatment.

It also noted: ‘Patients who used the technology – which included a Bluetooth-enabled weighing scale, Bluetooth-enabled blood pressure cuff, and mobile tablet with a symptom-tracking app that sent information directly to their physician each weekday – had lower symptom severity than participants who had standard weekly visits with their doctors. In addition, daily remote tracking of patient wellbeing, according to the researchers, enabled physicians to detect concerning symptoms early and respond more rapidly, compared to usual care.’

While treating serious ailments, medical images, such as computed axial tomography (CT), magnetic resonance imaging (MRI), digital mammography and positron emission tomography (PET), can be connected, stored and shared with cloud-based connectivity and online sharing platforms, as confirmed by several studies. This would enable physicians to build better and deeper referral networks, for better diagnosis and speedier treatment inventions to patients.

‘Connected healthcare’ is fast growing:

As the above Accenture study indicates, many countries have started implementing  ‘connected healthcare’ systems to deliver cost-effective, high-quality and speedy healthcare services to the population with better outcomes. Some of these nations are, Australia, Canada, England, France, Germany, Singapore, Spain and the United States.

According to the New Market Research report titled, “Connected Healthcare Market – Global Industry Analysis, Size, Share, Trends, Growth and Forecast 2018 – 2022,” published by Wise Guy Research: ‘Globally, Asia-Pacific region is one of the fastest growing markets for ‘connected healthcare’. It was valued at USD 2.65 billion in 2015, and is expected to reach USD 23.8 billion by 2022, at the rate of 30.6% during the forecast period.’ During this span, ‘The global connected healthcare market is expected to reach $105,337.5 Million by 2022 at a CAGR of 30.27%,’ with North America commanding largest market share of 36.7%, the report highlights.

‘Connected health’ shows a high potential in India:

The above report also indicates, ‘mobile-health services’ accounts for the largest market segment in the UK, Italy, Japan, China and India. E-prescribing is the fastest growing segment in Asia Pacific and is expected to grow at the rate of 31.27% CAGR during the forecast-period.

E-Health initiative of the Government of India, which is aimed at using of Information and Communication Technology (ICT) in health signals a good potential for ‘connected health’ in India. Fast penetration of mobile technologies even at the hinterland of India will facilitate this process.

Another article titled, ‘Why Connected health is the key to reducing waste and increasing efficiency,’ published in Healthcare India on July 25, 2017, brings to the fore some key benefits of ‘connected healthcare’ in the country. It says, ‘connected healthcare’, can bring path-breaking changes in the country. Following are a few examples:

  • Today when almost 70 percent of the medical expenses are borne by the patient, a ‘connected health’ ecosystem, would reduce admissions by early intervention and potentially deter surgeries.
  • Having access to a patient’s entire medical record, physicians’ will be able to minimize ‘over diagnosis’, amounting to multiple tests, over-medication and avoidable prescriptions, thereby reducing out of pocket health expenditure of patients.
  • When patients are referred from one doctor to the other, or from the rural medical centers to district hospitals, they often need to repeat all the tests, as there is no connected health ecosystem. In doing so, they lose time and sometimes don’t show up for follow up treatments and consultations with their treatment remains incomplete.

Leading private players in ‘connected health’ area:

Some of the leading market players in the global ‘connected healthcare’ market, reportedly, include Agamatrix Inc. (USA), Airstrips Technology (San Antonio), AliveCore Inc. (Australia), Apple Inc. (USA), Athenahealth Inc. (USA), Boston Scientific Co. (USA), GE Healthcare (UK), Honeywell Life care Solutions (UK), Medtronics (Ireland) and Philips Innovation Campus (Bengaluru, India).

Would ‘Connected healthcare’ disrupt pharma’s legacy commercial model:

McKinsey Digital’s March 2012 paper titled, “Biopharma in the coming era of connected health” explains, how ‘connected healthcare’ has started disrupting the legacy commercial models of pharma and Biopharma industry. One of the related examples cited in the article is, pharma’s less emphasis on large sales forces “selling” to physicians.

As this new system gathers wind on its sail, information transparency will allow customers, regulators, and competitors to understand and independently assess the performance of various drugs, often better than what the manufacturers present. These powerful new data sources would reveal true efficacy of medicines, in the real-world settings. No doubt, it will be a significant patient empowerment.

Would pharma be caught off-guard?

Despite such clear signs of changes, the way the pharma industry continues to operate, which as perceived by a majority of the population, is generally self-serving in nature. It has remained virtually unchanged over several decades. Another strong public perception is, patients often get trapped by a two-way financial interest, existing between doctors, hospitals, pharma, biotech – medical devices/diagnostic companies, in various forms. Notwithstanding, industry lobbyists pooh-poohing it, it remains a robust general perception, nonetheless.

That said, this situation can no longer be allowed to remain frozen in time. Today, time is making many things obsolete, including human behavior and business practices, much faster than ever before. This gets fueled primarily by two catalytic factors – one, rapid progress of technology, and the other, which is even more fundamental – the changing demographic profile and social fabric. Together, these are creating a new, informed, more assertive and expressive mindset of people – signaling their needs, preferred choices and processes, even for a health care solution. It’s for the industry now to shape up, soon.

Conclusion:

Joining all these dots, one gets a clear sign of ‘connected healthcare’ gradually evolving in India. Even if, it still takes some more time for an integrated ICT system to be in place, especially in India, it’s for sure that ‘connected healthcare’ will be a reality, surely.

As and when it happens, it will be a disruptive process. The process of sharing all requisite disease prevention, treatment and management related data, between patients, doctors and other care providers, including pharma companies – over regulatory approved, interconnected IoT enabled devices, machines and applications, will benefit all.

There will, of course, be several barriers to overcome, before this new era ushers in. One such hurdle being, many doctors still don’t express a favorable attitude towards adoption of ICT technology in their everyday practice. Alongside, the government with the help of regulators, should enact the requisite laws, and frame stringent rules to ensure enough privacy and security of confidential medical information of individual patients. In tandem, appropriate authorities must ensure that ‘connected healthcare’ system is effectively implemented by all concerned.

