Pharmacutical Off-label Gambits
 

Sales of ropinirole have run at a respectable clip approaching 400 million USD per year and GSK is about to introduce a new RLS drug called Horizant. Why get FDA approval for a drug that treats a condition that your own cheaper drug, ropinirole, can deal with just as well? It is alleged by another author that an overriding agenda rules the situation: off-label sales.

OFF-LABEL SALES

The term “off-label” refers to the legal sale of a drug for a use for which it is not FDA-approved. So long as a doctor approves, you can be taking levodopa for a sore throat. Firms are not allowed to advertise for these non-approved applications of their drug and so they have separate employees assigned called “Physician liasons” who are kept separate from the salespeople, and who are allowed to distribute published literature on off-label uses. They are also allowed to send physicians who might be famous for off-label uses around on an “educational speakers’circuit” so long as the docs don’t feel pressured to plug the drug being advertised.

Sadly many of the docs on the speaker circuit are well-compensated but often don’t even know they’ve been assigned this role. They’re led to believe that it’s more of an educational entertainment thing to get the drug sales rep’s face to face with other physicians to give their pitch. They often don’t realize that their discussion of off-label use is really indirect advertising that opens up a new market for the drug while saving them the 150M dollars or more required to meet all the hoops and hurdles that the FDA requires for formal approval, the most important one being safety.

It is alleged that there are big hopes for Horizant’s off-label use as an anti-Parkinson’s drug. If that’s true where’s the proof? Gabapentin, the active component is not a dopamine agonist. It works on the GABA receptors in the basal ganglia. Another form of gabapentin called Neurontin was originally approved for anti-seizure therapy and then was sold through off-label channels to treat everything from bipolar disorder to chronic pain–but never Parkinson’s. Neurontin’s maker, Pfizer withstood a great deal of criticism and was even sued for allegedly promoting the drug for off-label uses it knew it to be ineffective.

Well thankfully it turns out that gabapentin has been cited in numerous studies as far back as the late 90′s to be effective in treating the motor symptoms, motor fluctuations and tremor in PD. Formal FDA studies are very expensive. I imagine that dealing with complicated PD patients, most of whom already take one or several drugs, would make the task of FDA approval for its use in Parkinson’s a great deal more expensive and difficult. Proving safety of a drug that tends to be mildly sedating in a patient group at risk for traumatic falls might be near to impossible. The alleged off-label route would be much easier as I am certain FDA approval for treatment of RLS (a sedating drug in otherwise healthy patients going off to sleep and measuring leg motion) would prove to be much less complicated.

Thus, if what is being alleged is true, a new RLS drug on the horizon, aptly named Horizant will soon be available for off-label use in Parkinson’s: safety testing not-included.

I am cynical or merely paranoid ?
 

well IF

- 25% OF PD dx are incorrect,
- and dopamine meds are sometimes used as a diagnosis tool to see if the patient responds favourably,
- whilst DAs and their like are now used for RLS and the like indiscriminately (ignoring the known side effects)

and AGAIN IF the use of Dopamaine and DAs eventually desensitise the receptors they work on

then we seem to be exponentially growing the PWP population through a mixture of greed and medical ignorance ?

Horizant, eh? Love the names they come up with. Vurtical? Ambltori? Kommatose?

Heck, I started to spoof them but realized that they'd use the names.:)

Great fun
 

As far as fun goes, it's akin to coming up with new names for Ikea furnishings. The sad part is the enormous effort put into naming new drugs: the focthe psyhology behind the names, the focus of gwhat it sounds like it can do for you...if the mere power of suggestion that taking a pill will make you feel better imagine that with a designer name will make you feel twice as good- placebo at its finest. The amount of money spent on marketing a new drug is phenomenol from what I've heard in medical community; the scary thing is why do they feel the need to persuade or try so hard?

Off label works
 

Hello,
You have solved a mystery for me. I was housebound and unable to walk, in a great deal of pain july 12 to Sept. 12.
Then I was prescribed Gabapentin 300 mg 2x day 1 at bedtime. Within 7 days I could walk and pain was almost gone and today it is like befoe pd.
I take Stalevo125 5 times a day.
I am walking the dog and attending social functions.
I am thankful for each day it works.
Joyce

shills
 

"Sadly many of the docs on the speaker circuit are well-compensated but often don’t even know they’ve been assigned this role. They’re led to believe that it’s more of an educational entertainment thing to get the drug sales rep’s face to face with other physicians to give their pitch. They often don’t realize that their discussion of off-label use is really indirect advertising that opens up a new market for the drug while saving them the 150M dollars or more required to meet all the hoops and hurdles that the FDA requires for formal approval, the most important one being safety."

Really? I have never met an MD who is shilling for Pharma who does not know exactly what is involved. And I have met/know many of them. You know such individuals?

Update: Gabapentin and Stalevo still working for me, have cut Stalevo to 4 a day as I fall linto Donut Hole soon.
Insurance pays over 500.00 for Stalevo.
Wonder if Sinemet CR would work the same?

Stalevo in donut hole
 

Hello,
well the cost for Stalevo is now at 800 dollars so in the Donut hole I would be paying a 49%. Any ideas as to a possible replacement of 4 Stalevo125 a day, and does your Stalevo creat tremors and pain?
Thanks forany input
Joyce:eek:

i'd try a (1/2) 25/100 sinemet immediate release + 50/200 sinemet CR, 3-4 times a day? if you assume 60% availability for CR, then each dose is 50+120=170mg l-dopa.
i adjust the combo depending on what i need to do, if i exercise i'll take more immediate release and might take1/2 CR. but playing around with both might get you by. on immediate release, splitting a 25/250 is the cheapest way to go, i actually split those into qtr's to get appx 62.5mg.

you can pose your question at:
http://forum.parkinson.org/index.php?showforum=4
http://forum.parkinson.org/index.php?showforum=15

haha...............
In pharmacology, all drugs have two names, a trade name and a generic name. For example, the trade name of Tylenol has a generic name of Acetaminophen. Aleve is also called naproxen. Amoxil is also called amoxicillin and Advil is also called ibuprofen. The FDA has been looking for a generic name for Viagra. After careful consideration by a team of government experts, it recently announced that it has settled on the generic name of mycoxafloppin. Also considered were mycoxafailin, mydixadrupin, mydixarizin, mydixadud, dixafix, and of course, ibepokin

Sorry for interrupting!