Gout is an inflammatory condition caused by the deposit of uric acid crystals in the joints, and in 50% of the cases the joint of the big toe. This is caused when levels of uric acid in the blood become too high and the uric acid comes out of solution in the blood as crystals. The treatment of gout includes medications for an acute episode and long-term prevention. The medications used for acute episodes include non-steroid anti-inflammatory drugs such as ibuprofen, naproxen, and steroid drugs (prednisone), but for centuries colchicine was used and still used today for acute attacks.
Colchicine is obtained from the plant Colchicum autumnale. The extract from this plant has been referenced for inflammatory conditions as far back as the Ebers Papyrus 1500 B.C., and additional references from the first century A.D. and 550 A.D. However, it was not until 1820 that French chemists P.S. Pelletier and J.B. Caventau isolated colchicine, and in 1833 it was purified and named colchicine by P.L. Geiger. It is interesting to note that Benjamin Franklin, who suffered from gout, brought the Colchicum autumnale plants back to America, having become acquainted with this remedy while Ambassador to France.
In 2006, the FDA started a program called the Unapproved Drug Initiative. The purpose of this program was to remove unapproved drugs from the market and obtain more rigorous testing for safety and effectiveness for drugs like colchicine and other “unapproved drugs” that have been used for a long time.
A small Philadelphia company, URL Pharma (eventually acquired by the Japanese drug maker Takeda) applied to the FDA to do the testing on colchicine and was granted rights for the drug. URL Pharma did 17 studies investing $100 million, of which $45 million went to the FDA for the application fee. This gave URL Pharma monopoly power over the drug and it sued to have other colchicine products removed from the market. Until then colchicine tablets were sold as a generic drug by many generic drug-makers for as little as $0.09 per tablet. URL Pharma quickly raised the price for their colchicine (naming the product Colcrys and selling it as capsules) to $4.85 per capsule, almost 54 times increase in price.
Currently, a colchicine product by another manufacturer is on the market but it still costs around $2.50 per tablet and Colcrys now sells for $4.15 per capsule. This price increase for colchicine has resulted in state Medicaid programs costs for the drug rising from $1 million to an estimated $50 million. Also, Medicare costs have been significantly impacted by this situation. It has been argued that the government and insurers could have done the testing themselves and saved a considerable amount of money.
The FDA program, Unapproved Drug Initiative, had the unintended consequences of making an old inexpensive generic drug into a branded product with market exclusivity. This same situation occurred in the case of other drugs such as thalidomide and pyrimethamine. Pyrimethamine is the famous drug that once the manufacturer had market exclusivity the price was raised from $13.50 to $750 per tablet.
Proving safety and effectiveness of a medicine by clinical trials is an expensive undertaking and important to public safety. The rewards of a successful marketing of a drug are great, however, it is the competition between manufacturers that controls prices for the public good in the end.
Stay informed and stay healthy.
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