Category: Elitist Privilege

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SHAMED AT LAST: AIDS-drug gouger Martin Shkreli is marched to court by FBI after securities fraud arrest for running a Ponzi scheme to pay debts – and freed on $5 MILLION bond

  • Martin Shkreli, 32, has been arrested on charges of securities fraud and running a Ponzi scheme to pay off debts from an old company  
  • It is also alleged he illegally used stock from the biotechnology firm he owned, Retrophin Inc., to pay off debts related to MSMB 
  • Retrophin and its investors suffered a loss in excess of $11million because of Shkreli’s scheme according to United States Attorney Robert Capers 
  • He earned the moniker of ‘most hated man’ in September after raising the cost of an AIDS and cancer drug from $13.50 per tablet to $750 overnight 
  • MSMB Capital Management was founded by Shkreli in 2009 and shuttered in 2012, the same year Retrophin was founded and Shkreli became CEO
  • He was released on a $5million bond after bring arraigned in federal court on Friday

Martin Shkreli was released on a $5million bond after being arraigned on charges of securities fraud in federal court in Brooklyn Thursday afternoon.

Shkreli, the son of immigrants, was also forced to forfeit his passport.

The price-hiking pharmaceutical entrepreneur was picked up by the FBI in the early hours of Thursday following an investigation into a former hedge fund and drug company he previously headed.

It is alleged he illegally used stock from the biotechnology firm Retrophin Inc. to pay off debts related to his struggling hedge fund and to pay back angry investors.

He is being charged with seven counts of fraud for running what United States Attorney Robert L. Capers of the Eastern District of New York is calling a Ponzi scheme.

Shkreli, 32, pleaded not guilty to these allegations.

He faces a maximum sentence of 20 years in prison if convicted on all charges.


Free: Martin Shkreli was released on a $5million bond Thursday afternoon

Free: Martin Shkreli was released on a $5million bond Thursday afternoon

Art: A courtroom sketch shows defendants Shkreli (C) and Greebel (R) a former partner at law firm Katten Muchin Rosenman (R) during their arraignment

Art: A courtroom sketch shows defendants Shkreli (C) and Greebel (R) a former partner at law firm Katten Muchin Rosenman (R) during their arraignment

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Deepening Inequality Driving US Middle Class into Oblivion

“The hollowing of the middle has proceeded steadily for four decades, and it may have reached a tipping point,” Pew Research Center says

A closer look at the shift out of the middle reveals that “a deeper polarization is underway in the American economy,” says Pew Research Center report. (Image: DonkeyHotey/flickr/cc)

The American middle class is shrinking.

For the first time in more than four decades, middle-income households have lost their majority status in the U.S., according to new findings, and are now outnumbered by their counterparts on opposite ends of the income spectrum.

“The fastest-growing segments are the ones at the extremes, the very lowest and highest ends of the income distribution.”
—Pew Research Center

Based on the definition used in the Pew Research Center report released Wednesday, the share of American adults living in middle-income households—that is, with an income that is two-thirds to double that of the overall median household income, or $42,000 to $126,000 annually in 2014—has fallen from a high of 61 percent in 1971 to 50 percent in 2015.

At the same time, the share living in the upper-income tier jumped from 14 percent to 21 percent over the same period, and the share in the lower-income tier rose from 25 percent to 29 percent.

“The hollowing of the middle has proceeded steadily for four decades, and it may have reached a tipping point,” the Pew study suggests. Furthermore, a “closer look at the shift out of the middle reveals that a deeper polarization is underway in the American economy.”

“The movement out of the middle-income tier has been more than just a step in one direction or the other,” the report says. “The fastest-growing segments are the ones at the extremes, the very lowest and highest ends of the income distribution.”

In addition, middle class families have fallen further behind financially, the study shows, with the share of U.S. aggregate household income held by middle-income households having “eroded significantly over time.”

“Upper-income households now command the greatest share of aggregate income and are on the verge of holding more in total income than all other households combined,” the report reads. “This shift is partly because upper-income households constitute a rising share of the population and partly because their incomes are increasing more rapidly than those of other tiers.”

The Pew findings support what many 2016 presidential candidates, led by U.S. Sen. Bernie Sanders, have been saying on the campaign trail.

In an op-ed published this summer, Sanders decried what he called “the war against the American middle class,” marked by Wall Street greed, anti-worker policies, and corporate tax evasion.

And on Thursday, he tweeted:

There’s been a massive transfer of wealth from the 99% to the top 1%. We’ve got to bring that money back to working families.

A Wall Street Journal/NBC News poll in January found that 47 percent of respondents considered reducing income inequality an absolute priority for the government to pursue this year, with Democrats placing far greater importance on it than Republicans.

In a piece for Gawker on Thursday, Hamilton Nolan responded to Pew report with an irreverent eulogy.

“The Middle Class, a popular figure in American folklore, died this week after a long battle with capitalism,” Nolan wrote. “Its passing has been expected since the recent death of its partner, The American Dream.”

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‘No way West was unaware of ISIS-Turkey oil trade’

Turkey's Prime Minister Tayyip Erdogan © Umit Bektas
What will be the reaction of Ankara’s Western allies following Moscow’s revelations that Turkey is involved in ISIS oil smuggling, RT asked experts.

READ MORE: Russia presents proof of Turkey’s role in ISIS oil trade

The evidence presented by the Russian Defense Ministry will be “partly ignored and distorted” by Western MSM, says Foreign Affairs Editor Srdja Trifkovic.

I think that Erdogan will scream ‘blue murder’ and claim that this is all a set-up and a reaction to what he calls ‘justified downing of the Russian plane’. The real issue is what the US will do about this. Because it is quite obvious the Turkish tail has been wagging the American dog for far too long,” he said.

