How a Sleeping Drug Company Increased Prices 300% Without Anyone Noticing (click here)
Jazz Pharmaceuticals (JAZZ) has pushed up the price of its narcolepsy drug Xyrem fourfold since 2006, and it's a good example of how prescription costs in the U.S. are out of control. Xyrem now costs as much as $35,000 per year of treatment, and the company says it could double the price again without anyone noticing....
I am sorry, but, the idea any one can say anything to sell medications to the American public is nothing short of selling snake oil. I can't over look this. It is about the designer laboratories again.
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Jazz Pharmaceuticals is scheduled to launch 'the idea' that any medication can be applied to any ailment even on the authority of laymen. I don't think so. This is playing on the commercialization of desperation of the chronically ill. This is outrageous. Who the heck bought the courts on this one?
- Nature Medicine
- 19,
- 1
- (2013)
- Published online
...In fact, virtually anyone (click here) who doesn't work for the pharmaceutical industry can advocate for the off-label use of a medicine. Under the Food, Drug and Cosmetic Act (FDCA), which gives the FDA its regulatory authority, it is a crime to promote a drug for purposes not listed in its label. In FDCA language, “introducing a misbranded drug into interstate commerce” is illegal. GlaxoSmithKline's $3 billion settlement last summer for promoting Avandia and other drugs for unapproved uses is a stern reminder reminder that the FDCA means business.
But on 3 December, a federal appeals court changed the status quo by overturning the conviction of Alfred Caronia, a sales representative for Orphan Medical, who promoted a drug for uses not approved by the FDA. The case involved the drug Xyrem, the active ingredient of which is γ-hydroxybutryate, a compound federally classified as the 'date rape drug'. Xyrem is prescribed for certain types of narcolepsy, but Caronia was caught promoting the drug for patients with conditions as diverse as fibromyalgia, restless legs syndrome, chronic pain and Parkinson's disease....
Xyrem has been under study with UMDNJ since 2007 for the application for chronic fatigue syndrome and fibromyalgia without any published results to date. Where is Jazz Pharmaceuticals getting their authority to advocate this very dangerous trend in medication application in this country?
Xyrem has been under study with UMDNJ since 2007 for the application for chronic fatigue syndrome and fibromyalgia without any published results to date. Where is Jazz Pharmaceuticals getting their authority to advocate this very dangerous trend in medication application in this country?
...I have prescribed sodium oxybate (click here) in my own practice for patients who have both CFS and FM with good results. Anecdotally, patients reporting less pain also reported better quality sleep and less fatigue upon awakening. This has led me to hypothesize that sodium oxybate will reduce fatigue in patients with CFS alone (i.e., without also having FM).
To test this hypothesis, I propose doing a double blind, placebo controlled trial of sodium oxybate in 30 patients who fulfill a formal case definition for chronic fatigue syndrome and who do not also have FM.
The FDA has a long history of fast tracking medications, ie: HIV Medications (Initially AZT), that is not what this is. If this medication was proven to be safe for patients without harmful side effects worse than the disease itself or a threat to longevity the FDA would have approved it accordingly.
Anecdotally is a problem. Sincere trials are the only methods of achieving real information regarding a drug. Since when are drugs prescribed to patients on the basis of anecdotal knowledge? Patients are suppose to receive guarantees by established knowledge bases, not surprise effects they didn't know anything about.
γ-hydroxybutryate - Active Ingredient is different than chemical composition and/or generic name as in the case of Xyrem, sodium oxybate. It is a highly reactive compound that I have reservations about just looking at it. The half life of the compound is 30 minutes to one hour. How many of these can a person tolerate a day to sustain its effect? Toxic levels? And at this price the USA could be rooked out of a lot of money through those receiving Medicare while disabled. It is a mess.
This is it's parent compound, gamma-Hydroxybutyric acid. Sound dangerous? Right? I mean it is an acid after all. It is a naturally occurring substance found in the human central nervous system, as well as in wine, beef, small citrus fruits, and almost all animals in small amounts. GHB has been used in a medical setting as a general anesthetic, to treat conditions such as insomnia, clinical depression, narcolepsy, and alcoholism, and to improve athletic performance.
Basically, Jazz Pharmaceuticals put the parent compound through a chemical process to remove a H (hydrogen) and add a Na (sodium). It is a probably a very slick way of getting a patent for exploitation. If the parent compound is exposed to sodium chloride (NaCl) TABLE SALT, the ionic OH will be replaced with NA and the second product would be HCl, hydrocloric acid of which can be neutralized with H2O, water.
Yes, sir, it sure looks like a miracle drug to me.
Anecdotally is a problem. Sincere trials are the only methods of achieving real information regarding a drug. Since when are drugs prescribed to patients on the basis of anecdotal knowledge? Patients are suppose to receive guarantees by established knowledge bases, not surprise effects they didn't know anything about.
γ-hydroxybutryate - Active Ingredient is different than chemical composition and/or generic name as in the case of Xyrem, sodium oxybate. It is a highly reactive compound that I have reservations about just looking at it. The half life of the compound is 30 minutes to one hour. How many of these can a person tolerate a day to sustain its effect? Toxic levels? And at this price the USA could be rooked out of a lot of money through those receiving Medicare while disabled. It is a mess.
This is it's parent compound, gamma-Hydroxybutyric acid. Sound dangerous? Right? I mean it is an acid after all. It is a naturally occurring substance found in the human central nervous system, as well as in wine, beef, small citrus fruits, and almost all animals in small amounts. GHB has been used in a medical setting as a general anesthetic, to treat conditions such as insomnia, clinical depression, narcolepsy, and alcoholism, and to improve athletic performance.
Basically, Jazz Pharmaceuticals put the parent compound through a chemical process to remove a H (hydrogen) and add a Na (sodium). It is a probably a very slick way of getting a patent for exploitation. If the parent compound is exposed to sodium chloride (NaCl) TABLE SALT, the ionic OH will be replaced with NA and the second product would be HCl, hydrocloric acid of which can be neutralized with H2O, water.
Yes, sir, it sure looks like a miracle drug to me.
