Saturday, March 3, 2012

News and Events - 04 Mar 2012




02.03.2012 11:04:00

DOMINIC COYLE

Blockbuster drugs coming off patent will knock a major hole in our export figures and tax revenues

PHARMACEUTICALS HAVE been a driving force for Ireland’s export success in recent years. Even through the darkest days of our financial collapse and recession, the sector, dominated by the large multinational players, continued to deliver export growth and a glimmer of hope of economic recovery.

However, the most recent trade figures point to a looming problem for the Government. Reporting a 9 per cent fall in exports in December, the Central Statistics Office was unusually frank and detailed in stating that “a substantial part of the decline in the value of exports was due to a high value product in the chemicals and related products sector coming off patent”.

The drug is Lipitor, Pfizer’s blockbuster cholesterol lowering therapy and the world’s best-selling drug in recent years, accounting for revenues of $10.7 billion in 2010. Pfizer’s Cork plant produces 100 per cent of the company’s global requirements for the active pharmaceutical ingredient in the drug and a significant portion of the finished tablets.

Coming off patent will knock a major hole in the future revenues Pfizer can expect to get from the drug as generic competition kicks in. As a rule, loss of patent protection can hit the value of sales by anything between 40 and 70 per cent over time – and not much time at that.

For Ireland, the concern in the December figures was that, for now, generic competition to Lipitor is limited. If that was enough to skew the export figures so dramatically, the worry is what damage future, more intense competition will do to our trade balance.

And Lipitor is just one of a number of key drugs in which Ireland has a commercial interest and which are coming off patent. Chris van Egeraat, a lecturer in economic geography at NUI Maynooth, says seven of the 10 largest-selling drugs worldwide which are losing patent protection are currently produced in Ireland. They include the best-selling drug worldwide in 2010 after Lipitor; Sanofi/Bristol Myers Squibb’s blood clotting treatment Plavix, with sales of $9.43 billion. It comes off patent in May.

Globally, it is estimated that as much as $100 billion in sales will be lost to drug companies between 2009 and 2014 as a result of drugs coming off patent. Expected pipeline delivery in terms of market revenue over the same time amounts to about $30 billion, Dr van Egeraat says.

While he doesn’t expect the loss of patents to lead to huge imminent job losses, it does highlight the ambition of the Government’s new Action Plan for Jobs, which has targeted the health and life sciences sector for significant growth in the coming years to help reach the Government’s 100,000 job target.

However, loss of market sales will clearly impact on trade figures and tax revenues. The Irish Pharmaceutical Healthcare Association (IPHA notes that the pharmaceuticals sector accounts for roughly half of all exports and is the largest contributor to corporation tax, accounting for roughly 50 per cent of the ˆ3.5 billion collected last year.

In employment terms, IPHA president and Pfizer country manager David Gallagher says that about 25,000 people are employed directly in the industry, with a roughly similar number working in related sectors. He notes that pharmaceuticals has been more resilient than other sectors of the economy during recent “economically challenging times”.

The message is pointed, especially at a time when the sector is locked in a dispute with the Government over access to market for its new drugs and the contribution it can make to savings in the health budget sought by the State.

David Gallagher noted recently that an increasing number of innovative medicines are currently not being reimbursed by the Department of Health, despite being approved by regulators and meeting health technology assessments.

He recently accused the department of acting in bad faith by refusing to approve drugs for reimbursement as provided for under the industry’s current pricing agreement with the Department, even though the industry had delivered savings of about ˆ540 million over the past five years, a figure he says equates to a 20 per cent cut.

Even before the latest row, the IPHA said the delay between approval and market access had jumped by over 50 per cent to 157 days in recent years, and only 64 per cent of drugs that received market authorisation in the EU between 2007 and 2009 were made available to patients here.

Matt Moran, director of Ibec group PharmaChem Ireland, said Government policy “needs to urgently recognise the very serious challenges facing the industry”.

“A number of blockbuster drugs are coming off patent and healthcare spending in Ireland has been cut by ˆ600 million in the last five years,” he said. “The future success of the sector must not be taken for granted.”

In a speech last year, Gallagher said further price concessions were “simply untenable”, citing preliminary 2011 figures pointing to a 5.2 per cent decline in the value of the Irish market. “There is a limit to the amount which can be taken out of a market without its effective operation and employment being jeopardised,” he said.

