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Creative Pharma Marketers To Unshackle Covid Fetters

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Pharma industry, just as most others, has started recognizing that the business needs to be brought back to normal, despite Covid fetters. Some early evidences suggest, a new breed of pharma marketers is refusing to get confined to Covid triggered operational limits, without breaching any prescribed safety norms.

These pacesetters no longer grapple with finding right answers to the question – when and how the brand building activities can be brought back to the old normal? Truly speaking, none has its answer, as yet. Covid has the power to strike back, anytime – anywhere, in waves, when the guards are even slightly down. Moreover, as and when vaccines will come, these may not be ‘silver bullets’ for many – throughout a lifetime, at least, in the foreseeable future.

Accordingly, these forerunners are effectively leveraging the art of turning challenges into opportunities. They are conceptualizing new business models for making path-breaking progress in contemporary purpose driven branding exercises. For all pharma marketers, I reckon, this is the moment of truth, when what you do reflects what you really are, in this area. Thus, in this article. I shall deliberate, with examples, how these creative new age pharma marketers are trying to unshackle Covid fetters.

Today’s reality on the ground: 

A number of global surveys on how patients’ have reacted to Covid-19 pandemic with reasons behind the same, are now available. One such study was conducted by Medisafe, during March and April, 2020. Some of its key findings are as follows:

  • More than half of the respondents, especially those with comorbidities, worry about getting Covid infected while accessing to in-person treatments.
  • Over 9 out of 10 respondents were practicing social distancing, as a remedial measure.
  • Consequently, they are missing doctors’ appointments, and many are opting for telehealth wherever appropriate and necessary.

In many situations, such as,  common and repetitive health issues, including some mental health conditions, virtual health care are more convenient. It has also been established during the pandemic that telehealth can deliver similar outcomes at a lower cost, than in-person visits. In addition, remote monitoring of some key health parameters, like heart rhythm, blood sugar, weight, respiratory rate, also help people control their chronic conditions better, and assist clinicians with diagnosis and treatment.

More doctors prefer telehealth, but the majority wants some in-person visits too: 

An interesting study – ‘Want Both In-Person and Virtual Visits with Sales Reps,’ published by Bain & Company on June 02, 2020, ferreted out today’s reality, in this space. It found, prior to Covid, about three-fourths of physicians preferred face-to-face engagement with sales reps. In contrast, today more of them are asking for a reduction in Rep visit frequency and more remote support or virtual approaches. Curiously, a majority still prefers, at least some in-person interaction ‘once the pandemic passes.’

Interestingly, no one seems to know, just yet, when exactly will this pandemic get over. Besides, whether or not Covid will keep coming back in waves, for an indefinite period. Or, any similar or even worse global health crisis, in future, could bring greater disruption for the industry.

Driven by such apprehensions, it is possible that more and more patients will prefer telehealth, expanding access to health care for an increasing number of people. Nonetheless, one should also take into consideration that virtual health care has also some significant limitations, especially those which may lead to serious or life-threatening conditions.

Some key limitations to overcome:

Alongside multiple advantages of telehealth, it has some significant limitations, which can’t be wished away, either. This point was also well articulated in the article – ‘Where Telemedicine Falls Short,’ published in the Harvard Business Review (HBR) on June 30, 2020. The author, who is also a primary care physician gave a number of examples in this regard. For example, in one place he wrote:

‘I have found treatable cancers multiple times in routine exams that would be impossible to replicate in the virtual world. Could a Zoom visit detect a lymph node too firm, a spleen or liver too large, or an unexpected prostate nodule (with a normal PSA)?’ The paper also emphasized: ‘Trust and face-to-face encounters are even more important for patients with complex and intertwined problems.’

Be that as it may, the task to encourage patients, even with serious ailments, for in-person consultation and examination by doctors’ in their clinics, won’t be ‘a piece of cake’ too. On the contrary, it will be rather a colossal exercise.

Why will this task be colossal?

One can get a sense of tough challenges involved in this effort from the IQVIA report titled, ‘COVID-19 Pandemic and the Impact on SEA Healthcare Market.’ Along with other areas, the study captured several details of the above area, specifically for the South East Asia (SEA), as follows:

  • Decrease in patient visits (Out-Patient): 2 out of 3 hospital doctors are experiencing >60% decrease in patient visits.
  • Extended period of time before patient load resumes to normal: ~50% of doctors think that it will take 4 to 6 months to resume normal operations.
  • Increase in prescription duration: ~25% of doctors have 2x their standard prescription duration to reduce patient visits.

The study also observed, ‘in order to reduce the risk of getting infected, patients are reducing their visits to the HCPs.’ Such an unusual situation is unlikely to be mitigated, soon, with any traditional or ‘one size-fits all’ type strategy. Particularly when Covid threat still looms large on the population. As is happening today, even after signs of waning, Covid may return in waves – for an indefinite period. Thus, innovative marketing interventions, backed by actionable insights, are essential to help overcome the fear of getting Covid infected, by both patients and doctors.

How to respond to this situation in a creative way?

The creative marketing response to overcoming the possible barriers on the way, would call for predictive rather than reactive pharma strategies. The game plan not only needs to be purpose drivenfor the marketers, but should also be perceived that way by all concerned. For example, the core purpose of marketing in this scenario, will be to provide a life-saving patient ‘service’, with win-win outcomes.

And the additional ‘service’ in this case is encouragement in-person physician visits during early symptoms of life-threatening health conditions – taking all safety precautions and overcoming ‘paranoia’ of getting infected. The win-win outcomes will include – saving lives, preventing deterioration of the disease condition, and of course, facilitation of the brand demand. The good news is some global pharma majors have already started making progress in this direction.

Promoting doctor visits during the pandemic – an example:

Leaving footprints to follow, some pharma marketers have already started creatively working on it. Let me cite a recent example of this unique initiative. This was reported by Fierce Pharma in its November 02, 2020 issue. The marketing process carries all the required ingredients for excellence, as mentioned above.

It wrote, ‘Pfizer and Bristol Myers Squibb are the latest drugmakers to join the swell of campaigns promoting doctor visits during the pandemic.’ This decision was based on data, showing many people haven’t been going to their primary care appointments for symptoms that may lead to potentially serious conditions.

This initiative is focused on three critical health conditions, namely, atrial fibrillation, deep vein thrombosis and pulmonary embolism. The rationale for selecting these three indications is, these are all treated by the partners’ anticoagulant Eliquis.

