Monthly Archives: December 2017

Experiences of a rookie Field Based Medical Advisor (FBMA) | Guest Blog

From Pharmacology to FBMA: The Twisted Journey

A scene I come across almost every time after the exchange of basic pleasantries in a flight during a business trip!

Stranger: Hey! what do you do?

Me: I am a doctor! 

Stranger (with awe and respect): Oh great! So what do you specialize in?

Me: I am a Pharmacologist

Stranger: What is that???

Stranger (now with confusion): Do you work in a chemist shop? 

When this kind of a question comes from a person of a non-medical background, it seems very hard to explain, but fair enough. It doesn’t really hurt. But then there are days when this stranger, despite being from a similar background will stare at you as if ‘how can you call yourself a doctor? You don’t even see patients!’

So, this is my life. I completed my MD last year in the field of Pharmacology. Now it may come as a surprise to many people that I chose this subject over my available options of choosing a medical/surgical or so-called the clinical fields. But why would I ever do that? Who will ever choose pharmacology or for that matter any para-clinical or a preclinical field by choice? It is always taken up when there are no choices left!! After all, growing up, the image of a doctor has always been that of seeing patients. And I can say that now, after being in the industry, it is easy to argue a concept or an understanding or even a choice, but it Is hard to change the inherent beliefs. So, it wasn’t easy taking up a subject and telling the world, that yes I wanted to be a doctor and I even am, but I don’t want to see patients

Now the PG days, being a student, in this field are really not very interesting. I don’t know about others, but mine was mostly regular, very boring 9 to 5 college days where you read, take classes and just mind your own business. But, God was kind and I still had an awesome hostel life to look forward to, every day.

So in the hospital, when I used to accidentally bump into a batchmate, the first question used to be ‘ what are you doing in the hospital?’  And to be truthful, the only time I used to go there was while working on my thesis, doing audits, collecting ADRs or simply having coffee. All these words are not exactly what someone would call interesting, unless obviously, one understands the gravity of these small tasks, which to be very frank, as of now, still seems way too far ahead of us.  While I worked on my thesis, my clinical batch mates used to envy me. Because I was never tired, never a person dreading a 24-hour duty, never missing out on a holiday. I always had my plans ready, mapped out for the entire month.

In our department, we had the usual stuff. By usual I mean, when people don’t want to do much work, people who take this subject to have a chilled out life and like to gossip. But to give enough credit to my college, I was fortunate that we used to have plenty of seminars and journal clubs. Now when I look back and think of the way I critically appraised the journal articles, it seems very childish. But they laid the very foundation of where I never knew my life was going to start.

So, now we come to the advantage of being a pharmacologist. At the end of 3 years, when people were searching for jobs, I already had one in my hand, even before my exams. Fortunately, there are plenty of jobs available for a pharmacologist. The question is what all? Well, there is a whole spectrum of jobs that one can take (which is beyond the scope of my current topic of discussion), though most easily available and the toughest among them is that of a field-based medical advisor (FBMA). So, yes, I became one too!

Here is the beginning of a journey which is poles apart from that of a post-graduate life. Why so? because technically, the job profile of an FBMA isn’t exactly structured in our country. It sounds glorious when you enter with huge hopes in the industry and you are told that you have to handle an entire region by yourself. But simply put, you just do what is the need of the hour in your area as per the requirement of your sales colleagues or as decided by the marketing team. This can be a full range of things, from waiting outside a chamber for hours doing nothing to just getting on stage to introduce to the speakers, to being a ghost writer or just sitting and preparing slides for which you will never get the credit and then occasionally conducting small-scale meetings. This added to the fact that one doesn’t have a fixed routine and plus one has to travel to really small places sometimes, can be frustrating. It won’t be wrong when I say, that I get more emergencies than my father. Sometimes, the doctor gets a doubt suddenly just before a meeting, sometimes a slide set or an article is needed within 24 hours. Whatever be it, I have to be available, always.

These feelings will be echoed by many people in the same field. They are right too. So there came a time when I had to tell someone what this job means to me. To be very fair, this is just my perception on the take of things and anyone may agree to disagree.

It has been one and a half year since I have worked as an FBMA and  I know how much I have grown in terms of my knowledge and as a person.

