Organic and Inorganic Growth Strategy For Sustainable Business Excellence

Posted on April 30, 2018 by Tapan Ray

For an enthusiast, witnessing any organization growing consistently, is indeed exhilarating. This becomes even more interesting at a time when challenges and frequent surprises in the business environment become a new normal. A robust short, medium and long growth strategy turns out to be a necessity for sustaining the business excellence over a long period of time. This is applicable even to the pharma players in India.

The Chief Executive Officer (CEO) of an organization usually assumes the role of chief architect of this strategy, which needs to be subsequently approved by the Board of Directors of the company concerned, collectively. The Board holds the CEO, who ultimately carries the can, accountable to deliver the deliverables in creating the desired shareholder value.

Two basic types of growth strategies:

Based on the CEO’s own experience, and also considering the expectations of the Board of Directors, together with the investors, the CEO opts for either of these two following types of basic growth strategies, or a mix of these two in varying proportions:

Organic growth: Growing the business through company’s own pursued activities, or all growth strategies sans Mergers and Acquisitions (M&A) or by any other means not external to the organization.
Inorganic growth: Growing the business through M&A or takeovers.

There is nothing fundamentally wrong with either of these two types of basic growth strategies, or their mix in varying proportions. Nevertheless, it is generally believed that with the basic ‘Organic’ growth plan, the companies, or rather their CEOs have a greater degree of sustainable control in various critical areas. These often include, retaining senior management focus on the organizational core strength for sustainable excellence, or even maintaining the organizational culture and people management style, without any possible conflict in these areas.

In this article, I shall explore different aspects of these two basic growth strategies for sustainable business excellence. To illustrate the point better, I shall draw upon examples from two large but contrasting pharma companies. Let me begin this discussion with the following question:

When does a company choose predominantly inorganic growth path?

Its answer has been well articulated in an article of the Harvard Business Review (HBR). It says: “High-growth companies become low growth all the time. Many CEOs accept that as an inevitable sign that their businesses have matured, and so they stop looking internally for big growth. Instead, they become serial acquirers of smaller companies or seek a transformative acquisition of another large business, preferably a high-growth one.”

That said, none can deny that the short to medium term growth of a company following M&A is much faster and its market share and size become much larger than any comparable organizations pursuing the ‘Organic Growth’ path. Thus, more often than not, such initiatives create a ‘domino effect’, especially in the pharma industry, across the world.

Inorganic growth and key management challenges:

The short and medium-term boost in organizational performance post M&A, comes with its complexities in meeting similar expectations of the Company Board, shareholders and the investors, over a long period of time. This is besides all other accompanying issues, such as people related and more importantly in setting the future direction of the company. The cumulative impact of all this, propels the CEO to go all out for a similar buying spree. When it doesn’t materialize, as was expected, both the Board and the CEO are caught in a catch 22 situation. As mentioned earlier, I shall illustrate this point, with the following recent example covering some important areas.

The examples:

“Please don’t go, Ian Read. That’s the message Pfizer’s board of directors has made loud and clear to the almost-65-year-old CEO, who could very well retire with a $15.7 million pension package.” This is what appeared in an international media report on March 16, 2018.

Analyzing the current challenges faced by the company, the media report interpreted the indispensability of Ian Read in an interesting way. It reported: “The pharma giant considers Read the most qualified person to steer the company through a host of challenges, from oncology trial disappointments to investor pressure to make a big acquisition.” Investors are also, reportedly, sending clear signals to the CEO about the tough road ahead.

Thus, Ian Read “who turns 65 in May, also must remain CEO through at least next March and not work for a competitor for a minimum of two years after that to be eligible,” reported Bloomberg on March 16, 2018. It is interesting to note at this point that Mr. Read has been the Chief Executive Officer (CEO) of Pfizer – the world’s largest pharmaceutical company, since 2010.

A different CEO rated as ‘Top Performing’ pharma leader:

Pfizer CEO’s ‘exemplary leadership and vision’, has been captured in the Proxy Statement by the Independent Directors on the Board of the Company. However, Harvard Business Review (HBR) in its 2016 pan-industry ranking of the “best-performing” CEOs in the world, featured Lars Rebien Sorensen – the then outgoing CEO of Novo Nordisk. He topped the list for the second successive year. Sorensen achieved this distinction ‘Mostly, for his role overseeing astonishing returns for shareholders and market capitalization growth.’ All the CEOs were, reportedly, evaluated by HBR on a variety of financial, environmental, social, and governance metrics.

Interestingly, in the 2017 HBR list for the same, when the Novo Nordisk CEO was out of the race, no pharma CEO could achieve this distinction or even a place in the top 10. Pablo Isla of Inditex (Spanish clothing retailer), Martin Sorrell of WPP (PR major in the UK) and Jensen Huang of NVIDIA (American technology company occupied the number 1, 2 and 3 spots, respectively.

Two interesting leadership examples:

I shall not delve into any judgmental interpretations on any aspect of leadership by comparing the Pfizer CEO with his counterpart in Novo Nordisk. Nevertheless, one hard fact cannot be ignored. The accomplishments of Pfizer CEO were evaluated by its own Board and were rated outstanding. Whereas, in case of Novo Nordisk CEO, besides the company’s own Board, his performance evaluation was done by the outside independent experts on the HBR panel.

Was there any difference in their growth strategy?

Possibly yes. There seems to be, at least, one a key difference in the ‘growth strategy’ of these two large pharma players.

Novo Nordisk is primarily driven by ‘Organic growth’ with a focused product portfolio on predominantly diabetes disease area, besides hemophilia, growth disorders and obesity. This has been well captured in the company’s statement on February 6, 2017 where it says: “Organic growth enables steady cash returns to shareholders via dividends and share repurchase programs” and is driven by its Insulin portfolio.

Whereas, Pfizer, though in earlier days followed an ‘organic’ growth path, subsequently changed to ‘Inorganic Growth’ route. Pfizer’s mega acquisitions, in its quest for faster growth to be the world’s largest pharma player, include Warner Lambert (2000), Pharmacia (2002) and Wyeth (2009). The key purpose of these acquisitions appears to expand into a diversified product portfolio of blockbuster drugs.

Pfizer did contemplate changing course:

In 2010, barely two weeks on the job of CEO, Pfizer Inc., Ian Read indicated breaking up the company into two core businesses. However, after six years of meticulous planning, on September 26, 2016, the company announced: “After an extensive evaluation, the company’s Board of Directors and Executive Leadership Team have determined the company is best positioned to maximize future shareholder value creation in its current structure and will not pursue splitting Pfizer Innovative Health and Pfizer Essential Health into two, separate publicly traded companies at this time.”

Sustained value creation following the same path not easy:

After the decision to operate as one company and consolidate the business pursuing similar ‘Inorganic Growth’ strategy, Pfizer went ahead full throttle to acquire AstraZeneca for USD119 billion. But, on May 19, 2014, AstraZeneca Board rejected it. Again, on April 05, 2017, Reuters reported, “Pfizer Inc. agreed on Tuesday to terminate its $160 billion agreement to acquire Botox maker Allergan Plc, in a major victory to U.S. President Barack Obama’s drive to stop tax-dodging corporate mergers.”

Apparently, the current Pfizer CEO is now expected to finish his unfinished agenda, at least for the short to medium term, as the current blockbuster drugs continue losing the steam.

Conclusion:

It’s a common belief that slowing down of a company’s business performance is a compelling reason for its switch from the ‘Organic’ to ‘Inorganic’ growth strategy. The new CEO of Novo Nordisk – Lars Fruergaard Jorgensen also appears to subscribe to this view. While, reportedly, including negative growth at the low end in constant currencies in its guidance for 2017, Jorgensen apparently, confided that M&A will now be a part of the company’s growth search.

On facing a similar situation, the above HBR article suggested the CEOs to fight the short-term pressures of the business cycle of moving away from the ‘Organic’ growth path. This can be overcome by various means, as good ideas for organic growth can always attract required resources and support.

While choosing an appropriate basic growth strategy for the organization – ‘Organic’ or ‘Inorganic’, the CEO’s focus should be on what is best for sustainable and long-term business performance, without being trapped by the prevailing circumstances. Thus, addressing the internal causative factors, effectively, would likely to be a better idea in resolving the issue of a sustainable business performance. This is regardless of the underlying reasons, such as gradually drying up the new product pipeline while blockbuster drugs are going off patent, or due to several other different reasons.

Nevertheless, in the balance of probability, ‘Organic’ growth strategy appears to be less complex and is fraught with lower business risks and uncertainties. Consequently, it reflects a greater likelihood of sustainable achievements for the CEO, and in tandem, a long-term financial reward for the shareholders, investors, and finally the organization as a whole.

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.

Disruptive Digital Innovation To Reduce Medication Need?

Posted on May 1, 2017 by Tapan Ray

Application of digital technology in various spheres of not just business, but in our individual day to life also, promises a disruptive change for the better, from the traditional way of doing things and achieving goals – freeing a lot of precious time for us to do much more, and even faster. An impending tsunami of this digital revolution, as it were, is now all pervasive, with various digital application platforms becoming increasingly more cost effective, quite in tandem with the fast pace of cutting-edge innovation. This is so different from what is generally witnessed in the pharma business.

Interestingly, despite high demand for cost effective health care from all over the world, not much progress in this area is still visible within this industry, in general, and particularly in the pharma business. Various reasons may be attributed to this apathy, which I shall not venture to go into, today.

On the other hand, sniffing a huge opportunity in this largely vacant space, many tech giants and startups are investing heavily to make health care of people easier, and at the same time reap a rich harvest, far outpacing the big pharma players.

As I connect the different dots on world-class digital initiatives in the health space, a clear trend emerges on the global scenario. The way Internet revolution, to start with, followed by smartphones and many other wireless digital services is changing the rhythm of life for many making it much easier, is just amazing. These include a plethora of everyday ‘must-do’ and several other functions, such as, precise need-based information gathering, online banking, tax-filing, shopping, payment, social networking, cloud computing and storage, besides a gamut of other digital services.

Similar disruptive digital innovations are expected in the health care space too, involving many long-awaited patient-centric areas, such as, significant reduction in the cost of medication. I discussed a similar issue in one of my earlier articles, published in this blog. However, today, I shall focus on this specific area, in view of its possible huge impact on the traditional pharma business model.

May reduce need of medication:

That tech startups are developing digital tools that reduce the need of medication, was very recently reported in an article titled, ‘Digital disruptors take big pharma beyond the pill’ published in the Financial Times on April 24, 2017. For example, a California-based startup, has reportedly come out with a digital device, smaller than an iPhone and fitted with a cellular chip, that can keep instant and accurate track of blood sugar levels. If the readings fall in the danger zone, an appropriate text message will be automatically generated for the person, such as – “drink two glasses of water and walk for 15 minutes”. The individual can also seek further help over the telephone from a trained coach – a highly-qualified dietitian for further guidance, the article highlights.