Accordingly, the BMS-Pfizer Alliance launched a campaign to raise awareness and encourage people to seek prompt medical attention. The American campaign was built around the theme – ‘Your symptoms could mean something serious, so this is no time to wait.’ In tandem, the companies also widely communicated through multiple channels that ‘Decreases in Americans’ Primary Care Visits May Lead to Late Diagnoses of Potentially Serious Conditions.’

According to reports, the net result of this creative marketing, so far, is no less than outstanding, as compared to many other pharma players operating in similar situations. ‘Eliquis’ brand sales for the first six months of 2020 topped $4.8 billion, a 21% increase over the same time period last year. Doesn’t this initiative demonstrate that creative pharma marketers can unshackle even Covid fetters?

Conclusion:

Meanwhile, as on November 08, 2020 morning, India recorded a staggering figure of 8,507,754 of Coronavirus cases with 126,162 deaths. The average number of daily new cases appeared to have slowed down in the last few weeks. But, the threat of further spread of Covid infection, in waves, still looms large in the country.

Most scientists agree – while effective vaccines offer the best chance of reaching zero COVID-19 – eliminating the virus across much of the world, while not unthinkable, could take a significant number of years. Thus, it may be realistic for some time to focus on flattening the curve with stringent control measures, involving efficient contact tracing, testing and isolation, together with social distancing and mask wearing – till it happens, ultimately.

Meanwhile, the business must flourish, even amid a new normal. And this is, in no way, a pipe dream, but a proven reality, as we have seen above. No doubt, this calls for most pharma marketers wearing a fresh thinking cap, equipped with more cerebral power, as it were, to unshackle Covid fetters on their way – effectively.

By: Tapan J. Ray    

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

 

‘The Memory Thief’ Still Eludes Grasp Of Pharma R&D

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Over several decades, in fact, since its very inception, pharma R&D has been playing a crucial role in alleviating diseases of various types – from severe acute infections, to a large variety of non-infectious chronic illnesses, including many dreaded diseases, such as, cancer.

In the battle against diseases, pharma research and development initiatives, both by a large number of academia and also the pharma players, have mostly won, decisively. R&D has been consistently coming out with flying colors, both in finding cures and also in effective disease management, to prolong and improve the quality of life of billions of people, the world over.

However, there is still an important disease area, where pharma R&D has not been successful yet. Without any prior warning, this disease stealthily affects the human brain and completely erases the entire lifetime memory of the person, gradually but surely, over a relatively short period of time. This disease is known as Alzheimer’s, following the name of Dr.  Dr. Alois Alzheimer, who first detected it in 1906. Due to its devastating impact on human memory, some, very appropriately, term the Alzheimer’s disease – ‘The memory thief’.

I discussed this subject in one of my previous articles titled, “It Took 90 Years To Accept The Dreaded Disease Discovered In A Mental Asylum”, published in this Blog on December 01, 2014.

A recent alarm for a future epidemic:

A January 6, 2016 paper titled, “Sounding the alarm on a future epidemic: Alzheimer’s disease”, published by the well reputed public research university in the United States, ‘The University of California, Los Angeles (UCLA), made the following noteworthy observation:

“If the aging trend illustrates the success of public health strategies, it also raises the specter of a major public health crisis – a sharp rise in the number of people living with Alzheimer’s disease.”

Causing havoc in many lives and families:

‘Alzheimer’s Disease Education and Referral (ADEAR) Center’ of the United States, currently ranked Alzheimer’s disease as the sixth leading cause of death in the United States, but recent estimates indicate that the disorder may rank third, just behind heart disease and cancer, as a cause of death for older people.

According to Mayo Clinic, the frightful disease – Alzheimer’s, is progressive in nature. At the onset, the afflicted persons may exhibit just mild confusion and some difficulty in remembering.

Tragically, in around five years or a little after, Alzheimer’s would erase the entire lifetime memory of most of the affected persons, when they may even forget the important people in their lives and undergo dramatic personality changes.

The dreaded disease – Alzheimer’s, still without any effective medication in place, has been causing havocs in many lives and families since long, involving many great international personalities too. It is one of those ailments, where the disease process mostly commences almost a decade before the visible appearance of above clinical symptoms.

Worldwide Projections of Alzheimer’s Disease Prevalence:  

The above UCLA report highlights the worldwide projections of Alzheimer’s disease prevalence from 2005 to 2050, which includes both the early and late stage patients.

According to this report, the number of people afflicted by this total memory-erasing disease, would grow from 35.26 million in 2015 to as high as 106.23 million populations in 2050, as follows:

Year Alzheimer’s disease prevalence (in Millions)
2005 25.73
2010 30.12
2015 35.26
2020 41.27
2025 56.55
2040 77.49
2050 106.23 
Similar situation in India: 

The situation in India seems to be no different, though we are living today in the midst of the hype of ‘Demographic Dividend’.

According to the March 2012 report of ‘The Population Reference Bureau’ of Washington DC of the United States, India’s population with ages 60 and older, who are more prone to Alzheimer’s disease, is projected to increase dramatically over the next four decades, from 8 percent in 2010 to 19 percent in 2050. By mid-century, this age group is expected to encompass 323 million people, a number greater than the total US population in 2012.

Currently available treatment:

At present, there are no treatments available that can stop or slow down the progression of Alzheimer’s disease in the brain of the affected persons.

As I wrote earlier, very often the onset of this disease starts decades before the visible manifestation of even preliminary symptoms. Thus, there is a critical need for early medical interventions to arrest the disease progression.

Again, quoting Mayo Clinic, current Alzheimer’s disease medications and management strategies may at best temporarily improve symptoms. These symptomatic treatments can sometimes, help Alzheimer’s patients maximize cognitive and other related functions to the extent possible, and thereby maintain independence for a little while longer.

Primary reasons:

Many earlier research had postulated that plaques and tangles are primarily responsible for the permanent damage and destruction of nerve cells.

While the plaques are abnormal clusters of beta-amyloid protein fragments between nerve cells, tangles are twisted fibers made primarily of a protein called “tau” that accumulates in the brain cells, damaging and killing them.

The appearance of these two in the brain structure makes the affected persons suffer from almost irreversible memory loss, altered thinking pattern and associated behavioral changes, which are usually serious in nature.

However, I shall discuss below about a very recent research that is focusing on a different and novel target.

Key hurdles in Alzheimer’s drug development:

Despite all these, almost at a regular interval, we have been getting to know about various new studies on Alzheimer’s disease, mostly from academic and scientific institutions. It clearly vindicates, at least, the global academia and also some pharma players, are working hard to get an effective key to unlock the pathway of Alzheimer’s disease process.

