# Gout Pain **URL:** \ **Category:** In My Humble Opinion\ **Created:** [June 2, 2004, 5:42pm UTC](https://boards.straightdope.com/t/gout-pain/248291 "2004-06-02T17:42:39Z")\ **Posts on this page:** 20\ **Page:** 4
**Author:** ![CalMeacham](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/calmeacham/32/35_2.png) [@CalMeacham](https://boards.straightdope.com/u/CalMeacham)\ **Post date:** [April 17, 2012, 5:38pm UTC](https://boards.straightdope.com/t/gout-pain/248291/62 "2012-04-17T17:38:02Z")
That appears to be a correct summary of the current situation. More here, including how it came about: [http://www.townsendletter.com/June2011/gaby0611.html](http://www.townsendletter.com/June2011/gaby0611.html) [http://www.cbsnews.com/2100-18563\_162-20118283.html](http://www.cbsnews.com/2100-18563_162-20118283.html) The FDA’s hands were not completely tied by federal legbislation – they appear to have had some discretion in their rulings. This is an outrageous turn of affairs. > [@](#): > > “Did you anticipate that the pricing was going to go up 50 times?” LaPook asked [FDA Official] Autor. > “I think that companies have control over the pricing and we certainly hope that they would take into account the interest of consumers and not price them unreasonably.” Right. ---
**Author:** ![needscoffee](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/needscoffee/32/1076_2.png) [@needscoffee](https://boards.straightdope.com/u/needscoffee)\ **Post date:** [April 18, 2012, 6:16am UTC](https://boards.straightdope.com/t/gout-pain/248291/63 "2012-04-18T06:16:53Z")
Oddly enough, Colcrys has no effect at all on my husband’s gout, but generic colchicine alleviates it within a day. $0.48/pill, plus shipping. ---
**Author:** ![CalMeacham](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/calmeacham/32/35_2.png) [@CalMeacham](https://boards.straightdope.com/u/CalMeacham)\ **Post date:** [April 18, 2012, 12:18pm UTC](https://boards.straightdope.com/t/gout-pain/248291/64 "2012-04-18T12:18:19Z")
> [@needscoffee](#): > > Oddly enough, Colcrys has no effect at all on my husband’s gout, but generic colchicine alleviates it within a day. $0.48/pill, plus shipping. I’m confused by this post: 1.) Colcrys, from the cites above is _identical_ with “generic colchicine”. The biggest complaint people have is that it’s the same medicine, just with the price jacked up by a factor of 50. Some people have claimed that the dosage is halved, too. If so, maybe that’s your problem. 2.) The other complaint is that the makers of Colcrys have instigated lawsuits against makers of generic colchicine, so that they’ve cstopped making the stuff. This is the other complaint – they have been givejn a monopoly and have gone out of their way to drive the generics out of the market. So how are you even _getting_ generic colchicine? ---
**Author:** ![snowthx](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/snowthx/32/10660_2.png) [@snowthx](https://boards.straightdope.com/u/snowthx)\ **Post date:** [April 18, 2012, 12:57pm UTC](https://boards.straightdope.com/t/gout-pain/248291/65 "2012-04-18T12:57:01Z")
> [@CalMeacham](#): > > I’m confused by this post: > > 1.) Colcrys, from the cites above is _identical_ with “generic colchicine”. The biggest complaint people have is that it’s the same medicine, just with the price jacked up by a factor of 50. Some people have claimed that the dosage is halved, too. If so, maybe that’s your problem. > > 2.) The other complaint is that the makers of Colcrys have instigated lawsuits against makers of generic colchicine, so that they’ve cstopped making the stuff. This is the other complaint – they have been givejn a monopoly and have gone out of their way to drive the generics out of the market. So how are you even _getting_ generic colchicine? They are not exactly identical, as I understand it. The process may work like this: drug company identifies an old drug grandfathered by the FDA for a diagnosis, but not tested for efficacy, drug company adds a molecule or two to the formulation, gets FDA approval for “their” formulation for said diagnosis, then forces the FDA to abide by it’s own rules to stop all other manufacturers from selling the “old” drug for that diagnosis (they are not FDA approved). **needscoffee** says they are getting generic colchicine from Canada. ---
