Published on April 2, 2014
MEDICINMANField Force Excellence TM April 2014 | www.medicinman.net Marrying Medicalaffairs andMarketing In an era of increas- ing regulatory pres- sure and social activ- ism, medical advisers who can provide better insights about patient care will en- able pharma compa- nies to deliver true value and differen- tiate themselves in the crowded market- place. A t the INMAS 2014, (see here) it was enlightening to hear Sharad Tyagi, MD of Boehringer Ingelheim say,“Medical Affairs is at the core of pharma business and is the only function in a pharma company which can truly bridge the gaps between science and business.”According to him, people in this function are probably the only ones who understand the“Why”,“What”and“How”of pharma business. That is certainly true as pharma is about patient care and not just sales targets. The faculty at INMAS 2014 was a display of the abundant talent of medical advisers in Indian Pharma. Companies like Pfizer are pioneering roles like regional medical advisers, that are field-based and available to the field force on demand. It has been my experience while conducting workshops on KOL Management (see here), that very few Indian companies use medical affairs as a strategic partner. Instead, KOL Management becomes one more business development initiative that caters to the ego and other needs of doctors with a large prescription potential. In an era of increasing regulatory pressure and social activism, medical advisers who can provide better insights about patient care will enable pharma companies to deliver true value and differentiate themselves in the crowded marketplace. Considering the fact that most doctors find it difficult to manage time between patient care and knowledge updation, medical advisers embedded into the field force can bridge the gap – both in the knowledge of doctors and the field force. With the roll out of the Sunshine Act in the US, pharma will need better umbrellas and sun screens to do business without getting burnt with heavy fines. GSK has taken the lead by ending the practice of giving sales targets to its field force and has announced that it will be employing doctors to cater to the clinical information needs of doctors. Under the proposed changes, GSK aims to have the new compensation plan for sales staff rolled out globally by early 2015. It expects the changes in doctors’payments to be in effect around the world by 2016. Editorial Since 2011 “ ”
“ Anup Soans | Editorial: Marrying Medical Affairs and Marketing It is clear that doctors do not see much value in product centered promotions by sales force. Dr. Adam Urato, who gives lectures to doctors about conflicts of interest in medicine, says -“I’m interested in practicing evidence- based medicine. If there is a product that is out there and it works and it is good for the patient, I will use it. If not, I won’t use it.”1 GSK Chief Executive Andrew Witty says:“We recognize that we have an important role to play in providing doctors with information about our medicines, but this must be done clearly, transparently and without any perception of conflict of interest.”1 Doctors are also business savvy. Richard Vautrey, a GP in the U.K., said pharma companies have sharply reduced their spending on doctor payments and medical education in the U.K. in recent years. Glaxo’s move“may be a sign that companies recognize that the investment now made in that direction doesn’t influence doctors in terms of their prescribing,”he said.“It’s probably a business decision rather than for any other reasons.”1 These trends have important pointers for Indian Pharma. While India is unlikely to adopt these changes anytime soon, it can certainly innovate its current model of influencing doctors. Field sales people will remain at the forefront of pharma sales in India, but their thrust can shift from sales to science that benefits patients. Medical advisers embedded in the field force can take up the challenge of enhancing the knowledge of field force through digital and social media. One-to-one communication is the most effective way of increasing learning effectiveness and by understanding the unique clinical scenario of each territory, medical advisers are in a unique position to leverage the digital revolution to empower their field force with much needed knowledge and confidence needed to move corridor calls to meaningful interactions. Despite being one of the world’s largest producers of anti- TB drugs, India is plagued with extreme forms of TB that is resistant to standard treatment protocols. This is primarily due to improper treatment regimens and non compliance and non availability of drugs. Surely, Indian Pharma can provide the right scientific insights to manage these and many other disease burdens peculiar to India through a new business approach that recognizes its responsibilities to patients and partners with doctors through its medical advisers and field force. -AS 2 | MedicinMan April 2014 References: 1.“Drug Firms CurbTies to Doctors. Glaxo to End Payments for Drug Promotion.”TheWallStreetJournal. http://on.wsj.com/1dkMtru Connect with Anup Soans on LinkedIn | Facebook | Twitter Meet the Editor Anup Soans is an Author, Facilitator and the Editor of MedicinMan. Write in to him: firstname.lastname@example.org With the roll out of the Sunshine Act in the US, pharma will need better umbrellas and sun screens to do business without getting burnt with heavy fines. GSK has taken the lead by ending the practice of giving sales targets to its field force and has now announced that it will be employing doctors to cater to the clinical information needs of doctors. ”
