Me, the FDA and a Price Increase of 5300 Percent
I have gout. Gout is an extremely painful form of (generally) joint pain generally caused by high levels of uric acid in the blood. The uric acid "precipitates" crystals into the joints which then swell up in a characteristic way causing tremendous pain and disability. Gout is not new; King Henry VIII is usually portrayed eating a turkey leg with his leg up on a pillow on a stool. If he only knew that turkey was one of the reasons he had the gout. Well, I'm guessing they did know, but that's a story for another day. Gout has a very effective treatment. Colchicine. (kol'che-seen)(ˈkäl-chə-ˌsēn). Colchicine has been around a Veeeeeeeeery long time. It is derived from an extract (colchicum) of the autumn crocus plant's seeds. There is evidence that it has been used for gout since 1500BC. More recently, Ben Franklin brought colchicum to the United States from France to treat his gout. in 1820 colchicine was derived from colchicum in France. Colchicine has been a prescription drug in the US since the 1930s as far as I can tell, although some sources say the 1950s. It has a long history of being prescribed by doctors and taken by patients. Colchicine has never been approved by the FDA. It is one of about 20 drugs on the market that had this special status of being a prescription drug on the market prior to FDA regulations. A couple of years ago the FDA decided that it could no longer tolerate such nonsense, that all of these drugs must be regulated and go through thorough FDA clinical trials. But who would spend $100 million dollars to do this when colchicine was made by 20 manufacturers and sold at 9 cents a pill (and in my case, $10 for a 3 month, 180 pill prescription at Walmart (about 5.5 cents per pill))? One of the colchicine companies stepped up to the plate. URL Pharma ran two clinical studies for the FDA and the FDA approved colchicine under the brand name of "Colcrys", and made the manufacture of unapproved colchicine illegal. URL Pharma priced colchicine at $4.85 per pill. This happened about 1 year ago. Did you know about all of this? Neither did I. The FDA did, however, allow companies to sell out of the stock on hand. So for the past year I have been in ignorant bliss as Walmart continued to sell me colchicine, although they did raise their price about 6 months ago to about $11 for 60 pills, about 18 cents a pill. I asked them why it was removed from the $4/$10 prescription plan and the pharmacist just shrugged his shoulders. I bet HE knew why, but didn't want to get into it. Two days ago I needed a refill. I was told that colchicine had been "removed from the market by the FDA about year ago", they had been allowed to sell their stock. But now I had to get a new prescription for Colcrys specifically, even though my old prescription was for 0.6 mg colchicine, the exact ingredient and concentration in Colcrys. So I start thinking about all of this. I'm not going to rant on endlessly about the FDA now, and why they are doing this, their justification for doing it, their crowing about the results and their response to the price increase. Those are great questions but they are mostly political and philosophical. But I do have some other areas that aren't political nor philosophical. First off, how come my doctor didn't know about this and continued to prescribe colchicine to me without telling me? How come her prescribing software didn't bother to mention she was now prescribing a removed, illegal drug? How come my pharmacist didn't tell me he was filling a prescription for an illegal, unmonitored, unapproved drug from a manufacturer who had not been FDA inspected on this drug line? How come the FDA would allow a drug removed from the market to be sold for a year or more to the unsuspecting, not notified public? How could they not require patient notification? How come this company is given a special 7 year monopoly and can charge whatever they want for this drug under these very special circumstances? In all fairness to the greedy bastards at URL Pharma, they say their raw material costs are THREE TIMES what they used to be. Ohhh, I feel their pain, their costs must have increased from about a penny a pill to 3? Awwwww, poor babies. THEY are whining about increase in cost? Give me a break. But they HAVE set up an EXTREMELY generous patient assistance program for those without insurance and a co-pay assistance program for everyone else to limit co-pays to $15 (EXCEPT ONE STATE - MASSACHUSETTS WHERE I LIVE thank you Romneycare for making it illegal for companies to do that here). So they are raping the insurance companies and Medicaid and Medicare but not the end consumer (which is exactly what is wrong with the US system) but I digress. So my new prescription now will have to go through my insurance company instead of me just paying cash. Instead of me paying $10 per quarter to Walmart, the new prescription is about $325 per month, and my copay is $25 plus the $50 deductible I also have to pay to get it. So removing the deductible issue, my insurance company will pay about $300 and I will pay $25 per month for colchicine. Ben Franklin must be flipping over in his grave... if he can afford his colchicine. If not he's probably just whimpering in pain like me. |
