FDA Orders Manufacturers to Stop Making Colchicine

From Arthritis Today, link at bottom of story as well as editor's note.

Inexpensive supplies of gout drug colchicine may soon disappear from store shelves.
By Brenda Goodman   10/1/10

Companies that make unapproved versions of the drug colchicine, which is used to treat and prevent gout and familial Mediterranean fever, have been ordered by the U.S. Food and Drug Administration, or FDA, to discontinue manufacturing these pills within 45 days and to stop shipping them within 90 days.

The action means that within a few months, as pharmacies run through their supplies, the only kind of colchicine likely to be available to consumers will be a brand name version approved in 2009 called Colcrys.

So-called unapproved medications like colchicine are drugs that have been used by doctors since before the FDA began reviewing and approving new therapies in the 1960s, and they include medical mainstays like the painkiller morphine.

The FDA contends that these drugs may put patients at risk because they’ve never been reviewed for safety. Since 2006, regulators have been pushing companies that make and sell these older medications to put them through the rigorous approval process, which includes studying medications in clinical trials. In return, the manufacturers are promised market exclusivity for a period of time so they can recoup their supposed investments in the drugs.

The upside for consumers is that this effort will almost certainly help to identify potential dosing issues and drug interactions that were previously unknown to doctors and pharmacists.

The downside is that these unapproved medications, which are typically priced like generic drugs, will become much more expensive. In the case of colchicine, the retail price of the approved version, Colcrys, jumped from $.10 to $5 per pill.

After a chorus of criticism from doctors and patients, the manufacturer of Colcrys has added patient assistance programs that provide substantial price breaks for people hit hard by the increase.



Tom's left foot with gout.  Not a pretty picture.



The American College of Rheumatology, or ACR, has been encouraging other pharmaceutical companies to create more market competition for Colcrys; and on Sept. 30, 2010, Stanley Cohen, MD, the president of ACR, announced that a second drug company would apply to the FDA for the right to sell a branded form of the drug.

FDA Orders Manufacturers to Stop Making Colchicine

Colchicine has been used to treat gouty arthritis since before Christ.  Do we really need to run new tests to determine its usefulness?
This week Tom has been in bed since Tuesday because the pharmacies have run out of colchicine.
It went from $4.00 per month to about $20.00 per month. 
Colcrys is $150.00 for a one-month supply.
Thanks be to God and a caring Doctor, he seems to be on the mend today.  Prednisone and indomethacin.

Freedom of Speech

Prepare yourself to endure the "quasi-judicial" era in our constitutional, democratic form of government.
Webster’s New Collegiate Dictionary says quasi-judicial is "having to do with powers that are to some extent judicial, as those of certain boards and commissions."
The City of Greeley (along with other governmental entities) is using the phrase to nullify, circumvent and negate the heretofore constitutionally protected and guaranteed freedom of speech.
That’s right. The Greeley City Council, in its infinite wisdom and with the advice of its able legal staff, has found a way to "legally" keep you and me from speaking openly and freely with elected or appointed officials.
It also restricts the city officials in the freedom they once had to speak to you and me. But this serves their purposes so they overlook the loss of freedom.
Here’s a sentence from a city planning division form letter, dated Feb. 16, 2007: "The land use matter under consideration is considered ‘quasi-judicial’. This means that Zoning Board of Appeals, Planning Commission, and City Council members may not review or discuss the case with the applicant or the public outside of the scheduled public hearings . . ."
Yes, a case can be made that any of these city agencies sometimes performs "quasi-judicial" functions.
But the dictionary doesn’t say "quasi-judicial" means we can’t talk about things outside the quasi-courtroom of city hall. Quasi-judicial is a phrase that has escaped use in the Constitution, and the freedom of speech guarantee doesn’t say "except in quasi-judicial situations."
What it does mean is that the city aggressively blocks your freedom of speech and limits your oral contribution to hearings on city turf, at city convenience. Hearings are constrained, formal situations guaranteed to snuff out about 90 percent of what anyone would like to say. Hearings are conducted in an arena that gives the savvy bureaucracy strong tactical advantages.
So why are they being so cagey? It’s because they’ve already decided what they’re going to do. (This time it was a microwave tower.) It means they have no real interest in listening to what anyone else has to say – including owners of adjacent property. They have conveniently closed themselves off from reasonable discussion.
It means the average city official has to keep it straight in his head what issues he can talk about and what issues he can’t. (Pathological liars can’t keep their stories straight, either. And, sometimes silence itself is a bald-faced lie.)
What does silence protect? A secret. If, for example, a city councilman decided to "come clean" and "go public" about the secret machinations behind this dreadfully important microwave tower issue, he would be ostracized by his fellow bureaucrats.
His refusal to obey the quasi-legal gag order would cause great outrage among his peers. He will have blown their quasi-judicial cover, disturbing their complacency. Worse, the gabby elected official will have risked loss of membership in the Good Old Boys Club. Ouch. That would be the worst.
The city letter says the microwave tower permit issue was "considered quasi-judicial." Who was it who "considered" the issue to be quasi-judicial?
It should be pointed out that the city did offer "additional information" about the microwave tower issue – but you can bet your baby’s booties you didn't find anyone who would speak out loud about it.
Freedom of speech? Hardly.