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Expand Market Share Unleashing Digital Health Potential For All

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“Advancement in digital health is currently restricted mainly to economically and socially privileged populations. Those having access, resources and basic digital skills, are reaping disproportionate benefits from the technology and other associated infrastructure available for this purpose. Unfortunately, underserved population, mostly in rural hinterland and in some urban areas, still do not have much access to this technical advancement in the healthcare space. Ensuring affordable access to “Digital Health” in digital India, would help augment quality healthcare support with equity, to all in the country.” I wrote the above in my article on digital health, published in this blog, way back on March 09, 2015.

About two years down the line from that date, the IQVIA report – ‘The Growing Value of Digital Health’, published on November 07, 2017, also reported: ‘The impact of Digital Health on patient care is accelerating with the increasing adoption of mobile health apps and wearable sensors.’ It highlighted, among others, the following important points:

  • Health-related mobile applications available to consumers nearly doubled from the number available just two years ago, with increasing clinical evidence on app efficacy – supported by 571 published studies in 2017.
  • The use of Digital Health apps with proven reductions in acute care utilization include, diabetes prevention, diabetes management, asthma, cardiac rehabilitation, and pulmonary rehabilitation.
  • ‘Digital health’ signals a high potential in reducing overall health care cost for both patients and the providers – reducing huge burden on the health system, significantly.
  • Efforts by patient care organizations to fit ‘’Digital Health tools into clinical practice have progressed with 540 current clinical trials in the U.S. incorporating these tools, and an estimated 20% of large health systems shifting from pilot ‘Digital Health’ programs to more full-scale rollouts.
  • However, despite progress to date, several barriers still exist to widespread adoption by patient care institutions, and only an intermediate level of adoption has yet occurred.

In this article, I shall explore – how pharma marketers can expand their respective brand market share by unleashing the full potential of digital health, for all, and equitably, while formulating their marketing strategies of the new normal.

Digital health accelerated effective response to COVID-19 challenges:

Never has extensive operational overhaul been more urgent in health care than in the current climate of the COVID-19 pandemic – emphasized the article on ‘Digital health during COVID-19’, published in the February 2021 online issue of The Lancet (Digital Health). The paper underlined – the urgency of the pandemic prompted new models of patient treatment, providing medical professionals tools to respond effectively to the unprecedented crisis, with the advances in digital health.

However, the authors cautioned, ‘to ensure sustained adoption, it is necessary to not assume that digital solutions will naturally assimilate into clinical practice, and instead adopt participatory approaches that regularly involve stakeholders.’ Meanwhile, a confused signal is causing delay in the speedy adoption of digital health.

Is a confused signal delaying speedy adoption of digital health?

As Covid vaccination process gaining steam, the pandemic, apparently, is coming under control in many places of the world, just as it is in India. Alongside, several optimistic health care facilitators, providers and even regulators are probably awaiting the old normal to return – especially, F2F customer services.

Whereas, the above The Lancet (Digital Health) study finds – the clinical demand for digital services are gradually picking up – mostly because of the sudden surge in patient demand during the pandemic. Intriguingly, amid this situation, weak governance of digital technologies and platforms, is increasing health inequities and compromising human rights, which I wrote in my article on digital health, published in this blog, on March 09, 2015.

Weak governance of digital health results, increasing health inequities:

That weak governance of digital technologies and platforms, is increasing health inequities, was reiterated by yet another contemporary article titled – ‘Digital technologies: a new determinant of health,’ published in the November 2021 issue of The Lancet (Digital Health).

The article revealed, ‘The Lancet’ and ‘Financial Times’ Commission on governing health futures 2030’ has made important recommendations for successful integration of digital technologies in health. The bottom line of which is, weak governance of digital technologies is causing health inequities and compromising human rights. The study also emphasized, the future governance of digital technologies in health care ‘must be driven by the public purpose, not private profit’.  

Points to ponder for pharma marketers:

As iterated in the article of the November 2021 issue of The Lancet (Digital Health), the following facts needs to be considered by all, especially I reckon, by astute pharma marketers:

  • The COVID-19 pandemic has caused massive disruptions within health care, both directly as a result of the infectious disease outbreak, and indirectly because of prompt public health measures to mitigate against transmission.
  • This unprecedented disruption has caused rapid dynamic fluctuations in demand, capacity, and even contextual aspects of health care.
  • Therefore, the traditional face-to-face patient–physician care model has had to be re-examined in many countries, including India.
  • To rapidly tide over the crisis, and thereafter to avoid similar possible situations in the future, digital technology and new models of care are being rapidly deployed to meet the challenges of change, triggered by the pandemic.
  • The new models include remote digital health solutions such as telehealth, artificial intelligence – decision support for triaging and clinical care, and home monitoring of several ailments.
  • Operationalizing these new models will be based on the choice of technology support, clinical need, demand from patients, and manpower availability – ranging from pre-hospital to out-of-hospital models, including the hub-and-spoke model.

Conclusion:

It is widely believed today, the pan-industry shift toward digital health of different types is here to stay, in varying degree, though, and accelerate further for several strategic reasons. These include, adding more flexibility in attaining greater efficiency and effectiveness for customer engagement, and patient-perceived brand value delivery to them.

That said, as I wrote before, customer engagement may call for a hybrid business model of virtual and in-person F2F engagements. However, going back to the old normal of in-person F2F engagements for all doctors could probably be a far cry. Similarly, the initial success of e-customer engagement is unlikely to replace in-person and in-clinic F2F engagements of sales reps completely.

From the above perspective, I reckon, pharma marketers may now wish to expand their brand market share, significantly, by unleashing the full potential of digital health for all, and equitably, particularly, in the new normal.

However, in that process, they need to be vigilant for not deviating from the key purpose of digital health for the end users. This must reach across all socioeconomic strata, regardless of patient demographics or their geographical locations. It’s, no doubt, easier said than done, but has to happen – for the sake of health-equity - augmenting healthcare for all in India.

