“If results are good, drug developers and the public will benefit from the local Ivermectin clinical trials,” said the Department of Science and Technology (DOST) Undersecretary for Research and Development, Usec. Rowena Cristina L. Guevara.
In April 2021, the Department of Science and Technology (DOST) together with the Department of Health (DOH), announced its support for the conduct of local clinical trials on Ivermectin to provide data on the safety and efficacy of the drug in treating Filipino patients infected with SARS-CoV-2. The eight-month project is spearheaded by Dr. Aileen Wang of the University of the Philippines - Philippine General Hospital (UP-PGH).
In preparation for the start of the trials, the project is working with its own formulation to comply with the existing standards for double-blind, placebo-controlled trials. As explained by Usec. Guevara, the project team will make their own capsules because the trials require the placebo and the active drug to look the same to avoid patient and physician bias.
To standardize the study drugs to be used -- placebo and active drug, the project team has partnered with the UP Manila College of Pharmacy who can develop and compound the local Ivermectin capsules easily in a short period of time.
“We would like to reiterate that the compounded capsules to be used solely for the purpose of clinical trials will adhere to Good Manufacturing Practice and Compounding Practice, and will be subjected to tests for raw materials and finished product,” emphasizes Dr. Yolanda Robles, lead of the Pharmacy team of the ivermectin trials.
“The use of Ivermectin as medication for COVID-19 became a public clamor for the past months despite insufficient scientific evidence, if the results of this study is good, then the drug developers can use the results of the study for guidance on how to use ivermectin. Eventually, benefitting the public,” emphasized Usec. Guevara.
“We assure the public that our ultimate goal in the Philippine Council for Health Research and Development (PCHRD) is to provide them with solutions backed by scientific evidence,” says PCHRD Executive Director Jaime C. Montoya.
Currently, there are 75 registered clinical trials on the use of Ivermectin as COVID-19 treatment around the world. However, as of today, the DOH and the Food and Drug Administration (FDA) still do not recommend the use of Ivermectin for the treatment of COVID-19 due to insufficient scientific evidence.
The Department of Science and Technology-Philippine Council for Health Research and Development (DOST-PCHRD) in partnership with the Philippine Association of Medical Journal Editors (PAMJE) held a virtual convention on 20-23 September 2021 with the theme, “Research Integrity in the Time of the Pandemic.” More than 300 medical journal editors, librarians, and researchers attended the event each day to learn about trends and challenges faced in research during the pandemic, especially the proliferation of incorrect information.
The “infodemic” is a problem that “persists and worsens as floodgates to information continue to expand, especially now that the COVID-19 pandemic has made everyone completely reliant on the internet,” said PCHRD Executive Director Dr. Jaime Montoya in his message during the Convention’s opening ceremonies, and many of the speakers during the four days echo this sentiment.
According to the World Health Organization, “infodemic” is “an overabundance of information—some accurate and some not—that makes it hard for people to find trustworthy sources and reliable guides when they need it.”
Prof. Dr. Iris Thiele Isip-Tan of the Medical Informatics Unit of the University of the Philippines Manila College of Medicine added that “fake news” is a simple term to define the problem we are facing when it comes to information. “Sharing is caring” is not so true when the wrong information is shared without intent of harm. This is called misinformation. Disinformation, on the other hand, is when the wrong information—whether real or fabricated—is shared with the intention to manipulate or deceive.
Unfortunately, many medical researches readily available to the general public are unverified information, which may cause potential harm.
Dr. Elisabeth Bik of Harbers Bik, LLC and Dr. Wilfred Peh, former President of the Asia Pacific Association for Medical Editors (APAME) shared how images in research, such as X-rays and specimen samples, could be manipulated through simple techniques like duplication and zooming, and how some of these manipulated images may be used to fabricate court evidence or simply to get more positive results.
Dr. Art Gertel of MedSciCom talked about the public’s eroding trust in the scientific community because of the infodemic and what it has done to journal publishing of late. Recently, because of the demand for information during the pandemic, medical research articles scramble to get articles on COVID-19 published, which eventually caused retractions even from major medical journals. What Dr. Bik and Dr. Wilfred Peh shared about image manipulation simply adds to the reasons why the general public learned to mistrust the scientific community.
Dr. Bik stresses, however, that most scientists do honest work and that some instances of image duplications may simply be a case of innocent human error. She does state that most stories behind intentional medical research misconduct are rather sad, though.