As strong environmental needs will hasten this process, public access to high quality healthcare with better outcomes – and all at an affordable cost, will improve by manifold. Thus, I reckon, days aren’t too far to witness ‘connected health care’ in India. But, the hundred-dollar questions still remain unanswered – Are most pharma players ready for the ‘connected healthcare’ regime, or will it catch them off-guard?

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.

A New Pharma Marketing Combo Places Patients At The Center Of Business

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As discussed in several of my previous articles, most pharma players need to walk the talk on ‘patient-centricity’, coming out of prevailing high decibel lip-service. This is not an easy task, and far from being every company’s cup of tea.

Effective implementation of patient-centricity by an organization, entails understanding of behavioral science by today’s pharma marketers. Many of them, I am sure, have already studied it in Business Schools. Be that as it may, by harnessing this scientific knowledge, the insights that they will acquire on primary and secondary pharma customers, will be unique. The important cues that will come out of the insights, will help them create well- targeted strategic marketing game plans having a cutting-edge. When implemented on an ongoing basis, this will help catalyze a win-win business environment, for reaping a rich harvest over a long period of time.

In today’s article, I shall dwell on the increasing relevance of an interesting combo of behavioral science – predictive analytics and patient-centricity, for a sustainable business performance. This is especially for the millennial pharma marketers to try and implement. With blessings from the top management, this model will help them jettison – the increasingly counterproductive – ‘gratification model’ of pharma business, imbibing ‘patient-centric ones’ – that patients themselves can feel and will appreciate.

The basic requirements to make it happen:

The basic requirements of the pharma companies to make it happen is to gradually move away from its core strategy of ‘buying prescriptions’ that often happens through contentious means. No doubt, it has the power to create a temporary strong brand push. But is definitely not sustainable, as these usually go against patients’ health and economic interest.

For a sustainable demand for a pharma brand, pharma companies would need to design a strong ‘brand pull’ in the new paradigm. This would prompt drug companies acquiring deep insights on how to leave a cherishing treatment experience with the patients for the brand. This would, consequently, have a strong-positive rub-off effect on the corporate image, as well. Likewise, a doctor would also like to know, how to create similar patient-experience with his treatment, to draw more of them in the future. This is diametrically opposite to generation of demand for a brand through ‘payment to doctors for prescriptions.’

Pharma marketer’s understanding of behavioral science is necessary:

This is because, it helps to get targeted deep-stick studies done on the way pharma customers, such as doctors and patients, behave. The span of the behavioral study should commence from the onset of a patient’s search for a disease treatment process, right up to when the individual gets an ‘after treatment experience’ – good, bad or average. It is, therefore, necessary for a drug company, to become more patient-centric, rather than self-serving, for achieving the desired goals of pharma business, consistently.

This wisdom would enable pharma marketers developing the following five broad insights for being ‘patient-centric’:

  • Understanding the process of thinking of a type or a group of patients about making their treatment choices. It could often mean not going for any treatment at all, or not adhering to prescribed treatment.
  • What makes patients behave the way they do, while undergoing a treatment?
  • Understanding both mental and physical feelings of patients while suffering from certain disease conditions, for effective engagement with them.
  • What type of holistic treatment experience the patients would value most to cherish.
  • What type of treatment experience the doctors would value most to provide to patients to enhance their practice and professional reputation.

While doing so, pharma marketers would need to clearly harmonize the two areas – one pertaining to doctors, and the other involving patients. This is important for the purpose of a clear focus on a comprehensive brand strategy formulation, based on well-analyzed data.

The key point to note, however – a creative blend of behavioral science with new-age pharma marketing tools can bring a sea change in the business performance of a company, along with providing a delightful treatment experience to patients with its drugs.

Generation of a huge pool of customer behavioral data is the starting point:

The first step of making a patient-centric organization is the generation of a huge pool of data on customer-behavior dynamics. That said, making predictions on the company’s customer behavior for future outcomes of the brand performance, from this data pool, would involve the use data analytics, which for this purpose will be ‘predictive data analytics.’

The use of ‘predictive analytics’ in pharma marketing:

In my article titled, ‘Data: The New Magic Wand For Pharma Business Excellence’, published in this Blog on October 01, 2018, I discussed the importance of well targeted data-based decision-making process, across the pharma functional areas. Taking this idea forward, let me explain here the critical role that ‘predictive data analytics’ can play in acquiring insights of the trend of behavior of the customers, especially patients and doctors.

Simply put, ‘predictive analytics’ is a type of advanced analytics, which are used to get deep insights and making well-informed predictions, based on both past and current data feeds. In pharma, especially for the subject that I am discussing, it pertains to insights on doctor and patient behavior related predictions, encompassing the entire span of a disease treatment process. Skillfully executed, this will strengthen, at least, two critical success factors in the pharma business:

  • Acquiring predictable insights on the targeted customers’ behavioral trend and pattern any given time-frame.
  • With such customer insights making the organization ‘patient-centric’ for more effective engagement with its customers.

Combining the above two points, I can well say, by analyzing a huge pool of data from behavioral-science-based information – ‘predictive analytics’ helps acquire deep insights on predictable customer behavior, with high precision. These are so useful, not just for better engagement with doctors, patients and other stakeholders, but also in making the organization patient-centric, in true sense. Nevertheless, many still question - Is ‘patients centricity’ really feasible in the pharma industry?

Is ‘patient centricity’ really feasible in the pharma industry?

This question was also raised in the 2017 paper titled, “Patient Centricity and Pharmaceutical Companies: Is It Feasible?” -  published in Vol. 51(4) of the Therapeutic Innovation & Regulatory Science (TIRS). The paper captures patient-centricity as integrated measures for listening to and partnering with patients, and placing patients’ well-being at the core of all business initiatives. It represents a holistic approach to the disease management process.

The concept brand-oriented patient-centricity is not too difficult to understand. But, I reckon, the difficulty lies somewhere else. It is to fathom where and how a pharma player can predictably add differentiating value, for those patients who need a right kind of treatment. That’s why, the question of feasibility of ‘patient-centricity’ is being raised.

There is no doubt that such an effort presupposes considerable insights on patients’ behavior, alongside the requisite expertise to predict these, for different time-frames, with a great degree of precision. This not an insurmountable task, either, particularly in today’s paradigm – with state-of-the-art ‘predictive data analytic’ tools. This prompts me to believe, it is very much possible to make a truly patient centric organization, assuming that there will exist a strong will to survive in the business and prosper!

