USAID, August 2015
Quest-driven, yet reticent, Vidya Sagar Uprety, Senior Program Officer, (Clinical Trials) of a rotavirus Phase III efficacy study, was always the school topper. From the calm and peaceful environs of the hill state of Uttarakhand, to the hustle bustle of the Indian capital, Delhi, Vidya accepts that the city has offered him great opportunities. In his day-to-day work, he still relies on skills that he once learned as a keen adventure enthusiast. He also firmly believes that a lot of hard work goes into resolving challenges.
Pur How did you choose clinical research as your career goal?
I graduated from Kumoun University, Nainital in 1999 and came to Delhi to pursue higher studies in computers. While in Delhi, I learnt about a postgraduate course in clinical research, which I was told by my friends was a career oriented course and had a good future. I completed my studies from the Institute of Clinical Research in New Delhi and today I am happy to have taken this decision.
What do you find most exciting in your job profile in PATH?
Everything about clinical trials and the drug development process is exciting, because this is directly related to saving lives. You feel very proud and satisfied when the drug or vaccine that you have been working on is approved and available to help people. My job profile at PATH is special to me as I am involved in clinical operations for a large multi-centre community-based rotavirus Phase III efficacy study. It is a huge responsibility to oversee, manage, guide and assist sites involved in this trial and ensure that the highest international standards are followed and that they are in compliance with regulatory requirements and guidelines.
My responsibilities include project planning, development of study operational documents, investigator site identification and selection and helping sites prepare for the trial. This also includes site management, oversight of the contract research organization, conflict management and so on. The most exciting part of my profile is identification and selection of good and potential investigator sites and ensuring they follow international standards during the trial.
Do you face any challenges? If yes, what do you think is the best way to tackle them?
As a person, I have a simple rule for challenges. I often step back and take time to personally engage with conflicting issues or personalities.
You have been an adventure enthusiast – can you tell us something about that?
Yes, Uttarakhand is an adventure sport’s haunt. I have been actively interested in parasailing, rock climbing, paragliding, snow skiing and river rafting since I was 16. I have been hurt during these endeavors, but I have learned a lot. In parasailing I learned to how to control, without even the basic protective gear! All this taught me to focus and follow instructions!
What are your future plans?
I want to stay in the clinical research industry. In the course of my career, I have seen the complete development of a drug and I was very proud to be associated with something as exciting as this.Read more
One of the job perks at PATH is working with lots of smart people all relentlessly tackling a health and scientific challenge. Our vaccine development program is one such team of scientists, doctors, and other experts focused on accelerating progress on new vaccines for infants and children in low-income countries. We buttonholed Alan Fix, senior medical officer based in our Washington DC office, to find out about his work.
What does it mean to be medical officer?
The most important part of my job is ensuring that our clinical trials protect the safety of the volunteers and meet international standards for vaccine trials. Because safety needs to be built into the trial design, I help with setting up our trials and helping the clinical trial sites prepare. The additional important role in participating in, if not leading, development of the trials is helping to assure sound and relevant scientific approaches. I also support the sites throughout the trials and help with reviewing the results and distilling what we learn from the research.
How did you find your way to this work?
My training is in Pediatrics and Preventive Medicine, so working to develop and increase global access to effective pediatric vaccines has obvious appeal.. From the moment I started working in public health in the developing world, I have found it stimulating and invigorating. And at PATH, we’re focused on the children who are most vulnerable. For these children, vaccines offer perhaps one of their best hopes for a healthy shot at life. The exciting part of the work is that we are making rapid progress on vaccine candidates that could have substantial public health impact.
Can you say more about how you work with our trial partners?
We aim to share scientific and operational experience to move the work forward in a collaborative way. We work together on problem solving, for example how to adapt to meet shifting regulatory requirements or how to ensure the appropriate resources at the trial site that will meet the needs of the participants. Safety is the number one concern in any clinical trial, especially so in settings where children may have underlying health challenges such as undernutrition or exposure to pathogens in unsafe drinking water, compounded by limited access to care. We have to be ready to provide care if a child becomes ill during the study even if that illness is unrelated to the vaccine candidate.
That is why I am so impressed with our partners. For example, we are working with The Mahatma Gandhi Institute of Medical Sciences in Sewagram, India. This is a facility that is deeply committed to the community around it and is well structured to meet that commitment. They have attracted dedicated staff and students and they are tireless in their efforts to meet the community’s needs. It is inspiring to see the good they are doing and to be a part of that.Read more
Recently, my husband and I did a rare thing and attended a major league baseball game. We made ourselves comfortable in the outfield bleachers just fair of the foul pole, ready for a few lazy hours in the sun rooting on the Seattle Mariners. Then, in the third inning… CRACK… we heard the sound of bat on ball and, shockingly, saw the ball bulleting straight for us. It seared into the crowd and ricocheted into the seat next to us. My husband reacted quickly, dove into the bleachers, and grabbed it, beating out several other lunging fans. And with that, we were suddenly members of an elite group of fans that had beaten the odds and snagged a homerun ball.
