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EU-US historic trade deal: ‘Putting the corporation above the nation’

RT | November 11, 2013

The successful adoption of the EU-US trade agreement promises both parties massive gains of up to $159 billion, but the profits could come at the expense of the everyday consumer, who could see the quality of their products diminish as a result.

Over 50 US officials are in Brussels to negotiate the Transatlantic Trade and Investment Partnership (TTIP), which, if signed, will create the world’s largest free-trade area, which has also been dubbed an “economic NATO”. Officials meeting in Brussels this week will hammer out details to reduce trade limiting regulations.

The new round of talks will focus on reducing trade barriers on investment, energy, services, and raw materials, and key agreements will be announced Friday.

‘Non-tariff barriers’ increase the cost of business, whether it’s adjusting the voltage on an electronic device, changing a car’s exhaust system to comply with local environmental regulations or a difference in opinion of which chemicals are “harmful” or “hazardous” in the respective territories.

By limiting health, safety and environmental regulations in order to boost trade, the US and EU are “putting the corporation above the nation,” Glyn Moody, journalist and author, told RT in an on-air interview.

“That’s a very big assumption. People may not want to have their food less safe or environment polluted for the sake of more money,” Moody told RT.

Moody also warns the trade agreement could behoove giant corporations like Monsanto, who could use the new ‘de-regulation’ to sue the EU for billions of dollars if they refuse to import GMO products

The EU says the TTIP could bring annual benefits of $159 billion (€119 billion) to its 28 member states. This breaks down to an extra $730 (€545) in disposable income for a family of four in Europe and an extra $875 (€655) per family in the US, according to a March 2013 study on “Reducing Transatlantic Barriers to Trade and Investment”.

There would be fewer constraints and companies will benefit, but “the public will pay in terms of regulation reduced protection and that is never calculated in these trade agreements, it’s always about the bottom lines of the big companies,” Moody said.

The week-long round of negotiations were originally scheduled for October but postponed due to the US government shutdown.

On December 16-20 officials will meet in Washington DC for another round of talks. The first round was held in Washington in July after the G8 Summit in Northern Ireland.

The Perks

The trade flow of goods and services between the two blocs reached about $2.7 billion per day in 2012, according to the US Office of Trade and Commerce. Total trade in 2012 was $647 billion.

The agreement could boost employment on both sides of “the pond”, as increasing exports usually creates more jobs.

The European Commission has brazenly promised the deal could boost gross domestic product in the dilapidated EU by 1 percent.

Auto trade will especially benefit from jettisoning regulations. Turnover between the US and Germany could double if the trade agreement makes more umbrella standards- for example, if  a car is crash-tested in America, it need not be again tested in Europe.

North America is an important destination for Foreign Direct investment, and is home to about one third of European foreign direct investment. Investment activity between the EU and US suffered after the financial crisis in 2008, and both sides will also try to find a balance on trade regulation to save big bucks.

Broken trust

Limited trust over the fall out of the NSA spying scandal may also put a hamper on negotiations between the trade giants.

The feasibility of the deal came under question after  NSA whistleblower Edward Snowden leaked information showing the extent of espionage on allies abroad. France announced the wanted to temporarily postpone the talks over snooping, but they proceeded as planned.

The spying row shouldn’t affect US-EU trade talks, US Secretary of State John Kerry said as the trade partnership is “really separate from any other issues”. The US hasn’t provided any guarantees it will curb spying on its allies.

November 11, 2013 Posted by | Economics | , , , , , , , , , | Leave a comment

US, France playing good cop-bad cop in Iran talks

RT | November 9, 2013

America and France are playing ‘good cop-bad cop’ in the P5 + 1 talks with Iran over its nuclear program, so that Washington’s position would sound more reasonable, Robert Harneis, a journalist and political analyst has told RT.

Six major world powers and Iran are holding negotiations in Geneva over Tehran’s highly-disputed nuclear program.

RT: France seems to be the most skeptical of the negotiating nations about the outcome of the talks. What’s behind its skepticism?

Robert Harneis: It is always a little difficult to understand the position of the French here. They seem to take an extreme position all the time. There are a number of reasons for this. The first is that they are playing ‘good cop-bad cop’ with the Americans. Obama is suddenly being much more reasonable in his attitude with the Iranians, and the French are out there on the flank saying “Oh, you mustn’t agree too easily, Israel must be protected,” and so on. In a sense that’s, if you like, playing the game of the Americans so that they can sound more reasonable, the French sound more unreasonable.

There is another factor, which is that everybody knows the enormous pressure of the Israeli lobby in America. It’s not quite so well-known that it’s pretty considerable in France as well.

RT: The French Foreign Minister said Israel’s position must be taken into consideration. Why such concern for Israel when even Washington called Netanyahu’s condemnation of the deal ‘premature’?

RH: Yes, it’s interesting, isn’t it, that Mr. Netanyahu has said that the deal had been concluded. Everybody else is saying it hasn’t. At any rate, the position of the French, I think, is to say things that the Americans don’t want to say at the moment. I think that’s at the bottom of it, because frankly this posturing by the French President and the French Foreign Minister makes France look pretty ridiculous on the domestic front. There is a great deal of mockery of Laurent Fabius and his very aggressive statements internally in France.

RT: We’re used to the US being one of Tehran’s harshest opponents. Do you feel that Washington’s stance is genuinely changing?

RH: Well, one would like to hope – let’s put it this way – that this is a real diplomatic revolution. The Americans ever since 1979, when the embassy drama took place in Iran, have had this slightly ridiculous, slightly vengeful obsession about dealing with the Iranian nuclear threat.

