Dr. Thamir Alshammari is an advisor to the President of the Saudi Food and Drug Authority (SFDA). He is a pharmacoepidemiology and pharmacovigilance consultant. He is also a distinguished expert for the Chinese National drug safety and policy center at Xian, China, as well as an ambassador to the British Pharmacological Society. He is a senior researcher at the Medication Safety Research Chair.
Thamir has been an active contributor to the OHDSI community for several years. He collaborates in several workgroups, including Population-Level Estimation, Health Equity and the recently-completed Vaccine Evidence WG, and has been a contributor in several important network studies, which are discussed below. He also brings unique perspective as somebody working with a national government on critical healthcare issues.
Thamir discusses his journey in pharmacovigilance and health policy, and how that path found the OHDSI community, as well as some of the work he focuses on within OHDSI. He also discusses why OHDSI can be a difference maker in generating trustworthy evidence, tools and best practices within the community, and plenty more in the latest edition of the collaborator spotlight.
Can you discuss your background and what drove you to work in health policy and pharmacovigilance?
I hold a degree in pharmacy as background, and then I got my master’s degree in clinical pharmacy. During studying for my master’s degree, I was attracted to the areas of epidemiology, drug safety, and health policy because there is a need for these specialists in my country. After completing my master’s degree, I moved to work for the Saudi Food and Drug Authority (SFDA), which started 1-2 years before. It was great to be part of the establishment team, and I got different exposure to administrative work, like being part of the teams who were writing the policies and procedures. Also, I started to be responsible for answering any clinical and drug safety issues during that time. Based on that, I went to the United States (U.S.) to study health outcomes (Pharmacoepidemiology and Pharmacoeconomics) at the University of Rhode Island, Rhode Island. It was an excellent experience for me, and I got a lot of knowledge and practice there. I was lucky to do a summer internship with the office of surveillance and epidemiology (OSE), the U.S. Food and Drug Administration (FDA). Also, I did a post-doctoral fellowship at OSE, U.S. FDA, where I got more involvement with epidemiology, pharmacovigilance, and drug safety. When I returned to Saudi Arabia, I was responsible for pharmacovigilance and all related issues at the SFDA.
On another side, I tried to spread the knowledge and concept of health policy, health outcomes, and pharmacovigilance, and one of the ways I added some of these topics to the college curriculum I was leading. Also, I have done and am still doing different training programs and courses.
How did you find OHDSI, and what inspired you to join the community?
First time I heard about OMOP was during my post-doctoral at the FDA. Also, I was hearing about OHDSI and OMOP especially through publications that I have read and later on because we have an initiative to build a national database here in Saudi Arabia and we found that OHDSI is the best model to use, especially when we found many data are available on the OHDSI website. We also know Patrick Ryan, who was of big help and support during our initiative, and I decided to learn more by joining OHDSI community.
I learned a lot after joining the OHDSI community. I enjoyed all meetings that I have attended and what is unique in this community is that everyone is really wanting to help and support others. OHDSI is really an international community, and you can meet many people from all over the world and learn from them and get more experience. In the beginning I thought it will be just a few meetings like any other work-related meetings, but when I joined I saw it was different and it got my attention, especially the different research ideas, the use of different tools, and other interesting work. The community is really an inspiring community.
What workgroups do you collaborate in, and are there 1-2 current studies or initiatives that you would like to highlight?
One of the exciting things about OHDSI is having different workgroups that you can join and work with together. I participated in different workgroups; some did great work and finished all their tasks, like Vaccine Evidence, and I am participating in pharmacovigilance, health equity, PLE, and APAC. As for studies, I participated in several studies, and still, I’m participating in studies. All of these studies are unique and have a significant impact on the sciences. For example, I participated in a COVID-19 study-a-thon in which we all gathered and worked together in different teams. There was a lot of work; however, it was fun, and I enjoyed each part of it, especially since it was during the pandemic, and many things were unknown to us, and we were trying to find answers to the uncertainties and knowledge gaps. This study-a-thon resulted in different publications which did positively impact the sciences. For example, a study led by Jenny Lane entitled “risk of hydroxychloroquine alone and in combination with azithromycin in the treatment of rheumatoid arthritis: a multinational, retrospective study.” This work was published in the Lancet Rheumatology. This study showed the safety of one of the claimed medications that it was effective against COVID-19, and showed the risk of using this drug in the long run or long-term effect. Another important publication led by Kristina Kostka aimed to characterize patients with COVID-19 using a huge number of patients from different countries to represent patients with COVID-19. There are many other important publications from this study-a-thon.
Another work I enjoyed was the PIONEER group’s work within OHDSI. This work aimed to describe the demographics, characteristics, and outcomes of men with prostate cancer on initial conservative management. This work was interesting because it gathered different people from totally different experiences. OHDSI was an excellent source for the PIONEER group because of the availability of huge data that helped us as a group to have a great study.