The whiz kid developers of wearable digital devices and apps are now intently working on many innovative health care solutions. Many of these can help early disease detection, and chart the risk profile of persons prone to various ailments, based on an enormous amount of well researched scientific data, significantly reducing the need of medication through effective disease prevention and management protocols. For example, there are umpteen evidences, demonstrating that specific moderate physical exercises help control diabetes just as well as medication, when detected early.

Thus, I reckon, such wearable digital devices and apps carry a huge promise to detect many diseases like, diabetes at its very onset or even before, and influence the person to take the necessary measures. In case of diabetes, it could be like, walking a certain distance every day, along with regular dietary advices from a remote center. Won’t such digital interventions work out far cheaper and convenient than lifelong visits to physicians and administration of anti-diabetic drugs?

The notes of the pharma business playbook need to be rewritten?

Let me quickly elaborate this point with an example of a common chronic ailment, say, diabetes. For effective management of this disease, global pharma players prefer to focus on better and better antidiabetic drug development, and after that spend a fortune towards their effective sales and marketing for generating enough prescription demand. Branded generic manufacturers are no different. This is important for all of them as most patients will have to administer the medicines for chronic ailments for a lifetime, incurring significant recurrent expenses for effective disease control. The first access point of such disease management has always been a doctor, initially for diagnosis and then for lifelong treatment.

Disruptive digital innovation could change the first point of intervention from the doctors to various digital apps or devices. These digital tools would be able to check and capture the person concerned predisposition to chronic diseases like, hypertension and diabetes, besides many other serious ailments, including possible cancer. When detected early, primary disease management advice would be available to patients from the app or the device itself, such as, the above-mentioned device for diabetes. If the preventive practices can manage the disease, and keep it under control, there won’t be any serious need to visit a doctor or pop a pill, thus, avoiding any need of active medication.

In that sense, as the above FT article has articulated, ‘rather than buying a pill, people might buy an overall solution for diabetes’ can’t be more relevant. When it happens, it will have a multiplier effect, possibly impacting the volume of consumption of medicines, just as what disease prevention initiatives do. Consequently, the notes of the pharma business playbook may have to be rewritten with right proactive measures.

As reported, the good news is, at least a couple of global pharma players have started fathoming its impact. This is apparent from Sanofi’s collaboration on digital devices and patient support for diabetics, and to some extent with Pfizer on immuno-oncology, using expertise in data analytics to identify new drug targets.

The key players in this ‘healthcare value chain’:

When the digital health care revolution will invade the current space of traditional-health care, it will create both the winners and losers. This was clearly highlighted in an article titled, ‘A digital revolution in healthcare is speeding up’, published by ‘The Economist’ on March 02, 2017.

From this article, it appears, when viewed in the Indian context that primarily two groups of players are currently ‘fighting a war for control’ of this ‘healthcare value chain’, as follows:

Traditional innovators: These are pharma companies, hospitals and medical-technology companies, such as, Siemens, GE and Phillips.

Technology insurgents: These include Microsoft, Apple, Google, and a host of hungry digital entrepreneurs and startups – creating apps, predictive-diagnostics systems and new devices.

Where is the threat to traditional pharma innovators?

This emerging trend could pose a threat to traditional innovators as the individual and collective knowledge base gets wider and wider – the above article envisages. With the medical records getting increasingly digitized with new kinds of patient data available from genomic sequencing, sensors and even from social media, the Government, including many individuals and groups, can now get a much better insight into which treatments work better with avoidable costs, on a value-based yardstick. For example, if digital apps and wearable devices are found even equally effective as drugs, with the least cost, to effectively manage the menace of diabetes in the country, notwithstanding any strong ‘fear arising’ counter propaganda, as we often read and here and there, those will increasingly gain better acceptance from all concerned.

The moot question, therefore, arises, would the drug companies lose significantly to the emerging digital players in the health care arena, such as, Microsoft, Apple and Google?

Tech giants are moving faster:

In several disease areas like, cancer and diabetes, the tech giants are taking longer and bigger strides than the traditional pharma innovators. For example:

Microsoft has vowed to “solve the problem of cancer” within a decade by using groundbreaking computer science to crack the code of diseased cells so that they can be reprogrammed back to a healthy state.

Apple has a secret team working on the holy grail for treating diabetes. The Company has a secret group of biomedical engineers developing sensors to monitor blood sugar levels. This initiative was initially envisioned by Steve Jobs before his death. If successful, the advance could help millions of diabetes patients and turn devices, like Apple Watch, into a must-have.

Verily – the life sciences arm of Google’s parent company Alphabet, has been working on a “smart” glucose-sensing contact lens with Novartis for several years, to detect blood glucose levels through tears, without drawing any blood. However, Novartis has since, reportedly, abandoned its 2016 goal to start testing the autofocus contact lens on people, though it said the groundbreaking product it is “progressing steadily.” It has been widely reported that this could probably be due to the reason that Novartis is possibly mulling to sale its eye care division Alcon.

Calico, which is also owned by Google’s parent company Alphabet, has US$ 1.5 billion in funding to carry out studies in mice, yeast, worms and African naked mole rats for understanding the ageing process, and how to slow it, reports MIT Technology Review.

No wonder, why an article published in Forbes magazine, published on April 15, 2017 considered these tech giants as ‘The Next Big Pharma’. It said, ‘if the innovations of Google and Apple are another wake-up call for the life science industry, which oftentimes has relied on the snooze function of line extensions and extended-release drugs as the source of income and innovation.’

In conclusion:

An effective disease treatment solution based on different digital platforms has a key financial advantage, as well. This is because the process of generation of huge amounts of credible scientific data, through large pre-clinical and clinical trials, establishing the efficacy and safety of new drugs on humans for regulatory approval, is immensely expensive, as compared to the digital ones. Intriguingly, no global pharma player does not seem to have launched any significant digital health care solution for patients to reduce the overall cost of disease burden, be it prevention or management.

In that context, it’s encouraging to note the profound comment of the Chief Operating Officer – Jeff Williams of Apple Inc., made during a radio show – ‘Conversations on Health Care’, as reported by ‘appleinsider.com’ on January 06, 2016. During the interaction, Williams reiterated that the rapid progress of technology in this direction is very real, as ‘Apple’ and other smartphone health app developers are stretching the commoditization of computer technology to serve health sciences. In not so distant future, with relatively inexpensive smartphones and supporting health apps – the doctors and researchers can deliver better standards of living, even in severely under-served areas like Africa, where there are only 55 trained specialists in autism.

Thus, it now looks reasonably certain to me that disruptive digital innovation on various chronic health care solutions is ultimately going to reduce the need of medication for many patients, across the world, including India, significantly.

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.

Reticence Around Unveiling Clinical Trials

Posted on October 17, 2016 by Tapan Ray

While scanning through various publications, we now get to know, almost at regular intervals, about new clinical trials capturing the newer ways of treating different ailments. Such information instils an invigorating hope in the minds of doctors and the patients alike, to more successfully and predictably fight the battle against diseases in the ongoing pursuit for a better quality of life.

However, for independent and impartial assessment of any new drug before it comes to the market, an ethical and transparent process of unveiling clinical trials, sans any reticence whatsoever, are absolutely essential. Only this process would be able to satisfactorily establish, beyond an iota of doubt, the safety and efficacy levels of, especially, the new drugs. To move in that direction, the fundamental requirements will be diligently recording and publishing all types of data – positive, not so positive, and also negative, arising out of all clinical trials, conducted anywhere in the world, for the same drug.

Thus, there should be a system of open access to all clinical trial data, as each trial is completed. Otherwise, pharma companies’ publication bias, overwhelmingly on positive results, would continue, as alleged by many across the world. It is worth noting that over 60 percent of all clinical trials for new drugs are sponsored by the pharma and biotech companies.

There isn’t any dearth of examples of new drugs’ getting not just the required regulatory approval, riding on the back of robust ‘positive’ clinical trial data on safety and efficacy, but also becoming highly dependable money-spinners for the companies, and in no time, as it were. These cash churning new brands would also get well protected for monopolistic pricing all through their respective patent life, and sometimes even after that, in various different ways.

Nevertheless, at a later date, mostly post patent expiry, not all pre-launch new drug trials could be universally accepted as robust and conclusive, especially on their efficacy and safety claims. On the contrary, a number of detailed and deep-stick independent studies indicate that some new drugs are, in fact, much less effective, if not ineffective, and cause more serious side effects than what were published earlier.

Hence, some critical questions are now being asked by many stakeholders, with greater assertiveness than ever before and backed by solid evidence, in this arena. Although it has now started creating a snowballing effect, still, nothing much seems to have changed on the ground, just yet.

Why aren’t all clinical trial results, and for all new drugs not still published, or otherwise made available for public scrutiny, unveiled, and of course after protecting any reasonable commercial interest? Does business consideration, then continue to prevail over the need for transparency in clinical trial data disclosure for patients’ health and safety? The sneaking fear behind the reasons of this reticence of pharma players, in general, continues to torment many. I shall discuss this point in this article backed by recently published data.

Not a recent trend:

This isn’t a recent trend either, and continuing for decades, without any effective remedial measures by the appropriate authorities. I would give just a couple of examples, one from 1998 and the other from 2014, to drive home this point.

A British Journal of Clinical Pharmacology (BJCP) article, published way back in August 1998 would vindicate this point. This study revealed the following on clinical trial data:

“Substantial evidence of selective reporting was detected, since trials with positive outcome resulted more often in submission of final report to regulatory authorities than those with inconclusive or negative outcomes.”

Another study published on September 10, 2014 in the Journal of American Medical Association (JAMA) states as follows:

“Thirty-five percent of published reanalysis led to changes in the findings that implied conclusions different from those of the original article about the types and number of patients who should be treated.”

That said, I shall now focus on a very recent controversy in this area, related to a blockbuster drug that has now gone off-patent.

A contemporary example:

Statin class of drugs, especially, Atorvastatin is one of many such examples.

Pfizer launched Atorvastatin with the brand name Lipitor in early 1997. At that time, it was the fifth in the statin class of drugs for the treatment of hyperlipidemia.

It was launched on the back of a 1996 clinical study that concluded, Lipitor reduces bad cholesterol significantly more than the other statins, from the very onset of treatment to as long as the treatment continues. After that it’s a history in the pharma industry, Pfizer marketing turned it into the best-selling drug ever, in the history of pharmaceuticals, so far.

Over 14.5 years, Lipitor reportedly made over US$ 125 billion in sales, and provided up to a quarter of Pfizer Inc.’s annual revenue for years.

