I WILL TALK ABOUT EACH OF THE BELOW TOPICS THIS WEEK. HEALTH CARE FALLS INTO MANY CATEGORIES---FROM PLACES WE GO FOR HEALTH CARE, TO PLACES THAT RESEARCH AND CREATE NEW PRODUCTS IN HEALTH CARE, TO PUBLIC JUSTICE AND FEDERAL OVERSIGHT THAT PROTECTS THE AMERICAN PEOPLE AS REGARDS ALL OF THE ABOVE.
This week I will talk about the Affordable Care Act and the dismantling of public health in the US. I have shouted over and again the fact ACA is the Republican policy to end Federal health programs like Medicare and Medicaid by building private state health systems that take the poor and seniors after these Federal programs are ended. I also have made clear that the deregulation and consolidation of our health care system is the mirror of the Clinton neo-liberal policies that did the same with the financial industry giving us global Wall Street. ACA has a goal of creating global health systems that will be just as predatory and profit-driven as Wall Street and we are already seeing this. Make no mistake----unless you have strong private health insurance and can afford what will be soaring health care costs----you will become the people these health institutions can exploit and profit. Johns Hopkins in Baltimore has a long history of doing just what will become the norm as Baltimore has operated completely deregulated and corporate captured for decades. No public sector in Baltimore has allowed the worst of frauds and corruption with Hopkins being front and center. Let's take another look at universities operating as corporations under a completely deregulated and profit-driven model which is what Affordable Care Act is about. Think who backed this ACA -----labor and justice organization leaders to know which organizations need to get new leadership. In Maryland, the Clinton neo-liberals and neo-cons simply create private non-profits to promote these policies pretending they are progressive and knowing it ends badly for the American people.
The conflict of interest and ethics problem below starts with Johns Hopkins being the lead in circumventing lead paint laws and creating the existence of widespread availability of lead paint housing. Remember, for decades Hopkins was the force behind moving all Federal, state, and local funding for community development and low-income housing to their own corporate East Baltimore campus and downtown to subsidize billion dollar corporate building for the worst of criminal corporations. All of those billions of dollars in funds should have been channeled into abating the lead contamination and refurbishing homes in these communities in itself creating lots of employment for local citizens. Rather, out of town workers brought to build high-rise corporate structures left unemployment high and crumbling houses full of lead paint danger. A few years ago, Baltimore pols even pushed and passed a lead paint bill that made it harder for families victim of lead paint poisoning to sue landlords at the same time allowing more and more families desperate for housing to move into contaminated structures. None of this was necessary and it shows a level of medical and health immorality that shows how far these practices will go.
The Baltimore Lead Study
May 17, 2013 Bill Moyers
In the 1990s, a prominent research facility associated with Johns Hopkins University conducted an experiment that knowingly exposed children — mostly African American, some as young as a year old — to varying levels of potentially dangerous lead, as part of a study comparing different degrees of lead paint abatement. The researchers, at Hopkins’ Kennedy Krieger Institute, recruited poor families to move into homes that had only been partially abated using three different methods of lead paint removal at three different levels of cost.
The research was “conducted in the best interest of all of the children enrolled,” Dr. Gary W. Goldstein, president and chief executive of the Kennedy Krieger Institute, said in response to a class-action lawsuit filed by the families in 2011. “Over all, the blood lead levels of most children residing in the study homes stayed constant or went down.”
But in some cases, children placed in homes that received the two cheaper forms of abatement were exposed to levels of lead known to cause permanent neurological problems.
Here, public health historians Gerald Markowitz and David Rosner tell the story. You can read about it in more detail in this chapter of their book, Lead Wars.
Watch Bill’s entire interview with Gerald Markowitz and David Rosner.
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People may think these health research cases only affect people of color and the poor but patenting research now moves this open use of the public as unknowing research guinea pig mainstream. Again, I have mentioned the exploding number of class action lawsuits against PHARMA and medical devises all put onto the market without clinical trial under ever decreasing regulation of what standards need to be met before this research product goes to market. Johns Hopkins is having open debates by students in classes over whether clinical trials are even necessary. That point is mute when we know Hopkins is pushing their patents to market with little clinical trial first by sending it overseas where such research standards do not exist and then with global market imports to the US being expanded----these products come right back to the US having circumvented our medical research standards.
When you have executives at the top of these large institutions that are now simply corporations acting as they are-----CEOs and corporate research executives-----they are the kinds of people that do not go by the Hippocratic Oath----they are not healers-----they are profiteers.
THIS IS WHAT WE HAVE IN BALTIMORE IN JOHNS HOPKINS FOR DECADES AND THIS IS THE BEHAVIOR BEING BUILT IN OUR UNIVERSITIES THROUGHOUT OBAMA'S TERMS IN OFFICE AS CORPORATE RESEARCH IN OUR UNIVERSITIES WAS FUNDED BY HUNDREDS OF BILLIONS OF DOLLARS.
This was O'Malley's entire focus in health care during his terms----building that global corporate health structure for Johns Hopkins as with all Congressional pols in Maryland.
If you have a corporate executive leading the FDA at the same time class action lawsuits on damages from FDA approved medical PHARMA and devices soars----you know all of the Federal guidelines below are being ignored. Remember, Clinton neo-liberals and Bush neo-cons ignore all Federal laws and regulations so this is why EVERYONE is falling victim to unwittingly being a clinical trial participant. In other words----class action lawsuits now let us know when a medical device or PHARMA does not work but by then billions of dollars in profits were earned on that product. As a decades long academic with loads of time with medical research and IRBs I have watched as deregulation moved all of this protection to the sidelines to move that university's patent and profit forward.
WE HAVE TO PAY THE RESEARCH COSTS SAY CORPORATIONS! WE NEVER WORRIED ABOUT THAT WITH PUBLIC UNIVERSITY MEDICAL RESEARCH.
Clinical Trials Information Are there any gene therapy products approved by the FDA?
Currently there are no US FDA approved (i.e. FDA licensed) gene therapy products. Gene therapy products are still in the investigational stage, which means that the products are still being studied to assess their safety and efficacy. Gene therapy products must go through the same rigorous testing that all drugs go through before they are licensed by the FDA. Promising treatments that are not yet licensed are generally only available through a clinical trial.
What is a clinical trial? A clinical trial is a research study that seeks to determine if a treatment is safe and effective. Clinical trials are regulated by the federal government. Participants must be informed, both verbally and in writing, about the risks and benefits of participation in a clinical trial. The written document is called an "Informed Consent Document". Participation in clinical trials is voluntary.
What is Informed Consent? Before patients can be enrolled in clinical research, investigators are ethically and legally required to seek the patient's agreement. The process of describing the research procedures, risks, potential benefits and other relevant information to allow patients to decide whether to participate in research is called informed consent.
