Yo Bruce

I never looked up your photo before.

Guess what?   You have all the external presentations of a narcoleptic.... most notably the red swollen face and neck....
You have an oral infection and endotoxemia, probably induced by alcohol, bless your fat Irish heart.

Good luck with that.

Oh My

Such a lovely gift for me...  just what I wanted!

Central and Peripheral Metabolic Changes Induced by Gamma-Hydroxybutyrate.

Study Objectives:
Gamma-hydroxybutyrate (GHB) was originally introduced as an anesthetic but was first abused by bodybuilders and then became a recreational or club drug.1 Sodium salt of GHB is currently used for the treatment of cataplexy in patients with narcolepsy. The mode of action and metabolism of GHB is not well understood. GHB stimulates growth hormone release in humans and induces weight loss in treated patients, suggesting an unexplored metabolic effect. In different experiments the effect of GHB administration on central (cerebral cortex) and peripheral (liver) biochemical processes involved in the metabolism of the drug, as well as the effects of the drug on metabolism, were evaluated in mice.
Design:
C57BL/6J, gamma-aminobutyric acid B (GABAB) knockout and obese (ob/ob) mice were acutely or chronically treated with GHB at 300 mg/kg.
Measurements and Results:
Respiratory ratio decreased under GHB treatment, independent of food intake, suggesting a shift in energy substrate from carbohydrates to lipids. GHB-treated C57BL/6J and GABAB null mice but not ob/ob mice gained less weight than matched controls. GHB dramatically increased the corticosterone level but did not affect growth hormone or prolactin. Metabolome profiling showed that an acute high dose of GHB did not increase the brain GABA level. In the brain and the liver, GHB was metabolized into succinic semialdehyde by hydroxyacid-oxoacid transhydrogenase. Chronic administration decreased glutamate, s-adenosylhomocysteine, and oxidized gluthathione, and increased omega-3 fatty acids.
Conclusions:
Our findings indicate large central and peripheral metabolic changes induced by GHB with important relevance to its therapeutic use.

More evidence that Xyrem induces ketosis.   It's the Coma Diet.
Jazz charges about $5000 a month- not to mention all the doctor visits and expensive tests and insurance nightmare- to create a metabolic state that all people can experience for free by doing nothing. 

(cross posted at NN just for spite.   Man, I gotta stay away from there.   Makes me want to scream.)

Yeah they Do

Robert Reich: We let Big Pharma rip us off

Bruce needs a Boat

or two or something

Jazz Pharmaceuticals plc - (NASDAQ:JAZZ) CEO Bruce C. Cozadd sold 5,000 shares of Jazz Pharmaceuticals plc – stock on the open market in a transaction dated Tuesday, September 9th. The stock was sold at an average price of $170.32, for a total transaction of $851,600.00. Following the completion of the sale, the chief executive officer now directly owns 574,023 shares of the company’s stock, valued at approximately $97,767,597.

Strike that, Reverse it

So I finally got around to reading the Summary of the FDA Patient Conference on Narcolepsy.

Most of it is just reporting the annoying State of the Paradigm, but this part really bugs me...

Some participants commented on the need to better understand and target the underlying cause(s) of the disease, for example orexin or hypocretin loss.
A few commented that sodium oxybate targets the underlying cause (sleep consolidation) but that other options are needed for patients who cannot take sodium oxybate.

Who is telling people that narcolepsy is caused by a breakdown in sleep architecture?
Hmmmm.   I wonder.
That sounds kinda backwards to me.

Sorry I missed this

From 2010-
How a Sleeping Drug Company Increased Prices 300% Without Anyone Noticing

Yeah, I don't remember even a peep from Narcolepsy Network...

