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Gamification in Pharma: Creates Engaging Patient Experience For Better Results

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On January 03, 2019, media reports flashed – “A video game-based ‘digital medicine’ tool can help reduce symptoms in children with autism spectrum disorder (ASD) and attention/deficit-hyperactivity disorder (ADHD).” This study was published in the Journal of Autism and Developmental Disorders, confirming the feasibility and safety of the tool called Project: EVO, which delivers sensory and motor stimuli through an action video game experience.

This initiative reconfirms that technology is becoming a great enabler to provide integrated, comprehensive and cost effective approach in treating many diseases, particularly with ‘Digital Medicine.’ The above report on ‘Project EVO’ is an example of application of the concept of ‘gamification’ in digital medicine. Many consider ‘gamification’ as a game changer to create an engaging patient experience with added value. It makes patients getting involved in the disease-treatment process, especially for effective self-management of chronic disorders.

I shall focus on this area in today’s article, giving examples wherever available. However, let me start by recapitulating what is ‘gamification’ in the pharma industry.

Gamification: 

The Oxford dictionary defines ‘gamification’ as: ‘The application of typical elements of game playing (e.g. point scoring, competition with others, rules of play) to other areas of activity, typically as an online marketing technique to encourage engagement with a product or service.’ It further adds, ‘gamification is exciting because it promises to make the hard stuff in life fun.’

‘Gamification’ is assuming increasing importance, with disruptive digital innovations gradually becoming game changers in the pharma business. This is mainly because, it can deliver to a specific group of patients, doctors or other stakeholders exactly what they look for – with precision.

I suggested in my article, published in this blog on January 07, 2019 that pharma companies should facilitate self-management of chronicailments,not just for better outcomes, but also for improving the quality of patient engagement. To achieve this objective,‘gamification’ could play a remarkable role-such as disease awareness and prevention and when afflicted its desirable self-management. This has the potential to create a win-win situation between patients and a drug company.

This is so important, as ‘the old paradigm of the paternalistic model of medicine is now transforming into an equal level partnership between patients and professionals, aided and augmented by disruptive technologies. This comment was made in a study titled, ‘Digital health is a cultural transformation of traditional health care,’ published in mHealth on September 14, 2017.

‘Patient-doctor partnership is critical in the new paradigm:

One of the major ways to develop a partnership between the treating doctors along with the product/service providing pharma companies and patients is through mutually beneficial ‘patient engagement’ programs with added value.

That such programs can create a unique patient experience of better outcomes at a lesser cost, has already been established by a number of credible research studies. Taking a cue from quantum benefits that this initiative provides, many pharma companies are now making ‘patient engagement’ strategy as an integral part of their overall market access program, including the process of branding.

What does an effective patient engagement strategy involve?

An article titled, ‘Patient Engagement: A Key Element in Pharmaceutical Marketing Strategy,’ published in the IgeaHub on May 29, 2016 defines ‘patient engagement’ as a concept that combines a patient’s knowledge, skills, ability and willingness to manage his own health and care with interventions designed to increase activation and promote positive patient behaviors. This measure also involves offering relevant services to patients.

To assess the opportunity of patient services in the pharma industry, Accenture conducted a survey titled, ‘Pharma’s Growing Opportunity in Patient Services’, on 200+ pharma patient services executives, covering seven therapeutic areas – heart, lungs, brain, immune systems, bones, hormone/metabolism, and cancer. The study concluded,the future of patient services that requires patient engagement, is bright. It elaborated by saying, this approach offers pharmaceutical companies a tremendous opportunity – for those willing to invest in the right places and let patients know about them in the right way.

To move in this direction, ‘gamification’ is an efficient way for the pharma companies to follow. Let us see below how does ‘gamification’ work on the ground.

How does ‘gamification’ work?

According to the findings of Innovatemedtec, ‘gamification’ with health apps typically works in the following three ways:

  • Allowing users to share progress and results with their friends or other users of the service, creating a competitive spirit to elicit more or better use of the specific health app service.
  • Giving virtual gifts, such as badges, medals, stars during each stage of progress, generating a sense of achievement for greater patient motivation levels in disease monitoring and management.
  • Advanced medical health applications can provide real-time biofeedback with built-in sensors. Or using a storytelling approach and explaining health literature related to diagnoses, medical procedures and patient behavior.

Thus, the primary reasons for introducing ‘gamification’ in the pharma industry would be to improve the disease awareness and increasing patients’ motivation for self-management for mutual benefits.

Improves disease awareness and motivation for self-management:

The precise rationale for ‘gamification’ in the pharma industry was nicely articulated in the ‘M.Sc. Thesis titled, ‘Gamification in the Pharmaceutical Industry – Exploring how European Pharmaceutical Organizations can build and use Gamified Mobile Applications to Improve Relations with Patients.’ This was written by Nanna Birkedal and jointly delivered by the University of Stirling and Lund University.

It highlighted: “Patients and industry experts both argue that awareness is important; constant reminders about healthy habits are pivotal for an improved lifestyle. Patients furthermore need to be motivated to act upon this and actively implement the required lifestyle changes. If pharmaceutical organizations succeed in helping the patients with overcoming challenges related to their illness by motivating them to enact the needed lifestyle changes, it will increase the perceived trust towards their brand and thereby strengthen their relationship with the patients. This research argues that digital gamification is suited for this purpose, hence why it may be advantageous for organizations to incorporate digital gamification …”

Why and how to motivate patients for self-management of chronic disease?

As I said before, after proper diagnosis of a chronic ailment and charting out a medical treatment pathway, self-management of the disease by patients plays a critical role. Thus, the question arises, how to motivate patients and more importantly, keep patients motivated for engaging in self-management of such nature.

There is also a need for continuous improvement of the ‘gamification’ process for a long-term engagement of patients, leading to progressively better outcomes. Many examples of success with ‘gamification’ are available for chronic diseases, such as diabetes.

One of the metrics used in ‘gamification’ to help diabetic patients stick with a digital health platform, making it a higher priority in their daily lives, is to provide useful timely information on their disease condition. This metric may include informing the user about some tangible changes in their health risks due to the disease. For example: “Over the last month your effective glucose has reduced the risk of losing your eyesight by 10 percent.” Accordingly, the patients may earn points or badges for using the app and accomplishing certain important tasks.

