March 12, 2021
By Alisa Kim
The Senior Fellow program at the Institute of Health Policy, Management and Evaluation (IHPME) recruits thought leaders and executives who have had significant impact on Canada’s health system to engage with the IHPME community via lectures, round table discussions and mentoring. The program strengthens links between IHPME and health system policy makers and enables graduate students at the Institute to benefit from the expertise of established leaders through experiential learning and career counselling.
For Katherine Zagrodney, a PhD candidate at IHPME, the thought of getting additional mentoring from a leader who worked outside the university setting was appealing. She was paired with IHPME Senior Fellow Dr. Ted Witek, whose career in the pharmaceutical industry has spanned lab bench science, clinical research and executive leadership (he is the past president and CEO of Boehringer Ingelheim Inc. in Portugal and Canada).
“The Senior Fellow program offers a unique type of mentorship,” says Zagrodney, who with Witek, led research on drug advertising violations by U.S. pharmaceutical companies. “I valued the opportunity to use and build my skills outside of my thesis work. Overall, it enhanced my learning experience as I went through the Health Services Research program.”
Zagrodney, and colleagues, including incoming PhD student Natasha Sheikhan, published a paper titled “Drug advertising violations: a longitudinal trend analysis of FDA enforcement letters from 2005 to 2019” in the journal Pharmaceutical Medicine.
The aim of the study was to identify trends in enforcement letters sent by the U.S. Food and Drug Administration (FDA) to companies that breached regulations around the promotion of drug products during the period 2005 to 2019. Letters from the FDA specify the noncompliant advertisement and action required by the company to address the problematic promotion.
“For ads that did not comply, we looked at why, in what way were they against guidelines. The number one reason was minimizing the risks associated with drug use,” says Zagrodney.
The researchers found the total number of enforcement letters from the FDA decreased significantly over time, but the proportion of violations by smaller firms increased. They also found online promotion of drug products was a main source of advertising violations.
Witek notes that promotion of pharmaceutical products is important and beneficial when there is full disclosure about the possible effects of taking a drug. “It’s actually a good thing because the medical representatives working in the research-based pharmaceutical industry know the most about these drugs and that can be helpful to physicians. Promotion can be an important component of education, but when you’re dealing with drugs it is important claims are substantiated and to have fair balance between benefits and risks,” he says.
One hypothesis for why smaller drug companies represent most ad violations in recent years is that, unlike large drug companies, which have legal and regulatory staff that ensure their ads are truthful, small firms may not have dedicated personnel overseeing promotional activity.
Their research suggests small drug companies need to ensure balanced safety information is provided to consumers, especially in online advertising.
Obtaining the data for the research was not complicated, largely because the information about the FDA’s enforcement of regulatory standards is easily accessible, says Witek. “FDA surveillance is not only aggressive, it’s also public. We can access the same letter that the company received by accessing the FDA website. Anybody can do this to validate our findings,” he notes. The authors extended their observations to the sales volumes of the firm and the age of the drug in question.
Zagrodney, whose doctoral research is on the labour supply of personal support workers in Canada, says conducting the research with Witek via the Senior Fellow program was enriching. Not only was she able to work with graduate students from other disciplines, who are co-authors on the paper, the study also gave her an opportunity to travel to Scotland to present preliminary findings at the International Society for Pharmacoeconomics and Outcomes Research conference. In relating the research to the bigger picture of people’s health, she says, “I personally thought it was important to understand drug ad violations and enforcement activities since advertising has been found to play a role in drug prescribing behaviours, so, ultimately, it influences the health of individuals. That’s why I think that this is an important topic.”