As you saw from this article below it was 2009 that expansion of our public health and education exploded overseas. That is neo-liberalism for you and it sets the stage for Trans Pacific Trade Pact. The goal is merger and acquisition between US health corporations and research institutions with those in developing nations to create the kinds of global corporations that will come back to the US under Trans Pacific Trade Pact allowed to operate ignoring US Constitutional laws. It is a long-term goal of Clinton neo-liberals and Bush neo-cons seeking to end the few public sectors left in the US----along with our academic universities. Remember, this is when 'Democrats' had the super-majority and could have strengthened public health and Medicare and Medicaid but they did the opposite---they privatized and made global health systems. They did that because they are not Democrats----they are Clinton Wall Street global corporate neo-liberals. Moving these large US health institutions and universities overseas to avoid US laws and regulations protecting people's health mirrors the movement overseas to avoid labor laws and operate Asian sweat shops.....another Clinton policy.
Many Clinical Trials Moving Overseas Study says trend raises ethical, medical issues
HealthDay Feb. 18, 2009 | 5:00 p.m. EST + More
'Dr. Robert M. Califf, a Duke University medical professor who is rumored to be one of President Barack Obama's candidates to head the U.S. Food and Drug Administration, which oversees clinical trials in the United States, was a co-author of the research. Their report appears in the Feb. 19 issue of the New England Journal of Medicine'.
All we need are progressive liberals who install regulations and protect Constitutional rights of citizens to reverse this easy peasy. Federal laws do not allow these US health institutions that have received Federal funding from NIH and NCI for decades to suddenly take off to avoid US regulations and operate in ways that harm people....neo-liberals do that. If we look at the history of NIH funding you will see it is tied heavily to IRB and highly regulated ethics with requirements of paperwork with stringent oversight and accountability that all of these public protections are followed when any Federal grant is given. You will see over time where Federal taxpayer money was originally sent to public universities for public research and definitely was restricted to American research projects. Below you see how neo-liberal higher education reforms making universities corporations and markets global moved these NIH requirements with them-----taxpayers now fund private research sometimes by foreign US affiliates all while Americans are being told they can no longer access ordinary health care. The NIH has basically been made an import-export bank subsidizing medical products and patents as cheaply as possible regardless the efficacy or harmfulness to people.
'Eligibility Requirements In general, any organization is eligible to apply for regular NIH research grants, and unsolicited applications are welcome. The applicant is the research organization, although a principal investigator (PI) writes the research proposal; and if a grant is awarded, the grantee is the applicant organization. Applications may be submitted by domestic or foreign for-profit and non-profit organizations, public and private, such as universities, colleges, hospitals, laboratories, units of State and local governments, and eligible agencies of the Federal government. Racial/ethnic minority individuals, women, and persons with disabilities are encouraged to apply as principal investigators. The NINDS encourages applications from new investigators'.
NIH Requirements for Instruction in the Responsible Conduct of Research
Click for full NIH description of requirements for RCR .
MED 255 is a necessary, but not always sufficient, component of training in responsible conduct of research. Please be sure to contact your funder to inquire about additional requirements beyond MED 255.
In general, however, the NIH requires several components of training in the Responsible Conduct of Research (RCR) including:
- the required MED 255 or 255 C course;
- refresher RCR instruction at each stage of training (e.g., graduate, postdoc, etc);
- continuing informal or formal training in research ethics throughout the year; and
- the involvement of your departmental research faculty in supplemental and continuing instruction in research ethics.
1) Instruction Format
The NIH requirements highly encourage multiple forms of RCR training, including formal courses (such as MED 255 or Med 255C), small-group discussions, and instruction by research training faculty members.
NIH applicants will need to describe the format for Med 255, which is described in the template PDF below.
Applicants will also need to describe the format they will use to provide continuing and ongoing training and instruction in research ethics/RCR (using their own faculty) throughout the year for each year of the trainees’ fellowship. These may be lectures, panel discussions, colloquia providing refreshers on topics covered in Med 255 (see Subject Matter), but they may also cover topics of specific ethical concern in the trainees’ field not covered by Med 255.