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1. Listening to the Patient.......................................5 The answer to the simple question - “Dear patient, to which degree has your health problem been solved or alleviated?” - might be your company’s most important metric. Hanno Wolfram 2. Getting the Bang for Your Buck from Training....................................................................6 What you do post-training is crucial to the long- term effectiveness of your training programs. K. Hariram 3. 3 Principles of Steve Jobs .............................12 Using Empathy, Focus and Imputation to deliver value and to delight your customers. Prof. Vivek Hattangadi 4. Is Indian Pharma Future-Ready ..................14 The nature of healthcare delivery is changing rapidly. Can Indian pharma keep pace? Salil Kallianpur 5. Trial by Fire ......................................................17 Much rhetoric has muddied the water of what exactly is at stake for clinical trials in India. Dr. Viraj Suvarna 6. 42 Years at Pfizer.............................................21 Sudhir Ganguly recently retired after a 42 year stint at Pfizer. MedicinMan Volume 4 Issue 4 | April 2014 Editor and Publisher Anup Soans CEO Chhaya Sankath COO Arvind Nair Chief Mentor K. Hariram Advisory Board Prof. Vivek Hattangadi; Jolly Mathews Editorial Board Salil Kallianpur; Dr. Shalini Ratan; Shashin Bodawala; Prabhakar Shetty; Vardarajan S; Dr. Mandar Kubal; Dr. Surinder Kumar International Editorial Board Hanno Wolfram; Renie McClay Executive Editor Joshua Soans MedicinMan Academy: Prof. Vivek Hattangadi, Dean, Professional Skills Development Letters to the Editor: firstname.lastname@example.org CONTENTS (Click to navigate)
P harmaceutical companies rightfully want to know if their marketing, promotional, educational and other efforts deliver value. The question is, who decides whether health-care or drug producers delivered value? Hypothesis 1: The decision if any value has been added is made by the patient. Hypothesis 2: Any person becomes a patient because he or she has a problem which makes the person to approach the healthcare system. The then patient’s only objective is that the problem be solved or allevi- ated – full stop. Consequence: There is nothing easier than asking the patient if the value has been delivered. There is one question only: “Dear patient, to which degree has your health problem been solved or alleviated?” (Please, let no one hide behind the sentence:“We are not allowed to…”! Every patient, educated, informed or not, will know perfectly well his or her individual answer. Collect this answer from as many patients as possible, declare these numbers as your“Key KPI”and declare the improvement of this one and only value as your company goal! A lot of praise, improved public opinion, new trust and better repu- tation will follow. Revenue will be a result. -HW E ListeningtothePatient 5 | MedicinMan April 2014 The answer to the simple question - “Dear patient, to which degree has your health problem beensolvedoralleviated?”-mightbeyourcompany’smostimportantmetric. Hanno Wolfram is Managing Director at Innov8 GmbH, Germany. Write to Hanno: email@example.com Hanno Wolfram
E 6 | MedicinMan April 2014 K. Hariram I happened to be a part of this conversation recently. The CEO was asking his Sales Manager & HR head, “What is the point in spending money on sales training? Every year I find that we spend money on training programs. The reason cited is that the Sales Reps’ skills have to be improved. I do not find any perceptible change in their selling behaviors and the same is not reflected in their productivity. So are you going to spend the time and resources again this year on training them? Who is responsible once the training is done?” The CEO is not wrong in questioning the spending on training or his doubts about its impact on Reps’ productivity. Quite often, for the sales head and the HR, training tends to become a periodic ritual and helps them to achieve their KPI objectives. Training is also looked at as a panacea for solving sales problems. How is it possible to directly correlate ROI and training? Is it appropriate to look for improved returns or outcome because REPS are put through the training grind every year? Generally I have observed that during or after the training sessions, feedback from the participants is very What you do post-training is crucial to the long-term effectiveness of your training K. Hariram is the former MD (retd.) at Galderma India. He is Chief Mentor at MedicinMan and a regular contributor. firstname.lastname@example.org GETTINGTHE ‘BANGFORYOUR BUCK’FROM TRAINING
K. Hariram | Getting the Bang for Your Buck from Training 7 | MedicinMan April 2014 encouraging. No doubt, there are fresh perspectives and newer skills are picked up. Also, the trainees feel more confident as they feel that they have more clarity in tackling some of their problems. To some extent this is true, but what is often overlooked is,‘how long the new learning lasts?’ It has been statistically proven that around 80% of the learning’s’are lost by the end of 30 days, unless there is an EXPERIENTIAL learning through periodic and proper reinforcement. Why is this not included into the TRAINING process? Who is responsible for this proper and periodic reinforcement? Often, in the busyness of chasing business this is ignored or overlooked. Training involves direct cost and indirect cost including selling time. Hence when there is no impact on selling behaviors and increased productivity, doubts are bound to arise. So the solution lies in looking at the problem from a different angle. They are: 1. Incorporate timely and periodic reinforcement post training – to be through Front/Second line managers. 2. Front/second line managers to be trained on COACHING skills and better understanding of their role, particularly ON THE JOB COACHING. 3. Bring clarity in the field visit objectives of LINE managers. 4. Follow up on the outcome of the field visit. The fundamentals are very clear. If you want the‘BANG FOR THE BUCK’spent on training Reps’, then include training front/second line managers as effective coaches. If you expect the reinforcement to automatically happen, then you will continue to question the effectiveness of training cost. -KH The familiar proverb of“Give a man a fish, you feed him a day and teach man to fish and you help him to feed himself longer”is very apt when it comes to ON THE JOB COACHING to reinforce what is learnt in training sessions. -KH “ ” It has been statistically proven that around 80% of classroom learning is lost by the end of 30 days, unless there is an EXPERIENTIAL learning through periodic and proper reinforcement.