Product claim – then:

Claiming that in ‘one year alone, statins reduced numerous cases of cardiovascular-related complications and saved thousands of lives’, a Pfizer Paper on “The Value of Statin”, reiterated the drug’s role both in the treatment and prevention of Coronary Artery Diseases (CAD). I am quoting below from this paper to cite just one example each – treatment and prevention:

In a study of patients with Coronary Artery Disease (CAD) statin therapy reduced the relative risk of mortality by 50 percent in those > 80-years-old, 44 percent in those 65- to 79-years-old, and 30% in those < 65 years old, compared to CAD patients in the same age group not taking statin therapy (Ref. Chloe, Allen A., et al. ‘Statin Therapy Is Associated With Reduced Mortality Across All Age Groups of Individuals With Significant Coronary Disease, Including Very Elderly Patients’. JACC. 40: 10; 1777-1785)

An analysis of 18 trials, including 56,934 patients, primarily without CVD, demonstrated statins conferred a relative risk reduction (RRR) in all-cause mortality by 14 percent and stroke by 22 percent (Ref. Statins for the primary prevention of cardiovascular disease. Cochrane Database System Review. 2013 Jan 31; 1:CD004816).

Research findings for the same drug – now:

Among several other publications on statins, a July 26, 2015 article, published in the ‘World Journal of Cardiology’ concludes as follows:

“History has proven otherwise, and the global prevalence of Coronary Heart Disease (CHD), despite worldwide statin usage and cholesterol lowering campaigns, has reached pandemic proportions. Coronary heart disease is an extremely complex malady and the expectation that it could be prevented or eliminated by simply reducing cholesterol appears unfounded. After twenty years we should concede the anomalies of the cholesterol hypothesis and refocus our efforts on the proven benefits of a healthy lifestyle incorporating a Mediterranean diet to prevent CHD.”

To give one more example, let me quote from a contemporary study, published on June 12, 2016 in the ‘BMJ Open’, which also comes to a similar conclusion, as follows:

“High LDL-C (Low-Density Lipoproteins – Cholesterol) is inversely associated with mortality in most people over 60 years. This finding is inconsistent with the cholesterol hypothesis (i.e., that cholesterol, particularly LDL-C, is inherently atherogenic). Since elderly people with high LDL-C live as long or longer than those with low LDL-C, our analysis provides reason to question the validity of the cholesterol hypothesis. Moreover, our study provides the rationale for a re-evaluation of guidelines recommending pharmacological reduction of LDL-C in the elderly as a component of cardiovascular disease prevention strategies.”

Examples of other drugs:

Lipitor should not stand out as a solitary example, in this field. To establish this point, let me now put forth, just as illustrations, a few more examples of similar bias on positive results in clinical trial publications, besides many others.

An October 4, 2016 article titled, “Big Pharma’s Role in Clinical Trials”, published in the ‘Drug Watch’, quotes several other companies sailing in the same boat, as follows:

The Cochrane Collaboration, a nonprofit organization based in London that reviews health care information, concluded that unlike its promotional claims, Roche’s Tamiflu only shortened symptoms of influenza by one day, and it did not prevent hospitalizations or complications from influenza.

AstraZeneca reportedly paid US$ 647 million in lawsuit settlements for failing to inform the public of Seroquel’s side effects.

Takeda Pharmaceuticals reportedly settled lawsuits claiming the company’s anti-diabetic drug Actos caused bladder cancer, for US$ 2.37 billion.

In July 2012, GlaxoSmithKline reportedly pleaded guilty and agreed to pay US$ 3 billion to settle charges brought by the U.S. Department of Justice for failing to report clinical data on its anti-diabetic drug Avandia.

Johnson & Johnson was reportedly accused of hiding some dangerous side effects like, diabetes, substantial weight gain, stroke and gynecomastia – or breast development in boys for its product Risperdal – used to treat schizophrenia and bipolar disorder in adults and adolescents and autism spectrum disorders in children and adolescents. The company reportedly settled claims in Kentucky, Texas and Montana for a total of more than US$ 340 million and settled multiple cases in Pennsylvania for undisclosed amounts.

As reported by ‘Financial Times’ on February 03, 2015, Novartis was accused of manipulating trial data in favor of its anti-hypertensive drug – Diovan, and concealing side-effects associated with its Tasigna – for leukemia treatment. As a result, the company reportedly faced a temporary suspension of its business in Japan, as punishment for alleged manipulation of clinical trial data.

Possible reasons:

The above ‘Drug Watch’ article attributed several reasons to positive data bias in publications, as follows:

Researchers publish positive findings more often than negative findings as a result of human bias. Scholars want their work to contribute to medical advancement and not deter it.

Researchers do not want to put their time and energy into writing studies about negative results.

Journals seek positive results, and publish them more quickly to increase publicity.

Trial sponsors want to publish positive results to increase profit.

The article emphasized, “Big Pharma funds 60 percent of all clinical trials, and takes advantage of its power to persuade researchers and influence institutions. The result is an under-informed, and misinformed medical community giving advice to patients with false or incomplete data. The byproducts of industry cover-ups are scores of deaths and millions of dollars in industry profits.”

Indian scenario:

India is also not immune from such alleged wrongdoings. Indian clinical trial organizations have also been accused of trial related scams, and that too on a mega scale, reaching beyond the shores of the country. I am quoting below two such recent examples:

In August 2015, the European Union reportedly banned the marketing of around 700 generic medicines for alleged manipulation of clinical trials conducted by the domestic research company GVK Biosciences. This was reported as the largest EU-wide suspension of sales and distribution of generic drugs ordered by the European Commission that was applicable to all its 28 member nations.

In July 2016, the European Medicines Agency (EMA) reportedly recommended suspending the sale of dozens of generic medicines over concerns about “flawed” studies that were conducted by the Semler Research Center, located in Bengaluru. Many of these drugs are sold by Novartis and Teva Pharmaceuticals.

In September-October 2015, US-FDA also found “significant instances of misconduct and violations of federal regulations by the same research center, which includes substitution and manipulation of study subject samples.”

This year, the World Health Organization (WHO) also had issued a notice to Semler for the same reasons. After, examining the company’s computer servers, early and late last year, WHO reportedly found a spreadsheet file containing detailed instructions for manipulating drug samples that were used in clinical trials for its clients.

It is even more unfortunate that such malpractices are continuing, even after the Supreme Court of India’s widely reported observation in early 2013 that ‘Uncontrolled clinical trials are causing havoc to human life.’ The apex court of the country made this remark in response to a petition filed by the human rights group Swasthya Adhikar Manch (SAM).

The upshot:

Recent scrutiny of all original clinical trial findings of many new drugs by the independent experts, including statins, even if taken just as raising controversies, the question would still remain, why did such controversies not surface much earlier, or during the product patent life? No company would possibly be willing to unveil the fact behind this raging debate.

The good news is, pharma companies operating in Europe and the United States have decided to share trial data with qualified researchers, effective 2014, presumably in response to mounting pressure from clinical trial transparency campaigners, for quite some time.

The European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Research and Manufacturers of America (PhRMA) have jointly released a set of principles detailing plans to allow greater access to information from clinical trials. However, it fell short of public availability of all clinical trial data. Let’s wait, watch and hope that this seemingly good intent would be translated into reality by all their member companies.

Some pharma companies and their trade associations continue to raise issues of the various legalities against related to public disclosures of all trial data. Nevertheless, it is worth noting that in April 2014, a legislation was approved in Europe by the European Parliament to increase transparency in clinical trials by making the trial results publicly available. EMA was commissioned by the European Parliament to create a database where all interested parties could view comprehensive data from clinical trials. The transparency rules for the European Clinical Trial Regulation entered into force on January 1, 2015 and apply to clinical trial reports contained in all marketing authorization applications submitted on or after this date. On March 3, 2016, EMA announced the detailed guidance on the requirements for pharmaceutical companies to comply with the agency’s policy on publication of clinical trials data for all medicines. Chapter Three of this publication gives guidance to companies on how to anonymize clinical reports for the purpose of publication.

The EMA initiative of transparency of clinical trial data aims at ensuring that drug companies are aware of what is expected of them, and that they are ready for the publication of these critical data.

Besides Europe, in the United States too, though there is a clear mandate of the federal government that all clinical trial results related to serious or life-threatening diseases require to be published and uploaded on ClinicalTrials.gov – the database of the Government covering all clinical trials in America. However, this government mandate also seems to be hardly followed, both in its letter and spirit, according to reports. Similar scenario, reportedly, still prevails in most other developed countries, as well. India does not seem to be any different in this matter, either.

Intriguingly, the whole issue continues to remain polemical, with more number of initial clinical trial conclusions reportedly turning out to be not as transparent as these ought to be, carrying a significant bias towards positive treatment outcomes.

As a result, prevailing reticence around unveiling all clinical trials, including those of blockbuster drugs, is eventually pushing many patients to the brink of much avoidable and unforeseen serious health risk.

By: Tapan J. Ray

The Recent Ban On Irrational FDCs: History Repeats Itself

Posted on March 21, 2016 by Tapan Ray

The recent regulatory ban on a large number of irrational Fixed Dose Combination (FDC) drugs is not a new incident in India. A similar mega ban was announced even before, about nine years ago. Intriguingly, the saga continues, for various reasons, without any tangible outcome for the patients on the ground.

On March 11, 2016, the latest ban, again on a large number of irrational FDCs, was notified. It caused a flutter and an immediate sharp adrenaline rush to the impacted drug companies and was soon followed by an interim stay order, again by an honorable High Court of the country.

Thus, when I connect the past dots with the latest one, on mega ban of irrational FDCs in India, a similar sequence of events gets unfolded, following each of such ban notifications of the Government.

Looking back, 294 FDCs were banned by the DCGI in 2007. At that time too, the important issue of patients’ health, safety and economical interest, got converted into a legal quagmire. Many adversely affected FDC drug players chose to go to the court of law to protect their business interest, and also successfully managed to obtain a ‘Stay’ order from the Madras High Court.

Consequently, those 294 irrational FDCs, banned by the Union Ministry of Health on health and safety grounds, continued to be promoted, prescribed and sold to patients across India, without any hindrance, whatsoever.

The matter continues to remain sub judice, as we deliberate the issue here. Thus, whether the recent gazette notification on the ban of irrational FDCs would immediately be implemented, unlike the past ban, or the history would repeat itself, is indeed a big question mark, at this juncture.

Would this ban have similar outcome?

As discussed, close to a decade after the serious legal fall-out of the ban of 294 irrational FDCs in 2007, another mega ban of 344 irrational FDCs has been announced by the Government, through a Gazette Notification dated March 11, 2016. Some well known brands, such as, Corex, Phensedyl, Crocin Cold and Flu, D-Cold Total, Nasivion and Vicks Action 500 Extra, among others, reportedly come under this ban now. Here is the complete list of 344 banned FDCs.