The hurdles in developing a suitable drug for effective treatment of Alzheimer’s disease are many. A paper titled, “Researching Alzheimer’s Medicines: Setbacks and Stepping Stones Summer 2015”, published by the Pharmaceutical Research and Manufacturers of America (PhRMA) – a trade association of leading biopharmaceutical researchers and biotechnology companies of the United States, cited the following three major reasons as examples:

  • Scientists still do not understand the underlying causes and mechanisms of the disease. It remains unknown whether many of the defining molecular characteristics of the disease are causes, effects, or signs of progression. This scientific knowledge gap makes the identification and selection of viable targets for new medicines difficult. 
  • Current preclinical models of Alzheimer’s disease are limited in the extent to which they can be extrapolated or translated to the human condition. Better models are needed to facilitate preclinical testing of drug candidates and better predict the effects of the drug in humans. 
  • The absence of validated, non-invasive biomarkers to identify disease presence and progression means the diagnosis is delayed until an individual becomes symptomatic. This makes it particularly challenging to evaluate, enroll, retain, and follow up with patients in clinical studies. It also makes it challenging to assess the effects of the drug candidate. Ultimately, this leads to long and very expensive clinical trials. 

The PhRMA publication also states that “researchers believe that no single medicine will be able to defeat Alzheimer’s; rather, several medicines will probably be needed to combat the disease. Thus, researchers need not one, but an array of options to prevent or treat Alzheimer’s disease.”

High rate of R&D failure, with flickers of success:

The above PhRMA publication also indicates, between 1998 and 2014, 123 medicines in clinical development have been halted and have not received regulatory approval.

In this rather gloomy R&D scenario, there are also some flickers of success in this pursuit.

In a recent study, the scientists at the University of Southampton announced that their findings added weight to evidence that inflammation in the brain is what drives the disease. A drug, used to block the production of these microglia cells in the brains of mice, had a positive effect. The study, therefore, concluded that blocking the production of new immune cells in the brain could reduce memory problems seen in Alzheimer’s disease. This finding is expected to pave the way for a new line of treatment for Alzheimer’s disease.

Currently, most drugs used for the treatment of dementia targeted amyloid plaques in the brain, which are considered as a key characteristic of people with the Alzheimer’s disease. According to an article published in Forbes on March 20, 2015, several amyloid-clearing drugs have failed to show statistically significant benefits in large clinical trials. Notable among those are Bapineuzumab – developed by Elan Pharmaceuticals, Pfizer and Johnson & Johnson failed in 2009; Solanezumab of Eli Lilly failed in 2012; and so did Gantenerumab of Roche in 2014.

The latest study, as quoted above, published in the journal ‘Brain’, on January 8, 2016 suggests that targeting inflammation in the brain, caused by a build-up of immune cells called microglia, could halt progression of the disease.

Another flicker of hope is, another drug being developed by Biogen Idec for the treatment of Alzheimer’s disease appeared to slow down the inexorable cognitive decline of patients’, though in a small and a preliminary study.

Lack of research funding is a critical impediment:

Be that as it may, many experts believe that not enough is still being done in Alzheimer’s research, especially in the area of funding.

In an article titled, “Alzheimer’s disease: are we close to finding a cure?” published by ‘Medical News Today (MNT)’ on August 20, 2014, quoted the Alzheimer’s Society, as follows:

“Dementia is the biggest health and social care challenge of our generation, but research into the condition has been hugely underfunded. This lack of funding has hampered progress and also restricted the number of scientists and clinicians working in the dementia field.”

As an illustration, MNT mentioned that in the United States Alzheimer’s research received US$504 million in funding from the National Institutes of Health (NIH) in 2014, while cancer received more than US$5 billion. Breast cancer alone received more funding than Alzheimer’s at US$674 million. 

Quoting an expert in this field the report highlighted, “Other diseases have demonstrated that sustained investment in research can improve lives, reduce death rates and ultimately produce effective treatments and preventions. We have the tools and the talent to achieve breakthroughs in Alzheimer’s disease, but we need the resources to make this a reality.”

Conclusion:

From the published research reports, it appears that the quest to decipher the complicated Alzheimer’s disease process continues, at least by the academic and scientific institutions, with equal zest. 

These scientists remain committed to finding out the ‘magic bullet’, which would be able to effectively address the crippling disease. As a result, the research has also moved from discovery of effective amyloid-clearing drugs to search for new molecules that targets inflammation in the brain, caused by a build-up of immune cells called microglia. 

Undeniably, the challenges ahead are still too many.

Nevertheless, enough confidence is also building up to halt the epidemic of Alzheimer’s by overcoming those hurdles, the world over. Experts are hoping that both a cure and also successful preventive measures for the disease, are not too far anymore.

Though some Global Pharma majors invested significantly to discover effective drugs for Alzheimer’s disease, overall research funding in this area is still far from adequate, according to the Alzheimer’s Society. 

For various reasons, not many pharma players today seem to believe that it would be financially prudent for them to make significant investments in developing new molecules for the treatment of Alzheimer’s – the disease that robs memory of millions of people, completely, and without any prior warning whatsoever.

‘The Memory Thief’ continues to prowl, undeterred, still eluding otherwise brilliant Pharma R&D, across the world.

By: Tapan J. Ray

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

 

Unsustainable New Cancer Drug Prices: Resolution Remains A Far Cry

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Prices of new drugs for the treatment of life-threatening ailments, such as cancer, are increasingly becoming unsustainable, across the world, and more in India. As articulated by the American Society of Clinical Oncology in 2014, this is primarily due to the fact that their prices are disconnected from the actual therapeutic value of products.

Today, a very large number of poor and even the middle-income patients, who spend their entire life-savings for treatment of a disease like cancer, have been virtually priced out of the patented new drugs market.

The plights of such patients are worse in India and would continue to be so, especially when no trace of Universal Health Care/Coverage (UHC) is currently visible anywhere near the healthcare horizon of the country.

I discussed about the recent decision of the Government for shelving UHC in my recent Blog Post titled, “Would Affordable ‘Modicare’ Remain Just A Pipe Dream In India?”

Irresponsible pricing?

To highlight this point, I shall quote from the research paper titled, “Five Years of Cancer Drug Approvals, Innovation, Efficacy and Costs” published in JAMA Oncology dated April 02, 2015. This report states that just one year’s cost of treatment with a patented new cancer drug now routinely exceeds US$ 100,000. It is much known today that the medical bills for cancer treatment have become the single largest cause of personal bankruptcy, in many countries of the world.