EMPOWER YOUR FIELD FORCE KA$H=CASH REPEAT Rx Pharma-specific Training: Medical Representatives Field Sales Managers Senior Managers Learning and Development Programs from the Leaders in Pharma Field Force Excellence Signature Programs for Medical Representatives Constructed on the fundamental premise that a Medical Representative’s success depends on his Knowledge, Attitudes, Skills and Habits (KA$H). Representatives seek success in their personal and professional lives but look for it in the wrong places leaving them frustrated. Companies and bottom-lines suffer when the front-line is not ful- ly engaged. KA$H=CASH is a high-engagement module for customer-facing employees. Repeat Rx is an advanced module for customer-facing Representatives based on the book by Anup Soans. Repeat Rx focuses on building lasting relationships with Doctors by creating value through a process of Calling > Connecting > Consulting > Collaborating with the Doctor. At each stage of this Four Stage process the Represen- tative acquires measurable skills and competencies that enable him to add value in the Doctor’s chamber. Repeat Rx comes with detailed evaluation tools. In Any Profession, More KA$H = More Cash KNOWLEDGE ATTITUDES SKILLS HABITS MEDICINMAN
SuperVision for the SuperWiser Front-line Manager. WHY SHOULD ANY- ONE FOLLOW YOU? THE HALF-TIME COACH email@example.com | +91-934-2232-949 | www.medicinman.net Signature Programs for Front-line Managers Signature Programs for Second-line and Senior Managers Based on the best-selling book by Anup Soans, this program is for new and experienced Front-line Managers who would like to get breakthrough performance from their teams. SuperVision for the SuperWiser Front-line Manager focus- es on topics such as Team Building, Emotional Intelligence, Situational Leadership, Coaching and more. VALUE ADD: Psychometric Assessment* The Half-Time Coach is based on the concept of half-time in football. If half-time is so crucial in a game that last only 90 minutes, how much more important in a career that last a life time. The Half-Time Coach is a learning-by-reflection program with a focus on Coaching Skills for senior managers. Mod- ules also cover Self Awareness, Emotional Intelligence, Em- ployee Engagement and Sales Change Management. VALUE ADD: Psychometric Assessment* A walk-the-talk program for cross-functional senior managers to understand the process of employee engagement, creating trust and building relation- ships to build and sustain high-performance teams. VALUE ADD: Psychometric Assessment* *Psychometrics assessments give in-depth insights into one’s personality preferences and its impact on interpersonal relationships and teamwork.