**Author:** ![CalMeacham](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/calmeacham/32/35_2.png) [@CalMeacham](https://boards.straightdope.com/u/CalMeacham)\ **Post date:** [April 18, 2012, 1:40pm UTC](https://boards.straightdope.com/t/gout-pain/248291/66 "2012-04-18T13:40:46Z")
> [@snowthx](#): > > They are not exactly identical, as I understand it. The process may work like this: drug company identifies an old drug grandfathered by the FDA for a diagnosis, but not tested for efficacy, drug company adds a molecule or two to the formulation, gets FDA approval for “their” formulation for said diagnosis, then forces the FDA to abide by it’s own rules to stop all other manufacturers from selling the “old” drug for that diagnosis (they are not FDA approved). > > **needscoffee** says they are getting generic colchicine from Canada. That’s not what the news reports say – they say that Colcrys is _precisely_ the same as generic colchicine – no tampering of any sort. Hence the outrage – they’re charging an outrageous markup for the identical product. I didn’t notice that **needscoffee** was the same poster saying she got it from Canada. ---
**Author:** ![Morgenstern](https://avatars.discourse-cdn.com/v4/letter/m/f9ae1b/32.png) [@Morgenstern](https://boards.straightdope.com/u/Morgenstern)\ **Post date:** [April 18, 2012, 2:09pm UTC](https://boards.straightdope.com/t/gout-pain/248291/67 "2012-04-18T14:09:36Z")
> [@needscoffee](#): > > Colchicine is the only med that helps my husband’s gout, but only the generic version, which he now has to order through Canada because it’s not currently being sold in the US. I went to an urgent care with what I believed was a fractured ankle. It felt more like a million fractures actually. It was Gout. I was prescribed Colchicine, given a shot and sent home. Early the next morning my Internist’s office called and told me to not take the Colchinine. I have no idea why. ---
**Author:** ![CalMeacham](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/calmeacham/32/35_2.png) [@CalMeacham](https://boards.straightdope.com/u/CalMeacham)\ **Post date:** [April 18, 2012, 2:20pm UTC](https://boards.straightdope.com/t/gout-pain/248291/68 "2012-04-18T14:20:28Z")
I’ve beebn checking the references. Nothing indicates any change has taken place – in fact, URL Pharma’s testing of a long-used and successfuil drug would be most likely to take place with a completely unaltered drug, rather than introducing changes that might have a deleterious effect. URL’s objection to people calling the drug from other sources “generic colchicine” seems to be completely rooted in a legalistic interpretation of the meaning of “generic” as an FDA-approved product. Colchicine was never approved by the FDA because it was in use long before there was an FDA. URL’s chief action seems to be in reducing the dose. URL also emphasizes that “unapproved colchicine” might not be consistent in purity and concentration, but never suggest or imply any difference in formulation. ---
**Author:** ![timid1](https://avatars.discourse-cdn.com/v4/letter/t/a9a28c/32.png) [@timid1](https://boards.straightdope.com/u/timid1)\ **Post date:** [April 18, 2012, 3:55pm UTC](https://boards.straightdope.com/t/gout-pain/248291/69 "2012-04-18T15:55:00Z")
Indomethacine does the trick for me also. However, I recently had a bout of shingles on the back of my head. Lasted two weeks before I finally got some pain pills that helped. I was this close to jumping of a building. ---
**Author:** ![CalMeacham](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/calmeacham/32/35_2.png) [@CalMeacham](https://boards.straightdope.com/u/CalMeacham)\ **Post date:** [April 18, 2012, 3:55pm UTC](https://boards.straightdope.com/t/gout-pain/248291/70 "2012-04-18T15:55:27Z")
A succint recap: > [@](#): > > The price of colchicine is increasing by 50-fold, from about $0.10 per tablet to $5 per tablet, unless physicians and patients can convince the Food and Drug Administration to allow the colchicine made by generic manufacturers to stay on the market. A twice-daily dose of colchicine will increase from $6/month to $300/month because one company has taken advantage of FDA rules and the orphan drug law to the detriment of patients. > > Colchicine has technically been an “unapproved drug” rather than a “generic drug” as it predates the law that required drugs to be approved by the FDA. In recent years the FDA has been encouraging companies to do the studies to get these drugs approved by offering an exclusive marketing period, and removing some of the unapproved drugs from the market. To that end, Mutual Pharmaceutical Co./URL Pharma performed a clinical trial comparing two dosing regimens for acute gout, did some drug interaction studies in normal volunteers, and branded their previously generic/“unapproved” colchicine product as Colcrys. > > The FDA approved the drug with exclusive marketing