This is another example of big Pharma, with the approval of the FDA, ripping off the American public. I just declined to pay $1,100 for Colcrys. And I have insurance.
No wonder health care costs are out of control in the US.
On April 16, 2010, we summarized an article on an industry-sponsored randomized trial of colchicine for acute gout flares (JW Gen Med Apr 16 2010). But why did a drug company choose to perform this study? The answer to that question sheds light on a new controversy surrounding an old drug.
In 2006, the FDA launched the “Unapproved Drugs Initiative,” which targeted old drugs that had never been approved by the FDA. The rationale was that older unapproved drugs, including colchicine, deserve as much scrutiny for efficacy and safety as do newer drugs. In response to this initiative, the drug company URL Pharma decided to conduct pharmacokinetic and clinical research on colchicine with the intention of bringing it to market as a brand-name product. The clinical trial covered by Journal Watch General Medicine was sponsored by URL Pharma and was a key factor in the FDA's approval of brand-name colchicine (Colcrys) in 2009.
In that trial, patients with acute gout were randomized to receive an oral “low-dose” colchicine regimen (1.2-mg dose initially, followed by a single 0.6-mg dose 1 hour later), a “high-dose” colchicine regimen (1.2-mg dose initially, followed by 0.6 mg hourly for 6 hours), or placebo. At 24 hours, patients in the low-dose group were significantly more likely than placebo recipients to report a ≥50% reduction in pain (38% vs. 16% of patients), and side effects were similar in those two groups. In contrast, patients who received hourly dosing for 6 hours had substantial gastrointestinal toxicity but no additional benefit compared with low-dose patients.
The controversy enters the picture here: URL Pharma has been given market exclusivity for 3 years, and companies that produce “nonapproved” colchicine — the products that we've prescribed for decades — are required to phase out production in 2010. Patients will experience this transition as an extraordinary increase in the cost of the drug: Colcrys sells for US$5 per pill, whereas nonapproved colchicine costs pennies per pill.
URL Pharma, the FDA, and healthcare professionals (notably the physician leadership of the American College of Rheumatology) have been engaged in a rather testy debate about these developments. The drug company and the FDA defend their position that efficacy and safety are enhanced because Colcrys is manufactured with FDA oversight and because the prescribing information provides guidance on indications, dosing, and drug interactions. In contrast, the American College of Rheumatology contends that, with responsible prescribing, nonapproved colchicine is safe and effective and that patients who cannot afford Colcrys will suffer. URL Pharma has countered with a program to assist low-income patients.
Practical clinical issues have been overlooked in this debate. The FDA-approved prescribing regimen for Colcrys in patients with acute gout flares is the low-dose regimen from the randomized trial — 1.2 mg initially, followed by 0.6 mg at 1 hour — and nothing else. In the clinical trial, assessment of efficacy ended at 24 hours, because providing ongoing placebo for a painful condition was considered to be unethical. However, most colchicine-treated patients still had substantial pain at 24 hours. How should we manage those patients, who will need further treatment? Switching to a nonsteroidal anti-inflammatory drug (NSAID) or prednisone makes no sense: Most clinicians consider using colchicine for acute gout precisely in patients with contraindications to NSAIDs or prednisone, which are the usual first-line oral treatments. Stated another way, why would we pick an initial treatment regimen that likely will require “rescue” therapy within 24 hours? A 1-week comparison between a low-dose colchicine regimen and a standard NSAID regimen would have been far more clinically relevant than the comparison in the published study.
In the end, I doubt whether the marketing of Colcrys will change the way most of us manage acute gout flares. Indeed, clinicians generally prescribe colchicine not for acute gout but rather for long-term prophylaxis. In fact, the FDA has approved Colcrys for prophylaxis at a dose of 0.6 mg once or twice daily. It's the cost of long-term prophylaxis — $1800 to $3600 per year at full price — that will likely have patients and clinicians scrambling during the next few years. For more on this topic, we invite you to listen to our interview with Aaron S. Kesselheim, MD, JD, MPH (Brigham and Women's Hospital, Boston, MA).
This is another example of big Pharma, with the approval of the FDA, ripping off the American public. I just declined to pay $1,100 for Colcrys. And I have insurance.
