The other claims that seem totally unbelievable to me are:

1. nearly 200 people have died related to Colchicine toxicity (there have been a few from injections, but that was solved by withdrawing the injectable form)
2. The FDA asked all of their Colchicine manufacturers in the USA to get the drug approved (how and why?)
3. several hundred million dollars in clinical trials and development cost (where are the financial statements that back this?)

The last sentence is at best misplaced salesman’s zeal, but I prefer the description of a lie. The sentence before that has a ring of truth in blaming the FDA as they have acted immorally. Also.

Here is what goutispainful29 says: “Plus one 30 count bottle of Colchicine will only last about 4 or 5 flares and Colcrys will last for 10 (it also has a 36 month shelf life). ”

I am the proof, LIVING PROOF, (so far still living, if barely, :cry: ) not for goutispainful29, but for a 90 count bottle of Colchicine, bought in January of 1996 and the last pill taken in January of 2010. My 90 count bottle lasted a hell lot longer (14 years) and for more than just 15 flares (his claim) than his “30 count bottle of… Colcrys [which] will last for 10 flares and a 36 month shelf life.”

This response from goutispainful29 would have more credibility if there was some proof to accompany the claims.

If the issues were purely to do with safety, then there are much better ways to tackle this. Clearly this Colcrys fiasco has much more to do with money than health. No amount of pitching from it’s supporters is going to change that.

I am a reporter at the Wall Street Journal newspaper interested in discussing the experiences of gout sufferers who take Colcrys or unbranded colchicine. I am particularly interested in learning if anyone has experienced price increases or not. Please contact me at jonathan.rockoff@wsj.com. Thank you. Jonathan Rockoff, The Wall Street Journal

thanks to all
Nancy

http://www.kaiserhealthnews.org/Stories/2009/December/29/FDA-approval.aspx

Hopefully, I’ve banned this fool, but they seem to have nothing better to do than find ways of posting rubbish.

I have had to take the step of insisting that commenters must log-in before posting. There is a login form at the top every page. It requires a valid email address to get the initial login password, but I keep these addresses strictly private (except for spammers, of course, whose details get sent to their internet access provider and the police if necessary).

Nancy Sparks Morrison:
I am going to try to express myself, but am holding on to my temper because I do NOT understand the above post.
Whoever Dusty Wood IS, he or she certainly is showing NO compassion on this list with replies like the above. You can not GET OVER FMF
it is an inherited disease that at present is NOT curable and unlike gout which may be with you from time to time,
FMF is a part of your everyday life.
The problems with the FDA in the US in controlling colchicine causes problems for many of us. The cost of the pill which is supposed
to cost about 3 cents to make, has risen here from a cost of about $10.00 per month to a cost of over $400.00 per month because
of the FDA’s decision. It and the the disease are NOT something you get over.
I appreciate the help of Gout Pal tremendously in dealing with this problem.
Nancy

Nancy, I understand your anger. I am angry, too. I have seen some of the remarks to your posts. I am glad you are holding on to your temper. Do not waste your time and particularly your energy on morons with no mind, intelligence, knowledge, experience, and compassion. If you try to explain, they’ll feed on that and thrive. Totally ignore all that they are saying and not being recognized will eat them up, eventually.

With regard to FDA, if you, I, and everyone else likes it or not, the FDA has become a pawn for the pharmaceutical industry in their power play to control and exploit/extort the public. Don’t forget: The combined pharmaceutical industry is a trillion Dollar Powerhouse while the United States of American Government is a multi-trillion Dollar Poorhouse

Hans

Whoever Dusty Wood IS, he or she certainly is showing NO compassion on this list with replies like the above. You can not GET OVER FMF
it is an inherited disease that at present is NOT curable and unlike gout which may be with you from time to time,
FMF is a part of your everyday life.

The problems with the FDA in the US in controlling colchicine causes problems for many of us. The cost of the pill which is supposed
to cost about 3 cents to make, has risen here from a cost of about $10.00 per month to a cost of over $400.00 per month because
of the FDA’s decision. It and the the disease are NOT something you get over.

I appreciate the help of Gout Pal tremendously in dealing with this problem.
Nancy

The following post is here because of Kaiser Health’s permission to post with credit from their site:

The High Price of FDA Approval

There are NO Melungeon diseases.