My hunch is that the US will continue to be reluctant to really do something about it. They have had a chance to do so for 15 months prior to the beginning of the Russian air strikes on September, 25. The question of all questions is whether Erdogan will finally be pressed by his Western partners to shape up and to act like a civilized person, which unfortunately he is not,” Trifkovic told RT.


Read More Here

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Erdogan & his family involved in ISIS oil trade – Russian MoD



Published on Dec 2, 2015

Turkish leadership, including Erdogan & his family are involved in ISIS oil trade, Russian MoD announced on Wednesday, showcasing satellites images and footage from oil facilities and Syrian-Turkish border.



Russia presents proof of Turkey’s role in ISIS oil trade


The Russian Defense Ministry has released evidence which it says unmasks vast illegal oil trade by Islamic State and points to Turkey as the main destination for the smuggled petrol, implicating its leadership in aiding the terrorists.

READ MORE: Map, images from Russian military show main routes of ISIS oil smuggling to Turkey

The Russian Defense Ministry held a major briefing on new findings concerning IS funding in Moscow on Wednesday.

According to Deputy Defense Minister Anatoly Antonov, Russia is aware of three main oil smuggling routes to Turkey.

“Today, we are presenting only some of the facts that confirm that a whole team of bandits and Turkish elites stealing oil from their neighbors is operating in the region,” Antonov said, adding that this oil “in large quantities” enters the territory of Turkey via “live oil pipelines,” consisting of thousands of oil trucks.

The routes of alleged oil smuggling from Syria and Iraq to Turkey ©

Antonov added that Turkey is the main buyer of smuggled oil coming from Iraq and Syria.

According to our data, the top political leadership of the country – President Erdogan and his family – is involved in this criminal business.”

READ MORE: Russia says Turkey’s Erdogan & family involved in illegal ISIS oil trade

However, since the start of Russia’s anti-terrorist operation in Syria on September 30, the income of Islamic State (IS, formerly ISIS) militants from illegal oil smuggling has been significantly reduced, the ministry said.

The income of this terrorist organization was about $3 million per day. After two months of Russian airstrikes their income was about $1.5 million a day,” Lieutenant-General Sergey Rudskoy said.

At the briefing the ministry presented photos of oil trucks, videos of airstrikes on IS oil storage facilities and maps detailing the movement of smuggled oil. More evidence is to be published on the ministry’s website in the coming says, Rudskoy said.


Read More Here




‘Great partners’: Pentagon rejects Russian evidence of Turkey aiding ISIS

Col. Steve Warren © Khalid Mohammed
A Pentagon spokesman rejected Russia’s evidence of Turkey’s involvement in oil deals with Islamic State militants, calling Turkey a “great partner” just a day after his boss complained to Congress that Ankara was not fighting ISIS enough.

“Let me be very clear that we flatly reject any notion that the Turks are somehow working with ISIL,” said Colonel Steve Warren, spokesman for the US-led coalition fighting against Islamic State (IS, formerly ISIS/ISIL). “That is preposterous and kind of ridiculous. We absolutely, flatly reject that notion.”

Operation Inherent Resolve Spokesman Steve Warren: We flatly reject the notion that is working with .

Warren was responding to questions about the evidence presented by the Russian Defense Ministry on Wednesday, including satellite photos and maps pointing the finger at Turkey – and President Recep Erdogan personally – for aiding the militants in smuggling oil.

“The Turks have been great partner to us in the fight against ISIL. They are hosting our aircraft, they are conducting strikes, they are supporting the moderate Syrian opposition,” Warren told reporters during a weekly Pentagon briefing from Operation Inherent Resolve headquarters in Baghdad. “They’ve been good partners here. Any thought that the Turks, that the Turkish government is somehow working with ISIL is just preposterous and completely untrue.”

Just yesterday, however, US Defense Secretary Ash Carter was telling the House Armed Services Committee that most of Turkey’s military operations were directed against the Kurds, rather than the self-proclaimed Islamic State.

“Most of their air operations are not directed at ISIL,” Carter told lawmakers. “They are directed at the PKK, which we understand their concern about — it’s a terrorist organization within their borders — but we would like to see them do more against ISIL.”


Read More Here



US-led coalition not striking ISIS oil trucks despite evidence – Russia’s General Staff

A pair of U.S. Air Force F-15E Strike Eagles fly over northern Iraq after conducting airstrikes in Syria, in this U.S. Air Force © Senior Airman Matthew Bruch
Despite mounting evidence of ISIS oil smuggling, the US-led coalition in Syria and Iraq is not striking convoys of oil trucks heading to Turkey, Russia’s General Staff has said.

“It’s hard not to notice” the thousands of trucks used by terrorists for oil smuggling, Lieutenant General Sergey Rudskoy, deputy commander of the General Staff, said at a briefing in Moscow on Wednesday.

READ MORE: Russia presents proof of Turkey’s role in ISIS oil trade

“However, we see no strikes on those convoys by the coalition – only a tripling in the number of strategic UAVs has been observed,” he said.

With the US and its allies unwilling to act, the Russian Defense Ministry has reported the locations where Islamic State (IS, formerly ISIS/ISIL) oil tankers are concentrated, Rudskoy said.

Vehicles parked 8km west of Zakho, Iraq ©

The deputy commander stressed that defeating IS would be impossible without curbing its main source of income – the illegal oil trade – and urged the coalition to strike IS oil infrastructure.


Read More Here

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TPP Deal Finally Revealed

Details of the long-secret Trans-Pacific Partnership are public at last: it will undermine the safety of our food supply, make medicine more expensive, and give power to the biotech monopoly. Action Alert!

A few weeks ago, the full text of the Trans-Pacific Partnership (TPP) trade deal was finally released after many years of closed-door negotiations between officials from the US and eleven other countries, all of whom border the Pacific Ocean. Its provisions were apparently kept secret from all but the biotech and pharmaceutical industries.

