4/20/10 For the past few years, Peggy Lewis has paid $10 or less for a 90-day supply of her gout drug, colchicine. But Lewis, 71, fears she will soon be forced to pay hundreds of dollars more for that medication.
Lewis, of Fairfield, Ohio, has taken colchicine for about 20 years to prevent attacks of gout, a form of arthritis that causes flares of sudden pain, stiffness and swelling in joints.
But sometime this year, Lewis will have to replace her current version with a brand-name colchicine medication, Colcrys, which, she was told, could cost up to $550 for a 3-month supply.
“I think it’s a shame," she says of the price increase. “It would take my whole Social Security check."
The jump in price follows a push by the U.S. Food and Drug Administration (FDA) to stop the sale of hundreds of medications that had been grandfathered onto the drug market because they were dispensed before the agency began reviewing and approving new drugs.
Colchicine, for example, which is made from a flowering plant called the Autumn Crocus, was first used for gout treatment in the 1800s.
It’s estimated that thousands of drugs fall into this “marketed, unapproved” category, and they include many other medical mainstays, including forms of the painkiller morphine and the heart drug nitroglycerine.
The agency says it is concerned that many of these medications could have safety issues that have never been brought to light. In 2008, for example, the FDA banned injected forms of colchicine after 23 deaths were linked to its use.
The FDA has called on drug manufacturers to conduct clinical trials on these unapproved medications. In return, the Agency offers them some patent protections so they can recoup their investments in the drugs.
In 2009, Philadelphia-based company, URL Pharma, which is thus far the only company that has tested colchicine and submitted an application for FDA approval, was granted the exclusive rights, for three years, to market colchicine as a treatment for gout attacks. The company was also granted the right to be the sole supplier of colchicine as a treatment for familial Mediterranean fever, a rare disease, for seven years.
Colchicine currently accounts for about 3.5 million prescriptions in the U.S. annually, according to IMS Health.
Pharmacies still carry the unapproved, generic versions of colchicine, but as these versions are forced off the market, at some point, those supplies will dry up.
When that happens, the price of colchicine is expected to soar from about $.10 to $5 per tablet.
The steep increase of Colcrys has alarmed both patients with these diseases and the rheumatologists who treat them.
“Rheumatologists are incensed – there’s anger out there," says Edward Herzig, MD, an Ohio rheumatologist who treats Lewis.
In response to the price uproar, URL Pharma points out that their testing of colchicine revealed that lower doses were equally effective as the dose commonly prescribed by doctors. The company also points to newly-identified drug interactions between colchicine and some kinds of antibiotics and antifungal drugs, which might not have been identified without its research.
The company also promised to expand its patient assistance and co-pay programs, which, the company says, should make Colcrys affordable to all.
Nevertheless, the American College of Rheumatology in January said it asked the FDA to prolong the typical "grace period" of one year before forcing other colchicine makers to halt production. Read the ACRs letter to the FDA here.
America is blind to this stupidity!! try and find their special "Low Income" program.. dare ya!!! no such thing... they (URL Pharma) is just bilking Medicaire and insurance companies!!
AS DR DAVIS STATED THEY (URL PHARMA) HAS INVESTED MILLIONS OF DOLLARS FOR THEIR CLINICAL RESEARCH,STUDIES,ETC.I EVEN BELIEVE THAT THE PUBLIC APPRECIATES THE FACT THAT THEY CARED ENOUGH TO DO SO. DOES HE NOT UNDERSTAND THAT IT IS THE PRICE THAT HAS THE PUBLIC ANGRY??? I SAY TAKE THE "ACTUAL" COST OF RESEARCH AND DEVELOPMENT,ETC. AND DIVIDE THAT NUMBER BY THE 3.5 MILLION PRESCRIPTIONS SOLD PER THEIR 3 YEAR PATENT TO GET THEIR PRICING (3.5 MILLION PER YEAR X 90 PILLS (?)PER PERSCRIPTION = 315,000,000 X 3 YEARS=945,000,000 PILLS?) NOW, WHAT DOES THAT NUMBER LOOK LIKE? AT 50 CENTS PER PILL THAT EQUALS 472+ MILLION. AT $1.00 PER PILL THAT WOULD BE 945 MILLION.THE PROFITS DON'T LOOK AS GOOD AS CHARGING $5.00 PER PILL BUT IT WOULD BE THE RIGHT THING TO DO IN MY HUMBLE OPINION. THEY WOULD STILL MAKE A PROFIT AS THEY ARE THE ONLY ONES TO DO THE NECESSARY STUDIES AND THEREFORE THEY ARE THE ONLY COMPANY WITH THE THREE YEAR PATENT IN THE U.S. ( THE ONLY "APPROVED" COLCHICINE ON THE MARKET). ISN'T THAT ENOUGH REWARD? IF NOT, MAYBE THEY SHOULD INVEST IN A "NEW" MEDICATION; MAYBE A CURE FOR CANCER OR AIDS. THE PUBLIC WOULD BE A BIT MORE UNDERSTANDING ABOUT THE PRICING STRUCTURE.
