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

[Scott Howard]

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...

  Scott.