The high price of drugs

As I listened to Dr. Jackson T. Wright, one of the investigators of the SPRINT Trial, emphasize the importance of treating systolic blood pressure to the target of 120 mm Hg, I thought about the difficulty in treating blood pressure in the elderly.

Successfully lowering blood pressure even to the current target of 140 mm Hg systolic is one of the most difficult therapeutic tasks that I face. But, to my mind, the worldwide success achieved by hypertension therapy has had the most profound effect on cardiovascular medicine in the last half century. I am no epidemiologist, but the striking decrease in cardiovascular mortality in the United States associated with the introduction of the hypertension therapy is undeniable.

The pharmaceutical companies that developed of these drugs, some of which are still around and some that have merged with other entities, never priced these drugs at the potential benefit of decreasing the cost of hypertension to society. If they had, their price would be so exorbitant that their universal benefit to mankind would never have been seen. They were doing their job and returning significant benefit both to humanity and their investors. They priced the drugs so that we could afford to pay for them. All of these drugs – ACE inhibitors, calcium- and beta-blockers, and diuretics – are now available as generics and as a class have had a lasting and continuing impact on the societal cost and benefit.

Yet somehow, the world has changed. I am not the first to notice it. We now have drugs that can cost thousands of dollars a month and none of us can afford to pay for them. Because we now all share in the cost of drug therapy in one way or another, we all pay the cost. The justification for the high price is not based solely on their development cost, which in many instances were developed decades if not centuries ago, but on the presumed net expense of the untreated disease to society or to the achievement of entrepreneurial profits. Hepatitis C was one of the first in which the cost of new drug therapy was based on the net savings associated with the prevention of the chronic liver disease and its subsequent long-term societal expense. Since I am not a hepatologist, it took me a little leap of faith to accept the potential economic benefit of this therapy, but at least the current data suggest that indeed this therapy works. I remain dubious about the calculations of their societal net benefit cost.

Now move forward. We now have two drugs that can lower cholesterol, potentially to levels beyond our imagination, that are now on the high-expense list. According to recent rumors, evolocumab (Repatha, Amgen) and alirocumab (Praluent, Sanofi/Regeneron) will cost someone $12,000-$14,000 a year to lower serum cholesterol almost to immeasurable levels without any evidence of benefit in decreasing cardiovascular disease. (For those of you with short-term memory deficits, we just tried to pump up HDL cholesterol only to find that when successful, it increased mortality.) Now, if these drugs are successful in preventing the development and progression of atherosclerotic disease, as in the example of hepatitis C, I may change my mind and write the script for it.

Meanwhile, drug prices have escalated as a result of speculation in the pharmaceutical market by Wall Street entrepreneurs who buy up the drug patents that have been available for years like isoproterenol and digitalis, for the sole purpose of a creating a monopoly to inflate the price and return large profits to their investors. When questioned about the 20-fold increase in the cost of isoproterenol, a representative of one of the pharmaceutical companies stated, “that the price was based on many factors, including clinical benefits and the value they bring to the patients, physicians, payers, and society” (New York Times 2015 Oct 4 p. BU1, “Side Effects of Hijacking Drug Prices”). The audacity of drug company executives to presume that they are in a position to make that judgment is outrageous. And yet the U.S. Congress makes it illegal for Medicare and Medicaid to bargain for the best drug prices, while European and Asian pay a fraction of what we pay here.

These ruminations only suggest that madness in the pharmaceutical world is not limited to Wall Street but reaches even the higher levels of government. Get your checkbooks out everyone; the best is yet to come.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

As I listened to Dr. Jackson T. Wright, one of the investigators of the SPRINT Trial, emphasize the importance of treating systolic blood pressure to the target of 120 mm Hg, I thought about the difficulty in treating blood pressure in the elderly.

Successfully lowering blood pressure even to the current target of 140 mm Hg systolic is one of the most difficult therapeutic tasks that I face. But, to my mind, the worldwide success achieved by hypertension therapy has had the most profound effect on cardiovascular medicine in the last half century. I am no epidemiologist, but the striking decrease in cardiovascular mortality in the United States associated with the introduction of the hypertension therapy is undeniable.

The pharmaceutical companies that developed of these drugs, some of which are still around and some that have merged with other entities, never priced these drugs at the potential benefit of decreasing the cost of hypertension to society. If they had, their price would be so exorbitant that their universal benefit to mankind would never have been seen. They were doing their job and returning significant benefit both to humanity and their investors. They priced the drugs so that we could afford to pay for them. All of these drugs – ACE inhibitors, calcium- and beta-blockers, and diuretics – are now available as generics and as a class have had a lasting and continuing impact on the societal cost and benefit.

Yet somehow, the world has changed. I am not the first to notice it. We now have drugs that can cost thousands of dollars a month and none of us can afford to pay for them. Because we now all share in the cost of drug therapy in one way or another, we all pay the cost. The justification for the high price is not based solely on their development cost, which in many instances were developed decades if not centuries ago, but on the presumed net expense of the untreated disease to society or to the achievement of entrepreneurial profits. Hepatitis C was one of the first in which the cost of new drug therapy was based on the net savings associated with the prevention of the chronic liver disease and its subsequent long-term societal expense. Since I am not a hepatologist, it took me a little leap of faith to accept the potential economic benefit of this therapy, but at least the current data suggest that indeed this therapy works. I remain dubious about the calculations of their societal net benefit cost.