The issue is even more impactful and heart wrenching in India, as with much lower per capita income, compared to the global median, a cancer patient pays around the same price for the same patented drugs in the country. Much talked about Nexavar of Bayer, has been a good example.

The above report underscores, the big global pharma players still vigorously contend to establish that the high cost of drugs is required to support their research and development efforts. However, none would possibly deny the hard data that, when costs and revenues are balanced, the pharmaceutical industry generates high profit margins.

On a lighter vain – the fact that the richest person in India is a pharma player of ‘low price generic medicines’ vindicates this point.

The latest report on pharma R&D costs:

In a ‘Press Release’ of November 18, 2014, Tufts Center for the Study of Drug Development announced, “Cost to develop and win marketing approval for a New Drug is US$2.6 Billion”.

This is around 2.5 times more than its previous estimate published in 2003, which reads as US$802 million.

Although the study is not publicly available, neither has it been peer reviewed, it does reflect that above overall inflation rate, pharma R&D costs are reportedly going up at an annual rate of around 8 percent!

Even if the R&D cost of US$2.6 Billion is accepted as correct to justify high prices of patented drugs, one should note that this figure is applicable only to those types of New Chemical Entities (NCE) that did not receive any outside funding in their developmental process, such as, from the National Institutes of Health (NIH).

It is worth noting, such types of NCEs account for less than one-sixth of the annual new drugs approval in the United States.

Interestingly, Tufts Center receives its funding from the pharmaceutical industry, according to reports.

When is a high cost of medicine defendable?

According to some, high price may be justified, if novel products offer significant benefits to patients giving rise to indirect quantifiable economic value through restoration of health of patients.

This is understandable, as those patented drugs represent significant and well-accepted pharmacological advances over the existing ones, offering novel mechanisms of actions for better treatment value through ‘high-risk-high-cost’ research.

Price is a function of the value that a drug offers:

The price of any drug must be a function of the value that it offers to the patients. Not just the cost of its innovation, irrespective of the fact, whether it is a ‘New-Class (Novel)’ or ‘Next-in Class’ or even a ‘Me-too’ NCE.

The above April 2015 research report published in JAMA Oncology, investigated at length, whether novelty of medications or their relative benefits dictated drug pricing.

In that endeavor, the authors found out that from January 1, 2009, to December 31, 2013, the USFDA approved 51 drugs in oncology for 63 indications. During this period, 9 drugs received more than 1 approved indication.

The study observed:

Of these 51 drugs:

- 21 (41 percent) exert their effect via a novel mechanism of action

- While 30 (59 percent) are next-in-class drugs

Despite this fact, there was no difference in the median price per year of treatment between the 30 next-in-class drugs (US$119, 765) and the 21 novel drugs (US$116, 100).

Global cancer market is soaring high fuelled by astronomical prices:

According to a report that quotes an official of IMS Health, the overall cost for cancer treatments per month in the United States is now US$10,000, up from $5,000 just a year ago. At the same time, according to a 2014 study by the IMS Institute for Healthcare Informatics, global oncology spending has hit US$91 billion in 2013, and despite patent cliff is growing at 5 percent annually.

None likes nightmarish cancer drug-pricing trend:

None likes this worrisome drug-pricing trend, not even in the developed world. God forbid, just one cancer patient in the family can drag even a middle class household to the poverty level, especially in a country like India, where Out of Pocket (OoP) expenses for health hovers around 70 percent and Universal Health Coverage still remains a pipe dream.

Payers, including governments and private insurers, in the top cancer markets such as the United States and Europe, are trying hard to bring the cancer drug prices to a reasonable level through regulatory pressure of various kinds and forms. For example, National Institute for Health and Care Excellence (NICE) in the United Kingdom and the regulators for drug cost-effectiveness in other large European countries, are coming hard on patented new cancer drugs with small improvements in survival time but priced much higher than the existing ones.

Even many private insurers in those countries are now raising questions about the additional value offerings in quantifiable terms, especially for the new cancer drugs and other treatments for life-threatening ailments, such as hepatitis C. To give an example, in late 2014, Express Scripts in America negotiated hard for an exclusive deal with AbbVie to provide its hepatitis C treatment Viekira Pak over Gilead’s exorbitantly priced Sovaldi.

Action by the doctors outside India:

In 2012, doctors at the Memorial Sloan-Kettering Cancer Center reportedly announced in ‘The New York Times’ that their hospital would not be using Zaltrap, a newly patented colorectal cancer drug from Sanofi. This action of the Sloan-Kettering doctors compelled Sanofi to cut Zaltrap price by half.

Unlike in India, where prices of even cancer drugs do not seem to be a great issue with the medical profession, just yet, the top cancer specialists of the American Society of Clinical Oncology are reportedly working out a framework for rating and selecting cancer drugs not only on their benefits and side effects, but prices as well.

In a recent 2015 paper, a group of cancer specialists from Mayo Clinic also articulated, that the oft-repeated arguments of price controls stifle innovation are not good enough to justify unusually high prices of such drugs. Their solution for this problem includes value-based pricing and NICE like body of the U.K.

This Interesting Video from Mayo Clinic justifies the argument.

Tokenism by the Indian Government:

India sent a signal to global pharma players about its unhappiness of astronomical pricing of patented new cancer drugs in the country on March 9, 2012. On that day, the then Indian Patent Controller General issued the first ever Compulsory License (CL) to a domestic drug manufacturer Natco, allowing it to sell a generic equivalent of a kidney cancer treatment drug from Bayer – Nexavar, at a small fraction of the originator’s price.

In this context, it won’t be out of place recapitulating that an article published in a global business magazine on December 5, 2013 quoted Marijn Dekkers, the CEO of Bayer AG saying: “Bayer didn’t develop its cancer drug, Nexavar (sorafenib) for India but for Western Patients that can afford it.”

Whether, CL is the right approach to resolve allegedly ‘profiteering mindset’ at the cost of human lives, is a different subject of discussion.

Be that as it may, India did send a very strong signal in this regard, which some construe as mere tokenism. Nonetheless, this action of the Indian Government shook the global pharma world very hard, that it would find difficult to forget in a foreseeable future.

Government’s determination to make it happen is still eluding:

The headline of this article would probably invoke an instant negative response from my friends in the industry, an understandably so, expressing… ‘Hey, are you talking against innovation and suggesting one more regulator for the heavily regulated pharma industry?’ 