As far as anybody can tell and as far as the American security services themselves say, there is no Iranian nuclear threat. The Israelis, on the other hand, have 300 nuclear weapons. So the situation is a trifle absurd as it often is with western foreign policies.

And there are signs Obama is trying to put American foreign policy on a more sensible track. Why not have sensible relations with Iran – this is being asked in the US after all. For years, with the threat of the Soviet Union, they had no difficulty negotiating with [Mikhail] Gorbachev and men a lot more difficult than him. So, why can’t we negotiate with Iranians? Why do we have to take this ridiculous attitude that they cannot have what France, Britain, the US have – which is nuclear protection. And the Iranians say they don’t want it anyway.

So, it’s a difficult one to quite work out. But it could be that there is a real revolution taking place and the Americans are going to change their stance because they need to do business with Iran really.

RT:  Finally, what are your personal predictions? Will the sides involved manage to overcome their disagreements and strike a deal in the near future?

RH: Well, if I had to take my reputation as profit on the line, I would say that there is going to be a deal. Because they are, after all, talking only about a six-month deal, as far as we can understand it. A suspended sentence, so to speak. With the problems of gas pipelines from Iran to Europe, which Europe needs badly for its Nabucco pipeline – which has no gas without the Iranians – I think there is a very strong probability. And they’d just love to get in there and have all the contracts for rebuilding Iran. So, I hope it’s a real revolution.

November 9, 2013 Posted by | Economics, Wars for Israel | , , , , | Leave a comment

The Withering of Big Pharma?

By Martha Rosenberg | Dissident Voice | November 7, 2013

It used to be when a drug company settled illegal marketing charges that millions took its drugs under false pretenses, the news would be released on a Friday afternoon when no one would notice. That was then. Now almost all the drug companies have joined the Off label/Kickback club and the public doesn’t seem to notice or care.

On the surface, Johnson & Johnson’s $2.2 billion settlement this week for illegally marketing drugs to the elderly, children and the mentally disabled looks like a victory.  J&J’s subsidiary, Janssen Pharmaceuticals, will plead guilty to illegally promoting the antipsychotic Risperdal for “controlling aggression and anxiety in elderly dementia patients and treating behavioral disturbances in children and in individuals with disabilities,” reports Reuters. The promotions included a brazen kickback scheme to Omnicare Inc, a pharmacy supplying nursing homes, exposed by a whistleblower.

At least 15,000 elderly people in nursing homes die a year from drugs like Risperdal said FDA drug reviewer David Graham in Congressional testimony a few years ago. Eli Lilly who makes the similar drug Zyprexa and AstraZeneca who makes Seroquel have also settled charges that they churned the elderly drug market at the price of Grandma and Grandpa’s lives.

But it is not a victory. J&J made $24.2 billion off Risperdal from 2003 to 2010 and shareholders won’t even notice this week’s nano loss. J&J milked Risperdal for all it was worth and the patent had already run out by the time it was charged with illegal schemes. Other drug giants charged with illegal marketing schemes–Abbott for Depakote, Pfizer for Bextra,  Eli Lilly for Zyprexa, AstraZeneca for Seroquel, GlaxoSmithKline for Paxil and Merck for Vioxx–also got their money’s worth before the trivial nuisance of suit. Many, like Pfizer who illegally marketed its seizure drug Neurontin while under probation for illegal Lipitor activities–are brazen and shameless repeat offenders.

Many say the only justice that will get Big Pharma’s attention is frog marching the CEOs off to prison and/or cutting them off from their lucrative public trough of Medicare, Medicaid and military health programs.

Still, Big Pharma’s audacious business plan of asking forgiveness not permission is winding down. Not because Pharma, prescribers, consumers, regulators and health officials have seen the light but because there are no more big drugs to pimp. An estimated 100,000 workers will be losing their jobs at Pfizer, Sanofi, Roche, GlaxoSmithKline, AstraZeneca and Merck reported Yahoo finance last month.

Only two new drug campaigns seem to be brewing and they require a major suspension of reality on the part of doctors and patients. One tries to convince people with low back pain they actually suffer from ankylosing spondylitis an arthritis-like condition that causes chronic inflammation of the spine.  If your spine is stiff when you wake up in the morning you can take an immune suppressor like Humira which puts you at risk of tuberculosis and lethal viral, fungal and bacterial infections while costing you $12,000 to $17,000 a year. Line forms to the left.

The other, even more brazen campaign, tries to convince people with insomnia, tiredness during the day, moodiness and relationship problems that they actually suffer from Non-24-Hour Sleep–Wake Disorder, a disorder that affects mostly blind people. You don’t have to be blind to have the disorder, says the new Pharma message even though there have been fewer than 100 cases of sighted people with non-24 reported in the scientific literature. It sounds like a stretch but so did convincing people with job, money and marriage problems they really had depression or bipolar disorder.

Still it is obvious the bloom has fallen off the Big Pharma rose and it is now paying the piper for the high-flying party with drug settlements like Johnson & Johnson’s this week. But that doesn’t mean shady marketing, hidden risks, kickbacks and outrageous prices are gone from the medical field. They have just moved to the Medical Device industry.

~

Martha Rosenberg is a columnist/cartoonist who writes about public health. Her first book, titled Born with a Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp the Public Health, has just been released by Prometheus Books. She can be reached at: martharosenberg@sbcglobal.net.