By: Tapan J. Ray      

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

Shape of Future Pharma Operations – Emerging A Pragmatic Outlook?

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Just as newer reports come almost every day on safety, efficacy, dosage interval or span of immunity of Covid vaccines, similar reports are also reaching us about the possible future shape of pharma sales and marketing operations. Some hardcore optimists, apparently more from India, still believe that current changes in pharma customer behavior are mostly transient. All business processes will eventually fall in their traditional grooves, as the Covid menace disappears from our lives soon.

No doubt, several studies are also bringing out a number of respondent doctors’ preferences on reverting to F2F engagements, programs and events. Nonetheless, most other experts, including several large global pharma majors, believe that the future shape of business operations won’t be quite the same as the past. There are better ways to be more effective, leveraging the changing environment. Accordingly, they have initiated actions, reimagining the pathway of new operational frontiers. In this article, I shall explore the evolving pragmatic outlook in just two of these action areas:

  • The new and unique role of medical representatives
  • Digital health care solutions as a new growth opportunity

New role of medical representatives:

A recent survey published by Reuters Events Pharma on December 18, 2020, revealed that 30% of the respondents still expect that Medical Reps’ (MR) face-to-face access to HCPs would return to the status quo ante of Covid pandemic restrictions. However, a majority of 70% felt that the old normal is unlikely return as such. The study also brought out that the size and disposition of sales teams are under review by many of pharma players and smaller field forces look likely, as the industry moves on.

My personal experience with the Indian Pharma Industry sources suggests, when a Covid pandemic wave starts finding its peak, the feeling of the above 70% prevails. However, when the same wave climbs down from its peak to a transient trough, a large number of Indian companies and experts tend to feel somewhat akin to what the above 30% expressed in the Reuters Events Pharma survey. The process gets repeated with the emergence of the next wave.

Alongside, as the above survey also finds out, most physicians are no longer expecting – brand-driven high sales pitches, during any MR-Doctor interaction or the engagement process. Instead, they are increasingly looking for insights – in an integrated, personalized and value-driven interactions with the Reps.

Considering this as a trend of over last one year or so, it is likely that MR-doctor interactions will now need to be on digital and omnichannel platforms to deliver a personalized and value driven an experience to the customers. In this environment, the field force may be smaller in size than what it used to be in early 2020 but will have a unique new role to play. This process will come with a new challenge, especially to those inbred companies, who are still undecided about the road ahead for business excellence, in the new normal.

Three new pharma leadership challenges:

Apparently, a large number of domestic drug companies, irrespective of size and scale of operations still feel comfortable to be in the old comfort zone that had propelled the business in a growth trajectory. Most pharma sales and marketing staff members, at several levels, have grown within the industry, consistently delivering high performance.

This situation by itself, as the above research paper revealed, poses three fresh challenges for many companies to make their field-staff ready to play a unique and fresh role in e-marketing. Thus, the three new knots to untie in the virtual world, are the following:

  • Currently, most MRs are not proficient in selling in virtually,
  • They are being led by people who have also never sold virtually,
  • They are being trained by people who also have never sold virtually.

MRs will continue to have a role to play even in the digital world:

To overcome the above challenges, today’s reality prompts new L&D needs of pharma’s new e-environment. And from this perspective, I think, they would need professional domain experts’ hand-holding, at least, in the transition phase of digital marketing. Some companies have initiated this process for greater sales force effectiveness, since 2019. A recent example in this area may be quoted from a report on October 01, 2019.

The article highlights, ‘AstraZeneca sales reps have some new help in the coaching department, resulting improved interactions and better development of sales reps’ strengths. While leaders still manage reps, artificial intelligence—in the form of data generated from thousands of field-coaching forms—now adds machine-learned analysis and advice.’

Thus, it is worth noting that MRs will continue to play an important role, alongside remote digital marketing using omnichannel or multi-channel engagement platforms. The same also came out clearly in the latest study from healthcare consultancy ZoomRx, reported on April 08, 2021, where its findings raised an important question - ‘Did pharma overshoot digital sales rep calls?’ This dilemma was prompted by the study charts reflecting a decline in its effectiveness, during this specific survey period.

Thus, in my opinion, a hybrid business model for better performance will be more effective in the new normal. However, ascertaining the right mix of digital and MR’s in-person interactions, may pose a challenge for many pharma marketers.

Entry into digital health solutions – an opportunity for growth: 

Before Covid pandemic, digital therapeutics or digital health solutions were not an unknown area for several pharma companies, as a growth booster in the modern world. But, it wasn’t explored so intensively as it is being discussed today, for the same. A recent paper titled, ‘Digital health during COVID-19: lessons from operationalizing new models of care in ophthalmology,’ published in The Lancet on February 01, 2021, vindicates this point.

The paper emphasized, due to Covid pandemic ‘the traditional face-to-face patient–physician care model has had to be re-examined in many countries, with digital technology and new models of care being rapidly deployed to meet the various challenges of the pandemic.’ It further highlighted, these new models incorporate digital health solutions such as telehealth, AI based decision support for triaging, besides clinical care, and home monitoring.

Global pharma majors, such as Novartis, have publicly acknowledged on January 21, 202 that ‘digital innovation looks set to dominate the 2021 healthcare agenda.’ The statement said, COVID-19 was a catalyst for change in healthcare during 2020 and an accelerator for digital health. Similarly, 2021 looks set to continue the revolution – exploiting ‘an explosion of interest, traction and scale’ in the potential for digital solutions. These would not only support remote working, but also keep the very fabric of business, healthcare, education, and essential services in operation.