Academic and professional pressures as well as conflicts of interest are some of the reasons she cited for research misconduct. Some students and scientists are pressured to produce desired results because of threats thrown at them by professors and supervisors.
Dr. Bik also cites these pressures as a reason for the existence of paper mills, or underground businesses that produce research papers for a price.
Somewhat related to these pressures is the premium set by the current publication system in the Philippines on high-impact journals. This concern was raised during the fourth day of the convention as even though there are reliable local peer-reviewed publications by medical associations, they rarely qualify for points for professional advancement even in Philippine universities.
Pre-prints and Open Access: The Future of Publishing
Peer-review, at the moment, is the gold standard for research integrity. One of the many pitfalls of peer-reviewed articles, however, is the time it takes to get timely information out for consumption. This is why so many researchers look towards making their articles available through preprint servers to get their studies out.
The American Medical Writing Association (AMWA), European Medical Writers Association (EMWA), and the International Society for Medical Publication Professionals (ISMPP) released a joint statement on medical publication, pre-prints, and peer review, which Dr. Dikran Toroser of AMWA presented on the first day of the convention. The AMWA-EMWA-ISMPP Joint Statement acknowledges that there is a need to balance speed, which pre-prints provide, and quality, which peer reviews provide.
As a reaction to the joint statement, Prof. Dr. Nicholas Talley of the Medical Journal of Australia (MJA) boldly proclaimed that pre-prints are the future of publications. Albeit at the expense of medical journal editors’ own time and probably health, Prof. Dr. Talley said that it is possible to peer review pre-prints by pooling medical journal editors to review and edit articles within a set amount of time before feeding them into preprint servers, as MJA has been doing since the pandemic hit Australia.
Many of the speakers throughout the four-day convention agree that most articles released through pre-prints at the moment are junk, but Dr. Toroser concedes that there are some out there that could be cornerstones of pivotal discoveries.
All four panelists during the first day of the convention believe that though pre-prints could be the future of publication, there is a need to look into newer models that would allow pre-prints to be peer reviewed before being released.
On the other hand, Dr. Michael Diño, the Director of the Research Development and Innovation Center of the Our Lady of Fatima University, proposed open access publication as an alternative to traditional journal publishing. Open access publication provides scientists many avenues to get the results of their studies to the wider public, such as self-licensing or paying processing fees to open access journals. Dr. Diño shared that though there are many doubts about open access models, such as visibility, making peer reviewed research articles free for public consumption actually allows more people to view an article, open up conversations, and eventually contribute to the world’s pool of knowledge.
“Garbage In; Garbage Out”
This is one of the most important takeaways during Dr. Leonila “Inday” Dans’s 101 lecture on systematic reviews. “Garbage In; Garbage Out” means that a systematic literature review or meta-analysis will only be as good as the research used for them.
Dr. Dans also states that systematic reviews may serve as a compass for researchers to either give recommendations for policymaking or the direction they will take for their next research.
Dr. Jacinto Blas Mantaring III also mentioned pressure when he presented his reaction to Dr. Dans’s lecture. One of the pitfalls of systematic research is publication bias due to the prevalence of studies with positive results and the pressure to produce them. Dr. Mantaring stresses that though undesirable, negative results are still reliable and acceptable.
To ensure the quality of systematic reviews, Dr. Venus Cloma-Rosales, Managing Director of 101 Health Research, shared the updated Preferred Reporting Items for Systematic Reviews and Meta-Analyses or PRISMA.
Trust, Speed, and Veracity
Most of the panelists agree that in order for the scientific community to regain the trust of the public, the right information should be made available at the soonest possible time. However, as there are many avenues available to the public nowadays, especially unregulated social media, it is harder to manage the information that they get their hands on and how they interpret it.
The WHO Epidemic Information Network came up with a framework for epidemic response. The framework proposes that interventions and messages must be based on science and much be accessible to citizens; knowledge should be translated and presented into actionable behaviour-change messages that are understood by everyone; governments should tailor messages and advice to the audience they want to reach; all sectors of society should strengthen information analysis and amplification through partnerships; health authorities should be aware of circulating narratives and changes in the flow of information, question, and misinformation in the communities; and infodemic management approaches should be developed accordingly.
Depicted in films, books, and science fiction stories as a means to bring doom to humans, Artificial Intelligence (AI) actually can significantly change medicine and healthcare.