Are ‘predictive data analytics’ different from other analytics?

Yes, the following two key points make ‘predictive data analytics’ quite different from other data analytics:

  • General data analytics usually help acquire insights on the past and present.
  • Whereas, predictive data analytics help looking at near-mid and long-term future, regarding most probable customer behavior pattern and trend, with great accuracy.

Currently, with the ability to generate relevant and real-time big data pool, together with application of machine learning, data-mining and statistical modelling – predictive analytics have the power to help acquire future insights. This insight is totally data-based, sans any gut-feel. Thus, effective use of this process can enable pharma players effectively predict trends and behaviors of doctors and patients for meaningful engagement with them for their chosen brands.

Has potential to create a win-win outcome: 

To ensure a game-changing payback from this process, crafty dovetailing of the following three steps, complementing each other is critical:

  • Generate a huge pool of real-time data on doctors’ and patients’ behavior pattern, for a pre-selected time-frame.
  • With the knowledge of behavioral science, help analyze them with predictive analytics.
  • Understand from the results, the trend of behavioral dynamics of selected customers from the brand perspective.
  • Frame rewarding business strategies to create a win-win situation, involving both – the pharma players and the patients.

Some pharma players are on the ball:

One of the key reasons for imbibing patient-centricity, is the proliferation of ‘me-too’ types of brands – both patented and generics. It has started happening even in the market of high-priced oncology medicines, with not much difference in price between them.

In this situation, predictive data analytic tools can help understand multi-variable relationship between patient’s needs, their interaction with physicians, the oncologist’s prescriptions to them, type of physician-engagement of drug companies and patients’ experience before, during and after the treatment. This is not an easy task, nor all pharma companies have wherewithal of doing this, to gain brand market share, significantly.

With predictive data analytics, many pharma companies are keeping eyes on the ball, using it in different business areas, such as drug discovery. But not many of them, are using this combo-approach to make a patient-centric pharma organization. It is just a matter of time, I reckon, that global pharma will decide to move in this direction – fortified with deep pockets, but with a battered reputation, and facing a hostile pricing environment, across the world.    

Conclusion:

Customer insights, acquired through the crafty application of behavioral science, have immense potential to make sales and marketing decisions more informed, than what it is today. In tandem, it will help create a ‘worth remembering’ treatment experience for the patients with the brand used.

From this perspective, I reckon, skillful application of behavioral science to generate a huge pool of data, and their analysis with ‘predictive analytics’ will go a long way to create a truly ‘patient-centric’ organization.

When executed by a well-integrated expert team of market research, medical affairs and pharma marketing professionals, this new marketing-combo-approach has the potential to fetch a game-changing performance outcome, placing patients at the center of business. The net gain to the organization will be much more than the sum total of what each of these steps can ensue individually – remarkably enhancing corporate reputation, in tandem.

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.

‘Data-giri’: Critical For A Rewarding New Product Launch

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Success in new product launches is a fundamental requirement to excel in pharma business – regardless of whether the drug is innovative or a generic one. For a novel, innovative molecule, associated risks are much higher, as it carries a huge amount of associated R&D expenditure.

The launch plan for a generic formulation or even a ‘me-too’ patented variety, can broadly replicate the first in the class molecule. Whereas, for any breakthrough innovative medicine – it’s a whole new ball game. There are virtually no footsteps to follow. Nonetheless, there is one thing common in both – a robust launch plan is pivotal to success, across the board.

In this regard, the March 2014 article titled, ‘The secret of successful drug launches’, of McKinsey & Company captures an interesting scenario: “About two-thirds of drug launches don’t meet expectations. Improving that record requires pharmaceutical companies to recognize the world has changed and adjust their marketing accordingly.”

On the same issue, Bain & Company also drew a similar outline with its article titled, ‘How to Make Your Drug Launch a Success,’ published about three and half years later – on September 06, 2017. It reported: “Our research shows that nearly 50 percent of launches over the past eight years have under-performed analyst expectations, and more than 25 percent have failed to reach even 50 percent of external revenue forecasts.”

The bottom-line, therefore, is – even if the success rate of new product launches has marginally improved, for various reasons, there still isn’t much to write home about it. In this article, I shall deliberate what type of approaches, when used with powerful cerebral inputs, could possibly improve this rate – significantly and sooner. Could it be with ‘Data-giri’?

What is ‘Data-giri’?

A good question. ‘Data-giri’ is quite an unheard-of terminology, probably was first used by the Chairman of Reliance Industries – Mr. Mukesh D. Ambani, on September 02, 2016. This happened when he announced the forthcoming launch of his mobile network ‘Jio’. At that time, light-heartedly he said:”We Indians have come to appreciate and applaud ‘Gandhigiri’. Now, we can all do ‘Data- giri’, which is an opportunity for every Indian to do unlimited good things, with unlimited data.”

As is known to many, the word ‘Gandhigiri’ is generally used in India to express the power in the tenets of Gandhism. Similarly, the expression ‘Data-giri’ may symbolize the power that the effective use of the right kind and quality of ‘data’ could provide. Unleashing the potential of relevant and requisite data for value creation, would assume critical importance, even in drug launches, more than ever before.

‘Data-giri’ in drug launches:

Right kind and volume of relevant ‘Data’ is fast becoming an important marketing weaponry. Its variety and quality of usage in business, would ultimately differentiate between success and failure.

Today, data usage in pharma marketing can no longer be restricted to just retail and prescription audits, supported at times by a few custom-made marketing research initiatives. The data that I am talking about here, covers mostly real-life and ongoing data in many areas, such as customer behavior, their practices, thinking pattern, aspirations, together with associated changes in trend for each – captured right from the early stages. The cluster of customers includes doctors, patients, healthcare providers and all other stakeholders.

To unleash the hidden power of data for gaining a productive space for brands in customers’ mind, building an arsenal of data for engagement in pharma marketing warfare, is emerging as a new normal for pharma players.

Accordingly, the bedrock of any strategic plan is shifting from – key decisions based mostly on gut feelings, to all such decisions standing on pillars of a large pool of well-analyzed data. From a new product-launch perspective, the basic data requirements would encompass some critical areas, which need to be focused on. I would illustrate this point with a few examples, as below.