November 8, 2013 Posted by | Corruption, Deception, Economics | , , , , , , , , | Leave a comment

How Can the New York Times Endorse an Agreement the Public Can’t Read?

By Maira Sutton | EFF | November 7, 2013

The New York Times’ editorial board has made a disappointing endorsement of the Trans-Pacific Partnership (TPP), even as the actual text of the agreement remains secret. That raises two distressing possibilities: either in an act of extraordinary subservience, the Times has endorsed an agreement that neither the public nor its editors have the ability to read. Or, in an act of extraordinary cowardice, it has obtained a copy of the secret text and hasn’t yet fulfilled its duty to the public interest to publish it.

Without a publicly available agreement, readers are forced into the uncomfortable position of taking official government statements at face value. That’s reflected in the endorsement, which fails to note the myriad ways in which TPP has been negotiated undemocratically, shutting out public oversight while permitting corporate interests to drive the agenda. Given these glaring issues, it is disconcerting that the Times would take such a supportive stance on an agreement that is likely to threaten innovation and users’ digital rights well into the 21st century.

That situation leaves unanswered questions. Does the editorial board, for example, support the TPP provisions that would give private corporations new tools to undermine national sovereignty and democratic processes? Because “investor-state dispute settlement,” slated for inclusion in both the TPP and the EU-US trade agreement, the Transatlantic Trade and Investment Partnership (TTIP), would give multinational companies the power to sue countries over laws that might cut into expected future profits. This could allow corporations to unravel any policy designed to protect users against violations of their right to privacy or free speech online. The paper’s endorsement notes that copyright enforcement could be expanded to suit legacy media companies, but provides no explanation of why a trade agreement is an acceptable venue for deciding such issues.

Does the New York Times also endorse an initiative to scrap democratic oversight of TPP by elected lawmakers? After all, Senate Finance committee leaders, Sen. Max Baucus and Sen. Orrin Hatch have renewed their call to pass fast-track, which would hand over Congress’ constitutional mandate over US trade policy to the Obama administration. Fast-track, also known as Trade Promotion Authority, would restrict lawmakers from having any proper hearings on its provisions, limiting them to an up-or-down vote on the entire 29 chapter treaty.

The paper’s statement emphasizes how the Obama administration strives to make TPP’s policies “an example for the rest of the world to follow.” But if that’s the case, then it’s all the more important that the agreement be published immediately. Such a significant body of international law regulating digital policy must not be negotiated without proper, informed public debate. The secrecy of the process itself ensures that only some private interests will be represented at the expense of others. In addition, the U.S. Trade Representative’s history of pushing forth extreme copyright enforcement policies through other trade agreements gives little assurance that users’ rights will be considered in the TPP.

Trade representatives are working to finalize TPP negotiations by the end of the year. Negotiators are scheduled to meet in Salt Lake City next week to negotiate outstanding issues in this agreement, including provisions on liability for Internet Service Providers and anti-circumvention measures over DRM. Following that, trade delegates are seeking to finalize and sign this agreement in December in a ministerial meeting in Singapore.

It’s unfortunate that news outlets are giving little coverage to TPP, when media attention could have a major impact on how the US and the other 11 nations draft digital policy. But public media coverage is precisely the sort of accountability that official secrecy thwarts. Instead of endorsing an agreement the public can’t read, a responsible paper would condemn the secrecy involved. And if the Times has seen the text and knows what’s contained in the TPP, then they have a responsibility to publish the text immediately and expose the US government’s back room dealings.

In either case, it is deeply disappointing that the New York Times would even support the TPP when the public remains in the dark. An endorsement of TPP at this stage is an endorsement of opaque, corporate-driven policymaking.

~

We need to demand that our lawmakers oppose fast track, ask them to call for a hearing, and exercise their authority to oversee the U.S. trade office’s secret copyright agenda.

November 8, 2013 Posted by | Corruption, Deception, Economics, Mainstream Media, Warmongering | , , , | Leave a comment

In Bed with the Bully—Consensual U.S. Surveillance in Mexico

By Peter Watt | NACLA | November 7, 2013

The revelations leaked by Edward Snowden that the NSA committed acts of espionage against top Mexican officials and the president himself have so far provoked only mild indignation from the Mexican political class. Secretary of Foreign Affairs José Antonio Meade appeared to be reassured by President Obama’s ‘word’ that he would launch an investigation into the workings of the U.S. government. Notwithstanding the incongruity that any government investigating its own internal wrongdoing would have any interest in publicizing conclusive evidence of its own criminal activity, President Peña Nieto has been reluctant to push the Obama administration further on the issue, presumably for fear of undermining Mexico’s position as a staunch U.S. economic and political ally.

Ex-president Vicente Fox, meanwhile, enthusiastically endorsed U.S. spying on Mexican politicians, claiming he knew the U.S. spied on him while he was president. Indeed, Fox took comfort in the fact that the world’s superpower monitored his every move and his phone calls, evoking the ominous adage reminiscent of all authoritarian political institutions: one has nothing to be concerned about so long as one has nothing to hide and done nothing wrong. “Everyone will do better if they think they’re being spied on,” he noted, at once reinforcing the dubious entitlement of the U.S. government to act as the world’s police force while simultaneously apologizing for the illegal activities of the NSA. Mr. Fox seems unable to comprehend the basic moral and legal truism that merely because many are involved in committing criminal activities, the moral and legal implications do not simply vanish into thin air. A reasonable observer might instead conclude that the greater the number of international government institutions that are involved in criminal activity, the more serious the problem, not the reverse. “It’s nothing new that there’s espionage in every government in the world, including Mexico’s,” Fox observed. Flummoxed as to why Snowden’s revelations have provoked outrage among the Mexican populace and investigative journalists (if not in government itself), he declared, “I don’t understand the scandal.”