When I started with my induction, I had to learn everything about the molecule and the disease in a month! This along, with the working formats of any corporate, like using outlook, was a huge challenge for a person like me. I found it next to impossible, but I tried my best. With the help of my Head office based colleagues and an excellent mentor I would say, I managed fairly well. That was the first time I realized how much I am capable of pushing myself at every stage in life. After PG entrances, this was the first time I did it again.

After my induction (which was not even a full month), I came back to handle my region. New people, new faces and with no clue what is the next step, I felt like I had been thrown into the turbulent waters without a life jacket. So here was where I started fighting my battles, which are invisible to the outside world

The simplest and the most important role of an FBMA is to conduct meetings to discuss the scientific data on the relevant subject and molecules in question in an unbiased manner. So, I was naturally very frightened and nervous during my first meeting, wondering what questions will be thrown at me. But when I finally spoke in front of the doctors, most of them actually did not bother listening. This was my first battle. To figure out how to make people listen. Trust me, I have been trying to decode the formula since then, but at least, I knew where to work on myself now. This is when I learnt and concentrated on the art of presenting. Somehow I never bothered about it in college. But here it mattered! I read many books, I learnt a lot. So when people say that why are  FBMAs only taking small meetings, I am happy to say that it is needed. It is always better to start from basics and learn along the way. So then why do clinicians get to talk at big meetings? Because they also started from stage zero! We just weren’t there to witness it.  At that point, they were new too! Today at whatever stage they are, it is either because they have their experience visible as grey hair or they have the power to influence or capture the audience. They may not be good with statistics, but they are good with science!

I can be there too! Not today, but someday! There is enough for everyone in this world.  So, I learnt that insecurity about how small your work is just a mirror image of how small your thought process is. Gradually my meetings improved and I liked them more. They are still not perfect, but I am walking down that path, every day.

Then came the most dreadful part, the field visits! Imagine being a doctor and waiting outside another doctor’s office for hours with your sales colleagues and then your batch mate passes by and gives that derogatory look that says ‘you have to sit like a medical representative! see this is the difference between a real doctor and you’.  Strangely, I am a tough nut to crack, so it never bothered me. I have spent those hours, teaching science to my colleagues and learning sales tactics from them in return. For all what we may say, the world is run by sales, which may appear harsh but it is true. I learnt how my colleagues deal with things when they go wrong with customers, when the competition grows and when targets need to be reached. I realized I was happy, not being in their place. So, I learnt humility and I felt blessed.

Inside the chambers, my experiences have been widely different. Some people have been kind and really fair and insightful, some haven’t bothered much to talk. This was the first time I learnt how many types of people there can be! I listened to their version of current scenario of the medical profession, of the fears of litigation, of the over-hyped trials by media. There again, came the feeling, I felt blessed! I didn’t want to be on the other side of the table. I got reminded of a very simple saying which I had learnt from my childhood days ‘the grass is always greener on the other side’. So, I am not a person who feels that I ever made the wrong decision.

Apart from meetings or field visits, how else do I spend my time? After all, I don’t have an office to go to every day. So I may as well sleep till late and enjoy. That’s what the world would like to believe. I can’t keep an account of how many queries I answer, how much time I spend running here and there, or how much time I spend planning my month, just to see it get devastated by some new thing that might come up. But this is what a true test is! Isn’t it?  Push yourself every day because you love the work, without the need of incentives or any acknowledgements.  Be persistent, learn to adapt, face new challenges every day and be patient when things go wrong.

One year back, the doctors didn’t know me by my name. Today, they call me directly. They want me to present. They discuss cases. It may seem like a petty thing for a third person. But I feel like I make a difference. I matter.