Basic data requirements for a new product launch:

One such example in the above area, comes from United BioSource LLC (UBC) – a leading provider of pharmaceutical support service. It highlights 4 real-time basic data insights as critical to a successful drug launch, which I summarize as follows:

  • What market share I want to achieve?
  • Where are my potential high-volume prescribers?
  • What are the characteristics of patients who will receive my drugs?
  • Which physician specialties would prescribe my drug – immediate, medium and long term?

Successful companies do three things right:

Another example on what successful companies do right comes from the above research report of Bain & Company. It found that companies with successful launches do the following three things right:

  • They differentiate their drug through messaging, post-launch data and services.
  • They create broad customer advocacy via a superior customer experience.
  • They organize their launch as a micro-battle and ensure continuous ‘frontline feedback’.

The paper included a few other factors as, comprehensive market research, key opinion leader advocacy and competitive resourcing. The authors observed that pharma executives grossly underestimate several key success ingredients, including customer advocacy and organizing each launch as a micro-battle, with a real-time dual-feedback mechanism involving all concerned, to facilitate prompt intervention whenever required.

From both the above examples, none can possibly refute that without a meticulously created ‘data arsenal’, these exercises are feasible, in any way, for a rewarding new product launch outcome.

Data is fundamental to create a Unique Customer Experience (UCE):

As I wrote in my previous article, the expertise in creating a Unique Customer Experience (UCE) or aUnique Patient Experience (UPE) for a brand, would eventually separate men from the boys in the game of gaining product ‘market share’. Crafty use of data is fundamental for moving towards this direction.

One of the crucial requirements for UCE or UPE is taking a significant share of mind of consumers. This is possible by designing data-based cutting-edge differential advantages of the brand over others. In pharma marketing battleground, this could be done either – with only tangible brand features, or mostly with intangible benefits and perceptions, or an astute mix of both.

Data – essential to measure deviation against the strategic plan:

During any new product launch-phase, it is essential to capture and accurately measure all actual deviations against plan, taking place on the ground at each pre-defined milestone. The exact reasons for each need to be ferreted – both below or above expectations, for immediate necessary actions. This is important, as various studies indicate that the performance trend of a new product in the first six months from its launch, is a good indicator of its future performance.

All types of customer engagements, including selection of communication channels and platforms, should be ongoing research data-based. I emphasized this point in my previous article, as well. It was reiterated that ‘omnichannel content strategy’ for improving patient engagement and providing UPE, across all touchpoints in the diagnosis and treatment process, should be created over the bedrock of high-quality data.

Time for a switch from SOV to SOC:

Creating greater ‘Share of Voice (SOV)’ for a new brand, especially during its launch phase, would no longer work in pharma. This approach is based on the key premise of ‘Jo dikhta hai wo bikta hai’. This often-used Hindi phrase when translated into simple English, may be expressed as: ‘That which is seen is sold.’

In the pharma context SOV may be explained, as I understand: The percentage of total sales promotion and marketing activities for a brand within the sum total of the same in the represented therapy area. It is usually determined by measuring some key parameters, such as frequency and reach of doctors-call, or customer-contact, or even its rank in ‘top of mind brand recall.’

Greater SOV can make marketeers believe that enough is being done by the company to benefit potential brand consumers, which would help reaping a rich harvest. It may also reflect how busy they are with the execution of all planned-activities. On the other hand, consumer-experience may not be quite in sync with the intent and belief of the marketeers. They may not find enough value in the conventional brand marketing process. This is likely to happen much more in the future, as most consumers will want to experience a unique feeling of being cared enough by the company, while moving through all the touch points of the treatment process.

This trend calls for a major shift in pharma marketeers’ approach – from creating a greater SOV to offering greater SOC (Share of Care). I highlighted the importance of providing ‘care’ through several of my articles in the past, published in this blog. One such is titled “Creating A ‘Virtuous Cycle’ Through Patient Reach and Care”, published on April 09, 2018.

Conclusion:

The critical switch from SOV to SOC involves imaginative application of complex data of high quality.

A well-thought-out plan to fetch out critical answers aiming to provide UCE or UPE, will involve in-depth analysis of voluminous data of high quality, through modern-day analytics. From this perspective, fast learning of the art of ‘Data-giri’ is becoming a critical requirement for new product launch success in pharma, as we move on.

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.

Rewriting Pharma Strategy For ‘Doctor Google’ Era

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In search of more and more information on an ailment, a large number of Internet savvy individuals now feel comfortable to consult ‘Doctor Google’ – much before approaching a qualified medical professional for the same. If and when they visit one, many would possibly have arrived at a ‘symptoms-diagnosis correlation’ – based on their own interpretations of the sessions with ‘Doctor Google’– right or wrong.

‘Doctor Google’ – a ‘weird’ terminology, was virtually unheard of, until recently. This name owes its origin to universally popular ‘Google Search Engine.’ The number of frequent ‘consultations’ with ‘Doctor Google’ is breaking new records almost every day – primarily driven by deep penetration of smartphones – a versatile device that helps to charting unhindered, anywhere in the cyberspace.

In this article, I shall not go into whether this trend is good or bad. Nonetheless, the hard fact is, in the modern digital age, this trend is fast gaining popularity, across the world, including India. I shall discuss below, why and how the impact of ‘Doctor Google’ syndrome sends a strong signal to pharma companies to rewrite their business strategies for sustainable future growth.

‘Doctor Google’ syndrome:

To be on the same page with all my readers, ‘Doctor Google’ terminology is used for the process of getting various disease, treatment or medicine related information from cyberspace and especially through Google Search.This practice is currently being followed by many individuals who arenot qualified medical professionals, but through ‘Google Search’ often try to self-diagnose a disease or medical condition, or other health related issues. Some may even cross verify a professional doctor’s advice with ‘Doctor Google’.

Today, it is not uncommon to visit ‘Doctor Google’ first, instead of immediately visiting a General Practitioner (GP) for seeking professional advice. The areas of such search may range from trivial to even serious health conditions. The bottom-line therefore is, prompt ‘information seeking’ of all kinds, including health, and forming an opinion based on available information, is fast becoming a behavioral pattern within Internet canny and smartphone equipped population, across the world.