One document obtained by the National Security Archive at George Washington University details Janet Napolitano’s (then Secretary of the U.S. Department of Homeland Security) official meeting with President Peña Nieto in July 2013. According to Napolitano’s briefing, avoiding discussion of NSA spying on the upper echelons appears to be a Mexican, not solely U.S., initiative. The Mexicans, the document claims, wanted to ‘put to bed’ the issue of NSA intrusions. Indeed, nowhere in the summary of their meeting does the issue arise. Instead, discussions focus on maintaining and increasing border security in order to protect commercial interests and on reducing the number of undocumented migrants entering the United States.

The listless and at times surreal reaction to NSA surveillance by Mexico’s political class demonstrates their level of craven subordination to their U.S. counterparts. One can only begin to imagine the response of the U.S. political class and media pundits were they to discover that Mexican intelligence had repeatedly intercepted the electronic communications and tapped the phones of the Commander in Chief himself.

The Mexican reaction to NSA snooping on the inner circle of government stands in stark contrast to that of Brazil’s. Snowden’s leaks provoked fury within the government of President Dilma Rousseff. She blasted the NSA tapping of her phone and interception of government communications in a fiery speech clearly aimed at President Obama at the UN General Assembly. She lambasted the NSA for spying on millions of Brazilian citizens, tapping the phones of Brazilian embassies, and spying on the country’s partly state-owned petroleum giant, Petrobras. Interestingly, she remarked that the bulk of NSA spying in Brazil was not designed to thwart potential terrorists or to undermine the activities of transnational criminal organizations, but instead, to further U.S. business interests through both international economic and commercial spying. As a result, Rousseff cancelled her planned diplomatic visit to Washington, called for an international conference on data security, began setting up a protected governmental electronic communications system, and proposed changing underwater cables so that international Brazilian internet traffic would no longer pass through U.S. territory.

Brazil’s position, of course, is a reflection of the changing nature of U.S.-Latin American relations more generally. Brazil, the emerging regional power and now less of a fixture of Uncle Sam’s backyard, can afford to take an increasingly independent stance from Washington. Several countries in the region are integrating with each other politically and economically and establishing firm trade links with China, India, and South Africa—an unprecedented dynamic which has had the effect of undermining U.S. hegemony in the region.

Mexico, however, dependent on the U.S. market for 80% of its exports, is much less able to stand up to the superpower. Indeed, Mexico’s traditional position as a subordinate and reliable ally of its northern neighbor is becoming all the more crucial in maintaining the waning U.S. empire, increasingly defensive and militaristic as it reasserts its influence over the region. With a myriad of uncertainties lying ahead for U.S. power in a region that has witnessed the birth of new left-wing social movements that have had considerable success at the ballot box, it is becoming imperative for the United States to uphold and preserve its political, economic, and military alliances as per Mexico and Colombia. In Mexico, U.S. funding for the so-called ‘War on Drugs’ has provided a convenient pretext for heavy militarization throughout the country and a clamping down on political dissent and organized popular movements. Spying and surveillance programs are key to achieving the U.S. objective of continuing and reinforcing a status quo that now sees well over half the population in Mexico living in poverty and unparalleled levels of economic inequality.

As in Brazil, U.S. spying in Mexico seems less to do with the ‘War on Terror’ and the ‘War on Drugs’—two key rhetorical tenets of U.S. interventionism—and more to do with the realpolitik of ensuring that a pliant and subservient political class, personified by Fox, Calderón, and Peña Nieto, guard the current transnational dynamics—a socio-economic system that rewards the powerful moneyed neoliberal elites on both sides of the border and keeps the poor and marginalized in their place.

There is a further aspect to the Mexican response to NSA spying which warrants scrutiny. Throughout the Cold War, the CIA and its Mexican counterpart, the DFS, shared all manner of material and intelligence on dissidents (Marxists, communists, students, guerrillas, trade unionists, peasant activists, feminists, etc.) who were often incarcerated or liquidated because, as the authoritarian and paternalistic President Gustavo Díaz Ordaz claimed, they were a threat to ‘national security.’

The current partnership between the U.S. and Mexican governments allows for a level of surveillance of which Mexico’s Cold Warriors could only dream. In collaboration with telecommunications giants, the U.S. and Mexican governments provide the wherewithal and funding for large-scale spying on the Mexican citizenry. Indeed, Mexico’s Federal Ministerial Police (PFM) has recently designed a system of total surveillance and increased storage of electronic communications. In a climate in which there exist widening socio-economic disparities, a grave security crisis, and a growing disillusionment with the status quo, both the U.S. and Mexican governments have a shared interest in forestalling the development of a widespread popular political revolt and a potential ‘Mexican Spring.’ Were there any mystery as to why the Mexican response to Snowden’s revelations was so moderate, one would only need to recall Vicente Fox’s unintentionally shrewd observation that all governments have an interest in spying on one another and on their own citizens. The lackluster reaction from Los Pinos to the NSA revelations is reflective of the extent to which Mexican elite politicians acquiesce in the intrusions, largely because they themselves use domestic spying to further their own sectional interests in a country in which, little more than a decade after the ‘transition to democracy,’ the majority of the population are excluded from meaningful political participation.

