A USA Appeals Court upholds "Off Label" medication use?

Excuse me? Is it necessary under the new patent law to actually exploit the uses of this drug before the patients die of it or get sicker?

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. 

Event Details Title Jazz Pharmaceuticals at JPMorgan Global Healthcare Conference (click here) Date and Time Tuesday, January 8, 2013 10:00 a.m. PT   Location Westin St. Francis Hotel San Francisco, CA

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

 

07 January 2013

...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?

...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.

The NLRB is moving labor disputes forward to resolution. Thank you.

IATSE Local 500 (click here) is striking the Kravis Center right now in South Florida.

For more than 12 years, the Kravis Center has been in continuous violation of federal labor law.

Local 500 "would request that the public call [Kravis Center Directors] Judith Mitchell and Jim Mitchell at (561) 833-8300 and tell them to stop violating federal labor law."

In case the working public doesn't understand the verbiage, it is called UNFAIR LABOR PRACTICES!!! These practices prevents competition in the work place and lowers pay to citizens. The practices the NLRB litigates prevents poverty and expands the economic power of the Middle Class.

New Agreement Means $2.2M in Back Pay, New Work for Florida IATSE Members (click here)

January 4th, 2013 | Mike Hall

...McKenzie deadpanned, ‘Well, a strike had something to do with it.’

In 2000, the theater fired several IATSE members and withdrew recognition of the union after declaring an impasse had been reached in negotiations. In 2001, attorneys for the regional director of the NLRB concluded that Kravis had committed “massive and continuous violations” of federal labor law when it unilaterally withdrew recognition of the union, refused to negotiate, discharged union-represented department heads and other major violations.

Kravis appealed the decision to the Bush–era full NLRB, which took five years before the board ruled that the center violated the law when it ejected the union and fired union workers. But the center appealed to a federal appeals court, which upheld the NLRB ruling....

None of these health care insurance companies are moderate sized companies.

Wall Street is seeking to undo the new economy of the Democratic leadership. This is active political directives by Wall Street. There is no other reason for it, except, "They can not that they should."

The Wall Street health care insurance companies are a cartel. That is a fact. They are well organized and definitely 'bonded' by the purpose of defeating adverse political entities.

This is anti-trust in a very big way. Where they 'act together' against the free market system they are definitely an anti-trust entity.

Wednesday, December 12, 2012

Rise in Health Insurance Costs Outpacing Income Growth, Report Finds

Growth in employees' health insurance premium costs outpaced growth in income in all 50 states from 2003 to 2011, while deductibles nearly doubled during that period, according to a new report released by the Commonwealth Fund, Modern Healthcare reports.

The report, which aimed to better understand the financial strain on households and business budgets from the nation's rising health care costs, found that:

• A worker spent an average of $3,962 on premiums for employer-based family health coverage in 2011, an increase of 74% from 2003;
• 
  
• The average premium for a family plan in 2011 was $15,022, up 62% from 2003;
• 
  
• Seventy-eight percent of insured workers had deductibles in 2011, compared with 52% in 2003;
• 
  
• The average deductible for an individual health plan in 2011 was $1,123, an increase of 117% from 2003; and
• 
  
• The average deductible for a family plan in 2011 was $2,220, an increase of 106% from 2003 (Evans, Modern Healthcare, 12/12).

Premiums increased three times faster than incomes for workers in New Mexico, South Carolina and West Virginia, where the premiums exceeded 25% of median wages, the report found....

This is fairly straight forward. The companies are only allowed to keep 15% of its premiums. A full 85% is suppose to be spent on actual costs. The difference between that 85% and the actual cost to the subscriber over 15% has to be refunded in a premium refund.

The health care insurance CARTEL is front loading its profits while at the same time attacking a soft economic target in the Small Business Persons to prevent the American People from actually reclaiming their economy from Wall Street.

See, health care is mandated now. So, the Small Business Owner in a "Cartel Experiment" will seek to sink the growth of the USA economy in favor of their Chinese import counter parts. China's penetration into the global economies is shrinking. There are many reasons why that is the case, partly because statistically it was going to happen anyway (Bubble and Bust) and other factors such as energy costs.

But, Wall Street is talking to each other and seeking to control the impact of the Independent Business Owner in the USA that could actually see penetration into global markets when their products are better quality and a better value 'for the money.' There is nothing more precise than a product produced by an American Small Business Owner. There just isn't. They oversee everything and the quality is extremely important to them. 

So, Wall Street is scared to their skivvies. They see the curve on the success of the American economy of Small Business Owners and they know where their profit margins are headed as well as their bonuses.

Now, that health care is mandated in the USA with State Exchanges being established as of 2014. Which, by the way, I am happy as a bee on a honey pot, conservative states (Red States) aren't taking on the challenge. These states would seek to play excruciating politics with health care insurance to enforce their political goals. That said, the State Exchanges will provide a venue the current companies want. If the State Exchanges (as a larger group of nameless and faceless individuals) can be manipulated to PROVE this is a hugely bad idea, they may get their old methodology back.

Believe me, the PLANS these companies have to control the USA economy and the outcome of their profits and bonuses are amazing.

