Houston Area Liberty Campaign

FDA Grants Monopoly For Centuries-Old “New” Drug

They say that if you have your health, you have everything, and I’m sure glad that I don’t have a painful disease like gout.  Gout is a painful joint disease caused by buildup of uric acid in the blood.  About 75% of the time, people who come down with gout first find out about it when they get an extremely painful inflammation right at the base of the big toe.  Nowadays, when someone gets the gout, doctors usually treat it with a non-steroidal anti-inflammatory drug (NSAID) like Advil or Aleve.  You can’t take aspirin for the gout…aspirin only makes it worse.

But what did doctors do before nifty drugs like these were invented?  Well, for centuries, doctors treated gout with an extract of Autumn Crocus.  Sometime between 40 and 90 AD, the Greek physician Pedanius Dioscorides wrote about using autumn crocus to treat gout in his book of herbal remides, De Materia Medica, so this is something that has been around for a while.  Ben Franklin suffered from gout (if you don’t click on any other link in this article, please click on that one), and brought the use of autumn crocus extract over to American from France.  In 1820, a couple of French chemists isolated the active ingredient in autumn crocus extract, and named it colchicine.  Ever since, physicians have been prescribing it under that name, so colchicine was around long before the FDA.

For example, the “Aspirin, 325 mg, Pain Reliever Enteric Safety Coated, 1000 tablets” product does not have its “Drug Facts” header in larger font than the rest of the “Drug Facts” (see 21 CFR 201.66(d)(2).

And you might think that the story ends there, with a few drug manufacturers offering generic colchicine for the few unfortunate gout sufferers who can’t take NSAIDS for one reason or another.  Indeed, that was the case until the FDA decided to crack down a few years ago on herbal remedies of all sorts that were being offered as medicines without any sort of FDA approval.  This was done largely to protect the consumer from dubious claims for products made by fly-by-night drug “herbal remedy” companies with equally dubious quality controls.  Of course, a handful of these herbal remedies would likely have useful medical properties, so the FDA set up a process to “encourage” manufactuers of these substances to either pull them from the market or to submit them for a full FDA review.  And the neat thing about this process is that whoever ponied up the money to have all the testing done for FDA approval got exclusive marketing rights to the “new” drug.

Well, you might say that had nothing to do with colchicine, since it simply didn’t appear on the counter at the local stop-n-rob next to the ginko biloba, St. John’s wort, or any of those “energy” pills that promised “extra stamina”.  Indeed, you’d likely find it down at the local pharmacy, available by prescription only.  Colchicine is toxic in large doses, and invariably there would be a half dozen or so gout sufferers every year who managed to kill themselves by taking more of the pills than their doctor prescribed.  But the Federal Food, Drug and Cosmetic Act of 1938 provided that any drug covered by the provisions of the 1906 Pure Food and Drug Act was grandfathered provided that the label hadn’t changed regarding the drugs conditions of use (paragraph P, subparagraph 1).  Now, since colchicine (autumn crocus extract) had been around since, well probably since the good St. John was having his visions of the apocalypse, surely it was grandfathered, right?

Well, sort of.  According to the FDA, “[The] FDA believes that there are very few drugs on the market that are actually entitled to grandfather status because the drugs currently on the market likely differ from the previous versions in some respect, such as formulation, dosage or strength, dosage form, route of administration, indications, or intended patient population.”  Hmm.  Let’s run the list:

• Formulation – it’s still pretty much colchicine and some inert ingredient.
• Dosage or strength – hasn’t changed since Lincoln was President.
• Dosage form – Yup, still a little pill that you swallow.
• Route of administration – If you get this wrong, you need more than a doctor.
• Indications – This means, “What it cures”.  You take it for gout, just like your grandfather did.
• Intended patient population – For centuries, gout sufferers have been men in their late 30′s or older, or women even older than that.  (It takes at least 20 years or so after puberty for the disease to develop.)

So, to me, colchicine looks like an ancient herbal remedy, one that should definitely be a generic drug offered for a pittance.  I mean, maybe there’s some exotic strain of autumn crocus that yields a better drug, but aside from that, what is there to it?