Leaked documents during the trade negotiations provided reason to be concerned about the final agreement. And now, a review of the deal’s twenty-nine chapters and five thousand pages proves these early concerns were completely justified. The final package now awaits a vote in Congress, which is likely to take place in Spring 2016.

Here are some of the most pressing concerns for natural health advocates:

It Undermines the Safety of the Food Supply

The TPP contains a number of provisions that threaten current food safety laws.

Generally speaking, passage of the TPP would mean that any US food safety law concerning things like pesticides, food additives, or labeling that is more stringent than “international standards” may be considered an “illegal barrier” to trade, and subject to enforcement. We have learned to beware of such “international standards.” They are largely determined by global special interests.

The TPP expands corporate power in other ways. The deal includes an investor-state dispute settlement (ISDS) system in which multinational corporations can challenge a host company’s regulations in an international court. ISDS has been a fixture in other trade treaties, including NAFTA (the North Atlantic Free Trade Agreement), and has been used to challenge countries’ economic policies, anti-smoking efforts, and environmental preservation laws. It is another giveaway to Big Food and other powerful multinational interests—a recurring theme throughout the TPP document.

The trade agreement also undercuts US efforts to inspect food imports. The agreement limits food import inspections at the border “to what is reasonable and necessary,” and if an issue arises, a country must also provide an “opportunity for a review of the decision.” This provision, referred to as the Rapid Response Mechanism, may give exporting countries the right to challenge basic food safety provisions in the US.

It Gives New Patent Protections to Big Pharma

The TPP contains an entire chapter on intellectual property rights, with many provisions relating to pharmaceutical patents. No doubt heavily influenced by the pharmaceutical industry, the trade deal will force signatory countries to accept many of the same patent laws that have kept drug prices so astronomically high in the US.

The deal would extend and broaden certain patent and data protections for the pharmaceutical industry, which Big Pharma can then use to keep prices high and delay competition from generics. It is a wonderful gift to the pharmaceutical industry—but a grave loss to patients in developing countries looking for access to affordable drugs.

The TPP also allows a practice known as “evergreening,” which lets drug companies extend a patent on an old drug when it can be used to treat a new condition—another boon for Big Pharma’s monopoly power.

Even when Big Pharma loses in the TPP, it wins. One of the more controversial topics in TPP negotiations concerned patent and data protections for biologic drugs—medicines derived not from inert chemical compounds but from living organisms. Big Pharma wanted twelve years of exclusivity— they already have this in the US—and US trade officials pushed hard in the negotiations to make this the standard. Instead, the deal grants them at least five years of exclusivity and as much as eight.

It’s Also a Gift to Biotech Seed Companies

Finally, the TPP deal expands biotech’s monopoly over the seed industry. The deal requires all twelve countries to join a number of global intellectual property treaties. One of these treaties is the 1991 International Convention for the Protection of New Varieties of Plants (UPOV91), which emphasizes the rights of seed companies over farmers. Among other things, UPOV91:

  • Requires intellectual property (IP) protection for all plant species;
  • Provides IP protection for 20 to 25 years; and
  • Stops farmers from exchanging seeds—a common and important practice in many developing nations and indeed throughout human history.

In countries that have not already turned agriculture over to the biotech industry, this could mean a substantial rewrite of regulations meant to protect farmers.

Other treaties that signatory countries are compelled to join make it easier to apply for patents—making it very likely that more plants and seeds will be patented.

If these gifts to industry were not enough, President Obama moved earlier this summer to have the deal “fast-tracked”—that is, Congress will be given a fixed period to review the agreement, after which time legislators must make a yes/no vote without the possibility of amending the deal. Essentially, it’s “take it or leave it.”

We say: leave it. And if the US does reject it, do not worry about losing the reduction of tariffs that is already included. There will just be a second (and, we hope, a better) version to replace it.

Action Alert! Write to your members of Congress and urge them to oppose the TPP deal, which undermines consumers and farmers and extends monopoly rights to major industries. Please send your message immediately.



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Why the United States Leaves Deadly Chemicals on the Market

November 21, 2015  

By Valerie Brown and Elizabeth Grossman



Scientists are trained to express themselves rationally. They avoid personal attacks when they disagree. But some scientific arguments become so polarized that tempers fray. There may even be shouting.

Such is the current state of affairs between two camps of scientists: health effects researchers and regulatory toxicologists. Both groups study the effects of chemical exposures in humans. Both groups have publicly used terms like “irrelevant,” “arbitrary,” “unfounded” and “contrary to all accumulated physiological understanding” to describe the other’s work. Privately, the language becomes even harsher, with phrases such as “a pseudoscience,” “a religion” and “rigged.”

The rift centers around the best way to measure the health effects of chemical exposures. The regulatory toxicologists typically rely on computer simulations called “physiologically based pharmacokinetic” (PBPK) modeling. The health effects researchers—endocrinologists, developmental biologists and epidemiologists, among others—draw their conclusions from direct observations of how chemicals actually affect living things.

The debate may sound arcane, but the outcome could directly affect your health. It will shape how government agencies regulate chemicals for decades to come: how toxic waste sites are cleaned up, how pesticides are regulated, how workers are protected from toxic exposure and what chemicals are permitted in household items. Those decisions will profoundly affect public health: the rates at which we suffer cancer, diabetes, obesity, infertility, and neurological problems like attention disorders and lowered IQ.

The link from certain chemicals to these health effects is real. In a paper published earlier this year, a group of leading endocrinologists concluded with 99 percent certainty that environmental exposure to hormone-disrupting chemicals causes health problems. They estimate that this costs the European Union healthcare system about $175 billion a year.