In this way, gamification can immensely help self-management through behavioral changes, improving disease outcomes. As Healthcare in America also reiterates: ‘There is nothing more motivating than knowing your health is improving in real time.’

Another study, and two examples of ‘gamification’ in pharma:

Another study titled, ‘Gamification: Applications for Health Promotion And Health Information Technology Engagement’, published by ResearchGate arrived at an interesting conclusion. It reiterated: ‘Game-based approaches (gamification) can provide ideal strategies for health promotion, prevention, and self-management of chronic conditions. However, there is a need to clearly define components and uses of gamification in healthcare for increased patient engagement in health information technology.’

Elaborating the point further, the authors emphasized that many health/physical activity apps provide feedback in a clear and concise manner and in a variety of formats (e.g., graphs, text or icons). The available option to share the feedbacks on social networking sites allows for further engagement by individuals and adds additional motivation and encouragement in attaining users’ goals. However, it recommends more studies to explore and identify the suitability of ‘gamification’ for health in clinical settings.

There have been several instances of gamification efforts health care with powerful effects. Let me cite just two interesting illustrations from mobihealthnews, as follows:

Conclusion:

As available from various literature, such as Healthcare in America, there are enough well-verified testimony, indicating that patients are motivated by gamified elements.

Consequently, some major global pharmaceutical companies have started testing the water. For example, the Media Release of Roche dated June 30, 2017 announces, the company has acquired mySugr - an Austrian startup that offers gamified solutions for diabetes management in a fun way, both for children and adults. It, reportedly, has more than a million registered users in 52 countries and is available in 13 different languages. Post-acquisition, it will be an integral part of Roche’s new patient-centered digital health services in diabetes care.

Hence, ‘gamification’ in pharma carries potential to be a win-win strategy in creating engaging, motivating and a unique patient experience in self-management of chronic diseases, for better outcomes.

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 ‘Toxin’ Delaying Success of Biosimilar Drugs

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The above comment, although sounds a bit harsh, was made recently by none other than Scott Gottlieb - the Food and Drug Administration Commissioner of the United States. He expressed his anguish while explaining the reasons for a delayed launch of several important biosimilar drugs.

We know, this new genre of drugs has a potential to be a quick game changer, significantly improving access to affordable biologic medicines for many patients. Unfortunately, much desired accelerated progress in this direction, got considerably retarded in the face of a strong headwind, craftily created by the innovator companies, as is widely believed. There are various ways of creating the same. However, the two major ones can be ascribed to:

  • Getting caught in the labyrinth of complex patent challenge.
  • General apprehensions of many doctors on the efficacy and safety of biosimilars as compared to reference drugs.

This is happening in major markets, including India, in varying degree, though.  In this article, I shall deliberate on this issue, starting with the largest pharma market of the world and then focusing on India.

‘Toxin’ that delays biosimilar drug launch:

“Americans could have saved $ 4.5 billion in 2017, if all of the FDA-approved biosimilars were actually available in the United States, instead of getting delayed because of litigations or other agreements.” The Food and Drug Administration Commissioner of the United States – Scott Gottlieb, reportedly, made this comment on July 18, 2018.

Gottlieb referred to some of these as a “toxin” that have prevented other drug makers from launching biosimilar medicines. He accused the manufacturers of pricey biologic medicines of using “unacceptable” anti-competitive tactics to keep competitors off the market. These cost Americans billions of dollars – the report highlighted.

These tactics, as the US FDA commissioner said, are being deliberately used by the innovator pharma and biotech companies and can be corroborated with several examples. One such is the fact that despite the expiration ofthe ‘composition of the matter’ patent for Humira (adalimumab) in December 2016, its ‘non-composition of the matter’ patent would expire not earlier than 2022. The company has therefore made settlement agreements with Amgen and Samsung Bioepis, delaying the launch of adalimumab biosimilars until January 2023.

Protecting own patents Big Pharma challenging rivals’ patents:

Both these are happening for original biologic and biosimilar equivalents, often by the same manufacturers. For example, the Reuters report of October 02, 2016, titled  ‘Big Pharma vs Big Pharma in court battles over biosimilar drugs’ highlighted, although Novartis and Amgen are at each other’s throats in court over the Swiss drug maker’s Enbrel copy, but the two are still cooperating on a drug for migraines.

“One of the biggest surprises has been the number of innovator Biopharma companies, like Amgen, now developing biosimilars to compete with the products of other innovator companies,” the article observes. It also reports that Sanofi, Merck, Eli Lilly, Pfizer, Johnson & Johnson and Biogen are also embroiled in lawsuits over biosimilars.

This trend vindicates that the line dividing makers of brand-name drugs and copycat medicines is blurring as companies known for innovative treatments queue up to peddle copies of rivals’ complex biological medicines, Reuters noted. Consequently, they are now doing both – protecting their high-price products from biosimilars drugs,while simultaneously challenging rivals’ patent claims.

There is another interesting side to it. Notwithstanding, biosimilars are a cost-effective alternative to biologic drugs that could improve patients’ access to expensive biological medicines, prescribers’ perception of biosimilar medicines are still not quite positive, just yet.

Doctors’ attitude on biosimilar prescription:

To illustrate this point, let me quote from recent research findings in this area. One such is the May 2017 study on “Medical specialists’ attitudes to prescribing biosimilars.” The key points are as follows:

  • Between 54 and 74 percent of the specialists are confident in the safety, efficacy, manufacturing and Pharmacovigilance of biosimilars.
  • 71 percent of specialists agreed that they would prescribe biosimilars for all or some conditions meeting relevant clinical criteria.
  • Specialists are less confident about indication extrapolation and switching patients from an existing biologic.
  • The most common situations that they would not prescribe a biosimilar was where there was a lack of clinical data supporting efficacy (32 percent), or evidence of adverse effects.

Overall, medical specialists held positive attitudes towards biosimilars, but were less confident in indication extrapolation and switching patients from the original biologic. Several experts believe that constantly highlighting the fear factors against biosimilar drugs, such as possible risks of interchangeability with reference product, or immunogenicity related serious consequences, though very rare, are fueling the fire of apprehensions on the wide use of biosimilar medicines.