In general, the informed consent process involves both written and oral components, The written Informed Consent Document provides the basic details of the study-how it will be conducted, what it involves, by whom, the risks, potential benefits, alternatives to participation, right to withdraw, whether the patient will receive payment for participation and other key information. It is equally important that patients have an opportunity to meet with researchers and discuss the study in person. While the written informed consent document is an important part of the consent process, it is meant to serve as a starting point for the verbal discussion. Only after a patient has met with the researchers, had their questions answered, and decided that they would like to participate in the proposed research should they sign the Informed Consent Document. Signing the Informed Consent Document verifies that the patient's questions have been answered, that they agree to participate in the research, and their participation is voluntary. Many patients take the informed consent document home to read and share with family members before deciding to participate in clinical research. If a patient has additional questions, researchers are expected to make themselves available to discuss the concerns.
Voluntary participation is a cornerstone of ethical research. Therefore, when doctors are also researchers they should ensure that every patient is treated without prejudice whether they decide not to participate in a research study at all, or choose to withdraw from the study at a later time. This is an important point for patients to understand: signing an informed consent document does not require them to continue in the study if they change their mind. Also, if a patient decides to stop participation the researchers must ensure their medical needs are met and facilitate their further care.
The Informed Consent Document is developed by the individuals conducting the research and it must follow explicit government regulations for the protection of human subjects. In particular, the Informed Consent Document must be approved by an Institutional Review Board (IRB), a committee with the legal authority to protect the rights and welfare of research subjects. The IRB has the authority to require changes in the consent document if it believes that the information is incomplete or too complicated. After the IRB is satisfied that the Informed Consent Document is accurate, they approve the document.
Specific Issues About Consent for Gene Therapy The information provided above is a brief introduction to informed consent issues. Individual research studies involving gene therapy may raise additional questions. We encourage patients considering any clinical trial to learn more about informed consent through the following resources.
Further Reading About Informed Consent The US Department of Health and Human Services, Office of Human Research Protections has a series of Frequently Asked Questions about Informed Consent on their website. This includes questions that parents have regarding informed consent for children participating in clinical research and participation of those with diminished capacity to provide consent:
http://www.hhs.gov/ohrp/informconsfaq.html
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The urgency for the American people is the fact that Obama and Congressional neo-liberals spent these several years privatizing Federal Medicare and making block grants of Medicaid to break apart the entire Federal health structure. All of this can be reversed----those Federal structures and regulations are still there-----they are simply being torn apart just as all other Federal agencies were----from Department of Education and student loans----to Federal Housing Agency and subprime mortgage fraud----to Medicare and Medicaid and the hundreds of billions of dollars each year in fraud to these Federal programs to implode them with debt. Keep in mind Medicare is different in that WE THE PEOPLE PAY INTO THIS HEALTH ACCOUNT and we have pre-paid for all of the health care we will need----Clinton neo-liberals simply allowed these Trusts to be gutted with fraud.
What Obama and neo-liberals are creating with state health systems does not have a goal of fixing or improving health care----it has the goal of making Wall Street banks out of these health systems allowing them to act just as predatory and fraudulent as the financial industry.
We need to act on a state level to make these private health systems public with Expanded and Improved Medicare for All which will protect Federal Medicare. In states like Maryland with the most private and profit-driven health system in the nation-----
IT IS LABOR AND JUSTICE ORGANIZATION LEADERS WHO KEEP SUPPORTING THESE CLINTON NEO-LIBERALS DOING THIS TO OUR PUBLIC HEALTH. GET RID OF THESE LEADERS!
SURE WE NEED TO FIGHT TO END POLICE BRUTALITY AND FOR HIGHER WAGES BUT WHILE WE ARE BUSY WITH THIS SLOGANEERING----THEY ARE DISMANTLING OUR QUALITY OF LIFE THAT WILL END UP KILLING MILLIONS OF PEOPLE UNNECESSARILY.
The Affordable Care Act: What to Expect in 2013
Posted: 01/24/2013 3:35 pm EST Updated: 03/26/2013 5:12 am EDT The Affordable Care Act (ACA), crafted in large part by corporate stakeholders who are themselves responsible for the high costs of U.S. health care, is more secure with President Obama's win. But regrettably, the law will fail to control costs or prices, will not provide universal access to care, and at best will provide low value, high premium "insurance" that will still make essential health care unaffordable for many millions of patients and families.
The ACA's fundamental flaw is that it props up an inefficient and exploitative private health insurance industry while not recognizing that deregulated markets can't fix systemic problems of access, costs, quality, equity, accountability and sustainability.
President Obama has gained an impressive victory, and Democrats have held control of the Senate. Most importantly, corporate money, power, lies and deception on the right have not prevailed. But of course, the Republican-controlled House is likely to bring continued political gridlock. Overemphasis on austerity and deficit control threaten Medicare, Medicaid and safety net programs.
Going forward, we can expect to see wild battles across the health care landscape, including these examples:
Health care is just one more example of the 99/1 percent challenge facing the country. These are some of the directions that we, the citizens of this great country, can take in restoring hope that all Americans can gain their rightful access to the health care that they deserve:
Other advanced nations around the world learned many years ago that one or another form of public financing is fundamental to a good health care system. The U.S. remains an outlier among these nations in having the most expensive system that still does not provide universal access to essential health care -- even at that we have variable quality and worse outcomes. It is long overdue to learn from the experience of other countries that have coped more successfully with the same health policy issues that we face in this country.
John Geyman, M.D. is professor emeritus of Family Medicine at the University of Washington, author of Health Care Wars: How Market Ideology and Corporate Power Are Killing Americans, past president of Physicians for a National Health Program (PNHP), and a member of the Institute of Medicine.
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This article is too long to post but I encourage people to look at what the University of Chicago---home of neo-liberal policy has written about the steps forward now that Affordable Care Act deregulates and consolidates health care and makes corporate medical research of all of our universities----now public universities as well. Hoyer, Van Hollen, Cardin, Donna Edwards, Cummings, Sarbanes, and Mikulski were all champions of Affordable Care Act as Maryland and Baltimore has practiced deregulated and dismantled public health for decades. It is why the poor in Baltimore were allowed to be used for research as they had no other access to health care with pooled money coming from Medicaid and Medicare diverted to health industry profits. As this article says ACA freed the health industry across the nation to act as Johns Hopkins has acted for decades----forget all those cumbersome regulations that protected people from harm while in the hospital or receiving surgeries or taking PHARMA----just let them be the losers in this WINNERS AND LOSERS climb to profit.