I would very humbly say, no…I am suggesting neither of those two, but requesting to give shape to a very important decision already taken by the Government on this issue, in a meaningful way. That decision has been scripted in Para 4.XV of the National Pharmaceutical Pricing Policy 2012 (NPPP 2012) and was notified on December 07, 2012.

On ‘Patented Drugs Pricing’, it categorically states as follows:

“There is a separate committee constituted by the Government Order dated February 01, 2007 for finalizing the pricing of Patented Drugs, and decisions on pricing of patented Drugs would be based on the recommendation of this committee.”

The following long drawn unproductive events would vindicate, beyond even an iota of doubt, that a strong determination to make it happen, by even by the new Government, is still eluding by far.

Is this committee ‘Jinxed’?

To utter dismay of the patients and their well-wishers, the above committee took over six years after it was formed to submit its report.

It recommended ‘Reference Pricing’ for the Patented Drugs in India, after adjusting against India’s Gross National Income and Purchasing Power Parity. The suggested ‘Reference Countries’ were UK, Canada, France, Australia and New Zealand, where there exist a strong public health policy, together with tough bargaining power of the governments for drug price negotiations.

However, our Government found this report useless for various reasons and dissolved the panel. The grapevine in the corridors of power whispers, it could possibly be due to intense pressure from the global pharma players and their powerful lobby groups.

Interestingly, again by the end of 2013, the Department of Pharmaceuticals (DoP) set up a brand new inter-ministerial committee with four representatives each from the Ministry of Commerce and Industry, Ministry of Health and Family Welfare, National Pharmaceutical Pricing Authority (NPPA) and one from the DoP to resolve the same issue of ‘Patented Drugs Pricing’ in India.

Unfortunately, a serious issue of this magnitude has still remained unresolved, even under the new seemingly dynamic Government, till date. There were media reports though, just prior to the Union Budget in January 2015, that ‘the Government may negotiate prices of patented medicines with their manufacturers before allowing pharmaceutical companies to launch them in India.’

The scenario is still far from even sketchy. A lurking fear, therefore, creeps into the minds of many: Is this committee on ‘Patented Drugs Pricing’ jinxed or incompetent or has deliberately been kept non-functional under tremendous external pressure on pricing of patented drugs?

The way forward:

To find an implementable ‘Patented Drug Pricing Model’ soon, the new committee of the Government should consider Pharmacoeconomics Based or Value-Based Pricing (PBP/VBP) Model for the country.

Pharmacoeconomics, as we know, is a scientific model of setting price of a medicine commensurate to the economic value of the drug therapy.  Pharmacoeconomics principles, therefore, intend to maximize the value obtained from expenditures towards medicines through a structured evaluation of products costs and disease outcomes.

Thus, PBP/VBP basically offers the best value for money spent. It ‘is the costs and consequences of one treatment compared with the costs and consequences of alternative treatments’.

To the best of my knowledge, the Public Health Foundation of India, spearheaded by well-reputed internationally acclaimed physician – Dr. Srinath Reddy, has requisite expertise in this area and to build on it further, as required by the committee.

This new model would help establishing in India that the price of any drug is always a key function of the value that it offers and not of the so called ‘high cost of innovation’, irrespective of whether it is a ‘New-Class (Novel)’ or ‘Next-in Class’ or even ‘Me-Too’ NCE.

The concept is gaining ground: 

The concept of ‘Value-Based Pricing’, has started gaining ground in the developed markets of the world, prompting the pharmaceutical companies generate requisite ‘health outcome’ data using similar or equivalent products.

Cost of incremental value that a product delivers over the existing ones, is of key significance and should always be the order of the day. Some independent organizations such as, the National Institute for Health and Clinical Excellence (NICE) in the UK have taken a leading role in this area.

Conclusion:

Warren Buffet – the financial investor of global repute once said, “Price is what you pay. Value is what you get.” Unfortunately, this dictum is not applicable to the consumers of high priced life saving drugs, such as, for cancer.

Price tags of most of the patented new cancer drugs, do not seem to give any indication that the pharma players believe in this pricing model, even remotely. As JAMA Oncology has established in their recent research study, there is no difference in the median price of per year of treatment between ‘Next-in-Class’ and ‘Novel Drugs’.

Thus far, India has been able to address this issue either through section 3(d) or Compulsory Licensing (CL) provisions of its Patents Act. As the saying goes, ‘proof of the pudding is in the eating’, the net fall-out of these measures has been demonstrably profound. For example, the global pharma giant Gilead has entered into voluntary License (VL) agreements with several local companies to market in India one of the most expensive products of the world – Sovaldi, at a small fraction of its original price of US$1,000/tablet. 

That said, effective long-term resolution of ‘Patented Drugs Pricing’ issue, in my view, is long overdue in India, especially for the treatment of life-threatening diseases, such as cancer. This has been necessitated by the fact that in many cases, therapeutic benefits of most of these drugs are not commensurate to their high costs.

The provision for ‘Patented Drugs Pricing’ has already been made in the NPPP 2012, though not implemented, as yet. While working out an implementable mechanism for the same, the new committee of the present Government may consider ‘Pharmacoeconomics Based or Value-Based Pricing (PBP/VBP) Model’ to effectively resolve this crucial issue. The specialized group that will operate this system could be a part of the National Pharmaceutical Pricing Authority (NPPA) of India.

The struggle for life in the fierce battle against dangerous ailments, without having access to new life-saving drugs, has indeed assumed a mind-boggling dimension in India, especially in the absence of Universal Health Coverage. It would continue to remain so, unless the new Government demonstrates its will to act, putting in place a transparent model of patented drugs pricing, without succumbing to any power play or pressures of any kind from vested interests.

The bottom-line is: It has to happen soon…very soon. For patients’ sake.

By: Tapan J. Ray

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

Threats to Indian Generics: Failing in US Inspections is Just Half The Story

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At a recent event of the American Enterprise Institute, Dr. Harry Lever, a senior cardiologist at the Cleveland Clinic in Ohio, reportedly expressed his concern based on his personal experience regarding inconsistent quality among Indian generics. As a result, he requires switching patients off them, almost routinely, for desired therapeutic effects.

Many reasons may be attributed to such medical concerns on Indian generics in the United States, however limited those may be, the core issue can nevertheless be wished away.

Back home in India, many doctors reportedly have also expressed similar apprehensions on the quality of many generic formulations produced by over 10,000 pharmaceutical manufacturers in the country.

US-FDA on its part has taken action to protect health safety of the patients in the United States through import bans of drugs manufactured in all those facilities, which failed to meet its cGMP standards during inspection.