There are many other exciting works, especially the work done by the Vaccine Evidence group, which resulted in really important work that positively impacted the vaccine and COVID-19.
You collaborated on several important studies on drug early during the COVID pandemic; as somebody who works on regulatory decision-making for a national government, how critical was the generation of real-world evidence in a time of such unknowns?
I am glad that most of our work provided evidence on many areas that need an answer and resolved some of the uncertainties and gaps in different areas. OHDSI proved that generating real-world evidence timely is important and can answer uncertainties. For example, during the pandemic’s early days, there were many debates and questions about using angiotensin-converting enzyme inhibitors (ACEIs) and Angiotensin receptor blockers (ARBs) for patients who have hypertension and the sub-speciality to get COVID-19 easily. There was a big fear by healthcare professionals to continue their patients who are using ACEIs or/and ARBs. Many countries’ COVID-19 guidelines recommend stopping these medications in patients with COVID-19. As a response, within the OHDSI community, the largest study using ACEIs or ARBs led by Daniel Morales entitled “Renin-angiotensin system blockers and susceptibility to COVID-19: an international, open science, cohort analysis,” that I participated in with my other collaborators and colleagues provided needed evidence of using these medications. This work generates evidence using real-world data from over 1 million patients that use ACEIs or ARBs is not associated with an increased risk of COVID-19 or even hospital admission-related outcomes associated with using these medications. This work was used and cited by one of the largest regulatory agencies, the European Medicines Agency (EMA). Many countries follow EMA decisions, meaning this will positively impact patients in Europe and many worldwide. This study was published in the Lancet Digital Health.
Another work that generates important evidence, which I already have mentioned before, is using hydroxychloroquine during the pandemic. This work is entitled “risk of hydroxychloroquine alone and in combination with azithromycin in the treatment of rheumatoid arthritis: a multinational, retrospective study.” This paper’s results showed a risk associated with these medications and later found that this drug was wrongly introduced to many COVID-19 therapeutic guidelines in different countries.
Another example of why we need to generate real-world evidence in a time of such unknowns is the work of the Vaccine Evidence group. Following the introduction of COVID-19 vaccines, there were some safety concerns (thrombosis and thrombocytopenia) associated with some COVID-19 vaccines, and there were uncertainties about this risk. However, the risk was considered rare, which won’t be captured by clinical trials, and the characterization of this risk was unclear. Therefore, our group did great work concerning this matter and had different research questions, ideas, and uncertainties. One of our group’s outputs, led by Azza Shoaibi, estimated the background rate of thrombosis with thrombocytopenia (TWT), characterized TWT patients and explored the makeup of thrombosis types among TWT patients using applied multiple TWT definitions. This study highlighted important findings of catching the data about such rare risks. This work was published in Drug Safety. In addition, there are other important methodological papers from this group that added important information to the area of sciences.
Therefore, using real-world evidence is important and needs to be considered by stakeholders, especially the regulator agencies, because it can promptly provide strong evidence using real-world data.
What is it about OHDSI tools or practices that make you feel confident to trust its scientific output when making decisions for the people of Saudi Arabia?
What makes OHDSI unique is its way of conducting trustworthy research and taking care of every detail, starting from the research idea itself through validating the data and selecting the best methodological design. The other unique thing is OHDSI has different teams who take care of tasks related to their areas of expertise, like those working on the common data model (CDM). Having the OMOP CDM is another characteristic of OHDSI, which helps to conduct the studies. The number of databases within OHDSI represent most of the world, from North America, Europe, Asia, and Australia. Moreover, the continuous process of OHDSI and the workgroups within OHDSI to improve all tools we are using within OHDSI and update them. There are many other things that I am impressed with here at OHDSI. Therefore, the scientific outputs from OHDSI research are trustworthy and can be used by different stakeholders here in Saudi Arabia for policy-making decisions and clinical practice.
The global growth of OHDSI continues to expand. What should countries who are early in the journey or considering joining know about the kind of impact this community can have for their own healthcare environment?
I guess there are some areas that might not be known to many researchers and scientists worldwide. One of these is the CDM, the benefits of the CDM, and how it helps researchers in conducting excellent and validated research to produce validated results. But, also, many tools greatly benefit researchers who need to know about them.
I would love to see more involvement of OHDSI in many conferences in the Middle East and west of Asia to make people of these regions aware of OHDSI and all tools, practices, and experiences of OHDSI. Also, what OHDSI can bring to and help produce evidence-based research in a timely manner.
One of the main advantages of OHDSI that countries should be aware of is the community itself and how great it is. The different expertise, sharing knowledge, working together, and helping each other are examples of the beauty of this community.
What are some of your hobbies, and what is one interesting thing that most community members might not know about you?
Oh, hobbies, ummmm. I love watching football (soccer) and playing with friends once a week. I enjoy watching our local football league, the English Premier League, and the Spanish La Liga, I am a Real Madrid fan 😄.
I enjoy horseback riding, and I do that often. I also love to go camping and go away from the city and stay camping for a few days.