According to the Government, the reason for banning these drugs is that ‘they involve risk to humans and safer alternatives were available.’

Nevertheless, manufacturers of some of these mega brands have again obtained an interim injunction on the ban for their respective products, from the Delhi High Court.

Sometime during the day, i.e. on March 21, 2016, the honorable Delhi High Court is expected to take up this patient-centric issue. It apparently smacks a blatant self-serving interest of the concerned irrational FDC manufacturers, that defeats the core purpose and value of pharma products for their users.

Like most other issues, the Court directive on this issue, as well, would ultimately prevail, without any shade of doubt.

Is it a ‘bolt from the blue’ for the pharma industry?

Many industry watchers feel that this recent ban has not come as a ‘bolt from the blue’ for the pharma players, at all, as is being claimed by a section of the pharma industry. Even the Union Ministry of Health has, reportedly, clarified the following points on the recent notification:

“We have tried to bring objectivity to the issue by roping in the best of scientists to study the effects of these FDCs.”

“Show cause notices were also issued to more than 344 companies and they were given time to make further representations after the expert committee gave their recommendations. Some of them did not even care to respond. Everybody was given ample opportunity. After that, the move was initiated. It was done after much examination.”

“It is necessary and expedient in the public interest to regulate by way of prohibition of manufacture for sale, sale and distribution for human use, of the said drugs in the country.”

It is worth noting, at least, one of these well known pharma brands was, reportedly, banned in one of our neighboring countries – Sri Lanka, in 2012, for wide-spread drug misuse, long after its marketing approval in the country.

Some key events leading to the recent ban:

Besides the above articulation by the Union Ministry of Health, it is worth noting, especially, the following key developments to ascertain, whether this ban came suddenly to the irrational FDC manufacturers, and without any prior warning or appropriate communication:

The issue of manufacturing licenses being granted by some states for FDCs without prior approval of Central Drugs Standard Control Organization (CDSCO), was first discussed by the Drugs Technical Advisory Board (DTAB) in the year 2000, though without any major tangible outcome till 2007.

In 2007, Government banned 294 FDCs, and the consequent court proceedings had ‘Stayed’ this ban.

Expressing huge concern on pharma malpractices related to irrational FDCs, the Parliamentary Standing Committee on Health and Family Welfare in its 59^th report (2012) also had flagged this issue. The lawmakers observed in the report that manufacturing licenses for large numbers FDCs were being issued by the State Drug Authorities, without prior approval of the Central Drugs Standard Control Organization (CDSCO), in violation of rules. The committee also noted that multiple FDCs, which are available in India had been rejected by the drug regulators in Europe, North America, and Australia, while for many others never had marketing approval applications submitted outside India (Section 7 of [6]).

Subsequently, in June 2013, CDSCO announced the “Policy Guidelines for Approval of Fixed Dose Combinations (FDCs) In India.”

According to CDSCO, just 1193 FDCs were approved by the DCGI, since 1961 till November, 2014. Thus, all drug manufacturers should clearly know, which FDC has been approved by the DCGI, and when, leaving no scope for any ambiguity in this area. Thus, there should be no problem in total conformance to the above ‘FDC Policy Guidelines’ by these drug producers.

In the same year – 2013, a public notice was also, reportedly, issued, calling all those drug players manufacturing FDCs to apply with the requisite fee, in the prescribed form to the DCGI office, providing the required details.

In 2014, a six-member committee, chaired by Prof. (Dr.) Chandrakant Kokate, Vice Chancellor, KLE University, Jawaharlal Nehru Medical College, Belgaum, Karnataka, was formed to expedite the review process of the applications.

The Kokate Committee has, reportedly, reviewed about 6,600 FDCs, so far, and classified them under four categories – irrational, require further deliberations, rational and require additional data generation.

According to a report, 963 FDCs were found under the irrational category, providing reasons in detail for each.

In 2016, the Government finalized its action, based on the Report of Kokate Committee and also the response received (or still not received despite requests) from the concerned FDC manufacturers.

The March 11, 2016 Gazette Notification banned 344 ‘irrational’ FDCs, ruffling many feathers, but understandably to protect patients’ health interest.

On March 14, 2016, in response to an appeal against this ban through a writ petition, first by Pfizer, the Delhi High Court reportedly granted the company a stay, pending the next court hearing on March 21, 2016. Subsequently, several such stay orders by the honorable Delhi High Court have been issued with the same date of hearing.

Adverse health and economic impact on patients:

Besides serious health risks, the patients also suffer from a huge adverse economical impact, in rupee value terms, by consuming much avoidable irrational FDC formulations, which are generally more expensive than single ingredient drugs, if taken separately at times of necessity or convenience.

The ban of 344 FDCs is estimated to cover over 2,500 brands, in different therapy categories, including chronic diseases, where medicines are taken for a long period of time. Thus, a large number of patients were consuming these irrational formulations for a long period of time without any inkling of their necessity and more importantly serious adverse health impact that these irrational FDCs could cause.

To quantify how much have the patients collectively spent on these banned medicines, in the rupee value terms, I shall quote from the estimates of one of the well reputed and much quoted pharma retail audit and market research organization of India – AIOCD Pharmasofttech AWACS Pvt. Ltd.

According to its report of March 13, 2016, Indian Pharmaceutical Industry would lose Rs. 3,838 Crore (MAT), which is 3.1 percent of the turnover of the Indian Pharmaceutical Market (IPM), when calculated based on the retail sales of these FDCs in the last 12-month period.

Paraphrasing the same finding, one can logically conclude that Indian patients withstood an adverse economic impact of Rs. 3,838 Crore in a 12-month period, by spending on these unnecessary and irrational FDCs of dubious value, besides health risks.

To my surprise, some of the MNC pharma players contribute a major chunk to this avoidable expenditure of the patients, besides associating and avoidable health risks.

Quoting similar credible data, it is also possible to give company-wise break-up in this area, which, in my view, may not be meaningful here.

Two Critical issues to address:

Although, a lot of water has since flown down the bridges, a large number of irrational FDCs are still in the market, exposing patients to possible health hazards and economical hardship.

In this blog, I discussed this core issue in two of my articles, one on July 15, 2013 titled, “FDC Saga: Defiant Manufacturers, Sloppy Regulators and Humongous Inaction”, and the other on May 18, 2015 titled, “Booming Sales Of Unapproved Drugs: Do We Need ‘Safe In India’ Campaign For Medicines?”.

I reckon, the following two would still remain the critical issues, which need to be addressed, expeditiously, once and for all, for patients’ sake:

Stringent compliance with the latest CDSCO requirements by all the manufacturers of FDCs in India must be ensured. Any non-conformance should attract strong punitive measures, through a transparent process.

Whether such drugs are being widely misused, creating a grave risk for health and other safety hazards, must be ascertained periodically, based on credible data.

An important example:

Just the other day, Reuters reported that one of the largest pharma companies operating in India, was selling a FDC of the antibiotics cefixime and azithromycin, without approval of the DCGI.

Interestingly, this particular FDC has reportedly not received marketing approval in the major global pharma markets, such as, the United States, the United Kingdom, Germany, France or Japan.

After the ban of this irrational FDC, the company was compelled to stop manufacturing and sales of this powerful antibiotic cocktail that poses huge health risk to patients.

This Reuters report also states, the drug ‘had been promoted and administered as a treatment for a broad array of illnesses, including colds, fevers, urinary tract infections, drug-resistant typhoid and sexually transmitted diseases.’ It also found chemists who were selling the drug to prevent post-operative infection and for respiratory problems.

Many doctors and health experts have been saying that the spread and misuse of antibiotic combinations may be contributing to antibiotic resistance in India.

FDC approval must be hard evidence-based:

Since all pharmaceutical products, whether available as a single ingredient, or FDC formulations, are globally considered as ‘Evidence-Based Medicines’. Such evidences are established through robust, stringent and well regulated clinical trials for obtaining marketing approval from the drug regulators, unlike most ‘traditional medicines’.

Following this well-established global norm, and as recommended by even the World Health Organization (WHO), all irrational FDCs must be identified through a transparent and medical science-based process, and banned forthwith by the Government.

Establishing safety and efficacy for all FDCs through clinical trials, just like any other single ingredient drug, introduced for the first time in India, whenever it happens or had happened in the past, inadvertently or otherwise, should be a ‘must happen’ regulatory requirement, for all time to come.

Profit making interest through introduction of a plethora of irrational FDCs, should never be allowed to overshadow patients’ health and economical interest.

The bogey of even ‘25 to 30-year-old FDCs’ now being banned:

Some section of the industry is also raising this point, vociferously, protesting against the bans of their respective old and top-selling FDC brands, which have now been considered by the Government as irrational, and questioning: ‘why now?’

This point is irrelevant, as not taking action ever, against a wrong doing allowed over a long period time, does not make an irrational FDC formulation a rational one, for all time to come.

Moreover, this recent action of the drug regulator can not be considered as unique either. With the advancement of medical science, in the past years too, the DCGI issued banned notifications, covering many old FDCs, considering those ‘irrational combinations’ at a given point of time, such as, analgin + pitofenone, vitamins B1 + B6 + B12, cyproheptadine + lysine, just to name a few.

Conclusion:

As is known to many, pharmacovigilance is still at a very nascent stage in India. Consequently, ‘Adverse Drug Reactions (ADR)’ or ‘Adverse Drug Events’ reporting are still abysmally poor in the country. No information on ‘Adverse Drug Events’, as claimed by the manufacturers of these irrational FDCs, should, therefore, in no way mean that these drugs are safe and efficacious and beyond any reasonable doubt.

Although the laxity of the drug regulator in this area can’t also be condoned, in any way, the enormity of the risks posed by irrational FDCs to the innocent patients, is indeed mind boggling.

If the manufacturing and sale of all irrational FDCs are not legally stopped, even after a long and rigorous scientific and medical scrutiny by the experts, the patients in the country would, unfairly, continue to remain exposed to huge health and economic risks, without any fault of theirs. This is exactly what happened in 2007 also, when, after the stay order of the ban notification for 294 irrational FDCs by the honorable Madras High Court, all those FDCs continued to be promoted, prescribed and sold to patients across India, unhindered… but at whose cost?

Yet again, the gazette notification of the Government on the recent ban on 344 FDCs, has gone for judicial scrutiny, at least, for some money spinning key brands of the large pharma players.

This time, however, there is one significant difference, the Government seems to be far more assertive and committed to ensure that only safe medicines are available in the market, despite reported intense advocacy by the industry. This commitment on the part of the Government is also evident from the media report that the (DGCI) has again sent a new list of additional 1,200 FDCs for a probe to the panel, which recommended the ban of 344 irrational FDCs in the last week, and that too, after the court stay order on the latest ban.