Closer to home, Americans are routinely sickened by toxic chemicals whose health effects have been long known. To cite one infamous example, people exposed to the known carcinogen formaldehyde in FEMA trailers after Hurricane Katrina suffered headaches, nosebleeds and difficulty breathing. Dozens of cancer cases were later reported. Then there are workplace exposures, which federal government estimates link to as many as 20,000 cancer deaths a year and hundreds of thousands of illnesses.

“We are drowning our world in untested and unsafe chemicals, and the price we are paying in terms of our reproductive health is of serious concern,” wrote the International Federation of Gynecology and Obstetrics in a statement released on October 1.

Yet chemical regulation in the United States has proceeded at a glacial pace. And corporate profit is at the heart of the story.

That the chemical industry exerts political influence is well documented. What our investigation reveals is that, 30 years ago, corporate interests began to control not just the political process but the science itself. Industry not only funds research to cast doubt on known environmental health hazards; it has also shaped an entire field of science—regulatory toxicology—to downplay the risk of toxic chemicals.

Our investigation traces this web of influence to a group of scientists working for the Department of Defense (DOD) in the 1970s and 1980s—the pioneers of PBPK modeling. It quickly became clear that this type of modeling could be manipulated to minimize the appearance of chemical risk. PBPK methodology has subsequently been advanced by at least two generations of researchers—including many from the original DOD group—who move between industry, government agencies and industry-backed research groups, often with little or no transparency.

The result is that chemicals known to be harmful to human health remain largely unregulated in the United States—often with deadly results. For chemicals whose hazards are just now being recognized, such as the common plastics ingredient bisphenol A (BPA) and other , this lack of regulation is likely to continue unless the federal chemical review process becomes more transparent and relies less heavily on PBPK modeling.

Here we lay out the players, the dueling paradigms and the high-stakes health consequences of getting it wrong.

The dawn of PBPK simulation

The 1970s and 1980s saw a blizzard of environmental regulation. The Clean Air Act, Clean Water Act and Toxic Substances Control Act, along with the laws that established Superfund and Community Right-to-Know Programs, for the first time required companies— and military bases—using and producing chemicals to account for their environmental and health impacts. This meant greater demand for chemical risk assessments as the Occupational Safety and Health Administration (OSHA) and the Environmental Protection Agency (EPA) began to establish safety standards for workplace exposures and environmental cleanups.

In the 1980s, the now-defunct Toxic Hazards Research Unit at the Wright-Patterson Air Force Base in Dayton, Ohio, was investigating the toxicity and health effects of chemicals used by the military. Of particular concern to the DOD were the many compounds used by the military to build, service and maintain aircraft, vehicles and other machinery: fuels and fuel additives, solvents, coatings and adhesives. The military is responsible for about 900 of the approximately 1,300 currently listed Superfund sites, many of which have been contaminated by these chemicals for decades.

In the mid-1980s, scientists at the Wright-Patterson Toxic Hazards Research Unit began using PBPK simulations to track how chemicals move through the body. Known as in silico (in computers) models, these are an alternative to testing chemicals in vivo (in live animals) or in vitro (in a test tube). They allow scientists to estimate what concentrations of a chemical (or its breakdown products) end up in a particular organ or type of tissue, and how long they take to exit the body. The information can then be correlated with experimental data to set exposure limits—or not.

PBPK simulations made testing faster and cheaper, something attractive to both industry and regulators. But the PBPK model has drawbacks. “It tells you nothing about effects,” says Linda Birnbaum, director of both the National Institute of Environmental Health Sciences (NIEHS) and National Toxicology Program (NTP). Observational studies and laboratory experiments, on the other hand, are designed to discover how a chemical affects biological processes.

Even regulatory toxicologists who support PBPK acknowledge its limitations: “[PBPK models] are always going to be limited by the quality of the data that go into them,” says toxicologist James Lamb, who worked for the NTP and EPA in the 1980s and is now principal scientist at the consulting firm Exponent.

The late health effects researcher Louis Guillette, a professor at the Medical University of South Carolina famous for studies on DDT’s hormonedisrupting effects in Florida alligators, put it more bluntly: “PBPK? My immediate response: Junk in, junk out. The take-home is that most of the models [are] only as good as your understanding of the complexity of the system.”

Many biologists say PBPK-based risk assessments begin with assumptions that are too narrow, and thus often fail to fully capture how a chemical exposure can affect health. For example, a series of PBPK studies and reviews by toxicologist Justin Teeguarden of the Pacific Northwest National Laboratory in Richland, Wash., and his colleagues suggested that BPA breaks down into less harmful compounds and exits the body so rapidly that it is essentially harmless. Their research began with certain assumptions: that BPA only mimics estrogen weakly, that it affects only the body’s estrogen system, and that 90 percent of BPA exposure is through digestion of food and beverages. However, health effects research has shown that BPA mimics estrogen closely, can affect the body’s androgen and thyroid hormone systems, and can enter the body via pathways like the skin and the tissues of the mouth. When PBPK models fail to include this evidence, they tend to underestimate risk.

Because of its reliance on whatever data are included, PBPK modeling can be deliberately manipulated to produce desired outcomes. Or, as University of Notre Dame biologist Kristin Shrader-Frechette, who specializes in human health risk assessment, says: “Models can offer a means of avoiding the conclusions derived from actual experiments.” In other words, PBPK models can be customized to provide results that work to industry’s advantage.

That’s not to say PBPK itself is to blame. “Let’s not throw the baby out completely with the bathwater,” says New York University associate professor of environmental medicine and health policy Leo Trasande. “However, when you have biology telling you there are basic flaws in the model, that’s a compelling reason that it’s time for a paradigm shift.”

A handy tool for industry

That PBPK studies could be used to make chemicals appear safer was as clear in the 1980s as it is now. In a 1988 paper touting the new technique, Wright-Patterson scientists explained how their modeling had prompted the EPA to stop its regulation process for a chemical of great concern to the military: methylene chloride.