However, several reviews, like the one that I am quoting here finds that ‘switching from the reference product to related biosimilar drug is not inherently dangerous.’I discussed this issue, with details in one of my articles, published in this blog on July 31, 2017.

Any therapeutic difference between the original biologic and biosimilars?

As the US-FDA says: “Patients and their physicians can expect that there will be no clinically meaningful differences between taking a reference product and a biosimilar drug when these products are used as intended. All reference products and biosimilar products meet FDA’s rigorous standards for approval for the indications (medical conditions) described in product labeling.”

The key point to take note of is that the US drug regulator categorically reiterates: “Once a biosimilar has been approved by the FDA, patients and health care providers can be assured of the safety and effectiveness of the biosimilar, just as they would for the reference product.”

The invisible barriers to biosimilar drugs in India:

Although, there are no specific data requirements for interchangeability of biosimilar drugs with the reference product, as mentioned in the latest Indian Guidelines on similar biologic, other visible and visible barriers are restricting the rapid growth of drugs belonging to this genre.

An interesting research study finds, like many other drugs, the cost of biosimilars is a major barrier to the rapid growth of the market in India. The Deloitte Report, titled “Winning with biosimilars: Opportunities in global markets” also articulated: “Approximately 70 percent of the country’s population is considered rural and will focus on the cost of therapy – a 20-30 percent discount on originator biologics may not be sufficient.”

Moreover, many patients who are on original biologic drugs, costing higher than related biosimilars and want to switch over to affordable equivalents, are not able to do so. In many cases, doctors’ do not encourage them to do so, for various reasons, including the general assertion that original biologic drugs are more effective. India being considered as the global capital of diabetes, let me cite an example from this disease area, just to drive home the point.

A recent experience on biosimilar drug interchangeability in India:

Just the last week, I received a call from a friend’s wife living in Delhi who wanted to know whether Lantus 100 IU/ml of Sanofi can be replaced with Glaritus 100 IU/ml of Wockhardt, as the latter costs much less. I advised her to consult their doctor and request accordingly. She said, it has already been done and the doctor says Lantus is a better product.

To get a fact-based idea on what she told me, I referred to two circulars of the National Pharmaceutical Pricing Authority (NPPA) – one for Glaritus and the other one for Lantus and found that both are under drug price control and have respective ceiling prices. As both the circulars are of 2009, these may probably be treated as an indicative price difference. NPPA notified price for a 3 ml cartridge of Glaritus reads as Rs.135. 24. Whereas, the same for Lantus was mentioned as Rs.564.84.

Is an original biologic generally superior to Indian biosimilars?

US-FDA has already reiterated, “Once a biosimilar has been approved by the FDA, patients and health care providers can be assured of the safety and effectiveness of the biosimilar, just as they would for the reference product.”

However, to get India-specific, evidence-based information in this area, I checked, whether Lantus has any clinically proven therapeutic superiority over Glaritus. Interestingly, I came across the results of a 12-week study concluding that biosimilar insulin glargine, Glaritus, is comparable to the reference product, Lantus – providing a safe and effective option for patients with T1DM. Nevertheless, the researchers did say that more studies are required in this area.

The core question that needs to be addressed why is the doctor’s perception so different and the reasons for the same?

Conclusion:

In view of all that has been discussed in this article, I find it challenging to fathom that in the absence of any credible and conclusive specific study, how could a doctor possibly infer that higher priced imported original biologic drugs are generally superior to lower priced biosimilar equivalents? More so, when in India, there are no regulatory issues on interchangeability between original biologic and its biosimilar equivalent.

Or for that matter, a branded generic product is superior to all other equivalent generic drugs without a brand name? This can happen, especially when the vested interests actively work on ensuring that such a perception gains ground, boosting the sales revenue and mostly at the cost of patients’ interest.

As one would witness in many other spheres of life that creating a blatantly self-serving, positive target audience perception, by any means, primarily aimed at destroying the same of others, is assuming increasing importance. Are we seeing the reflection of the same, even in the field of evidence based medical science?

I reckon, it raises a flag for all to ponder, particularly after reading the recent candid comments of the US-FDA commissioner, as quoted above.

Could this be one of those ‘Toxins’, which delays success of biosimilar drugs?

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.

 

With ‘Cutting Corners’ Going North, Pharma Reputation Dives South

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Just a few months ago, on October 24, 2017, ‘New Jersey Law Journal’ came out with an eye-catching headline – “Sanofi Set to Pay $ 61M Settlement in Antitrust Suit Over Vaccine Bundling.” The suit says: “Sanofi-Pasteur allegedly suppressed competition for its pediatric meningococcal vaccine, Menactra, by charging physicians and hospitals up to 35 percent more for its product, unless they agreed to buy Sanofi’s pediatric vaccines exclusively. Sanofi-Pasteur is the vaccines division of French drug manufacturer Sanofi.”

Nevertheless, a statement from the company said: “Despite Sanofi’s strong defenses, Sanofi recognizes that continued litigation is likely to be extraordinarily expensive and time-consuming and thus has agreed to enter into this Settlement Agreement to avoid the further expense, inconvenience, risk and distraction of burdensome and protracted litigation. Sanofi is finally putting to rest this case by obtaining complete dismissal of the action and a release by settlement class members of all released claims.”

When such incidences – of various scales and dimensions, continue being reported by both the global and local media, over a long period of time, one can fathom the potential of their cumulative impact on public and other stakeholders. Severely dented image and reputation of pharma, in general, before the eyes of so many, across the world, is a testimony to this phenomenon. Considering these as ‘cutting corners’ syndromes, I shall discuss in this article, how fast is pharma reputation diving South, with incidences of ‘cutting corners’ keep going North.

‘Cutting Corners’:

The Oxford dictionary defines ‘cutting corners’ as: ‘Doing something perfunctorily so as to save time or money’. Putting it in the context, I reckon, legally or ethically questionable actions with a deliberate intent of making quick profits, if not profiteering, can be termed as ‘cutting corners’ or business malpractices.

‘Cutting Corners’ going North:

This is no way a recent phenomenon. Gradually increasing number of new reports on pharma’s alleged malpractices are not uncommon, either. On the contrary, these keep coming rather too frequently – baffling many industry watchers and its well-wishers, for different reasons.