firstname.lastname@example.org | +91-934-2232-949 | www.medicinman.net Methodology Webinars and E-Learning All programs are fully customizable. A pre-program questionnaire is used to capture the needs and expectations of the participants. Company’s may request a demonstration of a particular module at no expense (except conveyance to venue). Programs incorporate the principles of adult learning and are highly participative, audio-vi- sual and activity-based. Important truths are conveyed through games, stories and videos. Companies are advised to give participants the books on which the programs are based for continued learning and development. The same may be procured from the author at a discount. Company’s may choose to deliver a program as a webi- nar - giving the advantage of scale and lowering costs. Audiences are kept engaged using visually stimulating slides and powerful delivery. Emphasis is placed on taking charge of one’s success, even in the absence of oversight. Most recently 1,000 reps of a leading MNC were trained over four webinars with excellent feedback. Customized issues of MedicinMan, with inputs from the company can be given to the Field Force for their continuous learning and development. MedicinMan currently reaches 60,000 pharma professionals. Interactive Classroom Training Management Games Audio/Visual Learning-by-reflectionSimulation Case Studies iSharpenMMy Success is My Responsibiliti
A new book by Renie McClay published by ASTD Press is apt for the global executive with a local vision. “The Art of Modern SalesManagement”has12chapters,each writtenbyaleaderinthefieldfromaround theworld. Renie McClay, MA, CPLP, has been a dynamic performance improvement professional for 20 years. She has been successful in sales, management, and learning and performance roles at several Fortune 500 companies (Kraft, Pactiv, and Novartis). Founder of Inspired Learning LLC, she continues to bring her passion and practical approach to all project work. Inspired Learning LLC does design and delivery of energetic programs and projects around the world. Buy on Amazon. Download a free chapter of the book here. The Art of Modern Sales Management is a must read for any global sales leader. It's practical, relevant, and grounded in the experience of seasoned sales professionals who make a significant difference in the organizations that they serve. This book includes many useful tips and actionable ideas that any sales leader can use. --Kimo Kippen, Chief Learning Officer, Hilton Worldwide Renie has done a great job of selecting thought leaders that speak to the challenges of selling in our new, connected world. I absolutely love the framework of the book and found myself skipping from one chapter to another based on what I thought was most relevant to the problems I am most interested in solving today. This book is a must for anyone that understands that front-sales management is tomorrow’s competitive advantage. --Pat Martin, VP of Sales, Estes Express Renie is on top of her game again and brings the A Team to the world of Modern Sales Management. With the explosion of social media and the immediacy of shared experience for buyers and sellers, The Art of Modern Sales Management is a practical guide to navigating these changing realities, and the action plans offered provide tools to ensure the best opportunity for success. If you have a leadership role within the sales organization, you need this book as a guide and resource. --Gary Summy, Director of Business Development Global Accounts Operations, Xerox Corporation
A few days back I finished reading‘Steve Jobs’, the authentic biography of Steve Jobs by Walter Isaacson. The three principles of Steve Jobs as told to his biog- rapher Walter Isaacson has created a great impact in my mind. I would like to share this: 1. Empathy 2. Focus 3. Impute The first was empathy, an intimate connection with the feel- ings of the customer:“We will truly understand their needs better than any other company.” The second was focus:“In order to do a good job of those things that we decide to do, we must eliminate all of the unim- portant opportunities.” The third and equally important principle, awkwardly named, was impute. It emphasized that people form an opinion about a company or product based on the signals that it conveys. “People DO judge a book by its cover,”he wrote.“We may have the best product, the highest quality, the most useful software etc.; if we present them in a slipshod manner, they will be per- ceived as slipshod; if we present them in a creative, profession- al manner, we will impute the desired qualities.” Let us dwell a little more on these principles. 1. Empathy Empathy is about understanding people. Empathy and sympa- thy are not synonyms, they have different connotations. In sympathy, we feel sorry for a person. For example, when a friend of yours loses his job, we have‘sympathy’for the friend because we perceive the distress of the friend. When we have ‘empathy’for the friend we go into a similar emotional state of the friend if we accurately perceive the friend’s situation or predicament. Empathy is identifying ourselves with and Prof. Vivek Hattangadi 12 | MedicinMan April 2014 Using Empathy, Focus and Imputation to deliver value and to delight your customers. E 3PRINCIPLESTHAT DROVESTEVEJOBS Prof. Vivek Hattangadi is a Consultant in Pharma Brand Management and Sales Training at The Enablers. He is also visiting faculty at CIPM Calcutta (Vidyasagar University) for their MBA course in Pharmaceutical Management. email@example.com
13 | MedicinMan April 2014 understanding the situation, feelings and motives of the other person. It is our ability to not only know or detect what others are feeling, but to also experience that emotion ourselves. It is about empathy with the customer – both internal i.e. our medical representa- tives and the external customers – the doctors and the retailers. In all our interactions, we need to have empathy with our medical representatives if we have to establish our leadership. Emotional Intelligence is a prerequisite for effective leadership. 2. Focus Focus means to eliminate the many unimportant things, so as to do a good job of the important things. It means we need to understand our priorities and focus on important issues rather than end up doing a ‘fire-fighting’job when the important tasks become urgent. Learning to prioritize and then focusing on the most important issues is a skill which we must all develop. The most important skill is avoid the migra- tion of‘important but not urgent work to important and urgent’(fire-fighting). In the Mahabharata, when Dronacharya was testing the shooting skills of his pupils, all could see the beautiful leaves and flowers on the trees, the blue sky and so on. On the other hand, Arjuna could see only the eye of the bird – he was fo- cused! That is the kind of focus we all need to develop in our activities. Focus on important tasks! 3. Impute Impute literally means to relate to a particular cause or source; attribute the fault or responsibility to the actual cause (for e.g. imputed the rocket failure to a faulty gasket). Our doctors and retailers form an opinion about a company or product based on the signals that they receive from us during our interaction. “People do judge a book by its cover”. We may have the best of the products and of the highest quality. However, if we present our products to the doctors in a slipshod man- ner, our products may be perceived by the doctors as slipshod. If we present them in a creative, professional manner, we will impute the desired qualities. Therefore, the first-line managers need to empathize with the medical representatives, and focus on their development so that we impute their growth to our leadership skills. -VH Vivek Hattangadi | 3 Principles that Drove Steve Jobs “ ” Empathy is identifying ourselves with and understanding the situation, feelings and motives of the other person. It is our ability to not only know or detect what others are feeling, but to also experience that emotion ourselves. It is about empathy with the customer – both internal i.e. our medical representatives and the external customers – the doctors and the retailers.