Ireland is not alone. The commercial prospects for big pharma were also thrown into sharp focus with a report on the UK’s pharmaceuticals price regulation scheme, which reported collective industry losses of ?142 million in 2009 despite rising sales.

For its part, the Department of Health needs to find cuts in its budget. In a recent report on pharma pricing, the Economic and Social Research Institute (ESRI said that drug costs account for about 17.5 per cent of public health expenditure in Ireland, up from 14 per cent in 2000.

In 2009, the ESRI says, spending per head of population in Ireland on pharmaceuticals was “amongst the highest in the OECD”.

It is understood the Department of Health is targeting a saving of about ˆ112 million from the drugs bill – either in terms of pricing and access for new medicines or pricing of generics.

The ESRI report recommended a number of approaches. These included pricing drugs on the basis of the lowest cost in a basket of European markets rather than the average, and more regular price updates to capture the impact of falling prices earlier.

The industry says that, despite the small physical size of the Irish market, such a move would be negative in two ways. First, Ireland is itself a component of pricing baskets in eight other larger EU markets. A “match the lowest” price here will inevitably further eat into prices in other more important markets.

Secondly, the industry points to Ireland’s importance as a base of operations for most of the main players in the sector. An increasingly adversarial approach with the State will only damage the prospects for future investment, they say, with one industry source saying the recent approach of the department to market access for new drugs was creating a very poor impression in a number of important boardrooms State-side.

The seriousness with which the pharmaceutical sector views the current price negotiations in Ireland – where eight of the top 10 global players have operations – is highlighted by the engagement of some of the industry’s leading figures with the Government.

The chief executive of one major global player has made a point of briefly visiting Ireland next week. The message in his first visit to the State will not be lost on ministers. The following week, leading executives from another top 10 drug manufacturers gather in Dublin for a meeting at which the attitude of the State to the sector is certain to figure.

On the Government’s side, there is concern too at any adverse impact on such a major employer and contributor to the exchequer. Taoiseach Enda Kenny has recently engaged directly in private meetings with top industry figures here to assure them of the Government’s support despite the ongoing budgetary squeeze.

For their part, the drug companies say that current pricing pressures are restricting innovations. Without adequate compensation, they say, companies simply will not be able to invest in new products given the costs involved and the risk of failure.

This isn’t unique to Ireland. Reporting annual results earlier this month, Bayer chief executive Marijn Dekkers expressed concern “about the side-effects” of health service reforms taking place around the world “because the money we earn from today’s medicines pays for the development of tomorrow’s medicines”.

Pointing to the ˆ2 billion research and development cost of Xarelto, a new drug developed with Johnson Johnson to prevent blood clotting, he said: “We need innovative pharmaceuticals more than ever, because so many known diseases still cannot be treated adequately, or at all, with medicines.”

But that’s part of the problem for the major pharmaceutical companies. Many of the easy treatment areas are now well catered for. A good portion of the drugs that do so are shortly coming off patent and are easily accessible to generic competition.

The opportunities of the future lie in increasingly niche conditions or very high risk areas such as oncology and, especially, neurology. Added to this is the move to biologics and the trend towards more personalised medicines.

The challenge is evident in the fact that, last year, the US drug regulator, the Food and Drug Administration, licensed just a handful of new pharmaceutical therapies. Getting this more select group of drugs to as many markets as possible is increasingly critical for big pharma.

The age of the blockbuster is fading, along with the fat profit margins it offered. That presents major issues for the sector. Over time, through consolidation and acquisition, they have grown into massive unwieldy entities with poorly directed research failing to deliver sufficient pipeline.

In recent years, much effort has been devoted to streamlining operations and increasing productivity, especially on the research side. Thousands of jobs have been shed worldwide, and greater emphasis placed on outsourcing much of the early-stage RD work.

A case in point is Elan’s prospective Alzheimer’s treatment bapineuzumab. Originally developed by the company in association with Wyeth, it is now controlled by Pfizer (which acquired Wyeth to fill a perceived weakness in its biopharmaceuticals operations and Johnson Johnson, which bought an 18.4 per cent stake in Elan in 2009 in a deal valued at $1 billion. Its interest was driven largely by the Irish company’s pipeline – particularly bapineuzumab which is seen as one of the more promising candidates to address a disease with limited treatment options at present and which reports critical Phase III trial data later this year.