Further, a senior a senior official in the Health Ministry has, reportedly, reiterated that the Government will stand firm on its decision, and will support the ban with robust data, in the Delhi High Court.

Would history repeat itself, this time now? We, at least, would get a sense of it, as the proceeding of the honorable Delhi High Court commences today, on this issue.

Either way, it will possibly send a clear signal, whether the triumph of commercial profit motive with irrational FDCs would continue, unabated, over patients’ health, safety and economic interests, at least in the foreseeable future.

By: Tapan J. Ray

Evolving Trend Of Patient Engagement In Treatment Decisions

Posted on July 6, 2015 by Tapan Ray

Slowly but steadily the process of taking treatment decisions for the patients is undergoing a metamorphosis, where well informed patients no longer want to play just a passive role. These patients want the doctors to take a final decision on their treatment only after meaningful interactions with them.

Today, Internet is increasingly becoming a great enabler for the patients to get to know, learn and obtain more and more information about their fitness, overall health, illnesses, disease symptoms, various diagnostic test results, including progress in various clinical trials, besides drugs and their prices…and all these just with clicks.

As a result, equipped with relevant information from various dependable and user-friendly sources in the cyberspace, patients have started asking probing questions about the risks and benefits of various types of treatment decisions and diagnostics tests, recommended by the doctors. At times, such interactions even lead to changes, additions or deletions in choice of therapy, including drugs, devices and diagnostics tests.

Hence, this change, which could well be a game changer, assumes even commercial importance for the pharma companies and other healthcare players in this area.

The emerging trend of patients’ demand for engagement in the treatment decision making process by the doctors needs encouragement by all concerned, especially, doctors, marketers of pharma products and healthcare services.

This process would not just be more balanced, fair and humane; it would make the entire healthcare value chain more efficient and cost-effective, as it would also involve managing expectations of informed patients. Alongside, it would encourage outcomes based evaluation of healthcare process with commensurate pricing, making the system accountable and efficient more than ever before.

In an emerging situation like this, are the pharma companies connecting the evolving dots and re-strategizing their marketing game plans accordingly? In this article, that’s what I shall try to dwell on.

Pharma marketing still remains tradition bound:

Despite this gradually transforming scenario, which would possibly lead to a paradigm shift, especially in the way of making treatment decisions for the patients, most pharma players do not seem to be thinking so, as they continue to be tradition bound in their overall marketing approach.

Even today, to generate product prescription demand by influencing treatment decision of the doctors, the pharmaceutical companies provide them with not just product information through their respective sales forces, but also drug samples and a variety of different kinds of gifts, besides many other prescription influencing favors. This approach is working very well, albeit more intensely, in India too.

Be that as it may, this trend is a potential ‘Game Changer’.

Data vindicates continuation of traditional pharma marketing:

Broad types of marketing expenditure of the pharma industry vindicate that drug companies are still not deploying adequate resources for ‘patient engagement’ initiatives in creative ways.

According to a November 11, 2013 report of ‘The Pew Charitable Trusts’ titled, “Persuading the Prescribers: Pharmaceutical Industry Marketing and its Influence on Physicians and Patients”, pharma industry spent more than US$27 billion on drug promotion in 2012. Out of this expenditure, more than US$24 billion was incurred on marketing to physicians and over US$3 billion on advertising (mainly through television commercials) to consumers, wherever permitted by a country’s regulator.

This approach is traditional and is designed to promote drugs by influencing only the doctors’ prescription decisions and not so much towards ‘patient engagement’ for the same, as appears to be the emerging need of the time.

Expenditure by type of pharma marketing in 2012:

A. Direct Marketing:

According to Cegedim Strategic Data, U.S. Pharmaceutical Company Promotion Spending (2013), expenditure by type of pharma marketing in 2012 was mainly as follows:

	Type of pharma marketing	Expenditure in US$
1.	Detailing face-to-face to doctors	15
2.	Free samples to doctors	5.7
3.	Educational and Promotional Meetings	2.1
4.	Promotional mailings	1.2
5.	Journal and Web Advertisements	0.9
6.	Direct-to-Consumer Advertising	3.1

B. Indirect marketing:

As indicate in the earlier mentioned report of ‘The Pew Charitable Trusts’, indirect marketing of US$2.35 billion incurred by the pharma companies were mainly in the following areas:

Continuing Medical Education (CME):

In 2011, the pharmaceutical and medical device industries provided 32 percent of all funding for CME courses in the United States, amounting to US$752 million out of $2.35 billion.

It is worth mentioning that to prevent these courses from functioning as veiled marketing, the Accreditation Council for ‘Continuing Medical Education’ regulates them.

However, a 2007 Senate Finance Committee report found that “drug companies have used educational grants as a way to increase the market for their products in recent years.”

Grants to Health Advocacy Organizations (HAO):

In this initiative, patient advocates can mobilize large numbers of people for an event on a specific disease related issue, which often goes to the benefit of pharma companies that manufacture related drugs.

A study found that organizations that had received grants from pharmaceutical manufacturers often endorsed the companies’ positions, while groups that had received minimal financing focused their advocacy on the drugs’ potential side effects.

Thus, the bottom-line is, in the marketing bandwidth of the pharma players, ‘patient engagement’ initiatives targeted towards patients’ benefits did not occupy a significant space.

Need to move beyond drugs and doctors:

From the above reports, it appears that while strategizing the marketing initiatives; pharma players start with products or brands and use doctors as the main decision makers to generate prescription support for those brands.

As stated earlier, though some global pharma companies are now talking about ‘patient centric’ approaches, but not much about ‘patient engagement’ approaches to harvest rich benefits out of the emerging new paradigm, in a win-win way.

Going beyond the drugs and the doctors, deploying significant resources to actively engage with the consumers to satisfy their needs and expectations, and in that process influencing patients’ behavior favorably towards the products or brands, need to be a critical part of the pharma marketing warfare, as we move forward.

Influencing patients’ behavior is challenging:

Influencing patients’ behavior through patient engagement is indeed more challenging. It calls for a multi-pronged approach involving all concerned stakeholders.

Besides innovative use of the cyberspace, digital Health Apps, among others, could well fit in nicely to achieve this goal.

I discussed this subject in my article dated March 30, 2015 in this Blog titled, “Quantum Value Addition With Health Apps, Going Beyond Drugs”.

In that direction, I reiterate that keeping pace with today’s ‘technology revolution’, rapid advent of various game-changing and user-friendly digital platforms, including Health Apps for consumers, are showing immense potential in this area. To usher in a refreshing catalytic change in the overall landscape for ‘patient engagement’ in healthcare, these platforms could emerge as key differentiating factors from the pharma players’ perspective.

Informed patients would want getting more and more engaged:

Currently, relatively smaller numbers of patients are keen to get engaged in their disease treatment decisions of the doctors or with the pharma companies on this subject, directly or indirectly.

Still a much larger number of patients, for historical reasons, remain passive while seeking treatment from the doctors.

This is changing and would change even faster with growing knowledge and awareness of digital power and its fast penetration in the hinterland along with increasing usage of smartphones.

As the patients would try getting more and more engaged in their respective treatment decision process, it would eventually hold the key to rapid progress of healthcare all over world. It has to happen in the ‘Smart Cities’ of ‘Digital India’ too, which is just a matter of time.

An institutional patient engagement initiative:

Without any direct and significant involvement of pharma industry, there are already some exemplary organized moves towards this direction in several parts of the world. One such institution has recently been established through 2010 ‘Patient Protection and Affordable Care Act’ of the United States, known as ‘The Patient-Centered Outcomes Research Institute (PCORI)’. It helps patients in making informed healthcare decisions to significantly improve healthcare delivery and outcomes.

Active promotion of high integrity, evidence-based information that comes from intensive research, ably guided by patients, caregivers and the broader healthcare community, forms the bedrock of this Institute. PCORI ensures that, patients and the public at large have information that they can use to make decisions that reflect their desired health outcomes and other expectations.

This move can be termed as one of the key steps towards ‘Patients Engagement’ in the United States, setting a good example for many other countries to follow, across the world.

Meeting with the challenge of change:

To effectively respond to the challenges posed by the need of ‘Patients Engagement’ in the disease treatment process, some pharmaceutical companies, especially in the United States, have started developing more direct relationship with the patients. Besides innovative use of digital Health Apps, creation of ‘Patient Empowered’ social networks would help addressing this issue properly.

Global pharmaceutical majors, such as Pfizer, Johnson & Johnson, Novartis, Boehringer Ingelheim, AstraZeneca, Bayer, GlaxoSmithKline, Sanofi, Roche, Novo Nordisk, Becton, Dickinson & Co and Merck are now directly engaging with the customers through social media, such as, Twitter and Facebook. Some of them have also started experimenting with the Health Apps, as well; though in India not much green shoots are seen in this area.

Just to cite an example, I quote from the The Annual Review 2014 of Pfizer that captures the following:

“People today are able to access and exchange more information than ever before, and it’s no surprise that health is an area where information sharing is exploding. As patients become more informed, they become more involved – more active in their own care and the care of others, and in medical research.

This is the era of “patient-centricity,” where patients are far from passive subjects of study or treatment. Laypeople are taking starring roles in designing clinical trials; tracking and managing their personal health data; and, crowdsourcing new insights and solutions with diverse, far-reaching communities.”

This effort of Pfizer, by all means, is highly commendable, which leaves enough room for others in the pharma world to emulate, may be even more creatively.

Conclusion:

To achieve the objective of meaningful ‘patient engagement’ in the treatment decision making process, there is a primary need for the pharma players to put in place a credible, informative and interactive communication platform.

Today’s world prompts that this platform should ideally be digital and must be an outcome of extensive research on the information needs of patients in the identified areas. Patients’ queries and comments require to be appropriately answered by experts with compassion, remaining within the regulatory framework of the country.

Inputs and resources provided by the concerned pharma companies to the patients through these platforms would help strengthen the quality of their ‘patient engagement’ campaigns. This in turn would enable the patients to properly understand the disease, the rationale of treatment decision of the doctors, subsequent follow up steps and further treatment, if any, thereafter.

With such engagements, the image of the concerned pharma companies would grow by manifold in the eyes of the beholder – the patients. It would then expand much beyond just the buyer and seller relationship for drugs, transcending in the space of well-respected pharma institutions that helped patients in arriving at precise and most cost-effective treatment decisions for a better quality of life.

By: Tapan J. Ray

Quantum Value Addition With Health Apps, Going Beyond Drugs

Posted on March 30, 2015 by Tapan Ray

Besides all important brand attributes and how well those are communicated to the doctors, the ‘game winning’ differentiating factors in the prescription drug business, as it appears today, would revolve around overall quality of patient-centric approach and offerings of pharma companies, craftily tagged with the associated products.