Familial Mediterranean Fever is an inherited ilnness that is being found amongst descendants of Appalachian ancestry.
I do not believe the disease is rare, just being misdiagnosed as everything under the sun including, lupus,
fibromyalgia, RA and osteo-arthritis and any other illness ending in ‘itis.’

The High Price of FDA Approval

By Harris Meyer

Dec 29, 2009

Several months ago, Doris Webb was diagnosed with a rare disease called Familial Mediterranean Fever, a hereditary condition tied to her French ancestry that causes fevers, arthritis attacks and inflammation of the lining of the lungs and abdomen. Debilitating pain in her joints and bones was relieved by a prescription drug called colchicine.
To read the rest see:

http://familialmediterraneanfever.blogspot.com/

Love
Nancy

Hi Guys!

For 3 tabs of colcrys per day, my cost will be $90.00 per month and with this ONE drug, I will be put into the donut hole before the year end, where I will have to pay the whole cost of four hundred and some dollars, per month, not counting my other drugs.

It will be cheaper for me to pay out of pocket, I THINK, the $100.00 per 200 hundred ODAN colchicine from Canada and use the AARP program for my other drugs with perhaps help from my doctor giving me the brand name drugs that I use as samples when he can.

We NEED to keep working on this and hopefully with help from the Wall St. Journal article and the Washington free-lance reporter, we can do something about this. I will DIE without colchicine. It is a crime that I and others who do not have this even little bit of coverage will have to suffer or go without eating if we want to continue to LIVE.

If those of you living in Turkey, Israel and other countries where colchicine is very cheap could help those who have no insurance or who have multiple family members needing to take this drug, it would be very gracious and kind of you.

Sign me a VERY ANGRY
Nancy

I will talk w/ my Medicare Part D insurer on Monday and see how much they will pay for the Colcrys although I HATE to buy from them
just because of principle. Going to see if my physician will be able to get samples of colcrys as well. He is helpful about giving me
samples of the 2 expensive drugs I do take when he has them. It helps.

More when I know more.
Love
Nancy

I can walk on the treadmill a little over a third of a mile in 13 minutes now. That is better than having to hold onto the walls and furniture and not being
able to rise from a seated position without help. I still have to help myself up the stairs, using both hands on the handrail but it is taking less force to pull
me up.

I will write when I have been able to reach Wal-Mart. We have had and are still having snow. I am in for the count for several more days
at least :-) I do not go out in the snow!
Nancy

As you quite rightly commented earlier, the generic manufacturers had little to gain by an expensive battle to retain rights to a low profit generic. However, at least one of them had the business sense to do a strong marketing campaign before they lost their right to supply. I have no idea how much has been stockpiled by the more savvy wholesalers and retailers, but I would imagine they went for as much as they could get.

What I’m saying is, I called my local Wal-Mart Pharmacy, here in the rainy Pacific Northwest.

Colchicine 0.6 mg #30, is four dollars.

So it’s still on the Wal-Mart $4.00 list in my area. Trying to figure out if this IS a problem, or is GOING TO BE a problem.

Will send url when report comes out in the journal.
Thanks for all your help and support.
Nancy

It seems hopeless sometimes, but at least you have raised one voice. A few million more might bring some changes.

Perhaps small victories are all that are available at this time – like buying generic colchicine from reputable Canadian pharmacies.

I consider this to be a reality, not an excuse for not fighting them, being in my 80th year on this planet and 53rd in this country.

Nancy

For those w/ gout whose doctors don’t believe, BELIEVE me, those of us w/ FMF can surely sympathize. Doctors are still
questioning my diagnosis. I had an infection, went to an Urgent Care facility. I had no fever, in fact what came up was my
normal temp of 95.2. But tests did show a bacterial infection. That along w/ the FMF can just about do me in if I don’t get
an anti-biotic quickly enough.

