Silencing Critics Of A Pricey Gout Drug
12 CommentsBy Ed Silverman // July 7th, 2010 // 11:27 am
Here’s a lesson in social media. A number of rheumatologists are battling with URL Pharma over its new Colcrys med for treating gout, which is essentially a version of a very old drug called colchicine. Specifically, they complained about pricing on an online message board, and the drugmaker’s general counsel responded by sending letters to some docs about the “potential risks and liabiilty” of using unapproved versions, The Wall Street Journal writes.
URL Pharma didn’t threaten to sue, but warned the docs their comments expose them to liability lawsuits from injured patients. “These are shake-down letters to silence” critics, John Goldman, an Atlanta rheumatologist, tells the paper. He criticized URL in his postings for conducting limited research and for its pricing of Colcrys.
In a rather benign response, URL tells the paper it wrote the docs to educate them about its clinical trials and help them prescribe the drug appropriately, not to silence them. URL also insists it wasn’t targeting the message-board members, but did send letters to 150 doc who “mischaracterized unapproved colchicine as being safe or legal” in opinion pieces and elsewhere. “We were trying to alert this small group of misinformed physicians to the fact that they were being led into medical malpractice liability,” URL tells the paper. (You can read more on the URL web site).
URL charges about $5 a pill compared with just pennies for colchicine. Why? URL says clinical trials were expensive and the pricing is comparable to other gout treatments. Ed Herzig, a Cincinnati rheumatologist, wrote that one patient learned that a 90-day supply of Colcrys would cost $550. “What chutzpah!” he wrote, the Journal reports. Ed Fudman in Austin, Texas, encouraged docs to urge the FDA to allow unapproved colchicine to remain on sale. In March, the FDA issued a letter in response to complaints about pricing, but so far, the agency hasn’t taken any regulatory action to remove unapproved colchicine pills from the market as part of a 2006 initiative. Meanwhile, URL has also sued several colchicine makers for illegal marketing.
James
This is THE example that needs to be debated by the public regarding lack of humanity in pharma practices. Gout occurs most frequently in minority and impoverished demographics, and a generic equivalent has been available for 2,000 years, an equivalent the FDA has thus far failed to protect. This is not a tradgedy of the commons - it is the rapine of them, by suited lobbyists who have failed to produce anything other than a $5 version of a $0.10 drug.
Further, people diagnosed with FMF need upwards of 90 pills a month - how can they possible afford Colcrys?
Anne PME
CC: WSJ Health Blog
Does anyone else doubt that these types of legal strategies will play well in BRIC countries….?
Also, do these attorneys realize that the doctors and patients are their customers…maybe they do and talking about liability and engaging their cheaper priced competitors in lawsuits is somehow supposed to get the doctors to write more prescriptions for their medicine? I am not a lawyer, but would question whether these types of strategies are fair [trade] practices.
Anne PME
This same type of thing happened with a loop duiretic. It is the only loop duiretic that is not sulfur based so patients who are allergic to sulpha (and there are a lot of these patients) usually have to fight their insurer and pay higher co-pays or pay the full amount out of pocket. While the pharma co has a patient donation program, it is so complicated and asks for so much personal info that elderly patients are afraid or unable to apply for it without paid legal and/or accounting assistance.
Jared
I got one of the letters described in this article. It did NOT say anything about malpractice liability. What it DID do was demand that I write a letter to the FDA in support of URL Pharma’s policies and send a copy of the letter to the company’s attorney. They are correct in that no explicit threat was made, but receiving such a letter from an attorney, a letter which used the word “illegal” no less than 7 times, certainly conveys an implied threat.
yobo
This type of situation is being repeated all over the pharmacy and medical community.
It’s complicated, but Drug Efficacy Study Implementation (DESI) drugs are drugs that were marketed prior to 1962 that must be reviewed and be ruled if they’re effective, ineffective, or need further study. This project is done by the FDA and is still going on today in 2010. What happens is the FDA asks the manufacturer to do clinical trials that are up to today’s standards for the drug to be on the market. This also applies to any generic products that are on the market. What happens? Most manufacturers don’t want to undertake the expense of getting the drug “approved” and they just stop making it. Then you get a co. like URL Pharma that gets its version approved. Is it new or different? No. It’s just an approved version of a pre-1962 drug. There is no competition because all the other makers have decided to withdraw their products and it allows cos.like URL Pharma to “rape,” “steal,” or whatever you want to call it from consuners, insurers including the govn’t, but we the people are the ones who ultimately pay. Generic colchicine used to cost pennies per pill, now it’s dollars per pill… a complete rip-off. This is happening with many other products as well. Again, unintended consequences…
Anonymous
Did none of you read the FDA letter citing a previously unidentified safety risk with unapproved colchicine? And explaining the difference between an unapproved drug and a “generic” drug.