Not an old story:

Not so long ago, just in 2013, quality related concerns with generic drugs exported by India came to the fore after Ranbaxy reportedly pleaded guilty and paid a hefty fine of US$ 500 million for falsifying clinical data and distributing ‘adulterated medicines’ in the United States.

Thereafter, US-FDA banned drug imports from Ranbaxy and Wockhardt, manufactured in all those facilities that failed to conform to its cGMP quality standards.

Those are the stories for generic formulations. Most recently, following yet another ‘import ban’ and this time for Active Pharmaceutical Ingredients (API) manufactured at its Toansa plant, Ranbaxy has suspended all shipments of APIs pending review. With this step, Ranbaxy would virtually have no access to the top pharmaceutical market of the world.

A not very responsible remark either:

Unfortunately, in the midst of such a scenario, instead of taking transparent and stringent measures, the Drug Controller General of India (DCGI) was quoted as saying, “We don’t recognize and are not bound by what the US is doing and is inspecting. The FDA may regulate its country, but it can’t regulate India on how India has to behave or how to deliver.”

The DCGI made this comment as the US-FDA Commissioner Margaret Hamburg was wrapping up her over a weeklong maiden trip to India in the wake of a number of ‘Import Bans’ arising out of repeated cGMP violations by some large domestic generic drug manufacturers. Whereas, Hamburg reiterated the need for the domestic drug makers of India to make sure that that the medicines they export are safe for patients, the DCGI’s above comment appears rather arrogant and out of tune, to say the least.

Just recently, on the above comments of the DCGI, the American Enterprise Institute reportedly commented, “Indian drug regulator is seen as corrupt and colliding with pharma companies…”

Failing in US-FDA inspection is just half of the story:

Around 40 percent of prescriptions and Over The Counter (OTC) drugs that are now sold in the United States come from India. All most all of these are cheaper generic versions of patent expired drugs. Total annual drug export of India, currently at around US$ 15 billion, is more than the domestic turnover of the pharma industry. Hence, India’s commercial stake in this area is indeed mind-boggling.

It is now well known, if such ‘Import Bans’ continue or grow due to shoddy compliance of required cGMP standards, there could be a serious challenges for the Indian drug exporters to salvage their reputation on drug quality for a long time to come. Consequently, this will offer a crippling blow not just to their respective organizational business outlook, but also to future drug exports of India. It is worth mentioning that drugs and pharmaceuticals are currently a net foreign exchange earner for the country.

The other half of the story:

Threats related to export of Indian generic drugs on quality parameters, as flagged by the US-FDA in India, is just half the story. The other half of the story begins in the US, instead of in India, and is related to stringent new measures taken by the same regulator in its own land to have a check on the quality of imported generic drugs consumed by the patients in America.

A recent report highlights that around twelve academic centers of the United States are now involved in the firstever widespread safety and quality evaluation of generic drugs. This program is run by the US-FDA and would continue through 2017.

This initiative has been prompted by the fact that generic drugs currently contribute over 80 percent of prescriptions written in the US. In 2014, the said program will reportedly focus on cardiovascular drugs, ADHD treatments, immune-suppressants, anti-seizure medicines, and antidepressants. The grand plan is highlighted to project the priority emphasis of the US-FDA on the quality of generic drugs, especially after it banned medicine import from four India-based facilities over a period of last nine months.

Some Examples:

- A widespread testing program of USFDA followed its 2012 finding that generic copies of antidepressant medication Wellbutrin XL did not work as good as the original. This study eventually led the largest generic drug player of the world -Teva to withdraw its generic version from the market in 2012.

- According to the report, US-FDA is now reviewing a 2013 study done by a Boston-based researcher that found widespread impurities in the generic version of Pfizer’s anti- cholesterol drug Lipitor manufactured outside of the US. The research reportedly found that some generic versions of Lipitor produced overseas were rendered ineffective as a result of manufacturing impurities. However, US-FDA action on the same is not known, as yet.

Thus, the other half of the story unfolds the reality that, even if any exporter escapes USFDA inspection in India, there is a fair chance now that the generic formulations could be tested in the US itself under the above program and if found wanting in quality parameters, concerned generic formulation could face a ban in the United States.

Conclusion:

There is nothing like tightening all loose knots in the required cGMP process for all drugs manufactured in India, without bothering much about their testing in the US. If the drug quality consciousness becomes robust in the shop floor, well before the products leave the shores of India, there is no reason why the country would face similar embarrassing incidents in future, along with a strong global furore.

The US-FDA Commissioner’s recent calling on the DCGI to join hands with the US to enforce more rigorous oversight of drug manufacturing facilities, needs to be followed up with due earnest, the above avoidable comment of the DCGI not withstanding.

The Commissioner reportedly reiterated that the US would increase the number of FDA inspectors in India from 11 to 19 as it intensifies inspections of drug manufacturing plants, simultaneously with arranging cGMP compliance related workshops for the drug exporters. The DCGI also made an announcement that India intends to increase its inspectors from 1,500 to 5,000 over the next five years.

A deepening economic spat over cheaper generic drugs, not withstanding, all these good intents to maintain a robust drug quality standard need to be translated into reality.

Trying to find ghosts nurturing dubious intentions against India, especially in areas pertaining to drug quality standards, may not augur well for the patients at large, not just of the United Stated, but for our own homeland too.

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.

Buying Physicians’ Prescriptions in Cash or Kind: A Global (Dis)Order?

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Recently a European business lobby reportedly raised its voice alleging pharma Multinational Corporations (MNCs) in China have been ‘unfairly targeted’ by a string of investigations into bribery and price-fixing cases despite their generally ‘strong legal compliance’ and has suggested that China ‘must step back.’

Two comments of this European lobby group, presumably with full knowledge of its past records, appear indeed intriguing, first – ‘unfairly targeted’ and the second – ‘China must step back’, that too when a reportedly thorough state investigation is already in progress.

Reality is all pervasive:

However, while looking over the shoulder, as it were, an altogether different picture emerges and that reality seems to be all pervasive.

Over the past several decades, the much charted sales and marketing frontier in the pharmaceutical industry has been engagement into a highly competitive ‘rat race’ to create a strong financial transactional relationship, of various types and forms, with the physicians, who only take the critical prescription decisions for the patients. Most of the times such relationships are cleverly packaged with, among many others,  a seemingly noble intent of ‘Continuing Medical Education (CME)’ by the companies concerned.