Now here is something that I just found on FMF that may affect more of us than we now know:

Hereditary periodic fever syndromes.
Hematology Am Soc Hematol Educ Program. 2005;:74-81
Authors: Kastner DL
The hereditary periodic fevers are a group of Mendelian disorders
characterized by seemingly unprovoked fever and localized inflammation. Recent data
indicate that these illnesses represent inborn errors in the regulation of
innate immunity. Pyrin, the protein mutated in familial Mediterranean
fever, defines an N-terminal domain found in a large family of proteins involved
in inflammation and apoptosis. Through this domain pyrin may play a role
in the regulation of interleukin (IL)-1beta, nuclear factor (NF)-kappaB, and
leukocyte apoptosis. Cryopyrin/NALP3, another protein in this family, is
mutated in three other hereditary febrile syndromes and participates in the
inflammasome, a newly recognized macromolecular complex crucial to IL-1beta
activation. Somewhat unexpectedly, mutations in the 55 kDa receptor for
tumor necrosis factor also give rise to a dominantly inherited periodic fever
syndrome, rather than immunodeficiency, a finding that has stimulated
important investigations into both pathogenesis and treatment. Finally, the
discovery of the genetic basis of the hyperimmunoglobulinemia D with periodic
fever syndrome suggests an as yet incompletely understood connection
between the mevalonate pathway and the regulation of cytokine production. These
insights extend our understanding of the regulation of innate immunity in
man, while providing the conceptual basis for the rational design of targeted
therapies, both for the hereditary periodic fevers themselves and other
inflammatory disorders as well.
PMID: 16304362 [PubMed - indexed for MEDLINE]
Nancy

Thumbs up to both Goutpal at to the brave anonymous physician. Looking from my perch here in Canada I have sympathy for both of your views. I applaud our physician for making an attempt to understand the crisis and the need for links in what has been happening in the States. Those of us that do suffer from gout tend to get a little uptight when questioned about our Knowledge related to gout. I have spent decades researching anything I can find about the topic and when confronted with a doubter I tend to forget that they are not suffering from Gout attacks and usually don’t understand. I have had many M.D.’s treat me for my condition and it boils down to the fact that colchicine works (get new script) and don’t leave home without it. The states have a problem with socialized medicine that does affect Canada. Many of our Medical Professional people emigrate to the States to make more money (nuff said on that). For those of you that are sourcing colchicine from Canada, make sure that It has been manufactured in Canada, not third world sourced.

Apologies to Nancy if this is detracting from your fight. I should be doing more to promote your cause, but I’m having difficulty fining the time.

To everyone else:
Had this been in the UK, I’d have chained myself to Parliament (or similar stunt to publicize this outrage). Short of someone flying me over to invade the White House, I only have words.

I’ll hold my comments in check in future until I cool down.

Sheesh, no kidding. Is that how you get people on your side?

Sorry, on this side of the pond, we are allowed to express opinions. I do not want to mislead anyone by hiding my feelings. This is not really a fight of mine – I’m just trying to give it publicity.

Personally, I don’t take colchicine, but I am appalled at the treatment of people who need help, by those who should know better. It is not about taking sides – it is about treating people properly. I have no time for people who put profit before people, and not a lot of time for those who sit on the sidelines watching it happen.

It is easy to find excuses for doing nothing, and it is easy to find the legal situation (e.g. my comment of November 4, above).

California Court Denies Preliminary Injunction in Lanham Act Case Concerning Unapproved Colchicine Drugs [from one of several legal links on that page] In 2007, Plaintiffs [Mutual Pharmaceuticals - generics arm of URL Pharma] applied to the FDA for an orphan drug designation for its colchicine product. See 21 U.S.C. §§ 360aa-ee. On July 29th and 30th of this year, through the orphan drug approval process, the FDA granted to Plaintiffs a three-year exclusivity period to market their branded colchicine product – renamed Colcrys – for the treatment of gout flares and a seven-year exclusivity period for the treatment of FMF. After obtaining FDA approval and exclusivity, the price of Plaintiffs’ Colcrys increased from approximately $9 per bottle to $485 per bottle. According to Plaintiffs, despite the
exclusivity period granted to them by the FDA, Defendants [Watson, West-Ward, Excellium, and Vision] continue to distribute their competing colchicine products at substantially lower prices.

Blah, blah, blah. $ $ $

I’m sorry that you are offended by my tone – I thought Americans were made of stronger stuff. No wonder the thieves and vagabonds of the FDA & URL Pharma are running rings round you.

http://www.rfcexpress.com/lawsuit.asp?id=51388
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2009/10/california-court-denies-preliminary-injunction-in-lanham-act-case-concerning-unapproved-colchicine-d.html

Look for “Mutual Pharmaceutical Company, Inc. et al v. Watson Pharmaceuticals, Inc. et al”

Almost the very instant the company got FDA approval for the branded colchicine, they immediately filed suit against the generic manufacturers. From there, I don’t know all the legal ramifications, but clearly their intent is to clear the market so you will have no choice but to buy their five dollar pills instead of the ten cent pills.