And you see, that’s why I’m not head of a major drug company like URL Pharma.  You see, where ordinary folks like us see a cheap generic remedy, guys like them see a money-making opportunity.  Under the FDA’s program to push makers of herbal remedies like ginseng into listing their products as FDA-regulated pharmaceuticals, URL Pharma submitted colchicine as a “new” old drug.  Now, they did pay a fair bit of money to do a bunch of research on new applications for colchicine, on what the proper doseage is, and on what other drugs it interacts with.  All of this is new knowledge that is useful for physicians, and it seems only reasonable that URL Pharma should be compensated in some way.

What the FDA did was give URL Pharma exclusive rights to market colchicine under it’s brand name, Colcrys.  Now, if it was just the brand name, that would probably be well and good.  I mean, everyone knows that aspirin is a generic drug, but who hasn’t heard of Bayer aspirin?  But the FDA went a step or two beyond that.  When I said exclusive rights to market the drug, I meant exclusive.  As in, now URL Pharma is the only drug manufacturer allowed to sell colchicine in the US, and all “generic” colchicine is effectively “counterfeit Colcrys” and now illegal.  And if you think I’m making this up, they have now sued Excellium Pharmaceutical Inc., Vision Pharma LLC, Watson Pharmaceuticals Inc. and West-Ward Pharmaceutical Corporation to stop them from making and selling colchicine.

URL Pharma also has some interesting propaganda for doctors and patients, like this letter from the Colcrys website.  Here’s a sample paragraph:

“Apparently, some physicians have called the illegal unapproved colchicine products ‘generic’ including in public forums and letters to the FDA. Unapproved colchicine is neither legal nor generic.”

URL Pharma’s letter also refers to another letter that the FDA sent to Sunrise Pharmaceuticals in January of this year.  The FDA letter was basically a cease-and-desist type of thing, ordering Sunrise to stop making colchicine and several other drugs, and to relabel some of its products.  Here’s some of the text, an example of your tax dollars at work:

“Also, for your information, the formatting of the “Drug Facts” section on several of your OTC products is inconsistent with the requirements under 21 CFR 201.66. For example, the “Aspirin, 325 mg, Pain Reliever Enteric Safety Coated, 1000 tablets” product does not have its “Drug Facts” header in larger font than the rest of the “Drug Facts” (see 21 CFR 201.66(d)(2).”

Thank goodness that this blogging program automatically uses a larger font for the title than for the body text!  I feel that if it hadn’t, I’d have somehow run afoul of some FDA guideline or regulation.  Heaven forbid that some brainless consumer might not be able to find the “Drug Facts” on the bottle because the words, “Drug Facts”, didn’t appear in a larger font than the actual drug facts below.

You have this product out for at least a hundred years and all of a sudden it’s no good?

Now, you might be wondering just how horrible this all can be, since you’ll still be able to get a prescription for Colcrys if you ever need it.  Well, first there’s the price.  Some manufacturers were selling colchicine for as little as 7 cents per tablet…$7.00 for a bottle of 100.  Hardly free, but welcome relief from the pain of gout.  Well, unless you qualify for low-income patients (although I wonder about a ”low-income” program that a family of four making $132,000 a year can qualify for as you can see on the first page), your colchicine Colcrys will now cost you $5 per pill.  That’s only about a 7000 percent increase.  I wish I could jack my income like that, but I don’t have an in with the FDA.

So, how did the generic illegal colchicine manufacturers respond to URL Pharma’s master coup?  Well, Qualitest Pharmaceuticals stopped making the drug, and the other four that I mentioned earlier are going to fight it out in court.  One of them, Vision Pharma LLC, jacked its price to $1.17 a pill.  I guess they recognized a good thing and decided to jump on board.  Asked for a comment, Lou Dretchen of Excellium Pharmaceutical replied, “You have this product out for at least a hundred years and all of a sudden it’s no good?”

Thankfully, consumers know just exactly what to do about URL Pharma’s new US government-approved monopoly on a “new” drug that has been in use for over a thousand years.

They’re buying it from Canada.