2) Subject Matter
The NIH lists several topics they strongly suggest RCR programs to cover, all of which are covered in MED 255 (link):
- Conflict of interest
- Policies regarding human subjects
- Mentor/mentee responsibilities
- Collaborative research
- Peer review
- Data acquisition
- Research misconduct
- Contemporary ethical issues
In addition to the MED 255/Med 255C faculty, some training programs require that the department’s own faculty be involved in further RCR instruction. The NIH states:
“Training faculty and sponsors/mentors are highly encouraged to contribute both to formal and informal instruction in responsible conduct of research. Informal instruction occurs in the course of laboratory interactions and in other informal situations throughout the year. Training faculty may contribute to formal instruction in responsible conduct of research as discussion leaders, speakers, lecturers, and/or course directors. Rotation of training faculty as course directors, instructors, and/or discussion leaders may be a useful way to achieve the ideal of full faculty participation in formal responsible conduct of research courses over a period of time.” (see “Guidelines: Faculty Representation”)
Some institutes only require informal training by a faculty mentor, while others require actual formal instructor, preferably by faculty in training. If you participate in formal training, please include the names of the participating faculty members in your grant. Faculty and staff at the Stanford Center for Biomedical Ethics may also be available to assist by serving as additional panelists.
4) Duration of Instruction
The NIH suggests training in RCR that spans across a longer interval of time in order to allow sufficient exploration and consolidation of the material. Instruction should also involve at least 8 contact hours between you and the participating faculty. The duration of instruction for Med 255 and Med 255C is covered in the PDF template below. Applicants will also need to describe the duration of instruction beyond Med 255 or Med 255C.
5) Frequency of Instruction
Some institutes require ongoing instruction throughout the year for each year of fellowship in addition to MED 255 or Med 255C, or may require retaking MED 225 or Med 255C at each stage of training.
We have created a Template that you may use as the basis of your grant. Please be sure to supplement the template with funder-specific requirements, and address all structural components mentioned above.
Obama came into office and immediately started to create the next artificially created economic bubbles----with the help of that super-majority of Clinton neo-liberals in Congress. Wall Street wanted to implode governments to privatize all that is public so the legislation allowing the bond market crash were installed---and it wanted to expand US health institutions globally so all 'Federal stimulus' went to building overseas health system structures.....the jobs created overseas----they said job creations, they didn't say where.
Policy like Maryland's ENNOVATION placed Maryland university as corporation on steroids and all that deregulation and global market policy came from Baltimore's pols working for Johns Hopkins. McFadden even entered a bill that would have allowed Hopkins to receive private donations tax-free---feeding that university as corporation profiteering. All the while all of the funding that went into public health----student scholarships and financial aid to 4 year colleges disappeared and public schools in Baltimore were defunded to nothing because no corporate tax was paid and all city revenue went into this Hopkins and University of Maryland Medical System as patenting policy.
THIS IS WHY THE ENTIRE CITY OF BALTIMORE CRUMBLED AS HOPKINS EXPANDED ITSELF TO A GLOBAL CORPORATION BRINGING NO VALUE TO BALTIMORE'S ECONOMY.
Hopkins was in the expanding overseas business a few decades ago while building its health tourism and educating developing nation citizens to be health care migrant workers with funding brought by Ben Cardin and Barbara Mikulski who work for this very neo-conservative Hopkins while pretending to be progressive Democrats. Look where pols home districts are and the quality of life to see who is really a Democrat and who is a poser.
Below you see what is the movement of university researcher to corporate CEO as the only way to sustain this flood of reseaarch staffing is to bring public private partnerships----ergo----we have to partner with corporations to keep these jobs. As the article states----NIH was never about funding staff----it was to support the science. This entire process is only about building a structure in universities that will become completely corporate.