Jazz must be jizzing

Rescue of Alzheimer's memory deficit achieved by reducing 'excessive inhibition'

"We recently discovered an abnormally high concentration of one inhibitory neurotransmitter in the brains of deceased Alzheimer's patients," Chen said. He and his research team found the neurotransmitter, called GABA (gamma-aminobutyric acid), in deformed cells called "reactive astrocytes" in a structure in the core of the brain called the dentate gyrus. This structure is the gateway to hippocampus, an area of the brain that is critical for learning and memory.

Chen's team found that the GABA neurotransmitter was drastically increased in the deformed versions of the normally large, star-shaped "astrocyte" cells which, in a healthy individual, surround and support individual neurons in the brain. "Our research shows that the excessively high concentration of the GABA neurotransmitter in these reactive astrocytes is a novel biomarker that we hope can be targeted in further research as a tool for the diagnosis and treatment of Alzheimer's disease," Chen said.

Holy I can't remember what, Batman..  A huge new collection of Zombies to sell Xyrem to.
Frikkin frakkin Matrix may get us all yet...
Have some fruits and grains and don't think about it.

Abstract

Yo Netherlands

I LOVE YOU GUYS!!!!!!  

Glucose and Fat Metabolism in Narcolepsy and the Effect of Sodium Oxybate: A Hyperinsulinemic-Euglycemic Clamp Study.

INTRODUCTION:
Narcolepsy is associated with obesity though it is uncertain whether this is caused by changes in glucose and fat metabolism. Therefore, we performed a detailed analysis of systemic energy homeostasis in narcolepsy patients, and additionally, investigated whether it was affected by three months of sodium oxybate (SXB) treatment.
METHODS:
Nine hypocretin deficient patients with narcolepsy-cataplexy, and nine healthy sex, age, and BMI matched controls were enrolled. A hyperinsulinemic-euglycemic clamp combined with stable isotopes ([6,6-2H2]-glucose and [2H5]- glycerol) was performed at baseline. In seven patients a second study was performed after three months of SXB treatment.
RESULTS:
Glucose disposal rate (GDR) per unit serum insulin was significantly higher in narcolepsy patients compared to matched controls (1.6 ± 0.2 vs. 1.1 ± 0.3 μmol/kgFFM/min/mU×L; P = 0.024), whereas β-cell function was similar (P = 0.50). Basal steady state glycerol appearance rate tended to be lower in narcolepsy patients (5.2 ± 0.4 vs. 7.5 ± 1.3 μmol/kgFM/min; P = 0.058), suggesting a lower rate of lipolysis. SXB treatment induced a trend in reduction of the GDR (1.4 ± 0.1 vs. 1.1 ± 0.2 μmol/kgFFM/min/mU×L; P = 0.063) and a reduction in endogenous glucose production (0.24 ± 0.03 vs. 0.16 ± 0.03 μmol/kgFFM/min/mU×L: P = 0.028) per unit serum insulin. After SXB treatment lipolysis increased (4.9 ± 0.4 vs. 6.5 ± 0.6 μmol/kgFM/min; P = 0.018), and body weight decreased in narcolepsy patients (99.2 ± 6.0 vs. 94.0 ± 5.4 kg; P = 0.044).
CONCLUSION:
We show that narcolepsy patients are more insulin sensitive and may have a lower rate of lipolysis than matched controls. SXB stimulated lipolysis in narcolepsy patients, possibly accounting for the weight loss after treatment. While sodium oxybate tended to decrease systemic insulin sensitivity, it increased hepatic insulin sensitivity, suggesting tissue-specific effects.

I would like to thank the authors from the very bottom of my liver.
Although it looks like I may have the specific mechanism wrong (altering insulin sensitivity rather than amount), this study shows that narcoleptics do have altered glucose metabolism, retain more fat,  and that Xyrem affects that pathway.
Cha Ching!

Why Xyrem is so expensive

Why does Jazz charge so much for Xyrem?   Because they can.
Xyrem is patented for use as a narcolepsy drug and it has orphan drug status from the FDA.

That means that even though GHB is a generic drug, doctors can't prescribe it for narcolepsy patients unless they use Jazz' patented version.  And since it is a class C drug, doctors can't order it unless they disclose the patient's diagnosis.