In a report, the World Health Organization (WHO) describes how leveraging AI for healthcare holds great promise or potential. This potential is exactly what Harvard Medical School Assistant Professor of Ophthalmology Dr. Paolo Antonio Silva and his team are exploring with their current project on diabetic retinopathy.
Under the Newton Agham Program of the Department of Science and Technology - Philippine Council for Health Research and Development (DOST-PCHRD) and the United Kingdom Medical Research Council (UK-MRC), Dr. Silva’s team launched the UK-Philippines Remote Retinal Evaluation Collaboration in Health: Diabetic Retinopathy or REACH-DR.
On September 21, 2021, the REACH-DR team shared the first successful implementation of a validated AI algorithm in the clinical setting for ophthalmology in the country. Following this significant achievement, Dr. Silva shares their motivation and vision in pursuing the project, and their plans moving forward.
Establishing a telemedicine program for diabetic retinopathy
Building on AI technologies, the REACH-DR project aims to establish the very first inclusive telemedicine screening program for diabetic retinopathy in the country.
"Diabetic retinopathy is the most common complication of diabetes. Despite the availability of highly effective treatment, diabetic retinopathy remains the most common cause of visual loss and blindness among people with diabetes. This emphasizes the need for retinal evaluation.” Dr. Silva explains. “While screening for the disease early on is especially relevant, in-person retinal evaluation in the Philippines is not always possible, due to lack of access to medical facilities that is worsened by geographic, social and cultural constraints.” Deriving inspiration from the success of a DR screening program in the UK, Dr. Silva’s team set out to launch a similar project here in 2019. “One of the greatest success stories in diabetes eye care is the United Kingdom's National Diabetic Retinopathy Screening Programme. In 2014, for the first time in five decades, diabetic retinopathy was no longer the leading cause of legal blindness in the working-age population in England and Wales, due to the early detection of diabetic retinopathy by screening, along with improved control of blood sugar levels.” The team aims to implement a national DRSP in the country by completing three phases: 1) developing the necessary infrastructure by analyzing and validating existing telemedicine technology, 2) adapting the selected technologies into the Philippine setting, and 3) completing the technology transfer to the Philippine stakeholders. If successful, “the UK REACH DR program will help to identify eyes at high risk for losing sight, and this will have a direct benefit for individuals,” Dr. Silva says. “An additional benefit will be the promotion of awareness for the need for eye evaluations which will significantly improve the overall level of eye care and reduce the risk of diabetes-related visual loss among people with diabetes,” he added.
The first validated AI algorithm in the clinical setting for ophthalmology in PH
Now in its third year of implementation, the project achieved a significant milestone last week. “September 21, 2021, marks the first use of a validated artificial intelligence (AI) algorithm in a clinical setting for ophthalmology in the Philippines,” Dr. Silva shares. “Our REACH-DR team with the use of AI has successfully performed and completed diabetic retinopathy screening in a target community in Nueva Ecija to identify diabetic retinopathy and other vision-threatening retinal diseases.”
This development is a step closer to increasing access to retinal screening, which will pave the way for timely and accurate diabetic retinopathy detection.
“Evaluating retinal images is a highly skilled process, which requires training, continuous quality control, and maintenance of a specialized skill set. As trained retinal image readers are costly and difficult to train with limited numbers worldwide, it has become a necessity to seek automation processes in ocular telemedicine to increase throughput while maintaining cost-effectiveness and accuracy.”
The project will run until next year, June 2022, with the completion of the screening of the target population and is expected to provide the framework for the future implementation of diabetic retinopathy screening programs in the Philippines. With the nearing completion of the project, Dr. Silva highlights how conducting health research provides “opportunities to answer dilemmas unaddressed for many years.” “Health research changes lives and makes the world we live in much better than it is,” he says. __________________________________________________________________________________________________
Dr. Paolo Antonio S. Silva is a staff ophthalmologist and the chief of telemedicine at the Beetham Eye Institute of the Joslin Diabetes Center. He is an Assistant Professor of Ophthalmology at Harvard Medical School and a research collaborator and faculty at the Philippine Eye Research Institute.
The complexity of managing COVID-19 pandemic revealed the need for more researchers working in the field of public health. Public health research utilizes quantitative methods which combine the disciplines of epidemiology and biostatistics. Epidemiologic research is needed to ensure that public health measures and policies are data-driven and evidence-based.