The second focus is on developing new markets. But that presents its own problems, not least with business practices that have reflected poorly on the industry.

Several of the largest drug companies have been implicated in an ongoing legal action in Serbia in which a group of 10 doctors and drug company officials were charged with taking, or offering, more than ˆ500,000 in bribes to use specific products. While all deny guilt in this case, an examination of US Securities and Exchange Commission (SEC filings by the world’s top 10 drug companies has found that eight of them recently warned of potential costs related to charges of corruption in overseas markets.

Life is unlikely to get any easier for the sector over the coming two or three years. That raises the stakes in the ongoing price negotiations. The new accord was due to come into force yesterday and, as the leaked Commission assessment this week illustrated, pressure on the Government to deliver the necessary savings to ensure their budgetary projections is only likely to intensify.

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NHS Choices
29.02.2012 21:00:00

Patients with a common type of metal hip implant should have annual health checks for as long as they have the implant, according to the UK body for regulating medical devices. The all-metal devices have been found to wear down at an accelerated rate in some patients, potentially causing damage and deterioration in the bone and tissue around the hip. There are also concerns that they could leak traces of metal into the bloodstream, which the annual medical checks will monitor.

Hours before critical coverage from the British Medical Journal and the BBC, the Medicines and Healthcare products Regulatory Agency (MHRA issued new guidelines on larger forms of ‘metal-on-metal’ (MoM hip implants. Advice on smaller metal devices or those featuring a plastic or ceramic head has not changed. Previously, guidelines suggested larger MoM implants should only be checked annually for five years after surgery. The agency now says the annual check-ups should be continued for the life of the implant. Check-ups, they say, are a precautionary measure to reduce the “small risk” of complications and the need for further surgery.

Together with the recent controversy over PIP breast implants, the news has caused the media and patient groups to call for tighter regulation of medical devices, perhaps bringing the approval process into line with that of medicines. Before they can be approved for wider use drugs must undergo several years of laboratory, animal and human testing .

 

What types of implants are involved?

There are numerous designs and materials used to make hip implants. In recent days the MHRA has issued major updates to its advice on a type of metal-on-metal (MoM hip replacement. As the name implies, MoM implants feature a joint made of two metal surfaces – a metal ‘ball’ that replaces the ball found at the top of the thigh bone (femur and a metal ‘cup’ that acts like the socket found in the pelvis.

The MHRA’s updated advice concerns the type of MoM implant in which the head of the femur is 36mm or greater. This is often referred to as a ‘large head’ implant. The agency now says that patients fitted with this type of implant should be monitored annually for the life of the implant, and that they should also have tests to measure levels of metal particles (ions in their blood. Patients with these implants who have symptoms should also have MRI or ultrasound scans, and patients without symptoms should have a scan if their blood levels of metal ions are rising. The previous guidance on this type of hip implant, issued in April 2010, advised that patients should be monitored annually for no fewer than five years.

 

What about other types of hip implants?

Advice on monitoring patients with other types of hip implants remains the same, and guidance has not changed on:

  • MoM hip resurfacing implants – where the socket and ball of the hip bone has a metal surface applied to it rather than being totally replaced.
  • Total MoM implants where the replacement ball is less than 36mm wide.
  • A particular range of hip replacements called DePuy ASR – these hip replacements were recalled by their manufacturer, DePuy, in 2010 because of high failure rates. The company made three types of ASR implant.
  • Implants featuring plastic or ceramic heads.

 

How many people are affected?

It is estimated that, in total, 49,000 people in the UK have been given metal-on-metal implants with a width of 36mm or above. This represents a minority of the patients given hip replacements, who mostly have devices featuring plastic, ceramics or smaller metal heads.

In 2010 there were 68,907 new hip replacements fitted, and approximately 1,300 of these surgeries used an MoM implant sized 36mm or above – a rate of around 2%.

 

What exactly is the problem with MoM implants?

All hip implants will wear down over time as the ball and cup slide against each other during walking and running. Although many people live the rest of their lives without needing their implant to be replaced, any implant may eventually need surgery to remove or replace its components. Surgery to remove or replace part of the implant is known as ‘revision’ and, of the 76,759 procedures performed in 2010, some 7,852 were revision surgeries.