rights for gout for 3 years and for Familial Mediterranean Fever for 7 years; the longer exclusivity period for its use in Familial Mediterranean Fever is because that indication qualified it as an orphan drug. This by itself does not mean the other manufacturers of colchicine can’t continue to sell the drug, only that their formulations can’t be FDA-approved. Now that there is an FDA-approved drug available, however, most industry observers expect the FDA will stop the sales of the unapproved versions. But this is not mandatory, and we must urge the FDA to use its discretion to not ban the sale of unapproved colchicine. > > Not waiting for the FDA to act, Mutual/URL tried to eliminate its competition by filing suit against the other manufacturers of colchicine a few days after gaining approval of its version, claiming that merely by listing their colchicine for sale it falsely implies their products are FDA approved. A request for a preliminary injunction to stop unapproved colchicine from being sold was denied, with the court noting that the plaintiff was doing the very same thing until the day before Colcrys was approved, but the suit is pending. Meanwhile, either anticipating the FDA will ban the sale of unapproved colchicine or because of the lawsuit, three of the other four companies have stopped making colchicine. The one remaining competitor has raised the price to match Mutual’s $5/tablet. > > Although Mutual’s formulation of colchicine gained approval as an orphan drug for Familial Mediterranean Fever, the company conducted no new clinical trials with patients with FMF. The package insert states the evidence for efficacy in FMF and for gout prophylaxis “is derived from the published literature”—studies that ironically used the same unapproved colchicine that Mutual/URL seeks to force off the market. They have so perverted the orphan drug process—a process intended to facilitate the development of new drugs with a small market—that it has made an old drug less available instead of making a new one more available. > > The FDA should acknowledge the unintended consequences of its actions and announce that it will not remove unapproved colchicine from the market. Only then will generic manufacturers resume making colchicine available for pennies a pill, as they had been doing for decades. > **[Colchicine Deal Unfair to Patients](https://freerepublic.com/focus/f-news/2448650/posts)** ---
**Author:** ![CalMeacham](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/calmeacham/32/35_2.png) [@CalMeacham](https://boards.straightdope.com/u/CalMeacham)\ **Post date:** [April 18, 2012, 4:08pm UTC](https://boards.straightdope.com/t/gout-pain/248291/71 "2012-04-18T16:08:24Z")
New England Journal of Medicine on the topic: [http://www.nejm.org/doi/full/10.1056/NEJMp1003126](http://www.nejm.org/doi/full/10.1056/NEJMp1003126) ---
**Author:** ![CalMeacham](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/calmeacham/32/35_2.png) [@CalMeacham](https://boards.straightdope.com/u/CalMeacham)\ **Post date:** [April 18, 2012, 4:10pm UTC](https://boards.straightdope.com/t/gout-pain/248291/72 "2012-04-18T16:10:09Z")
Statement from a physicuian, from back when URL had “only” jacked the price up by a factor of 15, rather than 50: > [@](#): > > Speaking as a physician, this ruling by the FDA is a disaster for patients who take colchicine. > The drug trial by the pharmaceutical company looked only at acute gout. The treatment course was very short and most patients had residual pain at the end of the treatment course. > That’s the only clinical scenario the trial looked at. But that’s not how colchicine is usually used these days. Usually NSAIDS in high dose or prednisone are used for acute attacks in patients who can take these drugs. > The most common use of colchicine currently is in low dose chronically. For example it is often used to suppress flareups when starting a patient on a drug like allopurinol which is used to prevent gout attacks. In this circumstance it often has to be taken in low dose (eg 0.6 mg once)daily for weeks if not months. > Most physicians, I think, are aware of the toxicity of colchicine and know that dose modifications are essential in patients with certain common conditions. > By forcing the “usual” colchicine off the market, the folks at URL are going to raise the cost of treatment by a factor of 10 or 15 making it prohibitively expensive. > It is really aggravating that by doing a rather simple, very short term trial, using the drug in a way that it is not usually used any more, that the company can get this windfall. I am sure that if the FDA ruling stands they will more than recoup their investment. What’s next - aspirin? - another very old drug that could have the same thing happen. [http://pipeline.corante.com/archives/2010/04/14/colchicines\_price\_goes\_through\_the\_roof.php](http://pipeline.corante.com/archives/2010/04/14/colchicines_price_goes_through_the_roof.php) ---
