Ah biotech 86 Dr. Abraham Hassan knew he couldn’t put off the decision any longer. AH Biotech, the Bound Brook, New Jersey–based company started by this psychiatrist-turnedentrepreneur, had developed a novel drug that seemed to promise long-term relief from panic attacks. If it gained approval from the Food and Drug Administration (FDA), it would be the company’s first product. It was now time for large-scale clinical trials. But where should AH Biotech conduct those tests? David Berger, who headed up research and development, was certain he already knew the answer to that question: Albania. “Look, doing these trials in Albania will be quicker, easier, and a lot cheaper than doing them in the States,” he pointed out. “What’s not to like?” Dr. Hassan had to concede that Berger’s arguments were sound. If they did trials in the United States, AH Biotech would spend considerable time and money advertising for patients and then finding physicians who’d be willing to serve as clinical trial investigators. Rounding up U.S. doctors prepared to take on that job was getting increasingly difficult. They just didn’t want to take time out of their busy practices to do the testing, not to mention all the recordkeeping that such a study entailed. In Albania, it was an entirely different story. It was one of the poorest Eastern European countries—if not the poorest—with a just barely functioning health-care system. Albanian physicians and patients would practically line up at AH Biotech’s doorstep begging to take part. Physicians there could earn much better money as clinical investigators for a U.S. company than they could actually practicing medicine, and patients saw signing up as test subjects as their best chance for receiving any treatment at all, let alone cutting-edge Western medicine. All these factors meant that the company could count on realizing at least a 25 percent savings (maybe even more) by running the tests overseas. What’s not to like? As the Egyptian-born CEO of a start-up biotech company with investors and employees hoping for its first marketable drug, there was absolutely nothing not to like. It was when he thought like a U.S.- trained physician that he felt qualms. If he used U.S. test subjects, he knew they’d likely continue to receive the drug until it was approved. At that point, most would have insurance that covered most of the cost of their prescriptions. But he already knew it wasn’t going to make any sense to market the drug in a poor country like Albania, so when the study was over, he’d have to cut off treatment. Sure, he conceded, panic attacks weren’t usually fatal. But he knew how debilitating these sudden bouts of feeling completely terrified were—the pounding heart, chest pain, choking sensation, and nausea. The severity and unpredictability of these attacks often made a normal life all but impossible. How could he offer people dramatic relief and then snatch it away? What Would You Do? 1. Do the clinical trials in Albania. You’ll be able to bring the drug to market faster and cheaper, which will be good for AH Biotech’s employees and investors and good for the millions of people who suffer from anxiety attacks. 2. Do the clinical trials in the United States. Even though it will certainly be more expensive and time-consuming, you’ll feel as if you’re living up to the part of the Hippocratic oath that instructed you to “prescribe regimens for the good of my patients according to my ability and my judgment and never do harm to anyone.” 3. Do the clinical trials in Albania, and if the drug is approved, use part of the profits to set up a compassionate use program in Albania, even though setting up a distribution system and training doctors to administer the drug, monitor patients for adverse effects, and track results will entail considerable expense.
As a startup company that does not have a lot of time to wait to fund its first drug, it would make sense for the biotech firm to make use of doing the clinical trials in Albania, where the drug is needed and the doctors are willing to quickly participate. Get solution