SEE WHY STUDENT TUITION HAS TRIPLED AS THIS STARTED DURING THE CLINTON ADMINISTRATION AND IS SOARING UNDER OBAMA. ALL HEALTH RESEARCH MONEY SIMPLY SPENT ON STRUCTURES TO PRODUCE PRODUCTS.
October 17, 2010
Will the Biomedical-Research Bubble Burst?
By Lior Shamir
The United States still reels from the aftermath of the financial crisis. Many of us in the biomedical-research community, meanwhile, fear that our field may face a recession of its own in the not-too-distant future.
Reminiscent of the dot-com crash of the previous decade—and, indeed, of today's financial crisis, mainly precipitated by the implosion of the subprime-loan market--biomedical research is endangered by its precarious position atop a bubble of unsustainable financial practices. The unrestricted grant-making policies of the National Institutes of Health inflate the number of biomedical researchers in a fashion that cannot be matched by the availability of research funds and might eventually lead to a shortage of financial support for biomedical research.
The trouble begins with how lead scientists must often scrounge for money to keep their research programs alive. Grantees' home institutions—that is, universities and research institutes—typically pay principal investigators' salaries and start-up costs for a limited period of time, after which the lead scientists are expected to attract external backing that will cover their programs, including their salaries. Such a system allows universities and research institutions to hire more scientists and expand their research at little cost to the institutions themselves, while enhancing their own reputations and academic prestige. The system also provides universities and research institutions with a financial benefit: Overhead charges are deducted from grants raised by principal investigators. Thus, universities and research institutions have strong incentives to open ever-increasing numbers of such tenuous, grant-dependent, "soft money" tenure-track lines.
Enter the NIH—the primary agency that supports fundamental biomedical research in the United States—and other organizations, which provide money not only for materials, equipment, and stipends for research assistants, but also for the salaries of principal investigators once their start-up money has run out.
While the NIH Data Book does not provide detailed information about the increase in principal-investigator positions supported by NIH awards, the trend is nonetheless evident by the applications for career-development grants, which provide salaries for young investigators. The number of applications for these awards increased from 1,029 in 1997 to 3,340 in 2007. The success rate was consequently reduced from 51 percent to 31 percent.
Such an unbalanced incentive for universities and research institutes to continually bring new researchers onboard depends on the assumption that new money will keep getting into the system and that the flow of new money will satisfy ever-increasing growth. That, however, is rarely the case, whether one is dealing with start-up Internet companies, the subprime-loan market—or scientific research. In fact, the flexibility of the NIH budget and its potential growth are highly limited, as the NIH budget has been flat since 2003.
Because of the relatively low costs involved in opening "soft money" faculty positions, as well as institutional lust for expanding research and getting a larger piece of the NIH budget, it is expected that an increasing number of new, externally paid faculty positions will open and put increasing pressure on the NIH's extramural funding. This is the money that the NIH gives to research institutions and universities to support studies conducted outside of the institute.
Obviously, any future increase in available NIH funds is limited, so the inevitable result of this unbalanced growth is that, in the long term, the NIH will no longer be able to keep up with the demand for soft-money principal-investigator positions. Studies will run short on funding, research centers and laboratories will close, and scientists, research assistants, and support-staff members will lose their livelihoods.
To avoid such a recession in biomedical research, universities, research institutions, and the NIH must work together to ensure that any growth in the number of principal-investigator positions reflects the predicted growth in available financial resources.
One solution is to change the NIH's grant-making policy to require that a principal investigator's salary—or at least a substantial part of it—be paid for by the investigator's home institution. The National Science Foundation has already adopted such a policy, providing no more than two months' salary for a P.I. per year.
Clearly, if adopted by the NIH, such a policy would reduce the number of positions offered by universities and research institutions, slow down the growth in the number of available P.I. positions, and further increase the pressure on the academic job market.