No wonder health care costs are out of control in the US.
Is not obamcare i paid 160.00 for 30 colcry pill before obamcare ever happened .it is easy to blame anything but big phama and the lobbists.
The old / traditional dosage schedule for colchicine was significantly higher than current recommendation. Even when taken using the old dosage levels, 6 mg of Coycrys is less effective than 6 m,g of the older unregulated colchicine.
Like colchicine, he FDA also imposed themselves on hypo-thyroid drugs that had been available for nearly 50 years without the FDA's evaluation and oversight.. The result..... higher price with no benefit to the user.
When picking this up for spouse in July 2015, seven pills: $91.99 ($13.14 per pill) WITH INSURANCE! Cash price: $65.00 ($9.28 per pill). Unbelievable. No gout flares in several years so this new ripoff was a shock. We prefer our charitable dollars go to non-profits and those struggling, rather than to Big Pharma, (or insurance) thank you very much. Another shameful US government fail. I second the aspirin next remark. Off-shore pharma, here we come...
I have to agree. I am told that colcrys is colchicine. My experience is that it doesn't work anywhere near as well as colchiicine.
I have a friend who do not have medical insurance needed this medication.
In Walmart pharmacies (considered the cheapest among all the pharmacies) they are selling US$126 for 20 pills (this is brand name).
From online Canadian pharmacies, they are selling generic for 100 pills for $80 (or US$16 for 20 pills).
Then I asked a friend in Asia, she told me they are selling 20 pills (I believe generic) for (US$1.88) from reputable pharmacies too. I cannot believe it. You do not need any doctor's prescription and they are sold over the counter.
These pharmaceutical industries in US are just day light robbers.
Does anyone know if the original colchicine is due to be available again anytime soon? Seems like the 3 year exclusivity period must be just about up...
You misunderstood the three year period, that was an exclusive marketing period, not the patent period, the patent is for the standard 20 years, and renewable for another 20, in 10 year increments. This was a deliberate end run to profit a corporation, which the FDA did and I can almost bet someone involved in it, directly or indirectly will soon appear working at Pharma. That is the typical payoff for giving someone what will amount to hundreds of millions of dollars of very low cost investment return on their money, Pharma also got the patent for Quinine. Malaria patients will be suffering as well.
Congress is bought and paid for: How is it American Drug Companies are permitted to violate the anti-dumping laws? If Japan sold steel in America at lower prices than in Japan, International law would be evoked and the practice would have to stop. American Drug Companies have sold drugs lower in foreign Countries than they do in the US. The VA, Medicare, and Medicaid can not bargain for lower prices from American Drug Companies. We need to Impeach or recall any Congress person that votes against the welfare of it's representatives.
I remember several years back, during the Baby Bush administration when Congress, their leash-holders in big pharma, and the FDA began ranting about the "potential harm", "questionable quality control" and "accurate formulation" with respect to American citizens buying prescription drugs from Canada.
Apparently, the US pharmaceutical industry was miffed that Americans could buy prescription medications 50% to 75% cheaper via mail order from Canada. Obviously, big pharma wasn't about to have anyone muscle in on their turf. Too much money was involved. The solution was to essentially criminalize the whole process. Buy meds from Canada and you could go to jail. The irony was that many of the meds were actually manufactured in the USA. But the true hypocrisy was that the single biggest buyer of Canadian pharmaceuticals was the US Department of Defense. Apparently, US firms could not provide the prices - and subsequent cost savings - that Canadian firms could provide when Uncle Sam went out looking for a good deal on a medical contract.
The exclusivity shenanigans with colchicine and the blatantly criminal price increase comes as no surprise.
It's no longer about helping our citizenry, it's all about greed, and never mind at the expense of those who will suffer physical or financial pain. And I am speaking of corporations AND our government; both of whom hardly exhibit any discernible difference nowadays. This is criminal and should be investigated.
I recently had gout and realized that the generic colchincine could not be bought.
The Colcrys is so expensive, and indeed it is not effective as colchincin. It would take about 3 days for my pain to go away.
