2 ms·

Summary: "Once approved, the drug may not be marketed or promoted for so-called "off-label" uses – i.e., any use not specified in an application and approved by

Summary: "Once approved, the drug may not be marketed or promoted for so-called "off-label" uses – i.e., any use not specified in an application and approved by FDA. Pfizer promoted the sale of Bextra for several uses and dosages that the FDA specifically declined to approve due to safety concerns." Bextra was approved: "for the treatment of osteoarthritis, adult rheumatoid arthritis, and primary dysmenorrhea." [0] But was marketed for: "In such documents, PHARMACIA marketing team stated as the “intended” use and message for Bextra that Bextra was for “acute pain.”" [1] [0]: https://en.wikipedia.org/wiki/Valdecoxib#Uses_until_2005 https://en.wikipedia.org/wiki/Valdecoxib#Uses_until_2005 [1]: https://archive.is/20091207084948/http://www.usdoj.gov/usao/ma/Press%20Office%20-%20Press%20Release%20Files/Sept2009/PharmaciaPlea.html#selection-361.247-361.376 https://archive.is/20091207084948/http://www.usdoj.gov/usao/...

mtgx 5y ago
They most likely did this so they can extend their patent rights on the drug. By continuing to "reframe" what the drug does, they can continue getting new patents for it almost in perpetuity. It's a pretty common trick Big Pharma has been using these past few decades.
mumblemumble 5y ago
It's almost as if prescription drug marketing were inherently a severe conflict of interest that represents a danger to public health, and should therefore be much, much more tightly restricted.
- austincheney 5y ago
  Prozac was created for use as an anti-psychotic but filed with the FDA for use as an anti-depressant. Because there are soooo many depressed people which means more money for the same drug. Wikipedia says it is the 23rd most prescribed drug in the US(wtf).
  - mumblemumble 5y ago
    Do you have a source for that? I couldn't find any mention of that in the Wikipedia article (https://en.wikipedia.org/wiki/Fluoxetine#History https://en.wikipedia.org/wiki/Fluoxetine#History), and it seems, from the history I've tracked down, like SSRIs were specifically developed with an intent to treat mood disorders. There does seem to be a combination drug that includes prozac and olanzapine that's used to treat psychotic disorders. It's been on the market for a while; maybe that's resulted in some confusion?

mtgx 5y ago

They most likely did this so they can extend their patent rights on the drug. By continuing to "reframe" what the drug does, they can continue getting new patents for it almost in perpetuity. It's a pretty common trick Big Pharma has been using these past few decades.

mumblemumble 5y ago

It's almost as if prescription drug marketing were inherently a severe conflict of interest that represents a danger to public health, and should therefore be much, much more tightly restricted.

austincheney 5y ago
Prozac was created for use as an anti-psychotic but filed with the FDA for use as an anti-depressant. Because there are soooo many depressed people which means more money for the same drug. Wikipedia says it is the 23rd most prescribed drug in the US(wtf).
- mumblemumble 5y ago
  Do you have a source for that? I couldn't find any mention of that in the Wikipedia article (https://en.wikipedia.org/wiki/Fluoxetine#History https://en.wikipedia.org/wiki/Fluoxetine#History), and it seems, from the history I've tracked down, like SSRIs were specifically developed with an intent to treat mood disorders. There does seem to be a combination drug that includes prozac and olanzapine that's used to treat psychotic disorders. It's been on the market for a while; maybe that's resulted in some confusion?