In addition, Orphan Drug status means they can charge anything they want for it.  It's a program that was instituted to insure pharmas are financially compensated for providing a drug to just a small number of patients.  The drugs are required to be subsidized by insurance companies and the government too. So what has happened is a whole cottage industry of shameless companies have popped up taking advantage of desperately ill people.  Here's a good article.  
(update: here's an even better one. )

GHB is a generic chemical that is about as simple, and costs about as much to produce as alcohol.
99% of what Jazz charges for it is pure profit.

And in case you're interested- Xyrem works by raising your insulin sensitivity and lowering your insulin production.   You can accomplish the same thing using a special diet and exercise.

Same Shit, Different Day

Sorry I missed this-

Jazz Pharma Buying Experimental Narcolepsy Drug

Jazz Pharmaceuticals said Monday it is acquiring an experimental narcolepsy drug in a deal that could be worth more than $397 million.
The drug is called ADX-N05, and it is being developed by Aerial BioPharma. The drug is intended to treat daytime sleepiness in narcolepsy patients, and Jazz said it wants to start late-stage testing as soon as possible.
The Irish drugmaker agreed to pay Aerial BioPharma $125 million upfront, and it could make another $272 million in payments if the drug reaches development milestones and sales targets. Aerial BioPharma will also get royalties on sales if the drug is approved.

And this is why-
FDA grants orphan designation to Aerial BioPharma’s ARL-N05 for treatment of narcolepsy
(same drug, different name)

More of the same duplicitous thievery from Jazz- they are counting on being able to charge whatever the hell they please, and having taxpayers subsidize the bill.

Aerial’s Exec VP of Drug and Development Gary Bream said ADX-NO5 is chemically distinct from modafinil and amphetamines, which (also) target the noradrenergic and dopaminergic pathways. He said it is too soon to know if it offers benefits over existing treatments.

And they haven't tested that.   Only tested against placebo.

More on Orphan Drug Profiteering

How a drug for few patients was turned into $81 million in sales

But when the November 2001 bulletin was published, its listing for Trisenox included a mistake. The bulletin made it appear that Trisenox was medically accepted for four diseases, instead of just one. Subsequent issues added three more diseases, leaving the false impression that Trisenox was accepted and reimbursable for seven diseases in all.
Marchese understood that a mistake in the bulletin could lead states to reimburse for unaccepted uses. He emailed the company’s sales director: “How pretty are those Compendia bulletins!!! … [M]an do I like working the system. I figure even if 1 state doesn’t check its [sic] a bonus!!”
To which the director responded: “[E]ven if it works in one state, it’s a HUGE win! … Getting rich is a very good thing and it can’t happen soon enough!”

Part 1 is here

Pay no attention to the man behind the curtain

Some nice person sent me this link:   CafePharma Forum for Jazz.

Lots and lots of interesting stuff from sales reps in there...

"85k base pay and pretty easy scoring some cougar tail at the Jazz sales meetings. Not the most money or the best tail out here but both could be worse. Welcome to Jazz Land. The products do suck though. Enjoy while you work on something better."

No scruples.  No shame.  None.

Yo Jazz

We know you don't care one flippin bit about us or our misery.

Pharma's Windfall- The mining of rare diseases

Thirty years ago, Congress acted to spur research on rare diseases. Today, we have hundreds of new drugs — along with runaway pricing and market manipulation, as drugmakers turn a law with good intentions into a profit engine.