If they actually had a new drug, or even if they’d done something new with the old drug, I’d say they had a point, even if a bad point. But as best as I can tell, all they did was use a combination of govenrnment FDA bureaucracy and good old litigation to clear the market for themselves.

“CRY HAVOC !! And let slip the dogs of law.”

Anyway, now this is something that might interest a reporter, or you can present to your local congresscritter.

FDA Approves Colcrys(TM) (colchicine, USP) For Prevention Of Gout Flares
http://www.medicalnewstoday.com/articles/167904.php

Also see:
http://books.google.com/books?id=MfHn2sBJ8LEC&pg=PT104&lpg=PT104&dq=when+a+product+is+branded,+what+happens+to+the+generics&source=bl&ots=Ruhl_Tbh7S&sig=ORSkGBfBqjQvQ2F4RO6fM4gwGhk&hl=en&ei=GLIFS6alJMPVlAfOkdWrDA&sa=X&oi=book_result&ct=result&resnum=10&ved=0CCgQ6AEwCQ

If a maker of colchicine try to infringe on URL Pharma’s “patent”, it can be sued. No generics are allowed for 7 years after a drug is branded to allow the branding company to recoup the expense it put up to do the testing.

“How does a drug innovator protect its product?
When a developer of a new drug chemical believes it has a useful product, it may decide to apply for a patent, which if granted, will typically last for twenty years, depending on the jurisdiction in which its issued. This means that, among other rights, that the drug developer – the originator of the drug – has the sole right to obtain regulatory approval of, manufacture and market the drug, or license others to do so, during the life of the patent. Also, the brand name of an innovative drug is often protected as a trade mark and cannot be used by any other party. Developers often secure additional and ancillary patents after the initial patent is issued, in order to prolong their period of exclusivity. ”

Search this site for more on colcrys
http://www.google.com/search?hl=en&rlz=1G1GGLQ_ENUS351&ie=ISO-8859-1&q=colcrys&btnG=Search
Nancy

http://www.fdalawblog.net/files/colchicine—decision—2-09-cv-05700-pa-rz.pdf

and

http://dockets.justia.com/docket/court-cacdce/case_no-2:2009cv05700/case_id-450709/

In the latter, I notice multiple defendants. This “may” represent various manufacturers of generic colchicine.

I noticed this same company with respect to another drug, quinine, used “off-label” for nocturnal leg cramps. They might be playing the same game with that drug.

Seems they’re using litigation to sue the generics out of the market. But not a lawyer.

This is something I can work with. Look around and find original source links. Don’t approach newspapers and elected officials with hearsay.

Sheesh, no kidding. Is that how you get people on your side? Though not doubting anyone here, there is one detail I’m trying to nail down.

One drug company has branded colchicine. OK. That part I know, and is on the record.

Are the established companies prohibited from making generic colchicine? I’m looking for documentation of this. All I’m hearing is “I’ve heard” and “I was told”. Same about the story that the brand-name manufacturer is litigating to drive the generic manufacturers out of the market.

Does anyone have any links? I’m not going to approach public officials or newspapers with hearsay.

The links in my articles to the FMF support group, and to the forums here, provide plenty of independent proof that there is a real problem here.

One comment in particular in the FMF support group sticks in my mind. It is from someone in the pharmaceutical industry – not URL Pharma – who had a massive sales drive prior to the Colcrys announcements to off-load their stocks. Due to the nature of the supply chain, this means that right now, there are some distributors with plenty, and some pharmacists who are already noting the massive price rises. The piecemeal effect of shortages has played right into the hands of Killer Colcrys as they have dissipated the outrage.

Personally, I think you are very naive if you believe that the FDA are motivated by safety and efficacy. If this were true, there is plenty of action that they could have taken without awarding exclusive licenses. I’m sorry if this sounds harsh, as I truly welcome any help you can bring to this, but it is absolutely obvious that this is all to do with money.

I beg of you, if you can bring any influence to bear, then please do it now.