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| ron, cindy will make this teddy's 1st priority invention!!!! if only.  |
| Very interesting post Ron.... I'm not familiar enough with American health care and/or policies etc to comment, but it definitely seems pharmacuetical companies worldwide can, will and most certainly do screw people over on basic necessities because they know they can and they know you will pay for it somehow. |
| If I do the math based on what I used to pay per quarter and the new cost, I used to pay 0.0556 cents per pill, and the new price is 5.4167 is a 9642% increase, nearly 100 times more expensive. The FDA talks about 2 great findings from the data from the clinical trials; that the former guidelines for initiating colchicine were too aggressive and lower dosing was appropriate, and that they identified drug-drug interactions with some antibiotics. The lower dosing was already known around the world. The interaction knowledge is good, but the data from a gazillion people taking colchicine and adverse affects should EASILY have been enough for the FDA to "tease out" that pattern from the available information. THEY MISSED IT. Plus, unbelievably, the FDA claims THEY discovered the interaction and not the company doing and paying for the trials. LOL glory grabbing political bastards. I can't decide who is worse, the FDA or URL Pharma. I don't know who I should hate more. |
| Wow Ron...we didn't know about this either, and as you know Scott also suffers from periodic flair ups of gout . Colchicine is also (oddly) one of the drugs used to treat Autoimmune Urticaria, which I have...although my Dr. chose to go with a different treatment. Odd random thought (coming from someone who lives in a state which you can't easily drive out of  ) but can you go to a Dr. in a neighboring state, and get the lower rate that way? or do you have to be a resident of that state? |
| I am 24 miles (about 40 minutes on secondary roads) from the Walmart in Woonsocket, Rhode Island. Unfortunately, in addition to all of this, my physician's office is ALWAYS completely incompetent in prescriptions; it starts from the physician who I don't think has ever gotten all of my prescriptions correct on the first try, to the phone tag to the ordering system. I asked for two prescriptions; one for 30 days and another for mail order, so I can try to save one copay per quarter. I asked for the prescriptions to be printed and I would pick them up. First they printed two prescriptions for 180 days. Then they faxed the 30 day one to Walmart near me and printed the other. The $75 is for a $50 deductible plus the $25 copay; I had devious thoughts about cancelling the already filled script with the local Walmart, picking up the script at the doctor, traveling to Rhode Island, and seeing if the co-pay reduction might not pick up $60, thus covering my deductible. This really doesn't make me feel right to begin with, as in maybe this isn't the right thing to do, it's not a copay, it's a deductible... but I considered it. I'm human and I'm upset about this and it's $60 which is a noticeable amount of money for me. Then I also recalled that this script has already been filled at my local store and they'll have to return it to inventory and reverse the charges with the insurance company making extra, uncompensated work for everyone. Then when I get to Rhode Island perhaps the insurance company may not cover the charge because of the other one, and so forth with trying to straighten out the confusion, and I already took my last pill this morning. So for this one I'll be picking it up at WallyWorld in a little while, and paying the $75. Sheeeesh. It will be nice when my own economy picks up a little again, ya know? |
THAT truly sucks!  It is really unbelievable that they can get away with this stuff!! |
| Guess this means you won't be buying Bestdogs a new laptop? Keeping on topic, my rheumatologist put me on colchicine for some circulation problems. Guess it's lucky for me that it didn't help. I got really tired of carrying that big flask of green stuff around wherever I went...  |