Wondering what odds we had actually beaten, I did some research. In truth, the question has many answers depending on seat location, game attendance, stadium dimensions, etc. But, whichever way the data are cut, most calculations have the probability of catching a homer at less than one percent. Dare I say, that’s a ballpark figure.
Here in the United States, children dream of someday catching a ‘long ball’ and go to games with mitts in hand, hoping to beat the odds. But in less developed countries where poverty and disease are pervasive, children often dream of beating the odds in a far different way—making it past their fifth birthdays. For these children one of the most powerful health tools that can help make that dream a reality, vaccines, can be as elusive as catching a homer.
In baseball, choosing a seat in homerun territory has significant bearing on a person’s chances of catching one, but improving the odds beyond that is largely out of anyone’s control. In global health, being born in an impoverished country has considerable bearing on a child’s chances of making it to adulthood, but improving that child’s odds of survival is well within our power. Expanding access to vaccines in these regions can give children the tools they need to come from behind and win the faceoff with disease.
The good news is that a reversal of odds is in the process of playing out against many diseases, including two of the world’s top child killers—pneumonia and diarrhea. Thanks to assistance from groups like the GAVI Alliance, children in low-resource countries are gaining access to vaccines at an unprecedented rate and a chance at survival that they would not have had otherwise.
In the case of pneumococcal disease—the most common cause of severe childhood pneumonia—only one percent of the world’s infants had access to pneumococcal vaccines a decade ago, and only in the industrialized world.Today, 33 percent of the world’s infants have access to these lifesaving tools, including infants from 27 low-income countries and counting. Pneumococcal vaccine rollout in the developing world has occurred in record time and could avert over half a million child deaths by 2015 and up to 1.5 million such deaths by 2020.
Global rollout efforts for vaccines against rotavirus, the leading cause of deadly diarrhea in children, are also making history, having succeeded in introducing rotavirus vaccine in the United States and a GAVI-eligible country in 2006—the same year. If rotavirus vaccine rollout in GAVI-eligible countries continues as planned, at least 30 of the world’s poorest countries will have access by 2015 and more than 2.4 million young lives could be saved by 2030.
Part of the thrill of going to a baseball game is in the slim chance that a homerun could single us out in the crowd, but slim chances hold no thrill in the game of disease prevention. We may have had luck on our side at that Mariner’s game, but thousands of others at the game did not. Ensuring that access to a shot in the arm in the developing world ceases to be as elusive as catching a shot out of the park requires vigilant, continued investment and action from the global health community. Ultimately, universal vaccine access holds the promise that will give child survival odds we can live with. Everyone going home with a ‘shot’ would ruin the fun in baseball, but it would change the game in global health.
-- Lauren Newhouse, Communications Officer for the Vaccine Development program at PATHRead more
Diarrhea and pneumonia are the leading causes of mortality in children under 5, accounting for over 2 million deaths annually. More than 90% of these deaths occur in South Asia and sub-Saharan Africa, where children in the poorest, most rural areas are disproportionally affected.
One of the largest barriers to treatment is lack of access to adequate healthcare. Poor quality of care, long distances to health centers, and lengthy wait times hinder use of government facilities. In the predominantly rural Indian state of Bihar, 93% of households reported not using government facilities at all. As a result, nearly two-thirds of households across India seek healthcare from private medical providers. In rural India this sector is largely comprised of unregulated and fragmented providers with little formal medical training. These providers are businessmen motivated by frequently conflicting aspirations: profit generation and service to their communities.
To overcome these challenges, World Health Partners (WHP) developed Sky – a rural franchise network that seeks to leverage these private providers’ existing infrastructure and relationships to improve quality standards, while adding value to providers’ businesses. In addition to connecting these providers via telemedicine to qualified doctors in cities, all franchise owners are trained in the treatment of basic diseases, given access to a large-scale supply chain of Sky-branded medications, and linked to higher levels of care through referral schemes. This model creates a value proposition allowing WHP to incentivize provision of less lucrative services and adherence to quality standards through the generation of multiple revenue streams for the providers.
To understand how WHP’s model improves diarrheal care, consider the following scenario:
Pooja, a young mother of 4, brings her two-year-old son to the village doctor Malik—an informal provider who sells basic medicines in a small chemist stand—because her son has had loose stools for the past two days. Pooja stopped giving her son fluids because every time she feeds him, he has another episode of diarrhea. She asks the provider to give her some antibiotics to stop the diarrhea.