Make no mistake----your national labor and justice organization leaders knew where ACA was leading as they had workers and people of color----children all out fighting for the Affordable Care Act. Local people participating did not know because there is
NO DISCUSSION OF PUBLIC POLICY AT THE LOCAL LEVEL AND PEOPLE ARE NOT EDUCATING THEMSELVES AS TO THE HISTORY AND GOALS OF THESE POLICIES.
Remember, we all know the US had the most expensive cost in health care because of massive health industry fraud and profiteering. While for decades the American people had the best of public health and a strong public health system-----the Reagan/Clinton neo-liberals came in and dismantled Federal agencies of health and ignored Federal protections in an effort to install this Trans Pacific Trade Pact in place of our Constitutional protections giving corporations free reign to profit without limits of any civil right or public protection like our Federal health regulations and institutional protections allowing people to know what is done in a hospital or by a doctor was safe. Now, the American people are left not knowing when they enter a hospital that they will be safe as the procedures are geared towards that hospital acting in ways to maximize profit.
After the ACA: Freeing the market for health care
John H. Cochrane1
June 2014
Abstract:
I survey the supply, demand, and market for health care and health insurance. I conclude that a much less-regulated system is possible, and necessary. Cost control and technology improvement must come from disruptive competition by new suppliers, as it has in airlines, retail, internet, and other successful industries. People must direct their expenditures at the margin, and feel the benefits and costs of their decisions. Individual, portable, guaranteed renewable insurance can then emerge, addressing the pathologies of today’s insurance markets. I discuss how current law and regulations rather than fundamental market failures are the main reasons a healthy market does not emerge, and why a regulatory approach must fail. I address common objections to market-based health care and insurance.
1 University of Chicago Booth School of Business, National Bureau of Economic Research, Hoover Institution, and
Cato Institute. Address: 5807 S. Woodlawn Chicago IL 60637, john.cochrane@chicagobooth.edu, http://faculty.chicagobooth.edu/john.cochrane/.
This essay is an expanded version of remarks given at the conference, “The Future of Health Care Reform in the United States,” at the University of Chicago Law School, October 12 2012, and to be published in its conference volume. I am grateful to Anup Malani and W.E. Heasley for helpful comments.
After the ACA: Freeing the market for health care
I. Introduction
Most health-economics policy discussion takes for granted the bulk of our current legal and regulatory structure, and in particular that the government will have a heavy hand in providing, paying for, and directing the private provision of and payment for health care. Opponents of the optimistically-named Affordable Care Act delight in pointing out its unintended consequences, mangled incentives, and exploding budgets. Fans work to patch it up with new layers of regulation or “reforms.” Neither takes a ground-up, first-principles approach to understand why our current system is such a mess and how a better system might emerge. That is my goal.
I survey the supply, demand, and market for health care, and health insurance, to think about how those markets should work to provide quality care, low cost, and technical innovation. A market-based alternative does exist, and it is realistic.
Healthy markets do not emerge because our current web of health care laws and regulations forbid them from doing so, not because of intractable market failures. But deregulation is not easy. The impediments to well-functioning health care and insurance markets go deep in to federal, state and local law, regulation, and practice. And the pieces are linked: Greater competition, innovation and entry by suppliers, greater control by consumers, and insurance innovations that cure the current mess each need the others in order to function.
This analysis is obviously aimed at the long run. Thinking through how a freer and more competitive health care and insurance market can work, and how most of the regulatory apparatus is doomed, won’t get anyone hired as a consultant, lobbyist, or adviser, nor will it generate bundles of government or industry-provided research funding. It will not lead to immediate policy impact.
But such long-run thinking is important nonetheless. Opponents of the ACA who would see it repealed need a detailed, coherent alternative, and even if the alternative is “leave it to the market,” they need to understand and explain how that alternative can realistically address the cost, “access,” and other evident pathologies of contemporary health-care and insurance markets. The status quo was a mess, and the concerns that motivated the ACA were real. If the ACA remains, as is likely, but stumbles from one crisis to another and eventually falls apart of its own weight, it will be equally important to have that detailed coherent alternative in our back pockets.
I focus on the supply and demand for health care, which gives this essay a bit of novelty. Curiously, most of the current policy debate, and most of our regulation, focuses on health insurance, the question of who will pay the bill, as if the market for health care were functioning normally. The market for health care, which is if anything even more dysfunctional, and which underlies any health insurance scheme, is relatively neglected.
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Americans do not hear or read of what has been happening overseas as these US technologies are used in the developing nations. Widespread abuse of these procedures occur because no health regulations exist. So, from organ harvesting for profit to forcing people to donate in order to receive health care---all of these practices are documented and have been an international justice focus.
US global health corporations operating in India or China would do so without any Rule of Law and have been often under the guise of international corporate partners. Now, they want to bring this all back to the US under a deregulated and dismantled Federal oversight and under Trans Pacific Trade Pact protections of corporate profit for global corporations operating in the US. These US health systems are simply merging with health industries in developing nations getting ready to come to the US as global corporations no longer needing to abide by US Constitutional law. That is what Obama and Clinton neo-liberals have been doing for decades along with Bush neo-cons. Every time a national union or justice organization leader supports a Clinton neo-liberal----they know this is to where they are taking the US.
We already know illegal transplants are happening in the US ------deregulating and dismantling all Federal oversight and accountability will place this on steroids. Johns Hopkins has already been found guilty of this and they have the lack of morality and ethics at the executive level to allow this to expand.
Japan lacking in regulating human tissue use in transplants
July 18, 2012 THE ASAHI SHIMBUN
With advances in technology and medicine, people are becoming more valuable dead than alive, their body parts stripped to supply the active global trade in human tissue, such as skin, bones and tendons.
Collected from cadavers, these valuable body parts are used as materials in pharmaceutical products in everything from dental implants and cosmetics to sports medicine.
The increased demand for such tissue, however, has led to an increase in questionable practices for obtaining human tissue from cadavers.
The International Consortium of Investigative Journalists (ICIJ) looked into the hidden practices used and has compiled a report, which can be read at: http://www.icij.org/tissue
The Asahi Shimbun has also looked into the use of human tissue in Japan and has found there are no legal regulations.
No laws in Japan for controlling use of human tissue
Because the Ministry of Health, Labor and Welfare has made mandatory the confirmation of donors related to pharmaceutical products such as skin sheets made from human tissue, there have only been a few cases of approved use and they all have involved tissue from Japanese donors.
Moreover, the Japanese Society of Tissue Transplantation has guidelines for the use of human tissue for transplants. The guidelines are as strict as those for approved pharmaceutical products and as a result, tissue banks in Japan only handle those from Japanese donors whose identities have been confirmed.