The details of 20 largest settlements in this area reached between the United States Department of Justice and various pharmaceutical companies from 1991 to 2012, as available from Wikipedia, provide a glimpse to its magnitude and dimension. The settlement amount reportedly includes both the civil (False Claims Act) settlement and criminal fine. Glaxo’s US$ 3 billion settlement is apparently one of the largest civil, False Claims Act settlement on the record, and Pfizer’s US$ 2.3 billion settlement includes a record-breaking US$ 1.3 billion criminal fine. A federal court also recognized all off-label promotion as a violation of the False Claims Act, leading to a US$ 430 million settlement during that period, as this report highlights.

In one of my articles, titled ‘Big Pharma Receives Another Body Blow: Would Indian Slumber End Now?’, published in this blog on May 19, 2014, I quoted a few more examples from 2013 and 2014, as well. A few of these are as follows:

  • In March 2014, the antitrust regulator of Italy reportedly fined two Swiss drug majors, Novartis and Roche 182.5 million euros (U$ 251 million) for allegedly blocking distribution of Roche’s Avastin cancer drug in favor of a more expensive drug Lucentis that the two companies market jointly for an eye disorder.
  • Just before this, in the same month of March 2014, it was reported that a German court had fined 28 million euro (US$ 39 million) to the French pharma major Sanofi and convicted two of its former employees on bribery charges.
  • In May 2013, Sanofi was reportedly fined US$ 52.8 Million by the French competition regulator for trying to limit sales of generic versions of the company’s Plavix. 

Pharma reputation dives South:

That pharma reputation is diving south, is well captured in the ‘Business and Industry Sector Ratings’ by Gallup, dated August 2-7, 2017. According to this public rating, the top 5 and bottom 5 industries came up as follows:

Top 5:

Industry Total Positive % Neutral % Total Negative % *Net positive or negative %
Computer

75

15

8

+67
Restaurant

72

21

7

+65
Farming and agriculture

70

17

12

+58
Grocery

60

23

17

+43
Internet

59

21

18

+41

The bottom 5, including the federal government:

Industry Total Positive % Neutral % Total Negative % *Net positive or negative %
Airline

41

20

35

+6
Oil and gas

38

21

40

-2
Healthcare

38

18

45

-7
Pharmaceutical

33

16

50

-17
Federal Govt.

29

19

52

-23

*Net Positive is % Positive minus % negative (in percentage points)

Image rejuvenation campaign not yielding results:

Arguably, the richest and the most powerful pharma industry lobby group in the largest pharmaceutical market of the world, is incurring a mind-boggling sum of expenditure to mend the severely dented collective reputation and image of its members.

Vindicating this point, a January 18, 2017 media report articulated that a major pharma industry lobby group – PhRMA, is gearing up for a new image building campaign by spending in the “tens of millions” each year to drum up support for the reputationally challenged pharma industry. Such initiatives by PhRMA, as I understand, are not totally new, but rather ongoing. Be that as it may, as the Gallup survey confirms, pharma reputation keeps diving South, unabated.

Mending pharma’s reputation surfaces as one of the top concerns of the pharma industry. It, therefore, demands commensurate priority in working out a meaningful strategic plan, and its effective implementation on the ground, collectively. More so, when the POTUS – Donald Trump, has also emerged as a vocal pharma critic. He has already proclaimed that drug companies “are getting away with murder,” – as the above media report highlights.

Where is this campaign going off the mark?

On this subject, an article of September 5, 2017, published by Ars Technica – a technology news publication aptly epitomized, what is happening today with these campaigns, against what should have happened, instead. The column carries a headline ‘Big Pharma hopes research spending – not reasonable pricing – will improve image’.

The columnist wrote: “To scrub down their filthy reputations, drug makers could try lowering prices, a public mea culpa, or pledging to make pricing and marketing more responsible and transparent. But they seem to have taken a different strategy.” On this score, a relevant example, out of several others, was of Biogen introducing a drug in 2016, for a rare spine disorder and priced it at an eye-popping US$ 750,000 for the first years’ worth of treatment.

In pharma image revamp campaign, the focus on R&D spending or drug innovation, including blatant self-serving demands, such as strictest product patent and data exclusivity provisions, is rather overwhelming. It is understandable that all this fits in well with various pharma lobby group’s mission and mandate, but is unlikely to deliver what consumers would consider good behavior on the part of drug companies.

Is Indian pharma out of this loop?

The answer to this question is an emphatic – ‘No’. Alleged ‘dubious product quality’ related ongoing saga, is known today by all concerned. This had often culminated into US-FDA import bans of many drugs, manufactured by several Indian drug manufacturers – starting from the very top. Nonetheless, that’s not ‘the all’ or ‘end all’ in the ballgame of ‘cutting corners’ in India, as I explained above.

On September 26, 2017, a media report flashed: ‘The Income Tax (IT) investigation wing claims to have unearthed a nexus between a leading pharmaceutical company and doctors, and the evidence showing payments running into Crores to the latter for prescribing the company’s medicines.’

Close on the heels of ‘compromised drug quality standard’, such malpractices come as a double whammy for patients. But, the saga continues. In my article, titled ‘Healthcare in India And Hierarchy of Needs’, published in this blog on November 06, 2017, I mentioned about the October 31, 2017 public notice of the State Attorney General (AG) of Connecticut. The notice cited several instances of alleged drug price fixing in the United States. Interestingly, this lawsuit includes name of several large Indian companies, such as Dr. Reddy’s Laboratories, Emcure, Glenmark, Sun Pharma, and Zydus Pharma. The expanded complaint also names two individual defendants, one among them is the promoter, the chief executive officer and managing director of a large Indian pharma manufacturer.

Further, as I wrote before, the Maharashtra government’s recent announcement on enactment of a new law called the “Cut practices in Medical Services Act, 2017”, casts a darker shadow, not just on the doctors’ reputation, but also over the health care industry, in general, including pharma.

Today’s patients are more informed:

In today’s world, wider access to the Internet for a large number of global population has a profound implication in every sphere of life. News, discussions, opinions, comments and a plethora of other information on various industries, including pharma, are available from different credible websites, just as anything else.