It is an outrage that URL can create a monopoly for colchicine just because it ran some tests on a substance already out in the market for decades.
Why doesn't some enterprising pharma lawyers cut a deal with the FDA to demand that alcohol be classified as an untested/unapproved drug and patent alcohol? Then they will control everything from beer to whiskey. Is chocolate next?
I'm writing every Senator, congressperson and newspaper I can about this outrage.
Shame on URL Pharma and sociopath behavior of its corporate leaders. Shame on the employees who wrote on comments on here defending their own self-interest. Wake up and get a job doing good or at least stop doing harm.
URL Pharma, greed is evil and you will pay for yours. I have no doubt that it will be the downfall of your company.
I conducted corticosteroid research for Schering Corp. back in the fifties and formed a negative opinion of the FDA back then. What they've done with colchicine is a confirmation of my negativism.
I have since learned about the machinations by the FDA and URL Pharma and am absolutely furious. As others have pointed out, URL Pharma did not develop this drug; colchicine has been used, apparently quite safely, for decades. I can't imagine what tests URL Pharma could possibly have conducted that would justify a 44-fold increase in price. I refuse to be a victim of this greed and price-gouging; I will either find another drug, or order generic colchicine from Canada--probably the latter. I have never ordered drugs from Canada before, but now I am angry enough to do it.
What other medicines does URL Pharma produce? I want to make it a point not to do business with that company ever again.
While I understand the necessity to recoup the cost of clinical trials, it appears to me that taking a medication that has been effectively used for over 200 years, and relatively safely at that, and inflating the cost from an average of $0.07/tablet to $5.00/tablet is just pure piggish greed. URL Pharma has found a way to capitalize on the suffering of patients. The medicinal value of using colchicine was first identified in the first century A.D.
The statement "Unapproved colchicine products have never undergone FDA review for safety or efficacy, so there is no assurance that these products conform to the same standards as FDA-approved products" was obviously stated by a person without a chronic illness. How many other medications are prescribed - and effectively so - off label? Will you be doing clinical trials on these drugs and raising their prices?
Well I guess we can thank Dr. Davis and his team for taking the initiative "to take the clinically responsible step of seeking approval for unapproved oral colchicine". Will Dr. Davis and his team also be investigating other drugs that are prescribed off label so that they too can be outside the financial reach of most patients?
Since I've safely used "off label" colchicine since March of 1987 for FMF I suppose like many I too will be forced to purchase colchicine from Canada as I do not qualify for the PAP program (I checked your form). Shame on you URL Pharma!
Kaz: what I'm interested in is your assessment of my "significant risk". I've been on this drug for 33 years without any untoward effects. Please explain.
What I'm also interested in is how, after URL Pharma has "spent millions of dollars, and enormous effort, that has resulted in our discoveries that greatly improve the safe use" will protect me as I have been safely using colchicine for 33 years! (low dose 0.6 mg/day and PRN).
URL Pharma appears to be resting on their laurels that they are now protecting the public, after having spent millions. What URL Pharma does not tell the public is how much money they'll make with their efforts to gough the public.
I doubt URL Pharma's efforts were altruistic, protecting the public is a buzz-word for we're out to make a substantial profit.
You found a loop hole and jumped on it it URL Pharma - good for you - after all our system is based upon capitalism. Your company epitomizes and is synonymous materialism.
