Nasiba Abdul-Karim, M.P.H. ’04
School of Health Sciences and Practice
Her current job title may inspire a little good-natured ribbing—along with some questions— but Nasiba Abdul-Karim, M.P.H. ’04, is serious about her passion for drug safety.
She is a manager of pharmacovigilance. The phrase conjures up images of some Orwellian drug ministry straight out of the novel 1984, dedicated to making sure we all take our meds on time. You won’t find it in most dictionaries, but according to the online mega-reference Wikipedia, pharmacovigilance is the science of detecting, assessing, understanding and preventing adverse effects, particularly long-term and short term side effects of medicines.
But in describing her job with its intriguing title, Nasiba Abdul-Karim, M.P.H. ’04, puts it this way: “It’s all about drug safety and taking a holistic look at how patients and groups of patients react to the medications they take.” That has been her all-consuming passion since receiving a B.S. in Biology from Spelman College and going to work for Forest Laboratories in Jersey City, N.J., where she was assigned to the company’s drug safety unit tracking instances of adverse drug reactions (or ADRs), “almost by chance.”
Because clinical trials involve relatively small numbers of patients, less common side effects and ADRs (including severe Pharmaco-WHAT? Her current job title may inspire a little good-natured ribbing—along with some questions— but Nasiba Abdul-Karim, M.P.H. ’04, is serious about her passion for drug safety. By Bill McDaniel S ALUMNI Chironian New York Medical College 19 ADRs such as liver damage) are often unknown at the time a drug enters the market. And given the proliferation of medications today, drug interaction has become a major concern. Being on the lookout for potential hazards when medications are combined has become a necessity, although the investigations unfortunately often come after a report of an adverse reaction.
“I became interested in digging into instances of adverse drug reactions to find out what was going on,” she says. “It was like detective work. I enjoyed the research and searching for clues, connections and answers. That became my motivation to get my master’s degree. And since I’m a New York City woman, the School of Public Health at New York Medical College was the right choice for me.”
Since graduating with her M.P.H. in epidemiology, Ms. Abdul-Karim’s career has focused on drug safety. From her job at Pfizer, where she worked briefly after graduation, to The Medicines Company where, as manager of drug safety, she created company procedures to ensure compliance with FDA regulations, she has held increasingly responsible positions in the field of drug safety, or pharmacovigilance.
Her career path has now led her to Celgene Corporation, a biopharmaceutical company headquartered in Summit, N.J., that manufactures a number of innovative therapies to treat cancer and immunological diseases. One of them, thalidomide, is notorious for having caused devastating birth defects when taken by pregnant women in the early 1960s. Today, the FDA does not allow general sale of thalidomide but, with significant restrictions and careful monitoring by people like Ms. Abdul-Karim, does allow its use in studies of certain severe or life threatening diseases where there may be no other treatment.
As a result, Celgene requires those who prescribe and dispense its products to register in a special distribution program, which allows the company to closely monitor usage by patients and prescribers. Though pre- and post-marketing drug safety programs are mandated by the FDA, all pharmaceutical companies approach this requirement differently, with varying degrees of rigor. Ms. Abdul-Karim’s approach is most definitely proactive and rigorous. She uses an internal drug safety database, composed of reports from physicians, hospitals, pharmacists and patients, to actively assess the safety of these participants on a regular basis. She also monitors and collects information for her periodic safety reports to the FDA and international authorities such as the European Medicines Agency.
“While getting my degree, I decided on a concentration in epidemiology,” Ms. Abdul-Karim says, “because it is an ideal field of study for anyone interested in drug safety. Epidemiology focuses on research methodology and evidence-based medicine for identifying risk factors. Just as epidemiologists use research and analysis to identify causal relationships between exposures and outcomes, so do those of us interested in drug safety rely heavily on research and analysis to identify the causes of adverse drug reactions. That’s where the detective work comes in.”
Growing up in a close-knit neighborhood in New York City, her dreams and ambitions centered on cardiology and surgery. She volunteered in New York Hospital’s Nuclear Cardiology Research Department, Harlem Hospital’s Pediatric Center, as well as many non-profit youth and health outreach programs.
But at some point she realized that what she truly wanted went beyond her girlhood dream of being a doctor. She made the classic leap to a public health focus: populations rather than individuals, prevention rather than treatment. “I wanted to impact the patient’s life as a whole; to advocate for patients in ways they could not advocate for themselves and to advocate for good health practices on a larger scale,” she said. “And most definitely I love making a difference. If I notice something new or different going on—some different correlation or factor—hundreds, maybe thousands of lives can be saved.”