Additionally, the social media, collectively, have made exchanges and interpretations of such information within various groups and communities, as fast as these could be. Just as many other different things, wrongdoings or malpractices, if any, of various industries, also get quickly captured and shared by the Netizen with ease and élan. These include incidences of ‘cutting corners’ by constituents of the pharma industry too.

Conclusion:

The Public Relationship campaigns of pharma lobby groups, with a hope to bridging the industry’s ‘trust deficit’, have been reported from the United States and other countries. However, any such campaign for the pharma industry in India hasn’t arrested my attention, as yet.

It’s beyond any reasonable doubt or debate that the pharma industry, in general, has saved and is still instrumental in saving more lives, in every nook and corner of the world. Ironically, the same industry, for its own deeds prompted mostly by the self-serving needs, has been suffering a massive collateral damage.

The industry’s long unblemished image and reputation have been severely tarnished,   requiring rejuvenation with an inclusive approach. This may call for a mindset, at least, nearer to the same of George W. Merck – the legendary President and Chairman Merck & Co., Inc. He articulated a vision – “Medicine Is For The Patient, Not For The Profits”, and practiced it religiously. In today’s context, this may sound rather utopian in letters, but surely not in its spirit… be that as it may….

Pharma lobby groups hope to reverse the current trend by focusing only on R&D spending, drug innovation and strictest patent protection and data exclusivity ecosystem is apparently a non-starter. That ongoing multi-million-dollar pharma image revamp campaigns haven’t yet captured any tangible positive outcomes – not even in the United States, is possibly a testimony to this fact.

The status quo is expected to continue. More so, when ‘reasonable pricing’ of drugs is one of the top most demands of patients, patient groups and even many governments – and that’s exactly where the buck stops in pharma business.

In my view, pharma reputation restoration process isn’t merely a one-sided communication issue, as it appears today. A strategic blue print of this critical industry need, deserves to be drawn on a much broader canvass with a patient-serving mindset, instead of just a self-serving one. Otherwise, with incidences of ‘cutting corners’ going North, pharma reputation will keep diving South… till it finds its very bottom.

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 Stakeholder-Mix Has Changed, But Pharma Marketing Has Not

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“We try never to forget that medicine is for the people. It is not for profit. Profits follow, and if we have remembered that, they never fail to appear.”

In 1952, George Wilhelm Herman Emanuel Merck, the then President of Merck & Co of the United States said this. He was then aptly quoted on the front cover of the ‘Time Magazine’, epitomizing his clear vision for the company: “Medicine is for people, not for the profits”.

The globally acclaimed Management Guru – Peter F. Drucker had also clearly articulated in his management classics that, “Profit is not the purpose of business and the concept of profit maximization is not only meaningless, but dangerous.” He further said, “There is only one valid purpose of a business, and that is to create a customer” 

As this is an ongoing process, in the pharma perspective, it may be construed as ensuring access to new drugs for an increasing number of patients.

It really worked: 

In those days, driven by such visionary leadership, the pharma used to be one of the most respected industries and Merck topped the list of the most admired corporations in America. It is clear that pharma leadership at that time wanted to make ‘inclusive growth’, both in the letter and spirit, as an integral part of the organizational progress, moving with time.

Thus, it worked. The sales and marketing growth of the global drug industry at that time was not lackluster, either, in any way. The R&D pipeline of the drug companies used to be also rich, with regular flow of breakthrough new products too. 

Straying away from ‘inclusive’ to ‘self-serving’ strategies:

Much water has flown down the bridges, since then, so is the change in the public and other stakeholders’ perception about the pharma industry, in general. 

Sharply in contrast with George W. Merck’s (Merck & Co) vision in 1952 that “Medicine is for people, not for the profits”, in December 2013 the global CEO of Bayer reportedly proclaimed in public that: “Bayer didn’t develop its cancer drug, Nexavar (sorafenib) for India but for Western Patients that can afford it.” 

It appears that the focus of the pharma industry on ‘inclusive growth’ seems to have strayed away to ‘self-serving growth’, with the passage of time. As a result, a large majority of the new stakeholders started harboring a strong negative feeling about the same industry that continues its active engagement with the very same business of developing new drugs that save many precious lives. 

Granted that the business environment has changed since then, with increasing complexities. Nonetheless, there does not seem to be any justifiable reason for straying away from ‘inclusive growth’ strategies.                                         

As are regularly being reported, both in the global and local media, mindless arrogance on fixing exorbitant high new drug prices severely limiting their access, unabated malpractices in drug marketing and escaping with hefty fines, releasing only favorable clinical trial data, just to mention a few, are giving the industry image a strong tail spin.

Stakeholders changed, but pharma marketing did not:

Keeping the same strategic direction and pace, overall pharma brand marketing strategy also continued to be increasingly ‘self-serving’, and tradition bound. Success, and more success in building relationship with the doctors, whatever may be the means, is still considered as the magic wand for business excellence, with any pharma brand. Thus, since over decades, building and strengthening the relationship with doctors, continue to remain the primary fulcrum for conceptualizing pharma marketing strategies. 

It does not seem to have not dawned yet for the pharma marketers, that over a period of time, the market is undergoing a metamorphosis, with several key changes, and some of these would be quite disruptive in the traditional pharma marketing ball game. Consequently, the above key the fulcrum of pharma marketing is also gradually shifting, slowly but surely.

In this article, I shall deliberate only on this area.

A new marketing paradigm:

The key customer in the pharma business is no longer just the doctors. That was the bygone paradigm. The pharma stakeholders’ mix is no longer the same as what it used to be. 

The evolving new paradigm constitutes multitude of important stakeholders, requiring a comprehensive multi-stakeholder approach in modern day’s pharma marketing game plan.

Patients, governments, policy influencers, health insurance providers, hospital administrators, social media, and many others, have now started playing and increasing role in determining the consumption pattern of pharma brands, and their acceptability. More importantly, these not so influential stakeholders of the past, are gradually becoming instrumental in building overall pharma business environment too. This necessitates customized engagement strategy for each of these stakeholders, with high precision and relevance.

