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Colchicine or Colcrys - Enclosure of the Commons

by johnk Wednesday, Jul. 29, 2020 at 9:37 PM

A rundown of how the FDA helped make some big drug companies richer, and small drug companies bigger, by privatizing a 5000-year old drug.

I remember in the early 2000s I was given colchcine for gout. I had lost my drug benefits, but the price was pretty cheap, as I remember it. I think it was under $10.

Later, when I had Kaiser, it was free because the price per pill was less than the copay. The retail prices were around 30 cents to two dollars.

Today, the retail price is around $120, and the discounted price just under $60.

This happened because the FDA granted a temporary monopoly to URL Pharma to undertake clinical trials of the drug, to determine the best way to dose and use the drug. URL Pharma raised the price of colchicine, now branded as Colcrys. (I recall it was around $25.)

URL Pharma got bought up by Takeda. Takeda raised prices again.

To summarize the prices for a small bottle of the drug: in 2000 - under $10; 2020 - $120.

The high cost of the drug today is the direct result of privatization of this previously generic drug.

The government acted to enclose this public domain drug, to create new intellectual property, not through direct action, by paying for the drug research, but by using the neoliberal strategy of having the private sector do the work, in exchange for a monopoly on the drug. The intent was to help subsidize the existence of a small company, URL Pharma.

However, instead of growing the company URL Pharma sold out to Takeda.

The end result is that the people are charged more money and capitalists get wealthier. Takeda got larger, too.

This capitalist consolidation was virtually predictable, at least by any cold-eyed left-wing theory of how capitalism works and tends toward monopoly.

Unfortunately, in the US, even among the left, neoliberal fantasy predominates, and even this author assumed that the temporary monopoly would expire, and competition resume, and prices would drop, perhaps not down to cents-per-pill, but down into the dollar-per-pill range. How wrong I was.

The history below shows that, once a capitalist firm gets monopoly of a drug, the monopoly isn't ever fully released. Rather, the temporary monopoly is turned into a patent, which is licensed out, and turned into a more durable monopoly. After that, "price stickiness" takes hold, and none of the makers will lower prices very much, because the buyers are willing to pay the high prices.

In response to these high prices, people are now growing plants to extract the drug. The Autumn Crocus was the original source of colchicine, and you can sometimes find people selling this flower online, for the purpose of growing colchicine.

This is such a farce. The cost per pound to grow anything typically exceeds $1 a pound (so it’s rarely ever cost effective to grow anything but the more expensive herbs and vegetables).

Once you have the plant, how do you know if it's strong enough, or too strong? Unless you have a lab and knowledge of how to extract and test the chemicals, you don't.

Chinese sources of colchicine and colchicine plant extracts price their product from $10 to $500 per kg. The $10 price is for 98% pure, so it isn’t medical grade. It’s probably for orchid growers who want to impede cell division to produce plants with bigger flowers. The higher priced colchicines are for drugmakers.

The rest of this article is the history from Wikipedia:

An unintended consequence of the 2006 U.S. Food and Drug Administration (FDA) safety program called the Unapproved Drugs Initiative—through which the FDA sought more rigorous testing of efficacy and safety of colchicine and other unapproved drugs[37]—was a price increase of 2000 percent [38] for "a gout remedy so old that the ancient Greeks knew about its effects."[38]

Under Unapproved Drugs Initiative small companies like URL Pharma, a Philadelphia drugmaker, were rewarded with licenses for testing of medicines like colchicine. In 2009, the FDA reviewed a New Drug Application for colchicine submitted by URL Pharma. URL Pharma did the testing, gained FDA formal approval and was granted rights over colchicine. With this monopoly pricing power, the price of colchicine increased.

In 2012 Asia's biggest drugmaker, Takeda Pharmaceutical Co., acquired URL Pharma for $800 million including the rights to colchicine (brand name Colcrys) earning $1.2 billion in revenue by raising the price even more.[38]

Oral colchicine had been used for many years as an unapproved drug with no FDA-approved prescribing information, dosage recommendations, or drug interaction warnings.[39] On July 30, 2009 the FDA approved colchicine as a monotherapy for the treatment of three different indications (familial Mediterranean fever, acute gout flares, and for the prophylaxis of gout flares[39]), and gave URL Pharma a three-year marketing exclusivity agreement[40] in exchange for URL Pharma doing 17 new studies and investing $100 million into the product, of which $45 million went to the FDA for the application fee.

URL Pharma raised the price from $0.09 per tablet to $4.85, and the FDA removed the older unapproved colchicine from the market in October 2010, both in oral and intravenous forms, but gave pharmacies the opportunity to buy up the older unapproved colchicine.[41] Colchicine in combination with probenecid has been FDA-approved prior to 1982.[40]

July 29, 2009, colchicine won FDA approval in the United States as a stand-alone drug for the treatment of acute flares of gout and familial Mediterranean fever.[42][43] It had previously been approved as an ingredient in an FDA-approved combination product for gout. The approval was based on a study in which two doses (1.2 mg and 0.6 mg) an hour apart were as effective as higher doses in combating the acute flare of gout.[17]

Marketing exclusivity in the United States

As a drug antedating the FDA, colchicine was sold in the United States for many years without having been reviewed by the FDA for safety and efficacy. The FDA reviewed approved colchicine for gout flares, awarding Colcrys a three-year term of market exclusivity, prohibiting generic sales, and increasing the price of the drug from $0.09 to $4.85 per tablet.[44][45][46]

Numerous consensus guidelines, and previous randomized controlled trials, had concluded that colchicine is effective for acute flares of gouty arthritis. However, as of 2006, the drug was not formally approved by the FDA, owing to the lack of a conclusive randomized control trial (RCT).

Through the Unapproved Drugs Initiative, the FDA sought more rigorous testing of efficacy and safety of colchicine and other unapproved drugs.[37] In exchange for paying for the costly testing, the FDA gave URL Pharma three years of market exclusivity for its Colcrys brand,[47] under the Hatch-Waxman Act, based in part on URL-funded research in 2007, including pharmacokinetic studies and a randomized control trial with 185 patients with acute gout.

In April 2010, an editorial in the New England Journal of Medicine said that the rewards of this legislation are not calibrated to the quality or value of the information produced, that no evidence of meaningful improvement to public health was seen, and that it would be less expensive for the FDA, the National Institutes of Health or large insurers to pay for trials themselves. Furthermore, the cost burden of this subsidy falls primarily on patients or their insurers.[48] In September 2010, the FDA ordered a halt to marketing unapproved single-ingredient oral colchicine.[49]

Colchicine patents expire on February 10, 2029.[50]

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