Increasingly, across the globe, more questions are now being raised whether such pharmaceutical business practices should continue even today. These voices are gradually getting louder fueled by the recent moves in the United States to ‘separate sales and marketing related intents of the drug industry from the practice of medicine’, especially in large medical teaching hospitals, in tandem with the enactment and practice of ‘Physician Payment Sunshine Act 2010’.

A recent article titled, “Breaking Up is Hard to Do: Lessons Learned from a Pharma-Free Practice Transformation”, published in the ‘Journal of the American Board of Family Medicine’ deliberated on an interesting subject related to much talked about relationship between the doctors and the pharmaceutical players.

The authors argue in this paper that significant improvement in the quality of healthcare in tandem with substantial reduction in the drug costs and unnecessary medications can be ensured, if the decision makers in this area show some willingness to chart an uncharted frontier.

‘Questionable’ relationship in the name of providing ‘Medical Education’:

‘The Journal of Medical Education’ in an article titled “Selling Drugs by ‘Educating’ Physicians” brought to the fore the issue of this relationship between the pharma industry and individual doctors in the name of providing ‘medical education’.

The article flags:

“The traditional independence of physicians and the welfare of the public are being threatened by the new vogue among drug manufacturers to promote their products by assuming an aggressive role in the ‘education’ of doctors.”

It further elaborates that in the Congressional investigation in the United States on the cost of drugs, pharma executives repeatedly stated that a major expenditure in the promotion of drugs was the cost of ‘educating’ physicians to use their products.

The author then flagged questions as follows:

  • “Is it prudent for physicians to become greatly dependent upon pharmaceutical manufacturers for support of scientific journals and medical societies, for entertainment and now also for a large part of their ‘education’?”
  • “Do all concerned realize the hazards of arousing wrath of the people for an unwholesome entanglement of doctors with the makers and sellers of drugs?”

Financial conflicts in Medicine:

Another academic paper of August 13, 2013 titled, “First, Do No Harm: Financial Conflicts in Medicine” written by Joseph Engelberg and Christopher Parsons at the Rady School of Management, University of California at San Diego, and Nathan Tefft from the School of Public Health at the University of Washington, states:

“We explored financial conflicts of interest faced by doctors. Pharmaceutical firms frequently pay physicians in the form of meals, travel, and speaking fees. Over half of the 334,000 physicians in our sample receive payment of some kind. When a doctor is paid, we find that he is more likely to prescribe a drug of the paying firm, both relative to close substitutes and even generic versions of the same drug. This payment-for-prescription effect scales with transfer size, although doctors receiving only small and/or infrequent payments are also affected. The pattern holds in nearly every U.S. state, but it is strongly and positively related to regional measures of corruption.”

On this paper, a media report commented:

“The findings – based on recently released data that 12 companies have been forced to make public as a result of US regulatory settlements – will rekindle the debate over the limits of aggressive pharmaceutical marketing, which risks incurring unnecessarily costly medical treatment and causing harm to patients.”

A call for reform:

The first paper, as quoted above, titled “Breaking Up is Hard to Do” reiterates that even after decades, individual practitioner still remains the subject to undue influence of the pharmaceutical companies in this respect. It categorically points out:

“The powerful influence of pharmaceutical marketing on the prescribing patterns of physicians has been documented and has led to fervent calls for reform at the institutional, professional, and individual levels to minimize this impact.”

The rectification process has begun in America:

Interestingly, even in the United States, most physicians practice outside of academic institutions and keep meeting the Medical Representatives, accept gifts and drug samples against an expected return from the drug companies.

Many of them, as the paper says, have no other process to follow to become ‘pharma-free’ by shunning this hidden primitive barrier for the sake of better healthcare with lesser drug costs.

To achieve this objective, many academic medical centers in America have now started analyzing the existing relationship between doctors and the drug companies to limit such direct sales and marketing related interactions for patients’ interest.

This unconventional approach will call for snapping up the good-old financial transactional relationship model between the doctors and Medical Representatives of the Pharma players, who promote especially the innovative and more costly medicines.

An expensive marketing process:

The authors opine that this is, in fact, a very powerful marketing process, where the pharmaceutical players spend ‘tens of billions of dollars a year’. In this process more than 90,000 Medical Representatives are involved only in the United States, providing free samples, gifts along with various other drug related details.

The study reiterates that deployment of huge sales and marketing resources with one Medical Representative for every eight doctors in the United States, does not serve the patients interests in any way one would look into it, even in terms of economy, efficacy, safety or accuracy of information.

“But Don’t Drug Companies Spend More on Marketing?”

Yet another recent article, captioned as above, very interestingly argues, though the drug companies spend good amount of money on R&D, they spend much more on their marketing related activities.

Analyzing six global pharma and biotech majors, the author highlights that SG&A (Sales, General & Administrative) and R&D expenses vary quite a lot from company to company. However, in this particular analysis the range was as follows:

SG&A 23% to 34%
R&D 12.5% to 24%

SG&A expenses typically include advertising, promotion, marketing and executive salaries. The author says that most companies do not show the break up of the ‘S’ part separately.

A worthwhile experiment:

Removing the hidden barriers for better healthcare with lesser drug costs, as highlighted in the above “Breaking Up is Hard to Do” paper, the researchers from Oregon State University, Oregon Health & Science University and the University of Washington outlined a well conceived process followed by one medical center located in central Oregon to keep the Medical Representatives of the pharmaceutical companies at bay from their clinical practice.

In this clinic, the researchers used ‘a practice transformation process’ that analyzed in details the industry presence in the clinic. Accordingly, they educated the doctors on potential conflicts of interest and improved patient outcomes of the clinical practice. The concerns of the staff were given due considerations. Managing without samples, loss of gifts, keeping current with new drugs were the key concerns.

Based on all these inputs, various educational interventions were developed to help the doctors updating their knowledge of new drugs and treatment, even better, through a different process.

The experiment established, though it is possible to become “pharma free” by consciously avoiding the conflicts of interest, implementation of this entire process is not a ‘piece of cake’, at least not just yet.

Need for well-structured campaigns:

The researchers concluded that to follow a “pharma sales and marketing free” environment in the clinical practice, the prevailing culture needs to be changed through methodical and well-structured campaigns. Although, initiation of this process has already begun, still there are miles to go, especially in the realm of smaller practices.

One researcher thus articulated as follows:

“We ultimately decided something had to be done when our medical clinic was visited by drug reps 199 times in six months. That number was just staggering.”

Where else to get scientific information for a new drug or treatment?

The authors said, information on new drugs or treatment is currently available not just in many other forum, but also come with less bias and more evidence-based format than what usually are provided by the respective pharmaceutical companies with a strong motive to sell their drugs at a high price to the patients. 