However, data now suggest that large head MoM hip implants (those with a width of 36mm or greater wear down at a faster rate than other types of implants. As friction acts upon their surfaces it can cause tiny metal particles (medically referred to as ‘debris’ to break off and enter the space around the implant. Individuals are thought to react differently to the presence of these metal particles, but, in some people, they can trigger inflammation and discomfort in the area around the implant. Over time this can cause damage and deterioration in the bone and tissue surrounding the implant and joint. This, in turn, may cause the implant to become loose and cause painful symptoms, meaning that further surgery is required.

News coverage has also focused on the MHRA’s recommendation to check for the presence of metal ions in the bloodstream, potentially released either from debris or the implant itself. Ions are electrically charged molecules. Levels of ions in the bloodstream, particularly of the cobalt and chromium used in the surface of the implants, may, therefore, indicate how much wear there is to the artificial hip.

There has been no definitive link between ions from MoM implants and illness, although there has been a small number of cases in which high levels of metal ions in the bloodstream have been associated with symptoms or illnesses elsewhere in the body, including effects on the heart, nervous system and thyroid gland.

The MHRA points out that most patients with MoM implants have well functioning hips and are thought to be at low risk of developing serious problems. However, a small number of patients with these hip implants develop soft tissue reactions to the debris associated with some MoM implants.

 

How are medical devices regulated?

In the UK, the MHRA is the government agency responsible for ensuring that medical devices work and are safe. The MHRA audits the performance of private sector organisations (called notified bodies that assess and approve medical devices. Once a product is on the market and in use, the MHRA has a system for receiving reports of problems with these products, and will issue warnings if these problems are confirmed through their investigations. It also inspects companies that manufacture products to ensure they comply with regulations.

This system differs greatly from that for testing and approving drugs. Drugs require several years of research testing and trials before they can be approved for clinical use.

 

What action have regulators taken?

The MHRA has convened an expert advisory group to look at the problems associated with MoM implants. This meets regularly to assess new scientific evidence and reports from doctors and medical staff treating patients. The agency says it is continuing to monitor closely all the latest evidence about these devices and may issue further advice in the future.

In the US, the Food and Drug Administration (FDA says it is gathering additional information about adverse events in patients with MoM implants. In the meantime, it advises patients with MoM hip implants who have no symptoms to attend follow-up appointments as normal with their surgeon. Patients who develop symptoms should see their surgeon promptly for further evaluation.

 

What actions have critics called for?

In light of the PIP breast implant controversy and this new information on hip implants, there is currently intense scrutiny on the way medical devices are regulated in the UK and Europe, with patient groups and the media arguing that medical devices should be regulated in a similar way to medicines.

Clearing a medicine for use in the UK is a lengthy process involving several stages of laboratory and animal testing, and then carefully controlled and monitored tests in humans. Only once there is enough evidence to suggest that a medicine is reasonably safe can it enter clinical use, and even then patients will be monitored to look at the longer-term effects of the drug.

However, medical devices are not required to go through human trials before entering use, and can currently be approved on the basis of mechanical tests and animal research. While certain devices, such as hip implants, have been monitored through systems such as the National Joint Registry, in light of the recent health concerns over PIP breast implants, patient groups are calling for more testing before devices are allowed into clinical use, and closer mandatory monitoring schemes to ensure their safety once they enter the market.

Links To The Headlines

Annual blood tests for hip patients over poison fears. The Daily Telegraph, February 29 2012

Hip replacement toxic risk could affect 50,000. The Independent, February 29 2012

MHRA: Metal hip implant patients need life-long checks. BBC News, February 29 2012

Metal scare over hip replacement joints. The Guardian, February 29 2012

Toxic metal hip implants 'could affect thousands more people than PIP breast scandal. Daily Mail, February 29 2012




03.03.2012 23:05:37

Submitted by Brandon Smith from
Alt-Market

Americans Will Need “Black Markets” To Survive


As Americans, we live in two worlds; the world of mainstream fantasy, and the world of day-to-day reality right outside our front doors.  One disappears the moment we shut off our television.  The other, does not… 

When dealing with the economy, it is the foundation blocks that remain when the proverbial house of cards flutters away in the wind, and these basic roots are what we should be most concerned about.  While much of what we see in terms of economic news is awash in a sticky gray cloud of disinformation and uneducated opinion, there are still certain constants that we can always rely on to give us a sense of our general financial environment.  Two of these constants are supply and demand.  Central banks like the private Federal Reserve may have the ability to flood markets with fiat liquidity to skew indexes and stocks, and our government certainly has the ability to interpret employment numbers in such a way as to paint the rosiest picture possible, but ultimately, these entities cannot artificially manipulate the public into a state of demand when they are, for all intents and purposes, dead broke. 