To hasten business growth, being more and more patient-centric, in increasingly competitive, demanding and complex environment, pharma players would require to leverage the cutting-edge technology to its fullest for significant value addition in their respective sales and marketing models too.

Keeping pace with today’s ‘technology revolution’, rapid advent of various game-changing and user-friendly digital health applications for consumers are showing immense potential for a refreshing catalytic change in the overall landscape for patient-centric healthcare services as a key differentiating tool from the pharma players’ perspective.

The capability and capacity of ‘out of box’ thinking, professional expertise to choose and customize the right technological tools, making them key components of pharma sales and marketing models and above all, their effective implementation on the ground, would eventually differentiate men from the boys in the ball game of competitive excellence in the Indian pharma industry.

This emerging opportunity brings to the fore immense potential to revolutionize the treatment process of many serious chronic ailments with significant value creation, even in India, generating a unique synergy between the drugs and customized disease related digital tools.

In this evolving ball game; wearable, decent looking and user-friendly ‘Health Apps’, installable in smartphones having Internet and Bluetooth connectivity along with touch screens; signal a great potential for augmentation of the overall disease treatment process.

Consequently, it would kick-start a healthy competition within the pharma companies to continuously raising the bar of unique value offerings to patients, more than ever before.

A close experience:

Purely prompted by my keen interest in technology for a long while,the ‘Health App’ that I have bought and installed in my iPhone and wearing for sometime, is basically a multifunctional and multi-dimensional fitness tracker.

From the decent looking digital ‘Wrist Band’ that comes with it, the Health App tracks on a daily basis, kilometers that I have walked (from pre-calibrated steps), calories that I have consumed with intake of different food types and burnt up through physical workouts, total duration of time that I have slept in a day, quality of my sleep (sound and light sleep) with duration, number of times that I woke up at night, precise daily intake with quantity of nutrition, such as, fluid, carbohydrate, protein, fiber, different types of fat, salt etc., pulse rate, breathing and mood, besides many others.

Current users:

Besides some global pharma companies that I shall deliberate below, the current users of ‘Health Apps’ are mostly those people who are increasingly becoming fitness and diet conscious (at any age) and also want to take proactive measures for prevention of many chronic ailments.

A study:

According to a report co-authored by an official of IMS Institute of Healthcare Informatics, a study based on nearly 43,700 purported Health or Medical Apps available on Apple’s iTunes App Store, found that 69 percent of those Apps targeted the consumers and patients, while 31 percent were built for use by clinicians. Most of the ‘Consumer Healthcare Apps’ were simple in design and do little more than provide information.

The study observes, a large number of Health Apps are being designed to track simpler data on health and fitness. However, the more sophisticated Apps are capable to perform advanced functions, such as, real-time monitoring and high-resolution imaging.

Possibility for much wider use in healthcare:

Although, many of these Apps have been devised as personal fitness and health trackers directly by the consumers, the information and hard data thus captured can possibly be shared with the medical practitioners by the patients, as and when required. This data could serve as valuable patient life-style information inputs for the doctors, while managing their serious chronic illnesses.

Health Apps could also help the users reduce, at least, the primary care costs through preventive self-monitoring measures and take control of their own basic health.

In tandem, I reckon, there is a good possibility for a much wider use of such Health Apps in India by the pharma companies, along with many drugs, especially those, which are used for chronic ailments.

For example, real-time data tracking on:

-Exercise, diet and Body Mass Index (BMI) for patients on anti-diabetic and anti-hypertensive drugs

- Quality of sleep for patients with sleep disorders and are on related medicines

- Mood for patients taking anti-depressant medications

The data captured by the Health Apps in all such related areas could be useful for both the doctors and the patients in the process of effective disease management along with the drugs.

Going beyond drugs:

Based on this emerging trend, it is envisaged that in not too distant future, it won’t be very uncommon for patients, suffering from especially serious chronic diseases, to get prescriptions for both the drug and an the related customized Health App, for better quality of life through effective disease control.

Similarly, some hospital discharge orders may possibly include downloading of related mobile Health App on patients’ smartphones, primarily to provide an ongoing link between the doctor and the patient for better patient care and more effective follow-up visits.

Pharma players showing interest in Health App market:

It is, therefore, no surprise that pharma players have started showing keen interest in Health App market. In fact, this emerging market is now dominated by the big pharma players, with Bayer having 11.2 percent market share, followed closely by Merck, Novartis, Pfizer, and Boehringer Ingelheim.

The top 20 Health App makers are as follows:

No	Company	No. Of Health Apps
1.	Bayer	139
2.	Merck	111
3.	Novartis	108
4.	Pfizer	62
5.	Boehringer Ingelheim	51
6.	Janssen	45
7.	AstraZeneca	44
8.	GlaxoSmithKline (GSK)	41
9.	Roche	41
10.	Johnson &Johnson (J&J)	39
11.	Novo Nordisk	32
12.	Siemens	29
13.	Amgen	28
14.	Medtronic	27
15.	Abbott	24
16.	Biogen Idec	20
17.	Merial	20
18.	Sanofi	20
19.	Genentech	19
20.	Allergan	17

(Source: Pocket.md as of 12/2/2013)

A novel business expansion opportunity:

Pharma players in India may consider to actively focus on, with requisite resource deployment, to collaboratively develop and market smartphones based digital Health Apps, for quantum value addition in their brand promotion.

Moving towards this direction, pharma sales and marketing strategy for a chronic disease treatment should consider making Health Apps an integral part of doctors’ prescription along with the related drugs of the company.

Some examples:

To give an idea of the evolving trend, I am citing below a few examples, out of lot many, in this emerging area:

- Betaseron (interferon beta-1b) of Bayer: This drug is indicated for the treatment of relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. The company launched its first iPhone App, named ‘myBETAapp’ with ‘Personalized Tools’ to assist people on Betaseron (interferon beta-1b) in managing their Multiple Sclerosis (MS) treatment.

myBETAapp provides patients with injection reminders, injection site rotation assistance and injection history. Through Internet, myBETAapp also gives patients access to the BETAPLUS Web page on Betaseron.com, including links to educational tools, peer support and contacts listed on the site. With active phone service, patients enrolled in the BETAPLUS program can dial directly to speak to BETA Nurses, who are specially trained in MS.

- Tobi Podhaler (tobramycin inhalation powder) of Novartis: This drug is indicated for the treatment of Cystic Fibrosis.

Podhaler Pro App is an iPhone based navigation tool for patients and also the doctors during treatment with Tobi Podhaler. This Health App is a customizable digital pocket companion that helps, besides many others, with timely reminders to keep track of treatments, real patient stories and access to a live PodCare nurse to answer questions about taking treatment.

- Pradaxa (dabigatran etexilate)of Boehringer Ingelheim: This drug is indicated for ‘Reduction of Risk of Stroke and Systemic Embolism in Non-Valvular Atrial Fibrillation; Treatment of Deep Venous Thrombosis and Pulmonary Embolism and Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism’. It comes with a Health App, available in online ‘Apple Stores’. This is a tool providing healthcare professionals with information about stroke risk in Von-valvular Atrial Fibrillation.

Pradaxa Health App contains a ‘Stroke Risk Calculator’, ‘Bleeding Risk Calculator’, Renal function and dosing and administration information.

Pradaxa Health App also has a great resource section, split into ‘Patient and Health Care Professionals’ sections, which can be sent to patients via email.

- Xarelto (rivaroxaban) of Janssen Pharmaceuticals: This drug is indicated for ‘Reducing Stroke Risk in Patients With Non-valvular Atrial Fibrillation (AF); Treating Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE) and Reducing the Risk of Recurrence; DVT Prophylaxis After Knee or Hip Replacement Surgery’. It also comes with a Health App, called Xarelto Patient Center and available in online ‘Apple Stores’.

Xarelto Patient Center App features include, personalize questions that help patients speak with their doctors about treatment with Xarelto, Appointment reminder, Xarelto ‘Savings Programs’, Registration to receive more information, Videos that share more information on Xarelto and hear from others who have been treated with the drug, After receiving a prescription the patient can enroll in the ‘XARELTO CarePath’ patient support and savings program.

Thus, especially for high-risk ailments, such iOS Apps directed at patients with information on the drug, including interactions with other medicines, dietary requirements, fitness/health trackers, besides many others, can add additional value both to the prescribers and the patients in the process of effective disease management.

Tightening the loose knots:

A 2014 report titled, ‘r2g mobile Health Economics’ by ‘Research2Guidance’ states, even though they try hard, most of the pharma companies fail to have a significant impact on the mHealth App market. Some pharma companies have published more than 100 Apps available for iOS and Android, but have generated only limited downloads and usage.

It states, pharma companies have created only little reach within the smartphone/tablet App user base. In fact, the leading pharma companies have been able to generate 6.6m downloads since 2008 and have less than 1m active users.

Analysis and comparison of the App activities of the top 12 Pharma companies in the report, gives reasons why pharma companies have not succeeded in becoming leading mHealth Apps providers, as follows:

- The App portfolios are not globally available: Almost half of the pharma companies’ Apps target only local markets. This means that their apps are available only in 3 or less countries.

- The App portfolio is built around the core products of the pharma companies and not around the actual market demand: For example, if a company specializes in the treatment of hematological diseases, the App portfolio reflects that. Apps in this case would provide references to the latest research, support diagnosis and facilitate information exchange with/between the experts. There exists an App market for such products, but there are other segments e.g. health tracking, weight loss, fitness or diabetes condition management, which attract more users.

- No cross-referencing or common and recognizable design: So far, pharma companies have not used the full potential of cross-referencing between their Apps. They also do not use common style guides for their App portfolio. Both of these could improve their App visibility as well as strengthen their corporate identity in the App market.

From this research analysis, it is quite evident that there is a need to tighten the loose knots in the Health Apps space by the pharma players. All improvement areas, as indicated above, should be addressed, sooner, especially, the need to targeting patients globally and inclusion of segments such as health/fitness tracking, weight loss, together with patient management focus areas of chronic illness conditions, such as, diabetes or hypertension, which have been attracting more users.

A comprehensive look and well thought-out action would help realizing true potential of the Health Apps market in India.

Conclusion:

Based on the emerging trend, it appears, those days are not quite far off, when it will become quite common for the doctors and also for the hospitals to co-prescribe with the drugs, user-friendly, disease related smartphone based Health Apps for the patients. This practice would provide an ongoing link between the doctors and the patient, leading to not just better quality of treatment, but a comprehensive overall healthcare in that specific disease condition.

However, currently there does exist a down side to this approach, which can’t be totally ignored either. The reason being, such Health Apps are not quite affordable to many, just yet, especially in a country like India. This affordability barrier could probably be overcome, if Indian IT software and hardware development companies consider this area lucrative from an emerging business opportunity perspective, as the country moves on with its ‘Make in India’ campaign.