Other important and recent examples of digital health care solutions: 

Witnessing the COVID-19 pandemic pushing more people toward virtual doctor visits over the last one year, AstraZeneca, as reported on April 06, 2021, is preparing for it in the new normal, through a novel project with Massachusetts General Hospital. The Company is now in the process of establishing and validating its ‘recently launched digital health platform, designed to help patients with chronic illnesses manage their conditions without stepping foot into the academic medical center’s clinic.’

Similarly, several other companies, are also investing to be early entrants with user friendly state of the art technology in this space. Interestingly, many of these ventures were reported during March and April 2021.

Conclusion:

Arthur Miller’s play ‘Death of a Salesman,’ broadly addressed the loss of identity and a man’s inability to accept change within himself and society. Although, the book depicts a larger philosophical perspective of life – many pointed out similar issues in the drug industry perspective, as well.

Nonetheless, many studies have established, pharma MRs have been effectively delivering, since long, the endpoint deliverables, as expected of them – sales. However, the question that still haunts many – can this core process be re-imagined for greater efficiency and effectiveness at a lesser cost, harnessing modern technology. An article, published in the Pharmaphorum on March 11, 2011, has also suggested – ‘in the wake of the COVID-19 pandemic, there is an even greater need to re-examine the rep’s role. How can a field force evolve to deal with current challenges and be future-fit for the way we will be working in the post-pandemic world?’ 

There is no confusion today that MRs’ will have a key role to play in pharma’s digital endeavor. However, the key purpose of having them has evolved during the pandemic. Such as, from being an efficient way to achieve personal communication objectives – to be an orchestrator for physicians to navigate the difficult landscape, providing them a differentiated service. For this purpose, I reckon, a hybrid business model for better performance, will be more effective in the new normal, while quickly adapting to digital transformation. However, arriving at the right mix of digital and MR’s in-person interactions, may pose a challenge for many pharma marketers, as it will be a company-specific need.

Similarly, the criticality of leveraging opportunities to provide remote delivery of digital health care solutions to patients, has also come onto the radar of many pharma players, during this difficult time. Several players have already added this area as a lucrative business expansion platform – many more are expected to follow. Thus, in my view, the fast-evolving data-based trends are now giving a pragmatic shape to future pharma operations – especially on the new and unique role of medical representatives and the relevance of digital health care solutions, as a growth opportunity.

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.

Pharma ‘Chatbots’: For Better Stakeholder Engagement

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The critical value of meaningful interaction and engagement with individual customers – responding to their specific needs, is fast drawing attention of many businesses, for sustainable performance excellence. The same is happening in the pharma industry, as well. Creative use of this process leveraging modern technological support systems, would also provide a unique scope of cutting-edge brand service differentiation, in well researched areas.

That, it is a very important focus area for the pharma players, is no-brainer. Nonetheless, what really matters most is the novelty in strategizing such interactions and engagements, especially with patients and doctors. I also wrote about it in my article, titled ‘Indian Pharma To Stay Ahead of Technology Curve,’ published in this blog on May 22, 2017. Over two years ago, I clearly indicated there that application of AI via digital tools, called ‘Chatbots’ – the shorter form of ‘Chat Robot’, is one of the ways that pharma may wish to explore this area.

Illustrating this point in that article, I mentioned that on March 05, 2017, a leading bank in India announced the launch of an AI-driven Chatbot named Eva, coined from the words Electronic Virtual Assistant (EVA), to add more value to their services for greater customer satisfaction. ‘According to reports, Eva is India’s first AI driven banking Chatbot that can answer millions of customer queries on its own, across multiple channels, immediately.’

In this article, I shall dwell on this interesting area, with a primary focus on pharma sales and marketing, and assess the progress made in this space, thus far, by several drug companies, including some Indian players. Let me start by recapitulating the basic function and purpose of ‘Chatbots’ in pharma.

Pharma ‘Chatbots’ – the function and purpose:

Simply speaking, pharma ‘Chatbots’ are also AI-powered, fully automated virtual assistants. Its basic function is to mimic one-to-one human conversation on particular areas, as desired by the user. Likewise, its basic purpose is to genuinely help and assist the customers who are in search of right answers to specific disease related questions, in a one-to-one conversational format, having a higher source-credibility.

In that process, ‘Chatbots’ can effectively satisfy the patients and doctors by providing them the required information, immediately. In tandem, pharma companies also reap a rich harvest, by developing not just a trust-based healthy relationship with them, but also in building a robust corporate brand – creating a long-term goodwill that competition would possibly envy.  

Effective customer satisfaction is an area that can’t be ignored:

In the digital age, a new type of general need is all pervasive, with its demand shooting north. This is the need to satisfy a voracious appetite among a large section of the population for all types of information, with effortless and prompt availability of the required details – as and when these come to one’s mind.

When such information need relates to health concern of a person, such as – available treatment options against affordability, or drug price comparisons – factoring in effectiveness, safety concern – exactly the same thing happens. Most individuals won’t have patience even to write an email and wait for an answer, even the wait is just for a short while.

In the current scenario, it will be interesting to fathom, how would a pharma company, generally, interact or engage with such patients, to further business and creating a possible long-time customer? Some companies have started responding to this need – effectively and efficiently, by providing easy access to information through ‘Chatbots’, created on advances AI platforms. But, such players are a few in number.

Can pharma also think of ‘Chatbots’, like ‘Siri’ or ‘Alexa’?

Today, several people are using standalone and branded Chatbot devices in everyday life, such as, Siri (Apple), Alexa (Amazon), Cortana (Microsoft) or Google Now (Android). Interestingly, many industries, including a few companies in pharma, have also started developing their own version of ‘Chatbot dialog application systems.’

Industry specific ‘Chatbots’ are designed to meet with some specific purpose of human communication, including a variety of customer interaction, information acquisition and engagement – by providing a range of customized services to the target group.’ ‘Siri’ or ‘Alexa’ or the likes, on the other hand, are all-purpose general Chatbots, though, for everyday use of individuals. Thus, the question that comes up, in which areas pharma companies can use Chatbots to add value to their interactions and engagements with patients, in general, and also doctors.