In contrast, the establishment does have the ability to make specific demands or necessities illegal to possess, and can even attempt to restrict their supply.  Though, in most cases this leads not to the control they seek, but a sudden and sharp loss of regulation through the growth of covert trade.  The people need what the people need, and no government, no matter how titanic, can stop them from getting these commodities when demand is strong enough.

This process of removing necessary or desirable items from a trade environment leads inevitably to counter-prohibition often in the form of strict cash transactions, barter markets, or “black markets” as they are normally derided by those in power.  The problem for economic totalitarians is that the harder they squeeze the masses, the more intricate the rebellion becomes, especially when all they want is to participate in free markets the way our forefathers intended. 

The so called “drug war” is proof positive of the impossibility of locking down a product, especially one that has no moral bearing on the people who are involved in its use.  Only when a considerable majority of a populace can be convinced of the inherent immoral nature of an illicit item can its trade finally be squelched.  During any attempt to outlaw a form of commerce, a steady stream of informants convinced of their service to the “greater good” is required for success.  Dishonorable governments, therefore, do not usually engage in direct confrontation with black markets.  Instead, they seek to encourage the public to view trade outside mainstream legal standards as “taboo”.  They must condition us to react with guilt or misplaced righteousness in the face of black market activity, and associate its conduct as dangerous and destructive to the community, turning citizens into an appendage of the bureaucratic eye.

But, what happens when black markets, due to calamity, become a pillar of survival for a society?  What happens when the mainstream economy no longer meets the available demand?  What happens when this condition has been deliberately engineered by the power structure to hasten cultural desperation and dependence?

In this event, black markets not only sustain a nation through times of weakness, but they also become a form of revolution; a method for fighting back against the centralization of oppressive oligarchies and diminishing their ability to bottleneck important resources.  Black markets are a means of fighting back, and are as important as any weapon in the battle for liberty.  Here are just a few reasons why such organizational actions may be required in the near future…

The Mainstream Economy Is Slowly Killing Us

There are, unfortunately, some Americans out there who have not caught on yet to the grave circumstances in which we live.  Obviously, the stock market seems to have nearly recovered from its epic collapse in 2008 and 2009, and employment, according to the Labor Department, is on the mend.  The numbers say it all, right?  Wrong!  The numbers say very little, especially when they are a product of “creative mathematics”.

Despite the extreme spike in the Dow Jones since 2010, and all the talk of recovery, what the mainstream rarely mentions are the details surrounding this miraculous return from the dead for stocks. 

One of the most important factors to consider when gauging the health of the markets is “volume”; the amount of shares being traded and the amount of investors active on any given business day.  Since the very beginning of the Dow’s meteoric rise, the markets have been stricken with undeniably low volume interspersed with all too brief moments of activity.  In fact, this past January recorded the lowest NYSE volume since 1999:

http://www.bloomberg.com/news/2012-01-23/stock-trading-is-lowest-in-u-s-since-2008.html

Market volume has tumbled over 20% since last year, and is down over 50% from 2008 when the debt implosion began:


http://blogs.wsj.com/marketbeat/2012/02/24/trading-volume-anemic-this-year/

So then, if trade is sinking, why has the Dow jumped to nearly 13,000?  Low volume is the key.  In a low volume market, less individual investors are present to counteract the buying and selling of larger players, like international banks.  When this happens, the big boys are able to trigger market spikes, or market drops, literally at will.  Add to this the high probability that much of the stimulus that the Federal Reserve has regurgitated into the ether probably ended up in the coffers of corporate banks which then used the funny money to snap up equities, and presto!  Instant market rally!  But, a rally that is illusory and unstable.