| LOL that's the Uloric ad, for lowering uric acid. After you get the gout under control you can take uloric or something older like allopurinol to lower the uric acid levels. Interestingly, if you don't have active gout when you start to take uric acid lowering agents it frequently causes a gout flare, so they put you on colchicine to prevent the flare up while lowering the acid levels. BTW there is already a product on the market that contains colchicine in combo with probenecid, another uric acid lowering agent. So it's not like colchicine has never been in front of the FDA before. sheeeeeesh. You can't imagine how deeply ticked off I am. I mean I'm not stomping around or anything. It just gnaws. The government is raising the cost of healthcare while the leaders of the government are complaining that medicaid plans put forward don't do anything to address the cost of healthcare.... this was all done administratively without any act by congress. Then in a video explaining this, pharmacists in full military dress uniforms (surgeon general? FDA? No clue) discussed this and addressed the increase in cost saying "Unlike in other countries, the government does not have the authority to control prices..." AAAAAAAAAAGGGGGHHHHHHHH |
| Seriously? I'm sure someone in Canada can get it for you, on the cheap. I get my pain meds that way- over the counter and REALLY inexpensive, in comparison to what my doctor prescribes here. |
| Ron, you aren't just paying for the cost of the ingredients and manufacturing process. You are also paying for the cost of the FDA study. The study requires several years to produce, with patients taking the medicine and others used as a control group. There are lab tests and various scans. And staff to run the study and make sure it is done correctly. None of this is cheap - it's like as son as they hear there is a medica need fofr something, they jack up the price. The patent on the drug is usually good for 17 years, then generics may be be produced. So the company has to anticipate the number of people who will need the medication over the 17 years, the amount of medicine that will be needed, factor in a profit and figure out the money spent and interest on the money they spent, then can figure out the amount to be charged. I don't like it, but I do understand it is a business. |
| I understand the need for a company to make a profit. I understand running studies isn't free. This was a drug that has been around for 200+ years in this country. If the FDA felt a need to look into this drug, they could have looked have simply investigated the adverse event data instead of requiring this to be studied. Further, since this was a very special case, with very special 7 year exclusivity they could have gone the next step and negotiated other conditions of the deal, such as the price of the drug as well as a condition for this exclusivity. There are gazillions of people taking this drug... I haven't looked at this company's financials yet... care to make a bet with me about the cost of the study and the value to their bottom line for the exclusivity?  A huge part of the justification of 17 year exclusivity is the risk that the drug won't make it out of the trials. In addition, a lot of that 17 years is eaten up after patent and before marketing. How big a risk was there of finding this drug to be unsafe and/or ineffective after such a long history and other regulatory agencies around the world having approved it??? None. How much of the 7 years is going to be consumed by the study? None. They didn't need to develop the drug, pass through phase I trials and determine a dosage schedule, they had more than 50 years of prescribing experience and world data. To control costs in healthcare, as a country we MUST get the patient to have a stake in controlling costs; copays and percentages of treatment costs for EVERYONE but the most indigent of us, so that people stop demanding what is unreasonable. This approach stands that completely on it's head by insulating the patients from these costs and laying it all upon the insurance industry and the government. |
| How.... how can we bring this out... have you tried Colcrys during a attack??? takes 3 times more pills... taking 1 Colcrys a day as I did the Colchicine and experienced 4 attacks in 4 months!! Take 3 pills and wow Gout Free!!! This is a travesty and a blatant ripoff... my Aunt works for a Major ( 1 of the colors) and advised me that Gout is now a red flag!! Yup.. just like being Diabetic.. increase if not double or triple your rates from 2012 on.. Huh?? wonder where the profit really is.. Come on America!!! Stand Up and stop allowing the FDA to be the hired idiots of the drug companies and Insurance giants.. GW Bush signed this in for a reason.. right along with expanding the SSI with a supplement policy that only profits drug companies incredibly.. When will it stop??? |
| Steve suffers from gout on occasion, and when he has a flair up, he drinks Cherry Juice Concentrate for a few days and it is all gone. The Dr. Oz Show Amazing Antioxidants: Tart Cherry Juice http://www.doctoroz.com/videos/amazing- ... erry-juice |
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