But the upside is that universities and research institutions, if forced to bear the financial burden of hiring and paying investigators themselves, would plan their hiring strategies far more carefully. Because an investigator without funds for materials and research assistants is of little use, home institutions would also be forced to consider the present and future availability of research grants. That extra consideration, in turn, would ensure a better balance between the aspirations of universities and research institutions, and the ability of the NIH to subsidize those ambitions.
Lior Shamir is an assistant professor of computer science at Lawrence Technological University.
As a person with decades working in medical research university projects I saw this transition first hand. You are now sent packing if you cannot bring in grant money ---moving away from academics and towards naked capitalism. I knew decades ago that Hopkins had a reputation nationally for bad research practices from juking stats to abuse of participants. The ethics was never there. Look below to see Johns Hopkins as one of the largest NIH grant universities and know as well much of Hopkins research is done overseas. It was recently that the BioTech facility was built in East Baltimore so Hopkins could come to Baltimore and operate as it did overseas under Trans Pacific Trade Pact and that does not bode well for the citizens of Baltimore. Since we have absolutely no public sector----no oversight and accountability especially with health care----citizens of Baltimore are not receiving a boon----and much of the jobs created are simply people being moved from overseas to Baltimore.
This comment from a friend tells of the bad employment conditions under this kind of NIH financing and it is simply a mirror of Wall Street corporate ethos!
'See, during the time of the doubling of the NIH budget, greedy universities built new buildings and had wet dreams of hiring a gazillion soft-money scientists to fill them, and bring in indirect costs. So now ther eis the mad scramble to fill those buildings, and it just so happens that, thanks to the same kind of "must grow bigger" mentality, the makret is flooded with biomedical science PhD, many of whom are willing to take any crappy position they can get. So, they get hired, maybe get a grant to cover their salary, then they loose their grant, not necessarily because they are no good, but because everyone is chasing the same nickle. So then, the administration has to heat and cool and light and secure these empty buildings, maybe provide bridge funding or temporary salary support before finally booting out the unfunded investigator, and then shelling out money for a new search.
And before you know it, federal dollars are actually _costing_ universities more than they provide, but the universities have infrastructure and budget projections in place that would make it impossible to wean themselves off of it.
But, rest assured, this problem will be "solved" once everything collapses'.
UCSF Tops Public Institutions in NIH Biomedical Research Funds
By Kristen Bole on January 18, 2012 | Email | Print The University of California, San Francisco (UCSF) received more research funds from the National Institutes of Health (NIH) than any other public institution in 2011 and ranked second among all institutions nationwide, according to new figures released by the NIH.
The funding helps UCSF continue to perform world-renowned health sciences research amid state budget cutbacks.
UCSF received 1,056 grants last year, totaling $532.8 million for research and training, fellowships and other awards. In 2010, UCSF also was the largest public recipient, with $475.4 million in funding.
The federal funding plays a key role in supporting UCSF’s graduate-level biomedical enterprise, including research into the genetic, molecular and cellular basis of diseases, epidemiological and clinical-research studies, and efforts to develop innovative treatments and cures. That research has led to four UCSF faculty members receiving the Nobel Prize in Physiology or Medicine, and has fueled significant advances in biomedical sciences.
“These grants are absolutely essential in supporting the work of our scientists as they tackle the most pressing questions in the health sciences,” said UCSF Chancellor Susan Desmond-Hellmann, MD, MPH. “This broad-based support of UCSF research, in the context of increasingly competitive funds, is testament to the caliber of scientific discovery in each of our schools and the graduate division.”
UCSF has ranked among the nation’s top institutions in NIH funding for more than two decades, as have each of its schools. In 2011, the UCSF School of Pharmacy received $29.1 million in NIH funding, the most of any pharmacy school for the 32nd consecutive year. The School of Medicine received $420.2 million,* while the UCSF schools of Dentistry and Nursing received $19 million and $8.3 million, respectively.
Federal funding also buoys the local and regional economy, Desmond-Hellmann said, as the scientists purchase materials and instruments and employ laboratory staff. Other economic engines include patents and scientific advances generated by NIH-funded research and related industries, such as biotechnology.