Where to use ‘Chatbots’ as a new pharma marketing channel?

Some of the findings on the application of ‘Chatbots’, especially in pharma sales and marketing, featured in the CMI Media publication in December, 2016. It found that drug companies have a unique scope to leverage this new sales and marketing – channel, by developing ‘Chatbots’ in the company represented therapy areas. Following are just a few most simple illustrations of possible types ‘Chatbots’ for interaction and engagement with patients, which can be designed in interesting ways:

  • That can answer all types of patient questions on specific diseases, educate them about the disease and available treatment options with details.
  • That allows patients or physicians to get all relevant information about the prescription drugs that they require to prescribe for patients to start treatment, including potential side effects, adverse events, tolerability, dosing, efficacy and costs, besides others.
  • Once a treatment option is chosen, a third kind of Chatbot can help with patient adherence to treatment, provide reminders when the treatment should be administered, explain how to properly dose and administer the treatment, and other relevant information.

Chatbots could also be useful for doctors and nurses:

As the above paper finds, ‘Chatbots have value for serving healthcare professionals as well, for example:

  • When, physicians and nurses want to understand the pathogenesis, pathophysiology, and/or progression of a specific disease in their patients.
  • Although, such content may also be available on disease state awareness sites, but branded Chatbots would make that content readily available in more of an FAQ format.
  • When health care professionals would like to get data around safety/toxicity, or information about dosing strengths, calculations, and titrations, while using specific brands.

Chatbots can also be effectively utilized by the drug manufacturer to gain deep insights into customer behavior across all touchpoints, to enhance end-to-end customer experience, as I wrote in this blog on July 02, 2018. The data created through this process, can also be put to strategic use to design unique brand offerings.

Need to chart this frontier with caution:

Pharma, being a highly regulated industry in every country of the world, with a varying degree, though, the ‘Chatbot’ development process should strictly conform to all ‘Dos’ and ‘Don’ts’, as prescribed by the regulators of each country. Each and every content of the ‘Chatbot’ should pass through intense, not just regulatory, but also legal and medical scrutiny. Yet another, critical redline that ‘Chatbots’ should never cross is the ‘privacy’ of any individual involved in the process.

Three critical areas to consider for pharma ‘Chatbots’:

Effective pharma ‘Chatbots’ are expected to get ticks on all three of the following critical boxes:

  • Meeting clearly defined unmet needs of patients in search of a health care solution or most suitable disease treatment options.
  • Brand value offerings should match or be very close to the targeted patients’ and doctors’ expectations.
  • Should facilitate achieving company’s business objectives in a quantifiable manner, directly or indirectly, as was planned in advance.

Pharma has made some progress in this area, even in India:

To facilitate more meaningful and deeper engagements with patients, some drug companies, including, in India, are using ‘Chatbots.’ Here, I shall give just three examples to drive home the point – two from outside India and one from India.

October 23, 2018 issue of the pharma letter reported, a study from DRG Digital Manhattan Research found, ‘Novo Nordisk and Sanofi brands rank best for the digital type 2 diabetes patient experience.’ The article wrote, about some pharma players ‘facilitating deeper engagement through the use of automated tools like Chatbots to triage inquiries and get patients the answers they need faster, and through interactive content like quizzes and questionnaires that pull patients in and help them navigate health decisions,’ as follows:

  • Novo Nordisk‘s diabetes website includes an automated Chat feature dubbed “Ask Sophia,” helping patients access disease and condition management information more quickly.
  • Likewise, Merck & Co‘s website for Januvia employs interactive quizzes to educate patients and caregivers.

Similarly, on November 23, 2018, a leading Indian business daily came with a headline, ‘Lupin launches first Chatbot for patients to know about their ailments.’ It further elaborated, the Chatbot named ‘ANYA’, is designed to provide medically verified information for health-related queries. The disease awareness bot aims to answer patient queries related to ailments,’ the report highlighted.

Chatbots – global market outlook:

According to the report, titled ‘Healthcare Chatbots – Global Market Outlook (2017-2026),’the Global Healthcare Chat bots market accounted for USD 97.46 million in 2017 and is expected to reach USD 618.54 million by 2026 growing at a CAGR of 22.8 percent.

The increasing demand for Chatbot ‘virtual health assistance’, is fueled primarily by the following two key growth drivers, the report added:

  • Increasing penetration of high-speed Internet.
  • Rising adoption of smart devices.

Conclusion:

With the steep increase of the usage of the Internet and smart phones, general demand to have greater access to customized information is also showing a sharp ascending trend, over a period of time. A general expectation of individuals is to get such information immediately and in a user-friendly way.

Encouraged by this trend, and after a reasonably thorough information gathering process, mainly from the cyberspace, many patients now want to more actively participate in their treatment decision making process with the doctors. This new development has a great relevance to drug companies, besides other health service providers. They get an opportunity to proactively interact and engage with patients in various innovative ways, responding to individual health needs and requirements, thereby boosting the sales revenue of the corporation.

The unique AI-driven technological platform of pharma ‘Chatbots’, is emerging as cutting-edge tools for more productive stakeholder engagement – so important for achieving business excellence in the digital world. The recent growth trajectory of ‘Chatbots’ in the health care space, vindicates this point.

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.

India Needs More Integrated, High Quality E-Commerce Initiatives In Healthcare

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In the digital space of India, many startups have been actively engaged in giving shape to a good number interesting and path breaking ideas, especially since the last ten years. One such area is ‘electronic commerce’ or ‘e-commerce’.

