Toxic in High Doses

My extended family has a genetic predisposition to gout, which is caused by the body’s inability to flush uric acid. Crystals build up in the joints, and the painful swelling in the knees and feet can immobilize the worst cases for a week. Gout has been around for centuries, and so has its treatment by colchicine, a plant derivative.

In 2009 the Food and Drug Administration granted an exclusive marketing license on this venerable medication to a company named URL Pharma.

The price rise is a consequence of a Food and Drug Administration effort to improve the safety of long-used but unapproved drugs, with a trade-off often made between drug affordability and safety. [snip]

"It's not a new product. It's been out for hundreds of years. To all of a sudden have to pay $125 or $150 a month, after it only cost $5 or $10 a month, [bold added] is a real problem," said Stanley Cohen, a Dallas doctor who is the president of the American College of Rheumatology.

URL Pharma conducted “scientific” studies that confirmed what doctors have long known about colchicine; it can be toxic in high doses and/or over extended periods. For its trouble URL Pharma was awarded with a regulatory shield that has enabled it to sue small producers, who have stopped production.

The sudden financial squeeze on gout sufferers can be hard on elderly patients on fixed incomes, like members of my family. Another example of what happens when a powerful government agency, meaning to do well, expands its reach into an area that had previously escaped its attentions.