FYI- yes, gout is due to uric acid- if you have too much, it will precipitate out as very sharp, painful crystals; however, you need to check your facts. We do produce uric acid- it's a byproduct of purine degradation, nothing to do with fungi. Basically, anything that causes your body to breakdown purines into uric acid faster than you can excrete it into urine causes gout. It can be due to diet, genetics, lifestyle, medications, or any combination thereof.
Now back to the matter at hand. This isn't quite as bad as it's made out- colchicine is a standard treatment, but only for acute attacks of gout- it's very effective but also quite toxic, not something that any reasonable physician would prescribe for chronic treatment- that's what allopurinol is for. So while it will be far more expensive than it was, it's not a daily medication, and shouldn't bankrupt you.
However- colchicine has been used for years, and URL had nothing to do with developing it. Granting them seven years of exclusivity is blatantly disregarding the intent of patent law: to foster scientific advancement by providing economic incentive to make new discoveries. Patent law cannot be applied in this retroactive fashion, and allowing a pharmaceutical company to make a fifty-fold increase in the price of a standard medication that they did not develop borders on criminal. Either the medication is safe, or it is not. If not, ban it, if so, then write up the proper guidelines for it's use, and enforce them like any other drug.
Shall we cut to the chase? Gout is a uric acid disease, but we humans don't make uric acid...fungi do, but we don't. Plain and simple, colchicine kills fungus, a pathogen that can parasitize us. If this woman would take grains out of her diet (JAMA 1/02) because they, too are commonly contaminated with fungal metabolites, and use clove, garlic or inexpensive and safe remedies, she would not feel the stress of her medication fees increasing, nor the pain associated with gout.
For those of us who depend on colchicine to live normal lives, this is really scary!!!
Please put our lives before your profits!!!
I am very intrested in the knowing the cost related to the clinical trials performed by URL Pharma. (you know the cutting age research that only resulted in URL pharma getting the exclusive right to be only supplier).
I am horrified that the FDA has granted exclusive right to URL pharma to be the sole supplier of colchicine as a treatment for familial Mediterranean fever for SEVEN YEARS and then send a letter clarifying that the FDA can not control drug prices.
I work in health care and I am fully aware of the cost related to clinical trials (the ones that are really looking for new cures). I can understand rights for "one Year" to compensate the company for their efforts.
I think this deserves a fight as it will start a trend in a time that we are trying to control the cost of health care.
Virtually all drugs have side effects and so does the new Colcrys. Supposedly any decision to prescribe a drug comes down to risks versus benefits. The historical use of cochicine would seem to make it much safer than a great many commonly prescribed drugs. Besides, FDA approval does not always equate to safety - as we have amply seen with Vioxx, Fosamax, Avandia, Bexra, Alleve and a host of other drugs vouch safe and approved by the FDA.
Colcrys may be able to deliver better safety than colchicine, but there appears to be no justification for taking colchicine off the market and subjecting gout sufferers to much higher prices - other than to insure larger profits by Colcrys which would no longer have to compete with the much less expensive version.
The first place someone should look for gout relief in the first place is good old natural black cherry juice, such as Knudsen's.
I am Matthew Davis, M.D., from URL Pharma.
You have mentioned that you have patients with other diagnoses who cannot get help from our PAP. The registration form asks patients to answer four simple questions including diagnosis. The form says that if any answer is "NO" then they should call the telephone number. Thus far, no one who has applied to our PAP (by form or by calling) has been rejected. Your patients who need Colcrys, and who need assistance, will find that they will receive that assistance. Please, please, please tell them to call.
We did not realize that a "NO" answer would cause some patients to stop their application to our PAP even though the form tells them to call. Because of your input, we are going to change the form. It might be changed as early as today.
It is interesting how some people criticize us in the media but never communicated with us directly to give us a chance to consider their input. Anyone who has criticized us in the media has not given us the consideration of communicating with us directly. There is even one group who snubbed our attempts to communicate with them, took public stances, and only began to communicate with us after we sent a letter showing the facts. That group made clear misrepresentations that have now been documented.
Mary and Jared, it would have been helpful if you had brought these access issues, for patients with other diagnoses, to our attention earlier and directly. Still, we thank you for your input which will hopefully now help these patients. You have made a positive impact for change. We thank you.