Current NIH data list the top five recipients of FY 2011 research funding as follows (not including research contracts or ARRA grants):
- UCSF ($532.8 million)
- University of Michigan at Ann Arbor ($467.4 million)
- University of Washington ($455.8 million)
- University of Pittsburgh at Pittsburgh ($428.2 million)
- UC San Diego ($398.0 million)
- Johns Hopkins University ($645.3 million)
- UCSF ($532.8 million)
- University of Pennsylvania ($471.5 million)
- University of Michigan at Ann Arbor ($467.4 million)
- University of Washington ($455.8 million)
* Excludes $54.4 million in additional NIH support for multiple research programs.
You can see that the policies of sending all of this Federal, state, and local money to build these global health systems will not end well for American citizens or anyone in the world. When you cannot trust the quality of the medicine you are taking or the medical procedures being handed you at a hospital----you do not have health care. The creation of tiered access to health care which is what the Affordable Care Act was about makes health care for 10% of the world's citizens the same kind of care all citizens of America received for decades under progressive liberal policies of regulation, oversight and the patient's Bill of Rights.
Medical patents have been the focus in Baltimore for a few decades along with the policies that make research cheap and easy. TPP seeks to create this environment across the nation and it will get worse as third world values come with global corporations used to operating under no Rule of Law and regulation come to the US.
Medical research funded by Federal taxpayer money from the NIH and NCI was never patented----it was public and the procedures developed were for all citizens because THEY PAID THE TAXES FUNDING THIS RESEARCH. Now, under Clinton neo-liberalism we pay the taxes and they subsidize their corporate profits with it while allowing only a small percentage of people access the care. The US is almost the only one patenting and using TPP to make other nations move to patenting.
THIS IS THE DIFFERENCE BETWEEN PROGRESSIVE LIBERALISM WORKING FOR LABOR AND JUSTICE AND CLINTON NEO-LIBERALISM WORKING FOR WEALTH AND PROFIT.
NOVEMBER 13, 2013 Public Citizen
MEDICAL PROCEDURE PATENTS IN THE TPP:
A COMPARATIVE PERSPECTIVE ON THE HIGHLY UNPOPULAR U.S. PROPOSAL
The Trans-Pacific Partnership (TPP) Intellectual Property Chapter published by WikiLeaks reveals that after years of negotiations, the United States still seeks to impose medical procedure patents on Asian and Latin American countries. All eleven other negotiating countries oppose the proposal. Medical procedure patents raise healthcare costs. Health providers, including surgeons, could be liable for the methods they use to treat patients. Essentially, except for when a surgeon uses her bare hands, surgical methods would be patent eligible subject matter under the U.S. proposal. While U.S. law immunizes certain care providers from infringement liability, the U.S. TPP proposal fails to include these safeguards, risking yet more serious consequences for TPP negotiating countries.
Only Two Countries Recognize Medical Procedure Patents
Article 27.3 of the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) preserves member nations’ rights to determine whether to include diagnostic, therapeutic, and surgical methods – otherwise known as “medical procedure patents” – for treating humans and animals as patentable subject matter. Article 27.2 of TRIPS expressly grants members the right to choose not to recognize patents on inventions that have the potential
to intervene with the state’s efforts to protect public order, morality, and human, animal, and
Numerous free trade agreement (FTA) provisions, including NAFTA Article 1709(3)(a), reinforce TRIPS Articles 27.2 and 27.3, which expressly permits members to exclude from patentability “diagnostic, therapeutic and surgical methods for the treatment of humans or animals.” Other US FTAs that include provisions similar to TRIPS Articles 27.2 and 27.3 are the US-Australia FTA, the US-Bahrain FTA, the US-Colombia TPA, the US-Jordan FTA,9 the Korea-US FTA, the US-Oman FTA, the US-Panama FTA, the US-Peru TPA and the US-Singapore FTA.