Think it through. These are global companies and they don't want to give up any minuscule percentage of the USA economy they now hold. That is a baseline of success in profits for them. Now, how is it best to control the propaganda to the government committees that will ultimately make their decisions about rate hikes? Would the propaganda be contestable by INDIVIDUALS in a State Health Insurance Exchange or would the propaganda work best when addressing Small Business Owners who know their employees very well?

The propaganda would work best with a larger more random 'identity' of the insured. Yes, I am saying the companies will lie to the public to make their case a populous demand known to work well in the Right Wing electorate.

Getting the picture and why 'the truth' and getting down to the facts is important?

It is vital to the USA Economy to rid itself of 'mind speak political propaganda.' It is corrupt and it is toxic. It allows for easy manipulation of the electorate and discouraging it from participation in its own government. 

That is my focus when I read this mess. Wall Street definitely is not a trustworthy entity in the USA economy. Health Care Insurance Companies are among the worst of the worst of Wall Street.

I don't know how accurate this list is, but, it was available from US News and World Report, so it is probably fairly accurate. It is a good starting place.

The Top 25 Health Insurance Companies (click here)

The largest U.S. health insurers collected some $650 billion in premiums in 2009, the latest year for which data were available in early 2011. The top 25, ranked below by market share, accounted for nearly two-thirds of the total. Data were provided by the National Association of Insurance Commissioners, whose members direct the state agencies that license insurance companies....

Then realize there are certain known FIXED costs. Yes, the cost to Americans is somewhat known as a factor in the USA economy.

...But let's consider what 17 cents of every U.S. dollar is purchasing. (click here) According to the most recent report from the Organization for Economic Co-operation and Development (OECD) -- an international economic group comprised of 34 member nations -- it's not as much as many Americans expect.

In the United States:

• There are fewer physicians per person than in most other OECD countries. In 2010, for instance, the U.S. had 2.4 practicing physicians per 1,000 people -- well below below the OECD average of 3.1.
• The number of hospital beds in the U.S. was 2.6 per 1,000 population in 2009, lower than the OECD average of 3.4 beds.
• Life expectancy at birth increased by almost nine years between 1960 and 2010, but that's less than the increase of over 15 years in Japan and over 11 years on average in OECD countries. The average American now lives 78.7 years in 2010, more than one year below the average of 79.8 years....

Then imagine a mandated health care insurance in the USA that actually provides for 'No Deductible Screenings' for health risks. My, my the American citizen may live a long time without any huge health care costs to tap into to exploit. What is Wall Street going to do?

I could go on for awhile, but, I think that paints a fairly clear picture as to the cartel of health insurance companies and their desperate CEO's that just don't know how they are going to pay for their new seashore house in New Orleans. 

It surprised me the House was struggling with passing the Flood Insurance Funding bill. It told me a couple of things, like maybe the wealthy should not be funded for their losses, possibly the corruption in Congress is actually breaking down and the most important speculation is the FACT this funding is actually running out. Why? Either it wasn't funded in the first place and/or there is so much flooding damage in the USA because of the Climate Crisis the Flood Insurance Program simply can't keep up.


January 7, 2013
The Weather Channel
Current Temperature Map of the USA

Take for example the massive amount of flooding that is going to occur now that the USA has been frozen for about a week and is now going to thaw. So much for Spring.

Well. The idea the Health Care Insurance Companies are HONEST dealers in the USA economy is about the most naive thought any citizen could ever believe is true. They aren't honest dealers. Hell, they have killed people for profit margins. Get for real about these CEOs and their henchmen/women.

Health care costs are going down in the USA. We know that for a fact. The cost curve will bend down. The insurance companies know it, too. They are seeking to front load their profits before reality actually hits and do some damage to the recovering USA economy with Small Business Owners as the current focus of the DIABOLICAL profiteers.

Oh, one other thing.

There are those Right Wingers that ALREADY state, "Look at the increasing costs of heath care premiums for the sake of insuring a few million Americans." Now, if that isn't a lousy attitude to begin with, realize the insurance companies are seeing a lot more than insuring a few million more subscribers. 

THE HEALTH CARE INSURANCE COMPANIES can't cheat the subscriber anymore. That costs money. While the Right Wingers like to focus on a few million of Americans now being insured, there are far larger issues, such as the way they actually cheat legitimate subscribers and the fact they allow death when there are treatments that increase longevity. This is more than a few million people, it is QUITE FRANKLY, the entire nation and THE QUALITY OF CARE they actually get.

When Right Wingers state, "The USA has the best health care system in the world.," they don't mean that in a democratic way. The USA health care system MIGHT be the best in world, but, not accessible by many, many Americans. So, when defining BEST, what exactly does that mean?

"Morning Papers" - Its Origins (Click Here - Thank You)

The Rooster

"Okeydoke"

"Good Morning, Moon"

The waning crescent

24.2 day old moon

28.7% full

Top Ten Celestial Events to anticipate in 2013

1. Comet ISON: (click here) This event could be the most spectacular naked-eye astronomical event in decades. This comet will come within 0.02 Astronomical Units, or about 2 million miles, of the Sun toward the end of the year. If it breaks apart the comet could become nearly as bright as the moon, according to some guesses. Or it could be another relative dud like Comet Kahoutek — but probably not. “I think it will certainly be as good as Hale-Bopp,” said Anita Cochran, a University of Texas astronomer.  I recall Hale-Bopp being pretty cool back in 1997. In any case, this is easily my most anticipated event for 2013. (Mid-November through December)