Category Archives: Big Pharma

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

Do you have a story to be shared with the world, but need to be anonymous, then write to us at impasinfo@gmail.com

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The Modi effect in Cadila Pharma: Ex-employee went hammer & tongs on LinkenIn

We would have heard about employee’s rift with the company’s section head, employees ranting about their bosses or employees dissatisfaction over the company or an abusive employer etc. during a tea break or most commonly in a smoke room. But what happened a few days back was a bit surprising and it’s like straight out of a movie scene.

Mr Mukund Trivedy, Vice President – Corporate Communications, Cadila Pharmaceuticals expressed his displeasure over the company’s CMD, Mr Rajiv Modi’s work attitude and the company’s work culture along with this way of quitting his job during a board meeting on LinkedIn. You can read about his post and discussion below.

Click here for Mukund Trivedy’s post & discussion.

Rajiv Modi – CMD, Cadila Pharmaceuticals

Yesterday Cadila Pharmaceuticals came up with a press explanation and had expressed their intention to file a case against Mukund Trivedy, for which he is yet to respond.

Also check out the stock status of Cadila (August 22, 2017, 9:568 AM IST).

A loss of a good employee can sometimes be costly for a company either directly or indirectly

Loss of a good employee can sometimes be costly for a  company either directly or indirectly

Our opinion on this:

The bold attitude of Mukund Trivedy is laudable. It needs a lot of grit to stand up for one’s own dignity. But there is always a thin line between being bold and silly. This frustration or anger of Mukund Trivedy could have been due to a long suppressed/ un-vented emotion which burst out during a meeting.

What could have been done is, either to write a legal complaint about the company head’s attitude to employees grievance cell or anything similar available under the legal purview or talk head to head with the employer responsible for this (anyways there was  an intention to quit the company). But when we think this from his shoes, we feel sorry for Mukund Trivedy.

Comment your thoughts below about this issue.

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A curious case of “Medzol clone”

Originally trademarked by Themis (Mumbai Based Company) for Midazolam since 2012. Recently a pune based company named Medtab Pharma, released its product pantoprazole in the same name: Medzol (Med – MEDtab pharma | Zol – PantopraZOLe). This created a big ruffle on the social media. And based on our group discuss we concluded this to be photoshopped which was proven wrong by an order released from Directorate of FDA, Goa saying that both the medications are different and people in health care sectors should be careful about this. (https://drive.google.com/…/0BwEuX8U-TTgCRUhELVNETWdHRDA/view)

Recently, based on mail exchanges (Screen Shots attached below) we came to know the actual truth. Themis had asked Medtab pharma to withdraw the product from public use for which Medtab pharma agreed.

This once again reveals how lethargic and not-focused our Indian drug regulators are.

Share this and spread the message!

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Solanezumab | Tested for Alzheimer’s disease | has failed in the final phase of clinical trials

Solanezumab, has failed in the final phase of clinical trials. If it had succeeded, it had the potential to be a blockbuster drug.

Mechanism of Solanezumab

Mechanism of Solanezumab

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“Risk Based Inspection” by DCGI made the Pharma Biggies to land up in a soup

Risk Based Inspection” by the Indian drug regulator, DCGI brought the pharma biggies under limelight, but for a wrong reason. Pharma majors like Cipla , Pfizer are being inspected for allegedly selling poor quality medicines and noncompliance to manufacturing norms.

This is a first of such kind of inspection, where 200 companies are being inspected among which 36 from Tamil nadu, Maharashtra, Uttarakhand and Himachal Pradesh have been inspected.

This is not the first time that these biggies are coming under the lens of a drug regulator. Last year Sun Pharma and Dr.Reddy’s were among 7 companies for which US-FDA issued a warning letter on concerns for poor manufacturing practices. Read more about this news here.

Last year Govt. of India had framed few regulatory pathway to assist pharma companies mainly to facilitate speedy approvals, while bringing in transparency, accountability and predictability.

Also read about US-FDA risk based inspections herehere…& here.

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Cipla – Nacimbio tag upfor HIV/HepB drug innovation & Manufacturing

Cipla tied up with a Russian major_ Nacimbio to collaborate on HIV and Hepatitis C drugs.The companies have inked a Memorandum of Understanding on innovative antiviral medical products for HIV and Hepatitis C treatment and on technology transfer and active pharmaceutical ingredients (API) manufacturing.

Read more about it here.

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Novartis Biotechnology Leadership Camp 2016

The Novartis BioCamp India will be held at Hyderabad on July 17-20,2016

BioCamp is a pioneering seminar organised by Novartis that brings talented students from diverse faculties and different universities closer to the pharmaceutical industry. The programme is open to postgraduate students and young researchers in natural sciences, medicine, biotechnology, bio-informatics, pharmacy, business administration or law (specialization in Intellectual Property Rights) interested in pursuing a career in the pharmaceutical/biotechnology industry

At BioCamp, 50 students will have the opportunity to interact with leading experts in the pharmaceutical/biotech fields, learn about breakthrough medicines to address patients unmet medical needs, understand trends and challenges in the pharmaceutical sector, receive first-hand experience about starting and running a biotech company, explore career opportunities in the pharmaceutical and biotech industries and network with talented students from other universities.

Selection to BioCamp is based on academic excellence and extracurricular activities. Winning three students will be sent on an all expenses paid trip to participate at the International BioCamp taking place in Basel, Switzerland which brings together 60 selected top students from science, information technology and business universities from around the world.