Medical Journals also reported this trend:

This trend has been captured in medical journals, as well. For example, a paper on Dr. Google in the Emergency Department (ED), published by the Medical Journal of Australia (MJA) on August 20, 2018 concluded as follows:

“Online health care information was frequently sought before presenting to an ED, especially by younger or e-health literate patients. Searching had a positive impact on the doctor-patient interaction and was unlikely to reduce adherence to treatment.”

Yet another study titled, ‘What Did You Google? Describing Online Health Information Search Patterns of ED patients and Their Relationship with Final Diagnoses’, published onJuly 14, 2017 in the ‘Western Journal of Emergency Medicine’, came with a thought-provoking conclusion. Reiterating that Internet has become an important source of health information for patients, this study observed, many of these online health searches may be more general or related to an already-diagnosed condition or planned treatment, as follows:

  • 35 percent of Americans reported looking online, specifically to determine what medical condition they may have;
  • 46 percent of those reported that the information they found online led them to think they needed medical attention;
  • The majority of patients used symptoms as the basis of their pre-ED presentation Internet search. When patients did search for specific diagnoses, only a minority searched for the diagnosis they eventually received.

Availability of credible online ‘symptom-checkers’:

To help patients getting credible information on many symptoms, there are several highly regarded online sources for the same, such as, a Symptom Checker provided by the Mayo Clinic of global repute.

The purpose of this tool is to help narrow search along a person’s information journey. This is not purported to be a self-diagnostic tool. A ‘symptom-checker’allows searchers to choose a variety of factors related to symptoms, helping to limit the potential medical conditions accordingly. This tool does not incorporate all personal, health and demographic factors related to the concerned person, which could allow a definitive cause or causes to be pinpointed. It also flags, the most reliable way to determine the cause of any symptom, and what to do, is to visit a competent health care provider.

Further, the research letter titled, ‘Comparison of Physician and Computer Diagnostic Accuracy’, published in the December 2016 issue of JAMA Internal Medicine, records additional important findings, as follows:

  • Physician diagnostic error is common and information technology may be part of the solution.
  • Given advancements in computer science, computers may be able to independently make accurate clinical diagnoses.
  • Researchers compared the diagnostic accuracy of physicians with computer algorithms called symptom-checkers and evaluated the diagnostic accuracy of 23 symptom-checkers using 45 clinical vignettes. These included the patient’s medical history and had no physical examination or test findings.
  • Across physicians, they were more likely to list the correct diagnosis first for high-acuity vignettes and for uncommon vignettes. In contrast, symptom checkers were more likely to list the correct diagnosis first for low-acuity vignettes and common vignettes.

Nonetheless, the above examples further reinforce the fact that patients now have access to robust online health-related data, on various aspects of a disease treatment process.

Technology is rapidly transforming healthcare:

That technology is rapidly transforming healthcare is vindicated by the estimate that the global market for digital health is expected to reach £43 billion by the end of 2018. This was noted in an article, titled ‘3 ways the healthcare industry is looking more like Google, Apple and Amazon’, published in Pharma IQ on November 16, 2018.

Pharma companies are realizing that an increasing number of patients now have better access to online information regarding their overall health and medical conditions, including various prevention and treatment options with costs for each. As people take a more active role in managing their health, pharma players, especially in their engagement with patients, require moving from mostly passive to active communication platforms. Consequently, personalizing health care products and services is expected to become the new norm, making the traditional pharma business models virtually redundant, the article highlights.

While going through this metamorphosis, pharma sector would willy-nilly emerge as an integrated technology-based industry. More tech-based changes will call for in various critical interfaces related to an organization’s ‘patient-orientation’, which is today more a lip-service than the ground reality. Entry of pure tech-based companies such as Google, Amazon and Apple into the healthcare space would hasten this process.Although such changes are taking place even in India, pharma companies in the country are yet to take it seriously.

Pioneering ‘omnichannel’ engagement is pivotal: 

Again, to be on the same page with all, the term Omnichannel in the pharma parlance may be used for a cross-channel content strategy for improving patient engagement and overall patient-experience. This should include all touchpoints in the diagnosis and treatment process of a disease. It is believed, the ‘companies that use ‘omnichannel’, contend that a customer values the ability to engage with a company through multiple avenues at the same time.’ Thus, pioneering ‘omnichannel’ engagement is critical for a pharma player in today’s scenario.

A valid question may come up – is ‘Omnichannel (all-channel)’ patient engagement is just another name of ‘Multichannel (many-channel)’ engagement? No – not really. Interestingly, both will be able to deliver targeted contents to patients through a number of interactive digital platforms, namely smartphone-based Apps, specially formatted websites, social media community and the likes. But the difference is, as a related paper lucidly puts it - ‘Omnichannel approach connects these channels, bridging technology-communication gaps that may exist in multichannel solutions.’

That said, just as the above-mentioned pure technology companies, pharma players also need to learn the art of gathering a large volume of credible data, analyze those through modern data analytics for taking strategic decisions. This is emerging as an essential success requirement, even in the health care arena.

Precise data-based answers to strategic questions, as planned, are to be used effectively for omnichannel personalized patient engagement. This is fundamental to offer a delightful personal experience to patients, encompassing diagnosis, treatment, recovery, including follow-up stages of an ailment, especially involving the chronic ones. Only well-qualified and adequately trained professionals with in-depth pharma domain knowledge can make it happen – consistently, across multiple channels, such as social media, Apps and devices – seamlessly.

Real time customer data management is critical:

Virtually real time customer data management of huge volume that aims to provide ‘Unique Patient Experience (UPQ)’,is the lifeblood of success in any ‘omnichannel’ engagement. This is criticalnot just for right content strategy formulation, but also to ensure effective interaction and utilization between all channels, as intended, besides assessing the quality of UPQ. Once the process is in place, the marketers get to know promptly and on an ongoing basis, about the quality patient experience – as they travel through various touchpoints, to intervene promptly whenever it calls for. I explained this point in my article titled ‘Holistic Disease Treatment Solution: Critical for Pharma Success’, featured in this blog on October 29, 2018.