In the e-commerce business, particularly the following business model is gaining greater ground and popularity:

Here, an e-commerce company plans to generate large revenue streams on hundreds and thousands of items without producing and warehousing any of these, or carrying any inventory, handling, packaging and shipping. It just collects, aggregates and provides detailed and reliable information on goods and/or services from several competing sources or aggregators, at its website for the consumers.

The firm’s strength primarily lies in its ability to draw visitors to its website, and creating a user-friendly digital platform for easy matching of prices and specifications, payment and delivery, as preferred by the buyers.

Growing e-commerce in India:

Today, e-commerce players in the country are not just a small few in number. The list even includes many of those who have already attained a reasonable size and scale of operation, or at least a critical mass. Among many others, some examples, such as, ‘Flipkart’, ‘Bigbasket’, ‘HomeShop18’, ‘Trukky’ and ‘Ola’ may suffice in this context.

Currently, these companies try to satisfy various needs of the consumers related to, such as, lifestyle, daily households, logistics, and other chores, at any time of the users’ convenience and choice, with requisite speed, variety and reliability.

Healthcare initiatives need to catch up:

Despite the overall encouraging scenario, every day in India a large number of the population, even those who can afford to pay, at least a modest amount, still struggle while going through the unstructured and cumbersome process of access to better and comprehensive health care services. The situation continued to linger, despite the ongoing game-changing digital leaps being taken by many startups in various other fields within the cyberspace of India.

Nevertheless, the good news is, it has now started happening in the healthcare space, as well, though most projects are still in a nascent stage. The not so good news is, many of these world class services, though available, are still not known to many.

The medical treatment process is complicated:

The medical treatment process is just not complicated; it is non-transparent too. There is hardly any scope for doing an easy-to-do personal research by common people to ascertain even a ballpark number on the treatment cost, with requisite details of the various processes, that a patient may need to undergo. 

Thus, in pursuit of quality health care at optimal cost in today’s complex scenario in India, one will require to get engaged in time-intensive and complicated research, first to find out, and then to effectively manage the multiple variables for access to comprehensive and meaningful information to facilitate patients’ decision making on the same. For most people, it’s still a challenge to easily collect all these details on a user-friendly platform of any credible and transparent online website.

The usual treatment process:

The usual process that any patient would need to follow during any serious illness is cumbersome, scattered and non-transparent. This is, of course, a natural outcome of the generally deplorable conditions and, in many cases, even absence of quality public health infrastructure in India, forget for the time being about the Universal Health Care (UHC). 

During such illness, one will first need, at least, a General Practitioner (GP), if required a secondary and a tertiary doctor, alongside well-equipped diagnostic laboratories. Then follows the medical prescriptions, or advice for any invasive procedure, buying the right medicines, as required for the treatment of the disease condition, and thereafter comes the desired relief, hopefully. 

Each of these steps being different silos, there were not many easy options available to most patients, in this tortuous quest for good health, but to go for expensive private health care. Currently, this entire process is over-dependent on word-of-mouth information, and various advice from vested interests.

Never before opportunity:

There seems to be an immense opportunity waiting in the wings for any e-commerce business in India, providing a comprehensive and well-integrated information network for the patients directly, enabling them to take well-informed decisions for reliable, cost-effective and high quality health care services.

This has been facilitated by increasing mobile phone usage in India. According to India Telecom Stat of January 2016, the number of mobile phone users in the country has now crossed one billion. Experts believe that a large section of these subscribers will soon be the users of smartphones.

Rapid growth of internet connectivity with the affordable smartphones, fueled by the world’s cheapest call tariffs, commensurate availability of various attractive packages for data usage, would empower the users avail integrated, comprehensive and high quality e-commerce services in the healthcare sector too, sooner than later.

Would it reduce health care cost?

A transparent system of integrated health care services could bring health care cost significantly.

For example, one can find out from such websites, not just a large number of doctors from any given specialty, including dentistry. Alongside will be available many other important information, such as, their location, availability time and fees charged.

This would help patients comparing the doctors from the same specialty, especially from the quality feedbacks published on the website. This would facilitate patients taking a well informed decision for disease treatment according to their individual needs and affordability. The same process could be followed for selecting diagnostic laboratories, or even to buy medicines.

Such open and transparent websites, after gaining desired confidence and credibility of the users, would also help generate enough competition between healthcare service providers, making the private health care costs more reasonable, as compared to the existing practices.

These e-commerce companies would arrange immediate appointments according to the convenience and needs of the patients, and also help in delivering the prescribed medicines at their door steps. 

Some initiatives around the world:

Many startups are now setting shops in this area, around the world. Just to give a flavor, I would cite a few examples, as follows, among many others:

Name Country Services
Doctoralia http://www.doctoralia.com Spain A global online platform that allows users to search, read ratings, and book appointments with healthcare professionals 
iMediaSante http://www.imediasante.com/ France Provides patients to make medical appointments from a mobile for free. 
DocASAP http://www.docasap.com United States An online platform enabling patients to book appointments with the doctors and dentists of their choice.
Zocdoc https://www.zocdoc.com/ United States Solves patient problems with instant online appointment booking, provides verified reviews and tailored reminders.
Lybrate.com https://www.lybrate.com/ India Provides access to a verified online doctor database of over 90,000 medical experts, including in Ayurveda and Homeopathy, for appointments and to ask any question.
Practo http://www.practo.com/ India An online platform for patients to find and book appointments with doctors. Doctors use Practo Ray software to manage their practice.  

An Indian example:

In this sphere, one of the most encouraging Indian examples would be the Bangalore based Practo Technologies Private Ltd. This startup debuted in 2008, and in a comparative yardstick, has been the country’s most successful business in this area, so far. Its key stated goal has been bringing order to India’s rather chaotic health care system.

Currently, Practo connects 60 million users, 200,000 doctors and 10,000 hospitals. According to a May 27, 2016 report of Bloomberg Technology, Practo website is used to book over 40 million appointments, every year.