Peter Watt teaches Latin American Studies at the University of Sheffield. He is co-author of the book, Drug War Mexico. Politics, Violence and Neoliberalism in the New Narcoeconomy (Zed Books 2012).

November 7, 2013 Posted by | Civil Liberties, Corruption, Economics, Full Spectrum Dominance, Progressive Hypocrite, Timeless or most popular | , , , , , , , , , , | Leave a comment

Johnson & Johnson To Pay $2.2 Billion To Settle Deceptive Marketing Claims

By Chris Morran | Consumerist | November 4, 2013

For nearly a decade, various state and federal agencies have been looking into Johnson & Johnson’s marketing of the drugs Risperdal, Invega, Natrecor, and others, claiming the company was putting consumers at risk by paying kickbacks to doctors and pharmacists to suggest these drugs to patients and for pushing unapproved uses for these medications. Today, the Justice Dept. announced that J&J will pay out more than $2.2 billion to settle these claims.

The DOJ alleges that Johnson & Johnson subsidiary Janssen Pharmaceuticals violated the Food, Drug, and Cosmetic Act by introducing the anti-psychotic drug Risperdal — which had only been approved for the treatment of schizophrenia — into the market for unapproved uses, like the treatment of dementia and other non-schizophrenic conditions.

Johnson & Johnson and Janssen Pharmaceuticals are also accused of promoting Risperdal and another anti-psychotic, Invega, to doctors and nursing homes as a way to control behavioral disturbances in elderly dementia patients, children, and the mentally disabled. The drug makers allegedly failed to mention — or downplayed — possible side effects of Risperdal, like the risk of stroke in elderly patients.

Additionally, the DOJ accuses the companies of paying kickbacks to doctors in order to urge them to prescribe these drugs, while also kicking back money to the nation’s largest long-term care pharmacy in order to get pharmacists to recommend off-label use of Risperdal for nursing home patients who exhibited behavioral symptoms associated with Alzheimer’s Disease and dementia.

In addition to this being against the law and unethical, it meant that millions of dollars in Medicare and Medicaid payments were being paid out on prescriptions that should never have been written.

“Through these alleged actions, these companies lined their pockets at the expense of American taxpayers, patients, and the private insurance industry,” said U.S. Attorney General Eric Holder in a statement. “They drove up costs for everyone in the health care system and negatively impacted the long-term solvency of essential health care programs like Medicare.”

Holder says that J&J and Janssen will plead guilty to misbranding Risperdal, and will pay $400 million in criminal fines and forfeitures, in addition to $1.2 billion to resolve their civil liability under the False Claims Act. Johnson & Johnson will pay an additional $149 million to resolve claims relating to alleged kickbacks to a long-term care pharmacy.

But wait. There’s more.

Another J&J subsidiary, Scios, has been accused of promoting the heart drug Natrecor for off-label use without credible scientific evidence that it would have any health benefit. Scios pleaded guilty in 2009 to misbranding Natrecor and paid a criminal fine of $85 million, and along with J&J has agreed to pay an additional $184 million to resolve the latest allegations.

“Put simply, this alleged conduct is shameful and it is unacceptable,” says Holder. “It displayed a reckless indifference to the safety of the American people. And it constituted a clear abuse of the public trust, showing a blatant disregard for systems and laws designed to protect public health.”

“Today we reached closure on complex legal matters spanning almost a decade. This resolution allows us to move forward and continue to focus on delivering innovative solutions that improve and enhance the health and well-being of patients around the world,” said Michael Ullmann, Vice President and General Counsel, Johnson & Johnson, in a statement.

November 5, 2013 Posted by | Corruption, Deception, Economics | , , , , , , , | Leave a comment

Why Opening Up Clinical Trials Data Is Good For Pharma Companies Too

By Glyn Moody | Techdirt | November 5, 2013

Earlier this year we wrote about how AbbVie, the pharma company spun out of Abbott Laboratories, had gone to court to stop the European Medicines Agency (EMA) from releasing clinical trials information about one of its drugs. Despite what AbbVie claimed, this was not commercially sensitive in any way, but simply basic data about safety and efficacy.

It’s often overlooked that this data is mostly obtained by testing new drugs on volunteer members of the public who take the medicines in order to establish their safety. By definition, these volunteers are putting themselves at risk. They selflessly offer to do that in order to advance medicine and confer benefits on society as a whole. That means the clinical data obtained from such tests belongs to the public that made them possible, at least from a moral viewpoint.

If a company seeks to prevent the free dissemination of that safety data, as AbbVie is doing in Europe, it is breaking the implicit compact it made with the people who agreed to try out its drugs. Those invited to take part in future trials of AbbVie’s drugs might then begin to ask why they should endanger their health and even lives purely to boost one company’s profits.

But even if AbbVie is resistant to the argument that it has a moral obligation to allow the clinical trials data to be released, and is not concerned that the public might think that it has something to hide, perhaps it will be won over by a recent article in The New England Journal of Medicine, written by four people from the EMA. This puts forward a quite different argument, that releasing test data will directly benefit pharma companies themselves, and offers a number of reasons why.

First, access to the full data sets of completed studies will lead to improvements in the design and analysis of subsequent trials.

Basically, the more information that drug companies have about what works and what doesn’t, the better they can design their future tests.

Second, lessons from past trials about the heterogeneity of treatment effects not only will streamline drug development but also may enhance a drug’s value in the marketplace. Identification of a population with high unmet need in which a new treatment may be more cost-effective than other available treatments can aid sponsors during reimbursement negotiations.