The Department of Science and Technology (DOST) through Philippine Council for Health Research and Development (PCHRD) in cooperation with the Philippine National Health Research System Capacity Building Committee (PNHRS CBC) and University of the Philippines - College of Public Health will implement the one-year Fellowship in Epidemiology Program. The program is a crucial step to capacitate health researchers in this discipline in order for them to contribute in addressing gaps in public health.
The one-year course is designed to help the Fellows develop the necessary knowledge and skills in conducting quantitative public health research. Aligned with the DOST-PCHRD’s mission to develop and strengthen capacity for health research, the Fellowship Program aims to:
Develop the knowledge and skills of young researchers in quantitative methods in public health research;
Conduct intensive training in Epidemiology for fellows; and
Develop a pool of experts with the appropriate knowledge and skills to conduct quantitative public health research.
The applicants must:
Be a Filipino citizen;
Not more than 50 years old at the time of application;
Be willing to submit medical certification on physical and mental fitness;
Have a bachelor’s degree in health sciences, health social sciences, public health, or any health-related course with Biostatistics and population research in the curriculum (a master’s degree in any health-related course, doctor of medicine, and/or background in Biostatistics is an advantage);
Have at least 1 year of relevant experience in public health work, and 4 hours of relevant training;
Pass the exam, interview, and other screening procedures;
Be willing to render the required service obligation equivalent to the length of time the program was enjoyed; and
Must have a full-time commitment to the fellowship and must not engage in any form of employment (If employed, must be officially on leave from work) and not enrolled in any degree program during the fellowship period
Monthly Stipend (PhP 25,000.00)
Capacity Building Grant (May be used for attendance to local/international conferences in order to present (poster/oral) the research they have completed during the program)
The Fellows shall be selected based on the following selection process:
Technical Exam – Applicants shall take a technical exam which consists of multiple choice and essay-type questions to assess their existing technical knowledge on quantitative public health research.
Assessment of Written Work - Applicants shall submit a sample of their written technical output (i.e., research paper, research brief, or any technical document) for assessment of their technical writing skills.
Panel Interview – Applicants who passed the technical exams and have an acceptable written work shall be interviewed by a panel composed of representatives from DOST-PCHRD, PNHRS, University of the Philippines – College of Public Health, and other relevant stakeholders.
How to Apply
On September 21, 2021, the Philippine Eye Research Institute (PERI), in collaboration with the Queen's University of Belfast of the United Kingdom (UK), successfully deployed a validated artificial intelligence (AI) algorithm for diabetic retinopathy screening, marking the first use of AI in ophthalmology in the Philippines.
This is a significant milestone in Philippine ophthalmology and is a step towards establishing an inclusive program for diabetic retinopathy screening that has the potential to eliminate diabetes-related blindness. The UK-Philippines Remote Retinal Evaluation Collaboration in Health: Diabetic Retinopathy or REACH-DR is a Newton-Agham program that aims to establish a diabetic retinopathy screening program (DRSP) here in the country. Establishing a local DRSP will help in the timely identification of eyes at risk for diabetes-related blindness and visual loss.
To achieve this, REACH-DR pursues the following targets: 1) the development of the necessary infrastructure for a local DRSP by analyzing and validating existing telemedicine technology, 2) adaptation of the selected technologies into the Philippine setting, and 3) completion of technology transfer to the Philippine stakeholders.
“If we succeed in establishing a DRSP locally, we can help treat patients on time, save their eyesight, and help them remain socially active,” project leader and Harvard Medical School Assistant Professor of Ophthalmology Dr. Paolo Antonio Silva says. “Ultimately, we want to reduce the incidence of blindness and visual impairment caused by diabetic retinopathy, which will allow the patients to live independently,” he adds.
“We, at the DOST-PCHRD, are proud of the achievement that the REACH-DR team has achieved,”DOST-PCHRD Executive Director Dr. Jaime C. Montoya says. “This project is an example of how we build on research to make healthcare services more accessible for the Filipino people, and ultimately, help make their lives better,” he adds.
Currently, the REACH-DR team is conducting retinal screening among underserved communities in the National Capital Region (NCR) and Region 3. The screening is expected to be completed by June 2022.
The project is funded under the Newton Agham Program of the DOST-PCHRD and the UK Medical Research Council.