R apid change across the pharmaceutical industry in India is causing many companies to re-evaluate their sales and marketing strategies. The rampant generic nature of the market leaves it commoditized with little to no leg-room for branding and differentiation. The threat of price control and loose IP laws discourage the launch of innovative products leaving little hope of adding freshness to the port- folio. In such a scenario companies must focus on maximizing returns on revenues that accrue from existing products. Doing more with less, in an increasingly competitive market, inevita- bly puts pressure on the sales force. Today, sales forces have to prepare themselves to deal with two significant shifts in disease and healthcare management that can change the way they work in the future. As a response to disease patterns moving from acute to chron- ic, the first is a fundamental and significant shift in healthcare philosophy and medical research – from a world in which we “react”to disease and illness after it has happened, to one in which we will be doing far more in advance to“prevent”spe- cific health care problems. The driver for this massive change is the emergence of extremely specialized and highly person- alized medical treatments based upon one’s own particular DNA. The second shift (which is because of the first) is that health- care is now becoming: 1. Predictive – forewarn people of susceptibility to diseases. 2. Preventative – empower them with information and re- sources to take preventive measures and to keep themselves healthy. Salil Kallianpur 14 | MedicinMan April 2014 The nature of healthcare delivery is changing rapidly. Can Indian pharma keep pace? “ ” Pharmaceutical companies have managed their business in much the same way for decades. But significant changes in government regulations, market conditions, and technology will force the industry to look for new business models and practices. E ISINDIANPHARMAFUTURE-READY? “
15 | MedicinMan April 2014 3. Personalized – provide information that is most relevant to them and what they want to know instead of generic and unimaginative information (n=1, R=G). 4. Participative – make people a part of decisions made about their health. After all, it’s their lives. Enable them and trust them to hold themselves accountable. The common underlying cause for these two shifts is the advent of technology. Are the industry’s sales forces, with their current struc- ture and training, capable of leveraging to their ad- vantage the impact that the advent of technology has on the way patients seek treatment and on the way doctors treat them? The recipe for success is probably a pinch of creativity and a fist full of effectiveness. Pharmaceutical companies have managed their business in much the same way for decades. But sig- nificant changes in government regulations, market conditions, and technology will force the industry to look for new business models and practices. With a lit- tle bit of creativity, companies can achieve a lot more and adapt quicker to the changes. Sales teams must evolve to adapt to the impact that technology will have on the pharma business model. Consider a few changes in the buyer-seller dynamic that is expected to emerge in the pharmaceutical industry causing a deep seated transformation in its fundamentals. 1. In 1–2 years we will see a hybrid salesperson emerge, and they will be technically, culturally, social- ly, and skillfully diverse and astute. 2. In the Western world today about 85% of buy- er-seller interactions happen online through social media and video. Customers will not need a field salesperson to come on-site as regularly as they do today. 3. With the amount of information available through technology, the Internet, social media, smart phones, tablets etc, the customer won’t need to engage early in the sales cycle. A total of 60% of the buying process will already be completed before connecting with a salesperson. 4. Virtual interactions will replace face-to-face field visits. Right now, Skype, web conferencing, and video are quickly catching on over face-to-face visits and traditional meetings in other industries. Tele-consult- ing or tele-medicine is common. If doctors prefer to see patients online, what are the chances he / she will Salil Kallianpur | Is Indian Pharma Future-Ready? “ ” In the West today about 85% of buyer- seller interactions happen online through social media and video. Customers will not need a field salesperson to come on-site as regularly as they do today.