Changing mindset is critical: 

An effective response to this challenge of change, calls for a radical change in the marketing mindset of the top pharma marketers. The most basic of which, is a strong will to move away from the age old ‘one size fits all’ and ‘self-serving’ initiatives with some tweaking here or there, to a radically different ‘inclusive marketing’ approach.  In this game, both the types and the individual customer concerned, would occupy the center stage for any meaningful interactions on the brands and associated diseases, besides many other areas of relevance.

Multi-stakeholder – Multi-channel approach:

For a multi-stakeholder customized engagement, innovative use of multiple channels would play a crucial role, more than ever before.

Availability of state of the art digital tools, would facilitate crafting of comprehensive marketing strategies, accordingly. For example, for the doctors, some companies are moving towards e-detailing.

As I discussed in my article in this Blog titled, “e-detailing: The Future of Pharmaceutical Sales?” on September 13 2013, this modern way of interaction with the doctors is fast evolving. E-detailing is highly customized, very interactive, more effective, quite flexible, and at the same time cost-efficient too. Live analytics that e-detailing would provide instantly, could be of immense use while strategizing the game plans of pharmaceutical marketing.

A feel of the changing wind direction:

A relatively new book titled, “Good Pharma: How Marketing Creates Value in Pharma”, published in March 2014, and written by Marcel Corstjens, and Edouard Demeire, well captures some of the key changes in the pharma industry with a number interesting examples. 

The above book seems to somewhat respond to Ben Goldacre’s bestselling book ‘‘Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients’, which I discussed in this blog on October 15, 2012.  It made some important observations in many areas of pharma business. I am quoting below just a few of those incoming changes to give a feel on the urgent need of recasting the marketing models of the pharma industry:

On emerging markets’ like India:

“Emerging markets should not be seen as low-hanging fruits. Their prevalence of diseases may not be the same, the stakeholders may be very different. In addition, the healthcare infrastructure is often not very sophisticated, and these markets can be rather volatile and difficult to predict. It’s not a sure bet; you have to invest. … Companies need to commit seriously to building a heavily localized approach that is substantiated by a global reputation.” This is perhaps not happening in India, to a large extent, as I reckon.

On personalized Health Care (PHC): 

The new drugs brought to market by the pharma companies are not just expensive, but often work only for small segments of the patient population. In India this situation mostly leads to very high out of pocket expenditure, which often is wasted for the drug not working on the patient. Thus, the regulators and payers in the developing countries are setting the threshold for higher reimbursement. The authors observed that PHC is now being put forward as the industry’s best bet for satisfying stricter effectiveness criteria, not only by developing new drugs, but also by investing in the magical trio of the future: “drug-biomarker-diagnostic. In that case, pharma marketing would need to undergo a significant change, starting from now.

On ‘Category captains’:

The book also says, “The most financially successful companies in the past 20 years has been Novo-Nordisk. They have specialized in diabetes, they’re extremely good at that. Roche specializes in oncology. The larger the company, the more ‘captive’ areas they can have. The success of Novo-Nordisk, a relatively small company, proves firms of all sizes have a chance to compete, as long as they stick closely to their strengths. When this happens in a much larger scale, pharma marketing would also be quite different and more focused.

Many pharma companies are still avoiding to change, successfully. For example, as announced on May 31, 2016, Intercept Pharma of the United States announced its new liver disease drug with a hefty price tag of US$ 70,000 a year. According to the report, the company said, prices are justified by a drug’s level of innovation and cost savings for the healthcare system. This justification has now become very typical in the pharmaceutical world, which has been facing barrage of criticisms, including from Capitol Hill, about too-high drug prices.

However, as we move on, the writing on the wall seems to be very clear on the sustainability of health care business, the world over.

Conclusion:

Finally, the question arises, would the traditional approach still be good enough to achieve the desired sales and marketing objectives, any longer?

No, probably not, I reckon. With changed mindsets, ‘getting under the skin’ of each stakeholder, separately, would assume key importance. It would play a key role, while devising each component of any cutting-edge pharma sales and marketing strategy, tactic, and task.

The shift from the old paradigm, signals towards a total recast of pharma marketing to make it more ‘inclusive’, and not just ‘self-serving’. Newly crafted commensurate grand marketing plans and their effective implementation should satisfy the needs and wants of all stakeholders, simultaneously. Singular focus on building, or further strengthen the relationship with prescribing doctors, won’t be adequate enough, anymore.

Thus, the name of the new pharma ballgame would again be ‘inclusive marketing for inclusive growth’.

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.

“Kickbacks And Bribes Oil Every Part of India’s Healthcare Machinery” – A National Shame?

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“Corruption ruins the doctor-patient relationship in India” - highlights an article published in the well-reputed British Medical Journal (BMJ) on 08 May 2014. The author David Berger wrote, “Kickbacks and bribes oil every part of the country’s healthcare machinery and if India’s authorities cannot make improvements, international agencies should act.”

The author reiterated the much known facts that the latest in technological medicine is available only to those people who can pay for its high price. However, the vast majority of the population has little or no access to healthcare, and whatever access they have is mostly limited to substandard government care or to quacks, which seem to operate with near impunity. He further points out that “Corruption is rife at all levels, from the richest to the poorest”. It is a common complaint both from the poor and the middle class that they don’t trust their doctors from the core of hearts. They don’t trust them to be competent or to be honest, and live in fear of having to consult them, which results in high levels of doctor shopping.

Dr. Berger also deliberated on the widespread corruption in the pharmaceutical industry, with doctors bribed to prescribe particular drugs. Common stories usually doing the rounds that the decision makers in the hospitals are being given top of the range cars and other inducements when their hospitals sign contracts to prescribe particular expensive drugs preferentially.

The article does not fail to mention that many Indian doctors do have huge expertise, are honorable and treat their patients well. However, as a group, doctors generally have a poor reputation.

Until the profession along with the pharma industry is prepared to tackle this malady head-on and acknowledge the corrosive effects of medical corruption, the doctor-patient relationship will continue to lie in tatters, the paper says.

The saga continues through decades – unabated:

The above worrying situation in the space of medical treatment in India refuses to die down and continues since decades.

The article published in the British Medical Journal (BMJ) over a decade ago, on January 04, 2003 vindicates this point, when it brings to the fore, “Health care is among the most corrupt services in India”.