I have had 2 minor flareups of gout in past year. Today went to podiatrist who gave me a prescription for Colcrys along with cortisone injection in toe. Along with script he gave me discount coupon to get prescription for $15. When I went to pharmacy I found Medicare does not allow me to use the discount coupon and had to pay $40 as a tier 3 drug. So if I did not have a Medicare program, I get a better price. So pharmaceuticals are once again screwing the senior citizens and Medicare and all through the approval of tax paid FDA. This is the government at it's bestn this endeavor. How convoluted can this be. The seniors who need it the most have gone from a generic pennies a day program to $1+ a day with a drug program and close to $5 a day if you have no insurance. Where is our consumer protection. Lobbyist for drug companies really paid off big time. Is this another example of Obamacare?
I read your response and agree 100 percent. I lack one year of Medicare and you answered my question. I have no insurance, was treated yesterday for sever gout again, been on steroids. Gout flare up, back on steroids, received script for colcrys....the price for 30 pills was $ 288.79. Now what is wrong with this picture?
This is another example FDA facilitate drug company to exploit us patients
This really is rediculous. I'm sure that the pharmaceutical companies are now scouring the the list of useful generic drugs for others that they can hijack, patent and overcharge the american public for. Buy it elsewhere.
Call your senator and congressman. We need a law even if it is a special law just for colchicine. Millions of americans are affected.
My 85 year old grandmother had been taking colchicine for years for her gout. When she was forced to switch to Colcrys, the problems began. On generic colchicine she would MAYBE have one flare up a year that last 3-4 days. Since being on Colcrys for 1 year, she's had 4 flare ups. One of these flare ups requiring her to have a surgeon remove a tophi (build up on uric crystals) on a toe. Tophi's are caused by uric acid crystals that are so numerous they actually cause swelling and poor circulation because the surrounding tissue is so swollen. My grandmother is 85 and on warfarin ( a bllod thinner) and had to go 1 1/2 from her town to have the surgeon lance the area. Her flare ups now last up to 1 week. My point is why do you mess with something that is working. We got away with it though- ordered from Canada and haven't had a gouty flare up since.
The FDA it seems should be taken to task on this. Only the United States Patent and Trademark office can grant exclusive rights on methods and products for limited periods of time. No other entity has that right.
As a physician caring for many patients with familial Mediterranean fever, I have heard, of course, about the egregious jump in cost because of corporate greed. But moreover, I have heard from 4 patients that the Colcrys is not effective in suppressing their attacks of FMF whereas generic colchicine had been completely effective. Moreover, one complained that she couldn't take the Colcrys because it caused severe diarrhea, whereas generic colchicine was well tolerated.
Colchicine continues to be indicated at the first sign of a gout flare. It has disadvantages as prophyllaxis against flare. It does not affect uric acid levels; it is an anti-inflammatory agent. Flares may also be treated with NSAIDs or oral corticosteroids. The long term use of colchicine has been associated with myositis( NEJM). For lowering of uric acid, to prevent deposition of urates in joints or to achieve absorption of urates, i.e. tophi, etc. there are two commonly used medications: probenecid, safe and effective, increases urinary excretion of uric acid. Allopurinol, occasionally allergy causing, causes the body to manufacture less uric acid. They are equally effective (Cecil's Textbook of Medicine) Colchicine, therefore, is not a first line drug for chronic treatment of gout. When needed, Canada pharmacies have the generic form at reasonable prices. My chronic gout gives me no trouble, at little financial cost.
This is in response to the latest racket that the drug companies have schemed with the FDA's help.
My 82 year-old mother has been in pain for days now waiting to get her Colchicine ordered, approved and picked up. She has been taking Lorcet in lieu of Colchicine until she could get her medication. The Lorcet makes her very unsteady and she has had multiple near falls, she is also taking Coumadin. Plus, the Lorcet is not as effective.
Imagine my surprise when she questions me as to why her $4.00 co-pay is now $40.00. She is a retired nurse and I am a practicing RN. Ninety pills costs $456.48. We smell a rat!
What idiot thought this up? What is next, aspirin at $10 a pill? I guess the public should start hoarding these medications. I will surely recommend and pass on this information.
My mother has decided it is better for her to take the risk of falling and breaking a hip because of the Lorcet than to be robbed yet again by the drug companies and the healthcare system. What a shame. This will cause other patient's to make bad decisions and end up costing the healthcare system even more money for ER visits, falls, Dr. visits, etc.