16 | MedicinMan April 2014 want to see a sales rep in person? 5. With India moving towards Universal Health Cov- erage, doctors will no longer be the decision-makers. We will be up against non-medical decision-makers who may be tele-commuters or technologically savvy people. 6. It is only a matter of time before healthcare provid- ers would start prescribing mHealth apps as soon as they prove to be as or more effective than prescrip- tion drugs. So if your most important customers today (doctors) are not going to be the most important customers tomorrow, how well are we prepared to deal with non-medical people who are more clued on to technology and seek information from the internet, intranets, online groups, social media, patient activist groups etc? If doctors choose to decrease person- al interaction and seek information, diagnosis and treatment remotely, what impact will that have on the current model? Maintaining ongoing commercial operations, as it has been managed over the last decades, is economically unsustainable. Pharmaceutical companies must adapt to a new environment, which is more demanding than ever before. They must adopt lower cost models across the whole value chain and improve productivi- ty and efficiency in their commercial approaches. Dis- passionately analyzed, almost every“innovation”that we hear about in the industry is merely a tweak of the existing business and / or model. For an industry that has made colossal investment into research, pharma is uncharacteristically risk-averse when it comes to the changes coming in health technology. None of the changes mentioned above essentially threaten the fundamentals of the current model. The pharmaceutical business, in India, will continue to be a B-2-B model for the foreseeable future. However, customer needs and wants will evolve as technology adoption spreads. Patients who have more access to trustworthy information will seek to participate in decisions pertaining to their health while health providers will work to predict and prevent illness to contain costs. These developments create exciting opportunities for pharma marketers to differentiate and deliver value. The more creatively and effectively they do it, the better. -SK Salil Kallianpur is Commercial Head - Classic Brands Center of Excellence, GSK. He is a well-known pharma blogger and social media enthusiast. salilkallianpur.wordpress.com Salil Kallianpur | Is Indian Pharma Future-Ready? “ ” If your most important customers today (doctors) are not going to be the most important customers tomorrow, how well are we prepared to deal with non-medical people who are more clued on to technology and seek information from the internet, intranets, online groups, social media, patient activist groups etc?
17 | MedicinMan April 2014 I n Munnabhai MBBS, Boman Irani, as Dean of a Medical College, tells medical students on their first day, that doctors need to be clinical. He meant that as a doctor one cannot be too close to a patient as this can reduce objectivity and come in the way of sound clinical deci- sion-making. So what does clinical mean? The concise Oxford dictionary puts it as being coldly detached, dispas- sionate, and objective. Etymologically, it is derived from the Greek word,‘klinikos’, meaning bed or the bedside of the patient. Against this backdrop, one can’t help but reflect on the current media rhetoric surrounding the way clinical trials are being conducted in the country. I am not for a mo- ment discounting all that is being showcased but I would like to see this balanced with data. In any field, there will always be good and bad apples. One swallow does not a summer make. Similarly, a few bad apples should not spoil the entire basket. Before tainting and distorting reality let’s put the facts on the table and then decide. The word,‘trial’itself means an experiment. A participant (not a subject as no one is being subjected to the experi- ment) is one who is informed of everything that participa- tion in the clinical trial entails, and only after s/he has fully comprehended, and checked with his/her family doctor and relatives, is s/he expected to consent. Of his/her own volition, understanding that participation involves pos- sible risk and possible benefit, so as long as one believes that the benefit is worth the risk, one willingly partici- pates. It is this altruistic motive which makes a participant a hero. Not a guinea pig. A“guinea pig”is a misnomer as the animal is neither a pig (it is a rodent), nor from Guinea (from the Andes moun- tains). Even if one wishes to do a trial on animals, one needs to have permission from an ethics committee which Dr. Viraj Suvarna E TRIALBYFIREClinical trials in India have come under a lot of fire recently from civil society and the media. While there is no doubt an element of risk involved, much rhetoric has muddied the water of what exactly is at stake. Dr. Viraj Suvarna is Medical Director, Boehringer Ingelheim India Private Limited.