However, in medical treatment cases outside of the national health insurance program, there are no limits on doctors importing from abroad medical materials made from human tissue for treatment of patients. There are also no laws in Japan for controlling use of human tissue, such as skin and bones.
Unlike organs, such as the heart and lungs, which are strictly regulated under the Law on Organ Transplantation, there is no ban on the buying and selling of human tissue. Under the current situation, the health ministry cannot accurately estimate the extent of, or even know, if there is the import of such tissue from abroad.
Soichiro Kitamura, a president emeritus of the National Cerebral and Cardiovascular Center who is knowledgeable about tissue transplants, said, "While there will continue to be a need for human tissue in future treatment of burn patients, for example, there will also be a need to prevent the use of human tissue from abroad for which the origins are unclear. Legal revisions should be made so regulations conform to the Law on Organ Transplantation."
Japanese doctors depend on FDA for implant materials
A dentist in the Tokai region showed an ocher-colored thin strip measuring about one centimeter by two centimeters. The material crumbled into tiny particles when touched. Although the material did not give off any strong odor, it was granular material formed from freeze-dried cadaver bone.
The material is used to form the bone anchor for dental implant operations. For some teeth, the material is considered more suitable than artificial ones.
The dentist explains what the material is made of to his patients and he uses the material made from human bone in about 10 percent of the 1,000 or so cases he handles over the course of a year.
Because similar products are not sold in Japan, all the materials have to be imported. The product the dentist showed was bought from South Korea for about 10,000 yen ($130).
The box containing the material had a certification seal from the U.S. Food and Drug Administration (FDA). There was also a certification form inside the box that contained not only the product number but also showed the source of the material had never been infected with HIV or hepatitis. The manufacturer explained that it was possible to identify the donor of the bone.
The dentist said, "There are no problems with safety because of the FDA approval and because no accidents have yet to occur."
Fumihiko Watanabe, president of the Japanese Society of Oral Implantology, said, "There is some danger of infectious disease through the use of products made from human bone. Because there is no approval from the health ministry, the only thing the society can do is ask individual doctors to acquire the consent of the patient and assume responsibility when using the product."
In some cosmetic medicine cases, doctors have used their own prerogative to import human tissue for use in treatment.
For example, human skin is among the ingredients used in collagen products that are said to be effective in smoothing out wrinkles. More recently, there has been a decline in the use of such products because of greater use of hyaluronic acid, which is considered safer and cheaper.
(This story was compiled by Nobuya Sawa, Ayako Tsukidate, Ryota Kyuki and Kosuke Tauchi)
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We have known since 2010 the goals of TPP---it is not a trade agreement---it seeks to re-write Constitutional laws and end national sovereignty by making nations tied to a global corporate tribunal and court for public policy law and law enforcement. That opens the door to global corporations coming to the US and operating as they do in their own nations.
We know that will include health care and our public health system and Affordable Care Act was this TPP installed policy to bring the US down to the level of these unregulated nations having no public interest/Constitutional rights or protections.
Trans Pacific Trade Pact is illegal and a COUP against the American people and US Constitution so can be made VOID if we elect pols that are not Clinton neo-liberals. WE CAN REVERSE THIS! We simply need to do so NOW before they dismantle all of what was the public sector providing that oversight and accountability. In Baltimore, Johns Hopkins successfully dismantled the public sector and took control just as if it were a local global tribunal----that is why Baltimore has a few decades of having these TPP policies installed. Capturing the Democratic Party in Baltimore to a very neo-conservative policy machine happened because people in Baltimore were made desperate for jobs. When the economy crashes with the coming bond market crash the unemployment will again soar as TPP allows global corporations to come to the US with their own workers----immigrants from all over the world to work as they do in their own nations-----third world status for the US.
FR: Lori Wallach and Todd Tucker, Public Citizen’s Global Trade Watch
DT: Wednesday, June 13, 2012
RE: Public Interest Analysis of Leaked Trans-Pacific Partnership (TPP) Investment Text
After more than two years of negotiations under conditions of extreme secrecy, on June 12, 2012, a
leaked copy of the investment chapter for the Trans-Pacific Partnership (TPP) trade agreement was
posted at http://tinyurl.com/tppinvestment. Public Citizen has verified that the text is authentic.
An overreaching definition of “investment” that goes far beyond “real property” as defined
under domestic law would expose wide swaths of common domestic policy to attack. The
definition of “investment” in the leaked text would allow attacks on a vast array of nondiscriminatory
domestic policies before foreign tribunals. This includes health and land use
policies, government procurement decisions, regulatory permits, intellectual property rights,
regulation of financial instruments such as derivatives, contracts to operate utilities and more
(Article 12.2). The new rights and protections would extend to investments already existing before
TPP would go into legal effect.
· Overreaching definition of “investor” and lack of robust “denial of benefits” provisions allow
firms from non-TPP countries to exploit the extraordinary privileges TPP would establish for
foreign investors and the private investor-state enforcement regime. The text also includes an
overreaching definition of “investor” as a person or legal entity that makes an investment as
defined in the pact (Article 12.2). This includes firms from non-TPP countries that have
incorporated in a TPP signatory country. Thus, for instance, one of the many Chinese state-owned
corporations in Vietnam could set up subsidiaries in the U.S. and then sue the U.S. government in a
foreign tribunal to demand compensation under this text. Additionally, the leaked text fails to
require in the definition of “investor” that a person or entity have actual business activities or make
a significant commitment of capital in the host country. This has proved to be a serious problem in
past pacts, with firms that have made no real investment in a country dragging governments
through costly foreign tribunal proceedings. With respect to the denial of benefits language, past
trade deals include terms whereby an investor that is not native to a nation in the pact can be denied
the benefits of the deal. The ostensible goal is to discourage “free riding” and “treaty shopping” by
multinational firms. The thresholds to counter abusive nationality planning are whether an investor
has “substantial business activities” in the claimed home nation, and whether it is owned or
controlled by investors outside of the trade pact signatory countries. However, such “denial of
benefits” terms are not particularly robust, since even having a staff person or two and a minor
paper trail in the claimed home country can pass the “substantial business activities” threshold.
These low thresholds are replicated in the TPP text, allowing Chinese or German investors (for
instance) to channel investments through TPP nations in order to obtain the radical TPP foreign
investor protections and access to the private enforcement regime.
