Well, thoughtless or uncaring or both. I really despise arrogant stupidity. Case in point today: the FDA. Anyone with more active brain cells than a head of cabbage could have foreseen this:
A centuries-old drug [colchicine] used to treat excruciating gout pain had cost just pennies a tablet—until last year. Now, the retail price has skyrocketed to more than $5 and some of the manufacturers have ceased production amid a battle over marketing rights.
You see, the FDA decided a few years ago that in order to bring “grandfathered” drugs under its umbrella, it’d offer exclusive marketing rights to market such drugs to pharmas that would place them in FDA-approved clinical trials to establish FDA-approved dosages, side-effects and what not–despite the fact that such grandfathered drugs all have long enough histories of use to establish such things already.
Long enough histories? Well, for colchicine, that’s certainly the case!
The price increase is an unintended consequence of the FDA’s nearly four-year-old initiative to regulate unapproved drugs. These medicines were sold before the FDA was established, and therefore weren’t required to undergo approval. After decades of use, the medicines are considered safe by doctors, but haven’t been proven to satisfy the agency’s standards. Colchicine’s use has been traced back to the sixth century, according to the FDA.
URL Pharma did just that with colchicine and now is charging a price for the drug that is commensurate with its need to make a profit–and recover the costs of the FDA-approval-process clinical trials it paid a third party to run.
Anyone with even one active brain cell more than a head of cabbage could have foreseen that result. Since I assume there must be more than one active brain cell at the FDA, then “unintended consequences” simply means that the one (or perhaps more–hey! it could happen!) active brain cells at the FDA either just didn’t care about “unintended consequences” or any active brain cells at the FDA are simple too stupid or immoral (not giving a damn about the consequences of one’s actions is definitely immoral) to be classed as human.
The same government that gives us the Post Office, the EPA, the Department of “Education” and the FDA is going to determine what you can and can’t do regarding your health care on a much, much more intimate basis come soon. Now, isn’t that rally good news?
Imagine how much aspirin would cost if the FDA lures some pharma into this procedure–IF it could even pass FDA-approved clinical trials given all its negative side effects!
Just shoot me.
Aspirin is probably next.
I suspect that if aspirin were to be handled this way, the FDA would be burned to the ground and FDA bureaucraps tarred, feathered, run out of town on a rail, hung from the highest tree and then set on fire, so it probably will not receive this stupid attention.
Understand, that’s just my gut level suspicion… I could be wrong (though I think Lowe’s is a great place to buy rope). 😉
Well, after all, gout *IS* a rich man’s disease, right? So maybe this isn’t unintended!
Well, that’s gout’s reputation, but in these days of affluence (still, relative to past generations, despite Dhimmicrappic–and Dhimmicrappic Lite on the Repugnican’t side of the nearly Uniparty Aisle–machinations to destroy the US economy), I’ve known (middle) middle class folks with this affliction. The other thing I didn’t note in the post is that the FDA’s grant of a three year monopoly on the production of grandfathered drugs that are put through this process means that the pharma that grabs this brass ring both has to recoup expenses more quickly AND has no real disincentive to price gouging, a double-whammy that the FDA surely predicted. Surely.
I respectfully disagree with your analysis. My name is Matthew Davis, M.D. I am the Chief Medical Officer of URL Pharma. There is no such thing as “generic colchicine.” Generic products have been tested to ensure that they are exactly the same as branded pharmaceutical products and have been approved by the FDA as safe and effective. None of the colchicine products currently on the market have been by approved by the FDA, except for Colcrys. I personally ran the 17 clinical trials that lead to the FDA approval of Colcrys. Unapproved colchicine products have never undergone FDA review for safety or efficacy, so there is no assurance that these products conform to the same standards as FDA-approved products.
Also, our Patient Assistance Program is one of the most generous programs offered by any pharmaceutical company. It enables uninsured or Medicare Part D patients with household incomes up to four times the federal poverty level (up to $88,000 per year for a family of four) to receive Colcrys for $5 a month. Uninsured and Medicare Part D patients with household incomes between four and six times the federal poverty level (up to $132,000 per year for a family of four) can receive Colcrys for $25 a month.
And I, in turn, Matthew Davis, as respectfully as possible, throw the BS flag on your play. Colchicine has been used to treat gout for well over six centuries (“well over”? Well, yes. An early compound of the substance is described as used for treating gout as early as 2,000 years ago, although it seems the text was “lost” for a while and regained prominence in the early Renaissance), although the specific colchicine alkaloid wasn’t definitively refined for use as a gout drug until 1820. 1820. PLENTY of time (180 years worth) for clinical observations to accrue on the use of the refined alkaloid in treatment of gout. Saying there is no such thing as generic colchicine is playing a game of narrow definitions within the FDA rules-playing game and is disingenuous. Generic is something that is general, common, or inclusive rather than specific, unique, or selective. GENERIC colchicine’s use, as I have stated factually, far, far predates your company’s testing and marketing under FDA monopoly rules. You ought to be ashamed of yourself for such blatant BS. Its side effects have been well-documented over its centuries of use and safe, effective dosages have been arrived at over that six centuries of “testing”. My “analysis” of the issue, while simplistic, is far more accurate than your disingenuous apologia. Your appeal to your “Patient Assistance Program” for Medicare D patients is also repugnant, for reasons that ought to be apparent to any honest observer. Goodbye, and don’t let the door hit ya where the Lord split ya!
(Or, to quote that great Wisdom of the Ages, “Now, go away or I shall taunt you a second-uh time-a.”)