In the meantime the FDA needs to make serious adjustments to its old drug approval program to head off this kind of “unintended consequence” for other drugs. Thanks to URL Pharma it is now a recognized strategy that the pharmaceutical industry is willing to exploit.
Janine Jagger
For those from URL Pharma, all of the 'talking' in the world about what URL has done, what it is going to do with its PAP and why it has been done, is not going to take care of the damage done to the corporation over this PROBLEM WITH COLCRYS. The reputation of URL Pharma may be never be the same.
I know many of the folks who have written here, protesting the indecent price increase and the 7 year orphan status of a drug that is essentially a life saver for many of us.
No one who has not experienced Familial Mediterranean Fever first hand or via a close relative, especially when it has been left untreated for years, because it is THOUGHT to be RARE, can really understand what this problem has done to us. STRESS is a major cause of FMF exacerbations.
And this has been stressful enough without URL trying to defend an undefendable problem that they caused by their greed.
Let it go guys! Accept that you were wrong and the 'testing' for FMF use of colchicine was not done on site by your doctors, technicians, etc. We are all smart enough to read for ourselves and understand what has been going on. STOP! Do not make matters worse by continuing this diatribe.
Nancy
As has been alluded to earlier in this thread, I'm personally convinced that all these statements about safety are just a candy coating, a smoke screen, to hide the real motivation, which is $$$. If that were not the case, you would have priced your drug much lower. You're actually charging more for this old drug, on which you did a few fairly simple studies, than Takeda pharmaceuticals is charging for Uloric, which is a totally new gout drug that required a number of large scale international studies involving thousands of patients, far more than you looked at. It just sounds so much better to utter pious platitudes about safety than it does to admit you're looking to make a bunch of money on the backs of our patients.
I am Matthew Davis, M.D., at URL Pharma.
I respect your altruism. Although I do not agree with some of your points, I can see that you are the type of altruistically motivated physician who cares for his patients and probably supports other cost savings efforts such as the proposed reduction in payments to physicians. Again, although I don't agree with some of your points, I respect you.
There are many facts that you appear to be missing in your analysis. For example, you refer to unapproved colchicine as "generic" but this is factually and legally incorrect. I cannot give to you the knowledge base, that is required to understand this issue, in this blog. There is too much information involved in this issue for a blog. You appear to have the motivation and ability to read it and understand it. Thus, if you are a member of Dr. Cohen's organization, I would encourage you to get the letter from our CEO to Dr. Cohen dated March 29, 2010 and then the first letter that was sent by our CEO. This will explain why unapproved colchicine is not generic, the issue of being illegal, and many other medical, scientific, regulatory, and other issues. We hope that you will support our position after you get all of the facts. Having all of the facts can give someone a very different perspective.
And you should know that we have the utmost respect for the members of the rheumatology community. We think that many of those who have taken exception to these events will have a different view when they read these letters and thus get the facts. We are also working on a website to provide all of the needed materials to those who want to know the facts. Hopefully this website will be up and running within the next week.
I am Matthew Davis, M.D., at URL Pharma.
Please see my post (today) to Ms. Rodruguez. This should address your issues of affording FDA-approved Colcrys. You deserve the assurances of quality that is represented by FDA oversight and standards.
For the other issues that you raised, there is an enormous amount of information that you should read. We hope to have it on our website within the next week. All of your issues will be addressed there.
I am Matthew Davis, M.D., at URL Pharma.
You say that you don't qualify for our Patient Assistance Program (PAP) and you don't have insurance. If you don't have insurance, and you make less than $132,000 per year for a family of four, then you should qualify to get Colcrys for $5 per month or $25 per month. We think that this is very reasonable.
I checked with the company that administers this program and they told me that, thus far, no applicant has been rejected. I think that it is only fair that you at least apply to the program to allow us the chance to provide medication for you.
Regarding your personal financial information, we only require the financial information to assure that wealthy people, who have elected not to pay for health insurance, don't also get nearly free medication from us. I can't imagine what else someone might think that our motivation might be. We think that this is very fair. Also, we never see the financial information. It stays with the company that administers the program. We are not interested in it.