Credible data are all important – not just any data:

Real time voluminous data generation, coupled with astute analysis and crafty usage   of the same, has immense potential to unlock doors of many opportunities. The effective leverage of which ensures excellence in business. But most important in this endeavor, it is of utmost importance to ensure that such data are of high quality – always. Similarly, use of any high-quality data, if not relevant to time, in any way or outdated, can be equally counterproductive.

An article titled, ‘Hitting Your Targets: A Check-up on Data’, published at PharmExec.com on August 02, 2018, aptly epitomizes it. It says, no matter what sophisticated technologies a life sciences organization uses, and how smart its sales and marketing strategy is, if there are flaws and gaps in foundational provider data, the company will end up with wasted resources and lost market share. Implementing ongoing data governance and stewardship programs will help improve efficiencies, allocate resources, and target customers with increased precision.

Conclusion:

Going back to where I started from, it’s a fact that many Internet-friendly people now visit ‘Doctor Google’, much before they visit a medical doctor. Most probably, they will also arrive at a list of possible diagnoses, according to their own assessment.

While going through this process, they acquire an experience, which may or may not be new or unique in nature – depending on various circumstances. But the key point is, such patients – the number of which is fast increasing, are no longer as naïve as before on information related to a host of ailments. Consequently, the ‘pharma-patient interaction’ that has traditionally been passive, and through the doctors, will require to be more active and even proactive. This has to happen covering all the touchpoints in an involved disease treatment process where pharma is directly or indirectly involved.

To be successful in this new paradigm, pharma companies need to ensure that such ‘active communication’ with patients is necessarily based on a large pool of constantly updated credible data, exchanged through ‘omnichannel’ interactive platforms. The key success factor that will matter most is providing ‘unique patient experience’ through this process and its high quality. From this perspective, I reckon, rewriting pharma business strategy is of prime importance in the fast unfolding ‘Doctor Google’ era.

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.

Data: The New ‘Magic Wand’ For Pharma Business Excellence?

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Pharma companies focus more on defending their current practices, rather than doing things differently. A September 24, 2014 article by Bain & Company, titled ‘New Paths to Value Creation in Pharma’, made this observation.

This happens regardless of the credence that leaders who change too early, risk losing attractive cash flows from established business models, and those that move too late risk being disrupted by emerging competitors. However, analyzing the recent history, the authors observed that pharma leaders have more often erred on the side of holding on to old models for too long, leaving room for more aggressive players to disrupt them.

Analysis of the 10 companies in the above study also found: “With their sustained success, these companies refute the widely held assumption that serendipitous innovation is the key to success in pharma.” However, on the ground all 10 of these large global drug companies have prospered despite industry-wide trends such as declining R&D productivity and the demise of the primary care blockbuster model. The authors explained: “This is because they operate in a high-margin environment.”

Starting with this scenario, I shall submit in this article, why the importance of well targeted data-based decision-making process, across the pharma functional areas, is now more than ever before.

Rewriting notes in the business playbook, taking cue from new data:

Having charted in the high margin ambience, Big Pharma exhibit reluctance in recomposing notes in the business playbook, based on a new set of real-life data. This is essential for sustainable success in a fast-changing business, political and social environment. They keep maintaining a strong belief in what they have been believing, regardless of what a large volume of credible data overwhelmingly indicates. Ongoing near unanimity in their collective decision to further intensify expensive advocacy initiatives in the same direction, continues. Other pharma players follow the same course.

This vicious circle continues sans any positive outcome, neither for pharma, nor for the patients. Already dented reputation of the industry gets more dented. In my various articles in this blog, I deliberated on various areas that merit radical overhaul in the pharma business, including patient-centricity and transforming the business through digitalization.

Use of data and analytics leaves room for a huge improvement in pharma: 

Let me express upfront, I am not trying to say, in any way, that pharma companies, in general, are not making investments for customized data generation or in analytics for use in new drug discovery and development, aiming improved process productivity. But, in many other functional areas, such as drug marketing, stakeholder engagement or even in strategic corporate communication for greater effectiveness, usage of scalable data and modern analytics leave much room for improvement.

Quality of data-use – ‘the proof of the pudding is in the eating’: 

As the saying goes, the proof of the pudding is in the eating, let me give a couple of examples on the quality of data-use and their outcomes in the areas under discussion.

Sizeable data clearly establishes the wish of most stakeholders, including patients for transparency in drug pricing, alongside improved access to affordable medicines. However, Big Pharma and their associates trying to swim against the tide keep advocating how the expensive process of drug innovation merits high drug prices. Understandably, negative public perception towards the industry further intensifies. Assuming that data analytics are extensively put to use while developing such communication, can anyone possibly cite such efforts as examples of productive use data?

Similarly, if any pharma company, for example, Sanofi besides many others, claims that it aims at ‘promoting and sustaining ethics and integrity in all our activities’ and has developed a comprehensive body of policies and standards, to provide guidance on a range of challenges specific to pharma industry like anti-bribery. However, in practice, we hear and read, even very recently that ‘Sanofi to pay more than $25 million to resolve corruption charges’ and which is not a solitary instance, either. The question, therefore, surfaces, how can data play any role in the fight against corruption by uncovering, preventing and deterring corruption.

‘How data is changing the fight against corruption:’

There are many published research papers, which established that effective use of data can prevent such corruption, and surely in cases of alleged repeat or multiple offenders in the pharma industry. One such paper titled, ‘How data is changing the fight against corruption,’ published in the OECD Forum Network on February 13, 2018, also reconfirms this point. It says:Data – both big and open – is indeed changing the anti-corruption landscape, by uncovering, preventing and deterring corruption.

Is pharma leveraging the data power for holistic business success?

I am not sure, but available evidences suggest most of them are not – at least, aiming for holistic business success. This is because, in the pharma industry, including Big Pharma, as I wrotein the past, alleged corrupt practices are widespread and continue unabated. This is quite evident from the national and international business magazines and media reports, coming rather frequently. The Transparency International Report titled “Corruption in the pharmaceutical sector – Transparency International 2016”, discusses the raging issue across the various functions of many drug companies.