Again, the more information companies have about how different groups of patients responded to a drug, the easier it will be to spot particular sub-groups in the population who derive particular benefit. Selling products for that sub-group will be both easier, more profitable and more ethical than simply trying to sell to everybody, since the drug may be ineffective or even inappropriate for many of the general population.

Third, since several possible treatments for one medical condition are often available, comparative-effectiveness information is important to patients, prescribers, and sponsors seeking to position their products.

For a given condition, there may be several possible treatments. Making clinical test data available allows them to be compared, and the best one selected for future drug development, instead of investing huge sums in what may well be a relatively ineffective approach.

Finally, one of the inherent inefficiencies of data secrecy is the repetition of trials and projects that are doomed from the outset; drug developers may continue to pursue a given target even though clinical trials conducted by others have demonstrated the effort’s futility.

In many ways this is the most important reason. If the results of clinical trials are kept secret, companies run the risk of repeating the mistakes already made by others. Not only is that a waste of time and money that could be better spent on more fruitful avenues, it is putting test subjects at risk unnecessarily. As the NEJM points out:

In at least one documented case, the availability of data from completed trials could have spared trial subjects a potential health risk and saved millions of research dollars.

The article concludes:

A managed-release environment that allows sharing of patient-level data while ensuring patient privacy would create a level playing field for all stakeholders. What is sometimes labeled as “free riding” may ultimately pay dividends for innovative companies and for public health. It is ironic that the organizations that most resist wider access to data are the ones that stand to benefit so much from greater transparency.

In fact, this is no mere theoretical possibility. We know this approach works, because it is precisely what we see in the field of open source. Sharing the code freely creates a level playing-field that allows companies to innovate faster because they can build on the work of others. The rise of a multi-billion dollar software industry based around such sharing, and the unprecedented rate of innovation this drives, are yet more reasons that companies like AbbVie should be striving to promote, not prevent, the release and dissemination of clinical trials information as open data.

Follow me @glynmoody on Twitter

November 5, 2013 Posted by | Economics, Timeless or most popular | , , , | Leave a comment

Russia breaks oil output record

RT | November 2, 2013

Russian oil output, the largest in the world, reached 10.59 million bpd (barrels per day) in October, setting the record for the country’s post-Soviet period, Energy Ministry data showed.

The landmark was reached due to Rosneft increasing production at the Vankor field in the Krasnoyarsk Region, the Vedomosti paper reports.

The output at the field was 18.3 million tons last year, with the company planning Vankor reach 25 million tons annually.

Another influential factor is the larger amount of Gazprom-produced gas condensate, which has now reached 350,000 bpd.

The country’s total output in October reached 44,773 million tons, which is 1.3 percent higher than during the same period last year.

According to the International Energy Agency, Russia’s all-time production of black gold reached its peak at 11.41 million bpd in 1988, when it was still part of the Soviet Union.

The production of oil in Russia has been steadily growing since the setback caused by the global financial crisis in 2008, which saw output falling to about 9.8 million bpd.

In September 2009, it exceeded a monthly level of 10 million bpd, with the country overtaking Saudi Arabia as the world’s largest oil producer the next year.

Oil and gas remain the No.1 source of income for Russia, as hydrocarbons account for 80 percent of the country’s export.

November 4, 2013 Posted by | Economics, Malthusian Ideology, Phony Scarcity | , , | Leave a comment

Sun Sets on U.S. Wind Industry

Lisa Linowes | Wind Action | November 4, 2013

The U.S. wind power market staggered this year adding less than seventy (70) megawatts of new wind in the first three quarters. This is down from 4,743 megawatts installed during the same period in 2012.

Only three states reported wind expansions:

The American Wind Energy Association (AWEA) wasted no time blaming the precipitous drop in installations on uncertainty surrounding the wind production tax credit (PTC), the federal incentive most often credited for market growth in the sector.

That’s a convenient excuse that might resonate with sympathetic members of Congress, but it’s not accurate.

Wind’s Bubble Bursts

AWEA’s CEO Tom Kiernan bellyached last week that his people were exhausted by the “boom-bust” behavior sparked each time the industry faced possible withdrawal of the PTC. He showed no remorse that big wind was still economically impotent despite decades of public handouts meant to stimulate self-growth.  Instead he dug in and insisted the PTC be extended.

This is indicative of an industry that’s been coddled for too long and asked to show little in return. And why should it?

Every megawatt-hour generated by an eligible project during its first ten years of operation earns the production tax credit regardless of the location of the plant, the time of day and year when the energy is produced, or whether the energy is even needed. At $23/MWh, the PTC on a pre-tax basis ($35/MWh) equals or exceeds the wholesale price of electricity in many parts of the country. NO other form of reliable electric generation receives a federal subsidy as generous and condition-free as the PTC.

But wind didn’t falter in 2013 because of  Congressional indecision.

We’ve long known that Section 1603, the cash grant program enacted under The American Recovery and Reinvestment Act of 2009 (ARRA), fueled a wind bubble that was certain to burst, and it did.

Under 1603, roughly 30,000 megawatts of new wind was installed, more than doubling the wind capacity in the country. As much as 90% of the 13,000+ MW of wind installed last year alone can be attributed to Section 1603, not the PTC.

In order to receive the grant, projects needed to be in-service by the end of 2012. Developers raced to meet the deadline which flushed the industry’s project pipeline. It will take several years before additional proposals reach the shovel-ready stage.