In a money-driven industry, where science is hard to sell, this evolutionary role of a medical advisor may just be the foundation of a changing health industry. Criticizing a role, a job or any subject is way too easy, what is tough, is having the knack to learn from what you have at every step in your life. From a ‘Field Based Medical Advisor’  to an imperative role of being the ‘Fundamental basis of Medical affairs’; You are what you believe yourself to be’ – Paulo Coelho

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Platelet Rich Plasma (PRP) to treat Diabetic Foot Ulcers

Diabetes Mellitus (DM) is a disease which spares no tissue in the human body. While the big pharma has always been focused on small molecules (drugs) for curing the symptoms, the underlying pathology remains unattended. This puts the tissues under constant oxidative stress. The most vulnerable ones are the vascular and the neural tissue. Due to the accumulation of the advanced glycation end products and few other pro-oxidative products, the vascular endothelium and supplying nerve cells go for apoptosis. The end result leads to micro & macrovascular complications of diabetes. In this article, I am going to focus exclusively on diabetic foot ulcer (DFU).

DM is one of the leading cause of non-traumatic lower extremity amputation. Foot ulcers and infections are also a major source of morbidity in individuals with DM. The reasons for the increased incidence of these disorders in DM involve the interaction of several pathogenic factors: neuropathy, abnormal foot biomechanics, Peripheral Artery Disease (PAD), and poor wound healing. The peripheral sensory neuropathy interferes with normal protective mechanisms and allows the patient to sustain major or repeated minor trauma to the foot, often without the knowledge of the injury. Disordered proprioception causes abnormal weight bearing while walking and subsequent formation of callus or ulceration. Motor and sensory neuropathy lead to abnormal foot muscle mechanics and to structural changes in the foot (hammertoe, claw toe deformity, prominent metatarsal heads, Charcot joint). Autonomic neuropathy results in anhidrosis and altered superficial blood flow in the foot, which promotes drying of the skin and fissure formation. PAD and poor wound healing impede resolution of minor breaks in the skin, allowing them to enlarge and to become infected.

Approximately 15% of individuals with type 2 DM develop a foot ulcer (great toe or Metatarsal Phalangeal (MTP) areas are most common), and a significant subset will ultimately undergo amputation (14–24% risk with that ulcer or subsequent ulceration). Risk factors for DFU or amputation include: male sex, diabetes >10 years’ duration, peripheral neuropathy, abnormal structure of foot (bony abnormalities, callus, and thickened nails), PAD, smoking, history of previous ulcer or amputation and poor glycemic control. Large calluses are often precursors to or overlie ulcerations.

In a healthy individual, wound healing progresses through three sequential stages: the inflammatory phase which lasts three to five days, the proliferative phase lasting approximately two weeks, and the remodelling phase which can last from several weeks to several months, depending on the wound. Just prior to inflammation, a fibrin clot forms at the site of the wound site to provide hemostasis. Leukocyte infiltration is the hallmark of the inflammatory phase, whereby polymorphonuclear cells (PMNs) arrive to remove bacteria. Macrophages then follow and become the predominant cell by day two. Their function is antigen presentation, phagocytosis and release of various growth factors and cytokines. It is during this stage that granulation tissue formation begins. Around day three of the wound, fibroblasts begin to enter. This marks the beginning of the proliferative phase. The hallmark of this phase includes angiogenesis (neovascularization), re-epithelialization and extracellular matrix (ECM) formation. Immature type III collagen and fibronectin are deposited and make up the ECM. This highly integrated process is mediated by various growth factors and cytokines. The remodelling phase begins when the rate of collagen degradation and deposition equalize. This is characterized by continued collagen remodelling, from type III to mature type I collagen, and cross-linking within the ECM. In patients with diabetes, wounds remain stuck in the inflammatory phase. Neutrophils and macrophages continue to release inflammatory mediators. The critical balance between the proteases and their inhibitors is disturbed, preventing collagen remodelling and ECM formation. Certain functions of neutrophils and macrophages are inherently altered in diabetes, including cell adherence, chemotaxis, phagocytosis, and cytokine production and secretion. In addition, fibroblasts and keratinocytes display decreased response to growth factors, decreased migratory ability, and increased apoptosis.

The optimal therapy for DFU and amputations is prevention through identification of high-risk patients, education of the patient, and the institution of measures to prevent ulceration. High-risk patients should be identified during the routine foot examination performed on all patients with DM. Patients at high risk for ulceration or amputation may benefit from evaluation by a foot care specialist. Attention to other risk factors for vascular disease (smoking, dyslipidemia, and hypertension) and improved glycemic control are also important.