Dr. Viraj Suvarna | Trial by Fire 18 | MedicinMan April 2014 oversees research on animals. Those who feel that clinical trial participants are simply made to sign an informed consent document need to witness the process. A patient or participant information leaflet, written in a language that the participant can understand, is first explained to the participant in his/her own language. All queries that the participant may have are addressed by the principal and principled investigator/delegate. The informed con- sent form is also explained similarly. Innovative methods could include use of a speaking book which talks to the participant, the way books for children are designed, of what s/he is getting into when being part of a clinical trial. One could also think of using an iPad and make the partic- ipant see for himself/herself exactly what the participant will need to go through from beginning to end of the clinical trial. This way the participant sees himself/herself going through all steps of the trial, and only after the process has been explained does the participant make his/her decision. No force, no incentive. Vulnerable pop- ulations are not selected. Those who cannot make their own decisions are provided with assistance. Functionally literate participants may also be recruited with due legal precautions (impartial witness) being adhered to. Ethics committee members can and do oversee the process, and can do random spot checks. Video-recording of the pro- cess, with protection of the participant’s confidentiality, is another suggestion. As a sponsor of the trial, investigator selection is para- mount. Training is meticulously done. Regular oversight by a clinical research associate, quality standards person, and auditor follows. Inspection by a regulatory authority is also done, even by the US FDA and/or the EMEA as data from global trials, involving patients in India, is a part of global regulatory dossiers. The Drugs Controller General of India (DCGI)’s office now refers global clinical trial applications to the New Drugs Approval Committee (NDAC), comprising academic experts from the respective therapeutic area and pharma- cology. Going forward, the DCGI will ensure that contract research organizations, ethics committees, and sites are accredited. The serious players in clinical research will sur- vive while the fly by night operators will be weeded out. In short, there are enough checks and balances from all“participants”in clinical trials, each of whom has an equal responsibility towards the ultimate participant, the patient. Since 1994-95, global clinical trials have been placed in India by multinational ethical research-based corporations and the quality and ethical standard, viz.,‘Good Clinical “ ” There are enough checks and balances from all “participants” in clinical trials, each of whom has an equal responsibility towards the ultimate participant, the patient.
Dr. Viraj Suvarna | Trial by Fire 19 | MedicinMan April 2014 Research Practice’, is rigorously followed across the globe. Even if locally applicable regulatory requirements are relatively lax in some countries, the MNC’s Standard Op- erating Procedures, which are stricter than any regulatory standard, are adhered to. It is a myth to think that trials in India are cheaper. In fact because this is an out of pocket market where most have to pay for their healthcare related expenses, and very few are reimbursed, sponsors have to spend much more per patient, having to pay for all laboratory tests and diagnos- tic procedures. It is incorrect that India is being used as the destination for global clinical trials. The number of trials being placed in India and the number of participants from India in glob- al trials is decreasing, and more trials are being placed in China, Korea, other Asian countries, Central and Eastern Europe, and Latin America among the merging markets. At any point in time, the participant can withdraw from the trial without any problem or reason given. If an adverse event is experienced, the care of the participant is borne by the sponsor at no cost to the participant or institute. If the event is serious or results in death as an outcome, and is judged, to be related to the trial or drug tested in the trial, by the investigator and confirmed by the ethics committee, the same is compensable, though ideally the relatedness should be in agreement with the sponsor. This does not happen in many developed mar- kets where one has to claim for compensation. In India, the clause for compensation is included in the informed consent document. A formula for the same has also been proposed recently. It is only to be fervently hoped that this process is not misused. In what are called,“outcome trials”, death or a serious adverse event is an endpoint, i.e., a point at which the trial for that patient has ended. Naturally in such trials many such events are anticipated. However, such trials are also important as approving a new drug, only based on softer endpoints, e.g., blood pressure or HbA1c reductions, are not enough in the long run, as has been repeatedly seen with some drugs, which had to be withdrawn from the market later. Rarely is a new drug compared to a placebo. The placebo is almost always used as an add on to standard therapy in both arms, which makes it that much more difficult for a new drug to demonstrate efficacy, but in the interest of patient safety this is the preferred way of evaluating a new drug, even if this means many promising molecules may fall by the way side. When so much is happening in the right direction, why “ ” It is incorrect to say that India is being used as the destination for global clinical trials. The number of trials being placed in India and the number of participants from India in global trials is decreasing, and more trials are being placed in China, Korea, other Asian countries, Central and Eastern Europe, and Latin America among the merging markets.