This week I will talk about the Affordable Care Act and the dismantling of public health in the US. I have shouted over and again the fact ACA is the Republican policy to end Federal health programs like Medicare and Medicaid by building private state health systems that take the poor and seniors after these Federal programs are ended. I also have made clear that the deregulation and consolidation of our health care system is the mirror of the Clinton neo-liberal policies that did the same with the financial industry giving us global Wall Street. ACA has a goal of creating global health systems that will be just as predatory and profit-driven as Wall Street and we are already seeing this. Make no mistake----unless you have strong private health insurance and can afford what will be soaring health care costs----you will become the people these health institutions can exploit and profit. Johns Hopkins in Baltimore has a long history of doing just what will become the norm as Baltimore has operated completely deregulated and corporate captured for decades. No public sector in Baltimore has allowed the worst of frauds and corruption with Hopkins being front and center. Let's take another look at universities operating as corporations under a completely deregulated and profit-driven model which is what Affordable Care Act is about. Think who backed this ACA -----labor and justice organization leaders to know which organizations need to get new leadership. In Maryland, the Clinton neo-liberals and neo-cons simply create private non-profits to promote these policies pretending they are progressive and knowing it ends badly for the American people.
The conflict of interest and ethics problem below starts with Johns Hopkins being the lead in circumventing lead paint laws and creating the existence of widespread availability of lead paint housing. Remember, for decades Hopkins was the force behind moving all Federal, state, and local funding for community development and low-income housing to their own corporate East Baltimore campus and downtown to subsidize billion dollar corporate building for the worst of criminal corporations. All of those billions of dollars in funds should have been channeled into abating the lead contamination and refurbishing homes in these communities in itself creating lots of employment for local citizens. Rather, out of town workers brought to build high-rise corporate structures left unemployment high and crumbling houses full of lead paint danger. A few years ago, Baltimore pols even pushed and passed a lead paint bill that made it harder for families victim of lead paint poisoning to sue landlords at the same time allowing more and more families desperate for housing to move into contaminated structures. None of this was necessary and it shows a level of medical and health immorality that shows how far these practices will go.
The Baltimore Lead Study
May 17, 2013 Bill Moyers
In the 1990s, a prominent research facility associated with Johns Hopkins University conducted an experiment that knowingly exposed children — mostly African American, some as young as a year old — to varying levels of potentially dangerous lead, as part of a study comparing different degrees of lead paint abatement. The researchers, at Hopkins’ Kennedy Krieger Institute, recruited poor families to move into homes that had only been partially abated using three different methods of lead paint removal at three different levels of cost.
The research was “conducted in the best interest of all of the children enrolled,” Dr. Gary W. Goldstein, president and chief executive of the Kennedy Krieger Institute, said in response to a class-action lawsuit filed by the families in 2011. “Over all, the blood lead levels of most children residing in the study homes stayed constant or went down.”
But in some cases, children placed in homes that received the two cheaper forms of abatement were exposed to levels of lead known to cause permanent neurological problems.
Here, public health historians Gerald Markowitz and David Rosner tell the story. You can read about it in more detail in this chapter of their book, Lead Wars.
Watch Bill’s entire interview with Gerald Markowitz and David Rosner.
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People may think these health research cases only affect people of color and the poor but patenting research now moves this open use of the public as unknowing research guinea pig mainstream. Again, I have mentioned the exploding number of class action lawsuits against PHARMA and medical devises all put onto the market without clinical trial under ever decreasing regulation of what standards need to be met before this research product goes to market. Johns Hopkins is having open debates by students in classes over whether clinical trials are even necessary. That point is mute when we know Hopkins is pushing their patents to market with little clinical trial first by sending it overseas where such research standards do not exist and then with global market imports to the US being expanded----these products come right back to the US having circumvented our medical research standards.
When you have executives at the top of these large institutions that are now simply corporations acting as they are-----CEOs and corporate research executives-----they are the kinds of people that do not go by the Hippocratic Oath----they are not healers-----they are profiteers.
THIS IS WHAT WE HAVE IN BALTIMORE IN JOHNS HOPKINS FOR DECADES AND THIS IS THE BEHAVIOR BEING BUILT IN OUR UNIVERSITIES THROUGHOUT OBAMA'S TERMS IN OFFICE AS CORPORATE RESEARCH IN OUR UNIVERSITIES WAS FUNDED BY HUNDREDS OF BILLIONS OF DOLLARS.
This was O'Malley's entire focus in health care during his terms----building that global corporate health structure for Johns Hopkins as with all Congressional pols in Maryland.
If you have a corporate executive leading the FDA at the same time class action lawsuits on damages from FDA approved medical PHARMA and devices soars----you know all of the Federal guidelines below are being ignored. Remember, Clinton neo-liberals and Bush neo-cons ignore all Federal laws and regulations so this is why EVERYONE is falling victim to unwittingly being a clinical trial participant. In other words----class action lawsuits now let us know when a medical device or PHARMA does not work but by then billions of dollars in profits were earned on that product. As a decades long academic with loads of time with medical research and IRBs I have watched as deregulation moved all of this protection to the sidelines to move that university's patent and profit forward.
WE HAVE TO PAY THE RESEARCH COSTS SAY CORPORATIONS! WE NEVER WORRIED ABOUT THAT WITH PUBLIC UNIVERSITY MEDICAL RESEARCH.
Clinical Trials Information Are there any gene therapy products approved by the FDA?
Currently there are no US FDA approved (i.e. FDA licensed) gene therapy products. Gene therapy products are still in the investigational stage, which means that the products are still being studied to assess their safety and efficacy. Gene therapy products must go through the same rigorous testing that all drugs go through before they are licensed by the FDA. Promising treatments that are not yet licensed are generally only available through a clinical trial.
What is a clinical trial? A clinical trial is a research study that seeks to determine if a treatment is safe and effective. Clinical trials are regulated by the federal government. Participants must be informed, both verbally and in writing, about the risks and benefits of participation in a clinical trial. The written document is called an "Informed Consent Document". Participation in clinical trials is voluntary.
What is Informed Consent? Before patients can be enrolled in clinical research, investigators are ethically and legally required to seek the patient's agreement. The process of describing the research procedures, risks, potential benefits and other relevant information to allow patients to decide whether to participate in research is called informed consent.
In general, the informed consent process involves both written and oral components, The written Informed Consent Document provides the basic details of the study-how it will be conducted, what it involves, by whom, the risks, potential benefits, alternatives to participation, right to withdraw, whether the patient will receive payment for participation and other key information. It is equally important that patients have an opportunity to meet with researchers and discuss the study in person. While the written informed consent document is an important part of the consent process, it is meant to serve as a starting point for the verbal discussion. Only after a patient has met with the researchers, had their questions answered, and decided that they would like to participate in the proposed research should they sign the Informed Consent Document. Signing the Informed Consent Document verifies that the patient's questions have been answered, that they agree to participate in the research, and their participation is voluntary. Many patients take the informed consent document home to read and share with family members before deciding to participate in clinical research. If a patient has additional questions, researchers are expected to make themselves available to discuss the concerns.