If it makes sense…probably it does, it needs to be tried out sooner, in a much larger scale, for a win-win outcome. To begin with, the interested pharma players can tailor these well differentiated value offerings, at least to suit those, who can afford such augmented treatment process for a better quality of life, going much beyond drugs.

By: Tapan J. Ray

Pharma Sales Communication: Would ‘Cafeteria Approach’ Be More Productive Today?

Posted on March 23, 2015 by Tapan Ray

For sales communication, quality of access of pharma Medical Representatives (MRs) to many important and busy doctors has been steadily declining over the past several years, all over the world, and India is no exception.

This is mainly because the number of patients coming to these busy practitioners is fast increasing and the doctors are trying to see all these patients within the same limited time that was available to them in even earlier days. In tandem, their other obligations of various kinds, personal or otherwise, are also overcrowding the same highly squeezed time space.

In a situation like this, increasing number of MRs, which has almost doubled in the past decade, is now fiercely competing with each other to get a share of lesser and lesser available time of the busy doctors.

Added to this, a gross mismatch between the inflow of doctors with similar prescription potential and ever increasing inflow of patients, is making the situation even worse.

According to a study done by CMI Communication Media Research, about half of physicians restrict visits from MRs in one-way or another.

Thus the critical question that needs to be answered now, from purely pharma sales and marketing perspective is:

How to make sales communication effective to such busy medical practitioners in this extremely challenging scenario?

Pharma players are trying to respond:

This pressing issue has prompted many pharma companies, across the globe, to reevaluate their traditional sales communication models, which are becoming increasingly expensive as a result of diminishing commensurate returns from the MR calls.

Some drug companies have also introduced interesting digital interventions, though within the same traditional pharma sales communication process, to add speed and novelty, especially in sales administration and its execution processes.

Experimentations are visible even in India:

In India too, pharma companies are trying with several different approaches, in various combinations to make the prescription generation process through sales communication more productive.

Some pharma players also tried to push up the overall sales productivity through additional rural market coverage. In this regard, a 2012 report of ‘IMS Consulting’ states, acknowledging the seriousness around rural consumers, many drug companies in India are now expanding their sales operation to Tier IV cities and below. Quite a few of them even succeeded in their endeavor to create profitable business models around the hinterland and rural geographies.

These pharma players believe that extra-urban geographies require different approaches, though with the same traditional sales communication models. These approaches include, different product portfolio, distribution-mix, pricing/packaging and promotional tools, considering majority of the doctors are not as busy as their counterparts in the metro cities and large towns.

Initial strategic changes:

The above ‘IMS Consulting’ paper also highlights a few of the initial changes in the following lines:

Business Unit Structure (SBU): To bring more accountability, manage evolving business needs and use equity of organization for reaching to the middle of the accessible pyramid.

Therapy Focus Promotion: Generally seen where a portfolio is specialized, therapy focused, and scripts are driven through chosen few doctors; generally in chronic segment.

Channel Management: Mostly adopted in OTC /OTX business; mature products with wider portfolio width.

Hospital Task Force: Exclusively to manage hospital business.

Specialty Driven Sales Model: Applicable in scenarios where portfolio is built around 2 or 3 specialties.

Task Force: Generally adopted for niche products in urban areas, such as fertility clinics or for new launches where the focus is on select top rung physicians only.

Out-Sourced Sales Force: Generally used for expansion in extra-urban geographies or with companies for whom medico marketing is secondary (such as OTC or Consumer Healthcare companies).

Pharma MNCs took greater strides:

In addition, to increase sales revenue further, many innovator pharma MNCs engaged themselves in co-promotion of their patented products, besides out-licensing. A few of them pushed further ahead by adopting newer innovative promotional models like Patient Activation Teams, Therapy Specialists, or creating patient awareness through mass media.

Brand value augmentation offering a mix of tangibles and intangibles:

Realizing quickly that patients are increasingly becoming strong stakeholders in the business, some of the pharma MNCs also started engaging the customers by extending disease management services to patients administering their products.

This is indeed a clever way of augmenting the brand perception, through a mix of well-differentiated tangible and intangible product related value offerings.

These pharma MNCs engage even the patients by providing a basket of services at their home. Typical services include:

Counseling
Starter kits
Diagnostic tests
Medical insurance
Personalized visits
Exercising equipment
Emergency help
Physiotherapy sessions
Call centers for chronic disease management

Related doctors are reported about the status of the patients and the patients do not require paying anything extra for availing these services from the MNC pharma companies.

Despite all these, declining productivity of the traditional pharma sales communication models continue, predominantly from the extremely busy and very high value medical practitioners/experts/specialists, as mentioned above.

Communication preferences of busy doctors need to be factored-in:

From the above facts, it appears that pharma sales communication is usually tailored to focus on customer/market types and characteristics, rather than emerging unique customer preferences towards medium of sales communication and also differentiated message requirements for specific brands.

Should status quo be maintained?

Probably not, as many still believe that MR’s quality of access to doctors for productive sales communication would continue to remain a critical issue and become increasingly complex.

Even in this changing scenario, pharma companies, by and large, have kept the basic communication medium and traditional process of messaging unchanged, except some digital tweaking here or there. Some of these innovative means and user-friendly digital interfaces, at times, may attract quality attention to sales communication for top of mind brand recall by the doctors.

Is it enough? Again, probably not, as there is an urgent need to exploring various other medium and new ways of delivering strong and effective tailor-made brand messages, based on hard data of painstaking research.

e-marketing started taking roots, though in bits and pieces:

In 2013, facing this challenge of change, Pfizer reportedly started using digital drug representatives to market medicines, leaving the decision in doctors’ hands as to whether they would want to see them.

Prior to that, in 2011, a paper published in the WSJ titled, “Drug Makers Replace Reps With Digital Tools” stated that pharmaceutical companies in the United States are downsizing their sales force with increasing usage of iPad applications and other digital tools for interacting with doctors.

Lot many other fascinating experimentations with pharma e-marketing have now commenced in several places of the world, many with considerable initial success.

However, most of these efforts seem to be swinging from one end of ‘face-to-face’ sales communication with doctors, to the other end of ‘cyber space driven’ need-based product value sharing with customers through digital toolkits.

Two key questions:

All these experimentations and developments with various pharma sales communication models would probably prompt the following two key questions:

Whether or not traditional sales approach would continue to be as relevant as opposed to digitally customized sales applications?

Whether or not MRs would continue to remain as relevant in all areas of pharma prescription generation process, in the years ahead?

Not an ‘Either/Or’ situation:

According to AffinityMonitor™ 2014 Research Report, pharmaceutical and biotech companies have today at their disposal more than a dozen of promotional channels to include in their strategy, including traditional methods, like detailing and speaker programs, and digital ones, including email, microsites and videos.

The report states, every doctor engages with these channels in his or her own unique manner. Some physicians want to interact with MRs; others restrict MR details and instead get information from their peers. One doctor might regularly use a mobile application for product information, often during a patient consultation. Conversely, another physician, who might work in the same practice, would rarely wish to surf the Web for information. And some doctors simply won’t engage with any sales communication no matter what the channels are.

Thus, ‘one size fits all’ type of sales communication, delivered even by the best of MRs, is not likely to be productive in the changing macro environment.

Many facets of communication preferences:

Today, there are many facets of doctors’ choices and preferences to brand value communication medium.

As AffinityMonitor 2014 Research Report states, based on the availability of time and interest, each doctor engages with these channels in his or her own unique manner. For example, some doctors may want to interact with the MRs, while some others may restrict MR’s product details. A few others may prefer getting information from their peers, instead

Since doctors’ engagement with pharma brands is critical for the drug companies, it has now become absolutely imperative for them to know individual affinities of the doctors in this regard, or what channels and processes each physician would typically prefer to get engaged with a brand, directly or indirectly.

Pharma companies should, therefore, gather this particular information doctor-wise, to customize both the medium and the message for effective brand value communication, accordingly.

A shift to ‘Cafeteria Approach’:

Taking all the above research inputs into consideration, it appears, when many busy physicians’ doors appear closed to traditional pharma sales communication, drug companies should have the keys to unlock them with ‘Cafeteria Approach’ of sales communication, purely based on customer research. This approach would offer the ‘difficult to meet doctors’ a variety of choices regarding both the medium and also the message, that would best suit their temperaments, needs, time and interests, as discussed above.

It is important to repeat, to ensure productive outcome of the ‘Cafeteria Approach’, customized sales communication strategy for each important and otherwise busy doctor should purely be based on contemporary customer research.

Sales force remains the top channel out of several others:

According to AffinityMonitor Research Study, though MR’s quality access to busy doctors has declined steadily over the past decade, the sales force still remains the top channel for physician engagement, closely followed by ‘Digital’ ones.

Overall, around 47 percent of all Health-Care Providers (HCPs) consider ‘face-to-face’ promotion as one of the top three channels, which includes about 80,000 physicians, who favor the sales force as their second or third-strongest channel.

Of the 514,000 HCPs examined in AffinityMonitor Research Study, 162,000 show the strong affinity for ‘face-to-face’ promotion, 118,000 for digital push and 65,000 for digital pull or personal remote channels.

Increasing just ‘Sales Force Effectiveness’ not enough:

Thus, generally speaking, even the best of global sales force excellence programs could at best increase the MR productivity primarily for these 47 percent of doctors.

Brand sales communication reach and effectiveness to a large number of rests of the doctors would, therefore, call for innovative thinking and willingness to chart the uncharted frontiers.

Conclusion:

The decline in pharmaceutical MR’s quality of access to physicians for sales communication is now well documented. For example, in 2008, 23 percent of US doctors had restrictions on MRs, but that number rose to 49 percent in 2014, according to AffinityMonitor Research Study.

Therefore, the knowledge of whether a doctor would like to engage with traditional sales communication method by seeing a MR, or would just prefer to get his/her required information through any digital medium, is critical for success in the new ball game of generating increasing number prescriptions for any pharma brand.

Majority of the doctors’ choices would, in all probability, involve MRs, while a notable number of other choices may probably be independent of MRs.

In any case, that’s not going to be the main issue, as MRs are not going to disappear – not in any foreseeable future and would continue to remain a critical part of the overall pharmaceutical selling process, all over the world.

However, closely following the emerging trend, I reckon, ‘Cafeteria Approach’ is worth considering for effective customized brand communication, ensuring productive sales outcome.

By: Tapan J. Ray

A Patient-Centric State Initiative To Revolutionize Disease Treatment

Posted on February 9, 2015 by Tapan Ray

In his State of the Union address, just before the recent visit to India in January 2015, President Barack Obama articulated the need to develop “Precision Medicine” in his country – a bold, giant and perhaps unprecedented State initiative to remarkably improve effectiveness of disease treatment.