**Author:** ![CalMeacham](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/calmeacham/32/35_2.png) [@CalMeacham](https://boards.straightdope.com/u/CalMeacham)\ **Post date:** [April 18, 2012, 4:24pm UTC](https://boards.straightdope.com/t/gout-pain/248291/73 "2012-04-18T16:24:29Z")
Here’s something interesting and recent. olcrys is evidently the chief moneymaker for URL. And URL is being sought by Japanese pharmaceutical company Takeda, which sells most of its drugs in the US: [http://entertainment.verizon.com/news/read.php?id=19035020&ps=1014&srce=morenews\_class&action=2&lang=en](http://entertainment.verizon.com/news/read.php?id=19035020&ps=1014&srce=morenews_class&action=2&lang=en) ---
**Author:** ![needscoffee](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/needscoffee/32/1076_2.png) [@needscoffee](https://boards.straightdope.com/u/needscoffee)\ **Post date:** [April 18, 2012, 5:15pm UTC](https://boards.straightdope.com/t/gout-pain/248291/74 "2012-04-18T17:15:31Z")
> [@CalMeacham](#): > > I’m confused by this post: > > 1.) Colcrys, from the cites above is _identical_ with “generic colchicine”. The biggest complaint people have is that it’s the same medicine, just with the price jacked up by a factor of 50. Some people have claimed that the dosage is halved, too. If so, maybe that’s your problem. > > 2.) The other complaint is that the makers of Colcrys have instigated lawsuits against makers of generic colchicine, so that they’ve cstopped making the stuff. This is the other complaint – they have been givejn a monopoly and have gone out of their way to drive the generics out of the market. So how are you even _getting_ generic colchicine? We wish we knew why Colcrys has little to no effect and generic colchicine works so well and so fast. The dosage is a standard .6 mg. There is another thread from a few weeks ago about this same monopolistic situation with regards to another previously-common medication, where the price was jacked up 100x and pharmacists are no longer supposed to compound it themselves: [KV Pharma - A royal screwing w/o vaseline - The BBQ Pit - Straight Dope Message Board](http://boards.straightdope.com/sdmb/showthread.php?t=602583) ---
**Author:** ![CalMeacham](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/calmeacham/32/35_2.png) [@CalMeacham](https://boards.straightdope.com/u/CalMeacham)\ **Post date:** [April 18, 2012, 8:07pm UTC](https://boards.straightdope.com/t/gout-pain/248291/75 "2012-04-18T20:07:36Z")
Apparently similar “monopoly” rulings have occurred with nitroglycerine pills and the active ingredient in Mucinex: [http://www.cbsnews.com/8301-505123\_162-42844506/how-the-fdas-crackdown-on-unapproved-drugs-could-create-new-monopolies/](http://www.cbsnews.com/8301-505123_162-42844506/how-the-fdas-crackdown-on-unapproved-drugs-could-create-new-monopolies/) Maybe URL saw the handwriting on the wall and jumped in before anyone else could claim a monopoly? All of these cases are outrageous, going around a multiple-decades-old “grandfather” arrangement. But this all seems to stem from a 2007 FDA initiative to finally do something about those “unapproved” “grandfathered” drugs. [http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/UCM199776.pdf](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/UCM199776.pdf) Your FDA – indirectly driving up costs for your benefit. ---
**Author:** ![snowthx](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/snowthx/32/10660_2.png) [@snowthx](https://boards.straightdope.com/u/snowthx)\ **Post date:** [April 18, 2012, 8:47pm UTC](https://boards.straightdope.com/t/gout-pain/248291/76 "2012-04-18T20:47:54Z")
Not to derail this Gout discussion any further, but you may have heard of quinine, the anti-malarial drug that has also been around for ages. It was “branded” with the same strategy by AR Scientific which, you guessed it, is a division of URL Pharma… [http://www.qualaquin.com/](http://www.qualaquin.com/) From a different link: “Qualaquin is the brand name for the drug quinine sulfate. Made and sold by AR Scientific, a unit of URL Pharma, this prescription medication is sold in capsules containing 324mg of quinine. In August 2005, the U.S. Food and Drug Administration (FDA) granted Qualaquin “orphan drug” status, meaning AR Scientific received a monopoly to sell the drug exclusively for seven years. Quinine has a 400-year history as an anti-malarial drug.” ---
