Our Broken IP System

About a decade ago, I had a gout attack.  Among other things, I was prescribed Colchicine.

It was originally derived from the Autumn crocus, and has been in use for more than 2000 years.

My pills cost about $8.00 each.  

A year earlier they had cost $0.25 each, but the FDA had granted exclusivity, so the cost went up by 3,200%.

This was done as a part of the Orphan Drugs Act, which was intended to support the production of drugs that would not be otherwise be made, and because the FDA is thoroughly captured by big pharma, it was applied to drugs that were widely available.

The FDA has been aggressively pushing exclusivity, and higher prices for decades.

Now they are doing it again with Colchicine, this time turning it into a $20.00 pill for the prevention of heart attacks and strokes.  The justification for this grant of exclusivity is that that the pill has 0.5 mg of Colchicine, as opposed to the older pill that has 0.6mg, which is still under exclusive licensing and still about $5.00 a pill.

………

In 2009, the FDA allowed URL Pharma to bring colchicine to market under the brand name Colcrys at a new dose of 0.6 mg per pill. Under the Orphan Drugs Act, URL Pharma was given 3 years of market exclusivity at this dose for the treatment of gout. URL Pharma also received an additional 7 years to exclusively market Colcrys for the treatment of familial Mediterranean fever at the same dose of 0.6 mg per pill. As part of these agreements, unapproved single-ingredient colchicine could not be sold in the U.S. It disappeared from the market.

The FDA and the public soon recognized that the unintended consequences of the initiative also included drug shortages and higher prices to treat gout. With these new approvals, the cost of colchicine went from pennies to about $5 per pill. The rheumatology community and other groups were extremely upset when their patients could no longer obtain fair priced generic colchicine.

During the decade following the price increase, there was a 27% reduction in the use of colchicine among gout patients who needed it. In 2013, applications were filed (and later granted in several countries abroad) for new patents allowing colchicine to be marketed as a novel agent for the prevention of cardiovascular events. While there are now 17 patents for Colcrys, until last June there was only one FDA approved form of colchicine.

………

Meanwhile, Agepha just released a retail price for Lodoco of $621 for a 30-day supply — nearly $21/pill. It will be available with a coupon at Walgreens for $170/month or about $5.66/pill. Using either the retail or coupon price, Lodoco can cost as much as four to six times more than Colcrys.

Colcrys and Lodoco are essentially the same drug. Both have only one active ingredient — colchicine. The only difference is a tiny variation in the dose. Colcrys has 0.6 mg of colchicine, while Lodoco has 0.5 mg — a difference that could be considered of no clinical consequence.

This is deeply and profoundly corrupt.

IP, patents and copyright, are a form of societal rent-seeking.  

I understand why we allow companies to enact a private tax on us in order, "To promote the Progress of Science and useful Arts,"* but we have created a system that does not work.

We are now encouraging looting, not innovation.

^*US Constitution, Article I, Section 8, Clause 8.