Yet another example of why everybody mistrusts and hates the government .....
An obscene example of an FDA dominated by big pharma dollars. Disgusting. The purpose of government is to protect the people. Congress is now a multi-millionaire club. The majority has no representation.
This is an outrageous case of corruption. I learned that the company that manufactures it was bought out for 800 million dollars. Government officials that allow for this to happenare criminals and should be behind bars.
From a recent conference on stem cells in cardiac disease,it was apparent these treatments are available in most countries even the caribean, brazil,peru but not inUSA or Canada because of rigid regulatory processes of governing bodies.In 21 st century,the impediments of freedom will be our bureaucracies which are sinking us.
As one who has taken 3 colchicine per day for more than 25 years, and who will always need to do so for a condition other than gout, I find the government created monopoly on drugs pre-dating the FDA approval system unconscionable. My cost has gone from under $100 a year to over $2,000.
Clearly whether or not I can afford medication that I need to survive (not just to quell pain) is of little consequence. As they say, with friends like the FDA, who needs enemies?
Btw, will someone post which foreign pharmacies they trust? I would also like to explore getting my medication elsewhere.
I have been on Colchicine for over 2 years now. Since being on it, I have not had any episodes of my vasculitis. With my insurance, I was only paying $6.00 for a monthly supply. I was very surprised when I picked up my refill, and was informed that I now will be taking Colcrys. Pharmacy informed me that they will no longer carry colchicine. I spoke with my rheumatologist today and he informed me of the situation. This is terrible for the American public. As a former RN, I believe this is outrageous for our low income patients and for those without insurance. As the cost will now be $5.00 a pill. I can't believe the FDA would go this, and now this drug company will make profits off of this. Once again, it is a sad fact, that drug companies and the government feel that money is more important than sick people.
Well, well. A test not representative of past or expected practice (anyone out there stop taking it before the symptoms were gone?) and the price goes up 20 fold, all in the guise of protecting. Only entity protected is the maker, an organization apparently unable to survive in a real competitive environment. Count me as another consumer caught in a gout flare who got the bad news that we'll now pay twice, in pain and in $$$$. The biggest proponents of the free market are those with the greatest ability to game the system to take public domain knowledge and create a monopoly goldmine - they've got theirs and those with the audacity to become ill are pushed aside again, but not before having pockets emptied.
I was told that the original colchicine can be purchased in Canada at its original low price.
Just found out my 60 tab script went from $10 to $384. I have taken one .6 mg tab of colchicine a day for 3 years - no gout flares and also no side effects - after years of debilitating flares. There is absolutely no problem with the low dose generic colchicine. Many studies have shown that problems occur only at high doses, and that is also the case with Colcyrs. How can the FDA be so corrupted and so cold to abandon the needs of its citizens in favor of drug company profits. Clearly there is no invention here - this drug is not new - and they are allowed take control of it, and charge 38 times more for it at the expense of people with arthritis?? The justification was they could prove that the Colcrys dose is consistent and that low doses are effective? Non toxic dosage has been know for decades, and all manufacturers supplying in America have had consistent product since the formula was synthesized 30 yrs ago. Corruption and abuse of our system like this will continue to kill our economy and our country. Shame on our government. Yes please - we must get together to protest - and write your congressman - post your success in securing reputable foreign sourcing. We have no choice here. Do not pay their evil ransom!
I am trained as a clinical pharmacologist. My sister-in-law called me to say that the colchicine my father-in-law is taking has gone from $5 to over $80. I found this site and am outraged. This recently happened to another drug. Hydroxyprogesterone is used to prevent premature labor. It used to cost $10 a dose. The company KV pharmaceuticles won exclusive licensing rites and it now costs $1500 a dose. This is a trend. It is also sin.
Colchicine is an ancient remedy for gout and until now has been easily available at a fair and reasonable price. Gout sufferers do not have much of a choice in solutions for the relief and management of the disease. This is a crimminal act by the FDA handing over a medication to one resource that has no proprietary research necessary. My monthy supply has gone from $18.00 per month to $196.88 per month. This is an obscene and criminal act by the FDA.
