Healthcare reform is big news and is likely to affect doctors, insurers and drug companies. Cost control and improved access — two goals that aren’t entirely compatible — are major driving forces. In the healthcare reform debates, insurers and drug companies are often painted as the bad guys. While no one is perfect, insurers’ efforts to help people gain access to affordable medical care are laudable. And drug companies are the major innovators, creating the new products that actually help patients live longer healthier lives. HIGH COSTS NOT ALL BAD The high cost of new drugs has its advantages and disadvantages. Two recent events highlight the issue. First, Hoffmann-LaRoche is pulling out of the Accutane (isotretinoin) business. The introduction of generic isotretinoin has reduced Accutane sales. Accutane has been a godsend for patients with severe, scarring acne. But the teratogenicity of the drug has required a costly pregnancy-prevention program. Lawsuits have grown over other possible Accutane side effects as well. Branded Accutane carried a high cost, but the high cost permitted development and implementation of the pregnancy prevention program and made it feasible to keep this important drug available despite the enormous (litigation) risks. The high cost of new drugs also fosters innovation. Simple innovations, such as the development of spray and foam formulations of old active molecules, have made major differences in patients’ outcomes and quality of life. Perhaps the biggest innovators are manufacturers of the biologic drugs, using the rapidly developing understanding of immune function to specifically target key signaling pathways. While there could be tremendous innovation in this area over the next few years, these drugs carry a high price tag … at least until generics are introduced. Balancing Goals, Reducing Rancor In an effort to balance the goal of encouraging more innovation with a desire to lower medical care costs, the U.S. Senate recently passed a bill supporting a 12-year protection for biologics before generic versions can be introduced. Impressions of this bill depend on the eye of the beholder. People focused on improving access to treatment by lowering cost may think this bill moves generic competition too far into the future. People focused on improving access to new treatments by encouraging innovation may think this bill gives too little protection from generic competition to optimize investment in the development of new medical technology. Either way, though, people on either side of the debate have the same goal: helping patients get great medical care. Financial motivations may make people lean toward one side or the other in how they think patients can be best helped, but their intentions aren’t evil. Let’s not forget that. Reducing the vehemence and rancor in the debate over healthcare reform would be much appreciated. Steven R. Feldman, MD, PhD Chief Medical Editor Dr. Feldman is the author of Compartments: How the Brightest, Best Trained, and Most Caring People Can Make Judgments That are Completely and Utterly Wrong. Xlibris, Philadelphia, PA, 2009. For information, visit www.compartmentsbook.com.
HEALTH REFORM VS. HIGH-COST NEW DRUGS
Healthcare reform is big news and is likely to affect doctors, insurers and drug companies. Cost control and improved access — two goals that aren’t entirely compatible — are major driving forces. In the healthcare reform debates, insurers and drug companies are often painted as the bad guys. While no one is perfect, insurers’ efforts to help people gain access to affordable medical care are laudable. And drug companies are the major innovators, creating the new products that actually help patients live longer healthier lives. HIGH COSTS NOT ALL BAD The high cost of new drugs has its advantages and disadvantages. Two recent events highlight the issue. First, Hoffmann-LaRoche is pulling out of the Accutane (isotretinoin) business. The introduction of generic isotretinoin has reduced Accutane sales. Accutane has been a godsend for patients with severe, scarring acne. But the teratogenicity of the drug has required a costly pregnancy-prevention program. Lawsuits have grown over other possible Accutane side effects as well. Branded Accutane carried a high cost, but the high cost permitted development and implementation of the pregnancy prevention program and made it feasible to keep this important drug available despite the enormous (litigation) risks. The high cost of new drugs also fosters innovation. Simple innovations, such as the development of spray and foam formulations of old active molecules, have made major differences in patients’ outcomes and quality of life. Perhaps the biggest innovators are manufacturers of the biologic drugs, using the rapidly developing understanding of immune function to specifically target key signaling pathways. While there could be tremendous innovation in this area over the next few years, these drugs carry a high price tag … at least until generics are introduced. Balancing Goals, Reducing Rancor In an effort to balance the goal of encouraging more innovation with a desire to lower medical care costs, the U.S. Senate recently passed a bill supporting a 12-year protection for biologics before generic versions can be introduced. Impressions of this bill depend on the eye of the beholder. People focused on improving access to treatment by lowering cost may think this bill moves generic competition too far into the future. People focused on improving access to new treatments by encouraging innovation may think this bill gives too little protection from generic competition to optimize investment in the development of new medical technology. Either way, though, people on either side of the debate have the same goal: helping patients get great medical care. Financial motivations may make people lean toward one side or the other in how they think patients can be best helped, but their intentions aren’t evil. Let’s not forget that. Reducing the vehemence and rancor in the debate over healthcare reform would be much appreciated. Steven R. Feldman, MD, PhD Chief Medical Editor Dr. Feldman is the author of Compartments: How the Brightest, Best Trained, and Most Caring People Can Make Judgments That are Completely and Utterly Wrong. Xlibris, Philadelphia, PA, 2009. For information, visit www.compartmentsbook.com.
Healthcare reform is big news and is likely to affect doctors, insurers and drug companies. Cost control and improved access — two goals that aren’t entirely compatible — are major driving forces. In the healthcare reform debates, insurers and drug companies are often painted as the bad guys. While no one is perfect, insurers’ efforts to help people gain access to affordable medical care are laudable. And drug companies are the major innovators, creating the new products that actually help patients live longer healthier lives. HIGH COSTS NOT ALL BAD The high cost of new drugs has its advantages and disadvantages. Two recent events highlight the issue. First, Hoffmann-LaRoche is pulling out of the Accutane (isotretinoin) business. The introduction of generic isotretinoin has reduced Accutane sales. Accutane has been a godsend for patients with severe, scarring acne. But the teratogenicity of the drug has required a costly pregnancy-prevention program. Lawsuits have grown over other possible Accutane side effects as well. Branded Accutane carried a high cost, but the high cost permitted development and implementation of the pregnancy prevention program and made it feasible to keep this important drug available despite the enormous (litigation) risks. The high cost of new drugs also fosters innovation. Simple innovations, such as the development of spray and foam formulations of old active molecules, have made major differences in patients’ outcomes and quality of life. Perhaps the biggest innovators are manufacturers of the biologic drugs, using the rapidly developing understanding of immune function to specifically target key signaling pathways. While there could be tremendous innovation in this area over the next few years, these drugs carry a high price tag … at least until generics are introduced. Balancing Goals, Reducing Rancor In an effort to balance the goal of encouraging more innovation with a desire to lower medical care costs, the U.S. Senate recently passed a bill supporting a 12-year protection for biologics before generic versions can be introduced. Impressions of this bill depend on the eye of the beholder. People focused on improving access to treatment by lowering cost may think this bill moves generic competition too far into the future. People focused on improving access to new treatments by encouraging innovation may think this bill gives too little protection from generic competition to optimize investment in the development of new medical technology. Either way, though, people on either side of the debate have the same goal: helping patients get great medical care. Financial motivations may make people lean toward one side or the other in how they think patients can be best helped, but their intentions aren’t evil. Let’s not forget that. Reducing the vehemence and rancor in the debate over healthcare reform would be much appreciated. Steven R. Feldman, MD, PhD Chief Medical Editor Dr. Feldman is the author of Compartments: How the Brightest, Best Trained, and Most Caring People Can Make Judgments That are Completely and Utterly Wrong. Xlibris, Philadelphia, PA, 2009. For information, visit www.compartmentsbook.com.