Forecasting Wind Growth Based on RFPs

Despite no growth, AWEA touted the rosy potential for new wind development by pointing at the number of  utilities announcing RFPs (requests for proposal) for new renewables this year. Over 4,000 MW of new wind proposals are pending according to the trade group.

But RFPs and/or signed power contracts for the energy do not mean facilities will be built.

Consider the situation in New England as an example.

In September, four utilities in the Commonwealth of Massachusetts announced joint contracts to acquire 565 MW of new wind capacity from six wind projects to be sited in Maine and New Hampshire. Of the six projects, only one (Oakfield) has been approved for construction but the permit is under appeal in U.S. Federal Court.

Of the remaining five, one was withdrawn (Fletcher Mountain), and two (Passamaquoddy Wind Project and Peskotmuhkati Wind Project) were reported in breach of the utility contracts for failure to deliver the required development security payments.

Another (Bingham) was informed in August of serious environmental concerns by the Maine Department of Inland Fisheries and Wildlife. And the one New Hampshire project (Wild Meadows) is experiencing intense opposition from environmental groups and the host and surrounding communities. At this point, it’s not clear whether any of these projects will be built.

There are many other project proposals in the U.S. we can point to which are equally speculative but are likely still included in AWEA’s rosy forecast.

Other Challenges in the Wind

There are other significant challenges facing wind development which will make adding new projects more difficult. These include the lack of transmission capacity, record-low natural gas prices, and a growing, more organized public opposition to the towers.

Press reports about wind are increasingly negative and the PTC is starting to sound less like government ‘investment’ and more like corporate cronyism and government waste. Investors are rightfully worried about an industry that is subject to the whims of Congress and public opinion.

We are also learning lessons from the European Union which is several years ahead of the U.S. in terms of wind deployment.

Last month, CEOs from ten utilities in Europe responsible for nearly half of the energy capacity in the European Union argued for an end to wind and solar subsidies which they say are driving up energy prices for consumers and destroying Europe’s competitiveness. E.ON CEO Johannes Teyssen commented that the “subsidies are reaching a level which is totally unbearable. … This industry is the biggest kid on the block now, not a child any longer. And no longer needs a child’s nutrition.”

We agree!

November 4, 2013 Posted by | Corruption, Deception, Economics | , , , | Leave a comment

The NSA Killed the Radio Star and American High Tech

By Richard Silverstein · Tikun Olam · November 2, 2013

While I don’t pretend to be a technical expert, it seems clear to me that one of the major pieces of collateral damage regarding the NSA spying scandal is the savaging that the American technology industry has taken. Though they initially denied it, it became apparent that companies like Twitter, Facebook, Google, Microsoft, Yahoo and others essentially rolled over and played dead in the face of Justice Department and NSA directives that they essentially unlock their data for inspection. Later it became clear that the government didn’t really need these data dumps, it could invade the company servers and sift through data at will.

Now these same companies are telling us that they’ll regain our trust by encrypting their data so that it can’t be hacked by NSA snoops. Such encryption is not going to be an effective tool if the NSA retains the same privileges it’s had to subpoena any data at any time for any person it wishes. In such cases, the only thing standing in the way of wholesale exposure of virtually every secret is a toothless FISA court which never questions a subpoena or prevents any spying.

The only benefit to encryption is that it will make it harder for the NSA to collect the reams of data which it sifts through in order to decide which individuals’ records it wants to subpoena. But given the creativity and ingenuity of NSA spooks, you can be sure they’ll discover a way to circumvent even this obstacle.

There is a certain attraction for the average NSA hacker to et everything they can; to open all possible doors; to pry into every possibly nook and cranny. That’s what spooks do. You can’t blame them for that. But you can blame the executive branch and legislators who were supposed to exercise oversight and, with a few exceptions like Marc Udall and Ron Wyden, abdicated their constitutional responsibility. 9/11 made them all go soft in the head.

Now even Rep. James Sensenbrenner, one of the chief architects of that foul piece of legislation called the USA Patriot Act, seems to have second thoughts. He’s gone so far as to call the actions of the NSA “criminal.” But is it too late? Once the NSA let the horse out of the barn, how will the U.S. technology industry get it back in?

These companies, the backbone of the U.S. economy, have shown themselves to be at the beck and call of the government. The trust we customers placed in them to protect our security has been savaged. Does anyone believe anything Mark Zuckerberg, Steve Ballmer, Larry Page or Sergey Brin say on this subject?  Frankly, I think they can’t regain that trust no matter what they do.

The NSA has torn a hole in the high tech industry big enough to drive a super computer or Mack truck through. Countries like Brazil and others are already developing competing systems that will not be subject to the intrusive scrutiny of the NSA. Will any American want to maintain telecommunications accounts with U.S. companies?

If we lose the edge we’ve had in such technological development over the past 60 years, we will lose a huge sector of U.S. commercial innovation. We will hurt our economy, lose jobs, and slow the pace of development in our own country. In a strange and ironic way, NSA spying may ultimately hurt the U.S. and our national security.

An equally damaged victim of NSA spying has been our formerly warm relations with allies like Berlin, France, German, Mexico and Brazil.  One must ask: was the benefit of whatever was learned by hacking the phones of their leaders worth the years of damage and mistrust that will ensue from this mess? Further, one has to marvel at the hubris of U.S. spymasters who believed that their massive House of Spies would never be exposed. As a result of Edward Snowden’s revelations the House of Spies has become a House of Cards.

In addition to all the nations with whom we’ve had tense of even hostile nations over the last decade or so, now we have to add allies who have lost trust in us.