The Novartis International BioCamp is a pioneering three-day seminar that brings the biotechnology sector closer to talented students from top universities around the world. Held at Novartis International Headquarters in Basel, Switzerland, the program offers participants an opportunity to:

  • Interact with key Novartis scientists who lead our unique approach to drug discovery
  • Learn about breakthrough new medicines to address patients’ unmet medical needs
  • Understand trends and challenges in the biotechnology sector
  • Receive first-hand experience about starting and running a biotech company
  • Explore career opportunities in the healthcare and biotech industries
  • Network with talented students from other countries and get in touch with Novartis associates

As the online test for the shortlisted candidates,to participate in BioCamp-India, are over and the results are awaited, we will give you a glimpse of the previous BioCamp events and also our exclusive interview with the previous winners.

For More information check their website. Also check out the BioCamp 2015 video here.

 

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Indian CRO_Semler, Fiddle with trial data: US FDA

On April 20, 2016, the United States Food and Drug Administration’s (FDA or Agency) Notification (FDA Notification) to Pharmaceutical Companies that used Indian contract research organization (CRO) Semler Research Private Limited (Semler or Company) for conducting clinical and bioanalytical studies revealed that the studies are unacceptable due to data integrity concerns.

The FDA Notification also revealed that the Company’s bioanalytical facility was the subject of an inspection by the FDA during September 29, 2015 and October 9, 2015 that resulted in an Untitled Letter on April 19, 2016. The primary focus of the Form 483 and Untitled Letter are data integrity and controls over computer systems and records. These concerns were not limited to the FDA as the April 12, 2016 Notice of Concern (NoC) issued by the World Health Organization’s (WHO) Prequalification Team (PQT) reveals similar good clinical practices (GCP) and good laboratory practices (GLP) deficiencies.

In comparison to the FDA’s Form 483 and Untitled Letter, the WHO’s NoC identifies the products approved and pending approval under the Prequalification program that are implicated by the data integrity issues as well as alleges Semler engaged in organizational fraud at various levels of the organization

Check out these FDA notification to Pharma companies here. Also check out the FDA’s letter to Semler here. Read about the full story here.

 

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Top 25 drugs of High revenue | 2015

The prescription drugs market includes a large number of formulation products that address a diverse array of therapeutic requirements. Prescription drugs have life-cycle that is distinguished by high sales revenues during the patent-protected period. The parent companies invest in sales and marketing of the products to maximize their return on investment on research and development. The sales usually rapidly taper-off after patent expiry, as the products are exposed to competition from generics and biosimilars.

The global prescription drugs market was estimated to be USD 1,114 billion in 2015. A list of top-25 prescription drugs products based on sales revenues was collated using the reported revenues of the parent companies. These 25 drugs are marketed by 19 companies, that are the leading players in the pharmaceutical industry. The combined revenues of the top-25 drugs in this market together accounted for close to 15% of the global sales revenues of prescription drugs in 2015. Furthermore, these 25 drugs were also had a remarkably narrow scope of treatment profiles. Most drugs in the list are primarily for the treatment and management of cancer, diabetes, inflammatory disorders, and HIV or HCV infections.

Check out their list here.

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Top 10 pharma companies of world based on 2015 revenue!

Which one is your favourite? 😉

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A love spat between ex-employees of GVK biosciences opened up a can of worms which kept the biggie’s reputation at stake

In a special report, The Hindu reports on how a love affair between two staffers of GVK Biosciences – one of the largest Contract Research Organisations based in Hyderabad – spiralled into a blow for the company’s business. “A torrid love affair between two employees resulted in the international scrutiny of GVK Biosciences and a ban on marketing of around 700 generic drugs tested by the facility,” says this report.

Read about the fall in stocks and closure of trading here.

What did Dr.G.N.Singh mean when he stated “Having said that, one must understand that there is a bigger game being played out here” to an interview by Hindu?

What’s your comment on this?

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A curious Case of Turing Pharmaceuticals & Daraprim

Martin Shkreli (CEO of Turing Pharma): “I’m not affected by the anger. I don’t think much about the wider world. I work with my patients.”

Photograph: The Gaurdian

 

Read what “The Guardian” had published: Click

Beyond the Curious case of Turing pharmaceuticals and Daraprim (Pyremethamine) lies a fact how economical to get this drug in India. Check the prices here.

P.S: Also an example of non-cancer use of Leucovorin or Citrovorum Factor or Folinic Acid as a rescue agent. The high does of Sulfadoxine and Pyrimethamine in cases of immunocompromised patients infected with T.gondii demands a “Rescue”!

Read More about Daraprim here.

Dr.Arun Kumar: CEO of ADR-Plexus-A PG Entrance coaching institute, posted on his on this facebook wall:

Pyrimethamine is given for following diseases
1. In combination with a long-acting sulfonamide such as sulfadiazine, it is used for Plasmodium falciparum malaria
2. Actinomycosis
3. Isosporiasis
4. Pneumocystis jirovecii
5. Toxoplasmosis
Trade Name for Pyrimethamine is Daraprim . There are many shared post in facebook portraying Martin Shkreli as a Villain and worst businessman who escalated the price of the drug which is being used for treating toxoplasmosis in AIDS Patients . ….
But No One knew the hidden truth behind the sudden rise in price of this drug ….
Pyrimethamine is actually a novel drug and In 2011, a new research found out that pyrimethamine can increase ß-hexosaminidase activity, which helps in slowing down the progression of late-onset Tay–Sachs disease.
A series of clinical trials was initiated by many scientist to find out the beneficial role of Pyrimethamine in amyotrophic lateral sclerosis ….Oh yes You Guys Got it….It is the same disease for which you shared ICE BUCKET CHALLENGE ….. Very soon you can expect the approval of FDA for the use of pyrimethamine in ALS…
Guess what will happen in coming years…….Pyrimethamine rates will escalate to 5,00,000 rupees from existing Rs 49,500.
A research which is made inaccessible for Mankind is worth for nothing.

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