“I’m afraid few patients and healthcare professionals know how many new prescription drugs enter the market with limited evidence on their benefit and safety. They need more and better information, as do decision-makers and payers covering medicine costs,” says Dr Anita Wagner, an Associate Professor of Population Medicine at Harvard Medical School.
Wagner says that in the past decades, there have been significant changes in the drug approval process in the US, and more recently also in Europe. “Drug regulatory agencies, the FDA in the US and the EMA in Europe, increasingly use expedited pathways enabling new drugs to enter the market faster, and even regular pathways are more lenient than before. In the US, faster approvals have been applied to 75 percent of new drugs in the past decades, and to as many as 85 percent of new cancer drugs.”
“For patients, this means earlier access to drugs, and for manufacturers, quicker return on investment. However, faster market approval usually entails less evidence of benefit and safety. Manufacturers are expected to create post-marketing evidence while the drug is already being prescribed and used.”
“The launch prices of new drugs also increase rapidly, so we are in a situation where we spend more and more money on medicines with uncertain clinical benefits.”
What Wagner finds worrying is that while regulations on drug approval have changed, the regulations on communicating about them have not. “Many people think that every drug that has been approved by the FDA works and is safe. Doctors and insurance companies also have misconceptions and limited access to evidence behind newly approved drugs.”
We spend more and more money on medicines with uncertain clinical benefits.
Anita Wagner
Associate Professor
Dialogue with pharmaceutical policy authorities
Wagner currently works with the University of Eastern Finland under a Fulbright Finland-Saastamoinen Foundation Grant in Health and Environmental Sciences. “A goal we share with my colleagues is to find ways to better communicate evidence on new medicines so that everyone in the pharmaceutical system can make informed decisions, whether they prescribe, use or pay for the medicines.”
Together with Professors Katri Hämeen-Anttila and Anna-Maija Tolppanen at UEF’s School of Pharmacy in Kuopio, Wagner has set out to develop and implement a pioneering course in pharmaceutical policy for doctoral researchers from various fields of research. They also plan to make the course modules available to broader audiences later.
“We want to provide future leaders and decision-makers with an in-depth understanding of the complex, interconnected national and international pharmaceutical systems, including the different perspectives of politics, economics, research and healthcare,” Wagner says.
Hämeen-Anttila adds that an important aspect of the course is the global perspective. “We will look at the similarities and differences in the US and European systems, as well as those in low- and middle-income countries, how they interact with each other, and how the US system affects other parts of the world. This will be a mutual learning process, and I’m personally looking forward to drawing on Anita’s vast global expertise and networks.”
“Our plan is to develop the course in dialogue with Finnish pharmaceutical policy authorities such as the Finnish Medicines Agency Fimea, the Finnish Social Insurance Institution Kela and the Pharmaceutical Pricing Board, as well as Finnish university hospitals. It would be important to offer doctoral researchers not just theoretical background but also opportunities to engage with different stakeholders and to discuss pressing pharmaceutical policy issues,” Hämeen-Anttila notes.
Research collaboration and mentorship mastery
During a previous Fulbright Finland scholarship period in 2022, Wagner co-led the development of a Master’s level course in pharmaceutical regulation and policy at the University of Tampere.
“That earlier work provides a foundation for this new PhD level course, although a lot has changed in four years. The University of Eastern Finland seemed the perfect place to take the next step because with the expertise of Anna-Maija, Katri and their teams, we can bring together all the necessary pieces spanning from pharmacoepidemiology to pharmaceutical policy, communication and ethics.”
They also plan to further international research collaborations and mentoring. “Anita has already been providing us with valuable connections, for example to experts working with the Sentinel Initiative,” Tolppanen says.
Together with Harvard Medical School researchers, the FDA has created the Sentinel Initiative with the aim of developing new ways to assess the safety of approved medical products. “In 2022, Europe launched the DARWIN EU initiative to deliver evidence on the use and performance of medicines to the European regulatory network. My group has also participated in European Medicines Agency framework contracts to evaluate the feasibility of noninterventional designs in evidence generation, so I look forward to learning more about this from the US perspective,” Tolppanen says.
“Research related to medicines information and communication is certainly one area of collaboration. As Europe is going through its biggest pharmaceutical legislation reform in 20 years, that’s something we will likely be looking at together as well,” Hämeen-Anttila adds.
Harvard Medical School’s Department of Population Medicine has been awarded for its academic mentorship excellence. From her hosts, Wagner is now learning about academic mentorship at UEF to understand whether aspects of her experience are relevant for UEF’s School of Pharmacy. She will offer both individual and group mentoring to early-career researchers. “I have been blessed with tremendous mentors over the years, and the best way to show my gratitude is to pass it forward.”
“I am sure all of us will learn a lot from Anita, including those who are working in different research areas. Challenges such as increased productivity demand with limited resources and high rejection rates occur everywhere, and academia may sometimes seem daunting. However, reflecting on these issues with a peer or a more experienced colleague is helpful,” Tolppanen remarks.
“I love being in Finland and I owe my being here to a lot of people,” Wagner says, extending her gratitude to both Hämeen-Anttila and Tolppanen, the Saastamoinen Foundation and Fulbright Finland Foundation, the University of Eastern Finland and the School of Pharmacy, her previous host, the University of Tampere, as well as her home department at Harvard Medical School for allowing her the flexibility to work in Kuopio.