Methylene chloride is widely used as a solvent and as an ingredient in making plastics, pharmaceuticals, pesticides and other industrial products. By the 1990s, the U.S. military would be the country’s second greatest user. Methylene chloride was—and remains—regulated under the Clean Air Act as a hazardous air pollutant because of its carcinogenic and neurotoxic effects.

Between 1985 and 1986, the National Institute for Occupational Safety and Health estimated that about 1 million workers a year were exposed to methylene chloride, and the EPA classified the compound as a “probable human carcinogen.” A number of unions, including United Auto Workers and United Steelworkers, also petitioned OSHA to limit on-the-job exposure to methylene chloride.

In 1986, OSHA began the process of setting occupational exposure limits. Stakeholders were invited to submit public comments.

Among the materials submitted was a PBPK study by Melvin Andersen, Harvey Clewell—both then working at Wright-Patterson—and several other scientists, including two employed by methylene chloride product manufacturer Dow Chemical. Published in 1987, this study concluded, “Conventional risk analyses greatly overestimate the risk in humans exposed to low concentrations [of methylene chloride].”

Later that year, the EPA revised its previous health assessment of methylene chloride, citing the Wright-Patterson study to conclude that the chemical was nine times less risky than previously estimated. The EPA “has halted its rulemaking on methylene chloride [based on our studies],” wrote Wright-Patterson scientists in 1988.

OSHA, too, considered the Wright-Patterson study in its methylene chloride assessment—and its rulemaking dragged on another 10 years before the agency finally limited exposure to the chemical.

The usefulness of PBPK modeling to industry did not escape the Wright-Patterson researchers. “The potential impact,” wrote Andersen, Clewell and their colleagues in 1988, “is far reaching and not limited to methylene chloride.” Using PBPK models to set exposure limits could help avoid setting “excessively conservative”—i.e., protective— limits that could lead to “unnecessary expensive controls” and place “constraints on important industrial processes.” In other words, PBPK models could be used to set less-stringent environmental and health standards, and save industry money.

So far, they’ve been proven right. The work done at Wright-Patterson set the stage for the next 30-plus years. Results obtained using PBPK modeling—especially in industry-funded research, often conducted by former Wright-Patterson scientists—have downplayed the risk and delayed the regulation of numerous widely used and commercially lucrative chemicals. These include formaldehyde, styrene, tricholorethylene, BPA and the pesticide chlorpyrifos. For many such chemicals, PBPK studies contradict what actual biological experiments conclude. Regulators often defer to the PBPK studies anyway.

A web of influence

At the time that PBPK modelling was being developed, the chemical industry was struggling with its public image. The Bhopal, India, disaster—the methyl isocyanate release that killed and injured thousands—happened in 1984. The following year, a toxic gas release at a West Virginia Union Carbide plant sent about 135 people to hospitals.

In response to these incidents, new federal regulations required companies to account for the storage, use and release of hazardous chemicals. The minutes from a May 1988 Chemical Manufacturers Association (CMA) meeting show industry was feeling the pressure. Noting the federal scrutiny and the growing testing requirements, the CMA recommended that industry help “develop exposure data” and “explore innovative ways to limit required testing to that which is needed.”

Industry had already begun to do this by founding a number of research institutes such as the Chemical Industry Institute of Toxicology (CIIT), a nonprofit toxicology research institute (renamed the Hamner Institutes in an act of linguistic detoxification in 2007). This period also saw the rise of for-profit consulting firms like Environ (1982), Gradient (1985), ChemRisk (1985) and K.S. Crump and Company (1986), with which industry would collaborate advantageously in the following decades.

“Our goal was to do the science that would help the EPA and other regulatory bodies make the policies,” explained William Greenlee, Hamner president and CEO, in an interview for a business website. Indeed, over the past 30 years, Hamner and these consultancies have produced hundreds of PBPK studies, often with the support of chemical companies or trade groups. Overwhelmingly, these studies downplay or cast doubt on chemicals’ health effects—and delay regulation.

“I have seen how scientists from the Hamner Institutes can present information in a way that carefully shapes or controls a narrative,” says Laura Vandenberg, an assistant professor of environmental health sciences at University of Massachusetts Amherst. She explains that Hamner scientists often use narrow time windows or present data in a limited context, rejecting information that does not conform to their models. “These are the kinds of tactics used to manufacture doubt,” she says.

A close look at the authors of studies produced by these industry-linked research groups reveals a web of influence traceable to Wright-Patterson (see chart on following page). At least 10 researchers employed at or contracted by Wright-Patterson in the 1980s went on to careers in toxicology at CIIT/Hamner, for-profit consulting firms or the EPA. About half have held senior positions at Hamner, including the co-authors of many of the early Wright-Patterson PBPK studies: Melvin Anderson, now a chief scientific officer at Hamner, and Harvey Clewell, now a senior investigator at Hamner and principal scientist at the consulting firm ENVIRON. “I’m probably given credit as the person who brought PBPK into toxicology and risk assessment,” Andersen told In These Times.

A revolving door between these industry-affiliated groups and federal regulators was also set in motion. More than a dozen researchers have moved from the EPA to these for-profit consultancies; a similar number have gone in the other direction, ending up at the EPA or other federal agencies.

Further blurring the public-private line, CIIT/Hamner has received millions of dollars in both industry and taxpayer money. The group stated on its website in 2007 that $18 million of its $21.5 million annual operating budget came from the “chemical and pharmaceutical industry.” Information about its corporate funders is no longer detailed there, but Hamner has previously listed as clients and supporters the American Chemistry Council (formerly the CMA, and one of the most powerful lobbyists against chemical regulation), American Petroleum Institute, BASF, Bayer CropScience, Dow, ExxonMobil, Chevron and the Formaldehyde Council. At the same time, over the past 30 years, CIIT/Hamner has received nearly $160 million in grants and contracts from the EPA, DOD and Department of Health and Human Services. In sum, since the 1980s, these federal agencies have awarded hundreds of millions of dollars to industry-affiliated research institutes like Hamner.