**Author:** ![bobot](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/bobot/32/21622_2.png) [@bobot](https://boards.straightdope.com/u/bobot)\ **Post date:** [July 10, 2012, 3:48am UTC](https://boards.straightdope.com/t/gout-pain/248291/77 "2012-07-10T03:48:03Z")
I am currently experincing a gout attack in my left foot. I am utterly grateful that, this time, it’s in my pinky toe. I can still put my weight on my heel and big toe, and still walk. The last time, it was my big toe. The following is no exaggeration: After working and hobbling for 8 hrs. in my heavy steel toed woorkboots, I came home and became barefoot as quickly and gently as possible. I stood on my cool garage floor, with a shovel in my hand imagining that with one quick chop, my foot would betray me no more. I don’t usually complain of pain, but good God, gout hurts like a mo-fo! ---
**Author:** ![aruvqan](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/aruvqan/32/2891_2.png) [@aruvqan](https://boards.straightdope.com/u/aruvqan)\ **Post date:** [July 10, 2012, 4:14am UTC](https://boards.straightdope.com/t/gout-pain/248291/78 "2012-07-10T04:14:39Z")
> [@bobot](#): > > I stood on my cool garage floor, with a shovel in my hand imagining that with one quick chop, my foot would betray me no more. I don’t usually complain of pain, but good God, gout hurts like a mo-fo! I joke with my podiatrist about it, but we agree that if he did chop off my feet I would be in the small percentage of people who gets phantom limb pain :smack: ---
**Author:** ![MPB\_in\_Salt\_Lake](https://avatars.discourse-cdn.com/v4/letter/m/c0e974/32.png) [@MPB\_in\_Salt\_Lake](https://boards.straightdope.com/u/MPB_in_Salt_Lake)\ **Post date:** [July 10, 2012, 4:21am UTC](https://boards.straightdope.com/t/gout-pain/248291/79 "2012-07-10T04:21:00Z")
If it was me, I would immediately start chugging buckets of cold water, eating fistfuls of ibuprofen (well, as many as you can safely stomach) and then look into some cherry juice extract in the morning… (It’s not perfect, but barring access to the proper Rx drugs, probably the best thing you can do for the time being) ---
**Author:** ![aruvqan](https://sea3.discourse-cdn.com/straightdope/user_avatar/boards.straightdope.com/aruvqan/32/2891_2.png) [@aruvqan](https://boards.straightdope.com/u/aruvqan)\ **Post date:** [July 10, 2012, 10:02am UTC](https://boards.straightdope.com/t/gout-pain/248291/80 "2012-07-10T10:02:30Z")
> [@MPB\_in\_Salt\_Lake](#): > > If it was me, I would immediately start chugging buckets of cold water, eating fistfuls of ibuprofen (well, as many as you can safely stomach) and then look into some cherry juice extract in the morning… > > (It’s not perfect, but barring access to the proper Rx drugs, probably the best thing you can do for the time being) Even a doc in a box can prescribe colchicine and indocin [my current starter go to, I can usually beat down a CPPD flare if I hit it as soon as I get that tickle in my feet] ---
**Author:** ![robardin](https://avatars.discourse-cdn.com/v4/letter/r/43a26b/32.png) [@robardin](https://boards.straightdope.com/u/robardin)\ **Post date:** [July 10, 2012, 12:44pm UTC](https://boards.straightdope.com/t/gout-pain/248291/81 "2012-07-10T12:44:53Z")
This is awful. I never knew much about gout, and still don’t, but I am now reading up about it because my 76 year old father evidently has it. He’s complained for a 2 or 3 years about intermittent pain in his left leg - his calf swells up and becomes all red. He takes meds when this happens and it goes away after a little while. He hasn’t mentioned being in constant pain during these attacks, just that he doesn’t feel like walking around much and that his diet is restricted when it happens (no alcohol, primarily, and no red meat). It flared up again last week and I took a look at the pills he was taking, it was “Colcrys” which I hadn’t heard of before. (I’d expected Prednisone or some kind of NSAID as an anti-inflammatory treatment.) Googling it revealed that what he’s been having is gout ☹ Your descriptions of what an attack of gout is like first hand makes me marvel at my father’s steeliness. He really has not complained much at all. It seems this is a permanent condition, once it develops? It can only be controlled or ameliorated with medication, not cured? [Previous page](https://boards.straightdope.com/t/gout-pain/248291.md?page=3) [Next page](https://boards.straightdope.com/t/gout-pain/248291.md?page=5)