Dr. Viraj Suvarna | Trial by Fire 20 | MedicinMan April 2014 are we not looking at the full picture before passing judg- ment on the way clinical trials are being conducted in In- dia? Why are we not considering the tremendous benefits that accrue to clinical trial participants, doctors, institutes and society at large, besides of course the foreign direct investment inflow into the country? In many oncology trials the participants avail of the drug even after the trial is over, for the life of the participant, till disease progress- es or the participant cannot tolerate the drug. Why are we not thinking of the development of clinical research (CR) in the country that this will stimulate? When doctors are investigators in good clinical research practice it also helps them be better doctors in clinical practice. Sponsors may draft protocols but it is doctors who ultimately review, make changes, and finally approve the document after the protocol development meeting. It is the doctor’s patients whose data enters case report forms from source documents. It is this data that gets into the database, gets analyzed, and then included in the final study report. Only when all investigators are in agreement with the statistical analysis plan, analysis and report, does the report get signed after the end of study meeting. From the report is written the manuscript and again only after all the doctors, who participated in the trial, review and approve the content, does it get submitted to a peer-reviewed journal and finally published. Even negative trial results are published. Data Safety Mon- itoring Boards and Data Steering Committees, indepen- dent of the sponsor, can do interim analyses and decide on premature stopping of a trial based on futility, over- whelming efficacy or unacceptable safety in one arm. It begs the question,“whose trial is it anyway?”It is really a sponsor’s trial? Or is it an experiment in which all stakeholders own and share equal responsibility? Let us all exhort ourselves to remember this and do our duty diligently. We owe it to all our participants whose altruistic motive has helped advance medical science and enabled many more patients and their loved ones benefit from their participation. Credibility begins with CR (Clinical Research). -VS Disclaimer: These are thoughts of the writer, in his personal capacity, and not as an employee of Boehringer Ingelheim India Private Limited. “ ” When so much is happening in the right direction, why are we not looking at the full picture before passing judgment on the way clinical trials are being conducted in India? Why are we not considering the tremendous benefits that accrue to clinical trial participants, doctors, institutes and society at large, besides of course the foreign direct investment inflow into the country?
Special Feature Abdul Basit Khan Ajay Kumar Dua Amlesh Ranjan Amrutha Bhavthankar Andris A. Zoltners Anthony Lobo Aparna Sharma Arvind Nair Atish Mukherjee B. Ramanathan Chayya Sankath Craig Dixon Devanand Chenuri Venkat Dinesh Chindarkar Dr. Amit Dang Dr. Aniruddha Malpani Dr. Hemant Mittal Dr. Neelesh Bhandari Dr. S. Srinivasan Dr. Shalini Ratan Dr. Surinder Kumar Sharma Dr. Ulhas Ganu Geetha G H H. J. Badrinarayana Hakeem Adebiyi Hanno Wolfram Hitendra Kansal Iyer Gopalkrishna Jasvinder Singh Banga Javed Shaikh Jitendra Singh John Gwillim Jolly Mathews Joshua Mensch K Hariram K. Satya Mahesh Ken Boyce Mahendra Rai Mala Raj Manoj Kumar Mayank Saigal Milan Sinha Mohan Lal Gupta Neelesh Bhandari Neha Ansa Nishkarsh Likhar Noumaan Qureshi Parveen Gandhi Pinaki Ghosh PK Sinha Prabhakar Shetty Vivek Hattangadi Rachana Narayan Rajesh Rangarajan Ralph Boyce Renie McClay Richa Goyel Richard Ilsley RM Saravanan Sagar S. Pawar Salil Kallianpur Salil Kallianpur Sally E. Lorimer Sandhya Pramanik Sanjay Munshi Shafaq Shaikh Shalini Ratan Sharad Virmani Shiv Bhasin Spring Sudhakar Subba Rao Chaganti Sudhakar Madhavan Tony O’Connor V. Srinivasan Varadharajan K. Vijaya Shetty Vishal V. Bhaiyya Vishal Verma Vivek Hattangadi William Fernandez Our Authors MEDICINMAN invites contributions from Pharma professionals on topics related to Field Force Excellence. See: www.medicinman.net/author-guidelines for more information. Sudhirda, as Sudhir Ganguly is fondly called, bids adieu to Pfizer. Working for one company for 42 years must be something of a record in Pfizer worldwide and perhaps in the industry too. As Partha Ghosh put it, in 60 years of his life, Sudhirda spent only 18 years outside Pfizer! He was a boyish 18-year-old graduate when he joined Pfizer in October 1971 as a sales representative. His first posting was in Kakinada on the Andhra coast where he found himself to be the only Bengali in town. It was the first among many challenges that saw floods, wars, boy- cotts…and, on the personal front, cancer at the fag end of a rewarding career. He faced each challenge with poise. In Kakinada, he learned Telugu to converse with his customers in their language. You could never find him complaining, colleagues aver. He never thought of leaving Pfizer as the company offered him a learning experience he thought no one else could give. He picked on new colleagues' positive attributes, showing how they could use their strengths to achieve things they did not think possible. As the head of field force training he groomed several hun- dreds of sales colleagues who are grateful to him not only for teaching them how to sell, but how to be exemplars of integrity, professionalism and – something that he finds erod- ing today – connecting with fellow colleagues at a personal – familial, social, human -- level. Many of the photos in the audio visual screened at the farewell showed him with sales colleagues and their family members who all belonged to a larger, extended Pfizer family. His colleagues have a wealth of anecdotes that reveal the person and also take you to the times and towns of yester -years. Colleagues gave him an emotional farewell at the HO cafeteria on October 23. 42YEARSATPFIZER! E
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