Patients -- including me -- will be forced to go outside the country for affordable colchicine, where they will face increased risk of receiving bogus pills and where they will have no legal recourse for any damages if they do. That was not the case when they were using unapproved colchicine before.
This is an absolute sin...to take a drug that worked and was reasonably priced and turn it into a cash cow. Another example of how greed has trumped compassion and concern for patients in the drug industry. I guess since they did not take an oath of "do no harm" that they feel that they can take advantage of the consumer without limit. Shame on the FDA, URL and Pharma.
I have taken colchicine for at least 30 years, whenever I feel a gout attack coming on. I have never had any serious side effects. When I went to my pharmacy the other day to renew my prescription, I was told that colchicine was no longer on the shelves because the FDA had never tested and approved it. The replacement drug, Colcrys, was available, however, to the tune of approximately $6.00 per pill (colchicine cost pennies per pill). I am livid with anger that the drug company, URL Pharma, is gouging the public with the pricing of this drug. I am even more angry that the FDA allowed all of this to take place. This is a rip-off of astronomical proportions and contrary to everything that the new health care program is supposed to be in favor of. I will never take Colcrys, preferring instead to get colchicine from outside the country. Good luck with that, FDA!
I've used Colchicine Tabs 0.6 for years costing me only $10 through Medco mail-in for a 90-DAY supply. Yesterday, my pills came but was labeled Colcrys. I looked at the $420 bill for a 90-days supply and was shocked to say the least! I called the pahrmacy and they mentioned that FDA regulations says they cannot take it back or refund my money!! They mentioned that generic Colchicine Tabs is no longer available only the brand name Colcrys. Never again.
I was surprised to find my Colchicine Rx was changed to Colcrys. As an experienced Colchicine user I want to report a toxic like effect: I had been taking 1 or 2 Colchicine tablets per week, now 1 Colcrys tablets upsets my stomach and gives diarrhea. Colchicine has a threshold of 3 tablets before stomach complications. This old drug has been tried and tested.
This can only be greed on the company's part and frank undefensible craziness on the FDA's part. OK seek an approval process, but then allow a price my patients can't afford (low income or not) on a product some have used >35 years in my practice. No one can defend that price increase! Why allow a company to %^&!! patients?
How much Money must we spend to keep a suffer of Gout from severe Pain? In June of 2010 I went to a Hospital with severe pain in my feet, knees, shoulders and elbows. I spent 10 days in the Hospital because I could hardly walk or stand.They took a blood draw daily but neglected to analaze it for Uric Acid. I was again hospitalized in August (8 days) for the same symptoms and again the hospital Doctors neglected to give the correct diagnosis. From June 2010 to November 2010 I was in such severe agony that I would have paied as much as the pharmaceutical companies could/would charge. Eventually in November 2010 after the correct diagnosis and another 5 days of hospital confinement and a prescription for COLCRYS I was headed home somewhat relieved from the excruciating and agonizing pains.throughout the joints in my body. My prescription cost $389.00 for a thirty day supply of Colcrys. Of cource I paid the riped off charge.Any thing to alleviate the three months of unbareable agony. (Aug-Nov) This of course is the ploy of the pharmaceutical companies. Who in there right mind would not pay for the drug to rid the pain? They know this. Our government (Elected officals) allows these compaines to charge as much as they can in favor of receiving pharmaceutical money for their re-election campaigns. This is Outrageous and a crime against the American People for Congresses disreguard of this enormous expense.