The only TPP countries - and the only countries in the world - to recognize medical method patents are the United States and Australia. Unsurprisingly, in 2009, more than 80 countries had banned medical procedure patents. For example, the European Patent Office (EPO) does not permit the patenting of surgical, treatment, or diagnostic methods, pursuant to Article 53(c) of the European Patent Convention (EPC), which states that patents shall not be granted on “methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body...” The EPC prohibition against surgical, diagnostic, and treatment method patents is strictly enforced: the presence of just a single surgical step in a multi-step method would exclude the method from patentability.
Similarly, while the Japan Patent Office (JPO) will allow some medical procedures to be patented, it strictly enforces restrictions against the patenting of surgical, treatment, or diagnostic
In all of this privatization of public health comes the same for-profit health education full of fraud and poor quality health training. Baltimore and Maryland is full of these for-profit health businesses and much of the higher education tuition for citizens goes down the drain in all this fraud. Many of these for-profit job training corporations are tying themselves to these corporate university structures that make students from career college to 4 year university simply free labor apprenticeships to these corporate research universities. AND ALL OF THIS HAS NOTHING TO DO WITH MAKING THINGS BETTER---IT IS ONLY TIED TO MAXIMIZING PROFIT!
For-profit college settles class-action lawsuit
Mary Beth Marklein, USA TODAY 7:06 p.m. EDT July 26, 2013Former students say school offered a sham education(Photo: AP)
- For-profit college agrees to pay $5 million
- 4,000 students could be eligible for award
The agreement, approved late Thursday in the U.S. District Court for the Eastern District of Virginia, settles claims that Chester Career College, formerly known as Richmond School of Health and Technology, targeted minorities for enrollment and did not provide them an adequate education. The complaint, filed in 2011, also estimated that the college has received approximately $5 million a year in federal student loan programs.
"In other words, the federal government funded (the school's) scheme," says John Relman, of Relman, Dane & Colfax, a Washington, DC, law firm that represented the plaintiffs. Relman says more than 4,000 former students may be eligible to receive funds from the settlement.
In resolving the lawsuit, the School did not admit any wrongdoing.
A statement put out by the plaintiff's attorneys says that "in addition to $5 million in monetary relief, the settlement provides for continued reporting by the School regarding its students' success and career placement. These measures will improve and strengthen the School as it continues its mission of educating, graduating and assisting in the employment of hundreds of students in various medical fields in and around Richmond."
A website for the college provides program information for several health-related fields, including nursing, radiology and medical billing. Officials at the Richmond school's headquarters did not return calls Friday. When the lawsuit was filed, the owner, Margaret Knight, told a local NBC affiliate that the allegations are "unfounded" and "offensive."
The complaint described a pattern of behavior in which the college advertised on the BET (Black Entertainment Television) channel and other programming that reaches predominantly African-American audiences, encourages students to take out federal loans, and then fails to provide adequate training.
Sade Battle, one of the eight lead plaintiffs, said she was talked into joining a program for community home health care workers, but was never taught basic skills such as how to change catheters and make beds. She eventually withdrew from the program and says she later defaulted on her loans. The court awarded her $10,000 plus reimbursement of more than $16,000 to cover loans and other expenses.
"It's kind of like a relief that everything is over with," says Battle, who now runs a residential and commercial cleaning business.
In court records, former employees said the school engaged in "dishonest" and "fraudulent" practices. One instructor described practices such as "falsifying loan applications and changing grades to keep failing students in school."
A 2012 Senate investigation raised Committee found similar practices across the for-profit education industry, costing taxpayers more than $30 billion. For-profit colleges educate about 10% of college students and account for nearly half of student-loan defaults, that investigation found.
Relman said he hopes the case inspires more dissatisfied students to speak up.
"People are getting ripped off by proprietary schools, he said. "What this could mean is a lot of people are going to sit up and take notice and say, people are starting to hold these schools accountable."