This e-commerce company also offers online consultations, and home deliveries of medicine. Its software and mobile applications link people and doctors, as well as hospital systems, so that they can effectively manage the visits and billing, while helping patients find physicians and access their digital medical records.

At present, Practo offers services in 35 cities, and plans to extend that to 100 by the end of this year. The company reportedly is now expanding in Indonesia, the Philippines and Singapore, with a future expansion plan in Latin America, starting with Brazil in March 2016.

How would India shape up?

Although, these are still the early days, according to Grand View Research Inc., based in San Francisco in the United States, the global healthcare information technology market is right on track to reach US$ 104.5 billion by 2020. Increasing demand, especially from the middle income population for enhanced healthcare facilities, and introduction of technologically advanced systems, are expected to boost the growth of this industry.

Increasing rural penetration of e-commerce on integrated health care, would be a major growth booster for this industry in India.

Besides its distant competitor Lybrate, Practo does not have any tough competition in India, at present. However, the scenario may not remain the same, even in the near future. 

Keeping an eye on this fast growing market, two former top executives from India’s e-commerce leader – Flipkart are launching their own health-tech startup creating a new rival for Practo, according to the above Bloomberg report. Thus, it is a much encouraging fast ‘happening’ situation in the interesting digital space of the country. 

Conclusion:

Evolution of Indian e-commerce in health care is an encouraging development to follow. It would offer well-integrated, comprehensive and cost-effective health care services to many patients. Gradually penetration of this digital platform, even in the hinterlands of India, would help minimize quality health care related hassle of many patients, along with a significant reduction of out-of-pocket health expenditure cost.

Interestingly, there is no dearth of doomsayers against such novel initiatives, either. A few of them even say, it doesn’t make sense for the doctors to list themselves in the e-commerce directory for the patients to find them, as the patients desperately need them for any medical treatment, in any case. Others counter argue by saying that acquiring patients online should be a preferable way for doctors to maximize their income, among others, especially by eliminating the referral fees, which many specialists in India require paying for the source of referral.

However, I reckon, a larger number of credible and transparent e-commerce websites for integrated healthcare services, all in one website, would enhance competition, bring more innovation, and in that process delight many patients in India. Never before it was so promising, as the country is making a great progress in the smartphones’ usage, along with Internet access, in the country. The unique facility of free search for medical care services would also help patients immensely in choosing quality, and cost effective medical treatment interventions that would suit their pocket. 

To achieve this goal, the highly competitive digital process of integration and aggregation of requisite pre-verified latest information on different health care service providers and aggregators, in the most innovative and user-friendly way, would play a crucial role. In tandem, delivering the prescribed medicines at the patients’ door steps in strict compliance with the regulatory requirements, would really be a treat to follow in the rapidly evolving digital startup space of India.

The name of the game is ‘Idea’. The idea of offering innovative, well-integrated, comprehensive, user-friendly, and differential value delivery digital platforms for healthcare e-commerce. It shouldn’t just overwhelmingly be what the sellers want to force-feed, but where the majority of patients on their own volition can identify the differential values, and pay for these, willingly.

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.

The Curious Conundrum of New Drugs Approval Process

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Fathoming the details of just a short span of time, not going beyond the last 10 years, I find from the published data that many new drugs, such as, Alatrofloxacin, Aprotinin, Drotrecogin alfa, Lumiracoxib, Propoxyphene, Rofecoxib, Rosiglitazone, Sibutramine, Tegaserod, Tetrazepam, were withdrawn from a number of important global markets. Quite a few of those were withdrawn also from the world market.

The key reason for almost all these withdrawals was serious safety concerns for the patients while using these medicines. Interestingly, some of these new molecules were withdrawn even after attaining the blockbuster status, such as Rofecoxib.

Tens of thousands of patients have died only because of this reason, according to reports.

It is widely believed by the experts in this area, if full public disclosure of the entire data of drug clinical trials was made, most of these new drugs would not have seen the light of the day and without putting many patients’ health safety in jeopardy.

All this is a part of a curious conundrum in the new drug approval process, across the world, for various reasons. In this article, I would try to dwell on this issue.

Voices against this ‘unethical practice’ getting louder:                                             

On December 22, 2015, ‘CBC News’ published an interesting article, titled “Researcher issues ‘call to action’ to force release of hidden drug safety data: Bringing drug industry data into the light of public scrutiny.”

The article echoed the same belief of other global experts and, in fact, went a step forward. It categorically reiterated, if full disclosure of the entire data of drug clinical trials is made public, medical practice might have been quite different.

To drive home this point, the article cited the example of the arthritis drug rofecoxib (Vioxx), which has been linked to tens of thousands of deaths related to heart attacks.

It highlighted, although this risk was very much known to the regulatory authority of the United States, the relevant data was not released to the public for an impartial scrutiny.

Quoting different sources, the paper observed, almost half of the drug trials remain secret and the studies that are published, overwhelmingly report results that make the drug in question look good.

Independent experts’ views differed from the innovator companies:

In some cases, when researchers were able to see what is hiding in the filing cabinets of the drug innovator companies, a different picture altogether emerged on the overall profile of those drugs.

One group looked at 12 antidepressants, comparing the published studies with the internal US FDA assessments. They found that 94 per cent of the published studies were positive, as compared to 51 per cent, when they included all of the studies assessed by the drug regulator.

Based on a detailed study, the authors concluded, without considering all the data, drug effectiveness can often be exaggerated, leading doctors and patients to assume that the medications work better than what they actually do. The ongoing practice of the drug players may help them to significantly diminish the risks, related to the benefits offered by these medicines.

A few months ago, another group analyzed the data from an unpublished drug company study about the effect of Paxil on teen depression and found that the drug did not work and was not safe for the patients. This result completely contradicted the original, unpublished study on this drug.