Improving employment numbers are yet another financial hologram.  As most of us in the Liberty Movement are well aware, the Labor Department does not calculate true unemployment in the U.S.  Instead, it merely calculates those people who currently receive unemployment benefits.  Once a person hits the extension limit (99 weeks in many states on his benefits, he is removed from the rolls, and is no longer counted in the “official” unemployment percentage.  While Barack Obama and MSM pundits are quick to point out the drop in jobless to 8.3%, what they conveniently fail to mention is that MILLIONS of Americans have been unemployed for so long that they have been removed from the statistics entirely, and this condition is what has caused the primary fall in jobless percentages, not burgeoning business growth.

Roughly 11 million Americans who are jobless have nonetheless been excluded from the statistical government tally because of a loss of benefits:

http://dailycaller.com/2012/02/17/white-house-economic-report-hides-sharp-drop-in-number-of-working-americans/

According to the Congressional Budget Office, over 40% of the currently unemployed have been so for over 6 months.  It also points out that America is suffering the worst case of long term unemployment since the Great Depression:   


http://www.cbo.gov/sites/default/files/cbofiles/attachments/02-16-Unemployment.pdf

More than 10.5 million people in the U.S. also receive disability payments, which automatically removes them from the unemployment count, making it seem as though jobs are being created, rather than lost:


http://www.foxnews.com/politics/2012/02/19/report-millions-jobless-file-for-disability-when-unemployment-benefits-run-out/

Around 8.2 million Americans only work part time, meaning they work less hours than are generally considered to be necessary for self-support.  These people are still counted as “employed” even if they work a few hours a week.

True unemployment, according to John Williams of Shadowstats, is hovering near 23%:


http://www.shadowstats.com/alternate_data/unemployment-charts

Combine these circumstances with the ever weakening dollar, price inflation in foods and other commodities, and rocketing energy costs, and you have an economy that is strangling the life out of the middle-class and the poor in this country.  It is only a matter of time before the populace begins searching for alternative means of subsistence, even if that entails “illegal” activities.

Government Cracking Down On Freedom Of Trade

I was recently walking through the parking lot of a grocery store and ran into a group of women huddled intently around the back of a mini-van.  One of the women was reaching into a cooler and handing out glass containers filled with milk.  I approached to ask if she was selling raw milk, and if so, how much was she charging.  Of course, they turned startled and wide eyed as if I had just stumbled upon their secret opium ring.  Somehow it had slipped my mind how ferocious the FDA has become when tracking down raw milk producers.  The fact that these women were absolutely terrified of being caught with something as innocuous as MILK was disturbing to me.  How could we as a society allow this insanity on the part of our government to continue? 

That moment reminded me of the utter irrelevance of petty law, as well as the determination of human beings to defy such law. 

The Orwellian hammer has been thrust in the face of those who trade in raw milk, organic produce, and herbal supplements, while small businesses are annihilated by government dues and red tape.  In the meantime, law enforcement officials have been sent strapped to shut down children’s lemonade stands (no, seriously : 


http://www.cbsnews.com/2100-500164_162-20079838.html

Government legislation which would give the FDA jurisdiction over personal gardens has been fielded.  Retail gold and silver purchases of over $600 are now tracked and taxed.  The IRS even believes it has the right to tax barter exchanges, even though they do not explain how bartered goods could be legally qualified as “income”, or how they can conceive of ever being able to trace such private trade:

http://www.irs.gov/newsroom/article/0,,id=205581,00.html

Want to choose what kind of currency you would like to use to protect your buying power?  Not if  the Department Of Justice’s Anne Tompkins has anything to say about it. After the railroading of Liberty Dollar founder Bernard von NotHaus, she stated:


“Attempts to undermine the legitimate currency of this country are simply a unique form of domestic terrorism…”


“While these forms of anti-government activities do not involve violence, they are every bit as insidious and represent a clear and present danger to the economic stability of this country,” she added. “We are determined to meet these threats through infiltration, disruption, and dismantling of organizations which seek to challenge the legitimacy of our democratic form of government.”

http://www.fbi.gov/charlotte/press-releases/2011/defendant-convicted-of-minting-his-own-currency

As our economic situation grows increasingly precarious in this country, more and more people will turn towards localized non-corporate, non-mainstream business methods and products.  And, the government will no doubt attempt to greatly restrict or tax these alternatives.  This mentality is driven in part by their insatiable appetite for money, but mostly, it’s about domination.  They do what they do because they fear decentralized markets, and the ability of the citizenry to conceive of choices outside the system.  Slaves are not supposed to choose the economy they will participate in…

A “black market” is only a trade dynamic that the government disapproves of, and the government disapproves of most things these days.  Frankly, its time to stop worrying about what Washington D.C. consents to.  They have unfailingly demonstrated through rhetoric and action that they are not interested in the fiscal or social health of this nation, and so, we must take matters into our own hands. 

