“Each year in the United States about 30,000 babies are born with cystic fibrosis, a disease that causes severe lung and breathing problems (Kaiser, 2012). This inherited (genetic) disease occurs because an affected child inherits a defective gene from each parent. Modern medical treatments enable babies born with cystic fibrosis to survive to about age 40. Despite the improved care and therapies, there still is no cure.

In 2012, the U.S. Food and Drug Administration (FDA) and the health programs in Canada, the European Union, and other countries approved the drug Kalydeco (ivakator), which can restore lung function in a specific subtype of cystic fibrosis patients—about 4 of 100. Vertex Pharmaceuticals, the company that manufactures Kalydeco, charges $300,000 for a year’s supply of pills (taken twice daily). Most cystic fibrosis patients who respond to the drug will need to take it for decades to stay alive.

Many doctors, patients and their families, and insurers, including the U.S. government, which pays for the drug through Medicare Disability and Medicaid, object to the high cost. They point out that the scientific research that discovered the drug was paid for by taxpayers and that Vertex received considerable help from the Cystic Fibrosis Association and hence spent less than the typical $1 billion to $2 billion to develop the new drug. Without some adjustment in the price, as is being demanded by the U.S. and European governments, each patient receiving the drug will produce a multi-billion-dollar profit for Vertex. In the for-profit model of drug development and sale, Vertex is doing nothing illegal to price its product as it sees fit.

The cost of Kalydeco and other new drugs approved for serious diseases—especially cancer—which is almost always more than $100,000 per treatment or annually if the drug must be given continuously, is a pressing problem facing the healthcare system. With modern genetic technologies to help produce more drugs to treat small numbers of patients, industry and drug developers will be tempted to exploit their advantage financially. Detecting and treating genetic and other serious diseases are rife with ethical and economic concerns that will become critical in the coming years.”

References:

Edlin, G., & Golanty, E. (2019). Health & Wellness (13th ed.). Jones & Bartlett Learning

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