But the federal reliance on industry-linked researchers extends further. Since 2000, the EPA has signed a number of cooperative research agreements with the ACC and CIIT/ Hamner. All involve chemical toxicity research that includes PBPK modeling. And in 2014, Hamner outlined additional research it will be conducting for the EPA’s next generation of chemical testing—the ToxCast and Tox21 programs. Over the past five years, Hamner has received funding for this same research from the ACC and Dow.

Meanwhile, the EPA regularly contracts with for-profit consultancies to perform risk assessments, assemble peer review panels and select the scientific literature used in chemical evaluations. This gives these private organizations considerable sway in the decision-making process, often with little transparency about ties to chemical manufacturers. The upshot: Experts selected to oversee chemical regulation often overrepresent the industry perspective.

These cozy relationships have not gone unnoticed; the EPA has been called to task by both its own Office of Inspector General and by the U.S. Government Accountability Office. “These arrangements have raised concerns that ACC or its members could potentially influence, or appear to influence, the scientific results that may be used to make future regulatory decisions,” wrote the GAO in a 2005 report.

Asked for comment by In These Times, the EPA said these arrangements do not present conflicts of interest.

Decades of deadly delay

PBPK studies have stalled the regulation of numerous chemicals. In each case, narrowly focused models developed by industry-supported research concluded that risks were lower than previously estimated or were not of concern at likely exposure levels.

Take, for example, methylene chloride, the subject of the 1987 paper Wright-Patterson scientists bragged had halted the EPA’s regulatory process. Despite the chemical being identified as “probably carcinogenic to humans” by the U.N. International Agency for Research on Cancer, a “reasonably anticipated” human carcinogen by the U.S. National Toxicology Program, and an “occupational carcinogen” by OSHA, the EPA has yet to limit its use. EPA researchers noted this year that the 1987 PBPK model by the Wright-Patterson scientists remains the basis for the agency’s risk assessment.

Today, methylene chloride remains in use—to produce electronics, pesticides, plastics and synthetic fabrics, and in paint and varnish strippers. The Consumer Product Safety Commission, OSHA and NIOSH have issued health warnings, and the FDA bars methylene chloride from cosmetics— but no U.S. agency has totally banned the chemical. The EPA estimates that some 230,000 workers are exposed directly each year. According to OSHA, between 2000 and 2012, at least 14 people died in the United States of asphyxiation or heart failure after using methylene chloride-containing products to refinish bathtubs. The Center for Public Integrity reports that methylene chloride exposure prompted more than 2,700 calls to U.S. poison control centers between 2008 and 2013.

Another telling example of industry-funded PBPK studies’ influence is formaldehyde. This chemical remains largely unrestricted in the United States, despite being a well-recognized respiratory and neurological toxicant linked to nasal cancer and leukemia, as well as to allergic reactions and skin irritation. The EPA’s toxicological review of formaldehyde, begun in 1990, remains incomplete, in no small part because of delays prompted by the introduction of studies—including PBPK models conducted by CIIT/Hamner—questioning its link to leukemia.

If that link is considered weak or uncertain, that means formaldehyde—or the companies that employ the sickened workers—won’t be held responsible for the disease. The chemical industry is well aware that “more people have leukemia … than have nasal tumors,” says recently retired NIEHS toxicologist James Huff.

Some of this CIIT/Hamner research was conducted between 2000 and 2005 with funding from an $18,750,000 EPA grant. In 2010, Hamner received $5 million from Dow, a formaldehydeproduct manufacturer, for toxicity testing, including PBPK modeling. The ACC, which opposes formaldehyde restriction, also supported this research.

Consequently, apart from a few state regulations and a pending EPA proposal to limit formaldehyde emissions from composite wood products like plywood, companies can still use the chemical—as in the FEMA trailers.

Cosmetics and personal-care products can also be sources of formaldehyde exposure. This made headlines in 2011 after hair salon workers using a smoothing product called Brazilian Blowout reported nausea, sore throats, rashes, chronic sinus infections, asthma-like symptoms, bloody noses, dizziness and other neurological effects. “You can’t see it … but you feel it in your eyes and it gives you a high,” salon owner and hair stylist Cortney Tanner tells In These Times. “They don’t teach this stuff in beauty school,” she says, and no one warns stylists about these products or even suggests using a ventilator.

OSHA has issued a hazard alert for these products and the FDA has issued multiple warnings, most recently in September, but regulations prevent federal agencies from pulling the products from store shelves. So, for formaldehyde, as in the case of the paint strippers containing methylene chloride, exposures continue.

BPA rings alarm bells

The chemical currently at the center of the most heated debates about consumer exposure is BPA. The building block of polycarbonate plastics, BPA is used in countless products, including the resins that line food cans and coat the thermal receipt paper at cash registers and ATMs. While scientific evidence of adverse health effects from environmentally typical levels of BPA mounts, and many manufacturers and retailers have responded to public concern by changing their products, federal regulatory authorities still resist restricting the chemical’s use.

BPA does not produce immediate, acute effects, like those experienced by salon workers exposed to formaldehyde or machinists working with methylene chloride. But in laboratory tests on animals, BPA is a known endocrine disruptor. Structurally similar to natural hormones, endocrine disruptors can interfere with normal cellular processes and trigger abnormal biochemical responses. These can prompt numerous health problems, including cancer, infertility, and metabolic and neurological disorders. BPA has also been linked to increased risk of cardiovascular disease, diabetes and obesity.