Besides pharma and biotech R&D, there are many other critical areas, where leveraging data power with expert application of analytics, pharma players can reap rich harvest in terms of sustainable long-term business growth. However, for that there are some prerequisites, like – an open mind, unbiased approach, a mindset to accept reality as they are, and then neutralize the unfavorable ones with cerebral power. Trying to rationalize what is not working makes the situation worse, more complex, creating stronger headwinds.

Many sources of data capturing, still limited usage:

There are many sources of abundant data availability of various kinds, for pharma players. However, targeted data gathering of scale and appropriate analysis of the same, still remain rather limited in pharma. For example, while marketing their brands, numerous drug players in India don’t venture going beyond limited sources for data capturing for broad analysis. Such data may usually include, syndicated retail and prescription audits, besides internal sales and marketing details together with associated expenses or productivity related statistics. Data mining for dip-stick analysis is done seldom, according to industry sources.

Additionally, there are copious others who operate predominantly on ‘gut feeling’ and hearsay, sans any customer related meaningful and real-time data. When we create hype on patient-centricity, and alongside witness the general outcomes of such approaches, it requires no rocket science to fathom how much intelligent data input has gone behind such strategies.

The present system itself generates an enormous amount of real-time data in various areas, though most are not effectively utilized for weighty payoff, especially in pharma. The ongoing process of data generation also includes, drug innovation initiatives, manufacturing, supply-chain, distributor–wholesaler-retailer activities, digital apps and different websites, besides scores of other sources. But, the information, as stated above, apparently, is hardly analyzed through analytics to obtain targeted strategic inputs. Leave aside, intelligent application of the same to scale newer heights of all-round business success.

Data generation for swimming against the tide of public perception:  

Although, it’s not yielding positive results, I understand, pharma keeps spending a lot, both at the company level or through their trade bodies, to rationalize what they want the stakeholders to believe. For example,’ drug price control limits access to drugs’. Various reports to this effect are made public and used for the aggressive advocacy campaigns, though hardly taken seriously by those who matter.

Any price control, I reckon, may not be supported in ordinary circumstances. However, drug price control has definitely helped India to improve access to drugs without impeding any reasonable growth of the industry. That 5 or 10-year CAGR of the drug industry comes in double digit, despite continuation of drug price control regime for the last 48 years, offers a testimony to this fact. It’s a different issue, though, that Indian public health care system remains in shamble, even in the present regime. The lackadaisical attitude of all governments on public health related areas, is held responsible for this failure.

Conclusion:

The bottom-line is, expensive data generation effort, when gets primarily driven by self-serving motives, becomes increasingly counterproductive, as cited above. More informed stakeholders of date, including patients, probably other than the stock markets, want to see pharma players more in sync with the ground realities, and are acting accordingly. Thus, for sustainable business success, saner senses should prevail to generate adequate amounts of credible and targeted data, analyze them properly through analytics and use these with cerebral power to create a win-win situation in the pharma business.

In my view, any comprehensive ‘Decision Support System’ of an organization should go beyond the generation of mammoth internal business-related data. It should be integrated with the same kind of targeted external data of scale, with the use of modern analytics. This needs to happen – both at the macro level – as an organization, and also at the micro level – with its various functions. The corporate illusion of always ‘operating in a high-margin environment’ in pharma, will not guarantee sustainable business success, any longer.

From this perspective, using well-integrated internal and external data as the bedrock of all strategic decisions in pharma, I reckon, would soon prove to be a ‘magic wand,’ as it were, for pharma business excellence.

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.

 

Why MNC Pharma Still Moans Over Indian IP Ecosystem?

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Improving patient access to expensive drugs, paving the way for entry of their cheaper generic equivalents, post patent expiry, and avoiding evergreening, is assuming priority a priority focus area in many countries. The United States is no exception, in this area. The Keynote Address of Scott Gottlieb, Commissioner of Food and Drug at the 2018 Food and Drug Law Institute Annual Conference inWashington, DC by, on May 3, 2018, confirms this. Where, in sharp contrast with what the MNC Pharma players and their trade associations propagated, the US-FDA commissioner himself admitted by saying, “Let’s face it. Right now, we don’t have a truly free market when it comes to drug pricing, and in too many cases, that’s driving prices to unaffordable levels for some patients.”

Does US talk differently outside the country?

At least, it appears so to many. For example, in April 2018, the Office of the United States Trade Representative (USTR) released its 2018 Special 301 Report. In this exercise, the USPTO names the country’s trading partners for not adequately protecting and enforcing Intellectual Property (IP) rights or otherwise deny market access to U.S. innovators that rely on the protection of their IP rights.’ Accordingly, U.S. trading partners are asked to address IP-related challenges, with a special focus on the countries identified on the Watch List (WL) and Priority Watch List (PWL).

In 2018, just as the past years, India continues to feature, along with 11 other countries, on the PWL, for the so called longstanding challenges in its IP framework and lack of sufficient measurable improvements that have negatively affected U.S. right holders over the past year.

From Patient access to affordable drugs to Market access for Expensive Drugs: 

Curiously, the USTR Report highlights its concerns not just related to IP, but also on market access barriers for patented drugs and medical devices, irrespective of a country’s socioeconomic compulsion. Nevertheless, comparing it to what the US-FDA Commissioner articulated above, one gets an impression, while the US priority is improving patient access to affordable drugs for Americans, it changes to supporting MNC pharma to improve market access for expensive patented drugs, outside its shores.

Insisting others to improve global IP Index while the same for the US slides:

In the context of the 2018 report, the U.S. Trade Representative, reportedly said, “the ideas and creativity of American entrepreneurs’ fuel economic growth and employ millions of hardworking Americans.” However, on a closer look at the U.S. Chamber of Commerce’s annual Global IP Index for 2018, a contrasting fact surfaces, quite clearly. It shows, America, which once was at the very top of the overall IP Index score, is no longer so – in 2018, the world rank of the US in offering patent protection to innovators, dropped to 12thposition from its 10thglobal ranking in 2017. Does it mean, what the US is asking its trading partners to follow, it is unable to hold its own ground against similar parameters, any longer.

Should IP laws ignore country’s socioeconomic reality? 