You want safe and effective medicines and you want the FDA to ensure that they are safe and effective. When the FDA requests that manufacturers supply them with data for safety and efficacy evaluation you think that collecting that data costs nothing. And you think because the drug has been on the market for over 40 years that automatically makes it safe, effective and the products “generic equivalents”.
You are ignorant about the amount of research and the amount of data collected by companies to have new drugs approved as safe and effective and you don’t understand that the safety and efficacy of true generic equivalents is entirely dependent on the data generated by the innovator company.
Colchicine manufacturers were playing chicken to see who would flinch first. The company that submitted data first risked losing more money than the other companies. Their competitors can likely all submit less costly bioequivalence type data and thus the company that collected safety and efficacy data should be allowed to recover their investment before the competitors all get a bargain ticket to the ball.
Jared
That’s beside the point. What this article is about is the stupidity of a company sending intimidating letters to doctors who are otherwise likely to be the biggest prescribers of its product. The entire membership of the ACR is aware of how URL has behaved in this matter. This controversy has now been the subject of TWO articles in the Wall Street Journal and one in the New England Journal of Medicine. None of which would have happened if the company hadn’t decided to use strong arm tactics in an attempt to silence its critics. My mother told me you attract a lot more flies with honey than vinegar. I think this company should have listened to that advice.
Anonymous
Jared, Obviously I have not read the allegedly intimidating letter you received, but I read the 8 page letter to the president of the ACR dated 16Feb2010 posted on the URL Pharma website. It seems that polite and informative was ineffective in educating ACR members. I also read the FDA letter from Dr. Woodcock dated 03Mar2010. In my opinion the FDA has done a disservice to URL Pharma in allowing the illegal unapproved colchicine products to remain on the market, particularly after identifying the specific safety concerns with dose levels and drug interactions that are not part of the unapproved colchicine product labeling and information.
John
Anonymous - you forgot to tell us you work for URL Pharma.
3degrees
Jared mischaracterized the letter. I have a copy. Nothing was ever demanded in any way. As the article above states it pointed out that there is no generic for colchicine and indeed the “unapproved drug” most people think has been approved by the FDA has never been reviewed by them. If one looks at unapproved drug masquerading as “generics” it is scary. Several hundred deaths have occured on those drugs and none on the new formulation. The “unapproved” drug actually contain a byproduct that is lethal. The FDA never oversaw these drugs. The other thing about Colcrys - patients making up to $132,000 can get it for little or no cost. Most patients will pay either $0, $5 or $25. Go do a bit of research and look this up on line. The FDA even mentioned it in their video. Further, the unethical maker of “unapproved” drug jacked up their price so it is more expensive to get “unapproved” than it is to get a clean, stringently controlled, FDA approved version.
Gary
3degrees:
I just purchased this $0,5,25 drug from my pharmacy using my prescription drug plan. It cost me over $56.00. I make well under $132,000. Where do I go to get it for $0 dollars. I previousely obtained “unapproved” Colchicine for years from my local pharmacy which I am sure got it from american Drug manufactuers. This is a scam and a legalized theft of the american people. It will not stand. I advise all that read this to contact your Congressman and demand an inveastigation. If the government wants to insert itself into approving a drug that has been around since the first century it should minimise or pay for the testing. This is costing Medicare as well as private insurance and individual dearly.
industry insider
Yobo is correct. All drug companies agree to live by the results of the DESI review for pre-1962 drugs. While I sympathize with the gout sufferers who feel they are being ripped off, the DESI review on balance has succeeded in removing many ineffective drugs, unsafe drugs, and drugs whose manufacturers decided not to spend the money on clinical trials for cheap yet effective drugs where was little chance of recouping the investiment.