To set the ball rolling, in his budget proposal for the year 2016, President Obama earmarked an amount of US$ 215 million for this purpose. This includes an allocation of US$130 million for the National Institutes of Health (NIH) to create a national research database of about a million American volunteers by studying their genetics together with other relevant factors, such as the environments they live in and the microbes that live in their bodies.

‘Precision Medicine’ initiative is similar to path breaking 13-year and US$3 billion Human Genome Project, that has formed the bedrock of modern genomics, President Obama said. He also expressed hope that the private healthcare sector too, including universities and foundations, will get involved to “lay the foundation” for this new initiative of the Government for the interest of patients.

Why is this approach so relevant in today’s healthcare?

In an article published in the ‘British Medical Journal (BMJ) in October 2012, Richard Smith - an editor of BMJ until 2004 and a Director of the United Health Group’s chronic disease initiative wrote:

“Doctors know that many of the patients they treat with drugs will not benefit. Many patients know that too.”

Dr. Smith also emphasized, for centuries medicine classified diseases by what could be seen, felt, and smelt. Thereafter, medical scientists in this area started defining diseases anatomically, physiologically, and biochemically. Even today, this is by and large the paradigm where most medicines fall.

Smith underscored, because of imprecise diagnosis the treatment also becomes haphazard. There is big variation in how individuals respond to drugs and yet that variation is not usually recorded. The regulators approve drugs based on their average performance even today.

The White House release also reiterates, most medical treatments have been designed for the “average patient.” This “one-size-fits-all-approach,” treatments can be very successful for some patients but not for others.

This calls for broadening the scope of disease treatment – from the conventional and error-prone ‘Disease Oriented’ approach, to relatively more unconventional and better targeted with greater value – ‘Patient-Centric’ ones, wherever needed.

Two current trends:

To address this key deficiency in the effective treatment of several dreaded diseases for many patients, following two are the current trends, as stated by William Pao, M.D., Ph.D., who led Roche’s Oncology Discovery & Translational Area research unit since May 2014:

We now know that on a molecular level every cancer is different – not only between different tumors, but even between different areas within a single tumor! This means that we need to match the right drug to the patient who we know will respond best to the drug, at the right time during the course of treatment.

Patients will have their tumors profiled not only for genetic drivers, but also for predictive immunotherapy markers at different time points in their course of treatment.

Personalized and Precision Medicine:

The above trends in the endeavor of making treatments more patient specific – thus more effective, have thrown open scientific discourse and intense research on ‘Personalized’ and ‘Precision’ medicines.

As Pfizer has described in its website:

Personalized Medicine is a unique approach to medical practice in which the individual aspects of a patient are directly considered to guide treatment planning, including his or her genetic make-up, key biomarkers, prior treatment history, environmental factors and behavioral preferences. This approach can be used to optimize pharmaceutical treatments and overall care.

Whereas, Precision Medicine is an approach to discovering and developing medicines and vaccines that deliver superior outcomes for patients, by integrating clinical and molecular information to understand the biological basis of disease. Precision medicine is the biopharmaceutical research and development paradigm that will help enable more patient-centered clinical practice, including treatment decision-making based on genetic information – an emerging standard now often described as “personalized medicine”.

As President Obama said while announcing the proposal on January 30, 2015, ‘Precision Medicine’ promises delivery of the right treatment at the right time, every time, to the right person.

He also said that the new effort will “bring us closer to curing diseases like cancer and diabetes…and give all of us access to the personalized information we need to keep ourselves and our families healthier.”

‘Precision Medicines’ Dominate Oncology segment:

In the European Society for Medical Oncology (ESMO) 2014 Congress, pharma majors reported their latest advances on precision medicines in the cancer care. Bristol-Myers Squibb, Roche, AstraZeneca, GlaxoSmithKline (GSK), and Merck & Co. were among the companies presented updates of their most promising cancer drugs closer to this area.

According to a large pharma lobby group in the United States – The Pharmaceutical Research and Manufacturers of America (PhRMA):

“Recent advances in diseases such as cancer and cystic fibrosis are delivering on the promise of targeted treatments, and between 12 and 50 percent of all compounds currently being researched by the industry are potential personalized medicines. These advances hold great promise in improving patient outcomes and controlling costs by targeting the right medicines to the right patients.”

‘DCAT Connect’ Report of September 2014 also indicates significant increase in ‘Precision Medicines’ in the pipelines of the leading global pharma companies, which is a key change over the past decade.

In 2013, targeted therapies increased their share of the global oncology market, accounting for 46 percent of total sales, up from 11 percent a decade ago. According to IMS Institute for Healthcare Informatics, the global oncology drug market reached US$ 91 billion in 2013 with CAGR of 5.4 percent from 2008 to 2013.

Taking note of this trend, it appears that in the near future ‘Precision Medicines’ would possibly be the most promising class in the treatment of cancer, particularly in breast cancer, lung cancer and certain types of leukemia. This is mainly because medical scientists are already quite acquainted with the molecular signatures of different types of cancer related tumors.

Medical scientists and researchers are also working on ‘Precision Medicines’ to more effectively address many other diseases, such as, diabetes, cardiovascular and ailments related to several types of infections.

Increasing potential:

Realization of the potential of ‘Precision Medicines’ to improve care and speed the development of new treatments has just only begun to be tapped.

In recent times, scientists and researchers have accelerated efforts to understand more about biomarkers for this purpose. A study conducted by the German Association of Research-Based Pharmaceutical Companies (vfa) indicates that more than 20 percent of clinical trials carried out since 2005 focused not just on agents, but also on biomarkers. Before 1990, only one in twenty clinical trials addressed biomarkers.

According to another report, last year, 20 percent of all new drug approvals in the United States were for “Precision Medicine” treatments. This vindicates, yet again, the immense potential to turn genetic discoveries into innovative disease treatments for patients.

A bold state sponsored research initiative:

State funded, ‘Precision Medicine’ initiative is a bold new step of the American Government to revolutionize improvement in healthcare and treating disease. It is expected to pioneer a new model of patient-powered research that promises to accelerate biomedical discoveries and provide clinicians with new tools, knowledge, and therapies to select which treatments will work best for which patients.

As the White House release reiterates, most medical treatments have been designed for the “average patient.” As a result of this, “one-size-fits-all-approach” treatments can be very successful for some patients but not for others. This is changing with the emergence of ‘Precision Medicine’, an innovative approach to disease prevention and treatment that takes into account individual differences in people’s genes, environments, and lifestyles.

In this process, ‘Precision Medicine’ gives clinicians tools to better understand the complex mechanisms underlying a patient’s health, disease, or condition, and to better predict which treatments will be most effective.

Opposite view:

In an op-ed titled, ‘Moonshot’ Medicine Will Let Us Down, published recently in The New York Times, the author argued with his differing viewpoints.

I am quoting below three of those arguments:

“For most common diseases, hundreds of genetic risk variants with small effects have been identified, and it is hard to develop a clear picture of who is really at risk for what. This was actually one of the major and unexpected findings of the Human Genome Project. In the 1990s and early 2000s, it was thought that a few genetic variants would be found to account for a lot of disease risk. But for widespread diseases like diabetes, heart disease and most cancers, no clear genetic story has emerged for a vast majority of cases.”

“Another unexpected finding of the Human Genome Project was the problem of ‘missing heritability.’ While the statistics suggest that there is a genetic explanation for common conditions and diseases running in families or populations, it turns out that the information on genetic variants doesn’t explain that increased risk.”

“The idea behind the “war on cancer” was that a deep understanding of the basic biology of cancer would let us develop targeted therapies and cure the disease. Unfortunately, although we know far more today than we did 40-plus years ago, the statistics on cancer deaths have remained incredibly stubborn.”

I am sure, you will analyze the above points with the facts that you have at your disposal on this subject to arrive at a logical conclusion.

Current Applications:

Though these are still early days, initial benefits of ‘Precision Medicines’ have been reported in many areas, such as:

Genetic analysis of patients dealing with blood clots: Since 2007, the U.S. Food and Drug Administration has been recommending genotyping for all patients being assessed for therapy involving Warfarin.

Colorectal cancer: For colon cancer patients, the biomarker that predicts how a tumor will respond to certain drugs is a protein encoded by the KRAS gene, which can now be determined through a simple test.

Breast cancer: Women with breast tumors can now be effectively screened to determine which receptors their tumor cells contain.

Cystic fibrosis: In America, patients with a rare form of cystic fibrosis now can choose a drug designed specifically to target the genetic defect causing their illness. Specialized medical centers, such as “individualized medicine centers” at the Mayo Clinic, are also available to the patients for effective treatment.

Ethical issues:

While following this pursuit of excellence of the genetic scientists in the realm of disease treatment, some experts have reportedly raised flags of caution. They strongly feel that DNA code sequencing brings to light a “very real privacy concerns” of individuals.

GeneWatch UK is an organization that investigates how genetic science and technologies will impact on our food, health, agriculture, environment and society. They have been strongly arguing, if genome sequencing is extended to entire population, individuals and their relatives could then be identified and tracked by matching their DNA with the genome stored in the respective health records. This move, as contemplated by them, could “wipe out privacy” with an impact on the society.

Thus, the ethical and social issues in the development of ‘Precision Medicine’ primarily in the area of genetic testing need to be effectively addressed, sooner.

Conclusion:

The quest for moving away from conventional and error-prone ‘Disease Oriented Treatment’ paving the way for unconventional and value added individual patient-specific ones, may soon come to fruition.

Advances in ‘Precision Medicine’ have already led to powerful new discoveries and several new treatments that are tailored to specific characteristics of individuals, such as a person’s genetic makeup, or the genetic profile of an individual’s tumor. This is leading to a transformation in the way the world can treat diseases such as cancer.

Patients with breast, lung, and colorectal cancers, melanomas and leukemia, for instance, should be provided with facilities in specialist hospitals to undergo molecular testing as a part of patient care, enabling physicians to select treatments that improve chances of survival and reduce exposure to adverse effects.

Although, the potential for precision medicine to improve care and speed the development of new treatments has only just begun to be tapped, some skeptics do say that tailoring medical treatments to individual characteristics of each patient is both overly optimistic and cost-prohibitive.

Be that as it may, in the balance of probability the benefits of prudent use of ‘Precision Medicine’ far outweigh the concerns expressed. This evolving new paradigm would help saving not just significant expenses, but also precious time that is usually spent on ‘trial-and-error treatments’, by enabling clinicians to determine quickly which therapies are most likely to succeed.

Though lot many grounds would still need to be covered in this area, the State sponsored ‘Precision Medicine’ initiative of America to revolutionize disease treatment, in my view, is indeed a laudable one, every way.

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.

PILMAN

A Tapan Ray Website

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