This article was based on a survey released by the India office of the international non-governmental organization ‘Transparency International’. At that time, it ranked India as one of the 30 most corrupt countries in the world. The study covered 10 sectors with a direct bearing on people’s lives, where the respondents rated the police as the most corrupt sector, closely followed by healthcare.

Medical Council of India (MCI) is responsible for enforcing the regulations on medical profession. Unfortunately, the MCI itself is riddled with corruption, fueled by the vested interests. As the first BMJ article indicates,   Subsequently, there has been controversy over the surprise removal, on the day India was declared polio-free, of the health secretary Keshav Desirajus, possibly in response to his resistance to moves to reappoint Desai to the reconstituted MCI.

Another point to ponder: Quality of Doctor – MR interactions

It is a well-established fact that the ethics, values and belief in pharmaceutical sales and marketing are primarily derived from the ethics, values and belief of the concerned organization.  Field staff systems, compliance, accountability, belief, value and culture also flow from these fundamentals. Thus, considering the comments made in the BMJ on the pharma companies, in general, let me now also deliberate on the desired roles of the Medical Representatives (MR) in this area.

It is well known that MRs of the pharma players exert significant influence on the prescribing practices of the doctors and changing their prescribing patterns too. At the same time, this is also equally true that for a vast majority of, especially, the General Practitioners (GPs), MRs are the key source of information for various drugs. In tandem, several research studies also indicate that doctors, by and large, believe that pharma companies unduly influence them.

Theoretically, MRs should be properly trained to convey to the target doctors the overall profile – the efficacy, safety, utility, precautions and contra-indications of their respective products. Interestingly, the MRs are trained by the respective pharma companies primarily to alter the prescribing habits of the target doctors with information heavily biased in favor of their own drugs.

As a result, range of safety, precautions and contra-indications of the products are seldom discussed, if not totally avoided, putting patients at risks by creating an unwarranted product bias, especially among GPs, who depend mainly on MRs for product information. Thus, the quality of product communication is mainly focused on benefits rather than holistic – covering all intrinsic merits/demerits of the respective brands in a professional manner.

Considering the importance of detailing in delivering the complete product information primarily to the GPs, there is a critical need for the pharma companies to train and equip the MRs with a complete detailing message and yet be successful in winning the doctors’ support.

This issue also needs to be properly addressed for the interest of patients.

“Means” to achieve the goal need to change: 

Globally, including India, many pharma players have not been questioned, as yet, just not on the means of their meeting the financial goals, but also the practices they follow for the doctors. These often include classifying the physicians based on the value of their prescriptions for the specific products. Accordingly, MRs are trained to adopt the respective companies’ prescribed ‘means’ to influence those doctors for creating a desirable prescription demand. These wide array of so-called ‘means’, as many argue, lead to alleged ‘bribery’/’kickbacks’ and other malpractices both at the doctors’ and also at the pharma companies’ end.

To address this issue, after the Chinese episode, GlaxoSmithKline (GSK) has reportedly announced that by the start of 2016 it will stop paying doctors to speak on its behalf or to attend conferences, to end undue influence on prescribers.

The announcement also indicated that GSK has planned to remove individual sales targets from its sales force. This means that MRs would no longer be paid according to the number of prescriptions they solicited from the doctors met by them.

Instead, GSK introduced a new performance related scheme that will reward the MRs for their technical knowledge, the quality of the service they deliver to support improved care of patients, and the overall performance of GSK’s business. The scheme is expected to start in some countries effective January 2014 and be in place globally by early 2015.

Further, GSK underscored that the latest changes were “designed to bring greater clarity and confidence that whenever we talk to a doctor, nurse, or other prescriber, it is patients’ interests that always come first.”

This is indeed a refreshing development for others to imbibe, even in India.

Capturing an Indian Example:

Just to cite an example, a couple of years ago Reuters in an article titled “In India, gift-giving drives drug makers’ marketing” reported that a coffee maker, cookware and vacuum cleaner, were among the many gifts for doctors listed in an Abbott Healthcare sales-strategy guide for the second quarter of 2011 in India, a copy of which was reviewed by Reuters.

It is interesting to note from the report, even for an antibiotic like Nupod (Cefpodoxime), doctors who pledge to prescribe Abbott’s branded drugs, or who’ve already prescribed certain amounts, can expect some of these items in return, the report mentioned.

Since decades, media reports have highlighted many more of such instances. Unfortunately, the concerned government authorities in India refused to wake-up from the deep slumber, despite the alleged ruckus spreading like a wild fire.

Self-regulation by the industry ineffective:

This menace, though more intense in India, is certainly not confined to the shores of this country. As we all know, many constituents of Big Pharma have already been implicated in the mega pharma bribery scandal in China.

Many international pharmaceutical trade associations, which are primarily the lobbying bodies, are the strong votaries of self-regulations by the industry. They have also created many documents in these regards since quite some time and displayed those in their respective websites. However, despite all these the ground reality is, the charted path of well-hyped self-regulation by the industry to stop this malaise is not working.

The following are just a few recent examples to help fathom the enormity of the problem and also to vindicate the above point:

  • In March 2014, the antitrust regulator of Italy reportedly fined two Swiss drug majors, Novartis and Roche 182.5 million euros (U$ 251 million) for allegedly blocking distribution of Roche’s Avastin cancer drug in favor of a more expensive drug Lucentis that the two companies market jointly for an eye disorder.
  • Just before this, in the same month of March 2014, it was reported that a German court had fined 28 million euro (US$ 39 million) to the French pharma major Sanofi and convicted two of its former employees on bribery charges.
  • In November 2013, Teva Pharmaceutical reportedly said that an internal investigation turned up suspect practices in countries ranging from Latin America to Russia.
  • In May 2013, Sanofi was reportedly fined US$ 52.8 Million by the French competition regulator for trying to limit sales of generic versions of the company’s Plavix.
  • In August 2012, Pfizer Inc. was reportedly fined US$ 60.2 million by the US Securities and Exchange Commission to settle a federal investigation on alleged bribing of overseas doctors and other health officials to prescribe medicines.
  • In April 2012, a judge in Arkansas, US, reportedly fined Johnson & Johnson and a subsidiary more than US$1.2 billion after a jury found that the companies had minimized or concealed the dangers associated with an antipsychotic drug.