Now move forward. We now have two drugs that can lower cholesterol, potentially to levels beyond our imagination, that are now on the high-expense list. According to recent rumors, evolocumab (Repatha, Amgen) and alirocumab (Praluent, Sanofi/Regeneron) will cost someone $12,000-$14,000 a year to lower serum cholesterol almost to immeasurable levels without any evidence of benefit in decreasing cardiovascular disease. (For those of you with short-term memory deficits, we just tried to pump up HDL cholesterol only to find that when successful, it increased mortality.) Now, if these drugs are successful in preventing the development and progression of atherosclerotic disease, as in the example of hepatitis C, I may change my mind and write the script for it.

Meanwhile, drug prices have escalated as a result of speculation in the pharmaceutical market by Wall Street entrepreneurs who buy up the drug patents that have been available for years like isoproterenol and digitalis, for the sole purpose of a creating a monopoly to inflate the price and return large profits to their investors. When questioned about the 20-fold increase in the cost of isoproterenol, a representative of one of the pharmaceutical companies stated, “that the price was based on many factors, including clinical benefits and the value they bring to the patients, physicians, payers, and society” (New York Times 2015 Oct 4 p. BU1, “Side Effects of Hijacking Drug Prices”). The audacity of drug company executives to presume that they are in a position to make that judgment is outrageous. And yet the U.S. Congress makes it illegal for Medicare and Medicaid to bargain for the best drug prices, while European and Asian pay a fraction of what we pay here.

These ruminations only suggest that madness in the pharmaceutical world is not limited to Wall Street but reaches even the higher levels of government. Get your checkbooks out everyone; the best is yet to come.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.

As I listened to Dr. Jackson T. Wright, one of the investigators of the SPRINT Trial, emphasize the importance of treating systolic blood pressure to the target of 120 mm Hg, I thought about the difficulty in treating blood pressure in the elderly.

Successfully lowering blood pressure even to the current target of 140 mm Hg systolic is one of the most difficult therapeutic tasks that I face. But, to my mind, the worldwide success achieved by hypertension therapy has had the most profound effect on cardiovascular medicine in the last half century. I am no epidemiologist, but the striking decrease in cardiovascular mortality in the United States associated with the introduction of the hypertension therapy is undeniable.

The pharmaceutical companies that developed of these drugs, some of which are still around and some that have merged with other entities, never priced these drugs at the potential benefit of decreasing the cost of hypertension to society. If they had, their price would be so exorbitant that their universal benefit to mankind would never have been seen. They were doing their job and returning significant benefit both to humanity and their investors. They priced the drugs so that we could afford to pay for them. All of these drugs – ACE inhibitors, calcium- and beta-blockers, and diuretics – are now available as generics and as a class have had a lasting and continuing impact on the societal cost and benefit.

Yet somehow, the world has changed. I am not the first to notice it. We now have drugs that can cost thousands of dollars a month and none of us can afford to pay for them. Because we now all share in the cost of drug therapy in one way or another, we all pay the cost. The justification for the high price is not based solely on their development cost, which in many instances were developed decades if not centuries ago, but on the presumed net expense of the untreated disease to society or to the achievement of entrepreneurial profits. Hepatitis C was one of the first in which the cost of new drug therapy was based on the net savings associated with the prevention of the chronic liver disease and its subsequent long-term societal expense. Since I am not a hepatologist, it took me a little leap of faith to accept the potential economic benefit of this therapy, but at least the current data suggest that indeed this therapy works. I remain dubious about the calculations of their societal net benefit cost.

Now move forward. We now have two drugs that can lower cholesterol, potentially to levels beyond our imagination, that are now on the high-expense list. According to recent rumors, evolocumab (Repatha, Amgen) and alirocumab (Praluent, Sanofi/Regeneron) will cost someone $12,000-$14,000 a year to lower serum cholesterol almost to immeasurable levels without any evidence of benefit in decreasing cardiovascular disease. (For those of you with short-term memory deficits, we just tried to pump up HDL cholesterol only to find that when successful, it increased mortality.) Now, if these drugs are successful in preventing the development and progression of atherosclerotic disease, as in the example of hepatitis C, I may change my mind and write the script for it.

Meanwhile, drug prices have escalated as a result of speculation in the pharmaceutical market by Wall Street entrepreneurs who buy up the drug patents that have been available for years like isoproterenol and digitalis, for the sole purpose of a creating a monopoly to inflate the price and return large profits to their investors. When questioned about the 20-fold increase in the cost of isoproterenol, a representative of one of the pharmaceutical companies stated, “that the price was based on many factors, including clinical benefits and the value they bring to the patients, physicians, payers, and society” (New York Times 2015 Oct 4 p. BU1, “Side Effects of Hijacking Drug Prices”). The audacity of drug company executives to presume that they are in a position to make that judgment is outrageous. And yet the U.S. Congress makes it illegal for Medicare and Medicaid to bargain for the best drug prices, while European and Asian pay a fraction of what we pay here.

These ruminations only suggest that madness in the pharmaceutical world is not limited to Wall Street but reaches even the higher levels of government. Get your checkbooks out everyone; the best is yet to come.

Dr. Goldstein, medical editor of Cardiology News, is professor of medicine at Wayne State University and division head emeritus of cardiovascular medicine at Henry Ford Hospital, both in Detroit. He is on data safety monitoring committees for the National Institutes of Health and several pharmaceutical companies.