First, the FDA told me that there was NEVER any generic colchicine, only ILLEGAL colchicine. Secondly, URL Pharma has a 7 year hold on colchicine as the primary ingredient of their colchrys development. They have ‘branded’ colchicine with the help of the FDA. So there will be no ‘generic’ colchicine for that period of time. Watson Labs has stopped production of their colchicine product. After the other labs run out, and stop shipping to pharmacies, the only available source in the US is going to be URL Pharma. I suggest you write to them about this.
See:

FDA Approves URL Pharma Inc.’s Colcrys(TM) (colchicine, USP) for Prevention of Gout Flares
10/19/2009
URL Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Colcrys(TM) (colchicine, USP) for the prophylaxis (prevention) of gout flares. Colcrys was first approved by the FDA on July 30, 2009 for the treatment of acute gout flares when taken at the first sign of a flare. Colcrys is anoral, branded form of colchicine that has been formulated for optimal efficacy and tolerability. It is the only single-ingredient colchicine to be approved by the FDA for the prophylaxis and treatment of gout flares. Colcrys provides a formulation with the efficacy of colchicine while avoiding most of the toxicity of the unapproved products historically on the market. Colcrys is also indicated for the treatment of Familial Mediterranean Fever (FMF) in adults and children 4 years of age or older. Colcrys is available via prescription at pharmacies nationwide. Two randomized clinical trials assessed the efficacy of colchicine 0.6 mg twice a day for the prophylaxis of gout flares in patients initiating treatment with uric-acid lowering therapy. In both trials, treatment with colchicine decreased the frequency of gout flares. Colchicine has been shown to be well-tolerated when paired with uric acid-lowering agents such as allopurinol. The dosing of Colcrys for gout flare prophylaxis is one tablet (0.6 mg) once or twice a day. The maximum daily dose for prophylaxis is two tablets (1.2 mg). The most commonly reported adverse reaction in clinical trials of colchicine for the prophylaxis of gout was diarrhea. In the presence of mild-to-moderate renal or hepatic impairment, adjustment of dosing is not required for use in gout flare prophylaxis, but patients should be monitored closely for adverse effects of colchicine. In patients with severe renal impairment, the starting dose for prophylaxis of gout flares should be 0.3 mg per day and any increase in dose should be done with close monitoring. For patients undergoing dialysis, the total recommended dose for prophylaxis of gout flares should be 0.3 mg given twice a week with close monitoring. In patients with severe hepatic impairment, a dose reduction may be needed in prophylaxis

Might want to talk to the FDA as well.
Nancy

I understand the concept of the FDA wanting to clean up the loose ends of these old drugs that predated the FDA. They want safety and efficacy proven. Seems one manufacturer did what the FDA wanted.

What I’m looking for, are citations and links about the other part of this. Will the generic colchicine be removed from the market? Are existing manufacturers now, or in the near future, prohibited from manufacturing generic colchicine? I’ve read accusations that the manufacturer has filed lawsuits against the generic manufacturers, trying to get them to cease and desist from manufacturing the generic.

I’m looking for specific news citations. If anyone can provide the links and citations, I promise I’ll put them to good use.

Just to clarify. We are talking about the Food and Drug Administration here.
FDA Shame.
FDA Corruption.

In the meantime, the lawyers get rich whilst pharmaceutical companies play games with people’s pain and people’s lives.

Though originally derived from autumn crocus, colchicine has become an extremely cheap drug to manufacture.

Nothing has changed in the manufacturing process, but the FDA have given URL Pharma an exclusive deal to charge almost 50 times the price.

It is blatant profiteering, and it stinks that a public body that is supposed to protect citizens is putting those who cannot afford it at risk.

I do not know if the ‘tea’ has any colchicine in it, but it would be extremely dangerous to try to do that.

I have ordered my colchicine from Canada. Have been on it 5 days now and it seems to be doing just fine for me so far.

I ordered from

http://www.77canadapharmacy.com/

Cost more than US colchicine previously, at $102.00 for 200 pills and that includes shipping and handling. Will be able to get SOMETHING back from my insurance but not sure how much. However that is certainly less than what I would have been paying for Colchrys at $5.00 per pill. The brand name is ODAN, made in Canada.

Thanks for all your help!! :-)
Nancy

skremprime: Come to Canada, if you need colchicine.

That’s a good option if you’re near the border, but not for the majority of US citizens.

I know that if I were in a similar position I would be concerned about quality issues and customs interference when buying from abroad.

Has anyone any experience of ordering colchicine from Canada or beyond, into the US?

Nancy