Pricing is also another important area where the issue of both ethics and compliance to drug regulations come in. The key question continues to remain, whether the essential drugs, besides the patented ones, are priced in a manner that they can serve the needs of majority of patients in India. I have deliberated a part of this important issue in my earlier blog post titled “Is The New Market Based Pricing Model Fundamentally Flawed?”

There are many more of such examples.

Stakeholders’ anguish:

Deep anguish of the stakeholders over this issue is now being increasingly reverberated on every passing day in India, as it were. It had also drawn the attention of the patients’ groups, NGOs, media, Government, Planning Commission and even the Parliament.

The Department Related Parliamentary Standing Committee on Health and Family Welfare in its 58th Report strongly indicted the Department of Pharmaceuticals (DoP) on this score. It observed that the DoP should take prompt action in making the ‘Uniform Code of Pharmaceutical Marketing Practices (UCPMP)’ mandatory so that effective checks and balances could be brought-in on ‘huge promotional costs and the resultant add-on impact on medicine prices’.

Despite deplorable inaction by the erstwhile Government on the subject, frequent reporting by Indian media has triggered a national debate on this issue. A related Public Interest Litigation (PIL) is also now pending before the Supreme Court for hearing in the near future. Its judicial verdict is expected to usher in a breath of fresh air around a rather stifling environment for the patients.

Let us now wait and see what action the new minister of the Modi Government takes on this issue.

A prescription for change:

Very recently, Dr. Samiran Nundy, Chairman of the Department of Surgical Gastroenterology and Organ Transplantation at Sir Ganga Ram Hospital and Editor-in-Chief of the Journal of Current Medicine Research and Practice, has reportedly exposed the widespread (mal) practices of doctors in India taking cuts for referrals and prescribing unnecessary drugs, investigations and procedures for profit.

Dr. Nundy suggested that to begin with, “The Medical Council of India (MCI), currently an exclusive club of doctors, has to be reconstituted. Half the members must be lay people like teachers, social workers and patient groups like the General Medical Council in Britain where, if a doctor is found to be corrupt, he is booted out by the council.”

Conclusion:

Efforts are now being made in India by some stakeholders to declare all malpractices related to pharma industry illegal through enactment of appropriate robust laws and regulations, attracting exemplary punishments to the perpetrators.

However, enforcement of MCI Guidelines for the doctors and initiatives towards enactment of suitable laws/regulations for the pharma industry, like for example, the ‘Physician Payments Sunshine Act’ of the United States, have so far been muted by the vested interests.

If the new Modi government too, does not swing into visible action forthwith, this saga of international disrepute, corruption and collusion in the healthcare space of India would continue in India, albeit with increasing vigor and probably in perpetuity. This would, undoubtedly, sacrifice the interest of patients at the altar of excessive greed and want of the vested interests.

This new government, as most people believe, has both the will and wherewithal to hold this raging mad bull of pharma malpractices by the horn, ensuring a great relief and long awaited justice for all.

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. 

Ethical Pharmaceutical Marketing Practices: ‘Self-Regulation’…’Voluntary Physician Payments Disclosure’…What’s next?

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Over a period of time, many stakeholders of the pharmaceutical industry and the public at large have been raising the issue of physicians being influenced in their prescription decisions by various types of payments made to them by the pharmaceutical companies. Such types of significant and seemingly avoidable expenditures, considered by the respective companies as a part of their ‘marketing costs’, are believed to be included in the maximum retail price (MRP) of medicines making them more expensive to the patients.On the other hand, most physicians believe that free entertainment, gifts, their travel costs and seminar sponsorships in no way influence their prescription decision for a patients.This issue is not India specific. It is indeed a global issue.

Self regulation by the industry is considered to be the name of the game:

To address this issue effectively, international pharmaceutical associations, like International Federation of Pharmaceuticals Manufacturers and Associations (IFPMA) and Pharmaceutical Research and Manufacturers of America (PhRMA) have come out with their own codes of ethical marketing practices with appropriate stakeholder grievance redressal mechanism to respond to stakeholder complaints, effectively.

In India, pharmaceutical industry association like Organization of Pharmaceutical Producers of India (OPPI) and Indian Drug Manufacturers’ Association (IDMA) have also formulated their own codes of ethical marketing practices.

Despite all these, it is indeed an undeniable fact that the perception and the allegation of the stakeholders including the general public towards the pharmaceutical industry, in general, have not changed much.

The government intervened in India:

Being alarmed by various media reports on the current pharmaceutical marketing (mal) practices scenario, the Department of Pharmaceutical (DoP) convened a meeting of the pharmaceutical Industry on the subject this year and advised the pharmaceutical industry to develop a ‘Uniform Code of Marketing Practices (UCMP)’, which will be applicable to the entire pharmaceutical industry in India.

‘Uniform Codes of Marketing Practices (UCMP)’:

It is believed that the UCMP is in its final stages of release along with its stakeholder grievance redressal mechanism in a transparent procedural format. Everybody expects that all stakeholders will help maintaining the sanctity of the UCMP to address this sensitive global and local issue effectively.

A new trend of public disclosure of ‘payments to the physicians’ by the global pharmaceutical companies:

Around third quarter of 2008, in an industry first step, Eli Lilly announced its intent of full disclosure of payments that the company made to the physicians for various commercial reasons. Eli Lilly indicated disclosure of payments of more than US $500 to the physicians for advice and speaking at the seminars. Over a period of time, the company indicated that it will expand such disclosure to include other forms of payments to the physicians like gifts, various entertainment and travel.

Eli Lilly was soon followed in this direction by global pharmaceutical majors like Merck and GlaxoSmithKline (GSK).

Skepticism with such voluntary disclosure will still exist:

Many are still skeptical about such ‘voluntary disclosure of payment to the physicians’ announcements by the global pharmaceutical majors to bring in better transparency in the functioning of the industry. They believe that there are hundreds and thousands of pharmaceutical companies who will not follow such precedence of voluntary disclosure in the absence of any properly enforced regulation.

Conclusion:

‘Self-regulation of pharmaceutical marketing practices’ and ‘voluntary disclosure of payment to the physicians’ by some pharmaceutical companies are laudable steps to address this problem. However, the moot question still remains: are all these enough?

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.