Despite preventive measures, foot ulceration and infection are common and represent a serious problem. Due to the multifactorial pathogenesis of lower extremity ulcers, management of these lesions is multidisciplinary and often demands expertise in orthopaedics, vascular surgery, endocrinology, podiatry, and infectious diseases. The plantar surface of the foot is the most common site of ulceration. Ulcers may be primarily neuropathic (no accompanying infection) or may have surrounding cellulitis or osteomyelitis. A growing number of possible treatments for diabetic foot ulcers exist, but they have yet to demonstrate clear efficacy in prospective, controlled trials. A consensus statement from the ADA identified six interventions with demonstrated efficacy in diabetic foot wounds: (1) off-loading, (2) debridement, (3) wound dressings, (4) appropriate use of antibiotics, (5) revascularization, and (6) limited amputation. Amputation of the foot is 15 times more common in diabetics than in the general population. The male: female ratio among amputees is 30:1 among nondiabetics compared to 2:1 in diabetics. Nearly 20 percent of hospital admissions of diabetics is with problems of the foot. These problems are beset with prolonged suffering, crippling disability and loss of life.

The conventional treatments of diabetic foot ulcers are costly and often require patients to be hospitalized for long periods of time, thus representing a huge burden on any health care system. The use of autologous platelet-rich plasma (PRP), which is rich in multiple growth factors, may bear some similarities to the natural wound healing process. Various growth factors, including platelet-derived growth factor (PDGF), transforming growth factor (TGF), vascular endothelial growth factor (VEGF), and insulin-like growth factor (IGF), are secreted from the α-granules of concentrated platelets activated by aggregation inducers. These factors are known to regulate processes including cell migration, attachment, proliferation and differentiation, and promote extracellular matrix (ECM) accumulation by binding to specific cell surface receptors. Due to the presence of high concentrations of these growth factors, PRP has been used in a wide variety of surgical procedures and clinical treatments, including the treatment of problematic wounds and maxillofacial bone defects, cosmetic surgeries and gastrointestinal surgeries.

In the general aspect, the mechanism by which PRP associates with wound healing begins by α-granules degradation. This phenomenon in turn, activates other related growth factors including platelet-derived growth factor (PDGF), vascular endothelial growth factor (VEGF), platelet-derived endothelial growth factor (PDEGF), transforming growth factor ß (TGF-ß), epidermal growth factor (EGF), insulin-like growth factor (IGF), platelet growth factor 4 (PF-4) and interleukin 1 (IL-1). All these mentioned growth factors have been proved to play roles in wound healing process. PRP is also capable of recruiting macrophages due to its chemotaxis properties and act as an anti-infection agent as well. Angiogenesis, the formation of new blood vessels from pre-existing ones mostly occurs in pathological conditions such as tumour growth, corneal neovascularization and psoriasis. On the other hand in physiological conditions, this process is mainly responsible for two main events: wound healing and female reproductive cycle. Although PRP is consists of different growth factors affecting different cells, it seems that one of the possible pathways of its action is through the induction of angiogenesis. In angiogenesis process, VEGF is a strong inducer of angiogenesis that affects proliferation and migration of endothelial cells (ECs) which are two main steps of angiogenesis. Also, VEGF is responsible for induction of other angiogenic factors. Also PDGF, TGF-ß and IGF in PRP are noted as strong angiogenic factors. In this condition, the new vascular branches could provide enough blood supply (both nutritional and oxygenation support) and also are able to remove the dust of wound healing process.

Now, the next question to be asked is, whether PRP production process has any role in the efficacy of healing DFU?

The Answer is Yes!

PRP can either be autologous (by venesection of patients) or allogeneic (pooled platelet from platelet bags available at the blood banks). The efficacy depends on the patient’s age, disease conditions, lifestyle factors, etc. Also, it depends upon the platelet activation process which determines the amount of angiogenic and other growth factors available in the PRP pool for regeneration. There are different ways of degranulating α-granules, which can also be called as activation and can be done by using calcium chloride (Ca-PRP), fetal bovine serum (FBS-PRP), pooled human thrombin (tPRP),  freeze-thaw cycles (FT-PRP), bead mill homogenizer processing (BM-PRP) and many others. Different companies offer various modalities which I am leaving it to the reader’s choice!

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