As the father of two boys, ages 6 and 14, who take 45 and 60 tablets a month respectively, I am very concerned with the fact that I am currently scouring the local pharmacies for whatever colchicine they have left. The wholesaler reps have told the local pharmacies that they are running out and they do not know if or when they are getting any back in. My sons have taken the medicine since they were infants. Before FMF was diagnosed in my oldest son, he was suffering from severe abdominal pains and fever in excess of 103 degrees over the course of a year culminating in an attack for almost 45 days straight. He was 2 years old and we gave him Tylenol and Advil alternating every 3 hours just to keep his fever down. Colchicine was a miracle. Once he was given the drug his attacks stopped within days and have been kept at bay for the past 12 years with an adjustment in dosage. By keeping him attack free, the physical damage FMF can cause has also been kept from materializing. With genetic testing we determined that my other son also has the condition and he was prescribed the medicine prophylactically at 6 months old. He thankfully has never suffered an attack. With colchicine they would live normal lives with a normal life span, without it these two otherwise healthy boys are in jeopardy of suffering debilitating attacks that can damage their internal organs and shorten their life expectancy unnecessarily. Is this fair that a drug that has been available for generations with no dangerous side effects produced from a plant that is readily available and grows in the wild, become regulated, limited and then overpriced to compensate the already wealthy drug companies at the expense of innocent children? With a wealth of information regarding the use and history of the drug, did the pharmaceutical companies really need to spend money to test and approve this drug? Is there a valid reason that this pill should go from costing pennies to dollars per tablet? I know it is known also to treat gout, otherwise known as "the rich man's disease", but many people who have gout and especially those who have FMF are not likely to be that wealthy. If they are they won't be for very long with the pills costing $5 per tablet. My sons, as well as many other FMF sufferers who are usually diagnosed when they are children, will need to take this medicine daily for the rest of their lives. Thankfully we have insurance, but I am concerned that this added expense will put pressure on our insurance companies and they may find a way to deny us or my sons insurance in the future. Without insurance the cost today would be $525 per month for my family. Like many others, we cannot afford this enormous expense. Something reasonable needs to be done!
First it was the IV colchicine that they pulled from the market, which had some merit, but I have not heard of any plans to bring it back. It was a uncontrolled manufacturing problem. Now they have given soul source rights to a to a product that that has been in use for centuries. I would suspect that this is just the first step in removing it from the market in favor of another drug that is being developed at an even higher price. The original colchicine was derived from the Autumn Crocus plant.
I have used colchine for 20 years with great results. If the federal govt does this with one pill, how can they effectively regulate health care for 350,000,000 people?
I have been taking colchicine for 6 years with no side effects or gout flairups. Price..$ 5-15.00. Now it will be co-pay $180. for the same med. What a rip off.
Outrageous-- downright theft of a material that's been in the public domain for 150 years. Saying that's ok because they have a program for low-income people is saying that it's ok to steal from middle & upper income patients? It stinks of a money pay-off. FDA should rescind the withdrawal of generic colchicine.
IF you ever doubted that we have an immoral corporate owned government here is your proof. That a corporation would be allowed to openly steal from the public by getting a patent on a drug that has been around for years and years is nothing short of criminal. My disgust for corporate owned government has reached a new high. I am a retail pharmacist and express my opinion to those being ripped off by this white collar theft.
Colchicine has been around for ages. I have used it for about 20 years. Another example of government knows best. I thought we were trying to reduce drug costs. My cost went up 19 fold.
Again our government has failed us.No need for me to elucidate. Our founding fathers knew when they forewarned "one day our government will no longer adequately perform"(paraphrased). So here is concrete proof(as if we needed more). I already see hundreds of patients who can not afford their prescribed regimens, but don't worry Obama Care will fix it all (NOT)
Sorry, I meant Lewy bodies dementia, that can be related to deposition of an Amyloid-like substance, and Colchicine does show positive results when dosed to Amyloidosis patients. May be 1mg qd will be enough, as for Chondrocalcinosis
Encouraged by comments from an old USA established physician, some of my female menopausal patients took Colchicine for relievement of dry-eye sindrome, several responses were oberved, but also some leukopenias. Deserves a formal clinical trial? A theoretical background exists for dosing Colchicine to Lewis bodies dementia patients, as related to Amyloid -like deposition. Another CT?
This is a regrettable misuse of the regulatory system. The FDA should enlist better advice than it apparently had.
If they had any decent products we could boycott their other products. This is a crime against humanity, pure and simple. Greed at its worst!
A boycott is a good idea, let's start a movement that boycotts any company that participates in this rip off trial drug scam. We could list all the companies that benefitted from the testing of established, non tested drugs. This thing is money motivated, we need to attack it where it started.
I sent the FDA a note asking who went to bed with whom on this deal. No common sense! I won't use use it any more at $5 /pill are they nuts!
For the name "colchicine" to become proprietary property after being used for untold number of years seems ridiculous. It is akin to giving names like "digitalis" or "aspirin" similar status.The unseemly increase in cost of colchicine is almost criminal.