A common course of treatment that Malik and many other rural health providers in India might prescribe is an antibiotic for the infection and an anti-motility agent to slow bowel movements. For most informal private providers, medicine sales are a main source of revenue, with antibiotics providing much greater profit margins than ORS. In addition, the prevailing mentality—seen in developed and developing countries alike—is that antibiotics are the best quality treatment. As a result, if Malik doesn’t give Pooja antibiotics, she may take the child to be treated elsewhere, affecting Malik’s profits and reputation.
WHP aims to train private providers like Malik on the importance of appropriate treatment for diarrhea, which consists of oral rehydration salts (ORS) and zinc, rather than antibiotics, which can actually destroy “good” bacteria lining the intestines and worsen diarrhea. The commonly held belief of antibiotics as a cure all has contributed to the rise of antibiotic-resistant diseases in India.
Ideally, after training from WHP, Malik will have the skills and understanding to correctly counsel Pooja. In addition, Malik will receive a new supply of WHP’s SkyMeds branded zinc tablets and ORS sachets through WHP’s last mile-focused supply chain, which attempts to give him bigger profit margins than other brands and allows him to profit. With this strategy, zinc has the potential to replace antibiotics as the trusted “goli”, or tablet, for diarrhea.
While informal providers like Malik offer a unique inlet to improve the quality of care for India’s poorest, most vulnerable populations, WHP still faces a number of challenges relating to the structure of this for-profit system and societal misconceptions of healthcare which continue to drive inappropriate use of antibiotics. WHP’s goal is to address the above challenges through direct financial incentives, creating value-add propositions, and providing education by connecting them together in a cohesive, standards-driven support network. If successful, this approach could be a gateway to not only improve medical services for India’s rural poor, but also to expand health education and awareness for both the informal providers and the communities they serve. Together, these improvements in understanding of health and quality of care have the potential to greatly reduce preventable deaths and the severe financial burden due to childhood illness across India’s rural population.
-- Anoop Muniyappa is a 2nd year student in the UC Berkeley – UCSF Joint Medical Program. He is currently working with World Health Partners in India to evaluate the quality of care for childhood illness delivered by informal private providers within the WHP network.
-- Jacqueline Kingfield is World Health Partner’s Development and Communications Project Manager.
Photo credit: PATHRead more
As part of my work for PATH, I recently had the pleasure of visiting the Kasturba Hospital in Sewagram, India. My colleague and I were given a tour of the facility by a young doctor on staff there, Dr. Abhishek, and his enthusiasm for the hospital and its practices was, dare I say it, infectious. Aside from the open-air aspect of the main floor of the facility and the huge number of motorbikes in the parking lot, the hospital seemed to have many of the same things that we would find at most major medical centers in the US – an emergency room, X-ray and MRI machines, blood bank, pharmacy, etc. However, I was intrigued by what I learned regarding their common practices for women who come to the hospital to give birth.
Among the interesting facts Dr. Abhishek shared with us was that this hospital has been promoting breastfeeding within the first half-hour of birth for decades. Given breastfeeding’s proven impact on reducing infant illnesses, including diarrhea and pneumonia, this seemingly progressive approach to initiating early breastfeeding has surely saved countless young lives in this central Indian district. I couldn’t help but draw comparisons with my own experiences in giving birth at a hospital in Washington, DC. It wasn’t until well over an hour after I gave birth that the nurses finally suggested that I try breastfeeding my son. From my work in child health, I knew that it would have been ideal to do it sooner. But, being a first-time mom and feeling completely unsure about everything, I found myself relying entirely on what the doctors and nurses in the hospital told me to do, and I was hesitant to speak up and suggest something different. It was great to hear that the women giving birth at Kasturba Hospital aren’t faced with this situation, and instead are encouraged to begin breastfeeding right away.
In addition, no matter how natural and normal the delivery is, Kasturba Hospital always keeps mothers and babies as patients there for three full days after birth. Dr. Abhishek said that if a baby survives the first day of life, he is three times more likely to survive his first year. For that reason, they have a strong focus on the first 28 days of life, when most child deaths occur, and they have found that keeping a close eye on mother and baby for those first three days is critical to keeping them healthy in the longer term. In the US, women who have given birth naturally seem to be practically pushed out the door of the hospital just 24 hours after giving birth, so this seemed like a really different approach.
I’m honored to have had the chance to visit this hospital and learn about how it serves its local community so well, particularly its new mothers and their babies. It’s easy to see why Dr. Abhishek enjoys giving these tours to visitors so much. They know what works best for their community and, most importantly, what keeps new babies healthy and thriving, and they have put that into practice in the best possible way.
-- Allison Clifford, Communications Officer for Vaccine Development program at PATH
Photo credit: PATHRead more