MNC Pharma often articulated, it doesn’t generally fall within its areas of concern, and is the Government responsibility. However, an affirmative answer, echoes from many independent sources on this issue. No wonder, some astute and credible voices, such as an article titled “U.S. IP Policy Spins Out of Control in the 2018 Special 301 Report”, published by the Electronic Frontier Foundation on May 01, 2018, termed 2018 Special 301 Report – ‘A Tired, Repetitive Report.’ It reiterates in no ambiguous term: ‘The report maintains the line that there is only one adequate and effective level of IP protection and enforcement that every country should adhere to, regardless of its social and economic circumstances or its international legal obligations.

The ever-expanding MNC Pharma list of concerns on Indian IP laws:

The areas of MNC Pharma concern, related to Indian IP laws, continues to grow even in 2018. The letter dated February 8, 2018 of the Intellectual Property Owners Association, Washington, DC to the USTR, makes these areas rather clear. I shall quote below some major pharma related ones, from this ever-expanding list:

  • Additional Patentability Criteria – section 3 (d): The law makes it difficult for them to secure patent protection for certain types of pharma inventions.
  • TADF (Technology Acquisition and Development Fund)is empowered to request Compulsory Licensing (CL) from the Government:Section 4.4 of India’s National Manufacturing Policy discusses the use of CL to help domestic companies access the latest patented green technology.This helps in situations when a patent holder is unwilling to license, either at all or “at reasonable rates,” or when an invention is not being “worked” within India.
  • India’s National Competition Policyrequires IP owners to grant access to “essential facilities” on “agreed and nondiscriminatory terms” without reservation. They are not comfortable with it.
  • Regulatory Data Protection: The Indian Regulatory Authority relies on test data submitted by originators to another country when granting marketing approval to follow-on pharma products. It discourages them to develop new medicines that could meet unmet medical needs.
  • Requirement of local working of patents: The Controller of Patents is empowered to require patent holders and any licensees to provide details on how the invention is being worked in India. Statements of the Working, (Form 27),must be provided annually.Failure to provide the requested information is punishable by fine or imprisonment. It makes pharma patent holders facing the risk of CL, if they fail to “work” their inventions in India within three years of the respective patent grant.
  • Disclosure of Foreign Filings: Section 8 of India’s Patent Act requires disclosure and regular updates on foreign applications that are substantially “the same or substantially the same invention.” They feel it is irrelevant today.

Pharma MNCs’ self-serving tirade is insensitive to Indian patient interest:

Continuing its tirade against some developed and developing countries, such as India, the US drug manufacturers lobby group – Pharmaceutical Research and Manufacturers of America (PhRMA) has urged the office of the US Trade Representative (USTR) to take immediate action to address serious market access and intellectual property (IP) barriers in 19 overseas markets, including India, reports reported The Pharma Letter on February 28, 2018. It will be interesting to watch and note the level active and passive participation of India based stakeholders of this powerful US lobby group, as well.

Government of India holds its ground… but the saga continues:

India Government’s stand in this regard, including 2018 Special 301 Report, has been well articulated in its report released on January 24, 2018, titled “Intellectual Property Rights Regime in India – An Overview”, released by the Department of Industrial Policy and Promotion Ministry of Commerce and Industry (DIPP). The paper also includes asummary of some of the main recommendations, as captured in the September 2016 Report of the High-Level Panel on Access to Medicines, constituted by the Secretary-General Ban Ki-Moon of the United Nations in November 2015.  Some of these observations are as follows:

  • WTO members must make full use of the TRIPS flexibilities as confirmed by the Doha Declaration to promote access to health technologies when necessary.
  • WTO members should make full use of the policy space available in Article 27 of the TRIPS agreement by adopting and applying rigorous definitions of invention and patentability that are in the interests of public health of the country and its inhabitants. This includes amending laws to curtail the evergreening of patents and awarding patents only when genuine innovation has occurred.
  • Governments should adopt and implement legislation that facilitates the issuance of Compulsory Licenses (CL). The use of CL should be based on the provisions found in the Doha Declaration and the grounds for the issuance left to the discretion of the governments.
  • WTO members should revise the paragraph 6 decision in order to find a solution that enables a swift and expedient export of pharmaceutical products produced under compulsory license.
  • Governments and the private sector must refrain from explicit or implicit threats, tactics or strategies that undermine the right of WTO Members to use TRIPS flexibilities.
  • Governments engaged in bilateral and regional trade and investment treaties should ensure that these agreements do not include provisions that interfere with their obligations to fulfill the rights to health.

The DIPP report includes two important quotes, among several others, as follows:

Joseph Stiglitz, Nobel Prize for Economics (2001) – an American Citizen:

-       “If patent rights are too strong and maintained for too long, they prevent access to knowledge, the most important input in the innovation process. In the US, there is growing recognition that the balance has been too far tilted towards patent protection in general (not just in medicine).”

-       “Greater IP protection for medicines would, we fear, limit access to life-saving drugs and seriously undermine the very capable indigenous generics industry that has been critical for people’s well-being in not only India but other developing countries as well”.

Bernie Sanders, an American Citizen and Senior U.S. Senator:

-      “Access to health care is a human right, and that includes access to safe and affordable prescription drugs. It is time to enact prescription drug policies that work for everyone, not just the CEOs of the pharmaceutical industry.”

-      “Healthcare must be recognized as a right, not a privilege. Every man, woman and child in our country should be able to access the health care they need regardless of their income.”

Conclusion:

Why is then this orchestrated moaning and accompanying pressure for making Indian IP laws more stringent, which apparently continues under the façade of ‘innovation at risk’, which isn’t so – in any case. But, cleverly marketed high priced ‘me too’ drugs with molecular tweaking do impact patient access. So is the practice of delaying off-patent generic drugs entry, surreptitiously. Instead, why not encourage Voluntary Licensing (VL) of patented drugs against a mutually agreed fee, for achieving greater market access to the developing countries, like India?

Whatever intense advocacy is done by the vested interests to change Indian patent laws in favor of MNC pharma, the intense efforts so far, I reckon, have been akin to running on a treadmill – without moving an inch from where they were, since and even prior to 2005. The moaning of MNC Pharma on the Indian IP ecosystem, as I see it, will continue, as no Indian Government will wish to take any risk in this area. It appears irreversible and is likely to remain so, for a long time to come. The time demands from all concerned to be part of the solution, and not continue to be a part of the problem, especially by trying to tamper with the IP ecosystem of the country.

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.