The paper indicated that there are enough instances where the doctors replaced the process of getting information supplied by the Medical Representatives through promotional literature with monthly group meetings to stay abreast on the latest drugs and treatment, based on peer-reviews.

‘Academic detailing’:

In the process of ‘Academic detailing’ the universities, and other impartial sources of credible information, offer accurate information without bias, whenever sought for. In the United States, some states and also the federal government are reportedly supporting this move now, which is widely believed to be a step in the right direction.

Moves to separate sales and marketing of the drug industry from the practice of medicine:

As stated above, there are many moves now in the United States to ‘separate the sales and marketing influence of the drug industry from the practice of medicine’, especially in large medical teaching hospitals, as the paper highlights.

The study also reported that of the 800,000 physicians practicing in the United States only 22 percent practice in the academic settings and 84 percent of primary care physicians continue to maintain close relationships with the pharmaceutical companies.

Citing examples, the new report indicated various tangible steps that primary care physicians can possibly take to effectively mitigate these concerns.

Emerging newer ways of providing and obtaining most recent information on new drugs and treatment together with educating the patients will hasten this reform process.

A commendable move by the Medical Council of India:

Taking a step towards this direction, the Medical Council of India (MCI) vide a notification dated December 10, 2009 amended the “Indian Medical Council (Professional Conduct, Etiquette and Ethics), Regulations 2002″. This move was welcomed by most of the stakeholders, barring some vested interests.

The notification specified stricter regulations for doctors in areas, among others, gifts, travel facilities/ hospitality, including Continuing Medical Education (CME), cash or monetary grants, medical research, maintaining professional Autonomy, affiliation and endorsement in their relationship with the ‘pharmaceutical and allied health sector industry’. These guidelines came into force effective December 14, 2009.

With this new and amended regulation, the MCI, on paper, has almost imposed a ban on the doctors from receiving gifts of any kind, in addition to hospitality and travel facilities related to CMEs and others, from the pharmaceutical and allied health sector industries in India.

Moreover, for all research projects funded by the pharmaceutical industry and undertaken by the medical profession, prior approval from the appropriate authorities for the same will be essential, in addition to the ethics committee.

Although maintaining a cordial and professional relationship between the pharmaceutical industry and the doctors is very important, such relationship now should no way compromise the professional autonomy of the medical profession or any medical institution, directly or indirectly.

It is expected that the common practices of participating in private, routine and more of brand marketing oriented clinical trials would possibly be jettisoned as a pharmaceutical strategy input.

However, inability of the Indian regulator to get these guidelines effectively implemented  and monitored has drawn sharp flak from all other stakeholders, as many third party private vendors are reportedly coming up as buffers between the industry and the physicians to facilitate the ongoing illegal financial transactions, hoodwinking the entire purpose, blatantly.

No such government guidelines for the industry yet:

MCI under the Ministry of Health, at least, came out with some measures for the doctors in 2009 to stop such undesirable practices.

However, it is difficult to fathom, why even almost four years down the line, the Department of Pharmaceuticals of the Government of India is yet to implement its much hyped ‘Uniform Code of Pharmaceutical Marketing Practices (UCPMP)’ for the entire pharmaceutical industry in India.

‘Physicians payment induced prescriptions’ – a global phenomenon:

Besides what is happening in China today with large pharma MNCs alleged involvement in bribery to the medical profession soliciting prescriptions of their respective drugs, world media keep reporting on this subject, incessantly.

For example, The Guardian in its July 4, 2012 edition reported an astonishing story. Since quite some time many pharmaceutical giants are being reportedly investigated and fined, including out of court settlements, for bribery charges related to the physicians.

In another very recent article titled “Dollars for Docs Mints a Millionaire” the author stated as follows:

“The companies in Dollars for Docs accounted for about 47 percent of U.S. prescription drug sales in 2011. It’s unclear what percentage of total industry spending on doctors they represent, because dozens of companies do not publicize what they pay individual doctors. Most companies in Dollars for Docs are required to report under legal settlements with the federal government.”

In India, deep anguish of the stakeholders over this issue is also getting increasingly reverberated all across, without much results on the ground though. It has also been drawing attention of the patients’ groups, NGOs, media, Government and even the Parliament of the country. 

Another article titled, “Healthcare industry is a rip-off” published in a leading business daily of India states as follows:

“Unethical drug promotion is an emerging threat for society. The Government provides few checks and balances on drug promotion.”

Physician Payment Sunshine Act of 2010:

To partly address this issue under President Obama’s ‘Patient Protection Affordable Care Act’, ‘Physician Payment Sunshine Act’ came into force in the United States in 2010. 

Under this Act, any purchasing organization that purchases, arranges for, or negotiates the purchase of a covered drug, device, biological, or medical supply or manufacturer of a covered drug, device, biological, or medical supply operating in the United States, or in a territory, possession, or commonwealth of the United States is required to publicly disclose gifts and payments made to physicians.

Penalty for each payment not reported can be upto US$ 10,000 and the penalty for knowingly failing to submit payment information can be upto US$ 100,000, for each payment.

Centers for Medicare and Medicaid Services (CMS) has already released their ‘Physician Payment Sunshine Act’ reporting templates for 2013. The templates apply for reports dated August 1, 2013 – December 31, 2013.

Should the Government of India not consider enacting similar law in the country  without further delay?

Conclusion:

That said, these well-researched papers do establish increasing stakeholder awareness and global concerns on the undesirable financial influence of pharma players on the doctors. Product promotion practices of dubious value, especially in the name of ‘Continuing Medical Education (CME), seem to strongly influence the prescribing patterns of the doctors, making patients the ultimate sufferer.

The studies will help immensely to establish that achieving the cherished objective of a ‘pharma sales and marketing free’ clinic is not only achievable, but also sustainable for long.

The barriers to achieving success in this area are not insurmountable either, as the above article concludes. These obstacles can easily be identified and overcome with inputs from all concerned, careful analysis of the situation, stakeholder education and identifying most suitable alternatives.

Thus, I reckon, to effectively resolve the humongous ‘physician payment induced prescriptions’ issue for the sole benefit of patients, it is about time for the pharmaceutical players to make a conscientious attempt to shun the ‘road much travelled, thus far, with innovative alternatives. However, the same old apprehension keeps lingering:

“Will the mad race for buying physicians’ prescriptions in cash or kind, much against patients’ interest, continue to remain a global (dis)order, defying all sincere efforts that are being made today?  

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.