A Video Game Only A Pharmacist Could Love Ferrets Out Drug Fraud

(Bloomberg) — Robert Lodder, a professor at the University of Kentucky’s School of Pharmacy and a biopharmaceutical entrepreneur, has long enjoyed a good video game. Now he’s turning his passion for gaming into a powerful tool to identify defective and dangerous drugs.Together with Heather Campbell, an engineer in the pharmaceutical industry who has a penchant for software coding, Lodder has created a video game to help hospitals and pharmacies ferret out shoddy drugs. The pair have already deployed their game to lead them to a disturbing insight: Some pharmaceutical firms may be skimping on active ingredients to save money at the expense of drug quality. For someone with a headache, that could mean a bit of added discomfort. For a patient recovering from heart surgery, a weakened drug could cause serious harm.   

Lodder and Campbell are in the early stages of building out their game. The idea is to recognize patterns that may signal foul play within the drug industry. Think of it as more flight simulator than Super Mario. “The government’s been doing this for a long time,” Lodder said. “It goes back to Rand Corp. and war games, but nobody’s done it for the pharmaceutical industry.”The videogame relies on inputs from real world experience including one gleaned from another project Lodder helped to develop. As part of that other project, pharmacy students run quality tests on drugs that come through the university’s hospitals and clinics under the University of Kentucky health-care system umbrella. Examples of quality measures include whether a medication contains all the ingredients a company claims and whether it harbors impurities that could signal contamination.The game is still in early beta form but it will help Lodder’s pharmacy students prioritize which drugs to test in real life since analyzing everything that comes through the university’s health-care system isn’t feasible. Lodder and Campbell have held a few tournaments played by a dozen University of Kentucky students sitting in rows in high-backed chairs in the school’s gaming  lounge.  Nuance and verisimilitude are layered in to create scenarios from which players choose. The first screen shows a bird’s eye view of a drug manufacturing factory floor with early 2000s-style graphics. Players choose chemical ingredients from a drop-down screen and then set up production lines. From there, they can “badge in” to the factory floor. From that moment, they enter a part of the game Campbell has designed with state-of-the-art graphics in first-person player mode — meaning players get a realistic view of their actions — as they navigate different tasks designed to test their scruples.Players make several decisions as they advance through new levels of the game. Will they clean out an industrial vat to prepare the new drug? Or will they skip that step to save time and money?  Should they risk FDA’s wrath and sell an unapproved version of a drug? Should they throw out a batch of drug that tests positive for impurities or just mix it in among some good product? How players respond will affect the company’s revenue as well as the dug’s quality. The game is also designed to test players’ ethics: Will they do the right thing for patients or focus more on the bottom line? Whoever makes the most money wins.The university testing program that has influenced Lodder and Campbell’s work on the video game is one of just a few across the country that independently analyzes the quality of drugs. The U.S. Food and Drug Administration doesn’t regularly test treatments, instead relying on pharmaceutical companies’ own routine testing. Yet spot FDA inspections at drug production plants have turned up problems ranging from accuracy of testing data to sanitation issues, suggesting that relying on the industry to self-police its own quality can be problematic.

The promise of Lodder and Campbell’s videogame is that it may help hospitals and other large purchasers of drugs recognize signs of bad behavior long before the FDA has a chance to document it.During Campbell’s work on the game, she played out a scenario that Lodder’s drug-testing project had come across in real life: One generic drugmaker selling a medication at half the price of two of its competitors. Testing yielded a surprise. It determined the higher-priced drugs contained lower levels of a key active ingredient than the cheaper one – levels low enough the drugs no longer met FDA standards.

Intuitively, it would seem the opposite should be true – that the vials that cost more should be of higher quality. So Campbell played the game, using the same pricing and active ingredient levels as the real-life scenario and found the bottom lines of the companies selling the more expensive and lower quality drug remained healthy even if they lost some market share to lower-priced competition because of savings garnered by cutting back ingredients.

Lodder and Campbell recreated the situation during an April tournament and observed that players used the strategy regularly.Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists, called the video game concept fascinating. His association represents hospital pharmacists and welcomes the use of predictive models that can help them understand risk.“On the front lines, it helps us prepare for a vulnerability in a drug’s supply chain,” he said.Lodder and Campbell still have a lot of work to do before they can deliver on that promise. Their next step is to get clearance from a university review board to run videogame tournaments, with cash prizes, as official research trials. If they get the green light to do that, they’ll be able to start publishing their results, providing hospitals a valuable tool for ferreting out potential drug-maker funny business.

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