[LINK] After the drug patents run out - there's drug monopolies

Kim Holburn kim at holburn.net
Sun Mar 27 09:40:45 AEDT 2011

On 2011/Mar/27, at 5:20 AM, Scott Howard wrote:

> On Thu, Mar 24, 2011 at 11:58 PM, Kim Holburn <kim at holburn.net> wrote:
>> <http://www.techdirt.com/articles/20110324/02181913605/fda-suddenly-bans-drugs-that-have-been-market-decades.shtml>>
>> In 2006 the first "new" monopoly that was created by this FDA process was
>> for the malaria drug quinine sulfate. This left only Mutual Pharmaceutical
>> Company to manufacture quinine in the US (pdf). While malaria is not a
>> disease that affects many people in the US, it is big business worldwide.
>> Malaria causes 300 to 500 million infections and over 1 million deaths each
>> year. Treating this disease with quinine used to cost pennies a day. In
>> fact, the British turned this treatment into a cocktail, the gin and tonic
>> (quinine water).
> According to Wikipedia :
> "From 1969 to 1992, the U.S. Food and Drug Administration (FDA) received 157
> reports of health problems related to quinine use, including 23 which had
> resulted in death"
> "As of 2006, quinine is no longer recommended by the WHO as first line
> treatment for malaria and should be used only when artemesinins are not
> available."
> "Until recently, quinine was also a common "off-label" treatment for
> nocturnal leg cramps. This practice is now considered dubious by the FDA."
>> Another drug removed was the antihistamine carbinoxamine, which was
>> created prior to needing FDA approval, in the early 1950s. It was approved
>> by the FDA in a slightly modified form in 2006. It is now sold exclusively
>> by Mikart, Inc and Pamlab, LLC with no future competition because the FDA
>> has banned all 120 other versions of carbinoxamine. You can imagine just how
>> much that must increase the profits for Mikart and Pamlab on carbinoxamine,
>> though that seems to come at the expense of consumers.
> Again from Wikipedia :
> "In June 2006 the FDA announced that more than 120 branded pharmacy products
> containing carbinoxamine were being illegally marketed, and demanded they be
> removed from the marketplace. This action was precipitated by twenty-one
> reported deaths in children under the age of two who had been administered
> carbinoxamine-containing products. Despite the fact that the drug had not
> been studied in this age group, a multitude of OTC preparations containing
> carbinoxamine were being marketed for infants and toddlers. At present, all
> carbinoxamine-containing formulations are approved only for adults or
> children ages 3 or older."
> I'm not suggesting that these necessarily warranted the pulling of these
> drugs, nor even that what's on Wikipedia is correct itself - but as is often
> the case it's clear that there's more to the story than first reported...

Here's one that is a useful drug:


> FDA grants monopoly over preterm labor prevention drug: 15,000 percent price increase then announced
> Sunday, March 13, 2011 by: Ethan A. Huff, staff writer
> Still think the US Food and Drug Administration (FDA) has your best interests in mind? According to new reports, the agency has arbitrarily decided to grant exclusive approval to KV Pharmaceutical to produce the one-and-only FDA-approved premature birth prevention drug -- which is really just a modified, patented version of the common hormone progesterone -- administered to women with a high risk of preterm delivery. So what used to cost women as little as $10 to buy from their local compounding pharmacy will now cost $1,500, thanks to the FDA.
> Progesterone injections have long been custom-made by compounding pharmacies and sold for very little to women in need of them because, frankly, they cost very little to produce. But a backroom deal over at the FDA has changed everything, allowing a single pharmaceutical company to gain monopolistic control over the drug, which in turn allows that company to charge whatever it wants to for the injections, even if it is thousands of times more than what the drug actually costs to produce.

Kim Holburn
IT Network & Security Consultant
T: +61 2 61402408  M: +61 404072753
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