To promote the idea that BPA is safe, the chemical industry routinely lobbies policymakers and “educates” consumers. What has not been widely discussed, however, is how industry has backed PBPK studies that marginalized research showing risks from environmentally typical levels of BPA. Many of these doubt-inducing studies have been conducted by researchers whose careers can be linked to the PBPK work done at Wright-Patterson. In published critiques, health effects researchers—among them Gail Prins and Wade Welshons—have detailed the many ways in which these PBPK models fail to accurately reflect BPA exposure.

PBPK and endocrine disruption

Over the past several decades, our evolving understanding of our bodies’ responses to chemicals has challenged previous toxicological assumptions— including those that are fed into PBPK models. This is particularly true of endocrine disruptors.

Cause-and-effect relationships between endocrine disruptors and health problems can be hard to pinpoint. We now know that early—even prenatal— exposure to endocrine disruptors can set the stage for adult disease. In addition, a pregnant woman’s exposures may affect not only her children but also her grandchildren. These transgenerational effects have been documented in animal experiments. The classic human evidence came from victims of DES, a drug prescribed in the 1940s, 1950s and 1960s to prevent miscarriages. Daughters of women who took the endocrine disruptor developed reproductive cancers, and preliminary research suggests their daughters may be at greater risk for cancer and other reproductive problems.

“The transgenerational work raises an incredible specter,” says Andrea Gore, who holds the Vacek Chair in Pharmacology at the University of Texas at Austin and edits the influential journal Endocrinology. “It’s not just what you’re exposed to now, it’s what your ancestors were exposed to.”

Complicating PBPK modeling further, hormone-mimicking chemicals, just like hormones, can have biological effects at concentrations as low as parts per trillion. In addition, environmental exposures most often occur as mixtures, rather than in isolation. And each individual may respond differently.

“PBPK doesn’t come close” to capturing the reality of endocrine disruption, the late developmental biologist Louis Guillette told In These Times, in part because modelers are “still asking questions about one chemical exposure with one route of exposure.” Even for health effects researchers, understanding of mixtures’ effects is in its infancy.

The debate over how endocrine disruption can be represented in PBPK models has intensified the unease between regulatory toxicologists and health effects researchers. That tension is particularly well-illustrated by a recent series of events that also reveal how some journal editors privilege the industry’s point of view.

A life-and-death debate

In February 2012 the World Health Organization (WHO) and the U.N. Environment Programme (UNEP) published a report intended to inform regulation worldwide. The authors were an international group of health effects researchers with long experience studying endocrine disruption.

“There is an increasing burden of disease across the globe in which [endocrine disruptors] are likely playing an important role, and future generations may also be affected,” said the report. These diseases, it continued, are being seen in humans and wildlife, and include male and female reproductive disorders, changes in the numbers of male and female babies born, thyroid and adrenal gland disorders, hormone-related cancers and neurodevelopmental diseases.

The backlash from toxicologists was immediate. Over the next few months—as the EU prepared to begin its regulatory decision-making on endocrine disruptors—the editors of 14 toxicology journals each published an identical commentary harshly criticizing the WHO/UNEP conclusions.

The commentary included a letter from more than 70 toxicologists urging the EU not to adopt the endocrine disruption framework. The letter said that the WHO/UNEP report could not be allowed to inform policy because its science is “contrary to all accumulated physiological understanding.”

This commentary was followed by further attacks. One critique, published in the journal Critical Reviews in Toxicology, was funded and vetted by the ACC.

These commentaries infuriated health effects researchers. Twenty endocrine journal editors, 28 associate editors and 56 other scientists—including several WHO/UNEP report authors—signed a statement in Endocrinology, saying in part:

The dismissive approach to endocrine disruption science put forth … is unfounded, as it is [not] based on the fundamental principles of how the endocrine system works and how chemicals can interfere with its normal function.

Endocrinology editor Andrea Gore tells In These Times that she and other health effects researchers don’t think the scientifically demonstrated dangers of endocrine disruptors are subject to debate. “There are fundamental differences between regulatory toxicologists and what I refer to as ‘people who understand the endocrine science.’ ”

The outcome of this debate and the structure of future regulatory toxicity testing in the United States and Europe is not yet clear. The EPA appears to be attempting to incorporate endocrine disruption into PBPK models, but many scientists are skeptical the process will produce reliable results, given the models’ limitations and the complexity of endocrine effects.

From science to activism

Although couched in complex language, these arguments are not academic, but have profound implications for public health. Disorders and diseases, increasingly linked to exposure to endocrine disruptors— including metabolic, reproductive, developmental and neurological problems—are widespread and increasing. About 20 percent of U.S. adults show at least three of the five indicators of metabolic syndrome: obesity, diabetes, high blood pressure, high cholesterol and heart disease. Neurological problems, including behavioral and learning disabilities in children as well as Parkinson’s disease, are increasing rapidly. Fertility rates in both men and women are declining. Globally, the average sperm count has dropped 50 percent in the last 50 years.

Scientists typically shy away from activism, but many now believe it’s what’s needed to punch through the machinations and inertia regarding chemical regulation. Shanna Swan, Mount Sinai professor of preventive medicine, obstetrics, gynecology and reproductive medicine, notes that some of the biggest reductions in chemical exposures have happened in response to consumer pressure on both industry and policymakers. Or, as the University of California’s Bruce Blumberg says, “I think we need to take the fight to the people.”

The Endocrine Society stressed the urgency of addressing these public health impacts in a statement released September 28. Not surprisingly, industry disagreed, calling this science “unsupported” and “still-unproven.”

Meanwhile, PBPK studies continue to succeed in sowing doubt about adverse health effects of endocrine disorders. Their extremely narrow focus leads to narrow conclusions that often result in calls for more research before regulation. In regulatory decisions, “the assumption is that if we don’t know something, it won’t hurt us,” says University of Massachusetts, Amherst professor of biology R. Thomas Zoeller. In other words, the burden of proof remains on health effects researchers to prove harm, not on industry to prove safety—and proving harm is difficult, especially when other scientists are seeding doubt.