You should know that we don't make any money on our PAP. The co-pay does not come to us. We provide the medication for free. We pay the PAP company to administer this program. We are also spending over one million dollars to mail information about our PAP to every pharmacy and doctor in the country each month. We sent out letters about our PAP to 185,000 healthcare professionals in March, 90,000 physicians electronically in April, another mailing to 67,000 pharmacists going out this month, another mailing to 180,000 physicians by early May, and so forth. We don't think that it is fair for people to cast dispersions upon us for these efforts.
If it is "impossible" for you to get health insurance, due to your illness as you say, then please apply to our PAP. You sound like the type of person who we want to help.
Colchicine (in its previously sold generic form) was not an "unsafe" medication. Consider that, according to an FDA report from June 2009, the OTC medication, acetaminophen, which is freely available to anyone, accounts for an estimated 400 deaths annually in the U.S. Contrast this with a number quoted by URL Pharma CEO (known here as "Matthew") in his letter to Dr. Stanley Cohen, president of the American College of Rheumatology: "FDA has reports of 169 deaths related with illegal colchicine..." (A.k.a. generic colchicine.) Considering the 3.5 million generic colchicine prescriptions written each year in the U.S., that number is, frankly, underwhelming!
Kaz/Lou/Matthew and any/all other URL Pharma representatives performing PR damage control on this site or elsewhere--do not insult the intelligence of the rheumatology community or our patients with your claims, aside from your desire to reward your shareholders with record profits. I hypothesize that this discussion of safety was manufactured as an "angle" through which URL Pharma could feign concern for their consumers, while cornering the colchicine market by litigating their competitors into oblivion (or at least out of the colchicine-producing business.)
As a contrast to your motivation, I (and the many other rheumatologists who are speaking out against this injustice in this forum and elsewhere) am speaking without a financial stake in this discussion. My only motivation in speaking is to defend my patients and our health care system against this terrible example of government-sanctioned price gouging.
URL Mutual made and sold unapproved Colchicine--what your company is now calling "illegal Colchicine" for years. Where was your concern for patient safety then?
I think your company's decision to go through FDA approval for Colchicine was a strategic way to eliminate competition and gouge.
I understand that you are offering patient programs--but my personal information and financial information are none of your business and I do not wish to share them to get a few months supply of a drug I take daily, and will take daily for life, at a cheaper rate. At any rate, I don't qualify for your program.
I realize the FDA approval process cost you money, but face it, you did not spend 20 years developing this drug. More effective purification of any drug does not warrant a 50-fold increase in its price.
Lower the price from $3.50/tablet to $0.50/tablet and we patients will be a lot more understanding.
BTW, I have been writing my Senators and Congressional Representatives about this. It has been impossible for people like me, who have Familial Mediterranean Fever, to get private health insurance. You make matters worse for us by raising the rate of our daily med from $6-10 retail a month to $350 retail.
Again, shame on your greed!
Dr Flood's comment alludes to letters from the company to rheumatologists. I know several rheumatologists who got Fed-Ex'd letters from URL's head lawyer, telling them to write to the FDA in support of URL (and send copies of the correspondence back to the company attorney!). The implied threat was of legal action if they didn't comply. The only thing they had done was to write comments such as these in a private email forum for rheumatologists sponsored by the American College of Rheumatology.
I don't think anyone faults the company for their research. The problem is all about price, and about how they've tried to pressure rheumatologists, who are the biggest prescribers of colchicine. This has become a public relations disaster for the company. There have been articles in the last week in the Wall Street Journal and in the New England Journal of Medicine about this very issue. I hope that URL and other pharmaceutical companies learn from this experience. And that the FDA realizes the unintended consequences their actions can cause.
Obviously employees of URL are monitoring this conversation. I'm curious as to if (and how) the company plans to address the issue of off-label use in their patient assistance programs.
More importantly, studying a drug interaction or demonstrating that a dose lower than what some people have used in the past is effective for acute gout (only one of many uses for colchicine) does not justify a company getting a monopoly on an old drug. It's a legalized scam that the FDA is complicit with. Everyone should read the New England Journal of Medicine editorial that was referenced in the article.