A crusader emerged in Canada:

Interestingly, the same article, as above, states that Mathew Herder , the health law associate professor at Dalhousie University in Halifax, Canada is now taking up the fight. He is now “calling on other doctors, researchers and journalists to bombard Ottawa with their own demands for drug industry data, using the new legislative lever called the ‘Protecting Canadians from Unsafe Drugs Act,’, which was passed late last year in Canada. 

He has also created a template to help doctors, researchers and journalists access drug safety data at Health Canada. Herder reportedly could even include biomedical researchers, doctors who prescribe medicine, investigative journalists pursuing questions about drug safety, and other activists and patient groups.

This example is worth imbibing elsewhere.

The ‘Rule Books’ are in place, though with loopholes:

To curb such alleged patient unfriendly practices of the innovative drug manufacturers, while obtaining the marketing approval of new drugs, various rules and procedure were put in place, by various authorities.

I shall deliberate below a few of these rules, and enough loopholes therein, enabling the interested parties to hoodwink the external experts, at the cost of patients.

International Clinical Trials Registry Platform:

Much before Herder, following a ministerial summit on Health Research in 2004, a World Health Assembly Resolution passed in 2005 called for unambiguous identification of all interventional clinical trials. This resolution led to the establishment of the ‘World Health Organization (WHO) International Clinical Trials Registry Platform’. It collates information on trials that have been notified in a network of clinical trial registries.

According to W.H.O, “The registration of all interventional trials is a scientific, ethical and moral responsibility”.

In the latest version of the Declaration of Helsinki, it reiterates, “Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.”

It unambiguously states, “Researchers have a duty to make publicly available the results of their research …. Negative and inconclusive as well as positive results must be published or otherwise made publicly available”.

Understandably, W.H.O statement underscores, “There is an ethical imperative to report the results of all clinical trials, including those of unreported trials conducted in the past.”

It is worth mentioning here that on January 1, 2015, by a new policy on publication of clinical data, ‘European Medicines Agency (EMA)’ also decided to proactively publish all clinical reports submitted as part of marketing-authorization applications for human medicines, by the by pharmaceutical companies.

Big Pharma's serious apprehensions on greater Public transparency:  

Before finalization of the above policy, EMA sought comments on its draft from various state holders. On September 5, 2013, in its remarks on the draft, ‘The European Federation of Pharmaceutical Industries and Associations, EFPIA’ expressed its apprehension about the public health safety oriented proactive move by the EMA as follows:

“We are worried by a move towards greater transparency of clinical trials data that appears to be putting transparency – at whatever cost – ahead of public health interests. Our detailed response to the EMA draft policy speaks to this concern. While EFPIA values other voices and opinion in the conversation surrounding clinical trials data, we believe there are better alternatives than what the EMA is presenting.” 

This is of course understandable. That said, it also gives satisfaction to note that EMA did not wilt under any pressure on this score, whatever the anecdotal might of the external force be. 

Gross non-compliance, endangering patients’ health safety:

Although, the standards and requirements of “Public Disclosure of Clinical Trial Results” have been well specified now, and even in most of the Big Pharma websites one can find disclosure norms of clinical trial data, their overall compliance on the ground, is still grossly inadequate, endangering patients’ health safety.

An article published in the BMJ Open on November 12, 2015 titled, “Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012”, well captured the magnitude of this issue. 

Nevertheless, the study analyzed just a subset of drugs approved in a single year, 2012. The researchers only examined whether clinical trials were registered and reported, not what that data suggested about how the drugs worked.

The paper reported the results as follows:

“In 2012, the US FDA approved 39 novel new medicines, known as NMEs, and 35 novel drugs. Combining these lists, the FDA approved a total of 48 new drug entities, 15 of which were sponsored by 10 large pharmaceutical or biotechnology companies with market capitalizations valued over US$19 billion. A total of 342 trials were conducted to gain regulatory approval of the 15 drugs, 24 of which were excluded from our analysis, leaving 318 trials involving 99 599 participants relevant to our study, a median of 17 trials per drug.”

Based on the findings, the authors concluded asunder:

“Trial disclosures for new drugs remain below legal and ethical standards, with wide variation in practices among drugs and their sponsors. Best practices are emerging. 2 of our 10 reviewed companies disclosed all trials and complied with legal disclosure requirements for their 2012 approved drugs. Ranking new drugs on transparency criteria may improve compliance with legal and ethical standards and the quality of medical knowledge.”

Simultaneously, The Washington Post in an article of November 12, 2015, titled, “How pharma keeps a trove of drug trials out of public view”, summarized this report by highlighting to the general public that one third of the clinical trial results that US FDA reviewed to approve drugs made by large pharmaceutical companies in 2012, were never publicly reported. 

Unethical practices skewing medical science:

On July 25, 2015, ‘The Economist’ published an article titled, “Spilling the beans’. It highlighted again that the failure to publish the results of all clinical trials is skewing medical science. 

This article also brought to the public attention that half of the clinical trial results are never published over several decades. It broadened the discourse with the observation that this specific unwanted practice, distorts perceptions of the efficacy of not just drugs, but devices and even surgical procedures too, in a well planned and a systematic manner. What is most important to note is, it has seriously compromised with patients’ health interest, across the world. 

It keeps on happening, as there are no firm obligations on the part of drug companies for making public disclosure of all such data, both for and against, though all these data are required to be filed with the regulatory authorities. Hence, the overall assessment of the drugs, weighing all pros and cons, is just not possible for any outside expert agency.

For granting necessary marketing approval, the designated authorities, at least theoretically, ensure that the drugs are reasonably safe, and have, at least, ‘some beneficial effects’. However, the prescribing doctors would continue to remain ignorant of the untold facts, the article states. 

According to ‘The Economist’, although in the United States the relevant laws were modified, way back in 2007, to address this issue, it still remains as a theory, the actual practices in this regard are mostly not so.

