Marya Lieberman, professor of chemistry and biochemistry, is the 2020 winner of the Reinhold Niebuhr Award in acknowledgement of her work on Paper Analytical Devices (PADs). This award recognizes a faculty member or administrator whose life and body of academic work promotes or exemplifies the pursuit of social justice in modern life.
Over the past 10 years, Professor Lieberman has worked tirelessly spearheading the Paper Analytical Device Project (padproject.nd.edu). The aim of this project is to develop low-cost, high-quality analytical tools that will make a difference in the developing world. Through user-centered design, manufacturing prototyping, and extensive field testing and validation in low- and middle-income countries (LMICs), Lieberman has gone beyond the usual arc of an analytical chemistry project in order to achieve real impact on a recalcitrant problem.
The Lancet Global Health Oxford Statement on global access to quality-assured medical products highlights the fact that poor-quality medical products have a disproportionate impact on the poorest and most vulnerable populations. The World Health Organization (WHO) estimates that less than a third of world governments can effectively regulate medical products, and that one in ten medicines in LMICs are substandard or falsified. These ineffective products cost lives and money. WHO’s epidemiological models show that substandard and falsified drugs kill hundreds of thousands of children under age 5 each year and contribute to development of drug-resistant pathogens.Since the global market for pharmaceuticals in LMICs is over $300 billion dollars per year, at least $30 billion is being wasted buying substandard and falsified drugs in the most vulnerable countries.
The PAD is a complete lab-on-paper that can pick out fake and substandard medicines, all for about fifty cents. The user does not need to supply electrical power, chemicals, solvents, or expensive instruments. The PAD can “fingerprint” over 60 different pharmaceuticals and identify substandard versions of many of these compounds. The card itself stores the reagents, mixes them in the correct order, and can be read by eye or with a cell phone app. The PAD can let drug inspectors screen many more samples at lower cost so that bad quality products can be found more quickly. A validation study in Tanzania showed that 20 drug inspectors using PADs could analyze 3,000 samples in under six weeks with 94% accuracy. Use of the PAD in routine drug surveillance is estimated to reduce the cost of detecting bad quality products by a factor of eight.
There are many examples of the real world impact of the PAD.
- In 2015-2016, collaborators in an East African country noticed an unusual color on PADs that were used to test one brand of amoxicillin-clavulanic acid. Chemical analysis showed that the clavulanic acid in the antibiotics was completely degraded and the degradation products had created the new color. The drug regulatory agency quarantined the product, protecting tens of thousands of people from exposure to an ineffective drug.
- In spring of 2018, community health workers in a SE Asian country noticed that an amoxicillin sample’s PAD did not show the expected colors from the active ingredient. Additional samples were purchased at the same pharmacy that afternoon, producing the same suspicious PAD results. Chemical analysis of the suspect product showed that it did not contain any amoxicillin, but instead was composed of calcium carbonate and starch. The collaborators immediately followed up with their drug regulatory agency and a follow-on study with 300 PADs has been initiated in several urban and rural areas to try to track how this product is getting into the country.
- In 2018-2019, the government of Ethiopia and the Walther Cancer Center funded a PAD study of chemotherapy drugs at public clinics. The Lieberman group developed a PAD that could analyze the tiny drops remaining in the vial after treatment of patients. These PAD results identified three lots of cisplatin that contained only 50% of the stated chemotherapy drug content. The results have just been published with the director of the regulatory agency as a co-author, and the regulatory authority is working to strengthen its capacity on all aspects of the regulatory functions (i.e. registration, inspection, quality control and post marketing surveillance) for anti-cancer drugs.
Professor Lieberman has also used this project as a vehicle to train a new generation of scientists to take up such causes. The Lieberman group has transferred the technology needed to make PADs to research groups in Ethiopia, Bangladesh, Malawi, and Kenya to increase access and build research capacity in these LMICs. Working with faculty from the London School of Hygiene and Tropical Medicine and the Purdue/Kilimanjaro School of Pharmacy MS program for drug regulators, she has trained over 130 drug regulatory agents from LMICs and developed an extensive network of research collaborators in Africa and SE Asia. In 2016, Professor Lieberman realized that many colleges and universities have more analytical resources than entire countries do in Africa, and developed the Distributed Pharmaceutical Analysis Lab (DPAL) to provide instrumental analysis capacity to collaborators in LMICs. The DPAL program involves hundreds of undergraduate students each year in rigorous analytical study of samples that really matter. There are currently 28 DPAL schools, including the US Coast Guard Academy, Niagara University, Boston University, Gonzaga University, and IU Bloomington. The DPAL schools analyzed 2,000 samples from 2016-2020 and identified substandard or falsified metformin, ampicillin, and amoxicillin-clavulanic acid.
Even in countries like the US, where more sophisticated testing is available, the PADs can prove useful. Professor Lieberman has developed a new PAD to prevent opioid drug overdoses, which kill 70,000 people each year in the US. The idPAD can detect illicit drugs including cocaine, heroin, methamphetamine, and even fentanyl, and is being trialed by the Coroner’s Office in Indianapolis to identify drugs found at fatal overdose scenes and by harm reduction groups in Chicago to warn drug users if their drugs contain unexpected hazards like fentanyl.
Professor Lieberman exemplifies applying scientific knowledge and research prowess to work toward social justice for “the least of these” in society. She is using the PAD technology to protect those most vulnerable from falsified pharmaceuticals, and she is using this project as a vehicle to inspire students from all walks of life to pursue their dreams and change the world.