Beyond Prescriptions: Insights from Dr. Rajmohan Seetharaman (Part-1)

I am a medical physician with a specialization in MD Pharmacology, a field that has gained lots of importance recently due to significant developments in the pharmaceutical industry, for example the way oncology trials have evolved with adaptive designs like Basket and Umbrella Trials.

My decision to pursue MD Pharmacology stemmed from my strong interest in research during my undergraduate years. In my second year, I began working on research projects, and to my surprise, I won a prize in the first conference where I presented my work as an oral paper, despite being an underconfident speaker. This success motivated me further, leading me to receive an ICMR STS grant in my third year, which reinforced my passion for research. In my final year, I founded a Student Research Forum (SRF) with the dean's permission, where I served as the charter president, guiding numerous students in applying for grants and projects.

Therefore, I decided to pursue this field and joined Lokmanya Tilak Medical College Mumbai, where I focused on diabetic nephropathy for my thesis. During my MD, I had the privilege of working on several clinical trials, including a Phase 3 and Phase 4 Clinical Trial and an investigator-initiated trial. I find immense satisfaction in my work, as it allows me to make a difference in a unique way beyond what a conventional physician can achieve.

I have always known that I wanted to make an impact on a larger scale, and research provided the perfect avenue for this. In clinical practice, while you see hundreds or thousands of patients, the scope for significant change at a mass scale is limited. In contrast, research allows you to reach millions of people through your work. For instance, during my thesis i discovered that Metformin, a drug used in diabetes and is Contraindicated in CKD patients with GFR <30 was safely prescribed to CKD patients with GFR 15-30 without any reports of lactic acidosis. I carried out a deep literature review on this topic and published a research letter in the Diabetic Medicine Journal, which could potentially influence the update of US FDA guidelines on metformin use in CKD which has remained the same since 2016.

This kind of opportunity for impact is rare at a junior level in clinical practice but achievable as a junior researcher in MD Pharmacology.

In MD Pharmacology, we primarily focus on theoretical aspects of Pharmacology and Clinical Research, along with some Pre-Clinical Research. However, transitioning into medical affairs allows us to have a broader impact. For example, we can influence the patient journey, especially concerning the accessibility of anti-cancer medications. While these medications may be available in the market, not all patients can afford them, and their accessibility is limited.

In medical affairs, we have the opportunity to increase awareness, improve the patient journey, and assist in providing access to medications, we play a crucial role in disseminating the best evidence to physicians, leveraging real-life experiences to inform pharmaceutical companies. This way, we can contribute significantly more to society than just through research.

In my academic journey, each year, we had to study 3 or 4 subjects, and sometimes we had the freedom to choose which subjects interested us more or less. Although we had to cover all the subjects, some students, including myself, ended up focusing more on one subject than the others. For me, this preference became evident in my undergraduate studies, where I dedicated almost half of my second year to Pharmacology and split the remaining time among the other three subjects.

My interest in Pharmacology was apparent right from my undergraduate days, and it was during my MD that I delved deep into the subject. The MD program pushed me beyond the confines of textbooks, requiring me to explore investigator brochures and understand various terms. I even pursued courses outside the academic curriculum to grasp concepts not commonly taught by our academic teachers. Post-graduation, I had to dig deep into MD Pharmacology, expanding my knowledge beyond the surface.

The difference between Pharmacology and pharmacy lies in the clinical aspect of the former. In Pharmacology, we are more involved in the clinical side, consistently thinking about how our work will benefit and impact patients. On the other hand, pharmacy deals more with pharmaceuticals, formulations, and chemical properties. We also consider aspects like risk management plans, efficacy, and effectiveness in Pharmacology.

I believe that both these aspects are important because M Pharm people have in-depth knowledge about pharmacokinetics, PKPD modeling, and structure-activity relationships. They acquire this knowledge right from the beginning of their academic journey and need inputs regarding the clinical side whereas Medical professionals are needed for their clinical knowledge and expertise. The entry points and job roles for these two streams are very different in the industry and Academia.

I honestly believe that 5 and a half years are not enough to become a doctor. It can take ten to fifteen years practically to fully understand all aspects of medicine. However, if we consider a three-year period, one can manage some common medical conditions. It is essential to acknowledge that in rural areas, where there are no doctors, even this limited knowledge can make a significant difference.

Having a backup system of healthcare professionals who can provide first aid or immediate assistance is essential. However, gaining comprehensive knowledge in medicine requires a substantial investment of time, and even ten years may not be enough.

Recently, I read about the challenges faced by pharmaceutical companies when manufacturing costs rise. Companies strive to maintain high standards and produce quality generics rather than compromising on quality. They also need to ensure that their generics remain cost-effective.

Sometimes, due to various reasons, there may be price hikes in medications. However, I found something surprising. While there were reports of price hikes, it turned out that the prices had actually decreased instead of going up. This discovery was made when I submitted a research letter on this topic to the Lancet Regional Health South Asia and received feedback from the reviewer, who confirmed that the prices had indeed come down, not increased as initially believed.

Recently, there were reports in the news that the prices of generics would increase due to common reasons. However, when I wrote a research letter on this topic, I was asked to recheck the information. Surprisingly, the prices of most generics had actually gone down instead of increasing, despite the initial news suggesting otherwise.

However, there are some medications, like semaglutide (Ozempic) which do not come under the National Essential Drugs List, where the prices are indeed higher. In contrast, for most essential generics rumored to have price hikes, they did not materialize, and the prices decreased instead.

In situations where certain medications are still unaffordable for patients, pharmaceutical companies must find alternatives to improve patient access. For instance, offering deals like one cycle of a drug free with two cycles or using crowdfunding methods can help make expensive drugs more accessible to patients in need. Pharmaceutical companies should work towards making non-essential medications not covered by insurance, like semaglutide, more affordable for the benefit of patients. Despite the fluctuations in pricing, the overall trend in the industry has been a decrease in the prices of generics, not an increase.

The Drug Price Control Order (DPCO) exists to regulate prices, but its implementation seems to be lacking. In a cost variation analysis study we conducted, we found an alarming 1000% variation between the prices of the most expensive brand and the least expensive brand for the same medication. This significant variation highlights the need for stricter adherence to the DPCO regulations, and it's essential to raise awareness about its inadequate enforcement.

So, there certainly are rules and regulations in place, but it is crucial to ensure their effective implementation to maintain fair pricing and accessibility of medications for all patients.

While prescribing medications, there can be a lot of challenges. For example, in a government setup, many times these medications are not available, even though they are very cheap. They are not affordable, and the patients have to pay out of pocket to buy the product. Moreover, outside the government setup, they are given different brands instead of generic ones, which further increases the cost for the patient. As a result, some patients may end up not purchasing the required medication, leading to increased disease severity.

Apart from the availability and affordability issues, there is a lot of evidence to follow, but it can be very difficult to adhere to it. New guidelines may recommend certain drugs that are not expensive, but they might not be easily accessible. This poses a significant challenge when prescribing medication for patients.