Voluntary participation is a cornerstone of ethical research. Therefore, when doctors are also researchers they should ensure that every patient is treated without prejudice whether they decide not to participate in a research study at all, or choose to withdraw from the study at a later time. This is an important point for patients to understand: signing an informed consent document does not require them to continue in the study if they change their mind. Also, if a patient decides to stop participation the researchers must ensure their medical needs are met and facilitate their further care.
The Informed Consent Document is developed by the individuals conducting the research and it must follow explicit government regulations for the protection of human subjects. In particular, the Informed Consent Document must be approved by an Institutional Review Board (IRB), a committee with the legal authority to protect the rights and welfare of research subjects. The IRB has the authority to require changes in the consent document if it believes that the information is incomplete or too complicated. After the IRB is satisfied that the Informed Consent Document is accurate, they approve the document.
Specific Issues About Consent for Gene Therapy The information provided above is a brief introduction to informed consent issues. Individual research studies involving gene therapy may raise additional questions. We encourage patients considering any clinical trial to learn more about informed consent through the following resources.
Further Reading About Informed Consent The US Department of Health and Human Services, Office of Human Research Protections has a series of Frequently Asked Questions about Informed Consent on their website. This includes questions that parents have regarding informed consent for children participating in clinical research and participation of those with diminished capacity to provide consent:
http://www.hhs.gov/ohrp/informconsfaq.html
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The urgency for the American people is the fact that Obama and Congressional neo-liberals spent these several years privatizing Federal Medicare and making block grants of Medicaid to break apart the entire Federal health structure. All of this can be reversed----those Federal structures and regulations are still there-----they are simply being torn apart just as all other Federal agencies were----from Department of Education and student loans----to Federal Housing Agency and subprime mortgage fraud----to Medicare and Medicaid and the hundreds of billions of dollars each year in fraud to these Federal programs to implode them with debt. Keep in mind Medicare is different in that WE THE PEOPLE PAY INTO THIS HEALTH ACCOUNT and we have pre-paid for all of the health care we will need----Clinton neo-liberals simply allowed these Trusts to be gutted with fraud.
What Obama and neo-liberals are creating with state health systems does not have a goal of fixing or improving health care----it has the goal of making Wall Street banks out of these health systems allowing them to act just as predatory and fraudulent as the financial industry.
We need to act on a state level to make these private health systems public with Expanded and Improved Medicare for All which will protect Federal Medicare. In states like Maryland with the most private and profit-driven health system in the nation-----
IT IS LABOR AND JUSTICE ORGANIZATION LEADERS WHO KEEP SUPPORTING THESE CLINTON NEO-LIBERALS DOING THIS TO OUR PUBLIC HEALTH. GET RID OF THESE LEADERS!
SURE WE NEED TO FIGHT TO END POLICE BRUTALITY AND FOR HIGHER WAGES BUT WHILE WE ARE BUSY WITH THIS SLOGANEERING----THEY ARE DISMANTLING OUR QUALITY OF LIFE THAT WILL END UP KILLING MILLIONS OF PEOPLE UNNECESSARILY.
The Affordable Care Act: What to Expect in 2013
Posted: 01/24/2013 3:35 pm EST Updated: 03/26/2013 5:12 am EDT The Affordable Care Act (ACA), crafted in large part by corporate stakeholders who are themselves responsible for the high costs of U.S. health care, is more secure with President Obama's win. But regrettably, the law will fail to control costs or prices, will not provide universal access to care, and at best will provide low value, high premium "insurance" that will still make essential health care unaffordable for many millions of patients and families.
The ACA's fundamental flaw is that it props up an inefficient and exploitative private health insurance industry while not recognizing that deregulated markets can't fix systemic problems of access, costs, quality, equity, accountability and sustainability.
President Obama has gained an impressive victory, and Democrats have held control of the Senate. Most importantly, corporate money, power, lies and deception on the right have not prevailed. But of course, the Republican-controlled House is likely to bring continued political gridlock. Overemphasis on austerity and deficit control threaten Medicare, Medicaid and safety net programs.
Going forward, we can expect to see wild battles across the health care landscape, including these examples:
- Continued mergers among the major players, including insurance companies, hospital systems, medical groups and others, which will end up increasing costs and prices while limiting patients' choices of physician and hospital.
- Continued lobbying by the insurance industry to mold accountable care organizations and insurance exchanges in their interests (i.e. cherry pick enrollees and pass along sicker patients to public programs).
- Further privatization and exploitation of Medicare and Medicaid.
- Efforts by insurers to limit definitions of minimal essential benefits.
- Further fragmentation and increasing bureaucracy of our market-based health care system with worse health outcomes.
Health care is just one more example of the 99/1 percent challenge facing the country. These are some of the directions that we, the citizens of this great country, can take in restoring hope that all Americans can gain their rightful access to the health care that they deserve:
- Speaking out, individually and collectively, at community, state and federal levels to expose the abuses and cruelty of what passes for health care in its under-regulated state.
- Fighting for a defined benefit program that covers all Americans in a single risk pool with full choice of physicians, other health professionals and institutions. (H.R. 676)
- Supporting efforts at the state level for single-payer financing in the event that reform may first need to be demonstrated at the state level before a national program can be passed by Congress.
- Pushing for a more responsible government oversight of health care at state and federal levels to oversee health care, including an independent, well funded national institute to deal with coverage and cost-effectiveness issues on the basis of scientific evidence, not upon which profit-based interest group can scream the loudest.
- Supporting and participating in divestiture efforts against abusive insurers and other stakeholders in the health care marketplace.
Other advanced nations around the world learned many years ago that one or another form of public financing is fundamental to a good health care system. The U.S. remains an outlier among these nations in having the most expensive system that still does not provide universal access to essential health care -- even at that we have variable quality and worse outcomes. It is long overdue to learn from the experience of other countries that have coped more successfully with the same health policy issues that we face in this country.
John Geyman, M.D. is professor emeritus of Family Medicine at the University of Washington, author of Health Care Wars: How Market Ideology and Corporate Power Are Killing Americans, past president of Physicians for a National Health Program (PNHP), and a member of the Institute of Medicine.
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This article is too long to post but I encourage people to look at what the University of Chicago---home of neo-liberal policy has written about the steps forward now that Affordable Care Act deregulates and consolidates health care and makes corporate medical research of all of our universities----now public universities as well. Hoyer, Van Hollen, Cardin, Donna Edwards, Cummings, Sarbanes, and Mikulski were all champions of Affordable Care Act as Maryland and Baltimore has practiced deregulated and dismantled public health for decades. It is why the poor in Baltimore were allowed to be used for research as they had no other access to health care with pooled money coming from Medicaid and Medicare diverted to health industry profits. As this article says ACA freed the health industry across the nation to act as Johns Hopkins has acted for decades----forget all those cumbersome regulations that protected people from harm while in the hospital or receiving surgeries or taking PHARMA----just let them be the losers in this WINNERS AND LOSERS climb to profit.