Market manipulation= donating to doctors and patients organizations

(also posted at NN just for the fun of it.)

related post

Brain Eating Zombies of the Day

Concert Pharma, Jazz Pharma Strike $120M Deal for Narcolepsy

The deal calls for the two companies to work together on a modified version of sodium oxybate (Xyrem) for narcolepsy, a neurological disorder that leads to excessive daytime sleepiness. Under the deal, Jazz will get the worldwide commercial rights to Concert’s compounds that swap in deuterium elements into sodium oxybate, including one dubbed C-10323

Although the Concert drug hasn’t yet entered clinical trials, Jazz is hoping it will provide a long line extension for its franchise drug sodium oxybate, which was first FDA approved in 2002. The drug is cleared for narcolepsy to reduce excess daytime sleepiness and reduce cataplexy (weak or paralyzed muscles) attacks. Sales have been booming recently, up more than 60 percent, to $102.6 million in the most recent quarter ended Sept. 30. The first patents on the drug begin to expire in 2019 and 2020, according to the FDA Orange Book.

That's what I call thinking ahead.  They are paying 120 million dollars to modify one hydrogen atom so they can get a new patent and keep charging you an arm and a leg for a drug you don't even need.  They have no intention of ever distributing a generic version.

Is this the type of spending on narcolepsy research you were hoping for?
Frankly, I think it's outrageous and unconscionable.

More misery, more Money

Jazz Pharma Earnings Top Estimates As Xyrem Ramps

As usual, most of Jazz's sales came from its narcolepsy drug Xyrem, which provided 58% of revenue. It also continued to drive growth, rising 64% from Q3 2011.
On the conference call with analysts, Jazz CEO Bruce Cozadd said Xyrem volume rose 9% year over year, so much of the revenue growth was due to price increases. Xyrem is the only drug with U.S. approval for two symptoms of narcolepsy — daytime sleepiness and loss of muscle tone — so Jazz has been able to act like a semi-monopoly, charging tens of thousands of dollars per year for Xyrem

GHB is a drug that is about as easy and cheap to produce as alcohol...
Which explains how they pay for these lawyers:

Ruling Is Victory for Drug Companies in Promoting Medicine

In a case that could have broad ramifications for the pharmaceutical industry, a federal appeals court on Monday threw out the conviction of a sales representative who sold a drug for uses not approved by the Food and Drug Administration. The judges said that the ban on so-called off-label marketing violated the representative’s freedom of speech. ... 

The ruling, in United States v. Caronia, involved the conviction of Alfred Caronia, a former sales representative for Orphan Medical, which was later acquired by Jazz Pharmaceutical. Mr. Caronia was selling Xyrem, a drug approved for excessive daytime sleepiness, known as narcolepsy. He was accused of promoting it to doctors as a treatment for insomnia, fibromyalgia and other conditions. He became the target of a federal investigation in 2005 and was caught on an audiotape discussing the unapproved uses of the drug with a doctor who was a government informant. He was convicted by a jury in 2008.
Mr. Caronia appealed the conviction, arguing that his right to free speech under the First Amendment was being illegally restricted. The appellate court decision applies only to the Second Circuit, which comprises New York, Connecticut and Vermont, but some lawyers said that the government was likely to appeal and that the case could find its way to the Supreme Court.

That's your money and tax dollars going to fund the undermining of drug regulation- starting with the dangerous drug that doesn't even address the source of your illness.   It's gobsmacking.

To Be Clear

Narcolepsy Network is NOT a patient organization.
Narcolepsy Network does not exist to help or educate Narcoleptics.
Narcolepsy Network does not want you to get better. 
Narcolepsy Network is now almost fully funded by drug companies.  It is not a source FOR patients.  It is a Source OF Patients.
Look at it-  their goal is "Raising Awareness".  Translated, that means "Drum up Business".
Find you as soon as po$$ible, get you into a Doctor$ office, give you lots of Te$ts and put you on ¢Pap and Drug$.
And then suck your family into the vortex, too.

It's not about you.  It's about your diagnosis.  Period.
Narcolepsy makes you eligible for life-long big-dollar insurance reimbursement.


The patient forum and conference are merely ways to get you to become personally invested in their charade. And do their public relations for them.

Jazz has coopted the Zombies into literally trolling schools to find kids to put on Xyrem.