Brilliant or despicable?

Fucktard

Fucktard

Well-Known Member
Was reading the NEJM online, and came across a journal article and subsequent letters to the editor on this topic. I will put it (somewhat) in a nutshell for you all, and I am interested in seeing what you all think.

Colchicine has been available in the US as a generic product since the 19th century. Physicians have used it to treat gout for a zillion years. Cochicine has never gone through the FDA process as an "approved" drug. There are many manufacturers of it. Its length of time on the market, success in treatment, and lack of adverse events (few on record and mostly due to human error) lend it as an acceptable treatment for gout, and FMF.

Along comes URL Pharma out of Philadelphia, who does a study on safety/efficacy of their colchicine, which they have named Colcrys. Studies are done, FDA approves the drug. URL is now granted 3 years of exclusivity of Colcrys for gout. Under the Orphan Drug Act, it is granted exclusivity for its use in FMF - Familiar Mediterranean Fever, for SEVEN years. URL then immediately turns around and files suit against every other colchicine manufacturer, getting all other forms taken off of the market, as Colcrys is now the only approved version.

URL also turned around and immediately priced their Colcrys at $4.85 per pill. Colchicine has been available previously for 99 cents per pill.

The director of the FMF clinic in California wrote in and stated that a 50 fold increase would lead to these patients missing doses and the disorder causes debilitating fevers and abdominal pain, which when not controlled with colchicine, will increase physician/ER visits and hospitalizations.

Now what do you think of this? I would imagine that there are some of you that think this is brilliant, that URL deserves to be rewarded for this "hard work." I know there are others, like me, who find this despicable and ridiculous. In these economic times, to turn around and burden payers, patients, Medicaid, Medicare, etc., with a 50X increase in cost on a very old drug is criminal.

Feel free to read what I read - www.nejm.org. You can find these entries under rheumatology, and these are free articles.
 
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It's despicable and bullshit and sounds like something an attorney like John Edwards was - would engineer. It's also part of what's wrong with our country.
 












It is both brilliant and bullshit. There are other treatments for gout? Is it URL's fault or the regulatory agencies fault?

In a true free market, this could not happen, but those who love regulation never want to blame regulation.

I am guessing some will say what need is another law.

As hou mention, here is a drug that never went through the regulatory process and came to market during a time of no regulation. But, in a time of reguulaton that some people adore, costs go up.

Amazing how that happens isn't it? But, I guess it will be easier to blame URL because to do otherwise would force some to change their worldview and that can't happen.

I don't have gout so I don't much give a shit
 


















Since neither Makena nor Colcrys are bringing anything of significant value in terms of efficacy or safety to the patient, the FDA should have denied exclusivity for both. Especially with the very old colchichine, someone should have had the balls to stand up and say, "No! This is ridiculous! Where is the common sense?"

The pharmaceutical business is full of so many things lacking in common sense.
 






  • ~T~   Mar 31, 2011 at 03:00: PM
Grody sums it up well:

"It is especially ironic that the relative rarity of FMF allowed the manufacturer of Colcrys to invoke the Orphan Drug Act of 1983 and thereby receive 7 years of market exclusivity for its use in this disease, as compared with just 3years for its use in gout. We seriously doubt that this is the sort of “protection” for patients with rare disorders that was envisioned by the framers of that legislation."

Wayne W. Grody, M.D., Ph.D.
Terri Getzug, M.D.
UCLA–David Geffen School of Medicine, Los Angeles, CA

FT - They found a loophole and squeezed themselves through. Brilliant business move but morally despicable..
 






Same thing Adams did with time released guaifenesin and labeled it Mucinex. Used to be cheap, now very expensive for snot med.
 
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  • Wonka   Mar 31, 2011 at 05:04: PM
Same thing happened with Guaifenesin when Mucinex came along.
 






I think the whole Pharma industry is despicable. I was watching yet another Drug commercial on TV and this one was advertising- Niastat- and what is it -Niacin- Niacin is a cheap mineral, yet this Pharma Co turned it into a drug and now price gauges the patients. I can't even tell you how many times my (old) Pharma co pushed thru the FDA an "extended release" version of drugs we had just to extend the patent.

True, this is another example of what is wrong with the whole greed culture.
 






Fucktard said:
Since neither Makena nor Colcrys are bringing anything of significant value in terms of efficacy or safety to the patient, the FDA should have denied exclusivity for both. Especially with the very old colchichine, someone should have had the balls to stand up and say, "No! This is ridiculous! Where is the common sense?"

The pharmaceutical business is full of so many things lacking in common sense.
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Yes, but it was only a matter of time before the FDA pulled it because it was unstudied. The orphan drug protection and pricing both make sense considering the costs of doing the safety studies and all the legal requirements of a company to provide free drug for many low income patients. You hear the stories all the time about patients not getting their meds because of costs but, either they have insurance and pay a low percentage of the cost, or they are uninsured and if they are low income, can get the drug free --- if the lazy doc will fill out the paperwork.

Health care is a business and it's time people remember that!
 






Filing and meeting production demands probably drove the cost up. I doubt they are making out like the bandits pictured in this thread. Getting an indication costs millions.
 






ILA hit the nail on the head.

The real culprit here people is that good ole government agency the FDA. If you want to get all angry at anyone, then get angry at the FDA. They have too much power and they use it inappropriately. Another great example of over-regulation!

This isn't so much a tale of greed as it is government stupidity and over-involvement in the marketplace. Medicine isn't practiced "on-label" and yet we have allowed the FDA to make a big deal out of approved "indications". It's insanity.
 






tinkrbelle said:
I think the whole Pharma industry is despicable. I was watching yet another Drug commercial on TV and this one was advertising- Niastat- and what is it -Niacin- Niacin is a cheap mineral, yet this Pharma Co turned it into a drug and now price gauges the patients. I can't even tell you how many times my (old) Pharma co pushed thru the FDA an "extended release" version of drugs we had just to extend the patent.

True, this is another example of what is wrong with the whole greed culture.
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That's generally the strategy, intro the b.i.d. version, let the patent run out then come out with the extended time release version to get another 17 yrs or whatever the fuck it is.
 






I Love America said:
It is both brilliant and bullshit. There are other treatments for gout? Is it URL's fault or the regulatory agencies fault?

In a true free market, this could not happen, but those who love regulation never want to blame regulation.

I am guessing some will say what need is another law.

As hou mention, here is a drug that never went through the regulatory process and came to market during a time of no regulation. But, in a time of reguulaton that some people adore, costs go up.

Amazing how that happens isn't it? But, I guess it will be easier to blame URL because to do otherwise would force some to change their worldview and that can't happen.

I don't have gout so I don't much give a shit
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Black cherry juice from the health food stores will keep your uric acid levels down. If you ever DO get gout, you will give more than a shit. My husband takes a couple of ALEVE when his flares up. Shellfish and very dark chocolate causes his flare ups. He has it in his big toe and knee.

KV Pharm did a similar thing. Has a drug to stop early labor, costs $1500 - but there are compounds costing less than $100 the doctor can use. The FDA has filed a lawsuit against them for price gouging.
 


















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