Make no mistake----your national labor and justice organization leaders knew where ACA was leading as they had workers and people of color----children all out fighting for the Affordable Care Act. Local people participating did not know because there is
NO DISCUSSION OF PUBLIC POLICY AT THE LOCAL LEVEL AND PEOPLE ARE NOT EDUCATING THEMSELVES AS TO THE HISTORY AND GOALS OF THESE POLICIES.
Remember, we all know the US had the most expensive cost in health care because of massive health industry fraud and profiteering. While for decades the American people had the best of public health and a strong public health system-----the Reagan/Clinton neo-liberals came in and dismantled Federal agencies of health and ignored Federal protections in an effort to install this Trans Pacific Trade Pact in place of our Constitutional protections giving corporations free reign to profit without limits of any civil right or public protection like our Federal health regulations and institutional protections allowing people to know what is done in a hospital or by a doctor was safe. Now, the American people are left not knowing when they enter a hospital that they will be safe as the procedures are geared towards that hospital acting in ways to maximize profit.
After the ACA: Freeing the market for health care
John H. Cochrane1
June 2014
Abstract:
I survey the supply, demand, and market for health care and health insurance. I conclude that a much less-regulated system is possible, and necessary. Cost control and technology improvement must come from disruptive competition by new suppliers, as it has in airlines, retail, internet, and other successful industries. People must direct their expenditures at the margin, and feel the benefits and costs of their decisions. Individual, portable, guaranteed renewable insurance can then emerge, addressing the pathologies of today’s insurance markets. I discuss how current law and regulations rather than fundamental market failures are the main reasons a healthy market does not emerge, and why a regulatory approach must fail. I address common objections to market-based health care and insurance.
1 University of Chicago Booth School of Business, National Bureau of Economic Research, Hoover Institution, and
Cato Institute. Address: 5807 S. Woodlawn Chicago IL 60637, john.cochrane@chicagobooth.edu, http://faculty.chicagobooth.edu/john.cochrane/.
This essay is an expanded version of remarks given at the conference, “The Future of Health Care Reform in the United States,” at the University of Chicago Law School, October 12 2012, and to be published in its conference volume. I am grateful to Anup Malani and W.E. Heasley for helpful comments.
After the ACA: Freeing the market for health care
I. Introduction
Most health-economics policy discussion takes for granted the bulk of our current legal and regulatory structure, and in particular that the government will have a heavy hand in providing, paying for, and directing the private provision of and payment for health care. Opponents of the optimistically-named Affordable Care Act delight in pointing out its unintended consequences, mangled incentives, and exploding budgets. Fans work to patch it up with new layers of regulation or “reforms.” Neither takes a ground-up, first-principles approach to understand why our current system is such a mess and how a better system might emerge. That is my goal.
I survey the supply, demand, and market for health care, and health insurance, to think about how those markets should work to provide quality care, low cost, and technical innovation. A market-based alternative does exist, and it is realistic.
Healthy markets do not emerge because our current web of health care laws and regulations forbid them from doing so, not because of intractable market failures. But deregulation is not easy. The impediments to well-functioning health care and insurance markets go deep in to federal, state and local law, regulation, and practice. And the pieces are linked: Greater competition, innovation and entry by suppliers, greater control by consumers, and insurance innovations that cure the current mess each need the others in order to function.
This analysis is obviously aimed at the long run. Thinking through how a freer and more competitive health care and insurance market can work, and how most of the regulatory apparatus is doomed, won’t get anyone hired as a consultant, lobbyist, or adviser, nor will it generate bundles of government or industry-provided research funding. It will not lead to immediate policy impact.
But such long-run thinking is important nonetheless. Opponents of the ACA who would see it repealed need a detailed, coherent alternative, and even if the alternative is “leave it to the market,” they need to understand and explain how that alternative can realistically address the cost, “access,” and other evident pathologies of contemporary health-care and insurance markets. The status quo was a mess, and the concerns that motivated the ACA were real. If the ACA remains, as is likely, but stumbles from one crisis to another and eventually falls apart of its own weight, it will be equally important to have that detailed coherent alternative in our back pockets.
I focus on the supply and demand for health care, which gives this essay a bit of novelty. Curiously, most of the current policy debate, and most of our regulation, focuses on health insurance, the question of who will pay the bill, as if the market for health care were functioning normally. The market for health care, which is if anything even more dysfunctional, and which underlies any health insurance scheme, is relatively neglected.
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Americans do not hear or read of what has been happening overseas as these US technologies are used in the developing nations. Widespread abuse of these procedures occur because no health regulations exist. So, from organ harvesting for profit to forcing people to donate in order to receive health care---all of these practices are documented and have been an international justice focus.
US global health corporations operating in India or China would do so without any Rule of Law and have been often under the guise of international corporate partners. Now, they want to bring this all back to the US under a deregulated and dismantled Federal oversight and under Trans Pacific Trade Pact protections of corporate profit for global corporations operating in the US. These US health systems are simply merging with health industries in developing nations getting ready to come to the US as global corporations no longer needing to abide by US Constitutional law. That is what Obama and Clinton neo-liberals have been doing for decades along with Bush neo-cons. Every time a national union or justice organization leader supports a Clinton neo-liberal----they know this is to where they are taking the US.
We already know illegal transplants are happening in the US ------deregulating and dismantling all Federal oversight and accountability will place this on steroids. Johns Hopkins has already been found guilty of this and they have the lack of morality and ethics at the executive level to allow this to expand.
Japan lacking in regulating human tissue use in transplants
July 18, 2012 THE ASAHI SHIMBUN
With advances in technology and medicine, people are becoming more valuable dead than alive, their body parts stripped to supply the active global trade in human tissue, such as skin, bones and tendons.
Collected from cadavers, these valuable body parts are used as materials in pharmaceutical products in everything from dental implants and cosmetics to sports medicine.
The increased demand for such tissue, however, has led to an increase in questionable practices for obtaining human tissue from cadavers.
The International Consortium of Investigative Journalists (ICIJ) looked into the hidden practices used and has compiled a report, which can be read at: http://www.icij.org/tissue
The Asahi Shimbun has also looked into the use of human tissue in Japan and has found there are no legal regulations.
No laws in Japan for controlling use of human tissue
Because the Ministry of Health, Labor and Welfare has made mandatory the confirmation of donors related to pharmaceutical products such as skin sheets made from human tissue, there have only been a few cases of approved use and they all have involved tissue from Japanese donors.