I am delighted to learn that attitudes in the international community toward Snowden are gradually changing. With every new insult to the national pride of these countries with further NSA spying charges, more people find Snowden’s work admirable. German legislators met with him over the past few days to determine whether he can travel to German to testify before the Bundestag about the hacking of Prime Minister Merkel’s cell phone. If they find a way to bring him to Germany, I fear the cat will be out of the bag.  As long as the U.S. could confine him to countries like China or Russia, with whom we have tense or hostile relations, Obama could dismiss Snowden as a crank.  But once he begins spilling his guts before national legislatures of U.S. allies, he becomes a technological Robin Hood.

November 2, 2013 Posted by | Civil Liberties, Corruption, Deception, Economics, Full Spectrum Dominance | , , , , , | Leave a comment

A Third of All U.S. Clinical Drug Trial Results Remain Unpublished after 5 Years

By Noel Brinkerhoff | AllGov | October 31, 2013

Nearly 30% of all large clinical trials in the United States have gone unpublished five years after their completion, often because those running them—pharmaceutical companies—don’t want their results known.

This failure to share information represents an ethical violation on the part of companies and organizations that are obligated to tell trial participants about testing results, scientists wrote in the British Medical Journal.

These experts say approximately 250,000 people took part in the 29% of trials that haven’t been published. Considering only those trials funded by the pharmaceutical industry, the number rose to 32%.

This “violates an ethical obligation that investigators have towards study participants,” Christopher Jones of Cooper Medical School of Rowan University, New Jersey, who worked on the study, told The Guardian.

Jones and his colleagues said changes must be made “to ensure timely public dissemination of trial data.”

Pharmaceutical manufactures are currently required to register all trials and report their results with the government through the database Clinicaltrials.gov. It is a global register and the largest such database in the world. But the study demonstrates that many companies are ignoring this requirement.

Síle Lane, director of campaigns at the U.K.-based AllTrials Campaign, told The Guardian that database postings are critical to science and, consequently, to patients. “There’s no excuse for not publishing results but a huge public health benefit to having a complete picture of what was found in trials conducted on treatments currently available to patients,” she said. “[For example,] trials from around the world are used to make UK prescribing decisions. So information from those trials is vital for UK regulators and researchers.”

Drug makers are sometimes motivated to not publish clinical trial information in order to hide details of side effects or outright failures of new treatments. They also try to avoid disclosing data that might help their competition.

Richard Stephens, a cancer patient who has been in five trials, told The Guardian that it’s important for testing to be made public.

“I would ask every researcher and every research funder out there to do all they can to make their results available. Patients become participants to add to knowledge and to eliminate uncertainties. Hiding results, no matter what the reason, isn’t in that spirit at all. In fact it is a betrayal of our trust,” Stephens said.

To Learn More:

Scientists Alarmed Over Ethics of Drug Trials Remaining Unpublished Up to Five Years After They’re Finished (by Sarah Boseley, The Guardian)

Non-Publication of Large Randomized Clinical Trials: Cross Sectional Analysis (by Christopher W. Jones, Lara Handler, Karen E. Crowell, Lukas G. Keil, Mark A. Weaver, Timothy F Platts-Mills; British Medical Journal)

Big Drug Firms Mobilize Patient Groups to Lobby against Publication of Secret Drug Testing Data (by Noel Brinkerhoff, AllGov)

Drug Companies Still Outsourcing Dangerous Trials to Poor Nations (by Noel Brinkerhoff and David Wallechinsky, AllGov)

October 31, 2013 Posted by | Corruption, Deception, Economics, Malthusian Ideology, Phony Scarcity, Timeless or most popular | , , | Leave a comment

UK $26bn nuclear plant contingent on gas price rise by 127% in decade

RT | October 31, 2013

Britain’s first nuclear plant in 20 years is a bet energy prices will rise. Experts say the new Hinkley Point facility will be “the most expensive power station in the world” and if the bet fails, the deal will prove “economically insane”.

“The Government is taking a massive bet that fossil fuel prices will be extremely high in the future,” the Telegraph quotes Peter Atherton and Mulu Sun, who analysed the finances of British energy companies for stockbroker Liberum Capital.

The deal to construct two nuclear reactors at Hinkley Point in southwest England – the world’s first nuclear deal since Fukushima disaster – was agreed by the UK, Electrcite de France SA (EDF) and China. To have a guaranteed return on the estimated $26 billion investment, the plant owners need the cost of fossil fuel such as oil and gas to rise dramatically.

The Liberum analysts estimate the minimum energy price would need to stand above £121 per megawatt hour within ten years, which means the wholesale price of gas would have to go up by about 127 percent over that period. Wholesale prices were about £60 last year, according to the energy watchdog Ofgem.

This is the equivalent to an oil price of well above $200 a barrel, compared with about $110 this week, the Telegraph reports.

“We are frankly staggered that the Government thinks it is appropriate to take such a bet and underwrite the economics of this power station. We are flabbergasted that it has committed future generations of consumers to the costs that will flow from this deal,” the Liberum Capital analysts say.

The $26 billion (£16 billion) price tag of the two reactors would be enough to build gas-fired power stations with output eight times higher, Liberum calculated.

“For the cost of £16bn for the 3,200MW to be built at Hinkley, the UK could build 27,000MW of new gas-fired power stations, solving the ‘energy crunch’ for a generation.”

October 31, 2013 Posted by | Economics, Malthusian Ideology, Phony Scarcity, Nuclear Power, Timeless or most popular | , , , , , , | Leave a comment