Despite vindication no tangible outcome yet:

As I said earlier, this fact got vindicated through extensive research by the ‘BMJ Online’ article and many other contemporary medical publications. 

For example, the evidence released earlier on  April 10,  2014 by the Cochrane Collaboration of London, UK, also shows that a large part of negative data generated from the clinical trials of various drugs were not disclosed to the public. 

Again, like Vioxx, though the US FDA was aware of all such data, for a well known drug Tamiflu, unfortunately the prescribing doctors were not. As a result, the U.S. Centers for Disease Control and Prevention (CDC), which doesn’t have the same access to unpublished data as the regulators, recommended this medicine not being able to evaluate it holistically. 

However, as the findings from the unpublished clinical trials eventually surfaced, CDC expressed serious apprehension on the overall efficacy of Tamiflu, quite contrary to the assessment of the concerned big pharma player.

Hence, despite quite a large number of vindications by the experts, no tangible outcome has been noticed on this pressing issue, just yet.                                                                

Conclusion:

Based on all this discussion, the moot question that springs up: Why do the doctors still prescribe such drugs, even after being aware of the full facts?

In this regard, an article titled, “Big Pharma Plays Hide-The-Ball with Data”, published in the Newsweek on November 13, 2014 raised a very valid question. 

It commented, even if Tamiflu does nothing, and there is just a slight chance of life-threatening side effects, why was it approved by the US FDA, in the first place?

Even more intriguing is: Why do the doctors continue prescribing these, especially after the Cochrane Collaboration took the Tamiflu’s maker, Roche, to task about many of its claims, in April 2014.

Incidentally, the Cochrane Collaboration is widely regarded as one of the most rigorous reviewers of health science data. It takes results of multiple trials, looks for faults and draws conclusions. It doesn’t accept funding from businesses with a stake in its findings.

The answer to this question may perhaps be too obvious to merit any elaborate discussion here. 

Be that as it may, this curious conundrum of ‘New Drug Approval’ with ‘Partial Public Disclosure of Clinical Trial Data’ needs to effectively addressed, without further delay. If not, patients’ health interest would continue to get seriously compromised with the continuation of prevailing laxity in its implementation process by the drug regulators.

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.

‘Orphan Drugs’ for ‘Orphan Diseases’ – is ‘Open Source Drug Discovery (OSDD)’ platform for discovery research the way forward?

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To meet the unmet needs of common and dreaded diseases intensive R&D activities are being undertaken by the Pharmaceutical Industry, the world over. At the same time, a percentage of human population, however small, also suffers from some rare diseases, for which there are no approved medical treatments even in the twenty first century, for the rich and poor alike.These rare diseases are also termed as ‘orphan diseases’, which are often chronic, progressive, degenerative, life-threatening or disabling. Many patients suffering from such rare diseases are denied their right to get their ailments effectively treated.It is indeed heartening to note that European Organization for Rare Diseases (EURORDIS) and National Alliances announced February 29, 2008 as the first ‘Rare Disease day’. Thereafter, the last day of February has been designated as ‘Rare Disease Day’ worldwide to call attention to the public health issues associated with rare diseases, which have been reported to affect around 30 million patients around the world.

People with rare diseases remain a medically underserved population even in a developed country. We can then well imagine the plight of such patients in India. The ‘Rare Disease Day’ is intended to bring together the patients and families with rare diseases to discuss the need for greater awareness, more research, and better access to diagnosis and treatment. I am not sure how various authorities, including our Government, are deliberating on this healthcare issue.

People suffering from ‘orphan diseases’ often face huge challenges compared to more common diseases. These include delay in getting an accurate diagnosis, few treatment options and difficulty finding medical experts. Many such rare diseases have no approved treatment. Moreover, treatments for ‘orphan diseases’ tend to be in most cases more expensive than treatments for more common diseases.

This year, the “Rare Disease Day” will be observed in India also, on February 28, though these are not very much talked about in our country, nor is there any proper definition in place for such diseases, as yet.

The drugs meant for treating ‘orphan diseases’ have been very appropriately termed as ‘orphan drugs’, mainly due to commercial reasons, as such drugs will be used on much fewer patients with commensurate return on investments towards R&D. Thus spending expensive R&D resources toward such drugs may not make sound commercial sense.

To address this need, in 1983, the Orphan Drug Act was passed by the Congress in the USA to extend financial incentives for companies to develop treatments for rare diseases. Since then, nearly 330 ‘orphan drugs’ and biologics have been approved by the U.S. FDA, which estimates that from 11 to 14 million Americans would benefit from these ‘orphan drugs’. However, despite such commendable measures taken by the US FDA, around 15 million Americans still leave with such ‘orphan diseases’ for which there is no approved treatment.

It is interesting to note that some of these ‘orphan diseases’ are now being diagnosed in India, as well. As India takes rapid strides in medical science, more of such ‘orphan diseases’ are likely to be known in our country.

Thus the moot question is how does India address this issue with pro-active measures? In the USA, even by giving adequate financial incentives, this problem could not be effectively addressed for commercial reasons.

In my view, one of the ways to properly address this issue is to follow the model of our very own the Council of Scientific and Industrial Research (CSIR) for an ‘Open Source Drug Discovery’ (OSDD) program with global partnerships, wherever required. This initiative has been pioneered by the well known scientist and Director General of CSIR Dr. Samir Brahmachari. Andrew Witty, the CEO of GlaxoSmithKline also had mooted a similar idea in another context in not too distant past.

Therefore, to address the issue of ‘orphan diseases’, in my opinion, the OSDD model with partnerships between private, public and academia will not only prove to be a viable and more practical model to discover ‘orphan drugs’, but will also help India to effectively contribute to this important global issue – not just by observing the ‘Rare Diseases Day’ on February 28 or 29, each year.

By Tapan Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.