I am Matthew Davis, M.D., the Chief Medical Officer of URL Pharma. Our CEO sent a letter to Dr. Cohen on March 29th, 2010, apologizing and clearly stating that he regrets if anyone interpreted our letter as threatening. Our CEO stated that "I apologize for any unintended disrespect or negative feelings that my letters may have caused". The letter from our CEO then detailed how we have received conflicting responses, why we felt compelled to send our letter to some physicians, and then explained the medical malpractice "perfect storm" that some rheumatologists are unfortunately being led into and how our actions were designed to protect rheumatologists but have been misinterpreted. If you are part of the organization that Dr. Cohen is the head of then please get a copy from him. If not then it will also soon be posted on our website so you will be able to get it there.
I hope that URL and other similar companies learn that this is a major public relations catastrophe. The subsequent offer of a PAP as an attempt to save face may help a little. The threatening letters from URL to rheumatologists will result in ill will that will not easily be fixed. I think an apology is in order.
BTW, I don't know any rheumatologists who used colchicine in the "traditional way" of multiple tablets a day for acute attacks. Most of us use it for preventing attacks as we address the underlying cause of gout--uric acid levels that are too high. In that use, low doses are used for several months (or longer) in order to prevent the excruciating flares of gout that frequently accompany institution of medication that lowers uric acid. I am not sure that URL even studied that use--but my patients are subjected to the increase cost.
It seems to me that it would be simpler from an adminstrative point of view to juct lower the darn price, and not have all the hassel of paper work, special cards, and revealing confidential information about income!
It is a dangerous assumption to think that unapproved colchicine must be safe because it’s been around so long. Such an assumption puts patients at significant risk.
The FDA reports that unapproved colchicine has been associated with 169 deaths; 60 of those deaths were due to dangerous interactions between unapproved colchicine and a commonly-prescribed antibiotic.
We discovered that colchicine may cause potentially fatal interactions with some commonly prescribed medications such as antibiotics and hypertension drugs, and our Colcrys label gives doctors guidance on how to adjust the colchicine dosing to avoid these serious interactions. This critically important information was not known before we conducted our research.
The safety information from our clinical trials was, in reality, unprecedented. Our safety discoveries, especially for drug-drug interactions, are particularly important for FMF patients who need to take high doses of colchicine. URL Pharma was the only company to design and conduct these studies, take the risks and make the significant investments that are now making a positive and meaningful difference in the lives of FMF patients.
In terms of impurities and other issues with unapproved colchicine, I invite you to read a White Paper on that subject on our website, www.urlpharma.com. It details the important safety differences between an FDA-approved drug and one that hasn’t been approved.
Mutual is gouging! They themselves used to sell unapproved Colchicine. They did no testing on FMF patients, they read the results of other studies and test--yet they were granted orphan status, 7-yr exclusivity for Colcrys.
Now Mutual is suing other US manufacturers, saying that their product is illegal.
Colchicine has been around since ancient times. Perhaps their "autumn crocus" is more pure than some other companies, but the Israeli versions are very pure too--and they don't charge $350 for 30 pills. URL Mutual--you should be ashamed of your greed!
Some doctors may assume that unapproved colchicine is safe simply because the physician does not know of any of their patients having experienced problems. Personal experience doesn’t prove a product is safe as evidenced by the fact that FDA reported169 deaths associated with unapproved colchicine use. Only scientifically rigorous studies, such as the ones we have conducted for Colcrys, can determine if a drug is safe. The letter from FDA regarding unapproved colchicine states this (HHS Response Letter Regarding Concerns Over Current Market Prices of Approved Oral Colchicine,” Janet Woodcock, Director, Center for Drug Evaluation and Research (March 3, 2010)).
But I do believe that URL Pharma got greedy on this product which has been in use for thousands of years. The doctors to the Pharoahs gave it to them for their gouty-arthritis problems. And yes, I looked at the side effects before I started taking it.
I had been for all intents and purposes bed-ridden for 2 years prior to finding I had FMF and colchicine has not only given me my life back, but I believe it has saved my life as well.
I'm grateful for the PAP program but the stress that I and others had to live through to get this was unbelievable and totally unneccessary in my opinion. I have heard the same thing from many of the folks on my FMF_Supportgroup.
Nancy
We have spend millions of dollars, and enormous effort, that has resulted in our discoveries that greatly improve the safe use of colchicine through our Colcrys formulation, AGREE trial results, and many other studies. The manufacturers of unapproved colchicine have not conducted even one clinical study. We conducted 17 studies including over 50 clinical centers across the U.S.
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