Black Market Advantages

If the events in EU nations such as Greece, Spain, and Italy are any indication, the U.S., with its massive debt to GDP ratio (real debt includes entitlement programs , is looking at one of two possible scenarios:  default, austerity measures, and high taxes, or, hyperinflation, and then default, austerity measures, and high taxes.  In the past we have mentioned barter networking and alternative market programs springing up in countries like Greece and Spain allowing the people to cope with the faltering economy.  Much of this trade is done away from the watchful eyes of government, simply because they cannot afford the gnashing buffalo-sized bites that bureaucrats would take from their savings in the process.  When a government goes rogue, and causes the people harm, the people are in no way obligated to continue supporting that government. 

Black markets give the citizenry a means to protest the taxation of a government that no longer represents them.  In a country stricken with austerity, these networks allow the public to thrive without having to pay for the mistakes or misdeeds of political officials and corporate swindlers.  In a hyperinflationary environment, black markets (or barter markets that have been deemed unlawful , can be used to supplant the imploding fiat currency altogether, and energize community markets that would otherwise be unable to function.  Ultimately, black markets feed and clothe the grassroots movement towards economic responsibility, and every man and woman with any sense of independence should rally around this resource with the intention to fight should it ever be threatened. 

“Legality” is arbitrary in the face of inherent conscience, or what some call “natural law”.  Without arbitrary legality, and unjust and unwarranted regulation, many federal alphabet agencies would not exist, including the FDA, the IRS, the EPA, the BLM, etc.  These institutions do not matter.  What they say has no meaning.  What matters is what is honorable, what is factual, and what is right.  Our loyalty, as Americans, is to our principles and our heritage.  Beyond that, we don’t owe anyone anything.  A black market in one place and time is a legitimate market in another.  For now, private localized trade is able to flow with only minor interference, but there will come a day when even the most practical and harmless personal transactions will be visited with administrative reproach and vitriol.  Alternative market champions will be accused of “extremism”, and undermining the mainstream economy.  We will be vilified as separatists, isolationists, terrorists, and traitors.  I believe it will be far more surreal than what we can possibly imagine now.  

They are welcome to call us whatever they like.  Honestly……who cares?  Let the paper pushers do their angry little dance.  The goal is freedom; in life, in politics, and in trade.    If we do not change how this country does business ourselves, the results will be far more frightening than any government agent at our doorstep, and the costs will be absolute…

http://www.zerohedge.com/news/guest-post-americans-will-need-%E2%80%9Cblack-markets%E2%80%9D-survive#comments



29.02.2012 7:47:07
HealthDay - TUESDAY, Feb. 28 (HealthDay News -- A pen-delivery version of the multiple sclerosis drug Avonex has been approved by the U.S. Food and Drug Administration, drug manufacturer Biogen Idec said Tuesday.



03.03.2012 9:00:00

On February 28, federal health officials added new safety alerts to the prescribing information for statin drugs, citing increased risks of memory loss, diabetes and muscle pain. It is the first time the United States Food and Drug Administration (FDA has officially...



02.03.2012 23:00:00
Alex Nussbaum reports on the growing concern over U.S. rules that allow “substantially equivalent” medical devices, known as predicates, to skip human testing phases of development. "The Food and Drug Administration’s [FDA] top medical-device regulator said the agency needs more power to block unsafe products and prevent…thousands of patient lawsuits…legislation [was introduced in the House of Representatives] this month to let the FDA reject devices that have designs based on past products that were recalled for safety flaws. The agency now lacks that authority in many cases, creating a 'loophole' that’s challenged the credibility of some device approvals, said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health…The [issue]…centers on the agency’s 510(k program, the system used to clear 90 percent of medical products in the U.S. each year."

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