Moreover, the Japanese Society of Tissue Transplantation has guidelines for the use of human tissue for transplants. The guidelines are as strict as those for approved pharmaceutical products and as a result, tissue banks in Japan only handle those from Japanese donors whose identities have been confirmed.
However, in medical treatment cases outside of the national health insurance program, there are no limits on doctors importing from abroad medical materials made from human tissue for treatment of patients. There are also no laws in Japan for controlling use of human tissue, such as skin and bones.
Unlike organs, such as the heart and lungs, which are strictly regulated under the Law on Organ Transplantation, there is no ban on the buying and selling of human tissue. Under the current situation, the health ministry cannot accurately estimate the extent of, or even know, if there is the import of such tissue from abroad.
Soichiro Kitamura, a president emeritus of the National Cerebral and Cardiovascular Center who is knowledgeable about tissue transplants, said, "While there will continue to be a need for human tissue in future treatment of burn patients, for example, there will also be a need to prevent the use of human tissue from abroad for which the origins are unclear. Legal revisions should be made so regulations conform to the Law on Organ Transplantation."
Japanese doctors depend on FDA for implant materials
A dentist in the Tokai region showed an ocher-colored thin strip measuring about one centimeter by two centimeters. The material crumbled into tiny particles when touched. Although the material did not give off any strong odor, it was granular material formed from freeze-dried cadaver bone.
The material is used to form the bone anchor for dental implant operations. For some teeth, the material is considered more suitable than artificial ones.
The dentist explains what the material is made of to his patients and he uses the material made from human bone in about 10 percent of the 1,000 or so cases he handles over the course of a year.
Because similar products are not sold in Japan, all the materials have to be imported. The product the dentist showed was bought from South Korea for about 10,000 yen ($130).
The box containing the material had a certification seal from the U.S. Food and Drug Administration (FDA). There was also a certification form inside the box that contained not only the product number but also showed the source of the material had never been infected with HIV or hepatitis. The manufacturer explained that it was possible to identify the donor of the bone.
The dentist said, "There are no problems with safety because of the FDA approval and because no accidents have yet to occur."
Fumihiko Watanabe, president of the Japanese Society of Oral Implantology, said, "There is some danger of infectious disease through the use of products made from human bone. Because there is no approval from the health ministry, the only thing the society can do is ask individual doctors to acquire the consent of the patient and assume responsibility when using the product."
In some cosmetic medicine cases, doctors have used their own prerogative to import human tissue for use in treatment.
For example, human skin is among the ingredients used in collagen products that are said to be effective in smoothing out wrinkles. More recently, there has been a decline in the use of such products because of greater use of hyaluronic acid, which is considered safer and cheaper.
(This story was compiled by Nobuya Sawa, Ayako Tsukidate, Ryota Kyuki and Kosuke Tauchi)
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We have known since 2010 the goals of TPP---it is not a trade agreement---it seeks to re-write Constitutional laws and end national sovereignty by making nations tied to a global corporate tribunal and court for public policy law and law enforcement. That opens the door to global corporations coming to the US and operating as they do in their own nations.
We know that will include health care and our public health system and Affordable Care Act was this TPP installed policy to bring the US down to the level of these unregulated nations having no public interest/Constitutional rights or protections.
Trans Pacific Trade Pact is illegal and a COUP against the American people and US Constitution so can be made VOID if we elect pols that are not Clinton neo-liberals. WE CAN REVERSE THIS! We simply need to do so NOW before they dismantle all of what was the public sector providing that oversight and accountability. In Baltimore, Johns Hopkins successfully dismantled the public sector and took control just as if it were a local global tribunal----that is why Baltimore has a few decades of having these TPP policies installed. Capturing the Democratic Party in Baltimore to a very neo-conservative policy machine happened because people in Baltimore were made desperate for jobs. When the economy crashes with the coming bond market crash the unemployment will again soar as TPP allows global corporations to come to the US with their own workers----immigrants from all over the world to work as they do in their own nations-----third world status for the US.
FR: Lori Wallach and Todd Tucker, Public Citizen’s Global Trade Watch
DT: Wednesday, June 13, 2012
RE: Public Interest Analysis of Leaked Trans-Pacific Partnership (TPP) Investment Text
After more than two years of negotiations under conditions of extreme secrecy, on June 12, 2012, a
leaked copy of the investment chapter for the Trans-Pacific Partnership (TPP) trade agreement was
posted at http://tinyurl.com/tppinvestment. Public Citizen has verified that the text is authentic.
An overreaching definition of “investment” that goes far beyond “real property” as defined
under domestic law would expose wide swaths of common domestic policy to attack. The
definition of “investment” in the leaked text would allow attacks on a vast array of nondiscriminatory
domestic policies before foreign tribunals. This includes health and land use
policies, government procurement decisions, regulatory permits, intellectual property rights,
regulation of financial instruments such as derivatives, contracts to operate utilities and more
(Article 12.2). The new rights and protections would extend to investments already existing before
TPP would go into legal effect.
· Overreaching definition of “investor” and lack of robust “denial of benefits” provisions allow
firms from non-TPP countries to exploit the extraordinary privileges TPP would establish for
foreign investors and the private investor-state enforcement regime. The text also includes an
overreaching definition of “investor” as a person or legal entity that makes an investment as
defined in the pact (Article 12.2). This includes firms from non-TPP countries that have
incorporated in a TPP signatory country. Thus, for instance, one of the many Chinese state-owned
corporations in Vietnam could set up subsidiaries in the U.S. and then sue the U.S. government in a
foreign tribunal to demand compensation under this text. Additionally, the leaked text fails to
require in the definition of “investor” that a person or entity have actual business activities or make
a significant commitment of capital in the host country. This has proved to be a serious problem in
past pacts, with firms that have made no real investment in a country dragging governments
through costly foreign tribunal proceedings. With respect to the denial of benefits language, past
trade deals include terms whereby an investor that is not native to a nation in the pact can be denied
the benefits of the deal. The ostensible goal is to discourage “free riding” and “treaty shopping” by
multinational firms. The thresholds to counter abusive nationality planning are whether an investor
has “substantial business activities” in the claimed home nation, and whether it is owned or
controlled by investors outside of the trade pact signatory countries. However, such “denial of
benefits” terms are not particularly robust, since even having a staff person or two and a minor
paper trail in the claimed home country can pass the “substantial business activities” threshold.
These low thresholds are replicated in the TPP text, allowing Chinese or German investors (for
instance) to channel investments through TPP nations in order to obtain the radical TPP foreign
investor protections and access to the private enforcement regime.
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