But the clock is ticking. As Washington State University geneticist Pat Hunt told In These Times, “If we wait [to make regulatory decisions] for ‘proof’ in the form of compelling human data, it may be too late for us as a species.”

This investigation was supported by the Leonard C. Goodman Institute for Investigative Reporting and published originally in In These Times.


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“Social Explosion” Begins In Greece As Massive Street Protests Bring Economy To A Fresh Halt

One thing that became abundantly clear after Alexis Tsipras sold out the Greek referendum “no” back in the summer after a weekend of “mental waterboarding” in Brussels was that the public’s perception of the once “revolutionary” leader would never be the same. And make no mistake, that’s exactly what Berlin, Brussels, and the IMF wanted.

By turning the screws on the Greek banking sector and bringing the country to the brink of ruin, the troika indicated its willingness to “punish” recalcitrant politicians who pursue anti-austerity policies. On the one hand, countries have an obligation to pay back what they owe, but on the other, the subversion of the democratic process by using the purse string to effect political change is a rather disconcerting phenomenon and we expect we’ll see it again with regard to the Socialists in Portugal.

After a month of infighting within Syriza Tsipras did manage to consolidate the party and win a snap election but he’s not the man he was – or at least not outwardly. He’s obligated to still to the draconian terms of the bailout and that means he is a shadow of his former self ideologically. As we’ve said before, that doesn’t bode well for societal stability.

On Thursday, we get the first shot across the social upheaval bow as the same voters who once came out in force to champion Tsipras and Syriza are staging massive protests and walkouts.


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Bloomberg Business

Greece Comes to a Standstill as Unions Turn Against Tsipras

November 11, 2015 — 6:01 PM CST Updated on November 12, 2015 — 6:04 AM CST
  • Unions hold general strike to protest against austerity
  • PM races to satisfy creditor demands in exchange for funds

As Greek workers took to the streets in protest on Thursday, Alexis Tsipras was for the first time on the other side of the divide.

Unions — a key support base for the prime minister’s Syriza party — chanted in rallies held in Athens the same slogans Tsipras once used against opponents. Doctors and pharmacists joined port workers, civil servants and Athens metro staff in Greece’s first general strike since he took office in January, bringing the country to a standstill for 24 hours.

As many as 20,000 protesters gathered in central Athens while a small group of anarchists at the tail of the demonstration threw petrol bombs at police officers at around 1:30 pm local time, a police spokesman said, requesting anonymity in line with policy. The police responded with tear gas and stun grenades.

Greece’s biggest unions, ADEDY and GSEE, are holding marches accusing Tsipras of bowing to creditors and imposing measures that “perpetuate the dark ages for workers,” as the country’s statistical agency released data showing that 1.18 million Greeks, or 24.6 percent of the workforce, remained unemployed in August.

The 41-year-old Greek premier, who was among anti-austerity protesters in previous general strikes, is now racing to complete negotiations with creditors on belt-tightening in exchange for the disbursement of 10 billion euros ($10.7 billion) to be injected into banks. Failure to reach an accord with euro-area member states and the International Monetary Fund on policies including primary residence foreclosures, and stricter rules on overdue taxes, would put the solvency of the country’s lenders in doubt.

“The economic policies Tsipras has to implement are definitely harsher than warranted, and also harsher than they would be if it wasn’t for these seven months of brinkmanship and extreme political uncertainty,” said Manolis Galenianos, a Professor of Economics at the Royal Holloway, University of London. “This wasn’t necessary, it could have been avoided, and the government will now implement deeper cuts to achieve less ambitious fiscal targets.”


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12:38 09.11.2015(updated 15:17 09.11.2015) 
Paul Craig Roberts

The re-enserfment of Western peoples is taking place on several levels. One about which I have been writing for more than a decade comes from the offshoring of jobs. Americans, for example, have a shrinking participation in the production of the goods and services that are marketed to them.

On another level we are experiencing the financialization of the Western economy about which Michael Hudson is the leading expert (Killing The Host). Financialization is the process of removing any public presence in the economy and converting the economic surplus into interest payments to the financial sector.

These two developments deprive people of economic prospects.  A third development deprives them of political rights.  The Trans-Pacific and Trans-Atlantic Partnerships eliminate political sovereignty and turn governance over to global corporations.

These so called “trade partnerships” have nothing to do with trade. These agreements negotiated in secrecy grant immunity to corporations from the laws of the countries in which they do business. This is achieved by declaring any interference by existing and prospective laws and regulations on corporate profits as restraints on trade for which corporations can sue and fine “sovereign” governments. For example, the ban in France and other counries on GMO products would be negated by the Trans-Atlantic Partnership. Democracy is simply replaced by corporate rule.I have been meaning to write about this at length. However, others, such as Chris Hedges, are doing a good job of explaining the power grab that eliminates representative government.


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Anonymous plot bonfire night Million Mask March

Protesters hold up their Guy Fawkes masks on the Liberty Bridge during a demonstration by supporters of the Anonymous movement as part of the global "Million Mask March" protests, in Budapest, November 5, 2014. © Bernadett Szabo
Activist collective Anonymous have released details of the 2015 Million Mask March, which will see coordinated demonstrations in cities across the globe protesting against corruption, human rights abuses and censorship.

Following in the footsteps of previous marches, the worldwide demonstration will take place on November 5, coinciding with bonfire night in the UK.

This year’s message is “building a better future through collective action,” a statement from the group released on Monday reads.

The London march in 2014 attracted over 1,000 participants who marched through the city center wearing distinctive Guy Fawkes masks, which have become the unofficial emblem of the movement.

Fawkes, part of a band of persecuted English Catholics, was captured and executed by the British state after attempting to blow up the Houses of Parliament in 1605. His image was popularized by the 2005 film adaptation of the Alan Moore graphic novel V for Vendetta.



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